Harry's Story Is One of Very Many Children and Young People Who Were Not Born Autistic but Became So, Most Probably As a Result of Multiple Vaccines

Harry’s Story

A Brilliant Boy’s Short Life

‘Harry’s Story’

INDEX

Introduction 2 Harry’s Story by JHR including- 6 -Litigation including submission to ECtHR 16 KR’s witness statement. 28 Carol and Martin Bailey’s witness statement. 53 Dr A Wakefield- report on HHR’s biopsy. 55 JHR’s Digest of Claimants’ Experts’ Reports in UK MMR/Autism litigation. 58 Dr. P Fletcher’s observations. 73 Dan Olmsted-The Amish Community. 87 David Thrower Briefing on Autism. 92 JABS Briefing with:- 112 -Manufacturers’ Product Sheet-warning/disclaimer. 114 -Report on US situation. 116 -Report on MMR in Japan. 116 Evidence of Harm-David Kirby. 136 Harry’s work including: 137 Moselle Series 1995-2000 Oak Lodge Series 2000-2005 The Bridge Series 2005-2008 Hoffmann Series 2008-2009 Daylight 2008-2009 The Way Forward.-after leaving school 206 Postscript 209 Appendices: 1.Schedule of ‘MMR 10’ Claimants 210 2.Hannah Poling legal judgment 211 3.Bailey Banks legal judgment. 254 4.Big Pharma Profits 312 E-Books references:- 314 -In Harm’s Way -Access to Justice

1 Introduction Harry was a gifted artist, model-maker, film-maker and musician. He developed skills throughout his childhood in North London, attending St Michael's School N6, Moselle N17, Oak Lodge N2 and finally The Bridge School in Islington.

He was a handsome and healthy boy and developed a Herculean build as he grew up. Harry was also autistic. He developed autism late having received the MMR jab aged one, to which he had a very bad reaction. From being a healthy baby boy ahead on all his milestones before he was one he had to adapt to a difficult life as an a autistic person as he grew up.

He lived with his parents Keith and Jennie and his sister Francesca in Islington, London. Life became difficult for them too, coping with a greatly loved and talented but autistic Harry.

The Tavistock Centre confirmed that Harry was highly intelligent and it was clear to all who knew him as he matured that he had a brilliant mind behind his autism.

Harry died tragically aged 20 as a result of medical error by his doctors. There is currently a Police Inquiry in progress to be followed by an Inquest.

Harry's story is one of very many children and young people who were not born autistic but became so, most probably as a result of multiple vaccines. There are many millions of such ASD people worldwide; an estimated 1 million in the USA alone. We tell the story of our most beloved Harry, hoping that it will not only commemorate his life but also will bring attention to the plight of so many others , the forgotten children of the 20th century and 21st century whose condition, created by big Pharma, is ignored by government.

It is we believe with good reason the greatest scandal in medical history of all time.

2 This book draws attention to the fact that among the US Amish and Chicago Homestead communities for example, communities which do not vaccinate, autism is unknown.

The worldwide epidemic of autism now raging is ignored by governments. Some estimates put the number of casualties of vaccine caused autism as high as one in 100 children or even more.

So research is urgently needed into causes and cures, but is not being done adequately in any nation in the world.

Maybe tests before vaccination could help children to avoid the life sentence that mostly comes with autism. The US Hannah Poling case for instance, where Hannah was found to have mitochondrial disorder; and whose autism was, it was conceded by the US Government, triggered by multi vaccines.

This story, Harry's story, carries a message for all the world's children because every child who receives multiple vaccines is at risk like Harry and Hannah of developing autism.

This book also tells the story of the long fight for legal justice for these children in the UK, where the trial of a 1000 Claimants including Harry and the ‗MMR 10‘ was aborted by the late removal of legal aid at the behest of the UK Government.

Though Harry and the ‗MMR 10‘ took their challenge to the withdrawal of legal aid to the High Court, Court of Appeal and the European Court of Human Rights with the professional help of Harry's parents Jennie a barrister and Keith an architect, they never received justice.

Jennifer was also involved advising 5000 US Claimants in the US Omnibus MMR autism cases in the Federal Vaccine Court, on the UK expert evidence from the aborted UK trial, 60 long technical of experts' reports which showed a strong

3 case for the UK Claimants. Some of the tests carried out in these reports were vital to US Claimants like Michelle Cedillo who with Colten Snyder and Brent Hazelhurst were lead cases in the US litigation. Those and subsequent lead cases in the US Federal Vaccine Court did not win. However Hannah Poling‘s case was conceded by the Defendant the US Government. In over 1,300 other such cases the Claimants had be given awards of compensation behind closed doors by the US Government.

In the US case of Bailey Banks Judge Abell made the finding that MMR had caused his autism.

Tests were done in the US and in Paris France on Harry's Bio samples in summer 2008 as a result of which Dr Bradstreet of Florida, an expert witness in the UK and US cases, was able to recommend treatment which helped Harry. Dr Bradstreet had helped gradually to cure Colten Snyder, one of the lead US cases. Dr Bradstreet was due to do further tests on Harry, tragically prevented by Harry's untimely death in December 2009 from the effects of a dangerous anti-psychotic drug prescribed by his psychiatrist.

Here too is a lesson for others from this book, the very many ASD victims who as they approach adulthood and become more anxious (anxiety being a major feature autism), will be vulnerable to misplaced treatment with anti-psychotic drugs. This may occur without even their parents knowing, as happened so tragically in Harry's case.

The use of dangerous drugs for these ASD victims, drugs which can kill, must be avoided and prevented. Harry's tragedy must be avoided for others. For his devastated family and his parents who write this book hope that 'Harry‘s Story' will help others to in deciding whether to vaccinate their children, and in preventing doctors abusing them with dangerous drugs if as victims they grow up with the affliction of autism.

4 We hope 'Harry‘s Story' will help others to avoid Harry's tragic fate.

We call on governments to do more research and more testing to prevent and avoid such tragedies for the future. This is the most urgent story for today's world.

5 Harry Horne-Roberts by Jennifer his mother

Harry was born in University College Hospital London on the evening of 29th June 1989 after a normal pregnancy. He was a most beautiful baby boy and received 10 out of 10 scores on his Apgar tests shortly after birth. There was no question that Harry was born perfectly well. We his parents Keith Roberts (Architect) and Jennifer Horne-Roberts (Barrister) were overjoyed to have a beautiful son-our first child-having found happiness together relatively late. Immediately following Harry's birth I watched him all night long in his cot at University College Hospital. Would he become an architect like his father I wondered, or perhaps an artist? I wrote a poem about his birth **** Harry made excellent progress in his first year, was well, and ahead on all his milestones. He had one slight cold during his first year, but other than that remained well and alert. At a Christmas party in 1989 for babies at our home in central London parents remarked how well Harry was doing "I would be so proud‖ one said ―if Harry were my son". Photo pictures from that time show Harry looking alert and adorable as he was. ****photos of HHR When Francesca was born just over a year later on 24th July 1990, a baby described after birth as "perfect" by her paediatrician, our joy seemed complete. ****photos Family However shortly before Francesca's birth when I was due to go into hospital for a pre-elective Caesarean, there was a measles scare in the media. Accordingly I checked with Harry‘s GP and she advised that Harry be given his MMR jab before I might go into labour and then into hospital for Francesca's birth. Therefore Harry received his MMR jab Pluserix, on 20th June 1990 nine days before his first birthday. At that time he was alert and well saying clearly ―apple‖ ―watch‖ ―ball‖. Government leaflets strongly advised MMR vaccination then as they continue to do today.

6 Not long afterwards Harry developed a very high temperature and was screaming. His GP who arrived gave him Amoxicillin. However not long afterwards he developed large purple patches all over his body. The GP thought he was allergic to penicillin, as Amoxicillin is penicillin based. However that proved not be the case, as a subsequent penicillin dose was to reveal.

We were bewildered by what had happened to Harry, a perfect baby. We were bringing up Francesca too, and at first thought that Harry‘s loss of speech was a reaction to her birth. I was practising at the Bar part-time and we had a good nanny, Anita; soon replaced by the excellent Sarah, a Norland trained nanny who was to prove first class in her care of both children.

When Harry was over two, in August 1991, his health visitor noticed that Harry did not respond when she called his name and she expressed her concern. He was referred to the Nuffield Centre for hearing tests but his hearing tested as normal.

Then began a series of bewildering tests and referrals. Harry had lost his early speech and had poor eye contact now, unlike when he was a bright and alert baby before his MMR jabs. We referred ourselves to the Tavistock Centre who did tests on Harry.

A report on Harry by a Child psychologist Albert Reid, recommended by them, finally made the diagnosis of atypical autism. when Harry was three and three quarters years old.

Although autistic in his social interactions Harry was found to have good imaginative skills. The Tavistock Centre was to state also that Harry was highly intelligent.

We had tried to place Harry along with Francesca at a Ladybird pre-school nursery aged two, but he was too difficult for them to handle. The same occurred

7 at the nursery he attended at St Michael's School, Highgate, London N6. He was given a one-to-one carer but by the age of six was to attend Moselle an S E N school in Tottenham, once the diagnosis of autism was confirmed. Things were clearly far from well with Harry.

Francesca made good progress and started first at Ladybird part-time aged two, then at St Michael's Primary nursery department at age three. Sarah our nanny remained with us until Harry was five when to our great regret she moved to the US to continue her studies. She had realised Harry had problems from an early age. I was in denial for a long time. He was my first child, and had been born well and healthy. What could have happened?

It did not occur to us then that the MMR jab could have caused Harry to regress into autism, so great was our faith in our doctors and the medical authorities responsible for the vaccine programme. We heard no controversy at this stage, and were so oblivious of any dangers that Francesca too was a inoculated with MMR shortly after her first birthday, and remained well and healthy, making good progress throughout her childhood.

We were totally bewildered and at a loss as to what had happened to Harry, so much so that he was given his MMR booster on starting school. Such was our naive faith in the vaccine programme as advised by our children's doctors and paediatricians and the government.

Tina a Swedish nanny replaced Sarah when Harry was five and Francesca four, but was able to remain for only a year before returning to continue her education. She like Sarah was very good with both children.

We had moved from Murray Mews, Camden Square NW1 to North Grove in Highgate N6 (both of which homes Keith built) in 1992 when Harry was 2 and Francesca 1 year old. St Michael's School was just around the corner, a short distance along North Road.

A psychologist Catherine Spence, who assessed Harry for the London Borough of Haringey where we then lived, recommended an S E N school for Harry, Moselle School in Tottenham N17. Harry was already showing great talent in art and music. I simply did not understand and was reluctant for him to leave mainstream schooling. Before long we both accepted the inevitable, even though as Catherine Spence put in her report ―there‘s something magic about Harry‖. That was always to remain the case.

There was a bewildering array of healthcare, social, therapeutic and educational provision for autistic children. We had to find our way through the maze largely unaided.

Also once Tina left we could not find a child carer able to cope adequately with an autistic child. We had to cope unaided, and our careers were to suffer as a consequence. Compounding this was a fraud Keith‘s practice suffered in relation to a golf resort project in East Kent, for which he was the architect.

We were unable to practise normally, such were the demands of caring for an autistic child, and financial stresses added to our burden.

Harry had to be watched every second as he would be off over the high garden walls of ‗Garden House‘ as we called our new home, and run naked through the streets and local playing-fields. He often took off his clothes. He ate very little at this stage in his life. We could find no child care, and were struggling financially as Keith lost a fortune on the Sandwich project as a result of the fraud. We were never compensated by the courts.

We had to sell ‗Garden House‘ in September 1995 in a hurry in a difficult financial climate nationally, and made a loss. We moved from the beautiful detached house in a garden which Keith had built us in Highgate Village to a terraced house in nearby Whitehall Park. Harry was now 6 but still not toilet trained. He

9 was beginning to gain speech at this time and would refer to himself as ―escaping boy‖.

For a long time Harry ate very little (his diet had been normal in his first year of life). Then he began to eat a mainly carbohydrate diet and it was difficult to get him to eat fruit and vegetables apart from apples and raisins in small quantities. He ate very little meat.

Harry‘s talented art work featured animals. For a long time he had difficulty portraying people, and as separate individuals. Gradually and with patient teaching at Moselle his artwork flowered; and he made brilliant models of dinosaurs and animals. He made an accurate timeline of over 20 dinosaur models, and spelled their names correctly, at a very early age. **** examples of HHR‘s Art work At weekends Keith and I took the children from an early age to parks and swimming pools, art galleries, museums, libraries and the zoo.

Harry was to develop strong intellectual interests not only in animals, natural history, dinosaurs and pre-history but in space and the universe and history and geography the weather and geology. As computers developed he became a wizard at ICT and also on the music keyboard. He loved CD-ROMs and books on a wide variety of interests. He sang beautifully and appeared to have perfect pitch, according to his music teachers, enjoying playing the music keyboard and drums.

Harry was to make great progress at Oak Lodge secondary-school, an S E N school in Barnet. As at Moselle the staff were caring and very kind and became devoted to Harry. At Moselle we remember Gemma, Sarah, Grammatike and Mrs. Harris as well as the excellent head teacher Andy Redpath. Harry in his turn became very attached to them. At Oak Lodge Caroline Downs who ran the autistic unit with Ros, Elizabeth Wickham(Wicky), young Amy and Lynda Walker, the head teacher, were all kind and caring. Wicky helped Harry develop his art

10 skills and at the end of his secondary school years at Oak Lodge when Harry was 16 Wicky arranged an exhibition of Harry‘s art at East Finchley Library which was a great success . We had a party at the library to launch the exhibition; however the party was too much for Harry so he was unable to attend and Dad took him home. ****examples of HHR‘s Art work at this exhibition Harry also gained entry level GCSE in art while at Oak Lodge an exam pass which in view of his disabilities was a remarkable achievement. It was unique in his peer group.

Keith and I had no help in caring for the children from the time Harry was five. At one time the strain proved too much for me and I had a breakdown partly due to wrong medication arranged by my GP. I recovered fairly soon. Keith was a rock for the family in very difficult circumstances and all the time dealing with the effects of the fraud which had decimated the family‘s affairs financially.

We built a life in Cheverton Road Islington N19. Francesca continued to do well at school but growing up with an autistic sibling was difficult for her. She was outgoing, caring and very good with Harry. Also her best friend Charlotte, daughter of the local vicar, had an autistic brother, Robbie, a bit younger than Harry.

Harry was never classically autistic. His art talents and skills at modelling, music and computers shone through. He learned to read and write well and had an extensive spoken vocabulary, its use limited only by his autism.

Throughout these years until 2002 when my mother Daisy ―Grandma Betty‖ to the children (that was her other name) moved into supported accommodation, we would visit her home in Hastings Old Town during every school holiday, and at least eight times a year. Harry loved East Hill and the Country Park, which extended along the Fairlight coast to the Firehills. We would swim in the local

11 swimming pool and explore the beaches. We would visit the fishermen's boats on the beach and enjoy beach rides, trampolines and other diversions on Hastings seafront. Keith and Harry took long walks over hills and the Country Park. Harry loved East Hill and the Country Park Harry took long walks with his father and me his mother and Francesca over the hills of the Country Park. Harry also love to visit the Hastings Museum above White Rock, and to see exhibitions of animals including dinosaurs, a great favourite of his. His artwork portrayed a wide variety of dinosaurs and monsters.

***** photos of the Family and Hastings-more Art work. My mother's old converted Georgian home was a haven for us. Once however Harry climbed out of the tiny second floor window (aged five) onto a neighbour‘s very high roof. Keith had to find and climb a ladder and crawl over the roof to rescue Harry. Years later Harry escaped while Keith was out with him on East Hill- Harry would stand at the locked front door at 8.30 every morning with Keith‘s hat in his hand waiting for their walk-and was subsequently found by a RNLI helicopter sitting naked on a rock at the foot of a cliff as the tide came in. The lifeboat could not get close enough nor could the helicopter so he was rescued by a dinghy in a difficult air-sea rescue after the helicopter lowered a member of the crew to be with Harry during this operation. We shall always owe the RNLI.

Ditto the Thames River Police who rescued Harry on another occasion from trying to swim across the Thames near Waterloo when he was aged 15-in his pea jacket and trainers. We did not know where Harry was overnight and although Harry asked to go ―back to Keith Roberts house‖ while in St Thomas Hospital they could not ring us as we were ex-directory. We soon remedied that. He had escaped from our locked home and found his way to the South Bank. We had been frantic with worry. There were other escapes- to the roof of Brent Cross, Harry being found naked outside the old Arsenal football stadium, and others.

12 Once Harry threw the black-and-white printer from an upstairs window crying ― it's not colour, it‘s not colour‖. Harry was a perfectionist. He had an excellent memory and it was clear as he matured that he had a brilliant mind behind his autism.

After my mother went into supported accommodation and her home in Hastings was sold to pay for her care, we began to take holidays in a holiday home at Rye Bay a self-catering cottage on the edge of a Country Park and across the river mouth from Camber Sands. We had excellent holidays there. Francesca too enjoyed the long walks around the bay, seeing nesting birds, including Terns and all the beautiful flora and fauna of Rye Country Park. We would visit Rye Town, Hastings, Bexhill, Battle, Bodiam Castle, the Fairlight Firehills and the local steam railway. We continued to enjoy lovely holidays there. **** photos of these places

Harry left Oak Lodge and joined the Bridge School in Islington for his 6th form. He stayed there for three years, the first two at the old building in Woodbridge Street EC1; and then the wonderful new school building at Holloway N7.

**** Pics of new school staff and pupils

Martha Starkurska was Harry's one-to-one teacher at the Old Woodbridge Street School. She helped Harry with his travel training to and from the London Museum as his other favourite places. She was dedicated, but her disciplined approach was difficult for Harry, who had a very strong will of his own, to accommodate.

We are grateful to all Harry's dedicated carers, including especially Peter Caine, Harry‘s 1 to 1 carer after Martha, who went with Harry from the old to the new Bridge School at Holloway for Harry‘s final school year. Tim Harry's class teacher and Penny Barrett the head teacher were among excellent staff who helped Harry to a productive and fulfilling final year at school.

Harry‘s art and music and computer skills continued to flourish. He loved swimming and enjoyed the trampoline. We took him to trampoline sessions at the Sobell Sports Centre after school; at other times swimming to Park Road Pools N8 which he loved. Every weekend we took Harry out on Saturdays and Sundays to the museums, parks and libraries. The Natural History and Science museums were favourites with Harry; also the British Museum, RAF Museum and London Museum - and all the libraries of Islington and Haringey which we visited at least twice weekly.

**** Pics of Swimming and Trampoline

Harry must have been the most frequent visitor to libraries in London for a boy of his age for many years-and he borrowed profusely-CD-ROMs and books on animals, space and the universe, the planets, world atlas and geography, science, history, the weather; and DVDs -many of Disney films. We also bought many items for him from the museums and zoo‘s in London and at Wipsnade on each visit.

Harry had an extensive library including music tapes and discs. We have tapes of some of his compositions including a song when grandma Betty died. When he was aged 15 Harry taught himself to make films on the computer. He made 15 times 4 minute films which include some of his own graphics and music which he had composed. Some of these films featured at one of the art exhibitions of Harry‘s work held at Lauderdale House in Highgate in 2006. It was very well attended and reported in the local press by the Islington Tribune and the Hampstead and Highgate Express. Many local friends and figures attended including Jeremy Corbyn MP a fan of Harry‘s talented work, and Dame Stephanie Shirley a benefactor in the autism community.

14 Harry‘s artwork included many animals and by now people, as well as space and the universe, factories and flowers, and lifeline sequences of the evolution of animals; and one of Harry's birth and development from seed and egg to young boy. He was prolific as well as very talented. **** examples of work on show there.

We struggled with Harry‘s care at home as he would often be up early and late, while we always had to be up with him. Sometimes in the night when he was younger he would pull the wall paper off the walls and later even the plaster; as we struggled to stay awake or to get up. He drilled holes in the walls at one time having found Keith‘s tools at night.

Harry would often assert himself as ‗escaping boy‘. He would run off, very fast, and there came a point where he could outrun us and we could not keep him safe. We are older parents, and like all parents of autistic children we feared what the future would bring for Harry when we were not able to care for him. After he was 18 we were offered a place for him nearby in supported accommodation with a staff of 10 and someone on duty 24/7. So with the greatest reluctance we made the most difficult decision of our lives, and Harry went into supported accommodation aged 18 years 2 months. We saw him virtually every day. We took him on visits every Saturday and Sunday, and swimming or trampolining on Wednesday evening; and on Thursday I visited him at school to go to the nearby John Barnes library. Keith took him out with Martha, then Peter Caine, every Friday.

Harry wanted to be home ―back to Cheverton Road‖ which was heartbreaking; but we had to think of the future when we could be no longer there to care for him. Also Francesca had suffered all her life from the difficulties of living with an autistic brother. He was often noisy and she could not bring her girlfriends home in case Harry took his clothes off. So for her sake too we made the momentous decision that her final year of A-level at Camden School for Girls would be peaceful and she would be able to study undisturbed. This she did, getting top

15 grades at A-level and winning a scholarship to study at Leeds University, where she is now in her first year. This followed a gap year travelling in India with a close friend Ellen, and teaching, all subjects, to secondary-school children in Lilongwe, Malawi as part of a Real Gap project. **** pics of Fran in Malawi We too benefited from having some rest and sleep. We thought that this way we could keep going for many years to help care for Harry, without the increasing strain of doing so 24/7. At Myddleton Road he had a joung fit, strong 1to1 carer and staff on duty 24/7. The ‗escaping boy‘ routine meant he was no longer safe with us.

Harry had his own large ground-floor room and bathroom at Hillgreen Care 53 Myddleton Road N22. The staff were kind and told us they grew to love him as he was most gentle and loveable despite the outbreaks of high anxiety which were a feature of his autism. ― The women here all love Harry. He is such a loveable boy. He‘s our little darling" Lola the house-mother told me in late November 2009.

Harry wanted to return to Cheverton Road. For this reason he did not visit for two years as he would never have left again. By this time he was 20 stone (he was 5‘11‘‘ and of Herculean frame) as he had gradually become a compulsive eater. I believe this was comfort eating as Harry knew he was autistic (the Tavistock Centre told us this when he was about six). Harry often asked ―what‘s wrong with Harry‘s brain‖ and would often say ―Harry is sad‖ ―Harry is crying‖. Our hearts are broken, but we did what we thought was in Harry's interest.

Litigation including Submissions to ECtHR We had been involved in the MMR /autism litigation for some years before legal aid was withdrawn in 2003. Harry solicitors were Richard Barr at Dawbarns, then Hodge Jones and Alan, then Alexander Harris.

16 Harry had been treated by Professor Walker Smith, Dr Andrew Wakefield and Dr Murch. He had a colonoscopy under this team at the Royal Free Hospital in Hampstead. The results showed that he had vaccine strain measles in his blood and body, and ileal lymphoid nodular hyperplasia- a degree of inflammation of the small intestine. This was abnormal and unlike healthy children.

This work seemed to fit in with what we had experienced of Harry‘s very bad reaction to his MMR jab and subsequent regression into autism. Nothing else had made sense or could explain the terrible affliction which had overcome our healthy, thriving baby boy.

When the MMR autism trial was aborted by withdrawal of legal aid we took an appeal to the Legal Services Commission Funding Review Committee. I did a great deal of work to prepare for this, reading all 60 of the experts' reports which Mr. Justice Keith, the trial Judge, allowed me to read privately. I did a digest of the Claimants‘ expert evidence which showed that we should have won the case on the balance of probabilities. Richard Barr the original solicitor and Dr Wakefield, both of whom had also read the evidence, agreed with me on this assessment. ****14 published the Digest here

Then with Keith's help-‗ we had no solicitor so did all paperwork and court preparation ourselves‘ I took the ―MMR 10‖ case against withdrawal of legal aid to court by way of Judicial Review in the High Court, the Court of Appeal and from there to the European Court of Human Rights. The latter did not give us a hearing. We were told subsequently by the vice-president of the court Sir Nicolas Bratza that the Court had effectively broken-down as they have a backlog of 200,000 cases with which they cannot cope. Also cases from the UK rarely get a hearing- priority is given to hearing cases against Eastern European Governments.

17 Our claim was based mainly on denial of ―access to justice‖ a right guaranteed to everyone under the European Convention of Human Rights and the Human Rights Act 1998.

The withdrawal of legal aid meant we could not afford to continue as expenses of the 60 expert witnesses mainly from the US to attend a trial would have been very considerable. None of the parents could afford the sums (several million GBP). Also withdrawal of legal aid meant we would not have been protected against huge adverse cost orders if at the end of the day and despite the strength of our experts‘ and parents‘ evidence, we had lost the case.

There was another important point, the limitation period under the Consumer Protection Act 1987 for a defective product i.e. vaccines, on which grounds we had sued. Unlike for negligence there is strict liability under the CPA and fault does not have to be proved. The limitation period was 10 years from the date of manufacture or giving of the vaccines, too short a period to recognise that vaccines were the cause of their child's injury in many cases and to organise the taking of legal action

The European Parliament and EC Commission had suggested that a 20 year or even lifelong limitation period was more appropriate. We asked the court to declare there the UK limitation period of the C P act was unlawful.

We got a one-page response to our application to the European Court of Human Rights declaring it "inadmissible". No reasons were given for this decision!

SUBMISSIONS TO ECtHR by JHR on behalf of the ‗MMR 10@ which included Harry. Statement of facts for the European Court of Human Rights This Application to the European Court of Human Rights is on the basis that the 10 child Applicants, all of whom suffer from ASD/IBD allegedly caused by MMR

18 vaccines, have been denied access to justice. See Schedule of Claimants attached Appendix.

They were deprived of a trial by legal aid having been withdrawn by the Legal Services Commission in the summer of 2003. The Funding Review Committee rejected their divers appeals against the withdrawal of funding in October 2004. Subsequently judicial review of that decision was sought in the High Court, and renewed in the Court of Appeal, on both occasions unsuccessfully.

Some £15 million had been spent preparing the case of over 900 ASD/IBD children to go to trial, funding originally having been granted for these cases in the mid-1990s and later. Generic legal aid was withdrawn in the summer of 2003. The claimants were not involved in that decision or its Judicial Review challenge in any way. JHR ('JHR') was denied the right to appeal the JR decision which was taken on behalf of a lead Claimant, who then declined to appeal. That lead Claimant acted as a sample, not as a representative of the group, as JHR was informed by her child's then Solicitors. These 10 Claimants therefore had no locus standi in, and could not be bound by that decision, as JHR argued.

The withdrawal of legal aid meant that the trial could not go ahead, as expert witnesses could not be paid for without legal aid; nor the necessary team of lawyers to ensure a level playing field against powerful pharmaceutical companies. Nor would the Claimant families be protected in costs without legal aid. Denial of legal aid deprived the children of access to justice in a case of worldwide significance as well as of the utmost importance to these severely injured children. The decision was disproportionate not only by virtue of the outstanding importance of the trial but also on the basis of relatively small projected further expenditure necessary to bring the case to trial. The then solicitors' estimate was £4 million more to include further research. We claim that

19 the evidence as it stood was enough to prove causality on the balance of probabilities.

Moreover the decision was disproportionate by virtue of other expenditures by the Legal Services Commission-for example some £250 million was spent on non¬ national asylum seekers cases in 2005 alone. This was cited to the Court of Appeal by one of the parents at the hearing. The present case concerns not only these children, but those of Europe, and the world, as there is now a worldwide epidemic of regressive autism, as to which evidence is included in the papers in this Bundle now before ECtHR. It is to be hoped that similar cases will reach the ECtHR from other countries within the ECtHR jurisdiction. The combined effect of such cases will it is hoped impress on the European Court that it is dealing with one of the greatest medical/legal scandals of all time. Access to justice has been denied to some of Europe's most vulnerable children. Access to justice is a small request to make, and a basic right. These children have been denied justice by the UK and now seek assessment of damages for denial of their basic right under Article 6 of the Convention; also under Article 8 as the family lives of these children have been devastated as a consequence of their injuries (see the parents witness statements); also Article 14 as some of those granted legal aid were ASD/IBD sufferers, and these Claimants have been unfairly discriminated against. The Claimant children also seek to challenge the 10 year limitation period of the UK Consumer Protection Act 1987 as was mentioned in the Court of Appeal hearing. As the European Parliament and the UK Law Commission have argued the limitation period for consumer protection cases should be extended very substantially or related to 'the foreseeable future of the product's use',. Preferably it should be extended indefinitely in this case. That is the situation for disabled children in negligence cases in the UK, and arguably, and it is so argued, the Consumer Protection Act 1987 should have its limitation period also extended

20 throughout the Claimant children's lifetimes: see Article 6(1) and Article 14 d also protocol 12 and also Article 13 - right to an effective remedy.

Legal Basis of Application to ECtHR

It is submitted that by denying the Applicants legal aid to enable a trial to take place in the UK of the MMR and ASD/IBD link, the UK courts have deprived these children of their right to access to justice.

This is a case of the utmost importance to the world, not only to these children. The decision to deny them a trial of the issue constitutes denial of access to justice, in the circumstances, contrary to Article 6(1) of the European Convention.

Some ASD/IBD claimants (two are known) were granted legal aid to continue their claim, so the Legal Services Commission/Funding Review Committee (‗LSC/FRC‘) decision was discriminatory against these 10 Applicant children contrary to Article14 of the Convention (see also protocol 12).

The injuries these children have suffered, and consequent devastation of the lives of their families, who struggle to cope, and in relation to which the UK has denied a trial, is also in breach of article 8 of the convention (see the witness statements of the children's parents).

The decisions to deny access to justice by the LSC/FRC, High Court and Court of Appeal, were disproportionate. The Applicants were denied a level playing field (equality of arms) at all stages of the legal proceedings following the abrupt termination of their legal aid in the summer of 2003.

The Applicants were left unrepresented and stranded in the middle of complex litigation. That too marks a breach of their right to access to justice. At no stage has there been a level playing field (equality of arms) in the attempt to continue the litigation against the pharmaceutical companies thereafter.

I JHR, a barrister mother, have taken on the task of furthering this case before the LSC/FRC, in the High Court, Court of Appeal, and before this ECtHR without, perforce, the benefit of any assistance from any solicitor. As soon as legal aid was withdrawn the Solicitors previously involved withdrew from and abandoned representation of the Claimants.

This case marks a great scandal in UK medical and legal history for which the Applicants now seek redress under Articles 6, 8, 14 (and Protocol 12) and Article 13 of the Convention, before the European Court. The limitation period which is 10 years under the UK Consumer Protection Act 1987 is discriminatory, and denies these Applicant children access to justice at any later stage of their lives, if circumstances were to allow, which is also contrary to Articles 6, 14 (Protocol 12) and 13. The limitation period should be extended indefinitely throughout the children's lifetimes; as is the case with clinical negligence for disabled children in the UK. See also the UK Law Commission Report 'Limitation of Actions 2001 LC 270'. It is therefore also submitted that the limitation period of the UK Consumer Protection Act should be declared unlawful by this Court; and a greatly extended limitation period be recommended to replace it.

The ―MMR10‖ consisted of the parents of Emily Boult, Matthew Butler, Jack Campbell, William Cramer, Geoffrey Files, Andrew Heather, Harry, Michael and Terry Thomas and Melissa Wickens. They are a group of wonderful parents all struggling to do the best for the injured children. Matthew Butler and William Cramer had the Pluserix MMR jab-as did Harry. Melissa Wickens had Imravax. These two jabs are Urabe strain, and Urabe strain had been banned in Canada as dangerous before being introduced into the UK in 1988. The other children members of the ―MMR10‖ had the MMRII strain so I was informed. The parents have received no compensation from the pharmaceutical companies or the UK government for our severely injured children and have to struggle on alone. Those of us affected are considering bringing a legal action against the UK

22 Government for wrongly licensing and using the MMR Urabe strain from 1988 when they knew it was dangerous. We are also preparing a complaint to the Met Police on behalf of Harry and others of ‗crimes against humanity‘ by the UK Government in respect of the lisencing an use of the Urabe strains of MMR when these strains had already been withdrawn in Canada as dangerous.

In 2007 and 2008 I was UK Counsel in the US Omnibus Vaccine Court cases involving 5,000 injured Claimant children alleging an MMR/autism link. Although three lead cases were lost as the result of poor judicial decisions, some 10 other cases were conceded by the Defendants the US Government, including the case of Hannah Poling. In these cases, some settled as secret deals, the US government admitted that multi-vaccines had caused the children's autism, and awarded them compensation (undisclosed amounts). In the case of Bailey Banks, Judge Abell decided that MMR caused the Claimant‘s autism. Three more cases William Mead, Jordan King and Colin Dwyer have been lost, again as a result of inadequate judging.

Other Claimants will fight on in the Federal Courts, mindful of the fact that the Thalidomide and the Tobacco personal injury claims fights took decades before victory was achieved.

Harry was prescribed small nicotine patches from September 2008 following extensive bio-tests of his samples in the US and French expert laboratories. He was prescribed the patches by Dr.Bradstreet a US expert who had been one of the witnesses for the Claimants in the original UK/ MMR autism litigation. He was also a leading expert for the Claimants in the US Omnibus proceedings. Dr.Bradstreet‘s expert opinion was that Harry had been injured by the MMR jab he received as a baby. This corroborated the findings of Dr Wakefield and the team of the Royal Free Hospital following Harry's colonoscopy. Harry left school in July 2008. Keith and I were anxious that he should adjust to supported accommodation a year before he had to leave school. Both these were traumatic events for Harry who was extremely sensitive. We did our best to

23 help him to adjust to what must now be his adult life. In due course we hoped he would develop his talents in art, model-making, music, computers and film- making to the point where he could lead a productive creative life as an artist/musician.

When Harry left the Bridge School in July 2008 after his 19th birthday (the leaving age, despite our trying to extend his term there) there had already been a number of exhibitions of his work at London venues. We then provided for art lessons for him at the studios of the Hoffmann Centre for autistic adults in Park Avenue, Wood Green, near where he lived in Myddleton Road. Under the tutelage of Ian Wilson, an artist, and his assistant Dan, Harry's art began to develop very impressively, during three art afternoons per week.

He was about to start music at Nordoff-Robbins Centre in Gospel Oak NW5 again provided for by us. Nordoff-Robins had assessed Harry as being musically very talented.

On two days per week Harry went to the Daylight Centre at Highbury run by the London Borough of Islington for those with special needs. With the help of Hannelore Bout, head of the autistic unit, Ray, Andrew, Lucy, Michaela and Kristin he developed very well and was enjoying more film making with Kristin, singing with Lucy, a professional jazz singer, and swimming and walking and exploring London with Andrew and Ray.

Keith and I continued to take Harry on outings every Saturday and Sunday-to Epping Forest, Golders Hill Park, Hampstead Heath, Kenwood and the Zoos to libraries at Alexandra Park, Highgate and Muswell Hill in Haringey and John Barnes, Mildmay and Archway in Islington. We also took him regularly to all the museums he loved- the Natural History and Science Museums in South Kensington and the British and Geffrye Museums and many more. He would buy books and CD-ROMs on every visit. He had an extensive library of books and

24 CD-ROMs on natural history, science, nature, space and the universe, world atlas and history- as well as DVDs, many of Disney films.

On Wednesday early evenings we continued to take him trampolining at the Sobell Centre in Islington then to the Park Road indoor and outdoor pools in Crouch End N8. On Thursday and Friday Keith would often take Harry and his carers on outings from the Daylight Centre.

Keith and I took Harry on four holidays per year to Rye Bay including in 2009. We had great times and on each of the four times the weather was good. We walked around Rye Bay, and every day visited Rye, Bodiam Castle, Hastings and other sites, and Harry enjoyed a private session at the pool in Frenchman‘s Beach every evening. With nicotine patches prescribed by Dr Bradstreet his speech was improving (it was always good) and he was becoming more settled at Myddleton Road. He came home to Cheverton Road for Halloween and again at Thanksgiving in late November 2009, preparing him for an extended stay with Mum and Dad at Christmas.

Harry's progress was so good that hopes were high for him to continue to improve. Dr Bradstreet was due to do more tests on Harry's bio-samples in 2010. He might even be cured; as Dr Bradstreet had cured Colten Snyder, one of the boys in the US Omnibus cases in which I as a barrister was advising and representing some of the 5,000 Claimants.

When we went away Harry had his medication as prescribed by Dr Jaydeokar, his psychiatrist. I was told at Harry‘s Social Services Review on 9th March 2009 that this medication was Citilopram. I took a contemporaneous note at that review, and on researching Citilopram on the internet ascertained that it was prescribed for anxiety, and was safe.

25 Keith and I had met Dr Jaydeokar at Harry's appointment with him in December 2007(he was employed by the Haringey Learning Disabilities Partnership- under Haringey Mental Health Trust). I wrote to him in March 2009 and Keith received a reply which he forgot to show me before filing. This said that Harry was anxious. It made no mention of any particular medication. I wrote again in May 2009 and no response was received. I have copies of these letters. Monitoring and a Care Plan were agreed and confirmed in writing at the meeting in December 2007 by Keith and Dr Jaydeokar. I had had to leave the room as I was distressed about Harry. Dayo Harry‘s 1 to 1 carer was present at the meeting.

None of the follow up was done. Keith and I had tried to see Dr Jaydeokar when he was due to visit Harry in mid 2008. We were told he was late and left our mobile number returning less than half-an-hour later to be told that he'd been and gone (we had not been invited to wait in the home which only had one small reception room).

We accepted that Harry was on Citilopram, a tranquilliser, and wrote to Dr Jaydeokar as we wished to follow up and participate in Harry's healthcare in which we were experts. Although we asked to continue to be involved in all Harry's appointments, medical and dental, while he was with Hillgreen Care we not always told of these so could not attend.

Our most beloved and brilliant boy, our so talented Harry was to die of heart failure in his sleep on the morning off 16th December 2009. My world stopped.

We discovered only afterwards to our utter horror that he had been prescribed Chlorpromazine since February 2009. We had never been informed or consulted contrary to the requirements of the Mental Capacity Act 2005. Nor had a mental capacity test been done on Harry contrary to the requirements of that Act of Parliament then in force.

26 Professor Iqbal Singh wrote an independent Review on behalf of Dr Jaydeokar‘s employers the Haringey Mental Health Trust. (Although Harry was in the care of the London Borough of Islington his health care was under the Trust and a Haringey GP Dr Prasad). Professor Singh's Review stated that Harry should have been given tests before being prescribed Chlorpromazine (CPZ) a dangerous anti-psychotic drug. He should also have been given monitoring tests while on it. This drug was in any event totally inappropriate for Harry. None of the tests were carried out. CPZ increases weight and appetite. It was therefore doubly inappropriate for Harry who was never psychotic or manic and was only anxious and should not have been prescribed an anti-psychotic drug. As he was 20 stone he was therefore at extra risk of heart failure. CPZ is known to cause sudden death and heart failure, as occurred to Harry.

We had urged weight loss to Hillgreen Care as a matter of great urgency. Unbeknown to us our urgings were wholly undermined and contradicted by his being placed on a dangerous drug CPZ leading to weight gain and appetite increase. The coroner for Haringey has ordered an Inquest into Harry‘s death; and now he has referred the matter to the Metropolitan Police for an Inquiry into Harry's treatment. Since his treatment was reckless and caused his death we regard his death to have been murder by Dr Jaydeokar.

Harry was greatly loved in his life by those who knew him. He touched many lives. Over 150 friends and relatives attended his funeral at St Michael's Church, Highgate N6. Many more did not hear the dreadful news in time to do so. He was laid to rest in the Church garden in the month of his 21st birthday June 2010.

We are utterly heartbroken at the loss of our sweet natured and gentle, brilliant and talented Harry. So also is Francesca. RIP our most beloved Harry.

27 Witness Statement of Keith Roberts about my late son Harry.

Personal Details I am married to Jennifer Horne-Roberts (JHR). We had two children. Harry (d.o.b 29th Jun 1989; died 16th Dec 2009 age 20.) and Francesca(d.o.b.24th July 1990).

Family Medical History I am and always have been very healthy. My father died at 51 following a heart condition my mother died at age 89. I was previously married and have a son from that marriage. He is very healthy. Apart from the usual childhood ailments my wife had always been very healthy. She has a sister who is six years older then her. She is very well and there is no history of illness in her family. Her mother was aged 91 when she died. JHR's father had a serious allergy to wheat and tomatoes. JHR does not have any allergies but she does have mild asthma for which she takes medication. JHR's sister Carol also suffered from mild childhood eczema which resolved with appropriate treatment. There is no history of development delay or epilepsy in either of our families. My daughter, Francesca, is very intelligent and is healthy. Francesca had the MMR vaccination, with no apparent ill effects.

Pregnancy with Harry My wife's pregnancy with Harry was uneventful apart from a very slight bleed which occurred at approximately three months gestation. Otherwise JHR was extremely well throughout. The usual scans and blood tests were completely normal. During JHR's labour with Harry, she had a trial of labour, and went on to have a caesarean section because she had a small pelvic cavity. When Harry was born his Apgar scores were 10:10. He was mildly jaundiced for a few days afterwards and had some phototherapy treatment but apart from that he was very well. There were no problems or concerns about him.

The First Six Weeks of Harry's Life Harry was a perfectly normal baby. JHR breast-fed for six weeks then he was bottle-fed on SMA. In fact, things were so unproblematic that JHR returned to work soon after he was born. We had a nanny to look after him. Our nanny never mentioned any problems with Harry's physical or mental development. Harry was reviewed by our Health Visitor when he was 5 weeks old. In the Health Visitor's notes she made a note that the examination was satisfactory. The GP from Kentish Town Health Centre also confirmed that there were no problems. There was no motor delay, his vision was satisfactory, and his hearing was fine in that he was responding to sound and his social behaviour was at the expected age level.

Early Health and Development (cf Medical Records here) Harry slept well, fed well and was very advanced for his age. He was a lovely, bright and alert baby. He had very bright eyes and had extremely good eye contact.There is a note in the Health Visitor records which specifically states that Harry's 6 month check was satisfactory. Harry was a very hungry baby. I used to carry out the night feeds, which were sometimes up to four times a night. He would settle straight back to sleep without any problems. During his first year, Harry developed baby babble and smiled a lot. He was an extremely social baby. Before he was one year old he was attending a playgroup with our nanny; he was very sociable and interacted well with the other children. Harry was a relatively robust baby and when he was 6 months old, we went to Portugal. As far as I am aware, on holiday, in Portugal, he was not exposed to measles virus and had never been diagnosed with measles. He walked at 11 months old. Harry enjoyed his first Christmas party, he was very happy. Other mothers remarked on how lovely he was. He really enjoyed being with the other children.

29 Some of our friends remarked on how he was advanced for his age. In fact he was ahead of their children of the same age. Harry was healthy prior to the MMR. Francesca was born on 24 July 1990 when Harry was 13 months old and I distinctly remember that he was saying words like "Apple", 'Watch" and "Ball".

The Pre-MMR Vaccinations Harry was given the Diphtheria, Polio, Tetanus and Whooping Cough vaccinations on 1 October 1989, 1 December 1989 and 1 April 1990 without any ill effects. He was later given a single dose vaccine of Whooping Cough on 9 October 1992.

The MMR Vaccination Before the MMR was given we were given a pamphlet at the Health Centre about the MMR vaccination. The information in the pamphlet suggested that there was only a million to one chance of any side effects from the vaccine. In fact, it went on to say that the risks of not having the vaccination were so terrible that we felt there was no alternative but to have Harry vaccinated. On 20 June 1990 our Health Visitor made a note in Harry's records that Harry was a healthy baby - for early MMR. She also noted that he had had no previous reaction or no contra indications to the vaccine. On 20 June 1990, JHR took Harry to Kentish Town Health Centre for the MMR vaccination, which the GP, Dr. Dickinson, had approved first. It was given by the Practice Nurse. JHR noticed on entering the room, that the phial had been taken out of the fridge and placed on the work surface. JHR was concerned that this could have been a phial with a batch number that should have been withdrawn.

Immediate Reaction Harry was grizzly that day and for a few days following the vaccination. He also developed a fever. JHR swabbed him with cool water, she spoke to our GP on the telephone who advised her to continue with the tepid sponging, and she

30 gave him some Calpol. He also started screaming at night which he had never done before the MMR vaccine was given. On 6 July 1990, Harry was seen by our Health Visitor. She made a note that he was slightly pale, that he had thrush on his bottom and in his mouth, and that he had been screaming at night. She said he might be teething. On 18 September 1990, JHR took Harry to see our general practitioner because he had been unwell for at least a week. He had developed a fever and had had a cold for ten days. He had also developed diarrhoea. Our GP diagnosed that he had tonsillitis and prescribed a course of Penicillin for five days. JHR was advised to give him plenty of fluids and Calpol when necessary. After the antibiotics had been prescribed, Harry developed a rash and it was decided that he was allergic to Penicillin. The rash that he suffered consisted of large purple spots.

Harry at age 18 months. When Harry was about 18 months JHR and I became concerned because Harry's words were not developing. He seemed to lose his eye contact. I would take him for walks in the park, and I noticed that Harry did not take an interest in his surroundings. If a football was kicked nearby Harry did not seem to respond whereas, before he had received the MMR he would have run after the ball. We did not want to accept that there was anything wrong with Harry. We had a nanny who came to work for us shortly after Francesca was born and she recalls noticing that Harry had lost his eye contact very soon after receiving the MMR vaccine. At the time, we thought that Harry was just reacting to the birth of Francesca. JHR's mother also suspected that there was something wrong soon after he had been given the MMR. Both JHR's mother and our nanny did not want to upset us so they did not say anything. They just hoped that they were wrong. Also post-MMR, we noticed that Harry's diet changed. Whilst he did not have an extremely varied diet before he had the MMR he seemed to eat a very restricted diet after he had the vaccination. Later he would only eat things like Tracker Bars and carbohydrates, he would only drink Ribena.

Referrals On 5 June 1991, Dr. Dickinson, of Kentish Town Health Centre, saw that Harry had slow comprehension, did not understand simple commands and had few words. On 29 August 1991, Harry was referred to the Child Development Team at the National Temperance Hospital because his comprehension was poor and his speech was practically non-existent. At the Child Development Team Harry was seen by Dr. Martin H. Bellman, Consultant Paediatrician. He diagnosed that Harry had a deficit of language development. He also thought that Harry had social difficulties, lack of inhibition, lack of awareness of danger and needed constant supervision. He wrote this in a letter dated 13 February 1997 to our GP who was Dr. I. Robinson of St. John's Way Medical Centre. At the age of 22 months, our nanny took Harry to the Health Visitor Clinic. She noticed that Harry's speech was poor in that he was only saying three to four words. She also recorded that our nanny felt that Harry did not understand tasks that were asked of him. At Harry's three year check with the Highgate GP Practice things were not looking good. Our GP referred Harry to Dr. Kenyon of Harley-Street. He was a doctor of complementary medicine. During the consultation Harry was very impatient and difficult to manage. The doctor could tell immediately that Harry was autistic. He carried out some allergy testing and gave us some tips as to what Harry should eat and what he should not eat. JHR and I were also referred, along with Harry, to the Tavistock Clinic where we met with Sue Reid, Consultant Child Psychotherapist. Initially, Harry attended three days per week. The Psychotherapist also saw JHR and me. Sue Reid's husband, an Educational Psychologist, gave us a report when Harry was 3' years old which helped to get him statemented and into a school for special needs (SEN). Ms Reid diagnosed Harry with communication difficulties but did not feel at that time that he exhibited all the characteristics of what might be termed a "typically autistic" child.

32 Harry was subsequently referred again to St Ann's Child Development Centre for a developmental assessment by their team because he was still to have a confirmed diagnosis. He was seen by Dr Lingham, Consultant Paediatrician in Community Child Health who arranged for him to be referred to a child psychiatrist and also for specific blood and chromosome tests to be carried out. It was subsequently decided that the tests themselves were not necessary and unwise given that Harry was very reluctant to cooperate with such tests and this remained the case.Ultimately, the further assessments were not carried out and Harry continued to receive psychotherapy from Susan Reid at the Tavistock Centre. He made very good progress and was found to be advanced in a number of areas whilst still having a very clear and marked socialisation/communication disorder. He was assessed on 30.03.93 by Bernadette Gillespie, Speech and Language Therapists who confirmed that his level of impairment and social interaction and behaviour and symbolic development appeared to place him nearer to the autistic end of the continuum of communication disorder rather than the linguistic disorder end. A report was subsequently prepared by Dr Lingham on 30.03.93 and he confirmed that Harry's overall diagnosis would, be in the autistic spectrum. We commenced a number of therapies as a consequence of that diagnosis and had tried to stimulate Harry/s socialisation and interaction as much as possible. He was referred to Nordoff-Robbins Music Therapy Centre in September 1993 where he was seen regularly until January 1997.

Continuing Symptoms/Regression and other problems. As Harry got older we could not go out walking with him as he would try to escape. He had no sense of danger. On one occasion when Harry was in the toddler's playground he went missing. He managed to get out of the gate and onto the road. This happened a number of times.

33 We used to regularly visit Hastings, where JHR's mother lived, for holidays which Harry enjoyed immensely. We would go to the country park near to JHR's mother's home. I would get up early with Harry and we normally go for a walk through a wooded area. Harry would like to take the same route, to climb the same trees and sit on the seats throughout the woods and we had a regular routine. On 1 November 1999, when I was out walking with Harry in the woods, Harry went down a path and went out of sight. I kept returning to the trees that I knew Harry recognised and eventually I discovered that Harry was at the first tree. The following day, the same thing happened again. Harry walked off on his own and just turned off down the path and subsequently went off to the beach. I had to contact the police who later picked Harry up in a helicopter and lifeboat raft. He was found down by the cliffs where the tide was coming in on the beach. He had been found at the foot of the cliffs where he had taken off all his clothes and unknowingly had had a wonderful time.

Bowel Problems/Diet On 3 July 1997, it was noticed that Harry started having watery stools three or four times a day. Our GP referred him to the Royal Free Hospital where he was seen by Professor J.A. Walker-Smith. Professor Walker-Smith referred Harry to see Dr. Andrew Wakefield also of the Royal Free Hospital. On 11 January 1998, Harry underwent a colonoscopy investigation and biopsy. We had Dr. Wakefield‘s letter (exhibited later) informed us that Harry had inflammatory bowel disease and an inoperative lymphatic system as at 11 January 1998. We agreed that he could make use of the biopsy material in his research.

Due to Harry's restricted diet, he was seen by a Dietician in February 1999. The Dietician advised that he should take a multivitamin and mineral supplement. He was also seen in the Paediatric Autistic Clinic. The doctors there were exploring exclusion of cows' milk and wheat. He was also seen in the Food Allergy Clinic and was commenced on Pentasa which is an anti-inflammatory drug. This was commenced in, March 1998, and there seemed to have been

34 good progress. Since October 1999 we switched to homeopathic secretin. There was further marked progress. Whilst Harry developed loose stools after the age of 1 year old, it worsened when he was around 6 years old. This prompted the referral to the Royal Free Hospital.He was seen every four months at the Royal Free Hospital for check-ups. He had commenced on Mazalazine (Pentasa), Senna liquid and Paraffin Oil. Since March 1998, he had made some progress with his speech. More recently, since October 1999, we had given him homeopathic secretin which apparently was absorbed through the stomach and we had noticed that Harry's language was improving. Dr. Murch of The Royal Free Hospital approved the use of homeopathic secretin in October 1999. Recent investigations carried out by the Royal Free had identified the existence of bacteria in Harry's bowel. They had recommended and implemented a 3 month course of triple antibiotics which was being co-ordinated by Dr Murch. This was an experimental course and it was hoped that if the antibiotics worked to reduce the bacteria, they would then be able to concentrate upon managing the extent and nature of Harry's other problems. In addition, we had seen that Harry had stopped headbanging which he was doing a great deal before the treatment started and similarly, his language had improved and that he would now use a number of words to make a sentence. For example, he could use individual words and in some cases construct a full sentence such as "I want to go to Hastings". We firmly believed that Harry was well aware of his problems and got very frustrated by his inability to communicate what he wanted and that this was the cause of his. head banging and to an extent any disruptive behaviour. We had had comments from the school that his behaviour was much improved with the treatment that he had received.

There had been some discussion in the past that it might be possible to remove measles virus from his system by boosting his immune system. However this had been proposed as something for the future and was not then an option.

I understand that following Harry's assessments by the Royal Free Hospital, a sample of his bowel biopsy was tested for the presence of measles virus and this was confirmed to be positive. Harry had recently undergone blood tests to confirm the existence of measles virus in his peripheral blood supply. However due to Harry's aversion to any hospital procedures, had not been possible to take a blood sample. We had found that in response to the Royal Free Hospital's involvement and in particular to the antibiotics, Harry had calmed down a great deal and we had seen an improvement in his level of concentration. I had been shown a letter prepared by Dr Murch dated 19.09.2001 where he had suggested that Harry had a primary genetic form of autism rather than an immune associated regressive form. This had subsequently been discounted hence the antibiotic treatment and probable future efforts to try to boost his immune system. Harry had a relatively restricted diet. He will eat a lot of grain based products such as toast, pizzas and poppadums. He was also very keen on cheese toasties, hotdogs and crisps. All the food he ate he would only ate with his fingers.

Current Condition. Harry was very aware of his own condition however he could cope with it to an extent. He threw himself into his routines and in particular, we had to follow a very specific and consistent routine at the weekend. Usually this would consist of going to the same museum or the zoo and if we did not then Harry got very distressed. He loved to read books and could hold very articulate and informative conversations about science, history or the universe and space. This has to however be tempered with the fact that Harry still had very substantial difficulties in conducting his normal every day life. On occasions, Harry had gone missing and we were only able to track him down by thinking about the routines that he would follow and invariably, we found him either at a museum or on one occasion, the Police found him in a park but he had brought books from two different museums which he had clearly visited.

Whilst Harry had a number of very "intellectual" pursuits he was still very much an autistic child. He likes to play with soft toys and he has no friends of his own age to speak of. He was however well known at the zoos and museums that he visited regularly and he liked to go to the book shops and was well known to the members of staff who always said hello to him. For example, we went to the zoo and museum once a week every week and on nearly every occasion, he bought either a book, CD Rom or video.

The restrictions that Harry placed on himself by his routines were also evident during the evenings during the week when he insisted on going to the park. On a Sunday, we would always go to the Natural History Museum and then to the Science Museum. If we did not go to the museums then Harry would find a way of getting there himself, whether running off or making his own way there on another occasion

Education

Montessori Nursery 1992 Initially, Harry attended a Montessori nursery until he was aged 2'/2 years old. Following the MMR vaccination, Harry was always trying to escape and his safety had always been an issue for us to deal with.

St Michael's School (Primary).1993 Harry then started to attend St. Michael's Nursery School. There were two classes. He had one-to-one help there but towards the end of his time the teachers recognised that he would not go on to a mainstream primary school and the question of special needs education came up. JHR and I had a meeting with the Educational Psychologist and Harry's head teacher. They recommended that Harry should attend a special needs school. We subsequently went to see a NAS Special Needs School in Hertfordshire but we were not impressed by its suitability for Harry.

Moselle school 1993-98 We then went to see Moselle school. There were two autistic unit classes with five or six children in each class. All of the children had mild or moderate learning disabilities.

Oak Lodge School- 1998-2005 Harry next attended Oak Lodge School which had a specialist autistic unit. There were 5 in his class and Harry had a one to one carer throughout the day. He was transported to the school where he stayed during the day and returned home every evening. He continued to do very well with his music and he enjoyed singing although his language was poor and his social interaction at school was poor which was reflected in his lack of friends. A good example of Harry's poor interaction could be seen when he was in a crowd when he would quite often push to the front of the queue or a group so that he could see what was going on and would not say anything and people often took offence at this because they did not understand his difficulties.

An exhibition of art work by Harry was held at East Finchley library on 12th - 19th July 2005. This exhibition of work brought together Harry's unique artistic talent. His art teacher ‗Wicky‘ (Elizabeth Wickham) wrote a Notice for the exhibition ‗Harry is a sixteen year old boy with a special artistic talent. Harry is also autistic. He attended Oak Lodge School, in East Finchley for five years, and uses art as a medium for expressing his feelings about his surroundings and his relationships at home and at school. These can be at times happy; anxious, bewildered, frustrated and sometimes volcanic.

When Harry started a piece of art work he has an uncanny ability to visualise it in completion and knows precisely what materials and techniques he will adopt. As an observer it is a bit like seeing the making of a cake unfolding before your very eyes - the ingredients are assembled with the end product in sight and all the excitement of observing the process, the 'coming together,' on the way.

He regularly returns to favourite themes such as growing up; dinosaurs and the natural world. These can encompass natural disasters such as volcanoes and colourful perceptions of the planets in outer space. 'A child of nature', Harry likes nothing better than spending time in the garden or play park. H is weekend diary reads like a copy of Time Out - visits to art galleries; museums (The Natural History Museum a favourite) and libraries. He is adept at anything on the computer and some of the drawings on display are the result of Harry's firm grasp of techno skills.

Harry left Oak Lodge at the end of this Summer Term, for his new school and on the next part of his journey at The Bridge School in Holloway. ‗

39 The Bridge School. 2005- 2008

School

Harry has been at the Bridge school for three years. For his last year in school Harry has been able to use our new school building which he very much enjoys. Harry has been part of Gold class which is part of the sixth form. Harry has been following the National curriculum which includes swimming, art, music, PSHE, community awareness,,drama,dance and I.C.T. Harry has particularly excelled at swimming, music, art and I.C.T. He has also developed his ability to work in groups rather than being on his own. He is now also more able to initiate communication with others and enjoy interacting with his fellow students and staff. He has coped very well with all the big changes in his life in the past two years and we are all very proud of him. We all wish Harry well in the future and we will all miss him!

Art & Design Report. ‗I‘ve been teaching Art to Harry since 2001, and I feel that only now are we beginning to establish a good working relationship. Although attached to a tutor group he finds group work extremely difficult, and this should be avoided in order to keep his stress levels down. His main interests/strengths within art are making line drawings. using the computer to make collages of imagery picked from the net. On occasions he has enjoyed working with clay. These are usually geared around his obsessions which are predominantly Dinosaur & Animal life, and occasionally Cartoon Characters and various monsters such as Vampires. Harry finds transitions between activities difficult, he copes better punctuating "computer time" and "drawing time" with time out usually spent in the bathroom. Activities should be kept short (10-15 minutes). He has less interest/ finds it harder to draw people. Activities covered in scheme of work: Portraiture, Pablo Picasso, The Camden Town Group. Visual- Research, Drawing, Painting, Collage, Photography' Ceramics, Sculpture and Printmaking, Earning Objectives: To experiment with various tool-s and techniques, to use colours and materials to

40 create images and objects. To investigate art, design & craft from different cultures, develop new skills through practical making activities .Harry is a very talented student to work with, working well with the right adult to support he has a natural flair for art. His drawings are energetic and full of energy with an amazing illustrative style, which he of often uses to communicate his current interests. After an initially difficult adjustment into lessons he has settled into his 1:1 lessons well although he still usually opts out of his art lessons with Gold Group, during the Wednesday sessions he has continued to make line drawings as well as using the computer to produce art. We are currently working upon a ,.rewards system were he has short timed activities geared around his choice which I would hope will eventually encourage him to use different media such as paint and print and work on a larger scale. I would also like to see Harry work more from still life in order to advance his observational skills. He is always an entertaining character to have in the lessons.‘ Ryan McClelland 2008

This is about me…….

41 Line drawing in the Art room

Creative Projects

42 Doing a group dance

PSHE: Healthy living

43 Out and about with Dad and Peter

Working in the Tutor group

44 With Mum at the library

Receiving an achievement certificate from Tim

45 Me, Nick[Pink Floyd] and Pete!

Good luck, we shall miss you! Nitesh, Daniel, Nina and Andrew

46 ‗The Hoffmann Foundation for Autism has been providing services for people with autism since 1953, initially starting with children and later specialising in services for adults. In addition to the day centre, we have 6 residential homes, a home under the Supporting People scheme and an Asperger's counseling service and social skills group.

The day centre occupies a large Victorian house with a garden and workshop annex. This gives students the necessary space to develop basic skills, freedom to be alone, areas for relaxation and an outdoor area for gardening and sport. The day service offers structured programs, to enhance communication, independent Harry’s Drawings in PowerPoint Presentation 2006 (see attached video) living and leisure skills. The timetable is designed to suit the

needs of the individual and enhance his/her potential. Activities Hoffmann Day Centre 2007-2009 include basic education, cookery, art and crafts, music and drama, all based at the centre; horse riding, swimming and other leisure activities, in the community. We also provide outreach in users' homes, at work or college. Exhibitions of user art work are a regular feature of the day service.‘

47 Daylight Day Centre 2007-2009.

Effect on our Family Life.

Since Harry had the MMR, there had been an enormous strain on our family. We had not had a holiday abroad since Harry was 6 months old. We used to go to Portugal because we had a property out there. Since then we had not been able to go at all.

JHR and I could not go out at night as a couple. We could not do trips together as a couple.

JHR frequently went to bed very early at about 8.30 pm and she got up very early in the morning. I went to bed later than her and got up later in the morning, about 6 to 7 am. We needed to do this so there was an overlap and one of us would always be there to care for Harry. Sometimes Harry was up and about at 4 am in the morning.

We had not been able to make friendships, invite people round to our house and socialise as we used to.

The only friends we met were our children's friends.

I started working from home shortly after Harry was diagnosed as autistic. Harry had always needed constant supervision. Getting good childcare had been a problem. JHR continued working for many years but she has practised part time in recent years. She has been concentrating mainly on writing, paperwork and the family house.

JHR had to work part-time from when Harry was 5 years old. She had to spend time with him in order to teach him to speak again. It was during the recession in the 90s, and my work had taken a slump. It had a major financial effect on us. JHR would have worked full-time, but Harry was becoming very anxious at the

49 time, withdrawn and always running away. The Tavistock Centre said that if JHR personally did not spend much time teaching him to speak ―he would withdraw from planet earth". He had to be watched every second for safety reasons. No nanny could do this.

JHR and I had sustained a huge loss of earnings over the years since Harry was affected by the MMR vaccination. We had a beautiful house in Highgate which was repossessed because we could not afford to maintain it, on account of our need to be with Harry constantly, so that our earnings were drastically reduced.

We currently live in a four bedroom house in North London, a terraced house. Harry had a separate room to his sister and he was happy to play in the garden or climb trees. He had a very poor sense of danger and we therefore had locks on all the doors and windows. Whilst Harry would not necessarily jump out of a window,-he would quite happily sit on a windowsill several stories up and not fully appreciate the risk that he was placing himself in.

These windows therefore only partially open. Similarly, Harry could be quite destructive. If I had left any of my own tools around, Harry had a tendency to pick them up and start hitting the walls with them and we had a number of places where he had broken plaster off after hitting the wall with a hammer. I myself am still working in a family run business developing leisure facilities. JHR was also assisting me with this dealing with the contract legal aspects of the business as well as here practice as a barrister.

Harry's security had always been a problem for us. One of our nannies was not so vigilant, and Harry ran off from the 1 O'Clock Club at Parliament Hill NW5. Another time he ran across a field, and on another occasion he went missing in the woods when he was out with me, and he was rescued by a police helicopter.

JHR and I had to sleep in separate rooms. Harry often wanted to be with one of us or got up very early in the morning.

We had to go out alone if at all. We never got to go out to the opera anymore for example.

We always seemed to take turns in looking after Harry.

I used to like to play golf, but I only managed to do that about four times a year, if that. I used to like to play every week.

Francesca is a responsible girl. Her friends liked to stay over but unfortunately this could be embarrassing for her because Harry liked to take his clothes off.

Harry was very enthusiastic about swimming. Sometimes when we got to the baths he took his coat off and he had nothing on underneath. This could be a problem if we went shopping and Harry decided to take his coat off in a shop. He had been known to be naked under his coat.

Harry's Prognosis

Harry's future was uncertain. We worried about his safety. He had no sense of danger and needed constant supervision.

On a positive note, Harry loved CD-ROMs, at home he was very competent at using the computer, and we had seen some improvement since he had been taking the homeopathic treatment. The Tavistock Centre said Harry was very intelligent. He was artistically and musically gifted, with a lovely singing voice.

Vaccine Damage Compensation Unit

We did make a claim to the Vaccine Damage Payment Unit (‗VDPU‘) on behalf of Harry but our claim was turned down. We understand that this was not unusual. No ASD claims have succeeded before the VDPU.

Continuing Symptoms/Regression and Other Problems

As Harry got older we could not go out walking with him as he would try to escape. He had no sense of danger. On one occasion when Harry was in the toddler's playground he went missing. He managed to get out of the gate and onto the road. This happened a number of times. He could manage to crawl through a hedge and go missing.

We used to regularly visit Hastings where JHR's mother lived for holidays which Harry enjoyed immensely. We would go to the country park near to JHR's mother's home. I would get up early with Harry and we normally go for a walk through a wooded area. Harry would like to take the same route, to climb the same trees and sit on the seats throughout the woods and we would had a regular routine.

On 1 November 1999, when I was out walking with Harry in the woods, Harry went down a path and went out of sight. I kept returning to the trees that I knew Harry recognised and eventually I discovered that Harry was at the first tree. The following day, the same thing happened again. Harry walked off on his own and just turned off down the path and subsequently went off to the beach. I had to contact the police who later picked Harry up in a helicopter and lifeboat raft. He was found down by the cliffs where the tide was coming in on the beach. He had been found at the foot of the cliffs where he had taken off all his clothes and unknowingly had had a wonderful time.

Statement of Carol and Martin Bailey

Harry always struck us as a very lively, bright and responsive baby. As our only nephew, and with two boys of our own, we were very interested to watch him as he met and clearly enjoyed the world around him. We had a clear recollection even at this distance of happy giggling when we played a sort of peek-a-boo game with him for a few minutes while his Mother was holding him.

We certainly noticed nothing untoward about Harry's development during his early months; he was well advanced both physically and mentally.

We saw him pretty well weekly, and his progress seemed steady and sustained despite snuffles and minor bugs that afflict all babies. However, when he was about a year or so old, he developed what seemed a feverish cold which clearly made him feel wretched, made him very grizzly, and which followed an inoculation which we were told had been against a bundle of common illnesses including measles, mumps and German measles. Initially one assumed that the condition was attributable to a mild reaction against the injection; when his indisposition continued for several weeks, one forgot the injection and simply assumed that Harry was just suffering from prolonged sniffles.

It was after this that we first noticed that something about his manner had changed: he was not responding to people as he had done. After he had' finally shaken off his "cold", he seemed both oddly energetic and yet not interested in anything much. By now he was very mobile, rushing about the room, clambering up furniture and bookshelves. Over the next few months he noticeably failed to begin speech. He was also, now, quite clearly hyperactive and uncontrolled. He would not look one in the face, seeming to ignore everyone else unless he needed something from his parents.

53 From then on, it became clear that there was a major problem and that Harry was not simply going through a difficult phase. He had been a normal, happy, open, inquisitive baby, and had turned into a little boy who would not and could not engage with other people. His speech failed to develop; he could not dope with loud sounds, he seemed very rigid and unable to accept any compromise about what he wanted, and yet was wholly unable to explain what that might be. Inevitably, therefore, he appeared utterly frustrated and miserable, rather than happy and fulfilled.

Andrew Wakefield, MB, BS, FRCS, FRCPath. (Harry’s Biopsy)

7 February 2002 Dear Mr. Horne-Roberts

I am writing to you to give you the results of detailed analysis of H's biopsy tissue taken at the Royal Free Hospital. An extra copy is enclosed for passing on to your (GP. This biopsy was done as part of an investigation into your child's symptoms, and the possibility that the measles virus may be playing a part in the inflammation that has produced these symptoms.

This testing was carried out at the Unigenetics Laboratory at the Coombe Women's Hospital, Dublin by Professor John O'Leary and his team. Professor O'Leary is a molecular pathologist (he specialises in identifying at a molecular level, organisms such as viruses, which are affecting the tissues around them and causing reactions such as inflammation). Professor O'Leary uses up-to-date technology, which allows the identification of viruses even when they are present in very small numbers, and allows the virus to be identified within the cells it is infecting in the small biopsy sample available.

Professor O'Leary's technique identifies the virus present by detecting part of the gene of that virus. Measles virus genes are responsible for making certain proteins and other substances that are required for the measles virus to be able to copy itself, or replicate, in the body. This is how the virus spreads through the body. The main genes that can be detected for the measles virus are called F, N, M and H. Professor O'1 vary and his team use two techniques to detect the F- and the N-gene respectively. These two techniques are called TagMan PCR and In-cell PCR. TagMan is used to detect the F-gene, and In-cell is used to detect the N-gene of the measles Virus.

55 The tests carried out on H's sample showed that there was evidence of measles virus in the biopsy tissue. A copy of the result from the Unigenetics Laboratory is enclosed with this letter. You will see that the results page has been signed by Professor O'Leary who has personally checked the contents of the results. He has also included the working notes made during the analysis, and other technical information relating to the testing procedure. These techniques use state of the art technology and while there may be false negative results (the virus is present in the child but cannot be detected in this particular sample) it is extremely unlikely that this positive result is caused by anything other than the measles virus. In H's biopsy at least one of the tests was positive for the presence of measles virus. The implications for [larry's health are unclear. We are currently working hard to understand how measles virus may be causing tissue damage in your child with a view to developing possible treatments_ Persistent measles virus infection has been associated with inflammation and disorders of the immune system, mid it may be that these will resolve over time.

Unfortunately, this type of testing does take a long time to complete and I am sorry that you have had to wait for these results to be sent to you. Because very little research has been done on viral infections persisting in children with disorders such as autism or inflammatory bowel disease, the analysis of these cases had to be set against "control" cases (cases which had been admitted for colonoscopy for other reasons), and to ensure that these results are scientifically admissible, publication of the results (using anonmnised data) in a fully peer reviewed, scientific publication is essential. A copy of this study is enclosed.

As you may be aware I am no longer at the Royal Free Hospital, but I am still very much involved in investigating the cause of there problems, and acting on the children's behalf. Thank you for your help and patience in this matter. A Wakefield MB, BS, FRCS, FRCPath

56 Dr Andrew Wakefield, MB BS FRCS FRCPath, is an academic astroenterologist. He graduated in Medicine from St. Mary's Hospital, part of the University of London, in 1981, and pursued a career in gastrointestinal surgery with a specific interest in inflammatory bowel disease. He qualified as Fellow of the Royal College of Surgeons in 1985, and in 1996 he was awarded a Wellcome Trust Traveling Fellowship to study small intestinal transplantation in Toronto, Canada. Discoveries made during his time in Canada led him to pursue the scientific investigation of inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. In 1998, he and his colleagues at the Royal Free Hospital reported a novel inflammatory bowel disease in children with developmental disorders such as autism; the condition later became known as autistic enterocolitis. No stranger to controversy, Dr Wakefield resisted pressure to stop his research on the possible links between childhood immunisations, intestinal inflammation and autism, and left the Royal Free School of Medicine in 2001. He is involved in many scientific collaborations in the US and Europe. The main focus of Dr Wakefield's research is an investigation of the immunologic, metabolic, and pathologic changes occurring in inflammatory bowel diseases such as autistic enterocolitis, links between intestinal disease and neurologic injury in children, and the potential relationship of these conditions to environmental causes, such as childhood vaccines. During the course of his work on childhood developmental disorders, Dr Wakefield became increasingly convinced of the need for a research-oriented, integrated bio-medical and educational approach to these disorders in order to translate clinical benefits for affected children into measurable developmental progress. Dr Wakefield has published 132 original scientific articles, book chapters and invited scientific commentaries and was awarded the Fellowship of the Royal College of Pathologists in 2001. He is medical advisor to the United Kingdom charity, Visceral, and is the Executive Director of the not-for-profit organisation Thoughtful House Center for Children in Austin, Texas.

57 JHR’s digest of Claimants’ Experts’ Reports in UK MMR/Autism litigation.

In total this evidence substantiates the Claimants‘ case for MMR: Regressive Autism link to the civil standard of proof i.e. the balance of probabilities.

Index of the Reports:( Full reports on discs attached:)

Abou Donia: Mohamed B. Abou-Donia, Professor of Pharmacology and Cancer Biology,Duke University Medical Center, Durham, North Carolina 27710

Aitken: Dr.Kenneth J.Aitken, Independent Consultant Child Clinical Neuropsychologist, K.Aitken Consultancy, 57 Leamington Terrace,EDINBURGH, EH10 4JS.

Banks, Professor, Roles of the Blood-Brain Barrier in MMR

Bilsky, Dr. Edward Bilsky, Associate Professor of Pharmacology,University of New England College of Medicine: ―Molecular Mechanisms to Account for Proposed Developmental Neurotoxic Outcomes Following Exposure to the MMR Vaccine‖.

Bradstreet: Dr. James Jeffrey Bradstreet, MD, Fellow, AAFP, Founder & Director of Clinical Programs, International Child Development Resource Center, 1688 West Hibiscus Boulevard, Melbourne, Florida 32901

Byers, Dr.Vera S. Byers, MD, Ph.D.

Castagnoli: Professor N. Castagnoli

Cotter: Professor Finbarr E Cotter, Mb, Bs, Frcp, Frcpath, Phd

Fletcher: Dr A Peter Fletcher MB BS PhD FFPM (Dist)

Harpaz: Noam Harpaz: Associate Attending Pathologist, The Mount Sinai Hospital, Director, Division of Gastrointestinal Pathology, The Mount Sinai Hospital, and Associate Professor of Pathology, The Mount Sinai School of Medicine, New York.

Kennedy: Professor Ronald C. Kennedy, Ph.D. Professor and Chairman of the Department of Microbiology and Immunology at Texas Tech University Health Sciences Center, Lubbock, Texas.

Kinsbourne: Marcel Kinsbourne, D.M. (OXON), M.R.C.P. (LOND). Research Professor of Cognitive Studies at Tufts University and Professor of Psychology at the New School University in New York.

Krigsman: Arthur Krigsman. Pediatric Gastroenterologist, New York University Hospital in New York City. Specialting in pediatrics and pediatric gastroenterology. Consultant pediatric gastroenterologist at Lenox Hill Hospital in New York

March, Dr John March, Head of Mycoplasmology at the Moredun Research Institute (MRI), Edinburgh. ―MALDI-TOF-Based Profiles of Urine Samples Obtained from Autistic Children and Age/Sex-Matched Control Children‖ .

Marchalonis, JOHN J MARCHALONIS, Professor and Chairman of Department of Microbiology and Immunology of the University of Arizona, College of Medicine, Tucson, Arizona

McFadden, Professor Johnjoe McFadden, Professor of Molecular Genetics at the School of Biomedical and Life Sciences, University of Surrey, Guildford.

Menkes, John H. Menkes, M.D. Professor Emeritus of Neurology and Pediatrics

59 University of California, Los Angeles, Director Emeritus of Pediatric Neurology Cedars-Sinai Medical Center.

Montgomery, Scott M Montgomery

O'Leary, Professor John J. O‘Leary, MD, DPhil, MSc, BSc, FPathRCPI

Shapiro, Samuel Shapiro MB, FRCP(E), Visiting Professor of Epidemiology. Mailman School of School of Public Health, Columbia University, Emeritus Director. Slone Epidemiology Center. Boston University School of Public Health.

Sheils, PhD, FAMLS

Stott, Dr Carol Stott BSc (Hons) PhD (CANTAB) C.Psychol, Chartered Psychologist, University of Cambridge Senior Information Manager, Cambridge and Peterborough Mental Health Partnership NHS Trust

Suissa, SAMY SUISSA, Professor of Epidemiology and Biostatistics McGill University and Royal Victoria Hospital Montreal, Canada

Tedder, Professor Richard Tedder, am the Head of the Joint Department of Virology, sited on the Bloomsbury campus of University College London.

Thompson, Professor Edward J Thompson. MD, FRCP,FRCPath, DSc,PhD, Head of the Department of Neuroimmunology, National Hospital for Neurology & Neurosurgery.

Wakefield, Dr Andrew Wakefield MB BS., FRCS., FRCPath, Senior Medical Adviser to the UK charity, Visceral.

Walker-Smith, John Walker-Smith. I retired as Professor of Paediatric Gastroenterology at the Royal Free and University College

60 Medical School on 1 0ctober 2000. I am now Emeritus Professor of Paediatric Gastroenterology in the University of London

Wood, Troy D. Wood, Departments of Chemistry and Structural Biology, Natural Sciences Complex, University at Buffalo, Buffalo, NY 14260-3000

We refer to Dr. Wakefield‘s letter of 7th February 2002 attached and to the Eunigenetics Ltd report for Measles Virus Detection for H H-R, dated 9th July 2001.

Subsequent evidence has also come to light on which I wish to rely. i)Dr. Fletcher's letter to the LSC (August 20, 2004 and September 4, 2004)- copies attached. ii)Notes of three reports challenging the findings of the Madsen Report relied upon by the Defence. iii)Statistical evidence concerning ASD by F.Edward Yazbak. MD. iv)Report of Japanese case in which compensation was awarded to ASD claimants for injury caused by MMR (translation of the judgment of the case is in preparation. v)Bradstreet, Wakefield et al. Article Jl. Of American Physicians & Surgeons- Summer 2004,

The Claimants‘ evidence taken as a whole (and I refer also to our earlier submissions on behalf of our son) makes a convincing case for a causal link between MMR and regressive autism. Much of the expert evidence such as that of Dr Wakefield and his team, in very strong. They are fully backed up by other expert witnesses.

There exists a very strong case therefore that the trial of this action should proceed. In order for that to happen legal aid needs to be restored. A High Court

61 action is now essential in view of the widespread public interest attaching to this issue.

Professor Walker-Smith, formerly of the Royal Free Hospital and now of University College London, Paediatric Gastroenerologist, reports on the link between ileal ( and maybe colonic) lymphoid nodular hyperplasia (LNH) and autistic spectrum disorder(ASD) in the lead cases in this litigation and as set out in the Lancet paper of Wakefield at al in 1998. That paper looks at the inflamatory disorder ileal LNH and non specific colitis in 12 ASD children. That study was extended to a total of 60 children with development disorders in the Lancet paper of 2000 by Wakefield at al. Most children of the group had ASD, though a few had ADHD or schizophrenia. There was a control group of 37 normal children for the purpose of the study.

ProfessorWalker-Smith confirms the findings that ―inflammatory disorder of the ileo-colon described by Wakefield at al‖ was not the classic IBD(inflammatory bowel disorder) but appeared to be a new variant inflammatory disorder. He states it his report that ―from subsequent publications it appears to be part of a more general abnormality of the gastro-intestinal tract in children with ASD‖.

Professor Walker Smith responds to the Defence argument in the case that ileal LNH is ―normal in any young child‖ by flatly contradicting that assertion; ―such enlargement is not normal‖.

Dr A Krigsman described a similar syndrome in his study of ASD children in the USA. The term ― autistic enterocolitis‖ had been coined by Wakefield‘s team to describe the disease process. Professor Walker-Smith noted that the profiles of all the lead cases in the litigation fitted this description.

62 Dr Wakefield in his first report calls for further studies on ―a new varaint of inflammatory bowel disease present in this group of children with development disorder‖ i.e. the association between the brain and gastro-intestinal dysfunction in children with a ASD.

H H-R symptoms are consistent with this work-see Dr Wakefield's letter of February 2, 2002.already submitted. There are further published reports including that of Wakefield and Walker-Smith in Jl. of Paediatric Gastro. And Nutrition 2003; 4:539. inter alia.

Dr Wakefield's examination of the evidence and reports establishes that ―autistic enterocolitis is consistent with a viral disease‖. He states at . 92 ―on the balance of evidence, autistic enterocolitis is a novel pathology of viral aetiology, as set out in diverse medical journals by a variety of authors. He concludes ―autistic enterocolitis is a viral disease‖

In his second report Dr Wakefield summarises from his and other studies: ―It is widely recognised that measles viruses (MV) can infect the intestine, and particularly the lymphoid tissue terminal ileum and appendix‖. He concludes ―MV infects the intestine during the acute infection and the infection can cause intestinal LNH and mucosal inflammation‖.

From the evidence of Dr O'Leary and Dr Sheils of Unigenetics which also form part of the expert evidence in this litigation he points to ―persistent MV infection and immuno deficiency in children with autism, ileol- colonic LNH and nonspecific colitis‖.

H H-R has MV in his body (see the findings of Dr O'Leary's team) as well as ASD, so his symptoms are consistent with these findings. They are also

63 consistent with H's GP‘s records and his parents evidence of what happened to him following his MMR jab.

The technology of the detection of MV in the children including H H-R is as set out in thre report of Dr. Sheils. See also Prof O‘Leary‘s report.

Dr. Wakefield concludes that ― the data indicate the possibility of acquired immunodeficiency and persistent MV infection of Ileal lymphoid tissue in children with non specific colitis and autism‖ and ― the results are consistent with the presence of a persistent viral infection in affected children‖.

Dr. Singh gives evidence of elevated MV antibody in children with ASD, Dr. Wakefield states; and the study Oleske and Singh concludes ― the findings are consistent with a measles virus aetiology for autism in the relevant children‖.

The vaccine strain measles is found in H's biopsy, his IBD and ASD are all- consistent with the above research.

Another of Dr Wakefield's conclusions is that that ― in a genetically susceptible child, infection with a lymphotropic virus can cause autistic regression, associated with LNH and gastroenterological symptoms‖.

It is accepted that precisely how the gut-brain axis operates in the genesis of neurological injury is not known.

In my submission there is ample expert evidence to establish the link between vaccine strain MV, i.e. MMR and ASD in this case.

In the Thalidomide case reported in 1966 compensation was awarded despite the mechanism of damage not being understood.

64 Finally in his second report Dr. Wakefield asks: ―Do the aggregate findings on the balance of probabilities confirm that MV is the cause of entrocolitis and encepholopathy?‖ The answer is ―Yes‖. In his overview of the 8 lead cases his opinion is that ― the cause or contributory cause of ASD is MMR‖.

There is ample evidence therefore to justify this case proceeding to trial, and for the resoration of legal aid. Denial of legal aid would deny these children access to justice.

Dr. Fletcher in his report on: ―Granting of product licences (PLs) to three combined measles vaccines-a Pluserix, then Immravax a MMRII-a regulatory viewpoint‖ concludes, having examined data of the eight lead cases, that: ―in my opinion the only possible conclusion is that the administration of the MMR vaccine caused an auto-immune response in certain susceptible children which was responsible for the production of the auto antibodies which, in turn, caused physical damage to the hypothalamic/pituitary system resulting in depression of vasopressin and severe disturbance to temperature-control‖.

"There is very little doubt that MMR vaccination causes the development of autistic disorders in certain susceptible children.. This conclusion is strongly supported by the report of the exacerbation ( positive rechallenge) of autistic symptoms in one of the cases following a booster dose of MMR".

His report also highlights the lack of proper clinical trials by the Defendants before MMR was introduced, and the fact that requisite testing in accordance with the law was not complied with before the British Government, wrongly, granted product licences for MMR.

"There is no doubt that no UK studies had been completed by the date of the application (or indeed, by the time of the granting of the Product Licence) and that no reports were presented‖.

This evidence is a devastating indictment of the Defence case.

Dr O'Leary in his report states ―we have found the presence of measles virus RNA in gut samples, blood samples, cerebro-spinal fluid and brain tissue from tested children‖ and ―I conclude MV is present and that it is likely to have a triggering role in the pathological lesions observed in these children‖.

Dr Shiels in her report explains the mechanism of the findings she states: ―Among gut tissue biopsies examined there was a statistically significant biological association between presence of detectable MV and children whom we were told had ASD. The incidence of detectable MV was strikingly lower among children with normal development. Also as a result of our findings of MV in peripheral blood samples of Claimants, and given that where sufficient viral target was present, the detected virus was consistent with vaccine strain. I am of the opinion that such prolonged persistence of the virus is implicated in the disease process‖.

Dr Krigsman In his Report as to Findings of Enterocolitis in children with ASD reports on the group of ASD children referred to him complaining of gastrointestinal problems.

In 1999 a colleague had asked him to examine a few autistic children with persistent and unexplained gastrointestinal complaints. He says that: ―Upon learning of the Royal Free Hospital's IBD group reports of consistent patterns of colonic mucosal histopathology I checked for similar pathology in my patients‘ gastro-intestinal tracts. To my surprise I discovered the same‖.

He states: ―It is my view that my findings represent a new variant of an old disorder-namely a unique form of enterocolitis with previously undescribed and unrecognised symptom expression that appears to exist solely in this group of patients with ASD‖

Dr. Abou-Donia of Duke University of Durham North Carolina. In his "Report of testing of serum and cerebrospinal fluid for auto antibodies against biomarker proteins for autism and neurological deficit" states that the presence of auto antibodies in all 6 lead cases referred to him is consistent with the diagnosis of autism.

Dr. Aitken's Report. "Investigation into the pattern of development observed in a cohort of ASD individuals receiving both an initial and the second booster of attenuated live MMR vaccine, compared to a similar diagnosed group who have experienced a single exposure to a combined MMR vaccine"

He quotes Stretton, Howe and Johnson Jnr 1994 in line with what his findings in the case of an MMR exposure link to autism that " causality is strengthened by evidence that the risk of an outcome increases with higher doses or frequent exposure".

Professor Banks in his report as to "the role of the blood-brain barrier in the MMR cases" refers to virus in the blood leading to viral infection in the brain.

Dr. Bilsky in his Report: ―Modular mechanism to account for proposed developmental neurotoxic outcomes following exposure to the MMR vaccine" concludes that: a) There is a link between MMR vaccination and changes in the Claimants‘ gastrointestinal and immune systems, behavior and development; b) Alterations of opiodergic tone i.e. re opioids whether exogenous of the body and/or endogenous i.e. produced within the body) have negatively affected the lead Claimants in terms of gastro-intestinal and immune functions behaviour and development;

67 c) Preliminary urine test results suggest key differences between cases and controls in terms of the number of peaks, intensity of peaks and level of opioid peptides.

Dr.Bradstreet In his report concludes that ―measles virus of vaccine origin (based on gut findings) is at least one aetiolological agent of ASD‖. In supporting and validating the findings of Dr Wakefield at al he describes this work as ―the most stunning discovery of my career‖ i.e. that vaccine strain measles has set up a persistent and symptomatic presence in the brain of children with encephalopathy and autistic features.

Dr. Byers in her report deals with clinical and scientific issues concerning MMR vaccines, its effect on the human immune system and bowel pathology, and its possible association with immunological dysfunction, persistence of the MV in blood, gut and CNS, including its possible cause of neuropathology.

She concluded that: ‖Most of the children suffered from acquired immunodeficiency/immunodysregulation after their MMR vaccination and that the transitory immunodeficiency allowed the measles strain of the virus to persist in their bodies. This persistent presence of MV and concomitant, unsuccessful chronic inflammatory process caused the production of proinflammitary cytokines in the gut lesions, and entered the blood. These proinflammatory cytokines are neurotoxic and can pass the blood brain barrier, causing a disruption in the normal development of the brain".

Professor Castagnoli reports on: "A plausible link between the trivalent MMR vaccine and the development of regressive autism". He summarises the findings and conclusions of the other peptide theory experts for the Claimants-Bilsky, Banks, Wood and March, in examining the mechanism by which atypical IBD could lead to ASD in these children (compared with the control groups).

68 He views his "results as fully consistent with a mechanism of neurological damage that would be mediated by exposure to toxic agents at the time of the administration of the MMR vaccine".

Moreover "it remains plausible" that "exposure of the developing brain to excess of biologically active exorphins could alter gene expression and be responsible for the absence of low levels of endorphins found in the urine samples of the autistic children".

Professor Finbarr Cotter; report detailing the testing undertaken to investigate the presence of the measles virus in the various biological samples, as a replication/validation study of the findings of Eugenetics Ltd (O'Leary/Shiels). He confirms these findings.

Dr. Harpaz. Reports on and evaluates: "The pathology and endoscopic biopsies of one or more groups of children with neurodevelopmental disorders who underwent endoscopic examination as part of their management for digestive disease".

He concludes that the ASD children "show a high prevalence of evidence of idiopathic lower gastro-intestinal inflammation in intestinal biopsies" and that "it is likely that there is indeed some common underlying intestinal disorder, the nature of which is not defined"

Professor Kennedy: reports on the MMR vaccination and any association between the vaccine and a new disease entity termed "autistic enterocolitis" and between MMR and ASD.

Professor Kennedy surveys the lead Claimants and concludes: "The presence of an immune dysfunction resulted in an inadequate immune response to MV following MMR vaccination to allow for clearance of the MV from the host. The persistence of the MV in the immune dysfunctional host at a time when the

69 functional immune response should have cleared the virus is an unanticipated result. MV in a gut would be expected to result in gut disorders. MV in the CSF would result in CNS disorders similar to that reported in the literature for MV and morbilliviruses". He then states: "These conclusions are supported by literature described above and by clinical and laboratory virology and immunology evidence amongst these Claimants".

Dr. Kinsbourne‘s report concludes: "While scientific certainty is not yet available for several links in the causal sequence, and much research remains to be done, it is my opinion on a preponderance of the scientific evidence that MMR causes or significantly contributes to the causation and/or aggravation of autism". The legal standard of proof is met here even though the science remains to attain the 100% proof standard.

Dr. March reports on urine testing of the Claimant ASD children compared to a control group. The testing was designed to shed light on the mechanism of neural damage pleaded in the Amended Particulars of Claim known as the "opioid peptide mechanism".

He used mass spectrometry to test the urine and stated "our work to date actively supports the opioid peptide mechanism of damage in that "we have identified clear differences in the urinary profiles" of autistic children compared to controls. "This provides significant support for the opioid peptide mechanism of neural damage.

Professor Marchelonis, immunologist reports that the MV virus is known to be neurotropic and capable of causing neurological problems of many sorts. He also states: "Since MV is an RNA virus where frequency of mutations is relatively high, it would be expected that long-term persistence of replicating virus would generate variants capable of attacking the nervous system and gastro-intestinal system as well as other parts of the body". Moreover: "The length of time of

70 persistence of the virus would increase the probability of unexpected deleterious consequences".

Professor McFadden reports that: "If the Court accepts that active MV replication in the central nervous system is specifically associated with autism then the likely implication is that infection with MV plays a role in the disease". Here again the standard of proof is met on the balance of probabilities.

Professor Menkes, of the University of California reports: "To my knowledge the presence of a virus in CSF in a human with neurological disease has heretofor been demonstrated to be invariably pathogenic, and reflects the presence of virus within the brain. The absence of measles vaccine virus from the CSF of control subjects will strengthen this argument".

Dr. Scott Montgomery reports on the epidemiological evidence for a causal link between MMR and ASD. He expresses serious concerns as to the Madsen Danish Register Study (2000)refuting the MMR link, which is relied on by Defendants. The Report is seriously flawed. He concludes that the identity of viral material in patient tissue (Uhlmann study of 2002) may represent a useful marker of an ASD phenotype associated with MMR exposure that can be used to investigate causation".

Professor Shapiro reviews the epidemiological evidence concerning the relation of MMR vaccination to the risk of autism and summarises the range of opinion as reported in the medical journals. He too states that the Madsen Report is flawed and unacceptable. He states: " This study cannot be interpreted as having ruled out of increased risk of autism in MMR recipients"

Dr C Stott and Dr Scott, of Cambridge University, Psychologists, report assesses the statistics relating to the MMR: ASD link. They conclude: "It is our overriding opinion that the putative effects of exposure to measles containing vaccine must also be seriously considered as a primary contributory factor".

Professor Suissa of McGill University in Montreal, Canada, reports epidemiological issues concerning the MMR vaccine and the risk of autism. He views the Madsen Report's methodology as unacceptablly flawed. " I conclude that this study does not give any reliable answer to the question of whether MMR vaccination does or does not increase the risk of autism".

Professor Tedder of University College London, Virologist, reports on the detection of MV genome by Tacqman PCR as described by Dr Shiels and Dr O'Leary. He concludes that a) the Tacqman assay for measles RNA is sensitive, reproducible and specific, b) the components of the assay are appropriate: in noting their findings of "the measles RNA in the blood CS F and tissue of some children who have previously received measles vaccine‖.

Professor Thompson of the National Hospital for Neurology and Neurosurgery, Neuroimunologist., report examined six of the lead cases but found "no evidence for the production of antibodies within the brain‖.

Professor Troy Wood of the University of Buffalo, New York, ― LC-MS/MS Studies on Isolates from Urine Samples Obtained from Autistic and Control Children‖ : reports on LC-MS/MS studies on isolates from urine samples obtained from autistic children in the case and control children. He confirmed that opioid peptides have been detected in the urine at higher levels in patients with ASD compared to control patients, matched for sex and age. He notes that this has recently been confirmed by the Reichelt Group.

Conclusion: Accordingly the evidence is strong in favour of the Claimants, and the restoration of legal aid fully justified. To deny legal aid would be to deny access to justice for these severely injured children. As Mr. Justice Keith stated in his CMC judgment of 30th July 2004, ― the withdrawal of legal aid is hardly an advertisement for British Justice‖.

72 Dr. Peter Fletcher ‗I write in respect of MMR litigation for which the LSC has withdrawn legal aid. I am an Expert for the claimants and following the termination of the action have been approached by a number of individual parents considering the continuation of the case on that basis. I have agreed to provide them with expert opinion to the best of my ability. I was appointed as an Expert by the solicitors Alexander Harris as I had been a Principal Medical Officer in Medicines Division of the Department of Health (DHSS in those days) and was the Medical Assessor to the Committee on Safety of Medicines and later was promoted to Senior Principal Medical Officer and Chief Scientific Officer in charge of Scientific Services for the NHS. I understand from the Press Release dated 27 February 2004 that legal aid was discontinued on the grounds that the case had no reasonable prospect of success. As an Expert for Alexander Harris (solicitors) I was provided with a very large amount of information relating to the three triple vaccines that are involved and this included detailed records of the eight children selected as the lead cases. The three/four defendants gave disclosures extending to about 25,000 pages of which 4,500 dealt specifically with the lead cases. I have also been provided with the full expert reports from the defendants. I have also been sent the most recent Judgement of Mr Justice Keith concerning the case management conference on 26 and 27 July 2004. This refers to the probability that relevant evidence, which was available at the time of the original LSC decision, had not been evaluated in the decision to withdraw legal aid. I have also heard from colleagues and others that the decision of the LSC was based, almost exclusively, on scientific, pathological, biochemical and endoscopic evidence and, essentially, paid no attention to the purely clinical aspects of the lead cases. Mr Justice Keith also drew attention to the fact that the assessment made by the LSC was confined to claims in respect of just two adverse effects (AEs), autism and chronic inflammatory bowel disease, whereas several other AEs were implicated. He suggested that this may be a mechanism by which the

73 claimants could continue the case. With regard to his two points, the matter of unconsidered evidence and the extention of claims, there is no doubt whatsoever that the medical histories and clinical signs and symptoms of the lead cases (and others) contain information that is very relevant to the evaluation of causality. The officially approved literature in this country, the USA and elsewhere contains juvenile arthritis, Guillain-Barre syndrome, childhood diabetes mellitus and similar conditions as adverse reactions. These are autoimmune diseases so it is an indisputable fact that MMR can cause autoimmunity. It is common knowledge that the inflammatory bowel condition described by Wakefield is of autoimmune origin and there is also good evidence that a subset of autism has a similar pathology. The clinical signs and symptoms presented by most of the lead cases also strongly implicate a rare condition that is, in some cases, due to autoimmunity. Since there is no doubt that MMR can cause some well recognised autoimmune diseases there is no good reason why it cannot cause others. In support of this concept it should be understood that there is an uncommon condition known as APECED (autoimmune polyendocrinopathy candidiasis ectodermal dystrophy) which is characterised by the co-existence of several autoimmune conditions.

My opinion as given to the individual claimants is, firstly, that the LSC did not consider all the evidence that was available and thus reached a premature conclusion and, secondly, that the claimants should make clear their contention that MMR can cause autoimmune diseases, as stated in official literature, which would include autism, chronic inflammatory bowel disease and others. I understand that the Funding Review Committee (FRC) will meet at the end of September 2004 and that Mr Justice Keith will delay his final Judgement until about 20 October 2004. I would be most grateful if you would confirm that you will bring this e-mail to the attention of the FRC and that this will be made clear to Mr Justice Keith. Dr A Peter Fletcher MB BS PhD FFPM

1. Personal qualifications: Dr A Peter Fletcher MB BS PhD FFPM (Dist). 1.1 My original professional qualification is in medicine (for more detailed information see Appendix 1) which was followed by specialist training as a pathologist. The scientific aspects of pathology were my particular interest so I retrained in non-medical aspects of biochemistry, first at University College , London and then at St Mary‘s Hospital Medical School where I gained the PhD degree on glycoprotein structure supervised by Professor Albert Neuberger CBE, FRS, finally becoming a Senior Lecturer in his department. 1.2 In the mid-1970s I worked in Medicines Division of the Department of Health and also in the Toxicological Division. I was promoted to Principal Medical Officer with the title Medical Assessor to the Committee on Safety of Medicines. I gained considerable experience as the UK representative on numerous EEC and OECD (Organisation for Economic Cooperation and Development) committees and working parties concerned with the writing of Directives and guidelines.

1.3 I also gained experience in the pharmaceutical industry and after a short time running my own business I was employed by IMS (Intercontinental Medical Statistics) as their International Medical Director. IMS is the world‘s leading company providing the international pharmaceutical industry with information on medicinal products. My particular responsibility was the development of methods of post marketing surveillance and the use of computerised primary care data bases for drug safety purposes.

2. Introduction to the regulatory process 2.1 This report concerns legal claims that the vaccination of certain children with the measles-mumps-rubella (MMR) trivalent vaccine is causally related, either directly or indirectly, to the development of a clinical condition or conditions known collectively as autistic spectrum disorders (ASDs) and additionally, in some cases, inflammatory bowel disease (IBD). The report will provide an expert opinion from the point of view of the regulatory control of medicinal products which require the granting of a Product Licence (UK terminology) or Marketing

75 Authorisation (EU terminology) by the Licensing Authority before they become available to the public. In the present case the product is classified as a Prescription Only Medicine (POM) which mandatorily requires the authorisation of a Registered Medical Practitioner before it can be administered to a patient. In addition certain biological products, such as vaccines, require periodic approval or ‗batch release‘ before they may be marketed.

2.2 Before addressing the MMR case in any detail it is worth considering some of the more important general aspects of the regulatory system. In the United Kingdom it is still the Medicines Act 1968 that is the predominant legal foundation on which the licensing of medicinal products is based although the European Medicines Evaluation Agency (EMEA) and the Committee on Proprietary Medicinal Products (CPMP) are taking an ever increasing role in this function. The Medicines Act is solely concerned with the quality, safety and efficacy of products and is not concerned with the economics of drug marketing or purely social and non-clinical aspects. This is not to say that such factors do not have a secondary influence on the way in which medicines are presented to the public as, for instance, is the case with advertising and other information associated with particular products.

2.3 The regulatory system, in the first instance, has the power to grant or to refuse Product Licences (PLs) to applicants in respect of new medicinal products. The applicant is required to provide extensive data to support the product in respect of its quality, safety and efficacy which are assessed by the Licensing Authority which is assisted by advice from the committees (the Committee on Safety of Medicines (CSM) and its sub-committees) set up under Section 4 of the Medicines Act. If a licence application should be refused then the applicant has the right to appeal firstly to the CSM, secondly to the Medicines Commission and finally to a person appointed. Following the granting of a PL it is the responsibility of the Licence Holder to provide continuing evidence of the product‘s quality, safety and efficacy and also of any variations to the product or its use. In all these respects it is not in the power of the Licensing Authority to demand specific research or studies upon which the granting of a PL would be

76 conditional although informal advice may be given. For example the Licensing Authority cannot require a Licence Holder to conduct a post marketing surveillance study on a licensed product under the threat that the PL would be revoked if it were not done. In other words the system has relied entirely upon a priori advice and a posteriori retribution. The Licence Holder is thus expected to pay due attention to recommendations from the Licencing Authority, even though they have no legal force, on the understanding that if previously unknown adverse effects (AEs) do occur then the responsibility for failure to conduct appropriate post marketing studies will lie with the Licence Holder.

2.4 It is pertinent to the present legal case that so-called ‗combination products‘ which means medicinal products containing more than one active substance are regarded as ‗new products‘ when first introduced whether or not the individual active substances have current PLs. It is clear that MMR, with three active components (live viruses), was a new combination product and would be treated as such by the Licensing Authority. From the clinical point of view it would be essential to include in the data submitted with the application for a PL evidence that the combination had not altered the safety or efficacy of the individual components or had not created new effects as a consequence of the co- administration of three active materials. In the case of MMR this involves administration by either the subcutaneous or intramuscular routes. Although not legally required under the Medicines Act it is normally expected that a significant proportion of the clinical data with respect to safety and efficacy would have been generated in the UK. This would be a particularly important component of a Product Licence application for a vaccine such as MMR which would be administered to hundreds of thousands of children each year.

2.5 There are a number of factors that may influence the interpretation of data presented in an application that are not directly related to either the safety or efficacy of the medicinal product. A factor that is always of major importance is the health status of the patients concerned. In the case of a serious or potentially fatal disease then any evaluation of an effective substance would be more

77 tolerant of possible toxic reactions than otherwise. The opposite situation arises in the case of patients who are in good health and are taking the treatment for preventive purposes as in the administration of a vaccine. In these circumstances the patients can only benefit from the possibility that they have been saved from a future infection, but they carry the risk that they may suffer an otherwise avoidable adverse reaction. This is counterbalanced by the efficacy of the vaccine in controlling the spread of the disease. The balance between the risk to the individual patient and the benefit to the population is not an easy one to judge from the regulatory point of view.

2.6 Over the past three decades or so some overall opinions regarding acceptable risk levels associated with medicinal products have emerged. In the case of serious adverse effects, that is ones that involve permanent or long term disability, hospitalisation or death, an incidence of between 1 in 5,000 and 1 in 10,000 exposures would raise alarm although the need for regulatory action would depend upon the relevant clinical indications. If, for example, serious adverse effects were identified in a straightforward hypnotic (sleeping pill) at a level of 1 in 10,000 then revocation of the PL would certainly be considered, whereas in the case of a highly effective treatment for rheumatoid arthritis this could be regarded as quite well tolerated. Another factor of great importance in the solution of this difficult equation is the availability of alternative safe and effective treatments. If, for example, medical research were to discover an effective treatment for Alzheimer‘s Disease then a considerable level of risk would be acceptable but just another nonsteroidal anti-inflammatory agent would be treated quite differently.

2.7 In spite of this very general and unscientific standard, notable exceptions have arisen in which adverse effects that have been far less common than the indicative rates discussed above have resulted in restrictive action at both the regulatory and social level. An example of this, taken from my experience in Medicines Division, would be suspected carcinogenicity, possibly only found in animal studies, in a medicinal product intended for use in non-life threatening

78 conditions. In such a situation a single case in a hundred thousand or more exposures would be unacceptable.

2.8 The granting of a PL by the Licensing Authority is, therefore, based upon a judgement of the benefits and risks of a product in its intended clinical use. The clinical circumstances may change as experience with the new product increases as, for instance, in its extension to different clinical indications or in the detection of unexpected adverse drug reactions (ADRs). It is this latter situation that regulatory action may be required by the Licensing Authority.

3. The anatomy of adverse clinical events 3.1 Since 1993 I have been the author of the chapter entitled ―The Safety of Medicines‖ in The Textbook of Pharmaceutical Medicine. This book has now run to four editions, is curently published by the British Medical Association and is generally accepted as the recognised textbook for the Faculty of Pharmaceutical Medicine for their examinations. The chapter addresses the matter of the detection of such adverse events, their quantification and their causality. These three elements are the inseparable triad upon which adverse drug event reporting systems are based.

The Adverse Clinical Event Triad

1. Observation and reporting of adverse events

2. The magnitude of a potential problem

3. The elucidation of causal relationships

3.2 The interrelationships between the three elements and their essential importance for regulating the safety of medicines is probably fairly self-evident but may require some further explanation.

79 3.3 Most medicinal product related adverse clinical events originate as a series of observational reports from doctors or other health care professionals in respect of their patients. In such situations an immediate concern is the possible size of the potential problem and some assessment has to be made as to whether or not the event should be classified as serious or trivial and whether it might affect large numbers of patients or be restricted to a few susceptible individuals.

3.4 Closely linked to the magnitude of the problem is the fact that in many cases the nature of the adverse event may suggest a possible cause which will be based upon existing medical knowledge and previous experience. In some cases, however, the cause may be far from obvious either because it has not been previously described or because some considerable time has elapsed between cause and effect or because the reporting professional may not be aware of a potential relationship.

3.5 Observation, an estimate of magnitude and the elucidation of causality are thus inseparable components in the matter of safety. If we are confident of the accuracy of our clinical observations, if we have assessed the size of the problem and we have determined its cause then we will be in a good position to ensure safety.

4. The detection and reporting of adverse clinical events

4.1 By far the most commonly used system of adverse event reporting (‗pharmacovigilance‘ in EU terms) in virtually all developed countries is either the same as or is a minor variation of the so-called ‗Yellow Card System‘ in the UK. This system was developed by Professor William Inman in Medicines Division of the Department of Health and Social Security in the years between 1970 and about 1975. The generic term for this method is ‗spontaneous reporting‘ and relies upon the voluntary participation of certain health care professionals to report to the regulatory agency any observation of a potentially medicinal product

80 related adverse clinical event. Although not explicitly required this system inevitably involves a certain level of judgement in respect of possible causation on the part of the reporting professional. Professor Inman himself recognised the shortcomings of spontaneous reporting but promoted it as being the best that could be done in the circumstances.

4.2 In the chapter on the Safety of Medicines referred to above I opened the section on ‗Spontaneous Reporting‘ as follows: ―Spontaneous adverse event reporting may be defined as any system of safety data collection which relies upon physicians, other health care workers and sometimes patients to report adverse clinical events which, they suspect, may be causally related to the administration of a drug (or other medicinal products) or drugs.‖ The italics are not part of the quotation.

4.3 In the next paragraph I state that, ―It is one of those illogical quirks of new drug development that a method which is almost universally agreed to be seriously inadequate is, nevertheless, a major consideration in the organisation and running of the pharmaceutical company medical department. For this reason alone it is necessary to look into spontaneous reporting systems in some detail. Misunderstanding and confusion start at the very beginning. Is the clinical condition that is the subject of a report an event or a reaction? At the very least, in the eyes of the reporter, it is potentially an adverse reaction, as there was the suspicion of a causal relationship with a drug or drugs. For the personnel of a regulatory authority, who receive thousands of such reports every year, the perception may be totally different, knowing that the reporting doctor usually has little evidence to support an attribution of causality. This is no fault of the doctor, as the well known common ADRs are of little interest and the uncommon ones are so infrequent that any individual doctor may only observe a handfull in his/her entire career. The reporting doctor thus has no frame of reference by which to assess possible causality and has to fall back on clinical judgement, which is largely subjective.‖

81 4.4 I have included these quotations in full even though they were first written a decade ago since the situation remains unchanged and is pertinent to the present legal case. Virtually all the clinical safety studies on the various formulations of MMR have relied upon spontaneous reporting and, therefore, suffer all the limitations imposed by that method. The essentially voluntary nature of the system results in a high level of underreporting which has always proved difficult to estimate with any confidence. In the late 1980s and early 1990s more active monitoring systems had been developed which created the possibility of making comparisons with spontaneous reporting.

4.5 In 1991 I published a paper in the Journal of the Royal Society of Medicine on a number of large scale, observational cohort studies which provided an opportunity for such a comparison to be made [Fletcher AP (1991) Spontaneous Adverse Drug Reaction Reporting vs Event Monitoring: A Comparison J. Roy. Soc. Med. 84 341-34].

4.6 The design of these observational cohort studies required the participating doctor to complete a form every three months for the 1 year duration of the study which recorded all clinical events and prescriptions whether or not they had any relationship to the medicinal product under investigation. In particular the doctor was not required to make any judgement of causality but merely to record the event. A quality assurance programme monitored the recording capability of the doctor and provided advice if this should be required. Recording was thus an active ( as against a spontaneous) process and interpretation of the findings was reliant upon retrospective analysis by the study organisers. The participating doctor was also provided with a special form which he was encouraged to complete at any stage of the study if, in his opinion, an adverse event was causally related to the study drug. He was also asked if, in this situation, he had completed a Yellow Card and sent it to the MCA.

4.7 The paper reported on more than 40,000 patients and showed that ‗spontaneous reporting‘ as quantified by the special form was below 10% of ‗event monitoring‘ and that Yellow Card reporting amounted to only 50% of that. This would suggest that all safety studies using ‗passive‘ or ‗spontaneous‘ reporting involve a shortfall of at least 90% in the detection of adverse events

82 and in situations in which a latent period of more than 28 days between the administration of the medicinal product and the event occurs then this shortfall could be as high as 99-100%.

4.8 The availability of such observational cohort studies was well known by 1987-8 and two of the defendant companies (SB and MSD) had shortly after that used the method on two of their new drugs (nabumetone and lisinopril). As the International Medical Director of IMS (Intercontinental Medical Statistics) and Director of their subsidiary company PMSI Ltd (Post Marketing Surveillance International Ltd) I was responsible for both of these studies.

4.9 It should also be pointed out that the MCA were fully familiar with the observational cohort method which was the motivation behind their writing the so-called SAMM Guidelines (Guidelines for company-sponsored Safety Assessment of Marketed Medicines) in collaboration with the ABPI, CSM, RCGP and BMA. See ―Textbook of Pharmaceutical Medicine. 3rd Edition. 1998 Appendix III‖.

5. The problem of causality

5.1 The determination of causality is frequently a major problem and in many cases places great reliance upon a continuing accumulation of circumstantial evidence. This may be no more than such a number of ADR reports that they constitute convincing evidence in themselves. A dozen or so reports may be dismissed as due to chance whilst a hundred or more demand some regulatory response.

5.2 More convincing evidence may come from biological, pharmacological or physiological studies in animal models or human subjects.

5.3 Further evidence may require the conduct of epidemiological or other observational studies in appropriate patient populations.

83 Dr Peter Fletcher-from the Mail on Sunday 5th February 2005.

A former Government medical officer responsible for deciding whether medicines are safe has accused the Government of "utterly inexplicable complacency" over the MMR triple vaccine for children. Dr Peter Fletcher, who was Chief Scientific Officer at the Department of Health, said if it is proven that the jab causes autism, "the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history". He added that after agreeing to be an expert witness on drug-safety trials for parents' lawyers, he had received and studied thousands of documents relating to the case which he believed the public had a right to see. He said he has seen a "steady accumulation of evidence" from scientists worldwide that the measles, mumps and rubella jab is causing brain damage in certain children. But he added: "There are very powerful people in positions of great authority in Britain and elsewhere who have staked their reputations and careers on the safety of MMR and they are willing to do almost anything to protect themselves." His warning follows reports that the Government is this week planning to announce the addition of a jab against pneumococcal meningitis for babies, probably from next April. It is also considering flu jabs for under-twos - not to protect the children, but adults they may infect. In the late Seventies, Dr Fletcher served as Chief Scientific Officer at the DoH and Medical Assessor to the Committee on Safety of Medicines, meaning he was responsible for deciding if new vaccines were safe. He first expressed concerns about MMR in 2001, saying safety trials before the vaccine's introduction in Britain were inadequate. Now he says the theoretical fears he raised appear to be becoming reality. He said the rising tide of autism cases and growing scientific understanding of autism-related bowel disease have convinced him the MMR vaccine may be to blame.

84 "Clinical and scientific data is steadily accumulating that the live measles virus in MMR can cause brain, gut and immune system damage in a subset of vulnerable children," he said. "There's no one conclusive piece of scientific evidence, no 'smoking gun', because there very rarely is when adverse drug reactions are first suspected. When vaccine damage in very young children is involved, it is harder to prove the links. "But it is the steady accumulation of evidence, from a number of respected universities, teaching hospitals and laboratories around the world, that matters here. There's far too much to ignore. Yet government health authorities are, it seems, more than happy to do so." 'Why isn't the Government taking this massive public health problem more seriously?' Dr Fletcher said he found "this official complacency utterly inexplicable" in the light of an explosive worldwide increase in regressive autism and inflammatory bowel disease in children, which was first linked to the live measles virus in the MMR jab by clinical researcher Dr Andrew Wakefield in 1998. "When scientists first raised fears of a possible link between mad cow disease and an apparently new, variant form of CJD they had detected in just 20 or 30 patients, everybody panicked and millions of cows were slaughtered," said Dr Fletcher. "Yet there has been a tenfold increase in autism and related forms of brain damage over the past 15 years, roughly coinciding with MMR's introduction, and an extremely worrying increase in childhood inflammatory bowel diseases and immune disorders such as diabetes, and no one in authority will even admit it's happening, let alone try to investigate the causes." He said there was "no way" the tenfold leap in autistic children could be the result of better recognition and definitional changes, as claimed by health authorities. "It is highly likely that at least part of this increase is a vaccinerelated problem." he said. "But whatever it is, why isn't the Government taking this massive public health problem more seriously?" His outspokenness will infuriate health authorities, who have spent millions of pounds shoring up confidence in MMR since Dr Wakefield's 1998 statement.

But Dr Fletcher said the Government is undermining public confidence in vaccine safety by Sunday, 05 February 2006refusing to do in-depth clinical research to rule out fears of MMR damage to children. He added that the risks of brain and gut damage from MMR injections seem to be much higher in children where a brother or sister has diabetes, an immune disorder. "That is a very strong clinical signal that some children are immunologically at risk from MMR," he said. "Why is the Government not investigating it further - diverting some of the millions of pounds spent on advertising and PR campaigns to promote MMR uptake into detailed clinical research instead?" Now retired after a distinguished 40-year career in science and medicine in Britain, Europe and the US, Dr Fletcher said that without such research, health authorities could not possibly rule out fears about MMR. He said: "It is entirely possible that the immune systems of a small minority simply cannot cope with the challenge of the three live viruses in the MMR jab, and the ever-increasing vaccine load in general." He said he had decided to speak out because of his deep concern at the lack of treatment for autistic children with bowel disease, as revealed in The Mail on Sunday two weeks ago. He called the sudden termination of legal aid to parents of allegedly vaccine- damaged children in late 2003 "a monstrous injustice". After agreeing to be a witness for the parents, he received thousands of documents relating to the case. "Now, it seems, unless the parents force the Government to restore legal aid, much of this revealing evidence may never come out," he said.

86 Dan Olmsted – Autism in Amish population where parents do not ordinarily vaccinate their children.

According to officials in the nation's regulatory agencies, the main obstacle to proving or disproving a link between the autism epidemic and the mercury-based preservative, thimerosal, that was contained in childhood vaccines until a few years ago, and is still in flu vaccines, has been the inability to find a large enough group of people who have never been vaccinated to compare with people who have.

In fact, a few months ago, CDC officials claimed that such a study would be nearly impossible. On July 19, 2005, the CDC held a Media Briefing on the topic of vaccines and child health. On the issue of government research on autism, a reporter asked CDC Director, Dr Julie Gerberding: "are you putting any money into clinical studies rather than epidemiological studies, to verify or disprove the parents' claim about a particular channel, a particular mechanism by which a minority of genetically suspectable kids are supposed damaged?"

Gerberding replied: To do the study that you're suggesting, looking for an association between thimerosal and autism in a prospective sense is just about impossible to do right now because we don't have those vaccines in use in this country so we're not in a position where we can compare the children who have received them directly to the children who don't.

Dr Duane Alexander, of the National Institute of Health, agreed and said: It's really not possible ... in this country to do a prospective study now of thimerosal and vaccines in relationship to autism. Only a retrospective study which would be very difficult to do under the circumstances could be mounted with regard to the thimerosal question.

However, Dan Olmsted, investigative reporter for United Press International, and

87 author of the Age of Autism series of reports, appears to have solved this problem when he came up with the idea of checking out the nation's Amish population where parents do not ordinarily vaccinate children.

First he looked to the Amish community in Pennsylvania and found a family doctor in Lancaster who had treated thousands of Amish patients over a quarter- century who said he has never seen an Amish person with autism, according to Age of Autism: A glimpse of the Amish on June 2, 2005.

Olmsted also interviewed Dick Warner, who has a water purification and natural health business and has been in Amish households all over the country. "I've been working with Amish people since 1980," Warner said.

"I have never seen an autistic Amish child -- not one," he told Olmsted. "I would know it. I have a strong medical background. I know what autistic people are like. I have friends who have autistic children," he added.

Olmsted did find one Amish woman in Lancaster County with an autistic child but as it turns out, the child was adopted from China and had been vaccinated. The woman knew of two other autistic children but here again, one of those had been vaccinated.

Next Olmsted visited a medical practice in Middleburg, Indiana, the heart of the Amish community, and asked whether the clinic treated Amish people with autism.

A staff member told Olmsted that she had never thought about it before, but in the five years that she had worked at the clinic she had never seen one autistic Amish.

On June 8, 2005, Olmsted reported on the autism rate in the Amish community

88 around Middlefield, Ohio, which was 1 in 15,000, according to Dr Heng Wang, the medical director, at the DDC Clinic for Special Needs Children.

"So far," according to Age of Autism, "there is evidence of fewer than 10 Amish with autism; there should be several hundred if the disorder occurs among them at the same 166-1 prevalence as children born in the rest of the population."

In addition to the Amish, Olmsted recently discovered another large unvaccinated group. On December 7, 2005, Age of Autism reported that thousands of children cared for by Homefirst Health Services in metropolitan Chicago have at least two things in common with Amish children, they have never been vaccinated and they don't have autism.

Homefirst has five offices in the Chicago area and a total of six doctors. "We have about 30,000 or 35,000 children that we've taken care of over the years, and I don't think we have a single case of autism in children delivered by us who never received vaccines," said Dr Mayer Eisenstein, Homefirst's medical director who founded the practice in 1973.

Olmsted reports that the autism rate in Illinois public schools is 38 per 10,000, according to state Education Department data. In treating a population of 30,000 to 35,000 children, this would logically mean that Homefirst should have seen at least 120 autistic children over the years but the clinic has seen none.

It looks like the problem is finally solved. Thanks to autism's Dick Tracy, the government now has thousands of unvaccinated people to compare to people who were vaccinated.

December 21, 2005

Virus Detected in children with Autism, but not in controls by Dr. Bradstreet.

These data published today in the most recent Journal of American Physicians and Surgeons, represent the second in a series of direct observations of Measles Virus (MV) persistence in children with Autistic Regression. All children had been vaccinated shortly prior to the development of autistic symptoms. While all of the controls had also been vaccinated - they were all negative for viral persistence. Taken together with the finding of MV in the intestinal tract of these and other children previously reported by Uhlmann, this represents evidence of active replication of virus and further indicates either failure of the vaccine to protect these children from natural infection or more likely, given the lack of any history of MV apart form the vaccine, this represent vaccine strain persistence. Presently there is no proven intervention for viral persistence and it is the hope of the authors that these observations will stimulate additional reearch into the nature of the viral persistence and means of assisting the children in completely clearing the virus. While MMR vaccine is generally considered safe, we propose a subset of genetically vulnerable children lack the ability to clear the vaccine strain of the virus and that this is - on the balance of the available biological data - a direct cause of their symptoms. We recognize the failure of epidemiology to validate these observations, and beleive this specific hypothesis has never been adequately tested with any previous epidemiological study. Jeff Bradstreet MD FAAFP Director ICDRC Professor of Child Development Southwest College of Naturopathic Medicine and Adjunct Professor Stetson University 321-953-0278 This study is the latest in a series that examines the relationship between persistent measles virus infection and regressive autism. While the Institute of Medicine were made aware of these findings, and indeed similar findings in a

90 larger group of autistic children, they chose to ignore them in their latest report. This situation is quite unacceptable.

91 Regressive Autism, Ileal-Lymphoid Nodular Hyperplasia, Measles Virus and MMR Vaccine Summary of Published Studies Offering Evidence for Linkages

By David Thrower

This note summarizes:

• clinical evidence for the link between autism and a novel form of

inflammatory bowel disease • clinical evidence for the link between inflammatory bowel disease and

measles virus • clinical evidence for the link between measles virus and vaccination with

MMR • some of the other wider safety concerns over MMR

(A) The Link Between Autism and a Novel Form of Inflammatory Bowel Disease

There is now ample evidence, confirmed by independent groups of researchers, of a link between regressive autism and a novel form of inflammatory bowel disease. Full publication references are at the end of these notes.

• The possible association between MMR vaccine, regressive autism and intestinal symptoms was first recounted by parents to Dr. Andrew Wakefield, a UK gastroenterologist at the Royal Free Hospital, London, in 1995. The first group of children presenting in this way to Wakefield and colleagues at the Royal Free were reported in The Lancet as a clinical case series in February 1998 (1). Although the interpretation put on this paper at the time was the subject of intense controversy - particularly in the absence of corroborative clinical research by other researchers at that time - the strong evidence of a hitherto-unreported link between autism and a novel intestinal disease, ileal-lymphoid nodular hyperplasia, has not been disputed, and still stands as an

92 important initial clue as to the causes of regressive autism.

• A group of researchers led by Horvath (2) subsequently independently reported in 1999 upon patients with autism who had gastrointestinal symptoms, including a study of 36 children with autism that found grade I or II reflux esophagitis in 25 (69.4%), chronic gastritis in 15 (42%) and chronic duodenitis in 24 (67%).

• Further research published in September 2000 (3) by Wakefield, Anthony et al confirmed that ileal-lymphoid nodular hyperplasia (ILNH) was found in 54 out of 58 (93%) children with autism or other disorders

(50 with autism, 5 Aspergers, 2 disintegrative disorder, one ADHD, one schizophrenia, one dyslexia), but only 5 out of 35 (14.3%) normal controls, pointing to a very strong ILNH-autism link.

• Research published in 2001 by Furlano, Anthony et al (4) reported on ileocolonoscopy performed on 21 consecutively-evaluated children with autistic spectrum disorders and bowel symptoms, and made ―blinded‖ comparisons with 8 children who had a histologically normal ileum and colon, plus 10 developmentally-normal children with ILNH, 15 with Crohn's Disease, and 14 with ulcerative colitis. The study confirmed a distinct lymphocytic colitis in the children with ASD, in which the epithelium appeared particularly affected, offering further corroboration for gut epithelial dysfunction in autism.

• Research reported in 2001 by Buie (5) reported that, as a result of over 400 gastrointestinal endoscopies with biopsies and evaluation of digestive enzyme function, on children with autism, he had found the

presence of chronic inflammation of the intestinal tract, although the incidence was less frequent than in the Royal Free Hospital group of patients reported by Wakefield et al, and that biopsy results indicated

93 the presence of chronic inflammation of the digestive tracts, including esophagitis, gastritis and enterocolitis. Ileal lymphoid nodular hyperplasia, as first found by the Royal Free study, had been found in 15 of 89 children examined for it.

• A review (6) published in September 2002 by Wakefield, Anthony, Montgomery et al noted that as early as 1986, a researcher named Soddy had noted that recurrent gastrointestinal upsets were a constant feature of autistic children, and that in a systematic analysis of an unselected population of 385 children on the autistic spectrum, clinically-

significant gastrointestinal symptoms occurred in 46%, compared with 10% of 97 developmentally-normal controls, strongly suggesting a gastrointestinal-autism link. Mucosal lesions in the small and large intestine were consistent with an autoimmune pathology, and suggested the possibility of an autoimmune response leading to cerebral damage.

• A June 2002 presentation (7) by Krigsman to the US Congressional Committee on Government Reform reported that a large percentage of his autistic patients suffered from chronic unexplained gastrointestinal symptoms. Of 43 patients, the majority had a clear history of developmental regression, after previous normal development, suffering gradual or precipitous decline between age 12 months and 18 months. Most regressive children also exhibited poor growth. Patients had undergone colonoscopy. Findings were that the lymphoid nodules of the terminal ileum were markedly enlarged, thus confirming the early work of the Royal Free team. Evaluation of biopsy specimens confirmed that 65% had colitis, 51% had active colitis, 40% had chronic colitis, 7% had eosinophilic colitis, 90% had lymphoid nodular hyperplasia of the terminal ileum, and 35% had neither active nor chronic nor eosinophilic colitis. Patterns of inflammation were patchy and unpredictable, but findings were similar and consistent from patient

94 to patient within affected sub-groups.

• A November 2003 paper (8) published by Ashwood, Murch et al reported on the examination of 52 affected autistic children, compared with 25 histologically-normal developmentally-normal controls and a further 54 histologically-inflamed but developmentally-normal controls. Analysis of intestinal biopsies in regressive-autistic children indicated a novel lymphocytic enterocolitis with autoimmune features, though the precise linkage between the finding and cognitive functions still remained unclear. The study concluded that it provided further evidence of a pan-enteric mucosal immunopathology in children with regressive autism, that is distinct from other previously-known inflammatory bowel diseases.

• An April 2004 paper (9) by Torrente, Anthony et al identified, following earlier reports of lymphocytic colitis and small bowel enteropathy in children with regressive autism, that the gastritis in regressive autism was clearly distinct from that in Crohn's and other conditions, pointing to a distinctive form of gastritis being linked with regressive autism.

• A November 2004 paper (10) by Ashwood, Anthony et al found that molecules (cytokines) produced by immune cells in the intestine, that cause or control inflammation, showed an abnormal pattern in autistic children compared with non-autistic children. The pattern was different to other forms of intestinal inflammation, and the disease resembled a longstanding viral disease of the intestine, not unlike the intestinal inflammation seen on patients with other viral infections such as HIV- associated enteropathy (intestinal disease) that often accompanies infection with HIV.

• A February 2005 paper (11) by Jyonouchi, Geng et al further confirmed

95 the original ileal-lymphoid nodular hyperplasia/regressive autism link first reported by the Wakefield team in 1998. The study again found evidence of marked inflammatory and immune abnormalities in children with autism associated with gastrointestinal symptoms.

• An April 2005 published letter (12) by Balzola, Barbon et al , Pan-Enteric IBD-Like Disease in a Patient with Regressive Autism Shown for the First Time by the Wireless Capsule Enteroscopy - Another Piece in the Jigsaw of this Gut/Brain Syndrome? , reported that a 28-year-old male with regressive autism, severe constipation, bloating, abdomen distension and symptoms of gastroesophageal reflux was examined. Gastroscopy under general anaesthesia revealed hemorrhagic gastritis

with inflammatory pseudopolypsthat had reached the pylorum, with a pearl-necklace appearance, and a panenteric IBD-like disease consistent with previously-published descriptions of autistic enterocolitis was finally diagnosed. The wireless capsule images were the first to be obtained beyond the limits of the duodenum and terminal ileum, and demonstrated the potential for the entire bowel to be implicated in this inflammatory disease.

• A May 2005 study (13) by Balzola, Daniela et al reported on 9 consecutive patients (range 7-30 years) with autism and chronic intestinal symptoms (abdominal pain, bloating, constipation and/or diahorrea). Routine blood and stool tests and gastroscopy and colonoscopy with multiple biopsies were performed under sedation, and wireless enteroscopy capsules were used in three of the adult patients. Gastroscopy revealed mucosal gastritis in 4 patients, esophagitis in 1 patient and duodenitis in 1 patient, and histological findings showed chronic inflammation of the stomach and duodenum in 6 patients, inconsistent with celiac disease. The authors reported that preliminary findings were strongly consistent with previous descriptions of autistic

96 enterocolitis, and supported a not-coincidental occurrence. They showed for the first time a small-intestinal involvement, suggesting a pan-enteric localization of this new inflammatory bowel disease.

• Also in 2005, a further paper (14) by Wakefield, Ashwood et al was published, assessing ileocolonic lymphoid nodular hyperplasia in ASD and normal control children. Some 148 consecutive children with ASD, with gastrointestinal symptoms, were investigated by ileocolonoscopy, with 74 ASD children and 23 normal controls undergoing upper gastrointestinal endoscopy. The presence of lymphoid nodular hyperplasia was significantly greater in ASD children compared with controls, in the ileum (129 out of 144, compared with 8 out of 27 controls), and in the colon (88 out of 148, compared with 7 out of 30 controls). Comparative percentages were 90% vs 30% and 59% vs

23%. This was whether or not controls had co-existent colonic inflammation. The severity of ILNH was significantly greater in ASD children compared with controls, with moderate-to-severe ILNH present in 98 out of 144 ASD children compared with 4 out of 27 controls; percentages were 68% and 15%. On histopathological examination, hyperplasic lymphoid follicles were significantly more prevalent in the ileum of ASD children (84 out of 138, or 61%) compared with normal controls (2 out of 23, or 9%). The data thus further corroborated the finding that ileal lymphoid nodular hyperplasia is a significant pathological finding in autistic children.

• Additionally in 2005, a study (15) was published by Gonzalez, Lopez et al , seeking evidence of immunological alterations in 68 autistic children ages 22 months to 11 years and presenting with digestive systems, and

examining biopsies from their digestive tracts. Endoscopies and colosopies were undertaken, with biopsies of the esophagus, stomach, duodenum and colon, with verification of presence of inflammation,

97 eosiophil infiltration, lymphoid nodular hyperplasia and CD-4 and CD-8 cells. The results were that lymphoid nodular hyperplasia was discovered in 2/68 esophagus, 6/68 stomachs, 8/68 duodenums and 36/68 (53%) of colons. Eosiophil infiltration with more than 20 eosiphils per field were found in 3/68 eosphagus, 1/68 stomach, 8/68 duodenum and 24/68 (35%) colons. Inflammatory reactions were found in 56/68 (82%) esophogitis, 64/68 (94%) gastritis, and all (100%) presented with duodenitis and colitis. CD-4/CD-8 relationship existed of >3 in 42/68 (62%) and <1 in 16/68. The authors concluded that the children presented immunological and immunohistochemical alterations of the biopsies of their digestive tracts, and that there was a significant finding of lymphoid nodular hyperplasia, eosiophilinfiltration, and that prevalence of greater CD-4 than CD-8 cells in the inflammation of the intestinal wall demonstrated in favour of a Th2 type allergic reaction.

Taken together, the above now provide very convincing evidence from a number of wholly-independent groups of researchers of a link between the novel inflammatory bowel disease of ileal lymphoid nodular hyperplasia and regressive autism.

(B) The Link Between Inflammatory Bowel Disease and Measles Virus

These autism/inflammatory bowel disease findings were followed by findings that linked the novel form of inflammatory bowel disease with persistent measles virus in the gut of affected children:

• A paper (16) by Uhlmann, Sheils et al , noting that measles virus nucleoprotein (N antigen) had been detected in association with follicular dendritic cells (FDC) in patients, and seeking molecular confirmation of this result, found that :solution phase RT PCR yielded specific measles virus N gene amplification in affected children (10/10), and identified distinct measles virus genome in FDC reactive follicular centres by in-cell RNA amplification. None of the normal controls

98 showed any evidence of measles virus genome. The data highlighted a possible causal link between measles virus infection and ileo-colonic lymphoid nodular hyperplasia in affected children.

• A paper (17) presented in the year 2000 by Singh to the US House of Representatives Committee on Government Reform reported a hyperimmune response to the measles virus, with an association between measles virus antibody levels and incidence of brain autoantibody.

• An April 2000 paper (18) presented by O'Leary to the Committee on Government Reform reported the investigation whether measles virus was present n the gut biopsies of autistic children, and if so, where and how much. The paper reported that the biopsies of 24 out of 25 (96%)

of the autistic children examined were positive for measles virus, and that amongst normal (non-autistic) controls, only 1 out of 15 children (6.6%) were positive, strongly suggesting a connection between measles virus and autism.

• A February 2002 paper (19) by Uhlmann, Wakefield, O'Leary et al investigated the presence of persistent measles virus in the intestinal tissue of 91 autistic patients with new-variant inflammatory bowel disease (ileal-lymphoid nodular hyperplasia, or ILNH). Patient samples were provided by the Royal Free Hospital, London. The patients were ages 3-14, and 77 out of 91 were male. There were 70

developmentally-normal controls ages 0-17 years, 47 out of 70 being boys. Of these, 19 had normal ileal biopsies, 13 had mild non-specific chronic inflammatory changes, 3 had ILNH and had been investigated for abdominal pain, 8 had Crohn's Disease, one had ulcerative colitis, and 26 had undergone appendicectomy for abdominal pain including appendicitis. The results were that 75 out of 91 patients with a

99 histologically-confirmed diagnosis of ileal-lymphoid nodular hyperplasia and enterocolitis were positive for measles virus in their intestinal tissue, compared with 5 out of 70 controls. Using TaqMan RT-PCR techniques, 70 out of 91 affected children were positive for measles virus, compared with 4 out of 70 controls. Of the controls, measles virus was not detected in normal children or children with isolated ileal- lymphoid nodular hyperplasia. However, 4 out of 26 appendicectomy samples harboured measles virus genome; the study suggested that the prevalence of measles virus in the general population warranted further investigation. The study concluded that the data confirmed an association between the presence of gut pathology and of measles virus in children with developmental disorder. The study did not exclude the presence of alternative infections to measles virus.

• A February 2004 paper (20) presented by Singh to the US Institute of Medicine, Washington DC, measured antibodies in autistic children to five viruses, measles, mumps, rubella, CMV and human herpes virus 6. Researchers found that the antibody level of the measles virus alone, and not the other four, was significantly higher in autistic children than in normal children. The research also found a correlation between measles antibody and brain autoimmunity, which was marked by myelin basic protein antibodies. The two markers correlated in over 90% of the autistic children tested for them, suggesting a causal link between measles virus and autoimmunity in autism. The serology to other viruses and other brain autoantibodies did not show this correlation. This suggested a temporal link of measles virus in the etiology of autism.

An early-report presentation by Walker, Hepner et al , at the International Meeting for Autism Research, Montreal, June 2006, reported that PCR analysis on terminal ileum biopsy tissue from an initial 82 patients found 70 (85%) positive for measles virus f-gene amplicon. These preliminary results confirm earlier

100 findings of measles virus RNA in the terminal ileum. Full publication of this study is anticipated.

The above studies provide significant evidence for a link between measles virus and ileal lymphoid nodular hyperplasia, with the latter's earlier-demonstrated onward link with regressive autism.

•A July2002 paper (21) presented by O'Leary reported that the strain of measles virus used in MMR had been detected in the gut tissue of 12 autistic children. Medical histories had indicated that each of

the children had developed autism after the date of receipt of MMR, and none had exhibited outward signs of measles infection before becoming autistic.

•An April 2000 study (22) by Kawashima, Takayuki et al confirmed that, amongst 8 patients with Crohn's Disease, 3 patients with ulcerative colitis and 9 patients with autistic enterocolitis, and 8 children who were either healthy or who had SSPE, SLE or HIV-1, 1 out of 8 patients with CD, 1 out of 3 patients with UC and 3 out of 9 patients with autism were positive for measles virus. Controls were all negative. The sequences from patients with CD shared the characteristics of wild-strain measles virus. The sequences from patients with UC and from patients with autism were consistent with vaccine strain measles virus. These results were consistent with patients' medical histories, and point to a connection between autism and vaccine- strain measles virus.

•A May 2002 paper (23) by Singh, Nelson, Jensen and Bradstreet found that a significant percentage of autistic children examined had antibodies to myelin basic protein (up to 88% positive) and to MMR (up to 65% positive). Normal children did not exhibit these antibodies. The analysis of paired samples

101 (serum and cerebral spinal fluid from 7 autistic children also revealed a high degree of serological association between MMR and myelin basic protein. Some 50% of CSF had MMR antibodies, 86% of CSF had MBP antibodies, 75% of sera had MMR antibodies and 100% of sera had MBP antibodies. Therefore there was a strong correlation between MMR antibodies and myelin basic protein antibodies. By using monoclonal antibodies, the authors characterized that the MMR antibodies were due to the measles sub-unit, but not to the mumps or rubella sub-units, of MMR. In the light of this, the authors suggested that in some cases of autism, MMR might cause autoimmunity, and it might be doing so by bringing on an atypical measles infection that manifests neurological symptoms.

•An earlier 1999 paper (24) by Bitnun has previously and independently confirmed the presence of measles virus in the brain tissue of a previously- healthy child following exposure to MMR, when the child had no history of wild measles infection.

•A February 2004 paper (25) by Bradstreet, O'Leary, Sheils et al to the US Institute of Medicine, and subsequently published later that year, reported that three children with regressive autism had undergone cerebrospinal fluid assessment, including for measles virus. All three had had concomitant onset of gastrointestinal symptoms and had already had measles virus genomic RNA detected in biopsies of ileal-lymphoid nodular hyperplasia. None of the cases nor non-autistic controls had any history of measles exposure other than possibly via MMR. Serum and cerebrospinal fluid samples were also evaluated for antibodies to measles virus and myelin basic protein. The result was that measles virus f-gene was present in the cerebrospinal fluid of all three autistic cases but not in non-autistic controls. Further, serum anti-myelin basic protein autoantibodies were detected in all children with autistic encephalopathy. Anti-MBP and measles virus antibodies were detected in the CSF of two cases, but the third had neither.

102 The study concluded that the findings were consistent with a measles-virus etiology for autistic encephalopathy, indicating the possibility of a virally- driven cerebral immunopathology in some cases of regressive autism. The virus genome found in the autistic children was ―exclusively consistent with vaccine strain‖.

•A May 2006 study (26) by Wakefield, Stott and Limb investigated the hypothesis as to whether a dose-response effect of measles-containing vaccine on intestinal pathology existed. If it did exist, this would constitute evidence of a causal association. In the study, children with normal early development and autistic-like developmental regression were divided into two groups. Children were divided into two groups: some 23 re-exposed children, i.e. those who had received more than one dose of a measles- containing vaccine (MCV), and 23 children who had received only one dose of MCV. The groups were matched for sex, age and time that had elapsed from first exposure to time of endoscopy. Comparisons made included secondary gastrointestinal (GI) and related physical symptoms, and ―observer-blinded‖ scores of endoscopic and histological disease. The results were that re-exposed children scored significantly higher than only- once-exposed for secondary physical symptoms, including incontinence, presence of severe ileal-lymphoid nodular hyperplasia, the number of biopsies with epithelial damage, and number of children with acute inflammation. Markers of acute inflammation include number of children affected, and proportion of biopsies affect. The conclusion of the study was that the data confirmed a re-challenge effect (i.e. a double-hit effect) of measles-containing vaccines on symptoms, and also confirmed a biological gradient effect upon intestinal pathology. These findings thus link exposure to measles-containing vaccines to autistic-like regression and enterocolitis. (Note: it was stated in April 2001 by the Vaccine Safety Committee of the US Institute of Medicine that in the context of MMR and autism ―challenge rechallenge would constitute strong evidence of an association‖.)

103 Taken together, with the Walker, Hepner et al study, the above points to MMR as the means by which measles virus enters and persists in the gut, leading to ileal- lymphoid nodular hyperplasia, and in turn leading to regressive autism. The evidence to fully explain the complete causational mechanism by which this occurs is still emerging, and clearly requires further urgent research.

The intestinal disease has the features of a viral disease. Measles virus is known to infect the intestine, and produces the features described originally by Wakefield and colleagues in 1998.

All the findings described in the 1998 Lancet report by the Wakefield team - including the discovery of a possible new type of inflammatory bowel disease, have therefore been subsequently independently confirmed by other researchers in the US, in Italy and in Venezuela.

The studies suggest that in some children, brain damage leading to autism may be secondary to, or occur in parallel with, a disease in the intestine, and that vaccine strain measles virus has become the prime suspect in this complex investigation.

The findings to date have important implications for our understanding and treatment of the complex disorder of regressive autism.

(D) Wider Safety Concerns Over MMR:

It is also instructive to examine the original, and any subsequent, safety studies of MMR.

An authoritative independent review by the Cochrane Collaboration (27) of the safety studies of MMR vaccine concluded that ―the design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate‖. It further confirmed that neither before nor after the introduction of the MMR vaccine were proper safety trials carried out.

104 • A more recent review (28) from the same organization identified that safety studies for the single measles vaccine were better than those conducted for MMR: ―We found only limited evidence of safety of MMR compared to the single component vaccines, that had a low risk of bias‖. The authors of the Cochrane reviews were highly critical of the safety studies of MMR, which they stated ―need to be improved‖. Cochrane mentioned a specific concern that safety studies followed up the children involved for no more than three weeks, except for one study that lasted just six weeks.

• Concern over MMR's safety has been expressed (29) by a key former scientific adviser to the UK licensing authorities. Dr. Peter Fletcher , former Principal Medical Officer in the (then) UK Medicines Division, who was medical assessor to the Committee on Safety of Medicines, commented: ―Evidence on safety was very thin‖ , and ―Too few children were followed for a sufficient time... Big numbers were necessary, and computerised databases were already in place to permit this, but it was not done... Caution should have ruled the day... There should have been strong encouragement to conduct a 12-month observational study on 10,000-15,000 children...‖ (this was not done) "The granting of a product licence was premature.‖

•A year-2000 review (30 by Wakefield & Montgomery examined early safety studies of MMR, by Buynak et al 1969, Stokes et al 1971, Minekawa et al 1974, Schwartz et al 1975, Crawford and Gremillion 1981, and Miller et al 1987. The Buynak study identified viral ―interference‖, but the follow-up period was only 12 days. The Stokes study revealed persistent gastrointestinal problems in the US trial children, but the follow-up was only 28 days. Stokes compared 228 MMR children with 106 unvaccinated controls. Data, from Philadelphia and Costa Rica and San Salvador, was merged - a major methodological error. Gastroenteritis was found to be significantly more common in the Philadelphia vaccines (24%) compared with the unvaccinated Philadelphia controls (5.6%). No significant difference was found between the vaccinated and the unvaccinated in Costa Rica and San Salvador because of high ambient levels of gastroenteritis anyway (50% in vaccines, 44% in controls). Combining all the data masked these instructive differences. There was also significant ―unrelated‖ illness in

105 39% of Philadelphia vaccines (otitis, allergy, viral infection, abdominal pain), compared with 12.2% in controls. The potential relevance of this was not seen at time. The Minekawa study confirmed viral interference. The follow-up period was only 15 days. The Schwartz study also merged its data, so provided insufficient insight, and again follow-up was only 21 days. The study looked at two different populations, 282 children in Ohio and 926 children in Santo Domingo, Dominican Republic. Again, the merging of data from different countries was a serious error. No data was provided to permit analysis of adverse events. Crawford and Gremillion's study of USAF recruits confirmed viral interference, but the follow-up period was only 19 days. Some 512 vaccines were compared with 835 unvaccinated controls. The study noted increased fever and diarrhoea in those that received measles and rubella vaccines simultaneously. But the potential effect of trivalent vaccine was only seen as additive instead of potentially synergistic - a key point. The Eddes study (a small UK study) in 1991 compared reactions to MMR with monovalent measles vaccine. High rates of gastrointestinal disorders (41.9% and 37.8%) were found, but the authors dismissed these as normal background illness. The Dr. Elizabeth Miller study noted that diarrhoea was common (26% of vaccinees), but the follow-up again was only 21 days. This was a major missed opportunity to follow up a large cohort. The Stokes, Schwartz, Miller and Eddes studies were therefore all too small or too superficial to pick up uncommon adverse events. The Plesner et al study of gait disturbance following MMR ( Acta Paediatrica , 2000, 89, 58- 63) confirmed an association, and indicated that more severe cerebellar ataxias following MMR may be associated with residual cognitive deficits.

Cochrane was forced to conclude that ―the safety record of MMR is probably best attested by its almost universal use.‖ Or to put it another way, ―the best evidence of MMR's safety we can find is that fact that it's being widely used‖ - hardly a scientific test of a product's actual safety, particularly when the evidence of problems is through a hitherto-unsuspected link between MMR and autism, that would not have been monitored prior to 1998.

References

( on the link between autism and a novel form of inflammatory bowel disease )

106 (1) Wakefield et al, Inflammatory Bowel Disease Study Group, Royal Free Hospital London, Ileal Lymphoid Nodular Hyperplasia, Non Specific Colitis and Pervasive Development Disorder in Children , Lancet, 28th February 1998

(2) Horvath, Papadimitiou et al, Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Gastrointestinal Abnormalities in Children With Autistic Disorder , Journal of Pediatrics, 1999 November, Vol 135 (5), pp559-563

(3) Wakefield, Anthony et al, Enterocolitis in Children with Developmental Disorders , American Journal of Gastroenterology, Sept 2000, Vol 95, No. 9, pp2285-2295

(4) Furlano, Anthony et al, Colonic CD8 and T-Cell Infiltration With Epithelial Damage in Children with Autism , Journal of Pediatrics, 2001; 138; No. 3, 366- 372

(5) Paper by Dr. Timothy Buie, Harvard Massachusetts General Hospital, presented to the Oasis 2001 Conference for Autism, Portland, Oregon, November 2001

(6) Wakefield, Anthony, Montgomery et al, Inflammatory Bowel disease Study Group, Royal Free Hospital, University College Medical School, London, and Coombe Women's Hospital and Trinity College Dublin, The Concept of Enterocolonic Encepalopathy, Autism and Opioid Receptor Ligands , Aliment Pharmacological Ther, 16: pp663-674

(7) Presentation by Krigsman to the US Congressional Committee on Government Reform's June 2002 hearing, The Status of Research into Vaccine Safety and Autism, held in Washington DC

(8) Ashwood, Murch et al, Royal Free Hospital, London, Intestinal Lymphocyte Populations in Children with Regressive Autism: Evidence for Extensive Mucosal Immunopathology , Journal of Clinical Immunology, Vol 23 No. 6 Nov 2003 pp504-517

107 (9) Torrente, Anthony et al, Centre for Pediatric Gastroenterology, Royal Free Hospital and University College Medical School, London, Focal-Enhanced Gastritis in Regressive Autism, With Features Distinct from Crohn's and Helicobacter Pylori Gastritis , American Journal of Gastroenterology, Vol 99, Issue 4, p598, April 2004

(10) Ashwood, Anthony et al, Spontaneous Mucosal Lymphocyte Cytokine Profiles in Children with Autism and Gastrointestinal Symptoms: Mucosal Immune Activation and Reduced Counter-Regulatory Interleukin-10 , Journal of Clinical Immunology, Vol 24, No. 6, November 2004

(11) Jyonouchi, Geng et al, Department of Pediatrics, New Jersey Medical School, Dysregulated Innate Immune Responses in Young Children with Autistic Spectrum Disorders - Their Relationship in Gastrointestinal Symptoms and Dietary Intervention , Neuropsychobiology, February 2005, 51 (2) pp77-85

(12) Letter by Balzola, Barbon et al, Department of Gastroenterology, Department of Neuropsychiatry for Children, Department of Pediatric Gastroenterology and Department of Biomedical Sciences and Human Oncology, University of Turin, Pan-Enteric IBD-Like Disease in a Patient with Regressive Autism Shown for the First Time by the Wireless Capsule Enteroscopy - Another Piece in the Jigsaw of this Gut/Brain Syndrome? , American Journal of Gastroenterology, 2005; 100 (4) p979

(13) Balzola, Daniela et al, Department of Gastroenterology, Department of Neuropsychiatry for Children, Department of Pediatric Gastroenterology and Department of Biomedical Science and Human Oncology, University of Turin, Autistic Enterocolitis - Autistic Enterocolitis: Confirmation of a New Inflammatory Bowel Disease in an Italian Cohort of Patients , paper presented to the American Gastroenterological Association, May 2005 and published in Gastroenterology 2005: 128 Suppl 2, A-303

108 (14) Wakefield, Ashwood et al, The Significance of Ileo-Colonic Lymphoid Nodular Hyperplasia in Children with Autistic Spectrum Disorder , European Journal of Gastroenterology and Hepatology, 2005, Vol 17 No. 8

(15) Gonzalez, Lopez et al, Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with Gastrointestinal Symptoms: Preliminary Report , G.E.N. Suplemento Especial de Pediatria, no. 1, 2005; pp41-47

( on the link between inflammatory bowel disease and measles virus )

(16) Uhlmann, Sheils et al, Department of Pathology, Coombe Women's Hospital Dublin, Trinity College Dublin and Royal Free Hospital London, Measles Virus in Reactive Lympho-Nodular Hyperplasia and Ileo-colitis of Children

(17) Paper presented by Dr. Vijendra Singh, University of Michigan College of Pharmacy, to the US House of Representatives Committee on Government Reform, Washington DC, 2000

(18) Paper presented by Professor John O'Leary, Dublin Women's Hospital, to the US House of Representatives Committee on Government Reform, Washington DC, April 2000

(19) Paper By Uhlmann, Wakefield, O'Leary et al, Potential Viral Pathogenic Mechanism For New Variant Inflammatory Bowel Disease , Journal of Clinical Pathology, Molecular Pathology, 2002, 55, 0-6, published 6th February 2002

(20) Paper by Singh, Department of Biology Center for Integrated Biosystems, Utah State University, Logan, Autism, Vaccines and Immune Reactions , presented to the Institute of Medicine, Washington DC, February 2004

( on the link between measles virus and vaccination with MMR )

109 (21) Paper presented by O'Leary, Coombe Women's Hospital and Trinity College Dublin to the Pathological Society of Great Britain and Ireland, July 2002

(22) Kawashima, Takayuki et al, Detection and Sequencing of Measles Virus from Peripheral Mononuclear Cells from Patients with Inflammatory Bowel Disease and Autism , Digestive Diseases & Science, Vol 45, No. 4, April 2000, pp723-729

(23) Singh, Nelson, Jensen and Bradstreet, Abnormal Measles Serology and Autoimmunity in Autistic Children , Journal of Allergy and Clinical Immunology 109 (1) S232, January 2002, and also presented to the 102nd General Meeting of the American Society for Microbiology, Salt Lake City, Utah, May 2002

(24) Bitnun et al, Measles Inclusion-Body Encephalitis Caused by the Vaccine Strain of Measles Virus , Clinical Infectious Diseases Journal, 1999, 29 855-61 (October)

(25) Bradstreet, O'Leary, Sheils et al, Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid in Children with Regressive Autism by TaqMan RT-PCR: A Report of Three Cases , summarized at the Institute of Medicine, February 2004 and subsequently published as Bradstreet, Dahr et al, Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid of Children with Regressive Autism: A Report of Three Cases , Journal of American Physicians and Surgeons, Vol 9, No. 2 Summer 2004

(26) Wakefield, Stott and Limb, Gastrointestinal Comorbidity, Autistic Regression and Measles-Containing Vaccines; Positive Re-challenge and Biological Gradient , Medical Veritas 3 (2006) 796-802

Again, taken with the latest study by Walker, Hepner et al, this now provides evidence that it is highly likely that MMR vaccine is the source of the measles virus that is in turn linked via significant evidence with ileal lymphoid nodular hyperplasia, which in turn is strongly and convincingly linked with regressive autism.

110 ( on wider safety concerns over MMR vaccine )

(27) Jefferson, Price et al, Unintended Events Following Immunisation with MMR; A Systematic Review , Vaccine, 2003; 21: pp3954-3960

(28) Demicheli, Jefferson et al, Vaccine For Measles, Mumps and Rubella in Children (Review) , The Cochrane Collaboration, published Wiley & Sons, UK, from The Cochrane Library, 2005, Issue 4, art. No. CD004407

(29) Commentary by Dr. Peter Fletcher, Journal of Adverse Drug Reactions & Toxicology, 2001, 20 (1), 47 63 Oxford University

(30) Wakefield & Montgomery Through A Glass Darkly (A Look Back At MMR's Safety Trials), Journal of Adverse Drug Reactions, 2000 19(4), 265-283

111 MMR Vaccination Briefing Note JABS:-

MMR vaccine introduced into UK vaccination schedule 1988: Three brands of MMR vaccination were introduced into the UK childhood vaccination programme in October 1988. The vaccines were heralded as a one-off, life-long immunisation against three serious diseases, measles, mumps and rubella. The manufacturers' were SmithKline Beecham, brand name Pluserix , Merieux, brand name Immravax and Merck Sharpe, Dohme, brand name MMRII.SmithKline Beecham and Merieux used Schwartz strain measles, Wistar RA27/3 strain rubella and Urabe AM9 strain mumps. Merck Sharpe Dohme used Enders Edmonston strain measles, Wistar RA 27/3 strain rubella and Jeryl Lynn strain mumps.

JABS group founded in 1994 as serious vaccine problems were reported: When the JABS group was founded in January 1994 parents contacted us with their concerns about their children's serious ill health following childhood vaccinations. We asked parents to complete questionnaires on the vaccines given and to describe in detail their children's experience.We were astounded by the responses. Parents stated the number of days after MMR vaccination when their children had started to become ill and in many cases the number of days quoted were consistent with the incubation period of the vaccine viruses given. Many of the symptoms described were listed in the vaccine manufacturers' own product sheets. The parents reported that their children had suffered serious consequences after the initial symptoms and had not recovered to the health point they had had before the vaccination was given. The most remarkable aspect of` this is that the long term serious health problems that the children now have were also, in the main, listed in the same drug product sheets as the 'rare' events known to be associated with the vaccine. The UK adverse event surveillance system - 'yellow card': We asked each family if their child's doctor or consultant had reported the symptoms and change in the child to the UK's Committee on Safety of Medicines, using the adverse events surveillance mechanism known as the 'yellow card' scheme. The vast majority responded that the health professional had declined to use the reporting system

112 as he/she had dismissed the link with the vaccination as 'just a coincidence'. Therefore, the suspected reactions had not been put forward to the central body for detailed investigation. In theory the system should work to flag up any serious problems with drug products - the guidelines note that all suspected reactions should be reported. In practice the system was largely ineffective because health professionals made their own arbitrary decisions on whether to report the problems. The Health Protection Agency in its former role as Public Health Laboratory's Service is on record in the Lancet (Vol. 345. March 4, 1995) stating ''..there is an urgent need to find more reliable methods of adverse event surveillance.'' The point being that unless all reactions are put forward to a central body instead of being dismissed as ''unrelated'' or ''just a coincidence'' the central database will never hold accurate information on adverse events. How many coincidences are needed before it becomes meaningful enough to warrant scientific, clinical investigation?

Investigations: Families have urged their medical practitioners who are dealing with their children's problems to investigate the suspected connection with the vaccinations. Some parents have also reported that the doctor/consultant was not interested in finding the reasons for the child's ill health, stating that their role was to treat the problem and, therefore, they did not want to be involved in this aspect. During the course of the JABS group investigations we have discovered that the UK pre-introductory trials for MMR were inadequate in that they failed to follow up adverse reactions for more than just a few weeks. Serious degenerative conditions are known to take weeks and/or months to develop.

Withdrawn MMR brands: Proof of inadequacy is in the knowledge that it took the Department of Health four years to identify problems and withdraw two of the three original MMR brands that had been introduced into the UK vaccination programme in 1988. These two brands, Pluserix and Immravax were withdrawn by September 1992 because they contained a mumps strain known as Urabe which had caused

113 mumps meningitis in some children. Many of the badly affected children known to JABS have had these brands of MMR. It is also of concern that this problem must have been known by the UK's Department of Health Chief Medical Officer: The licence for the MMR vaccine containing the Urabe strain in Canada was revoked from May 1990. In Japan it was banned in 1993. A version of this vaccine made by Chiron was also withdrawn from use in Italy in March 2006.

Drug manufacturers' product sheets: The drug manufacturers of MMR vaccines have provided the Government's vaccine policy makers with product sheets which list the adverse reactions known to be associated with their vaccines. These lists are virtually identical from each of the drug companies. They state the minor side effects which doctors are happy to describe to parents: namely - rashes, raised temperature etc. These same sheets also state reactions only recently acknowledged in public by the Health Protection Agency e.g. febrile convulsions, blood disorders (ITP). The information sheets also state the severe adverse events: to name but a few - diarrhoea, nerve deafness, arthritis, Guillain-Barre syndrome (a paralysis syndrome), severe vision problems, seizures and encephalitis. Encephalitis (inflammation of the brain) can lead to a range of disabilities such as epilepsy, loss of speech and communication and acquired autism.

Responsibility for vaccine damage: Richard Ley, of the Association of British Pharmaceutical Industries said in the Daily Express (May 18 2000): 'The Government implemented the vaccination programme knowing in full detail what the possible side-effects were. They knew what they were taking on, the damage is therefore their responsibility and they should compensate people accordingly.'The MMR vaccine contains three live attenuated viruses; their major disadvantage is a danger of reversion of the virus strains to more reactive and virulent forms. In plain terms, if the wild virus can cause inflammation in the brain, joints, spine, eyes, ears and bowel then so can the vaccine-virus and to quote an extract from a letter published in the Times (February 9 2002) from Dr David Hall, President of Royal College of Paediatrics

114 and Child Health : 'Some children develop encephalitis (brain swelling) when they catch measles, mumps or rubella viruses and may be left with a variety of handicaps, including physical and mental impairment, deafness, internal organ damage and autism.....' Raising the issues with UK Government Minister and Health Chiefs: In October 1997 Dr Andrew Wakefield and Professor Walker- Smith from the Royal Free Hospital, London, JABS and its legal representatives, took part in a meeting with the then Health Minister, Tessa Jowell, also the Chief Medical Officer, Principal Medical Officer and others. During the course of the one hour meeting a full list of children, then affected, was presented. We asked that the Government should instigate a scientific investigation of the children believed to have been damaged which could have been useful on at least two fronts:i. To answer the question of MMR safety.ii. If the vaccine was found to be causing harm it may have been possible to identify ''at-risk'' groups which may have led to a screening programme with the potential to have improved vaccine safety for all children The Health Minister at the time stated she was willing to look at all scientific evidence but as parents it is very difficult for us to produce this. That is why we believe the current claims by the vaccine policy-makers that there is no scientific evidence to show the MMR vaccine is unsafe will continue to be made. Until the Government instigates a full investigation of the children believed to have been damaged, the ''scientific evidence'' required by the Department of Health is unlikely to emerge.

Vaccine Damage Payment Act 1979: The Government is well aware that vaccines sometimes cause severe damage; there is a branch of the Department of Social Security known as the Vaccine Damage Payment Unit. It was set up in 1979 following the Vaccine Damage Payment Act 1979. MMR vaccine damage payments have been awarded for various adverse effects including: epilepsy, Guillain-Barre syndrome (a paralysis condition), SSPE (a brain-wasting condition), neurological problems, profound deafness and death. Some of the children who received payments are detailed in the following article:

115 US experience: Any debate on vaccine damage will have Department of Health officials quoting the massive number of doses given to children in the United States. What is never stated by UK officials is that in the US they have a National Vaccine Injury Compensation Programme. In the last 18 years this programme has paid out hundreds of millions of dollars in payments to vaccine damaged children of which a 14% share has been paid out for MMR or its components.The drug companies have to contribute to the programme and up to August 1997 they had to pay an excise tax on each dose using a risk-based formula. The DTP and MMR were taxed at $4.56 and $4.44 respectively, polio vaccines at $0.29 and DT (diphtheria/tetanus) vaccines at $0.06. This must surely give an indication of which vaccines carry the highest risk of a serious adverse reaction. The problems associated with childhood vaccines are also being reflected in the United States as has been reported on the JABS web pages and on US sites:

Japanese experience and compensation: The MMR vaccine was introduced into the Japanese health programme in April 1989. Shortly after its introduction Japanese parents started to complain to the authorities that their children were suffering severe neurological damage. The Japanese Government failed to act. Many parents started to reject the MMR vaccination for their children and the Japanese Government continued to ignore public concern. Outbreaks of measles then occurred and, unfortunately, it was the most vulnerable group in society, babies under twelve months of age and too young to receive a measles vaccine, that were hit hardest and 69 deaths were recorded. The Japanese Government banned the MMR vaccine in 1993 and introduced a policy of separate measles and rubella vaccines. (The single Urabe mumps vaccine would not have been accepted as it had been held responsible for the neurological damage when combined in the Japanese MMR vaccine.) The Japanese MMR court cases were heard in March 2003. Over 1,000 children were awarded MMR damages against the Japanese Government and the Research Foundation for Microbial Diseases at Osaka University in Suita, Osaka Prefecture.

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MMR and Autism: The statement that the health secretary, John Reid, made on GMTV in November 03: "It is unequivocal that there is no evidence at all that MMR is linked to autism." needs to be challenged. World experts in the field of virology and pathology have replicated results found by Dr Wakefield's team when he was at the Royal Free Hospital, London and other independent Japanese scientists have also duplicated the findings. (Ref. 1 below) Children who have developed autism, epilepsy and other neurological conditions were progressing normally before they were vaccinated, had passed all milestones and had acquired skills appropriate to their age. * They did not simply fail to progress; they actually regressed, losing skills which they had already attained. In many instances this is borne out by videos taken of the children before and after they were vaccinated. * They showed other physical changes at the time that they became autistic (such as sleep patterns, appetite changes, temperature control etc. in addition to many of them suffering bowel problems). * The development of autism and other conditions are closely linked in time to the administration of the vaccine. The onset of this condition generally started within about a month of vaccination whenever the vaccination took place. In other words, it would be later for children vaccinated at 18 months than those vaccinated at 12 months. On top of that, a substantial proportion of the children had an immediate reaction to the vaccination, and the change which came over them dates directly from that reaction.

For more information on MMR, Thiomersal, Autism connection please refer to the home page of JABS (www.jabs.org.uk ) and http://www.putchildrenfirst.org/

117 MMR Legal Cases: Unfortunately, the UK MMR victims had their legal aid stopped just six months before the cases were to be heard at the High Court in April 2004. In some cases legal aid had been provided for nearly ten years to children with wide ranging health problems including autism, epilepsy, loss of speech and communication skills, chronic arthritis and deafness. Each family had to personally apply to try and prevent their child's legal aid certificate from being discharged. In the interest of justice, these children deserve to have the issue of MMR safety resolved in court and for this reason families need the help of legal aid. * Many parents believe that the withdrawal of legal aid prior to the court cases being heard was another way to delay or prevent access to justice for vaccine damaged children. The families' representatives were able to present to the legal aid appeal committee (the Funding Review Committee) evidence not only that measles virus had been found in cerebro spinal fluid (CSF) taken from three out of six of the test cases, but also that it had not been found in 19 out of 20 controls. If the measles virus is in the CSF then it must almost certainly be in the brain. Bearing in mind: * that these children, like all autistic children, suffer from a form of brain damage, * that measles is known to be able to cause brain damage and * that no other cause of autism has been suggested for the overwhelming majority of the families involved. Adding to the stress of this situation, one of the MMR drug companies had sent some parents a letter offering not to seek costs against the child or them if they signed an undertaking "not to issue any further proceedings arising out of vaccination with MMR against them in this or any other jurisdiction''.

The MMR court cases were and still are vital not only to the families involved in the pursuit of justice for their children, but for all parents who are concerned about whether the vaccines they are giving their healthy children are safe. JABS believes the Government can no longer claim that MMR is the "safest way to protect your child" as they have denied the parents an opportunity to have all the

118 information out in the open and heard properly. Until the evidence is formally presented in court the question mark over the issue remains.

At the moment (April 2006) a small number of parents have had MMR legal aid certificates re-instated for their children. Also, ten families who lost their appeal plan to take their children's cases to the European Court of Human Rights.

Single vaccines: The Government's Chief Medical Officer needs to reconsider the availability of single dose vaccines as a matter of choice. If there is a potential for measles epidemics they must provide a real choice for those parents who have lost confidence in the combined MMR but still want to vaccinate against the separate illnesses. It should not have to be MMR or nothing situation.It does not require new legislation it just needs the Department of Health to place orders with the drug companies currently supplying the UK market with the MMR vaccines.

When the MMR vaccine was introduced into the childhood vaccination schedule the doctors' Green Book, 'Immunisation against Infectious Disease' clearly stated: 'MMR vaccine will replace measles vaccine in the second year of life, or after this age if appointments have been missed. For children whose parents refuse MMR vaccine, single antigen measles vaccine will be available.' (Page 60, 10.2 Recommendations) Reference to this choice appeared in the 1988, 1992 and 1996 editions of this book. Why has this option been quietly removed without explanation?

Cochrane Review: A study by the respected Cochrane Library (October 2005) has said, on the basis of 31 pieces of research into the possible side effects of MMR, that it found no association between MMR, autism, Crohn's disease and long-term disability. The Department of Health is hailing it as another 'final nail' in the MMR controversy but there is another side to this that they have missed. Since the MMR vaccine was introduced in 1988 many parents have complained publicly that they believe

119 their children have been seriously damaged by MMR vaccine. Each time the Department of Health have cited many reports as being conclusive proof that the vaccine is both safe and effective. It is important to note that the authors of the Cochrane Review have scrutinised 5,000 related studies and in this context found the majority lacking. Only 31 of the 5,000 studies were thought to "possibly fulfill their inclusion criteria".

The Cochrane Review is a significant piece of work because it actually exposes all the 5,000 related studies as being inadequate in some way, as all fail to find any link with long-term disability for which compensation has been paid or acknowledged by the vaccine manufacturers in their own product sheets.Of course the MMR vaccine is responsible for long-term disability in some children. All drug products have the potential to cause both minor and serious adverse reactions one has only to read the manufacturers' product information sheets to be aware of this. Vaccine damage, and in this case, MMR vaccine damage has been recognised by Governments, three examples are:

1. The US Government has a National Vaccine Injury Compensation Programme and 14% of all claims have been paid out to children damaged by MMR vaccination.

2. The Japanese authorities have paid out substantial compensation to parents of MMR vaccine damaged children after a successful court case in March 2004. (There is an on-going UK case.)

3. The UK Government has a Vaccine Damage Payment Unit which has paid out hundreds of thousands of pounds to children affected by childhood vaccines including MMR vaccine.

Many children who suffer adverse reactions are individually assessed by Government doctors panels. These panels determine the reported adverse event and association with vaccination (known to the manufacturers) and make

120 recommendation for compensation for the individual. The criteria used is extremely high and compensation awards are not made lightly.For the medical authorities now to conclude that this review gives the MMR vaccine a clean bill of health does a great injustice to all those children who have been awarded vaccine damage payments by ignoring their existence It will also bolster those that sustain the failed passive vaccine reaction surveillance system which continues to ensure very few reactions are put forward or recorded in medical data. It is this poor data that was used in many of the reports reviewed by Cochrane which they identified as inadequate. Therefore a continued cycle of failure by the medical authorities to identify and reduce vaccine adverse events in children will be assured. For the Department of Health to continue trying to convince parents, many of whom have family and friends with children believed to have been affected by MMR vaccine, exposes them to being blind to the reality.

World Health Organisation (WHO) - Causality of Adverse Events: "Since the inception of vaccination, it has been recognized that adverse events following immunization (AEFIs) will occur." (Ref. 2 below) The WHO gives criteria to be considered when an adverse event is reported: 1. Consistency. The association of a purported adverse event with the administration of a vaccine should be consistent, i.e. the findings should be replicable in different localities, by different investigators not unduly influencing one another, and by different methods of investigation, all leading to the same conclusion(s). As already mentioned problems following MMR vaccination have been reported and accepted in Japan and the United States. A report from Finland described the immunization of 1.8 million individuals and gave rise to 173 potentially serious reactions claimed to have been caused by MMR vaccination. In all, 77 neurologic, 73 allergic and 22 miscellaneous reactions and 1 death were reported. (Ref. 3) Furthermore most of these cases were not followed up for more than a few weeks. And this Finnish study "did not examine the relationship

121 of MMR and autistic spectrum disorders.....and does not therefore provide useful evidence on this point." Medical Research Council December 2001.

2. Strength of the association. The association should be strong in the magnitude of the association (in an epidemiological sense), and in the dose-response relationship of the vaccine with the adverse effect. JABS has been contacted by thousands of families who believe their children have suffered severe damage or died following the MMR/MR vaccination. In the main, doctors cannot give any other medical explanation for the child's deterioration or death. It must be remembered that many of the children have been given the now withdrawn Urabe containing MMR vaccines which were known to cause inflammation of the brain. Furthermore, many of JABS children shared the same batches of MMR vaccine and subsequently suffered the same long term effects.

3. Specificity. The association should be distinctive and the adverse event should be linked uniquely or specifically with the vaccine concerned, rather than its occurring frequently, spontaneously or commonly in association with other external stimuli or conditions. The three viruses, measles, mumps and rubella, are known to be linked with the children's conditions in their wild state. The vaccines contain the live viruses.

4. Temporal relation. There should be a clear temporal relationship between the vaccine and the adverse event, in that receipt of the vaccine should precede the earliest manifestation of the event or a clear exacerbation of an ongoing condition. For example, an anaphylactic reaction seconds or minutes following immunization would be strongly suggestive of causality; such a reaction several weeks after vaccination would be less plausible evidence of a causal relation. A substantial proportion of the children had an immediate reaction to the vaccination, and the change which came over them dates directly from that reaction.

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5. Biological plausibility. The association should be coherent; that is, plausible and explicable biologically according to known facts in the natural history and biology of the disease. The viruses are known to be linked with the health problems when caught as the wild diseases. The vaccine manufacturers' acknowledge this by recording these problems as the 'rare' adverse events associated with their products. Many of the children have had a variety of medical tests and examinations to rule out other causes.

The WHO continues with: a. The requirement for biological plausibility should not unduly influence negatively a consideration of causality. Biological plausibility is a less robust criterion than the others described. If an adverse event does not fit into known facts and the preconceived understanding of the adverse event or the vaccine under consideration, it clearly does not necessarily follow that new or hitherto unexpected events are improbable. Biological plausibility is most helpful when it is positive; it is less so when negative. This is an important statement as it makes it quite clear that just because something has not been recognized as linked with the vaccine in the past doesn't mean it isn't linked. This supports our concern that with the failure of the post-vaccination adverse event surveillance system to collect data on unexpected reactions and therefore a failure to investigate them could be allowing a serious problem to go undetected. This could lead to a catch 22 system; because the problem hasn't been linked with MMR vaccine before, further reports of the same problem are not put forward because they are not known to be linked with the MMR vaccine. b. Consideration of whether the vaccine is serving as a trigger (trigger in this context is an agent that causes an event to happen which would have happened some time later anyway). When acting as a trigger, the vaccine may expose an underlying or pre-existing condition or illness. An example of the latter would be

123 an auto-immune condition triggered non-specifically by the immune stimulus of the vaccine. This is an interesting point. Many of the parents report that their child's health problems are not known in the family's medical history but they have been told by their medical practitioner that the vaccine acted as a trigger to reveal the underlying condition. What is particularly worrying is that the child usually has more than one, supposedly, rare condition that started at the same time e.g. autism and bowel problems, epilepsy and loss of speech and communication and a failure to move on mentally from the point of vaccination. Some children developed health problems when vaccinated at four years of age or ten years of age or sixteen years of age after many years of good health and development progress. c. In the case of live attenuated vaccines, if the adverse event may be attributable to the pathogenicity of the attenuated vaccine microorganism and thus not be distinguishable (except, perhaps, in severity) from the disease against which the vaccine is being administered, a causal connection is more plausible. Identification of the vaccine organism in diseased tissue and/or in the body fluids of the patient in such a situation would add weight to causality. There are exceptions to both these above points. Measles virus has been found in the spinal fluid - and therefore the brain - in three of the six children at the centre of the huge UK high court battle over the safety of the vaccine. It has also been found in 18 children in the United States who developed autism after receiving MMR.

Financial cost: Letter submitted to the Lancet (Spring 2004) by David Thrower Sir, AUTISM As one of the parents who, through enforced circumstance, has become involved in the controversy surrounding the causes and consequences of autism, I wish to respond to your commentary (1). As you imply, the 2002 UK autism research funding of $2.75m was lamentably inadequate, and should be set against the

124 very considerable economic costs of autism. It has previously been estimated that just one severe case of autism will cost the community up to £3m over that person's lifetime. The degree of severity and consequent precise costings could be debated at length. Costs include special needs education, home-to-school taxiing, escorts, daily respite care, overnight respite breaks, transport, health care, attendance and disability allowances, carer's allowance, and loss of tax revenues from the parent who has to cease work to become the child's carer. From age 16, you can add-on independent living fund payments and incapacity benefit. From age 19, schooling costs cease, but most of the other costs continue for life, and you also have to add in the lost tax revenue from the autistic person. In these circumstances, the estimate of £3m for the costs of a severe case of autism may well be an underestimate. But let us stay with £3m, for the sake of simplicity. So the 2002 autism research grant, for the UK, was actually less than the lifetime cost of just one severe case of autism. And then you can try to estimate the numbers of UK cases. The recent unsuccessful UK High Court action alone involved 1,300 families. There have been many attempts at trying to gauge the numbers of UK autism cases. But hard State-collected data from the US Individuals With Disabilities Education Act database points to there being 120,000 children and young people ages 6-21 in full time education in the US with a primary diagnosis of autism, so a pro-rata application of those figures to the UK would give around 35,000 cases in the UK within that age-band. Obviously, not all cases are severe, but a reasonable estimate would be that an assumed 35,000 cases would cost the taxpayer somewhere between £35 billion and £100 billion over the next seven decades, or between £500m and £1.4 billion per annum. This of course, excludes any future cases that enter the autistic population over that time, plus the present existing small numbers of autistic adults. If autistic children continue to emerge at the rate now being recorded across the US, then the UK taxpayer could be facing an immense autism bill of several billion pounds per annum, within a couple of decades. On those terms, even your sought-after £12.5m for autism research therefore seems grossly inadequate to research a condition that is clearly already creating an economic burden, and one that seems set to increase. And these future autism costs will

125 apply wholly irrespective of the current controversy about autism's actual detailed causes. The children already exist now, today, for whatever reason. The economic stakes over seeking autism's causes are therefore extremely high. I would also strongly support the efforts of Dr. Tom Jefferson in bringing adverse event surveillance out of the nineteenth century and into the twenty-first (2). But I would ask, how genuinely keen is our Department of Health, and government departments in other countries, to actively seek out every potential case of vaccine damage, and to analyse the data proactively? There seems to have been a marked lack of enthusiasm to date. The Medicines & Healthcare Products Regulatory Agency's existing Yellow Card system has been admitted by its predecessor, the Medicines Control Agency, to record only 10%-15% of even serious adverse events, yet the Agency seems quite content to live with that. In other areas of life, it is very difficult to imagine (say) the Vehicle Inspectorate being content with such a poor system for vehicle inspections, so why is medicine's Yellow Card scheme's inadequacy tolerated so readily? Perhaps the Agency lacks the determination that parents of damaged children have to investigate adverse outcomes. Finally, as you rightly point out, "the discovery of a possible link between bowel disease and autism is a serious scientific idea...... and one that deserves further investigation." The original Royal Free team paper was in February 1998. It is now Spring 2004. It is the continued abject failure to fund clinical research in this area, based upon the detailed examination of regressive-autism cases, that is the least acceptable aspect of the autism controversy, and I would welcome some candid explanation from the relevant authority, the Medical Research Council, as to what it has - or has not -been doing over the past six years. David Thrower , Stockton Heath, Warrington, Cheshire WA4 2DZ

References: (1) Commentary, The Lessons of MMR, Lancet, 2004, 363 (2) Jefferson T, Price D, Demicheli V et al. Unintended events following immunisation with MMR: a systematic review. Vaccine 2003; 21: 3954-60

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Summary: In our opinion the current Government has failed in its duty of care. At the meeting in 1997 the Health Minister should have instigated a scientific study of the children believed to have been damaged to discover why the children's lives changed so dramatically within such a short time of MMR/MR vaccine being given. Since that meeting the reports of MMR/MR damaged children to JABS has greatly increased. The issue of safety surrounding the MMR vaccine has not yet been resolved. The Department of Health have relied on epidemiological studies as their basis for stating the vaccine is safe. These studies are not designed to collect data on 'rare' events. The Department of Health has failed to adopt the precautionary principle. Until the question of MMR safety is resolved the option of single dose vaccines should be made available for parents who have lost confidence in the combined vaccine. A question that must be asked of the present Health Minister is: if the drug companies have informed the Department of Health's doctors of the known vaccine problems and parents have informed the doctors that these problems are occurring. Why is the Department of Health denying the problems and ignoring the parents? It could be argued that the vaccine manufacturers have a duty to provide compensation, as they have to in the United States by contributing to the US National Vaccine Injury Programme. The pharmaceutical industry profits from the supply of vaccines to the UK and also, ironically, from the victims because they produce the anti-convulsants, pain killers and other medical products these children need. At the moment however, in the UK, they do not contribute financially in any way to the vaccine damage payment scheme. The UK Vaccine Damage Payment Act 1979 has gone some way to address the issue. Unfortunately, because the criteria are so strict most families cannot access justice for their children through this Government scheme and therefore it is relatively ineffective. Until a compensation programme similar to the US scheme is implemented in the UK, parents will seek redress through the courts

127 and for this reason families need the support of legal aid to pursue justice. Legal aid should be re-instated. Critics of the JABS group must think of this: If our members had been anti- vaccine lobbyists our children would not have been taken for vaccines and subsequently damaged. We are parents who put our faith in the UK healthcare system; our children have reacted usually in the time frame known to the manufacturer and, in the main, are living with long term problems also known to the manufacturer. We want the children to be recognised and compensated and clinically investigated to help develop a screening programme to improve vaccine safety. JABS believes in a safe vaccination programme but the emphasis is on safeand reducing risk wherever possible.

Acknowledgements: We are extremely grateful to:-David Thrower for his input and to Parents who submitted the JABS questionnaire.

References: Ref. 1: MMR and Acquired Autism (Autistic Enterocolitis) - A Briefing Note byDavid Thrower March 2006 http://www.jabs.org.uk/pages/Autism_Review.pdf Relevant Extracts: 93. Paper by Uhlmann, Sheils et al, Measles Virus In Reactive Lympho-Nodular Hyperplasia and Ileo-Colitis of Children, (publication date not known), Department of Pathology, Coombe Womens' Hospital, Dublin, Trinity College Dublin and Royal Free Hospital London. This paper noted that measles virus nucleoprotein (N antigen) had been detected in association with follicular dendritic cells (FDC) in patients,and sought molecular confirmation of this result. It found that: * Solution phase RT PCR yielded specific MV N gene amplification in affected children (10/10). * Distinct measles virus genome was identified in FDC reactive follicular centres by in-cell RNA amplification

128 * None of the normal controls showed any evidence of measles virus genome * The data highlighted a possible causal link between measles virus infection and ileo-colonic lymphoid nodular hyperplasia in affected children 96. Paper Presented to US Congressional Oversight Committee on Autism and Immunisation, Professor John O'Leary, Dublin Womens Hospital, April 2000. This paper reported a study using biopsy material from children examined at the Royal Free in London. Dr. Wakefield at the Royal Free had posed three questions to the O'Leary team, (1) was measles virus present in gut biopsies of affected children? (2) where was measles virus located in the gut biopsies of the affected children? (3) how much virus was present? * The O'Leary team used in-situ hybridisation (with/without tyramide signal amplification), in-cell PCR, solution-phase PCR, TaqMan quantitative PCR and DNA sequencing to determine the answers to these questions. * Using TaqMan PCR the team was able to quantify the measles virus copy number per 1,000 mucosal cells using gene dosage correction formulations.The copy number of measles virus in gut biopsies from children with autistic enterocolitis was low, at approx. 30-50 measles virus genomes per 2,000 mucosal cells (inc. Gut, epithelial, lymphoid and dendritic cells). * Confirmation of the presence of measles virus genomes was achieved using positive and negative strand sequencing of cDNA measles amplicons. * The results were that 24 out of 25 (96%) of the autistic children were positive for measles virus, including 2 children from the USA who were included in this analysis: * In the controls, only 1 of the 15 children (6.6%) was positive for measles virus. * The study therefore localised, quantified and sequenced measles virus genomes in gut biopsies of children with autistic enterocolitis. The study team then posed the question, "how did it get there?". 97. Paper by Kawashima, Takayuki et al, Detection and Sequencing of Measles Virus from Peripheral Mononuclear Cells from Patients with Inflammatory Bowel Disease and Autism, Digestive Diseases & Sciences Vol. 45, No. 4, April 2000, pp723-729 Following reports that measles virus might be present in the intestines

129 of children with Crohn's Disease, a new syndrome was reported in children with autism who exhibited developmental regression and gastrointestinal symptoms(autistic enterocolitis), in some cases after MMR vaccine, was reported (see papers by Wakefield et al). It was not known whether the virus, if confirmed as present in these patients, derived from wild strain or vaccine strain. This study carried out the detection of measles genomic RNA in peripheral mononuclear cells (PBMC) in 8 patients with CD, 3 patients with UC and 9 patients with autistic enterocolitis. As controls, the study used 8 cases of either healthy children or children with SSPE, SLE or HIV-1. The results were: * 1/8 patients with CD, 1/3 with UC and 3/9 with autism were positive. Controls were all negative *The sequences from patients with CD shared the characteristics with wild-strain virus. *Sequences from patients with UC and children with autism were consistent with vaccine strain measles. *These results were consistent with the exposure history of the patient. This study is obviously particularly important because it points to infection with vaccine-strain measles virus Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid of Children with Regressive Autism: a Report of Three Children J.J. Bradstreet, MD., J. El Dahr, MD; A.Anthony MB, PhD; J.J.Kartzinel, M.D; A.J.Wakefield, MD.Ref. 2: World Health Organisation http://www.who.int/vaccine_safety/causality/en/ Causality assessment of adverse events following immunization Since the inception of vaccination, it has been recognized that adverse events following immunization (AEFIs) will occur. The frequency of AEFIs is directly related to the number of vaccine doses administered. AEFIs can be causally related to the inherent properties of the vaccine, linked to errors in the administration, quality, storage and transport of the vaccine (programmatic errors), but it must be recognized that when large populations are vaccinated, some serious events that occur rarely with or without vaccination will be observed coincidentally following vaccination. Thus, investigating causality of AEFIs, particularly those that are most serious, is challenging. The clearest and

130 most reliable way to determine whether an adverse event is causally related to vaccination is by comparing rates of the event in a vaccinated and non- vaccinated group in a randomized clinical trial. Such trials, however, can never be large enough to assess very rare events, and postmarketing surveillance systems are required to identify events potentially related to vaccination. Postmarketing surveillance capability is improving; more countries now have AEFI monitoring systems, and more importance is attached to the reporting of suspected links between vaccination and adverse events. These systems have been successful in bringing to light serious AEFIs after vaccines have been marketed. A recent example is in tussusception after administration of reassortant rhesus rotavirus vaccine. Assessments of whether a given vaccine causes a particular adverse reaction vary from the casual observation to the carefully controlled study. The majority of individuals are not trained in interpreting such studies and are unlikely to understand the enormous difference in significance between these two extremes. Nonetheless, the public frequently forms a decision about a vaccines safety based on the information available to them is often a report based on unscientific observations or analyses that fail to stand the scrutiny of rigorous scientific investigation. Certain reports of AEFIs published in the medical literature over the past few years have resulted in controversy. The studies on which these reports are based, while generating provocative hypotheses, have generally not fulfilled the criteria that would be needed to be able to draw conclusions about vaccine safety with any degree of certainty. Yet these reports have had a major influence on public debate and opinion-making. When this debate spills over to the political arena, to policy-making and to determining the public acceptance of a vaccine by balancing the known benefits against possible but unverified risks, it is clear that a correct assessment of causality is vital. Submitting a study to a scientific process rather than to partially informed opinion is crucial in determining whether a vaccine actually causes a given reaction. If undertaken carelessly or without scientific rigour, the study results will be inconclusive at best, may result in the inappropriate withdrawal of a valuable vaccine from use, or at worst may result in the exposure of a population

131 to a dangerous vaccine. In 1999, WHO launched the Immunization Safety Priority Project to establish a comprehensive system to ensure the safety of all immunizations given in national immunization programmes. The development of mechanisms to respond promptly and effectively to vaccine safety concerns is a major area of focus of this project. As part of this effort, the Global Advisory Committee on Vaccine Safety (GACVS) was constituted by WHO in September 1999. The Committee's mandate is to enable WHO to respond promptly, efficiently and with scientific rigour to vaccine safety issues of potential global importance. 1. Consistency. The association of a purported adverse event with the administration of a vaccine should be consistent, i.e. the findings should be replicable in different localities, by different investigators not unduly influencing one another, and by different methods of investigation, all leading to the same conclusion(s). 2. Strength of the association. The association should be strong in the magnitude of the association (in an epidemiological sense), and in the dose-response relationship of the vaccine with the adverse effect. 3. Specificity. The association should be distinctive ñ the adverse event should be linked uniquely or specifically with the vaccine concerned, rather than its occurring frequently, spontaneously or commonly in association with other external stimuli or conditions. 4. Temporal relation. There should be a clear temporal relationship between the vaccine and the adverse event, in that receipt of the vaccine should precede the earliest manifestation of the event or a clear exacerbation of an ongoing condition. For example, an anaphylactic reaction seconds or minutes following immunization would be strongly suggestive of causality; such a reaction several weeks after vaccination would be less plausible evidence of a causal relation. 5. Biological plausibility. The association should be coherent; that is, plausible and explicable biologically according to known facts in the natural history and biology of the disease. Building on the seminal work on determining causality of the Surgeon

132 General is Advisory Committee on Smoking and Health (1964),3 the generally established criteria underpinning vaccine adverse event causality assessment that the GACVS uses may be summarized as follows: a. The requirement for biological plausibility should not unduly influence negatively a consideration of causality. Biological plausibility is a less robust criterion than the others described. If an adverse event does not fit into known facts and the preconceived understanding of the adverse event or the vaccine under consideration, it clearly does not necessarily follow that new or hitherto unexpected events are improbable. Biological plausibility is most helpful when it is positive; it is less so when negative. b. Consideration of whether the vaccine is serving as a trigger (trigger in this context is an agent that causes an event to happen which would have happened some time later anyway). When acting as a trigger, the vaccine may expose an underlying or pre-existing condition or illness. An example of the latter would be an auto-immune condition triggered non-specifically by the immune stimulus of the vaccine. c. In the case of live attenuated vaccines, if the adverse event may be attributable to the pathogenicity of the attenuated vaccine microorganism and thus not be distinguishable (except, perhaps, in severity) from the disease against which the vaccine is being administered, a causal connection is more plausible. Identification of the vaccine organism in diseased tissue and/or in the body fluids of the patient in such a situation would add weight to causality. There are exceptions to both these above points. Clearly, not all these criteria need to be present, and neither does each carry equal weight for a causal relationship between an adverse event and the vaccine to be determined. In addition to the general principles mentioned above, there are a number of provisos or considerations that need to be applied for determining causality in the special field of vaccine safety. They are: 1. Well-conducted human studies that demonstrate a clear association in a study design that is determined a priori for testing the hypothesis of

133 such association. Such studies will normally be one of the following, in descending order of probability of achieving the objective of the study: randomized controlled clinical trials, cohort studies, and casecontrol studies and controlled case-series analyses. Case reports, however numerous and complete, do not fulfil the requirements for testing hypotheses, although on occasion such reports can be compelling if there are clear biological markers of the association, as is the case for vaccine-associated paralytic poliomyelitis. 2. An association that is demonstrated in more than one human study and consistent among the studies. The studies would need to have been well conducted, by different investigators, in different populations, with results that are consistent, despite different study designs. Demonstrable association in the studies between dose and the purported adverse effect (either the dose or the number of doses administered, or both) will, in many cases, strengthen the causal association between the vaccine and the adverse event. This is not always the case, especially if there is an immunological relationship. 3. A strong similarity of the adverse event to the infection the vaccine is intended to prevent, and there is a non-random temporal relationship between administration and the adverse incident. An association between vaccine administration and an adverse event is most likely to be considered strong when the evidence is based on: It is important that there should be a strict definition of the adverse event in clinical, pathological and biochemical terms, as far as that is achievable. The frequency in the nonimmunized population of the adverse event should be substantially different from that in the immunized population in which the event is described, and there would not normally be obvious alternative reasons for its occurrence that are unrelated to immunization. An adverse event may be caused by a vaccine adjuvant or excipient, rather than by the active component of the vaccine. In this case, it might spuriously influence the specificity of the association between vaccine

134 and adverse event. As far as possible, safety issues should be clarified in premarketing controlled clinical studies, with attention being given in such studies to safety issues and their monitoring, although with extremely rare unexpected events, this may not be achievable because of the need for extremely large sample sizes to detect them. When adverse events are attributable to a vaccine, it is important to determine whether there is a predisposed set of subjects (by age, population, genetic, immunological, environmental, ethnic, sociological or underlying disease conditions) for any particular reaction. Such predisposition is most likely to be identified in case-controlled studies. A systematic effort should always be made to exclude confounding programmatic errors and variability and aberrations in vaccine manufacture. The latter quality issues are most likely to be revealed by careful attention to batch and lot testing. Since observational studies are not randomized and since individuals who are ill are generally less likely to be immunized (but more likely to have an adverse outcome), epidemiological studies on vaccine safety need to pay special attention to contraindications as potentially confounding factors. The consequences of this bias may be false-negative studies. Ref. 3: > Serious adverse events after measles-mumps-rubella vaccination during a 14 year prospective follow up. Pediatr Infec. Dis J. 2000;19:1127_34 Annamari > Patja,MD, Irja Davidkin, MSC, Phd, Tapio Kurki,MD, Phd, Markku J T Kallio, > MD, Martti Valle, MD, Phd and Heikki Peltola, MD, Phd

Briefing note compiled by JABS, WARRINGTON, CHESHIRE, WA3 3RF

Editors note: All the information shown herein is shown in good faith, and is the opinion of the contributors, not the editors.

135

EVIDENCE OF HARM : Mercury in Vaccines and the Autism Epidemic - A Medical Controversy by David Kirby

Autism, rare in the past, is exploding in the United States , where it is now found in one in 166 children. Attention-deficit disorder also has skyrocketed. And 1 in 6 children today has a learning disability. David Kirby investigated whether one of the causes of these childhood afflictions is thimerosal, a vaccine preservative that contains mercury, a well-documented neurotoxin. In the 1990s, the mercury- containing additive was injected into children far in excess of federal safety levels. Kirby told the story of stonewalling, denial and cover-up by federal regulators, medical groups and the pharmaceutical industry. And he documents covert efforts by some of those same powerful forces - along with the U.S. Congress - to grant blanket immunity for drug companies that put mercury in vaccines. Like so many scientific controversies involving complex science and big business, the topic is controversial. Kirby's careful and meticulous reporting is exemplary in its balance, accuracy and documentation.

136 Harry Horne-Roberts- His Work. Harry attended Moselle, Oak Lodge and The Bridge School. After leaving school he went to the Hoffman Day Centre and to Daylight (LBI) where he continued with his art, movie making, and music work. He died when he was 20.

Harry was autistic and he saw the world quite differently to most people. At times he was relaxed and very much in touch with the world around him, ready to hold interesting conversations with his companions, but quite often he was within his own world which he was trying to express through his art work.

Looking at Harry's work one might be introduced to the kind of world Harry was living in.

Harry regularly returned to his favourite themes or interest such as dinosaurs and the natural world or his favourite cartoon characters. He was eager to combine his drawing techniques with his computer skills and some of the work in this exhibition represents this combined technique combining Google SketchUp with freehand work and text, all in vibrant colour.

Harry was a talented Artist, who spent a lot of his time drawing and produced hundreds of drawings during 2005-2009.

Harry seemed to be putting on the paper what he clearly "saw" in his head. He was always very certain and quick with his drawing, and always knew straight away when his work (lines, curves) were correct or needed correction. Quite often, after hours of drawing, pictures that look magnificent (to outsiders, but not to Harry), the perfectionist artist Harry, not precisely happy with the result of his work, was willing to destroy it. Sadly, quite a lot of Harry's work was been destroyed by him.

Harry led an interesting if short life. The description of his weekend activities looks like a copy of Time Out magazine; visits to London's art galleries and museums with the Science Museum the Natural History Museum, The Tate Modern, the Zoo and the Museum of London on the top of the list. This Exhibition of Harry's work is a celebration of his too short life. July 2010.

137

LIST OF WORK.

1: Moselle Series 1995-2000.

M 01. Whales. M 03. Giraffe. M 04. Hippo. M 05 Prehistoric Animals. M 06. Gorilla.

138 139 140 141 142

143 2: Oak Lodge Series 2000-2005

OL 02. Dino. OL 05. Tigger. OL 06. Animals. OL 07. Dragon. OL 08. Uintithehopn. OL 09. India. OL 10. Genie. OL 11. Shark Monster. OL 12. Deep- Sea. OL 13. Fossils. OL 14. Parrot. OL 15. Monsters. OL 16. Harry at work. OL 19. Rhunkhosaurus OL 20. Tweedle‘s ScaryFace. OL 22. Crocky Wock. OL 23. Zebra. OL 25. Space. OL 27. Harry drawing. OL 29. Harry‘s Birth. OL 32. Sharks. OL 33. Solar System. OL 34. Crocodile. OL 35. Elephant. OL 36. Dinosour.

144 Gallery 2. 02:Dino

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05:Tigger

146 06:Animals

147 07: Dragon

148 08 Uintothehopn

149 09:India

150 Genie

151 11:Shark Monster

152 12:Deep-Sea

153

13:Fossils

154 14: Parrot

155 15:Monsters

156

16: Harry at Work

19:Rhunkhosaurus

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20: Tweedle‘s ScarryFace

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22: Crocky Wock

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23: Zebra

161 27: Harry drawing

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29:Harry‘s Birth

163 32: Sharks

164 33: Solar System

165 34 Crocodile.

166 35:Elephant

36: Dinosaur

167

168 2. The Bridge Series 2005-2008. TB 03. Doggy. TB 04. Geese. TB 06. Elephant. TB 07. Duck. TB 08. Cock. TB 09. Seagull. TB 10. Tortoise. TB 11. Rabbit. TB 37. Mythical Monster. TB 38. Baby Dino‘s. TB 39. Smiling Bear.

169 170 171 172 173 174 175

176

3. Hoffmann Foundation for Autism

It has become evident that Harry‘s work was strongly influenced by autism, what was being shown was very different ways of looking at and understanding the world. The objective of Harry‘s art classes was to confront the dominance of art that depends upon strict adherence to normal visual rules. These rules act as a barrier to people with perceptual and co-ordination problems and he was encouraged in his unorthodox approach to the visual medium. The attached illustrations of Harry‘s work at Hoffmann and elsewhere will help establish the special and unique characteristics in the work of people who are autistic and the exceptional visual principles that reflect the way they understand and relate to the world around them. The aim is to illustrate potential links between these principles and establish a practical method of understanding how art can be made, enjoyed and shared in this new and unique way by others.

3: Hoffmann List 2006-2009

01 Mural, model +sketch 02 In Front of the Wall 03 The Plant. 07 Harry at Wipsnade 2009. 08 Rye Harbour. 09 In the Plant House 11 In the Red Armchair. 15 Rye Nature Reserve. 16 On the Trampoline. 20 Adeola and Harry. 22 Tropical Plants 25 Self Portrait. 33 Rye Boats.

177 34. The Swimmer. 35. Palm House. 36. Cactus.

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3.1 Gallery

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186 187 188 189 190 191 192 193 194 195 196 197 198 199

3: Daylight:

In 2008, when Harry had come to the end of his school days he was accepted at L B Islington‘s day centre ‗Daylight‘ which provides a service for adults with learning disabilities many of whom have a range of additional needs including physical disability and autism.

Daylight has a specialist autism service which is accredited with the National Autistic Society. With the help of Hannelore Bout, head of the autistic unit, Ray, Andrew, Lucy, Michaela and Kristin he developed very well and was enjoying more film making with Kristin, singing with Lucy, a professional jazz singer, and swimming and walking and exploring London with Andrew and Ray. Harry's favourite song to sing with Lucy was the theme from the Snowman. He also loved to sing the songs from the Disney Hercules film.

Harry was supported to make decisions about how he would like to spend his time and to think about what he wanted to get out of being a part of Daylight. He participated in a variety of sessions such as art, cookery, drama, micro gardening, music and pottery. He often used the on-site sensory room as can be seen in the video attached.

As well as building-based activities, Daylight staff supported Harry to take part in community- based activities such as bowling, shopping, swimming, trampoline sessions and visiting museums and galleries.

Unfortunately he was only offered two days a week due to shortage of places there but he made the most of his time there working on his ‗movies‘ with Kristin on the PC and swimming with Andrew, Lucy. While in the pool Ray guarded the fire exit door to prevent Harry escaping from the pool direct to the street; a thing he had done a number of times often in wintertime clad only in his trunks and hotly pursued by his carers also in their trunks.

However he was happy there and we are forever grateful to the wonderful staff who looked after him.

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3.1

3.2: see Daylight video attached.

202

Harry’s condition at the time of his untimely death. Harry was very aware of his own condition; however he could cope with it to an extent. He threw himself into his routines and in particular, we had to follow a very specific and consistent routine at the weekend. Usually this would consist of going to the same museum or the zoo and if we did not then Harry became very distressed. He loved to read books and could hold very articulate and informative conversations about science, history or the universe and space. This had however to be tempered with the fact that Harry still had very substantial difficulties in conducting his normal every day life. On occasions, Harry had gone missing and we had only been able to track him down by thinking about the routines that he would follow and invariably, we had found him either at a museum or on one occasion, the Police found him in Green Park having brought books from two different museums which he had clearly been to.

Whilst Harry had a number of very "intellectual" pursuits he was still very much an autistic child. He liked to play with soft toys and he had no friends of his own age to speak of. He was however well known at the zoos and museums that he went to regularly and he liked to go to the book shops and was well known to the members of staff who always said hello to him. For example, we went to the zoo and museum once a week every week and on nearly every occasion, he bought either a book, CD rom or video.

The restrictions that Harry placed on himself by his routines were also evident during the evenings during the week when he insisted on going to the park. On a Sunday, we would always go to the Natural History Museum and then to the Science Museum. If we do not go to the museums then Harry would find a way of getting there himself, whether running off or making his own way there on another occasion.

203 204

THE WAY FORWARD FOR OTHERS - AFTER LEAVING SCHOOL.

(1) To establish supported residential centres for children and people with autistic spectrum conditions in association with local Housing Associations which cater for their special needs. (2)To train adults with autism so that they may be able to secure and retain employment and or places in suitable Day training and or Occupational Centres. (3) To increase the awareness of the carers and of the general public in the ways in which they may support people with autism. (4) To share information and experience within the community of those involved in the business of supporting and working with people with autism and associated special needs.

Information:  Special Education Needs: It is vital that the SEN Statements by LEAs acknowledge the wide and varied needs of pupils that fall within the category of ASD. Students at the higher functioning end of the autistic spectrum may have more subtle needs viz a viz those with classic Kanner autism. Failure to address these needs could have a damaging impact on their chances of an inclusive education. Post-16 students with Asperger's Syndrome may need peer mentoring, life skills classes and named pastoral contacts.

Respite Care:  Respite carers spend a few hours a week with a person with autism or Asperger syndrome or their families. We need to match volunteers with autistic people and their families who have something in common.  A carer might: . Be an extra pair of hands on a shopping trip . Take a child out to the park or for a walk

. Go along with a teenager to a youth club or aerobics class

205 . Meet up with an adult for lunch or to go and see a film

. Spend time listening and talking to a member of the family . Offer the family a short break by spending time with a child in the home.

Residential Support: The need is to establish supported residential centres (flats) for autistic people by association with local Housing Associations catering for their special needs.

Frequently Asked Questions: • What happens when I’m not there for him/her? See (5) above.  Lost and Found: Are you anxious about losing your child in a public place and concerned that they couldn't communicate with the person who found them? We need to working together to offer a service and product that could help.  The Child Safe registration service has been extended and developed with the NAS to allow the storage of information for the whole family. This is a national scheme to help reunite a lost child or vulnerable adult with their family as quickly as possible, whether in the UK or abroad.  Colourful, friendly tags and wristbands can help anyone finding your child to quickly contact you directly through the 24-hour support line

Forums:  Accommodation: For some young autistic people, remaining with a family is not an option. These may be young people in residential care or those who simply cannot stay at home for what ever reason. For them, supported accommodation provides an important alternative. To increase the range of appropriate supported accommodation for young people making the transition from home/care, we propose to: a) Evaluate existing models of supported housing for home/care leavers.

206 b)Target dissemination of the results of this evaluation to local authority care leaving teams and those responsible for setting local housing priorities in order that they fully inform the next phase of local housing strategies; and c) Establish a capital investment fund to support the provision of dedicated accommodation for people with autism. d) Articulate an agreed policy with Local Authority’s Housing Departments and Social Services Directorates and Housing Associations which will allow them to develop supported housing specifically for autistic people where they are not ready for independent living.. e) The range of accommodation under consideration should vary, with different levels of support including some specific accommodation for single parents and physically disabled autistic people. This dedicated accommodation means that autistic people are with their peers and together as a group of people, with the same corporate parent helping the local authority to ensure they are supported effectively. f) Develop a formula to determine the level of support needed to provide for young autistic people in supported accommodation who go on to higher education.

Five years ago it was indeed the case that we knew little about the causes of autism, how it emerged in the young child, and what impact it had on the developing brain. Today we know much more about all of these, opening up the exciting prospect that this knowledge can be translated into improved therapies and a better quality of life for all those affected. It has become possible to put ‗Science in the Service of Autism‘. Autism is a lifelong disorder affecting around 1 in 100 people. Its disabling effects cost the UK £28bn a year, but as a nation we spend less than 0.02% of this sum on research. This under funding must be addressed if we are to understand and treat autism responsibly and effectively.

More than half a million 500,000 Individuals in the UK are affected by Autism

207

The Way Forward For Others Postscript 'Harry's Story' ended in tragedy. Keith and Jennie his parents will along with others continue to campaign for:- 1. Better testing of vaccines including multi-vaccines, before they are introduced and licensed. We are not anti vaccine but vaccines must be safe.The testing of MMR by big Pharma, lasting only three weeks before its introduction, was wholly inadequate. 2. Routine testing of children before vaccination to discover any vulnerabilities which might make them susceptible to vaccine injury, including autism. 3. More research on both the above and also on possible treatment and even cures for autism. Some victims of vaccine injury in the US who developed ASD have subsequently been cured by careful biomedical intervention and monitoring by DAN doctors e.g. Colten Snyder whom Dr Bradstreet treated. 4. We must ensure that ASD sufferers are not treated with dangerous drugs, such as anti-psychotics, which may put them and even their lives at risk. 5.The continuing involvement of relatives/parents in the supervision of care and medical treatment of ASD adults is essential. 6. Overall we must seek to turn the tide of the overwhelming epidemic of autism which now engulfs the world. 7. We must campaign for prevention, better treatment, and hopefully cures for ASD sufferers.

We must continue this fight, for a future more fit for our grandchildren.

Harry Horne-Roberts’ First Memorial Exhibition Alexandra Park Library Jul-Aug 2010.

208

APENDICES: 1. Appendix Schedule of Claimants ‘MMR 10’

2. Appendix.

HANNAH POLING – JUDGMENT.

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS (E-Filed: April 10, 2008) No. 02-1466 V

209 ______) HANNAH POLING, a minor, ) TO BE PUBLISHED1 by her Parents and Natural Guardians, ) TERRY POLING AND JON POLING, ) Disclosure of ―information‖ to ) a non-party to a vaccine Petitioners, ) proceeding requires consent; ) 42 U.S.C. § 300aa-12(d)(4)(A); v. ) When consent withheld, request ) for disclosure presented to a SECRETARY OF HEALTH AND HUMAN ) special master SERVICES, ) ) Respondent. ) ______) ORDER DEFERRING RULING ON PETITIONERS‘ MOTION FOR COMPLETE TRANSPARENCY OF PROCEEDINGS Pending before the court are: (1) Petitioners‘ Motion for Complete Transparency of Proceedings (Petitioners‘ Motion); (2) Respondent‘s Response to Motion for Complete Transparency of Proceedings (Respondent‘s Response); (3) Petitioners‘ Reply to Respondent‘s Response to Motion for Complete Transparency of Proceedings (Petitioners‘ Reply); (4) Respondent‘s Sur-Reply to Petitioners‘ Motion for Complete Transparency of Proceedings (R‘s Sur-Reply); and (5) Petitioners‘ Surreply to Respondent‘s Surresponse to Motion for Complete Transparency of Proceedings (Petitioners‘ Sur-Reply). For the reasons discussed more fully below, the undersigned DEFERS ruling on petitioners‘ motion for a period of 60 days. 2 Hereinafter, for ease of reference, all ―section‖ references to the Vaccine Injury Compensation Act will be to the pertinent subsection of 42 U.S.C. § 300aa (2006 ed.).

210 3 The Omnibus Autism Proceeding (OAP) is a coordinated proceeding before the Office of Special Masters structured to facilitate the handling of nearly 5000 vaccine petitions involving claims that children who have received certain vaccinations have developed autism. 4 The adopted procedure for addressing the claims in the OAP involves the conduct of a two phase proceeding. The first phase of the proceeding inquires into the general causation question of whether certain vaccinations can cause autism and, if so, under what circumstances. Three general causation theories advanced by petitioners are being evaluated in nine test cases. The conclusions reached in these test cases will inform the second phase of the OAP proceeding. The second phase of the proceeding involves applying the information acquired during the first phase of the proceeding to decide the specific causation question of whether the received vaccinations caused the autistic condition alleged in an individual case. At the request of petitioners‘ counsel, through a designated Petitioners‘ Steering Committee (PSC), petitioners were afforded a generous period of time to conduct discovery that would inform their theories concerning causation. After an extended discovery period, hearings were conducted in three test cases on the first general causation theory in the OAP. The hearings were held in May 2007, October 2007, and November 2007, respectively. 2

211 I. Background On October 25, 2002, petitioners Terry and Jon Poling, the parents and natural guardians of Hannah Poling, filed a short-form autism petition pursuant to the National Vaccine Injury Compensation Program2 (the Act or the Program), 42 U.S.C. § 300aa-10 et seq. As permitted by Order dated July 8, 2002, petitioners electing to participate in the Omnibus Autism Proceeding (OAP) were permitted to file a short form ―opt-in‖ petition.3 See OAP Order of 7/8/02 at 4. Each short form petition consisted of the name of the injured child, the names of the injured child‘s parents or legal representatives, and an election to opt into the OAP proceeding. Id. at 1. The petition did ―not contain a detailed account of the relevant vaccinations and the vaccinee‘s disorder.‖ Id. Nor were the vaccinee‘s medical records required to accompany the petition. Id. By filing a short form petition, petitioners in this case elected to opt-in to the OAP.4 In September 2007, the court received for filing a compact disc containing petitioners‘ medical records. On September 17, 2007, a committee of petitioners‘ counsel in the OAP, known as the Petitioners‘ Steering Committee, designated this case (with petitioners‘ permission) as a potential test case to be heard on the second theory of general causation in the OAP. The second theory advanced by the Petitioners‘ Steering The coordinated trials permit the 5 witnesses, who will be testifying for the parties in

212 each of the three test cases, to avoid lengthy, duplicative proceedings for the taking of the same general causation theory testimony. 3 Committee in the OAP is whether thimerosal-containing vaccinations can cause autism. Coordinated trials to hear testimony in the designated three test cases on the second theory of general causation are scheduled for the last three weeks in May 2008.5 On November 9, 2007, respondent filed a Rule 4 Report conceding that petitioner should be awarded compensation in accordance with 42 U.S.C. § 300aa- 11(c)(1)(C)(ii). Respondent stated that, based on a review of the petition, medical records and affidavits, the ―facts of this case meet the statutory criteria for demonstrating that the vaccination Hannah received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism and manifested as a regressive encephalopathy with features of autism spectrum disorder.‖ Rule 4 Report at 7. Respondent further stated in the Rule 4 Report that the onset of Hannah‘s complex partial seizure disorder, nearly six years after her July 19, 2000 vaccinations, was not related to her vaccinations. Rule 4 Report at 7. The filing of respondent‘s Rule 4 Report prompted the Petitioners‘ Steering Committee to search for another potential test case for the second theory of general causation to be heard in May 2008. See Petitioners‘ Motion, Attachment 1 (Order of

213 November 19, 2007 modifying the schedule for the designation by the Petitioners‘ Steering Committee of the third test case for the second theory of causation in the OAP). As explained in the e-mail attached to the issued November 19, 2007 Order modifying the schedule for the designation of an additional test case for the second general causation theory in the OAP, the Petitioners‘ Steering Committee stated that respondent‘s ―concession places the case in [a] procedural posture that makes it inappropriate as a test case for hearing in May 2008.‖ Id. The undersigned conducted a status conference with the parties to address the filed Rule 4 Report. During the status conference, petitioners stated that they intended to file an expert report from Andrew Zimmerman, M.D., Hannah‘s treating neurologist, in support of their claim that Hannah‘s complex partial seizure disorder was a sequela of her vaccine-related injury. The undersigned directed respondent to file a status report after reviewing Dr. Zimmerman‘s expert report that addressed respondent‘s position regarding petitioners‘ claim that Hannah‘s seizure disorder was vaccine-related. Petitioners filed the expert report from Dr. Zimmerman after the status conference. On February 21, 2008, respondent filed a Supplemental Rule 4 Report addressing Section 12(d)(4)(A) of 6 the Vaccine Act provides, in pertinent part, that: [i]nformation submitted to a special master or the court in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding

214 without the express written consent of the person who submitted the information. 42 U.S.C. § 300aa-12(d)(4)(A). 7 Although the motion refers to Hannah Poling as the petitioner, this vaccine claim is prosecuted by Hannah‘s parents because Hannah is a minor and is deemed legally incapable of prosecuting an action on her own. See Petitioners‘ Motion at 1; but see 42 U.S.C. 300aa- 11(b)(1)(A) (requiring the legal representative of a minor, who is alleged to have sustained a vaccine-related injury, to file the petition for compensation under the Vaccine Program). Accordingly, as is correctly reflected in the case caption, the undersigned refers to the Polings as the petitioners. 4 respondent‘s review of Dr. Zimmerman‘s expert report. See Supplemental Rule 4 Report at 1-2. Respondent stated that ―[h]aving reviewed this additional evidence, [medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC)] now recommend[] compensation for Hannah‘s seizure disorder as sequela of her vaccine-injury in accordance with 42 U.S.C. § 300aa- 11(c)(1)(C)(ii).‖ Id. at 2. Based on respondent‘s concession, a damages determination is now underway in this case. See Order of March 6, 2008 (addressing plan to schedule ―the filing of the parties‘ respective life care plans, or if possible, a joint life care plan‖); see also Order of

215 March 12, 2008 (establishing filing deadline for status report regarding damages determination). After the filing of the Supplemental Rule 4 Report, petitioners‘ counsel informally contacted the chambers of the undersigned requesting ―permission [for all parties] to discuss the details involved in the case of Hannah Poling v. Dept. of Sec‘y of Health and Human Svcs., 02-1466V.‖ See Order of February 28, 2008 at 1. As expressed in the court‘s Order, the undersigned subsequently learned that respondent‘s Rule 4 Report had become publicly available in an electronic format other than the format of the Public Access to Court Electronic Records (PACER) System, the court‘s official electronic medium. Id. Quoting section 12(d)(4)(A) of the Vaccine Act,6 the undersigned stated that disclosure of the Rule 4 Report was proscribed by statute unless express written consent was obtained first. Id. at 2. Subsequently, on March 4, 2008, petitioners filed a motion styled as ―Petitioner‘s Motion for Complete Transparency of Proceedings.‖7 See Petitioners‘ Motion at 1. As stated in the motion, petitioners ―request[] an Order permitting the parties, or their Respondent points out in the 8 filed Sur-Reply to Petitioners‘ Motion for Complete Transparency of Proceedings (R‘s Sur-Reply) that while petitioners ―did undertake initial steps necessary to permit discussion of their case before the Special Masters presiding in the Omnibus Autism Proceeding and before representatives of the Petitioners‘ Steering Committee[,] [i]n fact,

216 it is respondent who first approached and asked for petitioners‘ consent to permit the Secretary of Health and Human Services to disclose medical information regarding this case in order for the Secretary to address inaccurate statements that were being made publicly concerning respondent‘s position in this case.‖ R‘s Sur-Reply at 2. At petitioners‘ request, respondent drafted a consent document for petitioners to sign. Id. Having received no response from petitioners, respondent contacted petitioners‘ counsel to inquire about the proposed consent form and to ―inquire whether press reports were true that petitioners were planning press conference for the following day.‖ Id. Petitioners‘ counsel replied to respondent, and represented during a status conference in this case, that the reports of a planned press conference were not true. See id. Petitioners‘ counsel ―stated, for the first time, that petitioners would only provide their consent to the disclosure of medical information if respondent consented to the public disclosure of the Rule 4(c) reports filed in this case.‖ Id. Thereafter, ―[p]etitioners filed the current Motion, (continued...) 5 representatives, to freely discuss with any person each and every aspect of this case, including the details of the Respondent‘s concession that Hannah is entitled to compensation for her vaccine-related injuries, including her autism.‖ Id. at 4-5. Petitioners ―believe[] the public has a right to know the details of her case and the extent

217 of the Respondent‘s concession.‖ Id. at 3. As an attachment to their motion, petitioners have submitted a written ―Authorization‖ that ―express[ly] waive[s] [their] § 12(d)[(4)](A) rights to confidentiality of the materials submitted in [Hannah‘s] case (with the exception that the medical records can be discussed but not be made public).‖ Petitioners‘ Motion, Authorization at 1. The authorization, however, ―is contingent upon the respondent waiving its rights as well or upon the granting of [petitioners‘] motion for complete transparency.‖ Id. In their motion, petitioners assert that section 12(d)(4)(A) of the Vaccine Act ―clear[ly] . . . prohibits Special Masters from disclosing evidence submitted in a case without the written permission of a party who submitted the evidence.‖ Petitioners‘ Motion at 3 (citing 42 U.S.C. § 300aa-12(d)(4)(A)). But, petitioners argue, ―[a] ‗Respondent‘s report‘ that concedes entitlement to compensation is clearly not ―information submitted to a special master as evidence in a proceeding and is not protected by § 12(d)[(4)](A).‖ Id. at 3-4. After failed efforts by the parties to moot petitioners‘ motion by reaching an agreement,8 respondent filed his Response to Motion for Complete Transparency of 8(...continued) and two days later they held a press conference and appeared in nationally televised and print interviews discussing the case.‖ Id. Respondent explains in the filed Sur-Reply: Respondent agreed to petitioner‘s request for mutual consent to public disclosure in this case with the understanding that such consent on the part of respondent was effective only as to disclosures occurring after respondent‘s representative signed

218 the consent. Respondent‘s consent would not cover the disclosure of any information that occurred prior to the execution of the mutual consent form. Petitioners, however, refused to accept those terms . . . . Id. at 4. 9 Petitioners misstate in their argument that petitioners‘ expert reports from the OAP are ―filed on the internet.‖ Petitioners‘ Reply at 3. In general, filings with the Office of Special Masters (or the court) are not filed on the internet. Rather, access to filings with the Office of Special Masters is available only to parties, who have proper accounts, through the internet-based Public Access to Court Electronic Records (PACER) System. In the exceptional circumstances (continued...) 6 Proceedings (R‘s Response). Construing petitioners‘ motion to pertain primarily to a discussion of the Rule 4 Report and the Supplemental Rule 4 Report, filed by respondent with the court on November 9, 2007, and February 21, 2008, respectively, respondent contends that petitioners lack a legal basis for their request. R‘s Response at 2. Respondent argues that, contrary to petitioners‘ representations, the term information is not limited narrowly to ―evidence,‖ but is a broader term. Id. at 3. Respondent points to other sections of the Vaccine Act and to the Vaccine Rules that include certain limitations on the disclosure to non-parties of filings with the court and on the disclosure to nonparties of particular information contained in a decision to be issued by the court. Id. at

219 3-5 (citing sections 300aa-12(d)(3)(B) and 300aa-12(d)(4)(B) of the Vaccine Act and Vaccine Rule 18). Petitioners filed a Reply to Respondent‘s Response to Motion for Complete Transparency of Proceedings (Petitioners‘ Reply). Petitioners assert that under the Vaccine Act, an example of a circumstance in which ―respondent submits information to the court that requires protection from public disclosure by petitioners‖ is when the government, as it has done during discovery process in the OAP, provides data under government control to which privacy protections are attached or provides information that contains data that is proprietary to vaccine manufacturers. See Petitioners‘ Reply at 3. Petitioners further assert that protecting the expert reports filed by respondent in the OAP test cases from ―fil[ing] on the internet for all to see‖9 (as petitioners‘ experts have done 9(...continued) presented by the OAP, most of the documents filed into the OAP have been posted on the court‘s website for informational purposes, after obtaining the consent of the party who submitted the information. Therefore, any posting of petitioners‘ expert reports in the OAP on the internet, with the obtained consent of petitioners, is a matter of personal election by the petitioners. 7 with obtained waivers of privacy from petitioners) is an improper exercise of protection

220 from disclosure because the expert reports are ―based on exhibits filed by petitioners.‖ See id. Petitioners reason that because ―[a] rule 4 report summarizing records and indicating whether or not the respondent concedes or contests causation in a case can only be protected by the petitioners whose records are being described[,] . . . the disclosure of the rule 4 reports in this case are solely dependent on the will of the petitioners and that permission from respondent is not required.‖ Id. at 4. Petitioners contend that ―[t]here is nothing in these reports that is ‗information‘ supplied by the respondent and . . . [i]f there were such ‗information[,]‘ presumably the respondent would point that out.‖ Petitioners‘ Sur-Reply at 1. Petitioners submit that respondent‘s failure to ―offer[] a redacted Rule 4 Report demonstrat[es] . . . [that] there is no such ‗information‘‖ that requires protecting. Id. Petitioners‘ motion is now ripe for a ruling. II. Discussion Styled as a motion for complete transparency of proceedings, petitioners‘ motion specifically requests that the undersigned grant permission for the parties to discuss the details of this case now that petitioners have provided an express, written waiver of the protection against disclosure afforded to information submitted to a special master in section 12(d)(4)(A) of the Vaccine Act. See Petitioners‘ Motion at 4-5. While

221 petitioners‘ executed waiver permits a discussion of the medical records filed in this case, the waiver does not extend to the actual release of petitioners‘ medical records. Petitioners‘ Motion, Authorization at 1. At first glance, petitioners‘ motion appears to request relief that the undersigned is without authority to grant. As respondent has correctly observed in his response, see R‘s Response at 1-2, the undersigned lacks any authority to direct parties in a case to conduct discussions with non-parties about the details of a case ―without limitation.‖ The purpose of petitioners‘ motion, however, as clarified during status conferences held with the parties after the filing of the motion, is to obtain a ruling that respondent‘s two Rule 4 Reports filed in this case are not the type of ―information‖ contemplated by 8 section 12(d)(4)(A) of the Vaccine Act and thus, permission from respondent is not required for petitioners to discuss those Rule 4 Reports publicly. Based on this understanding, the undersigned construes petitioners‘ motion as a request for the public release of the filed Rule 4 Reports, or alternatively, for permission to discuss the two Rule 4 Reports publicly. A. Statutory Analysis Questions regarding statutory interpretation of the Vaccine Act are questions of law. Avera v. Sec‘y of Health and Human Servs., 515 F.3d 1343, 1347 (Fed. Cir. 2008) (An ―issue[] [that] turns on the statutory interpretation of the Vaccine Act [is] a question

222 of law.‖); Zatuchni v. Sec‘y of Health and Human Servs., 516 F.3d 1312, 1315 (Fed. Cir. 2008) (stating that a ―question of statutory interpretation . . . requires an analysis of the text and structure of the applicable statute‖). The statutory provision in question here is section 12(d)(4)(A) of the Vaccine Act. It states: Except as provided in subparagraph (B), information submitted to a special master or the court in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the express written consent of the person who submitted the information. 42 U.S.C. § 12(d)(4)(A). What this statutory provision means ―must, in the first instance, be sought in the language in which the act is framed, and if that [language] is plain, … the sole function of the courts is to enforce it according to its terms.‖ Caminetti v. United States, 242 U.S. 470, 485 (1917); 2A Sutherland Statutory Construction § 46:1 (7th ed. 2007) (quoting same); see also Robinson v. Shell Oil Co., 519 U.S. 337, 340 (1997) (―Statutory construction begins with the plain language of the statute.‖); White v. Department of Justice, 328 F.3d 1361, 1374 (Fed. Cir. 2003) (same). ―In the absence of a specific indication to the contrary, words used in the statute will be given their common, ordinary and accepted meaning, and the plain language of the statute should be afforded its plain meaning.‖ 2A Sutherland Statutory Construction § 46:1 (7th ed. 2007); see also Medrad, Inc. v. Tyco Healthcare Group, LP, 466 F.3d 1047, 1051 (Fed. Cir. 2006) (when

223 interpreting a statute, ―give words their ordinary, contemporary, common meaning unless Congress has indicated otherwise . . . with a view to their place in the overall statutory scheme‖)(internal quotations omitted); cf. 1A Sutherland Statutory Construction § 20:8 (6th ed. 2002) (―When a legislature defines the language it uses, its definition is binding upon the court even though the definition does not coincide with the ordinary meaning of the words.‖). 9 The term in section 12(d)(4)(A) of the Vaccine Act of particular interest to petitioners is ―information.‖ That term is not defined in the definition section of the Vaccine Act. See 42 U.S.C. § 300aa-33. Nor is a definition of that term found in the legislative history. Accordingly, consistent with the guiding principles of statutory construction, the term must be afforded its plain meaning, which may be supplied by its dictionary definition. See, e.g., Desper Products, Inc. v. QSound Labs, Inc.,157 F.3d 1325, 1333 (Fed. Cir.1998) (consulting the dictionary definition of a term to determine its ―plain meaning‖). As defined in Merriam-Webster‘s online dictionary, information is variously defined as ―the communication or reception of knowledge or intelligence,‖ ―knowledge obtained from investigation, study, or instruction,‖and ―intelligence, news, facts, data.‖ See http://www.merriam-webster.com/dictionary/information; see also The

224 American Heritage College Dictionary 712 (4th ed. 2002) defining ―information‖ as ―[k]nowledge derived from study, experience, or instruction,‖ ―[k]nowledge of a specific event or situation; intelligence or news,‖ and ―[a] collection of facts or data‖). The United States Supreme Court has instructed that ―[w]here the language [in a statutory provision] is plain and admits of no more than one meaning, the duty of interpretation does not arise and the rules which are to aid doubtful meanings need no discussion.‖ Caminetti, 242 U.S. at 485 (citation omitted); 2A Sutherland Statutory Construction § 46:1 (7th ed. 2007) (same proposition). It is the view of the undersigned that the breadth of the definition of the term ―information‖ does admit of more than one meaning and thus, requires some interpretation of what it means in section 12(d)(4)A) of the Vaccine Act. The Federal Circuit has counseled that judicial interpretation of words in statutory language must consider the ―place [of the words] in the overall statutory scheme.‖ See Medrad, Inc. v. Tyco Healthcare Group, LP, 466 F.3d at 1051 (Fed. Cir. 2006) (when interpreting a statute, ―give words their ordinary, contemporary, common meaning unless Congress has indicated otherwise . . . with a view to their place in the overall statutory scheme‖). The Supreme Court offered the following instruction in 1899 in Hamilton v. Rathbone: The general rule is perfectly well settled that, where a statute is of doubtful meaning and susceptible upon its face of two constructions, the court may

225 look into prior and contemporaneous acts, the reasons which induced the act in question, the mischiefs intended to be remedied, the extraneous circumstances, and the purpose intended to be accomplished by it, to determine its proper construction. Hamilton v. Rathbone, 175 U.S. 414, 419 (1899). Moreover, ―[t]he rules of statutory 10 The term information does appear in other sections of the Vaccine Act. The term appears in the title, ―Additional Information,‖ of the statutory subsection 300aa- 11(d), which provides that ―[a] petition may also include other available relevant medical records relating to the person who suffered such injury or who died from the administration of the vaccine.‖ 42 U.S.C. § 300aa-11(d) (emphasis added). The use of the term here applies to ―available, relevant medical records‖ of the vaccinee that exceed the scope of the documents required under section 11(c) of the Act, as an apparent effort to create as complete a record as possible for review. See Remarks by Sen Kennedy on introduction of S. 1922, 135 Cong. Rec. H29876, H29878 (daily ed. Nov. 17, 1989) (―We intend for the parties and the court to construe this provision broadly so as to require the submission of a meaningful file of information but not so as to hold up proceedings unreasonably if petitioner makes a good-faith effort to supply records and name unavailable ones.‖). (continued...) 10

226 construction require a reading that avoids rendering superfluous any provision of the statute.‖ Ishida v. United States, 59 F.3d 1224, 1230 (Fed. Cir. 1995). Applying these interpretive principles to glean the meaning of the word ―information‖ in section 300aa-12(d)(4)(a), the undersigned examines first the whole of section 300aa-12(d)(4) of the Vaccine Act. It provides: (4)(A) Except as provided in subparagraph (B), information submitted to a special master or the court in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the express written consent of the person who submitted the information. (B) A decision of a special master or the court in a proceeding shall be disclosed, except that if the decision is to include information– (I) which is trade secret or commercial or financial information which is privileged and confidential, or (ii) which are medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy, and if the person who submitted such information objects to the inclusion of such information in the decision, the decision shall be disclosed without such information. 42 U.S.C. § 300aa-12(d)(4) (emphasis added).10 10(...continued) Subsequently, the term appears in section 12(b)(2) of the Act. That provision prescribes a period of ―30 days after the Secretary [of Health and Human Services] receives service of any petition filed under [the Vaccine Act,] . . . [for] the Secretary [to] publish notice of such petition in the Federal Register‖ and the designated special master ―to . . . afford all interested persons an opportunity to submit relevant, written information . . . relating to any allegation in a petition‖

227 that a received vaccine caused or significantly aggravated an illness, disability, injury, or condition. 42 U.S.C. § 300aa-12(b)(2)(B). The information contemplated in this statutory subsection seems to refer to any information that would provide guidance with respect to petitioner‘s claim of a vaccine-related injury. Later in section 12(d)(3)(B) of the Act, the term appears in the enumerated list of what a special master may require ―[i]n conducting a proceeding on a [vaccine] petition.‖ 42 U.S.C. 12(d)(3)(B). That list includes, but is not limited to, ―such evidence[,] . . . the submission of such information[,] . . . the testimony of any person and the production of any documents[, and] . . . such hearings as may be reasonable and necessary.‖ Id. The use of the term in this context suggests that ―information‖ is a broader category of matter for a special master to consider than evidence, testimony, and produced documents. It seems to the undersigned that the use of the term ―information‖ in this statutory provision reflects an effort to permit a special master to become reasonably well-informed during the course of a vaccine proceeding. Additionally, the term appears in subsection 25(c) of the Vaccine Act which pertains to the release of certain information in the governmental process of recording and reporting claims of vaccine-related injuries. The subsection prohibits the release, either through a request pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, or otherwise, of

228 ―[i]nformation . . . in the possession of the Federal Government . . . which may identify an individual‖ who has received a vaccine. 42 U.S.C. § 300aa-25(c)(1). Subsection 25(c)(2) defines ―[f]or purposes of paragraph (1), the term ‗information which may identify an individual‘ . . . [to include only] the name, street address, and telephone number of the person who received the vaccine and of that person‘s legal representative and the medical records of such person relating to the administration of the vaccine.‖ 42 U.S.C. § 300aa-25(c)(2). Subsection 25(c)(2) states explicitly that the proscription against the release of ―information which may identify an individual‖ does ―not include the locality and State of vaccine administration, the name of the health care provider who administered the vaccine, the date of the vaccination, or information concerning any reported illness, disability, injury, or condition resulting from the administration of the vaccine, any symptom or manifestation of such illness, disability, injury, or condition, or death resulting from the administration of the vaccine.‖ Id. Subsection 25(c)(3) further provides that, with the exception of the ―information which may identify an individual,‖ ―all information reported under this section [concerning an alleged vaccine-related condition] shall be available to the public.‖ 42 U.S.C. § 300aa-25(c)(3). The information referenced in the subsection is clearly defined, and the statutory provision evinces an interest in public disclosure of reports involving

229 (continued...) 11 10(...continued) conditions alleged to have resulted from received vaccines as balanced against the privacy concerns of an individual. 11 Under the Vaccine Act, a decision issues either when a claim for Program compensation is denied or when a claim for Program compensation receives a damages award. See 42 U.S.C. § 300aa-12(d)(3)(A) (―A special master to whom a petition has been assigned shall issue a decision on such petition with respect to whether compensation is to be provided under the Program and the amount of such compensation.‖) see also Widdoss v. Sec‘y of Health and Human Servs., 989 F.2d 1170, 1175 (Fed. Cir. 1993) (stating that ―proceedings on a petition conclude with the special master‘s final act of ‗issu[ing] a decision on the petition‘‖). No decision has issued yet in this case. The merits of petitioners‘ claim were not litigated. Rather, respondent conceded the claim. Based on that concession, a damages determination is pending. Consistent with the Vaccine Act, a decision will issue after a determination of damages has been made. 12 The E-Government Act of 2002 requires federal courts, including the United States Court of Federal Claims, to provide on their respective websites ―[a]ccess to the substance of all written opinions issued by the court, regardless of whether such opinions are to be published in

230 the official court reporter, in a text searchable format.‖ 44 U.S.C. § 205(a)(5). The EGovernment Act further requires ―each court [to] make any document that is filed electronically publicly available online. . . . [with the exception of those] [d]ocuments that are filed that are not otherwise available to the public.‖ 44 U.S.C. § 205(c)(1), § 205(c)(2). Moreover, the EGovernment Act authorizes the United States Supreme Court to ―prescribe rules . . . to protect privacy and security concerns relating to electronic filing of document and the public availability . . . of documents filed electronically[, and] . . . such rules provide for the redaction of certain categories of information in order to protect privacy and security concerns . . . .[from the] copy [of the document] in the public file. ‖ 44 U.S.C. § 205(c)(3)(iv). 12 Section 12(d)(4) of the Vaccine Act places certain limitations on the disclosure to non-parties of ―information‖ submitted to a special master in a vaccine proceeding and on the disclosure of submitted information to a special master that is included in a decision issued by the special master.11 In subsection 12(d)(4)(A), the disclosure of submitted information in a vaccine proceeding is prohibited in the absence of express written consent from the person who submitted the information. In subsection 12(d)(4)(B), the person who submitted certain information (information of the type described in that statutory subsection) may object to the disclosure of ―such‖ information in a decision

231 issued by the special master. Effectively, section 12(d)(4)(B) of the Vaccine Act affords an opportunity for the redaction of certain information from a decision prior to the decision becoming publicly available, as is required by the E-Government Act of 2002.12 Although what constitutes information for purposes of section 12(d)(4) of the Vaccine 13 Act requires further analysis, the language of that statutory provision does make clear that before submitted information may be disclosed to a non-party or disclosed in a decision of the special master, either consent to the disclosure or an ascertainment that there is no objection to the disclosure must first be obtained. Subsection 12(d)(4)(A) is silent on what type of ―information‖ requires express written consent prior to disclosure to a non-party. Subsection 12(d)(4)(B), however, does provide some guidance regarding what type of information submitted by a person may not be disclosed if the submitting person objects to the disclosure. Subsection 12(d)(4)(B) defines two categories of information that are not to be disclosed over the objection of the submitting party: (1) information ―which is trade secret, or commercial or financial which is privileged and confidential;‖ and (2) information ―which are medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy.‖ 42 U.S.C. § 300aa-12(d)(4)(B). Although the Vaccine Act does not address what

232 constitutes ―similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy,‖ experience with vaccine cases teaches that ―files‖ submitted in connection with Program claims may include employment records, police records, social services records, and educational records that often contain factual information and personal identification information that, if disclosed outside of the vaccine proceeding, might be found to ―constitute a clearly unwarranted invasion of privacy.‖ Additionally, in connection with a damages determination in a vaccine case, information may be submitted to a special master from one or more life care planners that adverts to information contained in tax records, the disclosure of which also might be found to ―constitute a clearly unwarranted invasion of privacy.‖ It appears to the undersigned that the type of information that is to be afforded protection against disclosure, absent consent to the disclosure, is information that is commercially sensitive or that is unjustifiably intrusive into an area of privacy. As a practical matter, the information submitted to a special master in a vaccine proceeding that is privileged and confidential based on its trade secret, commercial or financial content is most likely to pertain to a vaccine manufacturer. The information submitted to a special master in a vaccine proceeding that is protected from disclosure to avoid ―a clearly unwarranted invasion of privacy‖ most likely pertains to petitioner and is

233 submitted by petitioner. Such ―information,‖ however, is not necessarily limited to information that pertains to petitioner, and such information may be submitted to the special master by respondent. Moreover, information submitted by respondent during the course of a vaccine proceeding generally incorporates information that was submitted originally by petitioner. A Rule 4 Report, in particular, is a document that is filed by respondent in a 13 This sharing of information in furtherance of the litigation process requires protection against unauthorized disclosures. Parties are urged to advise their retained experts and consultants to safeguard the shared information. Additionally, requiring the execution of a nondisclosure form by that party‘s retained experts and consultants is a strongly recommended practice. 14 vaccine proceeding and that incorporates medical information that pertains to petitioner. Moreover, the referenced medical information may have been submitted originally to the special master by the petitioner. Respondent files a Rule 4 Report in accordance with Vaccine Rule 4(c). That rule provides: Within 90 days after the filing of the petition, or in accordance with the schedule set by the special master after petitioner has satisfied all required documentary submissions, respondent shall file a report that shall set forth a full and complete statement of respondent‘s position as to why an award should or should not be granted. The report shall contain respondent‘s medical analysis of petitioner‘s claims. It shall also present any legal arguments that respondent may have in opposition to the petition. General

234 denials are not sufficient. Vaccine Rule 4(c), Appendix B, Rules of the Court of Federal Claims. This report is known as a Rule 4 Report. The report generally includes a detailed discussion of petitioner‘s medical history as well as a discussion of petitioner‘s claimed vaccine-related injury. The report may also contain an evaluation of petitioner‘s medical claim by one or more of respondent‘s experts. Additionally, the report may include the concession of a claim by respondent, together with an explanation for the position respondent has taken. The report is signed by counsel for the Department of Justice and includes contact information for counsel, which may include a direct dial telephone number. In the routine practice of the Office of Special Masters, what constitutes information under section 300aa-12(d)(4) of the Vaccine Act has not required close scrutiny. Admittedly, information pertaining to a petitioner is routinely shared in vaccine cases with non-parties to the litigation such as experts, litigation consultants (retained by petitioner), life care planners, and annuity brokers, among others, who work closely with counsel for the parties to resolve the pending claims. This information sharing is presumed to occur with the consent of petitioner, and the shared information should be handled with the care generally afforded to private, sensitive, and confidential material and with the care generally exercised by retained experts and consultants who are involved in the litigation process.13

235 15 Requests for disclosures, such as the one at issue in this case, to non-parties to the proceeding that permit unrestricted public access to information submitted in a vaccine proceeding, are unusual and necessarily compel close scrutiny. The presumption that information submitted to a special master in a vaccine proceeding is handled confidentially and is not made available to the public typically until a decision issues is implicit in Vaccine Rule 18 which addresses the availability of filings. That rule states, in pertinent part: (a) General. All filings with the clerk pursuant to the Vaccine Rules are to be made available only to the special master, judge, and parties, with the exception of certain court produced documents as set forth in subdivision (b) of this rule. A transcript prepared pursuant to Vaccine Rule 8(b) shall be considered a filing for purposes of this rule. (b) Decisions of Special Masters and Judges. When a decision of a special master or of the court is filed with the clerk, each party will be afforded 14 days in which to object to the public disclosure of any information furnished by that party (1) that is trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy. If the party furnishing information objects to disclosure, that information shall be redacted prior to public disclosure of the decision. In the absence of an objection, the entire decision will be made public. Vaccine Rule 18, Appendix B, Rules of the Court of Federal Claims (emphasis added).

236 The rule, which pertains to all filings in vaccine proceedings, limits the availability of filed documents to non-parties to the proceeding and specifically affords both parties the right to redact certain information from a decision issued by the court prior to public disclosure of the decision. Here, petitioners assert that the information sought to be disclosed in this case, specifically, respondent‘s Rule 4 Reports, could be obtained through a ―simple‖ request 14 The Freedom of Information Act (FOIA), 5 U.S.C. § 552, governs how government agencies (that do not have another statutory scheme in place establishing a procedure for the public disclosure of information) shall make information available to the public. See John Doe Agency v. John Doe Corp., 493 U.S. 146, 151 (1989) (stating that the ―fundamental principle . . . that animates the FOIA‖ is ―public access to Government documents‖). 16 under the Freedom of Information Act (FOIA), 5 U.S.C. §552.14 See Petitioners‘ Motion at 4. Petitioners‘ proposed FOIA request, however, is not necessarily a ―simple‖ one. As defendant points out in the filed responsive brief, FOIA does not apply when a statutory framework is in place that proscribes certain disclosures. See R‘s Response at 5 n.4 (quoting 5 U.S.C. § 552(b)(3) (stating that FOIA ―does not apply to ‗matters . . . specifically exempted from disclosure by statute . . . provided that such statute (A)

237 requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (B) establishes particular criteria for withholding or refers to particular types of matters to be withheld‖). Other exceptions to the statutorily authorized public disclosure of information held by governmental agencies under FOIA are set forth in section 552(b) of Title 5. Among the delineated exceptions to public disclosure are: (1) ―trade secrets and commercial or financial information obtained from a person and privileged or confidential,‖ 5 U.S.C. § 552(b)(4), and (2) ―personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy,‖ 5 U.S.C. § 552(b)(6). Notably, the language in section 12(d)(4)(B) of the Vaccine Act is substantially similar to language in the statutory subsection of FOIA delineating those matters to which the public disclosure requests do not apply. Compare 42 U.S.C. § 12(d)(4)(B) (stating that if the party to a vaccine proceeding submits information ―that is trade secret or commercial or financial in substance and is privileged or confidential; or . . . that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy‖ and the submitting party objects to the public disclosure of the information in an issued decision, that information ―shall be redacted prior to

238 public disclosure of the decision‖) with 5 U.S.C. § 552(b)(4), §552(b)(6) (information that a federal agency need not make available to the public pursuant to a FOIA request includes those matters that are ―trade secrets and commercial or financial information obtained from a person and privileged or confidential‖ and those matters that are ―personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy‖). These exceptions are of particular interest to the undersigned in the current statutory analysis because incorporated into the determination of what may be disclosed is a balancing of interests between the public‘s interest in disclosure and the privacy Because the intent of FOIA is to facilitate 15 the disclosure of and public access to information in the possession of governmental agencies, a purpose that is contrary to the conduct of private proceedings in the Vaccine Program, the undersigned is informed by the type of considerations that would prevent the disclosure, pursuant to a FOIA request, of personnel, medical, or similar file content because such disclosure would constitute a ―clearly unwarranted invasion‖ of privacy. The undersigned reasons that if such privacy concerns militate against disclosure under a statute that is intended to facilitate public access to information, then such privacy concerns may militate similarly against disclosure under the Vaccine Act, a statutory scheme that disfavors disclosure based on those same privacy concerns.

239 17 interests attached to the information sought.15 This balancing of interests is instructive in the instant case. The undersigned returns to an examination of the statutory provision at issue in this case, section 12(d)(4)(A) of the Vaccine Act. The broad term ―information‖ is used in section 12(d)(4)(A) of the Vaccine Act (and not the term ―document‖ or ―record‖) to describe that which is submitted to a special master during the course of a vaccine proceeding that requires the consent of the party who submitted the information prior to its disclosure to a non-party. By definition, information is the both the ―communication of knowledge or intelligence‖ as well as ―intelligence,‖ ―facts‖ and ―data.‖ See http://www.merriam-webster.com/dictionary/information; see also The American Heritage College Dictionary 712 (4th ed. 2002). The ―communication of knowledge or intelligence‖ includes the process of conveying ―intelligence,‖ ―facts‖ and ―data.‖ But, because the conveyance process is already contemplated by the word ―submitted‖ in the statutory phrase ―information submitted to a special master,‖ it is the view of the undersigned that the use of term ―information‖ in section 12(d)(4)(A) applies to the ―intelligence,‖ ―facts‖ and ―data‖ that are conveyed or ―submitted‖ to the special master in a vaccine proceeding. The use of the term ―submitted‖ and not the term ―filed‖ suggests that the proper focus of the undersigned is on the one who presented the

240 information for consideration. The use of the term ―person‖ (rather than the more limited term ―petitioner‖ or the term ―party‖) suggests that the statutory protection against the disclosure of submitted information to a non-party to the proceeding is available to persons providing information that is submitted in a vaccine proceeding. Such persons may include both parties to the proceeding, but the language of the subsection 12(d)(4)(A) does not limit ―persons‖ to ―parties.‖ Moreover, the language of section 12(d)(4)(B) of the Vaccine Act, does not restrict the information that can be withheld from disclosure in an issued decision, based on the expressed objection of the person who submitted the information, solely to information submitted by petitioner or information pertaining to petitioner. 18 Information, whether factual matters or opinions informed by factual matters, that is supplied in a vaccine proceeding for litigation purposes or as part of an effort to resolve a claim through alternative dispute resolution is likely to be more forthright and more complete when the person submitting the information is assured that the submitted information will not be disclosed before the granting of consent or, if consent is withheld, that no disclosure will occur prior to the issuance of a ruling by a special master on a presented request for disclosure. Accordingly, when consent to disclosure is not given, a

241 request for disclosure should be presented to a special master prior to the disclosure. A request for disclosure requires: (1) an examination of the information sought to be disclosed and the purpose of the disclosure; (2) consideration of the stage of the vaccine proceedings at which the request for disclosure is made and whether the requested disclosure will affect adversely the course of the proceedings; and (3) a determination of whether the information sought to be disclosed merits protection against disclosure on either of the grounds set forth in section 12(d)(4)(B) of the Vaccine Act. If the information sought to be disclosed does merit the statutory protection against disclosure set forth in section 12(d)(4)(B) of the Vaccine Act, a further determination of whether the implicated statutory protection might be provided by a redaction that permits some limited disclosure, if appropriate, should be made. In this particular circumstance, petitioners effectively seek the disclosure of respondent‘s two Rule 4 Reports. In each of the reports, respondent refers to information that was contained in medical records that were submitted in this vaccine proceeding by petitioners. Additionally, in the Supplemental Rule 4 Report, respondent refers to information that was contained in an expert report that was submitted in this proceeding by petitioners. Respondent points out in the filed Sur-Reply that ―legal argument supporting [petitioners‘] contention that a Rule 4(c) report is not ‗information‘ under section

242 12(d)(4)(A) of the Vaccine Act‖ is ―[n]oticeably missing from petitioners‘ Motion and Reply,‖ R‘s Sur-Reply at 1, and states that ―a Rule 4 report may not be publicly disclosed absent express, written consent from respondent,‖ id. at 3. Respondent, however, also fails to articulate the legal basis for its position that a Rule 4 Report is information, but the undersigned infers from ―respondent‘s position in every case brought under the Vaccine Act, pursuant to section 12(d)(4)(A),‖ that, in respondent‘s view, the act of filing a Rule 4 Report qualifies as a submission of information under that statutory provision and the disclosure of the report is prohibited absent express written consent. See R‘s Sur- Reply at 3. The undersigned has concluded, based on an interpretation of the statutory language, that ―information submitted to a special master . . . in a proceeding on a 16 Indeed, this practice has worked well for obtaining the necessary consent for the posting on the court‘s website of information relevant to the test cases for the first and second general causation theories in the OAP. Moreover, as respondent observed in the filed Sur-Reply, ―the lead attorney for the Petitioners‘ Steering Committee, Thomas Powers, Esquire, who is also co-counsel to petitioners in this case, has sought consent from respondent to share respondent‘s expert reports, and any other information filed by respondent, with other members of the

243 Petitioners‘ Steering Committee. At no time has respondent ever denied such a request.‖ R‘s Sur-Reply at 3 n.2. 19 petition‖ contemplated by section 12(d)(4)(A) can pertain to information that is included in a filed Rule 4 Report for which respondent must provide consent prior to the sought disclosure. But, a recitation of petitioner‘s medical history by respondent in a filed Rule 4 Report, without more, does not become information submitted by respondent that requires respondent‘s consent prior to disclosure simply because respondent has filed a document summarizing the content of petitioner‘s medical files. To avoid running afoul of the statutory protection against disclosure to a non- party, a party is well-advised to make efforts to secure, prior to a disclosure to a non- party (or to the public), the consent of the person who submitted the information.16 And if consent to disclosure is withheld, a party is urged to make application to the assigned special master for a ruling on the request for disclosure. In this case, petitioners seek the disclosure of two Rule 4 Reports filed by respondent that contain information about the vaccinee‘s medical condition and the basis for respondent‘s concession of petitioners‘ claim. The stated basis for respondent‘s concession reflects respondent‘s reasoning, based on medical facts pertaining to the

244 vaccinee, for its position that petitioners‘ claim should be compensated by the Vaccine Program. That reasoning set forth in the Rule 4 Report filed on November 9, 2007 arguably could be construed to be information as that term is used in section 12(d)(4)(A) of the Vaccine Act. Moreover, the disclosure of the direct dial number for respondent‘s counsel could be construed to ―constitute a clearly unwarranted invasion of privacy‖ in light of the strong public interest in and strong public opinions about autism cases in general and this case in particular. Respondent, however, has not advanced either of these arguments in the filed briefing. Rather, respondent has expressed in the filed Sur-Reply a willingness to ―agree[] to petitioners‘ request for mutual consent to public disclosure in this case with the understanding that such consent on the part of respondent [i]s effective only as to disclosures occurring after respondent‘s representatives signed the consent.‖ R‘s Sur- Reply at 4. Additionally, petitioners have attached to their motion a waiver of the 17 The undertaking of a balancing of the interests for and against disclosure in deciding whether to permit the requested disclosure is informed by section 12(d)(4)(B) of the Vaccine Act. When, consistent with section 12(d)(4)(B) of the Act, a request for redaction is presented prior to the disclosure of an issued decision, a special master takes care to safeguard the protected information without rendering the issued decision unintelligible. 20

245 protection against disclosure afforded to information submitted to a special master permitting a discussion of the details of their claim. See Petitioners‘ Motion, Authorization at 1. Notwithstanding the mutually expressed willingness to provide consent, the parties have been unable to execute a signed consent form. In light of the parties‘ expressed willingness to execute a signed consent form, the parties are strongly encouraged to effect the execution of a signed consent form. III. Conclusion For the foregoing reasons, the undersigned has determined that certain content in the two Rule 4 Reports filed by respondent, and sought by petitioners to be disclosed to the public, arguably is information as contemplated by the use of that term in section 12(d)(4)(A) of the Vaccine Act. Section 12(d)(4)(A) of the Vaccine Act requires that prior to the disclosure of such information to a non-party, consent from the person who submitted the information, determined in this case to be respondent, must be obtained. Although both parties have expressed a willingness to provide consent, the parties have been unable to execute a signed consent form. In light of the parties‘ expressed willingness to execute a signed consent form, the undersigned strongly encourages the parties to do so. As a practical matter, petitioners‘ request for disclosure of the two Rule 4 Reports in this case (styled originally as a motion for complete transparency) is moot based on an

246 earlier unauthorized disclosure. Nonetheless, had an unauthorized disclosure not already been effected in this case and were the parties still unable to execute a signed consent form, the undersigned would undertake a balancing of the interests for and against disclosure in deciding whether to permit the requested disclosure (or a modification of the requested disclosure), over the objection of the person who submitted the information.17 Among the interests to be considered would be the petitioners‘ interest in sharing the details of this case with the public, the public‘s strong interest in the details of this particular case, the impact of the disclosure on the final resolution of this claim, and the impact of this disclosure on the pending litigation of the autism cases in the OAP. Although a balance of the interests in this case might militate in favor of the disclosure of the requested reports after the parties have been afforded an opportunity, consistent with Vaccine Rule 18(b), to propose redactions to the reports, the disclosure of the documents 21 does not force a party to discuss the documents, and the undersigned is without authority to compel such discussion. The undersigned again observes that petitioners‘ request to disclose to the public the two filed Rule 4 Reports, which are documents submitted in the course of vaccine litigation, is an extraordinary request. To afford the parties another opportunity to execute a signed consent, consistent with the mutually expressed willingness of the

247 parties, the undersigned DEFERS ruling on petitioners‘ motion for a period of 60 days. If the parties are unable to execute a signed consent on or before Monday, June 9, 2008, the undersigned shall issue a ruling consistent with the reasoning set forth in this Order. IT IS SO ORDERED. Patricia E. Campbell-Smith Special Master

248

Hannah Poling: Case Study: Autism and Vaccines By Claudia Wallis What happened to little, red-haired Hannah Poling is hardly unique in the world of autism. She had an uneventful birth; she seemed to be developing normally — smiling, babbling, engaging in imaginative play, speaking about 20 words by 19 months. And then, right after receiving a bunch of vaccines, she fell ill and it all stopped. Hannah, now 9, recovered from her acute illness but she lost her words, her eye contact and, in a matter of months, began exhibiting the repetitive behaviors and social withdrawal that typify autism. "Something happened after the vaccines," says her mom, Terry Poling, who is a registered nurse and an attorney. "She just deteriorated and never came back." Parents of kids like Hannah have been fingering vaccines — and, in particular, the mercury-based vaccine preservative thimerosal — as a cause of autism for over a decade, but researchers have repeatedly failed to find a link. What's unique about Hannah's case is that for the first time federal authorities have conceded a connection between her autistic symptoms and the vaccines she received, though the connection is by no means simple. A panel of medical evaluators at the Department of Health and Human Services concluded that Hannah had been injured by vaccines — and recommended that her family be compensated for the injuries. The panel said that Hannah had an underlying cellular disorder that was aggravated by the vaccines, causing brain damage with features of autism spectrum disorder (ASD). A special federal vaccine court has yet to award damages, but the recommendation, made public last week, is causing a sensation in the autism advocacy community. The Polings, who live in Athens, Ga., were originally part of a group of nearly 5,000 families with autistic children seeking damages through the National Vaccine Injury Compensation Program. The other cases remain before the court. The Poling case is also causing deep concern among public health officials, eager to reassure parents that vaccines are safe and, indeed, hugely beneficial. In a public statement on Friday, Dr. Julie Gerberding, director of the Centers for

249 Disease Control and Prevention (CDC), insisted that "the government has made absolutely no statement about indicating that vaccines are the cause of autism, as this would be a complete mischaracterization of any of the science that we have at our disposal today." Gerberding and other health authorities point out that the benefits of vaccines far exceed their risks. They also note that thimerosal was eliminated from routinely administered childhood vaccines manufactured after 2001, and yet autism rates have continued to climb. The current CDC estimate is that 1 of 150 American children has an autism spectrum disorder. Nonetheless, there's no denying that the court's decision to award damages to the Poling family puts a chink — a question mark — in what had been an unqualified defense of vaccine safety with regard to autism. If Hannah Poling had an underlying condition that made her vulnerable to being harmed by vaccines, it stands to reason that other children might also have such vulnerabilities. But there are circumstances that make Hannah's case a bit unusual. For one thing, she received an unusually large number of vaccines in 2000 (when thimerosal was still in use). Because of a series of ear infections, Hannah had fallen behind in the vaccine schedule, so in a single day she was given five inoculations covering a total of nine diseases: measles, mumps, rubella, polio, varicella, diphtheria, pertussis, tetanus, and Haemophilus influenzae. "That was just too many vaccines," says Terry Poling. "I didn't find out for several months that they had thimerosal, which contains mercury, a powerful neurotoxin. Had I known, I never would have allowed it to be injected into my child." Another confounding issue in Hannah's case is the finding that she suffers from a mitochondrial disorder — a dysfunction in basic cell metabolism. Mitochondria serve as power generators for each cell in the body, converting food and oxygen into energy. There are a wide range of these disorders, causing symptoms that vary widely but can include muscle weakness, cardiac or liver disease, diabetes, developmental delays and susceptibility to infection. In Hannah's case, the vaccine court determined that the underlying dysfunction of her mitochondria put her at an increased risk of injury from vaccines.

250 That decision, however, comes as a surprise to experts on mitochondrial disorders. In response to the Poling case, the United Mitochondrial Disease Foundation has released a statement saying, "There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms." Dr. John Shoffner, the Atlanta-based neurologist who identified Hannah Poling's mitochondrial disorder, is "genuinely puzzled" by the court's judgment. Shoffner, who has been studying and treating these disorders for 20 years, says it's impossible to say whether Hannah's mitochondrial disorder was, in fact, a pre- existing condition that set the stage for her autism (as the government contends) or if it developed along with her autism. A specialist in mitochondrial disorders, he is investigating the relationship between autism and these disorders and plans to present a paper on the topic at the annual meeting of the American Academy of Neurology in April. "In some subset of people with ASD — a small group of patients, I think — mitochondrial dysfunction is an important part of their disease. But it's too early to say whether it gets the ball rolling or if it comes about after the ball got rolling." Experts on autism spectrum disorders believe that most cases are caused by a combination of genetic vulnerabilities and environmental factors. There may be hundreds of roads to autism, involving numerous combinations of genes and external factors. Could thimerosal or some other aspect of vaccines be one of these factors? "It's always possible that there's a small subset of kids that have this vulnerability," says Dr. Isaac Pessah, director of the Center for Children's Environmental Health and Disease Prevention at the University of California, Davis. Pessah's lab is looking at dozens of possible environmental factors, including pesticides, plastics and flame-retardants. "This is a very emotional debate," he says, "and we need more research directed at these questions." It's difficult to draw any clear lessons from the case of Hannah Poling, other than the dire need for more research. One plausible conclusion is that pediatricians should avoid giving small children a large number of vaccines at once, even if they are thimerosal-free. Young children have an immature immune system that's

251 ill-equipped to handle an overload, says Dr. Judy Van de Water, an immunologist who works with Pessah at U.C. Davis. "Some vaccines, such as those aimed at viral infections, are designed to ramp up the immune system at warp speed," she says. "They are designed to mimic the infection. So you can imagine getting nine at one time, how sick you could be." In addition, she says, there's some evidence, that children who develop autism may have immune systems that are particularly slow to mature. Van de Water worries that current vaccine schedules may be overly aggressive for some children. She suggests that parents who are concerned about vaccine safety ask their pediatricians to give fewer at a time. And, she adds, don't vaccinate a child when he or she is ill. Hannah Poling is now a third grader in public school, working one-on-one with teachers in a special-ed classroom. She continues to struggle with the effects of autism and also has seizures. Her parents are hoping her case will spur additional research into the causes of autism, including the roles of vaccines and mitochondrial disorders. "My daughter's case raises more questions than it answers," concedes her father, Dr. Jon Poling, a neurologist who also has a Ph.D. in biophysics. Poling believes in the importance of vaccinating children: "Vaccines are one of the most important advances in the history of medicine," he says, "but people need to know there is a risk to every medicine. There may be a small percentage of people who are susceptible to injury." He and his wife would like to see thimerosal eliminated from flu vaccines, which continue to be given to children and pregnant women, a fact that, he thinks, could be one reason autism rates haven't declined. And he urges pediatricians to take a hard look at the schedule on which vaccines are given. "I think we need a grassroots movement among pediatricians to be more conservative, and not give so many shots at once." Monday, Mar. 10, 2008

252 3. Appendix. BAILEY BANKS – JUDGMENT. In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 02-0738V Filed: 20 July 2007 * * * * * * * * * * * * * * * BAILEY BANKS, by his father * KENNETH BANKS, * * Petitioner, * PUBLISHED * Non-autistic developmental delay; Acute * Disseminated Encephalomyelitis; Expert SECRETARY OF THE DEPARTMENT * Credibility; Evidentiary Reliability; OF HEALTH AND HUMAN SERVICES, * Scientific Validity; Burden of Proof; * Causation in Fact; Proximate Causation Respondent. * * * * * * * * * * * * * * * * Michael G. McLaren, Esq., Black & McLaren, Memphis, Tennessee, for Petitioner; Alexis B. Babcock, Esq., United States Department of Justice, Washington, D.C., for Respondent. ENTITLEMENT RULING1 ABELL, Special Master: On 26 June 2002, the Petitioner filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act)2 alleging that, as a result of the MMR vaccination received on 14 March 2000, his child, Bailey, suffered a seizure and Acute Disseminated Acute disseminated encephalomyelitis (ADEM) is ―an acute or subacute 3 encephalomyelitis or infiltration and

253 demyelination; it occurs most commonly following an acute viral infection, especially measles, but may occur without a recognizable antecedent....It is believed to be a manifestation of an autoimmune attack on the myelin of the central nervous system. Clinical manifestations include fever, headache, vomiting, and drowsiness progressing to lethargy and coma; tremor, seizures, and paralysis may also occur; mortality ranges from 5 to 20 per cent; many survivors have residual neurological deficits.‖ DORLAND'S ILLUSTRATED MEDICAL DICTIONARY (30th ed. 2003) (SAUNDERS) at 610. 4 Pervasive Developmental Delay describes a class of conditions, and it is apparent from the record that the parties and the medical records are referring to Pervasive Developmental Disorder Not Otherwise Specified (―PDDNOS‖): Pervasive Developmental Disorder, Not Otherwise Specified (PDD-NOS) is a ‗subthreshold‘ condition in which some - but not all - features of autism or another explicitly identified Pervasive Developmental Disorder are identified. PDD-NOS is often incorrectly referred to as simply ―PDD.‖ The term PDD refers to the class of conditions to which autism belongs. PDD is NOT itself a diagnosis, while PDD-NOS IS a diagnosis. The term Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS; also referred to as "atypical personality development," "atypical PDD," or "atypical autism") is included in DSM-IV to encompass cases where there is marked impairment of social interaction, communication, and/or stereotyped behavior patterns or interest, but when full features for autism or another explicitly defined PDD are not met.

254 It should be emphasized that this ''subthreshold'' category is thus defined implicitly, that is, no specific guidelines for diagnosis are provided. While deficits in peer relations and unusual sensitivities are typically noted, social skills are less impaired than in classical autism. The lack of definition(s) for this relatively heterogeneous group of children presents problems for research on this condition. The limited available evidence suggest that children with PDD-NOS probably come to professional attention rather later than is the case with autistic children, and that intellectual deficits are less common. The Yale Child Study Center's Developmental Disabilities Clinic Webpage, article on PDD-NOS, available at http://www.med.yale.edu/chldstdy/autism/pddnos.html. See also DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDER, (4th ed. 2000) at 69 et seq. In the interest of consistency, the Court will follow the convention adhered to by the medical records and by the parties in this case, and this condition will be referred to herein as ―PDD‖. -2- Encephalomyelitis (―ADEM‖),3 which led to Pervasive Developmental Delay (―PDD‖),4 a condition from which he continues to suffer (the "Petition"). By the terms of the Petition itself, Petitioner brought this action under an actual causation theory of recovery, as the seizure was alleged to have occurred on 30 March 2000, sixteen days after the vaccination date, and outside of the time periods set on the Table. Petition at 2.

255 This petition was reassigned to my chambers on 22 December 2004. Eventually, a telephonic evidentiary hearing on the ultimate issue of entitlement for compensation was held on 1 June 2006. Hearing Transcript ("Tr.") at 1. Whereupon, the Court heard from medical expert witnesses for both parties: Dr. Ivan Lopez for the Petitioner and Dr. John MacDonald for the Respondent. Subsequent to that hearing, the parties filed closing briefs with the Court, and the case is now ripe for a ruling. As a preliminary matter, the Court notes that Petitioner has satisfied the pleading requisites found in § 300aa-11(b) and (c) of the statute, by showing that: (1) he is a valid legal representative of the injured party, Bailey Banks; (2) the vaccine at issue is set forth in the Vaccine Injury Table (42 C.F.R. § 100.3); (3) the vaccine was administered in the United States or one of its territories; (4) no one has previously collected an award or settlement of a civil action for damages arising from -3- the alleged vaccine-related injury; and, (5) no previous civil action has been filed in this matter. Additionally, the § 300aa-16(a) requirement that the petition be timely filed has been met. On these matters, Respondent tenders no dispute. The Vaccine Act authorizes the Office of Special Masters to make rulings and decisions on petitions, which include findings of fact and conclusions of law. §12(d)(3)(A)(I). In order to prevail on a petition for compensation under the Vaccine Act, a petitioner must show by preponderant

256 evidence that a vaccination listed on the Vaccine Injury Table either caused an injury specified on that Table within the period designated therein, or else that such a vaccine actually caused an injury not so listed. § 11(c)(1)(c). I. FACTUAL RECORD Despite their accord on certain factual predicates contained in Bailey‘s medical records, there is, unsurprisingly, a pronounced conflict between the parties as to the following issues: whether a biologically plausible link exists between ADEM and pervasive developmental delay (PDD) in a direct chain of causation, whether Bailey did in fact suffer from ADEM, and ultimately whether the administration of the MMR vaccine to Bailey actually caused ADEM which would then cause PDD that currently besets Bailey today. Considering these disputes and the Court‘s commission to resolve them, it behooves the Court to explain the legal standard by which factual findings are made. It is axiomatic to say that the Petitioners bear the burden of proving, by a preponderance of the evidence – which this Court has likened to fifty percent and a feather – that a particular fact occurred. Put another way, it is required that a special master, "believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the [special master] of the fact's existence." In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring). Moreover, mere conjecture or speculation does not meet the preponderance

257 standard. Snowbank Enterprises v. United States, 6 Cl. Ct. 476, 486 (1984). This Court is authorized by statute to render findings of fact and conclusions of law, and to grant compensation upon petitions that are substantiated by medical records and/or by medical opinion. §§ 12(d)(3)(A)(i) and 13(a)(1). Medical records are afforded substantial weight, as has been elucidated by this Court and by the Federal Circuit: Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events. Cucuras v. Secretary of HHS, 993 F.2d 1525, 1528 (Fed. Cir.1993). -4- Medical records are more useful to the Court‘s analysis when considered in reference to what they include, rather than what they omit: [I]t must be recognized that the absence of a reference to a condition or circumstance is much less significant than a reference which negates the existence of the condition or circumstance. Since medical records typically record only a fraction of all that occurs, the fact that reference to an event is omitted from the medical records may not be very significant. Murphy v. Secretary of HHS, 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d 1226 (Fed. Cir. 1992), cert. denied sub nom. Murphy v. Sullivan, 113 S. Ct. 263 (1992) (citations omitted), citing Clark v. Secretary of HHS, No. 90-45V, slip op. at 3 (Cl. Ct. Spec. Mstr. March 28, 1991).

258 A. MEDICAL RECORDS The Court turns first to the recorded facts drawn from the sources offered by the parties in this case. There is no dispute regarding the following facts, which are referenced to one degree on another in both parties‘ closing briefs: 1. Bailey Banks was born 26 October 1998. Petitioner‘s Exhibit (―Pet. Ex.‖) 2, 3. Bailey‘s development before his vaccination (both before and after birth) was normal and healthy. Pet. Ex. 1, 5, and 11. 2. At Bailey‘s fifteenth month check-up on 14 March 2000, no health concerns were noted, and he received the MMR vaccination at issue, his first. Pet. Ex. 11 at 2, Pet. Ex. 5 at 25. 3. Bailey then experienced a seizure 16 days later, on 30 March 2000, during which Bailey‘s mother witnessed his eyes rolling back and him choking, and he was taken to the Emergency Room. Pet. Ex. 4 at 5, 16, 52-54. At the Emergency Room, Bailey was found to be afebrile and irritable and to have vomited three times. Id. at 52. The treating doctor at the time characterized Bailey‘s condition as ―new onset seizure‖ and Bailey was admitted to the hospital for observation, where he remained apparently healthy for the remainder of his stay there. Id. at 4, 14, 53. 4. The following day, on 31 March 2007, an MRI scan was taken of Bailey‘s brain, which was interpreted by the treating radiologist, Bret Sleight, M.D., as ―most consistent with a demyelinating process of immune etiology such as may be seen with ADEM or perhaps post-vaccination.‖ Pet. Ex. 4 at 36-37.

259 5. Bailey then underwent, on 10 April 2000, a full neurological examination, administered by another neurologist, Bryan Philbrook, M.D. Pet. Ex. 5 at 40-42. Esotropia is ―strabismus in which there is manifest deviation of 5 the visual axis of an eye toward that of the other eye,‖ also known as ―cross-eye‖. DORLAND'S, supra, at 644. 6 Strabismus is ―deviation of the eye which the patient cannot overcome,‖ wherein ―[t]he visual axes assume a position relative to each other different from that required by the physiological conditions.‖ DORLAND'S, supra, at 1766. -5- The examination revealed ―slight left esotropia‖5 and ―gait and coordination [that was] extremely immature in that his gait was wide based. There was also some hyperextension of both knees noted with poor balance and frequent falling.‖ Id. Based on these observations, Dr. Philbrook concluded that Bailey suffered from ―mild gross motor developmental delay‖ and strabismus,6 and recommended further lab tests, ophthalmology consultation and physical therapy evaluation of Bailey‘s gait. Id. Dr. Philbrook also noted his medical opinion that ―[w]e reviewed the patient‘s MRI and felt that moderate hypomyelination was more likely than a demyelinating process like ADEM, but cannot rule out the latter with certainty.‖ Id. 6. An EEG performed while Bailey slept on 5 May 2000 was unremarkable. Id. at 3. Also, a brain MRI performed on 5 January 2001 evidenced in the same results as the MRI performed on 31 March 2000, with no significant changes since then. Id. at 16- 18, 24. 7. On 22 January 2001 Bailey was examined by another neurologist, Frank Berenson, M.D., who noted that Bailey was suffering from global developmental delays, which

260 included features associated with pervasive developmental delay. Id. at 46-48. His conclusion was based on his examination of Bailey, in which he observed that Bailey continued to assume a toddling gait, speech delays, and social interactive difficulties (e.g., poor eye contact and biting), despite suffering no additional seizures since the one suffered on 30 March 2000. Id. Dr. Berenson noted some cognitive progress since Bailey‘s last neurology visit, including speaking up to ten words, better comprehension, following simple directions, and identifying individual body parts. Id. at 46. Additionally, Bailey‘s motor skills had improved such that Bailey assisted with dressing and drank from a cup. Id. However, he added that ―[s]ocially there continues to be difficulty. His eye contact is variable. He has limited to no imaginary pretend play. He continues to bite excessively....‖ Id. Furthermore, even though Bailey remained alert during the visit, his speech development was found to be delayed. Id. Lastly, Bailey continued to walk with a ―somewhat toddling gait‖ that Dr. Berenson described as ―somewhat puppet-like‖ in appearance. Id. Beyond the medical records mentioned above, Petitioner‘s brief references several others, engendered between 2001 and the present, that support the claim that Bailey continued to display neurological developmental delays requiring therapeutic services. Petitioner‘s Closing Brief at 4-7. Only by 24 September 2002, in a ―Speech and Language Evaluation‖ report, were there clear signs of unequivocal improvement: Despite a severe language delay, some of Bailey‘s linguistic, social

261 and cognitive elements for further development seemed emergent. Pet. Ex. 11 at 16-17. ―An autism spectrum disorder is a brain disorder affecting a person‘s 7 ability to communicate, form relationships, and/or respond appropriately to the environment. Such disorders sometimes result in death. The ‗spectrum‘ of such disorders includes relatively high-functioning persons with speech and language intact, as well as persons who are mentally retarded, mute, or with serious language delays. Symptoms may include, but are not limited to, avoidance of eye contact, seeming ‗deafness,‘ abrupt loss of language, unawareness of environment, physical abusiveness, inaccessibility, fixation, bizarre behavior, ‗flapping,‘ repetitive and/or obsessive behavior, insensitivity to pain, social withdrawal, and extreme sensitivity to sounds, textures, tastes, smells, and light.‖ Autism General Order # 1, (Fed. Cl. Spec. Mstr. Jul. 3, 2002), quoting National Institute of Mental Health, Publication 97-4023. 8 Ataxia is a ―failure of muscular coordination; irregularity of muscular action.‖ DORLAND'S, supra, at 170. -6- Among the physicians treating Bailey, a neurologist named Dr. Ivan Lopez personally examined Bailey and diagnosed Bailey as follows: This patient has developmental delay probably secondary to an episode of acute demyelinating encephalomyelitis that he had at 18 months of age after the vaccine. He certainly does not ___ [sic] for autism because over here we can find a specific reason for his condition and this is not just coming up with no reason. Pet. Ex. 44 at 2. As Petitioner‘s testifying expert witness, Dr. Lopez maintained, reiterated, and

262 elaborated upon this threshhold diagnosis. Dr. Lopez‘s diagnosis appears to conflict with the diagnosis given by Bailey‘s pediatrician on 20 May 2004, who saddled Bailey‘s condition with the generalized term ―autism‖;7 however, that pediatrician later acknowledged that use of the term autism was used merely as a simplification for non-medical school personnel, and that pervasive developmental delay ―is the correct [i.e. technical] diagnosis.‖ Pet Ex. 35. Another pediatrician‘s diagnosis noted that Bailey‘s condition ―seems to be a global developmental delay with autistic features as opposed to an actual autistic spectrum disorder.‖ Pet. Ex. 30 at 4. B. EXPERT TESTIMONY AT THE ENTITLEMENT HEARING 1. Ivan Lopez Dr. Ivan Lopez is certified by the American Board of Psychiatry and Neurology in the field of Neurology, with specific subspecialty in the area of Child Neurology, and has been since 2000. Transcript (―Tr.‖) at 18. It is Dr. Lopez‘s professional medical opinion that ―Bailey‘s neurological deficit stem[s] from the vaccine he received on March 14, 2000.‖ Tr. at 29. Dr. Lopez explained to the Court that ADEM occurs when a subject ―has been exposed to a foreign protein, in this case [the] vaccine,‖ which causes the body to produce antibodies (specifically T-cells), such that the body‘s antibodies ―turn against [the myelin sheathing covering the nerves] and destroy it.‖ Tr. at 30. Dr. Lopez explained the clinical indicia that Bailey exhibited, indicia that support a diagnosis

263 of ADEM. He mentioned ataxia,8 stating that ―ataxia is one of the symptoms or signs of ADEM, Microcephaly is an ―abnormal smallness of the head, usually associated with mental retardation.‖ DORLAND'S 9 , supra, at 1151. 10 An autosome is ―any ordinary paired chromosome that is alike in males and females, as distinguished from sex chromosomes.‖ DORLAND'S, supra, at 183. Diseases that are autosomal dominant are those in which a genetic disorder need only be present in, and passed on from, one parent, in order for a child to inherit the disease. See Medline Plus website (a service of the National Library of Medicine and the National Institutes of Health), available at http://www.nlm.nih.gov/medlineplus/ency/article/002049.htm. -7- but...it‘s not specific for ADEM.‖ Tr. at 36. The same can be said, according to the doctor, for vomiting and irritability. Id. Dr. Lopez then discussed the medical records created around the time of Bailey‘s seizure. He explained that Dr. Sleight‘s MRI notations were consistent with a diagnosis of ADEM, as were also the MRI films themselves, which Dr. Lopez himself personally examined in preparations for this case. Tr. at 37. He elaborated further, explaining that, using the ―T2 technique‖ of analysis, the MRI showed an increased signal, indicating that ―the white matter in between the ventricles of the brain and the cortex‖ had taken on a more ―whitish‖ appearance than is normal, and such a result is consistent with ADEM. Id.

264 Dr. Lopez explained further to the Court that ADEM is a ―monophasic condition,‖ meaning that ―it only appears once.‖ Tr. at 38. He noted during direct examination that, in like manner, Bailey ―only had one episode of acute neurological deficits‖ as well, which were ―followed by the sequela of this condition‖ (i.e., the PDD). Direct examination of Dr. Lopez concluded with addressing potential alternative diagnoses and explanations for Bailey‘s condition. Considering Respondent‘s Expert‘s proffered hypothesis, that of a glucose disorder or a glucose deficiency, he gave three reasons for his disagreement: (1) that Bailey would have shown evidence of such a disorder in his first few months, not in the second year of his life; (2) that those suffering from glucose transporter 1 deficiency have microcephaly,9 a condition which Bailey does not have; and (3) that glucose transporter 1 deficiency is an ―autosomal dominant‖10 disease, such that one of Bailey‘s parents would necessarily have the condition as well, which they do not. Tr. at 40-41. Moving on to the alternative hypothesis/diagnosis of autism, Dr. Lopez distinguishes autism as a more generalized condition without a known etiology, and contrasted it to Bailey‘s condition, which he says is clearly attributable to demyelination based on neuroimaging evidence. Tr. at 41-42. Dr. Lopez also differentiated Bailey‘s condition from autism, because Bailey has been affected in more than one developmental skill area; he clarified by stating that Bailey has ―induced pervasive

265 developmental delay...due to ADEM.‖ Tr. at 32. He noted that the conflation of designations resulted from a medical convention created for the sake of explanation to laymen, but that the two are not properly interchangeable, but actually quite distinct. Id. Speaking more directly, Dr. Lopez stated that ―Bailey does not have autism because he has a reason for his deficits.‖ Tr. at 42. Dr. Lopez finished his direct examination testimony by averring that his opinion testimony in support of the Petition was given ―to a reasonable degree of medical certainty.‖ Id. The Court notes that the same medical record as was 11 referenced by Respondent also states that Bailey ―had good use of words up until he had a seizure‖ and that, ―MRI studies, separated by 9 months[,] suggest post vaccinal injury....‖ Pet. Ex. 7 at 8. -8- On cross-examination, Dr. Lopez acknowledged that ADEM cannot be diagnosed based solely on a radiographic reading, but must be correlated with supportive clinical findings. Tr. at 45. However, he took issue with Respondent‘s line of questioning regarding whether the correlative symptoms must necessarily precede onset of ADEM, opining that ―oftentimes those symptoms precede the onset of the disease, but it‘s not a must,‖ and that ―if [Bailey] hadn‘t thrown up three times,‖ it would not change his medical opinion and diagnosis. Tr. at 47. He stipulated that ―prior to the seizure it appeared that Bailey was healthy,‖ and that, hypothetically, Bailey‘s three vomiting

266 bouts could have resulted just from the afebrile seizure. Tr. at 49. Responding to questions posed by the Respondent, Dr. Lopez noted that the other treating neurologists in the medical records did not diagnose Bailey with ADEM. Tr. at 60- 61. Dr. Philbrook ―felt‖ hypomyelination was more likely than ADEM, a demyelinating condition, Doctors Berenson and Pearlman could not ascertain or simply did not state an etiology, and in December of 2004 Dr. Trasmonte noted a prior diagnosis of Bailey‘s condition as pervasive developmental delay, without concluding whether Bailey had suffered from either hypomyelination or demyelination. Tr. at 52-60. However, Dr. Lopez was quick to add: [J]ust because this neurologist didn't say specifically that Bailey has ADEM doesn't mean that he doesn't. As a matter of fact, it is not saying that he doesn't have ADEM. All of them are saying that he has pervasive developmental delay, to which I agree, and they just leave it right there. Tr. at 60. As to the alternative diagnosis of autism, Respondent questioned Dr. Lopez whether Dr. Kartzinel‘s assessment of Bailey‘s condition was autism (see Pet. Ex. 7 at 8), and Dr. Lopez agreed.11 On Redirect Examination, Dr. Lopez agreed that, despite several neurological examinations, no one heretofore has made a definitive diagnosis of Bailey‘s condition other than PDD, but that both radiologists–Doctors Sleight and Barnes–concluded from studying the MRI films that they were

267 consistent with a finding of ADEM. Tr. at 63-64. 2. John MacDonald Dr. John MacDonald is a pediatric neurologist and has been board certified in neurology with special competence in child neurology since 1980. Tr. at 67-68. Due to the nature of his work, he stated that he sees patients with ADEM on a fairly regular basis, considering the rarity of the affliction. Tr. at 68-69. After perusing the Record in this case, Dr. MacDonald offered his opinion, to a reasonable degree of medical certainty, that Bailey‘s current neurological symptoms are not related to the MMR vaccine administered on 14 March 2000. Tr. at 71. -9- After first addressing why this Petition does not qualify for one of the conditions entitled to a statutory presumption, Dr. MacDonald stated that unprovoked, afebrile seizures like the one that Bailey suffered are ―relatively common‖ and that ―[t]he vast majority of these are of unknown cause.‖ Tr. at 72-73. He disagrees with Dr. Lopez‘s opinion that Bailey suffers from ADEM, but agrees that ADEM ―is typically a monophasic illness,‖ which appears ―relatively quickly‖ and then peaks after two days. Tr. at 73. He describes the progress of the illness thusly: The child is generally quite sick with several symptoms. Seizures may be included, but most of the symptoms are much more physically dramatic -- paralysis, ataxia, coma. Then as the picture evolves, you do the brain scan and it typically does show some

268 changes, and then it runs its course. Most of these children are, if you suspect that diagnosis, are treated with high doses of intravenous steroids for at least three days. Many will make a partial improvement. But it's an acute onset disorder of the central nervous system that presents several symptoms over several days. The children are generally quite ill, and it just does not -- in my experience and reading the literature -- a single isolated seizure in which the patient recovers immediately is not hardly an acute let alone a disseminated encephalomyelitis. Tr. at 73-74. Also, Dr. MacDonald confirmed what had been heard throughout the proceeding, that doctors do not diagnose ADEM based solely upon MRI results. Tr. at 74 When questioned by the Court regarding his opinion on ―what could have initiated the seizure,‖ Dr. MacDonald noted that he does have some thoughts on the topic, but that they do not relate to ADEM, and that he sees no relationship to the administration of the MMR vaccine. Tr. at 74. His perspective is that the seizure‘s temporal proximity to the vaccine administration was purely happenstance, and ―does not directly relate to the vaccine at all.‖ Tr. at 74-75. When the Court inquired further, on whether there was a relationship between the seizure and the diagnosed PDD, Dr. MacDonald responded that ―[s]eizures in general, isolated seizures can be seen in patients with PDD, but they are usually not the presenting symptoms,‖ after noting that that is ―a more difficult

269 question.‖ Tr. at 75. Moving back into direct examination, Dr. MacDonald agreed that, but for the single seizure, Bailey did not present with ―the multiplicity of signs and symptoms that we associate with the typical ADEM case.‖ Tr. at 75-76. He ruled out the presence of ataxia at the time of the seizure, citing the physical examination statement upon discharge was ―totally normal.‖ Tr. at 76. However, he conceded that Dr. Philbrook had noted in his findings that ―[Bailey‘s] gait was somewhat immature, wide based,‖ but he believes that this circumstance is attributable to being a young child of a toddler‘s age, when children learn to walk. Id. He went further, stating, ―Ataxia during ADEM comes immediately with the onset. It doesn‘t show up later.‖ Id. He distinguished ataxia from what he believes to be merely ―delays in...fine and gross motor [skills],...neurological signs, coordination issues [which caused Bailey] to have an odd gait,‖ which, he avers, ―occurs in about 15 percent of the normal population.‖ Tr. at 77. Continuing further, he did state that such a condition is ―common -10- in people with PDD.‖ Id. He also agreed that Dr. Philbrook did not diagnose ataxia in his analysis. Id. Moving on to Bailey‘s MRI scans, Dr. MacDonald does not think that they are consistent with a diagnosis of ADEM, because they both ―look pretty clear,‖ and indicate a consistent, bilateral

270 white matter abnormality, whereas, he said, ―ADEM tends to be much more asymmetric.‖ Tr. at 77- 78. He elaborated further that MRI scans typically ―improve dramatically‖ following ADEM (however, some occasionally deteriorate), but, at any rate, ―they change over time.‖ Tr. at 78. He opined that ―the fact that they are unchanged really over years to me is more typical for the hypomyelination,‖ adding that the issues apparent in the MRI scans, ―in and of themselves are nonspecific.‖ Id. He went on to explain the difference between demyelination and hypomyelination: where the former indicates the loss of myelin which had previously existed, the latter expresses the circumstance where there is a slowed development or accrual of myelin over the nerve fibers. Tr. at 79. Dr. MacDonald next addressed his postulated theory to describe Bailey‘s injury: glucose transporter 1 deficiency. When he first examined Bailey‘s records, he became concerned because the glucose levels in Bailey‘s spinal fluids were ―quite low‖ at a value of 26. Tr. at 79-80. He admitted that he is ―always looking for rare disorders,‖ expressing that, when he suspects ―a rare but treatable condition,‖ he feels it is his duty ―to pursue that vigorously.‖ Id. He explained this rare deficiency as one where there is a critical shortage of important transporter enzymes that are responsible for bringing metabolic fuel (glucose) to the brain, across the blood- brain barrier, due to

271 a genetic abnormality. Tr. at 80. He described the effect of this deficiency, saying, ―all the initial cases presented with epilepsy in the first months of life, and a progressive neurological deterioration unless they were treated,‖ adding that ―there are milder forms,‖ in that ―[s]ome do not even have epilepsy...[but] only changes in their mental status.‖ Id. He summarized his opinion by saying, ―[W]hen I look at this picture, this is a problem with glucose metabolism of the brain,‖ which could be responsible for ―pervasive developmental disorder, which is a global brain dysfunction of neurons...‖. Tr. at 81. He disputed the earlier argument of Dr. Lopez, regarding whether this condition is ―autosomal dominant‖: ―Well, in a subtle sense it is [autosomal dominant], but there are at least 30 mutations of the genes; the parents can carry it but don't have to express it.‖ Tr. at 82. Regarding the medical records that indicated that Bailey was or is autistic, Dr. MacDonald said, ―I think he falls into that autistic spectrum pervasive developmental disorder category, and that seems to be fairly consistent.‖ Tr. at 84. He noted, however, that a majority of people ―use these terms somewhat interchangeably.‖ Id. When questioned about the existence of medical literature which establishes a ―relationship between MMR and autism or PDD,‖ Dr. MacDonald indicated his thought that ―all the medical literature is negative in that regard.‖ Tr. at 85. Also, he referenced a dearth of known literature to explain why he sees no connection between ADEM and PDD:

272 I can find no literature relating ADEM to autism or pervasive developmental disorder, and by its nature ADEM is a primary demyelinating disorder of the nervous system....PDD is a problem with the neurons, not the white matter of the brain, so it -11- doesn't make sense that autistic children would have had a demyelinating disorder before. In fact, MRI scans [that] have been done repeatedly in children with PDD/autism don't show demyelination, so there is no connection. Even if one believes the child has ADEM, there is no connection to the diagnosis of PDD. Tr. at 85-86. When questioned by the Court on the existence of ―one overarching etiology for Bailey‘s condition,‖ Dr. MacDonald again referenced his proffered theory of glucose deficiency, but ultimately concluded that ―Bailey falls into the large group of children with autism/PDD in which by our current evidence-based medicine we rarely can make a specific diagnosis.‖ Tr. at 86. Turning to cross-examination, Dr. MacDonald admitted that, in describing Bailey‘s postseizure, toddling gait, Dr. Philbrook had expressed that ―the gait and coordination were ‗extremely immature.‘‖ Tr. at 90. When asked if ataxia is definitionally a ―lack of coordination,‖ he clarified that ataxia manifests as a ―pronounced instability of gait that's not age- appropriate.‖ Tr. at 90-91. When asked during cross-examination, Dr. MacDonald agreed that Dr. Sleight had analyzed the MRI scan results as ―most consistent with a demyelinating process of immune etiology such as

273 may be seen with ADEM,‖ but he disagreed with this conclusion, admitting such disagreement was a necessary element of his ultimate conclusion in opposition to the Petition. Tr. at 91-92. However, later in cross-examination, Dr. MacDonald agreed that the IOM has reported a demonstrable biological plausibility for a causal relationship between the measles vaccine and demyelinating diseases, of which ADEM is one. Tr. at 101-02. When questioned regarding his theory of hypomyelination due to a glucose transporter deficiency, Dr. MacDonald thought it would be likely that a scan performed several months before the seizure would have manifested the same results, but admitted that there was no indication in any of Bailey‘s medical records that there was anything irregular with his health until after the seizure. Tr. at 98-99. He added that he assumed that the hypomyelination process was present for some time before Bailey received the vaccine, but said ―there is no way to know that.‖ Tr. at 99. He agreed that ―until the seizure there is [sic] no medical records or factual findings that indicate Bailey had any problems whatsoever.‖ Id. What this means is that, if Bailey suffered from hypomyelination before the vaccination, it would not be the cause of those conditions afflicting Bailey immediately after the seizure, which could have resulted entirely from some other cause. Tr. at 99-100. Lastly on the theory of glucose transporter deficiency, Dr. MacDonald agreed with the Court‘s

274 characterization of his opinion on this topic: ―He sees this as something that has to be looked at as a possible, not necessarily a probable diagnosis, but that he is not holding this out by a preponderance of the evidence more likely than not.‖ Tr. at 101. The Court asked Dr. MacDonald whether he would advise the Respondent to concede if, in fact, the diagnosis of ADEM was indisputable, to which he responded (a) that he is aware of no supportive medical literature that indicates ADEM leading to the pervasive developmental delays from which Bailey suffers; (b) that symptoms of ADEM are felt immediately, and do not aggravate with the passage of time; and (c) that ADEM affects motor ability and/or control, and would not have rendered the effects to Bailey‘s mental status seen in the facts of this case. Tr. at 104. -12- 3. Ivan Lopez Dr. Lopez was recalled by the Court sua sponte to offer more testimony on his opinion in support of the Petition. Tr. at 107. The Court specifically asked Dr. Lopez to explain the causative, logical link between the disputed occurrence ADEM and the undisputed PDD from which Bailey now suffers. Id. Dr. Lopez conceded that ―the majority of patients with ADEM improve significantly,‖ but added that ―the exception to this rule is when patients have been exposed to measles, just like in the case of MMR vaccine,‖ in which case ―sequela may occur in up to 50

275 percent of patients.‖ Tr. at 107-08. He elaborated that such sequela potentially include ―mental syndromes such as PDD and others, focal deficits, [and hemiparesis],‖ and opined that ―up to 50 percent of patients...who have had ADEM will show[,] as a consequence of this monophasic condition[,] PDD.‖ Tr. at 108. C. POST-HEARING SUBMISSIONS At the conclusion of the hearing, Petitioner was adjured to file certain additional supportive materials with the expectation that another hearing might be necessary to give both parties‘ experts an opportunity to comment thereupon. Whereupon, Petitioner filed the treating records completed pursuant to Bailey‘s visit with Dr. Ivan Lopez, followed by certain medical literature texts and a supplemental expert opinion report from Dr. Lopez. These were followed by a supplemental expert opinion report from Dr. MacDonald, followed by more medical literature from Petitioner, followed by yet another medical expert report from Dr. MacDonald, and followed finally with more medical literature from Petitioner. After these several filings, the parties agreed that a further hearing would be unnecessary, and opted instead to address any outstanding issues in closing briefs. Wherefore, the Court set a briefing schedule, which has since run its course, and this case is ripe for a ruling on the issue of entitlement. II. ULTIMATE FINDINGS OF FACT A. THE PARTIES‘ ARGUMENTS

276 Petitioner argues that the MMR vaccination Bailey received 14 March 2000 initiated a bout of ADEM, which led acutely to Bailey‘s seizure and eventually caused pervasive developmental delay that affects Bailey to this day. Petitioner references an article from 2000, filed as Pet. Ex. 26, which seems to contradict statements made by Respondent‘s expert. That study notes that ADEM can follow measles infections, and mentions that the ―most common presenting feature‖ is ataxia, followed by (inter alia) hemiparesis. Pet. Ex. 26 at 1310. It states: Although regarded as a monophasic condition, a characteristic feature of ADEM is the evolution of symptoms and signs over time. Ten children in this series deteriorated after admission to the hospital, with many developing new neurologic signs. Ataxia was usually present at the outset and did not develop later in the -13- illness....Although ADEM is typically described as a monophasic illness lasting from 2 to 4 weeks, relapses have been reported. Id. at 1310-11. Also, of particular note, the article later states that ―MRI is highly sensitive in detecting white matter abnormalities and is the investigation of choice in ADEM.‖ Id. at 1311. Petitioner also cites in their Brief to an article of older vintage which, discussing ADEM, states: Patients may recover completely or be left with residual symptoms, which may be mild or severe. There may be only slight motor disturbances or pronounced spastic

277 paraplegia and impairment of sphincter control. In children[,] recovery from the acute stage is sometimes followed by a permanent disorder of behavior, mental retardation or epilepsy. Pet. Ex. 27 at 530. Citing to Doctor Lopez‘s initial expert report, Petitioner seeks to establish a biologically plausible temporal connection between vaccination and the seizure and a means of showing the injury suffered: ADEM most commonly occurs in 3 to 15 days following vaccinations....The onset may be abrupt with seizures or less explosive with residual behavioral abnormalities, dementia, or motor deficits....Brain magnetic resonance imaging (MRI) generally reveals extensive abnormalities of white matter compatible with demyelination. Pet. Ex. 18 at 1. Likewise, Petitioner adds comments from the expert report of Dr. Patrick Barnes, a radiologist, who, in reviewing several of Bailey‘s CT and MRI scans concluded that, ―These findings, although not specific, are most consistent with a post-viral or post- vaccinal encephalopathy (e.g., Acute Disseminated Encephalomyelitis - ADEM),‖ but added that, ―Such findings must be correlated with the clinical findings.‖ Pet. Ex. 16. Petitioner argues that Dr. Barnes‘ opinion supporting ADEM, coupled with the treating opinions of Dr. Lopez and Dr. Sleight all support this explanation, and that, in order to hold Dr. MacDonald‘s contrary view, one must negate or ignore the professional opinions of these three doctors. Pet. Closing Brief at 12. Petitioner then argues in

278 detail as to why the facts support a finding of ADEM. Stipulating that ADEM is monophasic, Petitioner notes that Bailey‘s condition was not multi-episodic, but a continuous causal chain, from vaccine, to demyelination, to stunted development resulting from the demyelination. Id. Petitioner cites to two previous cases heard by this Court where the Special Master found that the MMR vaccine had caused ADEM: Tufo v. Secretary of HHS, No. 98-0108V, 2001 WL 286911, 2001 US Claims LEXIS 46 (Fed. Cl. Spec. Mstr. Mar. 2, 2001) and Lodge v. Secretary of HHS, No. 92-0697V, 1994 WL 34609, 1994 US Claims LEXIS 19 (Fed. Cl. Spec. Mstr. Jan 25, 1994). Petitioner also cites to the 1994 report of the IOM, which found the theory that a vaccine can ―induce...an autoimmune response...by nonspecific activation of the T cells directed against myelin proteins‖ to be ―biologically plausible.‖ See Pet. Ex. 36 at 19; see also Id. at 25 (stating ―measles virus is associated with demyelinating disorders‖). However, Petitioner concedes that ―there is a -14- paucity of medical literature on the issue of whether ADEM can result in a diagnosis of PDD,‖ but argues (without citation) that ―there is medical literature that supports the association.‖ Pet. Closing Brief at 18. To bolster the Court‘s current gathered knowledge that ―PDD is more descriptive than it is an actual diagnosis‖ (Tr. at 64), Petitioner references the Diagnostic and Statistical Manual of Mental

279 Disorder, 4th ed., filed in part as Pet. Ex. 49: The clinician using [that manual] should therefore consider that individuals sharing a diagnosis are likely to be heterogeneous even in regard to the defining features of the diagnosis and that boundary cases will be difficult to diagnose in any but a probabilistic fashion....Nonclinical decision makers should also be cautioned that a diagnosis does not carry any necessary implications regarding the causes of the individual‘s mental disorder or associated impairments. Inclusion of a disorder in the Classification...does not require that there be knowledge about its etiology. Pet. Ex. 49 at 10-12. Finally, Petitioner cites the data in Table 4 of the Tenembaum study (filed as Pet. Ex. 46) which indicates that three children within the study group (4% of those studied) suffered mental handicap as a residual deficit or neurologic syndrome after suffering from ADEM. Pet. Closing Brief at 22, citing Pet. Ex. 46 at 1229, Table 4. Moving now to Respondent‘s Post-Hearing Memorandum, the Court notes that Respondent‘s analysis hinges primarily upon legal arguments of burden of proof and credibility assessments. Respondent agrees with Petitioner that Bailey suffers currently from PDD and that ataxia is the most commonly manifesting feature of ADEM. However, Respondent contests that Bailey did not experience ataxia, that Bailey‘s PDD was not caused by ADEM, and that the PDD was not related to the MMR vaccination at issue.

280 Respondent relates the description of PDD from the same reference source as Petitioner used to describe PDD: Pervasive Developmental Disorders are characterized by severe and pervasive impairment in several areas of development: reciprocal social interaction skills, communication skills, or the presence of stereotyped behavior, interests and activities. Pet. Ex. 49 at 18-19. Respondent argues, based upon this quote, that ―PDD is the impairment of specific areas of development and does not refer to any cognitive abnormality,‖ adding that ―[w]hile there is no dispute that ADEM may leave survivors with ‗permanent neurological sequelae‘ [(Pet. Ex. 37 at 1)], Respondent is not aware of any documented instances of ADEM being associated with PDD.‖ Resp. Post-Hearing Memorandum at 16. Respondent makes a similar point by reiterating Dr. MacDonald‘s opinion seeking to distinguish Petitioner‘s injury from the findings of the Tenembaum study: -15- The Tennenbaum [sic] study does refer to a small group of children with ADEM that later developed what they call ‗mental handicap‘. Such a designation is very nonspecific and not germane to our discussion of the well-defined neuro[-]behavioral disorder (PDD), which is diagnosed by psychologists utilizing standard DSM-IV criteria. The ‗mental handicap‘ category is obviously vague and non-diagnostic of a specific neuro-behavioral disorder such as PDD, then they would have designated it as such in their conclusions. Resp. Ex. I.

281 Respondent next argues that the type of injury associated with ADEM is not the type observed in PDD, such that Respondent‘s expert ―does not see even a theoretical basis for an association between ADEM and PDD.‖ Resp. Post-Hearing Memorandum at 17. Respondent concludes, therefore, that ―[w]ithout any observed overlap in the presentation of these conditions, it is highly illogical to posit a causal association.‖ Id. Finally, Respondent‘s Post-Hearing Memorandum argues throughout that the law places a burden on Petitioner to disqualify by logical elimination all potential alternative causata in order to prove their theory of actual causation, and that, since alternative theories have been proffered by Respondent and were not wholly discredited by Petitioner, Petitioner has failed to carry such a burden. In his surresponsive post-hearing memorandum, Petitioner frames the issue of dispute thusly: ―Respondent acknowledges that Bailey experienced many symptoms that are recognized clinical features of ADEM, but argues that the symptoms did not present in a typical fashion....The possibility that Bailey‘s symptoms may not have manifest in a typical fashion certainly does not rule out ADEM.‖ Id. at 4. B. THE COURT‘S CONCLUSIONS In sorting out the disputed issues presented above, the Court first notes certain matters that appear not to be in dispute. Both parties agree that ADEM is a monophasic illness or condition that

282 reaches its apex quickly. Tr. at 38 and 73; Pet. Ex. 18 at 1. Both agree that ADEM should be diagnosed based upon a combination of radiographic scanning results and clinical examination findings. Tr. at 45 and 74; Pet. Ex. 16. The parties even agree that the IOM has cited demonstrative evidence of a biologically plausible relation between the measles vaccine and demyelinating diseases such as ADEM. Tr. at 101-02; Pet. Ex. 26 at 1310. Both experts are personally and professionally credible; that premise is beyond a cavil of doubt in the Court‘s mind. However, the Court must analyze the differences between the opinions offered to determine whether Petitioner has established a logical sequence of cause and effect that is biologically plausible to tie together the factual sequence and explain Petitioner‘s injury. See Walther v. Secretary of HHS, __ F.3d. __, 2007 WL 1247047, 2007 U.S. App. LEXIS 10006, (Fed. Cir. May 1, 2007); Althen v. Secretary of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Respondent seems to have abandoned the earlier argument that Bailey suffered from 12 autism, instead of PDD. The Court notes the various similarities between Bailey‘s condition and autism as defined above, but nonetheless rules that PDD better and more precisely describes Bailey‘s condition and symptoms than does autism. Respondent‘s acknowledgment serves to reaffirm the Court‘s conclusion on this point. -16- On its face, Petitioner has proffered a credible theory that, if the Court accepts its component

283 parts, evidences a chain of logical and biological connection. It seems that Respondent‘s challenge in disputing and denying Petitioner‘s case in chief is a question of degree not kind: whether Bailey‘s lack of balance amounts to ataxia, whether Bailey‘s PDD constitutes a mental handicap, etc. Respondent acknowledges that Bailey currently suffers from PDD,12 and that the MMR vaccine can cause ADEM. The only link on the logical ―chain‖ of Petitioner‘s theory that Respondent really disputes, as it relates to the question of ―can it?‖ (i.e., biologic plausibility), is whether ADEM can lead to PDD. Most of Respondent‘s contentions focus more narrowly on the issue of ―did it?‖: i.e., was the mechanism proffered by Petitioner‘s expert really at work in this individual in this set of facts? The Court first refers to the original treating records rendered by those individuals who were present to experience in a first-hand, sensory fashion the indicia of the injury which Bailey suffered. The first point worth noting is that Bailey was seen by a handful of neurologists, but not one of them actually diagnosed Bailey with ADEM. One, Dr. Philbrook, even cast aspersions on the conclusion of ADEM rendered by the treating radiologist. The plain truth, though, is that no diagnosis was given after Bailey‘s acute post-vaccinal incident because no etiology could be determined. Only later on was a diagnosis given, and that diagnosis was merely descriptive, not etiological: that of PDD,

284 which is the condition both parties acknowledge that Bailey currently experiences. Even Dr. Lopez‘s treating diagnosis focuses on PDD as the continuing diagnosis, even while ascribing its development as ―probably secondary to an episode of acute demyelinating encephalomyelitis that [Bailey] had at 18 months of age after this vaccine.‖ Pet. Ex. 44 at 2. Since most of the clinical symptoms of ADEM are nonspecific to ADEM, it is apparent from the medical literature filed that the primary diagnostic mechanism for ADEM is neural imaging scans, such as the MRI scan. These scans are administered by doctors with special skill and training in doing so: radiologists. As all have agreed, a full diagnosis of ADEM is best arrived at as a joint conclusion made between such a radiologist and a neurologist, the latter of whom can observe clinical indicia of the (admittedly nonspecific) symptoms associated therewith, in reaching that conclusion. However, it is clear that the MRI scan, administered by the radiologist, provides the most effective means of diagnosing ADEM. It is therefore very instructive to the Court that both radiologists opined that the results of the neural imaging were most consistent with a diagnosis of ADEM. Dr. Lopez, Bailey‘s treating neurologist and Petitioner‘s expert witness, has himself reviewed the MRI scans, and, for the reasons he explained, agrees with a diagnosis of ADEM. Tr. at 37. Also apparent from the medical literature filed is that ataxia is the most consistent clinical

285 sign associated with ADEM. It is statistically logical to presume that if Bailey suffered from ADEM in the period following his vaccination, symptoms would include ataxia, and that a treating clinician would look for such a sign as pertinent to diagnosis. Although Bailey visited several neurologists -17- since March 2000, only one viewed Bailey during the time closest to the seizure, when acute signs of ADEM would be most apparent. Dr. Philbrook examined Bailey 11 days after his seizure and noted that Bailey‘s ―gait and coordination [was] extremely immature in that his gait was wide based. There was also some hyperextension of both knees noted with poor balance and frequent falling.‖ Pet. Ex. 5 at 40 et seq. Respondent attempts to distance these observations from ataxia, which is defined in Dorland‘s Medical Dictionary as a ―failure of muscular coordination [and/or an] irregularity of muscular action.‖ Id. at 170. Respondent maintains that, Dr. Philbrook knew what ataxia is, and could have used that term in his records if he thought it was pertinent, but he did not use that term. Dr. MacDonald also points to the physical examination record following the seizure that stated, upon discharge, that Bailey was ―totally normal.‖ Tr. at 76. As noted above, Respondent‘s distinction seems one of degree, not of type, and strikes as a trifle semantic. As the rule cited in Murphy, supra, states, the Court looks more centrally at what a medical record does say, vis-a-vis what a record does not say. Respondent‘s expert quibbled that

286 Bailey‘s ―toddling‖ gait was not far outside normal ranges, as he was of the toddler age grouping, when children are beginning to learn to walk. This interpretation ignores the notation that Bailey‘s coordination was ―extremely immature‖. Indeed, this was the notation made by the neurologist, the doctor most attuned to Bailey‘s precise condition, and this doctor did not pronounce Bailey ―totally normal.‖ Presumably, Dr. Philbrook was basing his judgment on maturity–not by comparing Bailey to a mobile, fully-developed adult, but through comparison to a child of the same age range. Bailey‘s coordination was immature for his age in comparison to standardized norms of development, and, according to Dr. Philbrook, ―extremely‖ so. The fact that Bailey‘s extremely immature coordination caused ―poor balance and frequent falling‖ no doubt qualifies Bailey‘s condition as a ―failure of muscular coordination [and/or] an irregularity of muscular action‖. The Court therefore finds that Bailey experienced ataxia in the days or weeks following his post-vaccinal seizure, and that this atactic condition (or its residual effects) was described by Dr. Philbrook in the notes referring to Bailey‘s 10 April 2000 visit. There is likewise some dispute regarding whether Bailey‘s poor health was an acute, monophasic condition, or whether it was merely one increment in a generally retarded biologic process: whether Bailey suffered from demyelination or from hypomyelination. Were his symptoms

287 more consistent with the destruction of existing myelin structures, or were they the result of a failure to build or develop those structures? No one disputes that ADEM would fit correspondingly with the former of the two alternatives, but that it is not consistent with the latter. It appears from the Record that Bailey‘s condition significantly worsened after the seizure and ataxia. Dr. MacDonald argued that his condition did not present with ―the multiplicity of signs and symptoms [associated] with the typical ADEM case, but the literature filed indicates that while symptoms may vary, ataxia is by far the most common symptom. By all accounts, Bailey was a healthy child with no reported health problems or developmental delays of medical significance before his MMR vaccination. Then, beginning with his seizure sixteen days later, he began steadily to retrogress, before eventually improving gradually to his current condition. What was only ―mild gross motor developmental delay‖ at the time of Dr. Philbrook‘s examination eleven days after the seizure had then retrogressed into global developmental delays, which included features associated with pervasive developmental delay, by the next neurological visit on 22 January 2001. By the time -18- of that visit, Bailey was already showing gradual improvement and development (despite still showing significant residua from the developmental delay), which, altogether, was more consistent with a monophasic condition of limited duration, less so than a permanent, fixed disease of

288 congenital origins. This series of circumstances, corroborated by the medical records prepared by treating doctors, fits much more closely with the monophasic illness of ADEM than it does with any other etiology proffered by either party. Combined with the radiologists‘ analysis of the MRI scans, and the Court‘s finding of ataxia, the Court accepts that Petitioner has met the burden of proof in showing the fact that Bailey more likely than not suffered from ADEM. A finding of ADEM is not inconsistent with the medical records from the treating physicians in this case. The notations from both radiologists support this finding. At first glance, Dr. Philbrook seems to contradict this finding, but within his notes he gives only an impression, but no conflicting diagnosis; even though he doubted the diagnosis of ADEM, he was unable to rule it out. Dr. MacDonald argued that Bailey did not have ADEM because Bailey‘s prognosis remained unimproved for a longer period, whereas ADEM cases almost always ―improve dramatically‖ to benign effect, but that, in any event, ―they change over time.‖ Tr. at 78. This argument is repudiated by the medical records and medical literature filed in this case. First, as noted above, Bailey did slowly improve in some areas, after significant time had passed since his post- vaccinal seizure. Secondly, the medical literature noted that the monophasic nature of ADEM simply means that, after a precipitous period of acute symptoms, the patient either improves gradually, or retains residual

289 effects. See Pet. Ex. 27 at 530 and Pet. Ex. 46 at 1229, Table 4. From the facts presented to the Court in medical records, this fits most closely with Bailey‘s clinical history. In contrast, even Dr. MacDonald realizes that his hypothesis of glucose transporter deficiency would have required that Bailey experience early-onset epilepsy within the first months of life and progressive neurological deterioration. Tr. at 80. This description does not jibe with Bailey‘s medical records. That being said, the Court turns just for a moment to Respondent‘s proffered hypothesis of glucose transporter deficiency. This hypothesis, which Respondent‘s expert declined to incorporate as a plausible, probable theory of explanation, was used by Respondent to blunt Petitioner‘s theory of ADEM. However, this hypothesis was not given to a reasonable degree of medical probability or certainty, and Respondent‘s expert admitted that it was merely ―a possible, not necessarily a probable diagnosis, but that he is not holding this out by a preponderance of the evidence more likely than not.‖ Tr. at 101. Moreover, this hypothetical explanation does not square with the facts in the Record. Dr. MacDonald himself noted that, as a general rule, ―all the initial cases presented with epilepsy in the first months of life, and a progressive neurological deterioration unless they were treated.‖ Bailey‘s epilepsy was composed of one seizure event, when Bailey was a year-and-a-half old, and Bailey has since improved despite a notable delay in that progress. As such, the Court does

290 not accept that Respondent has proffered, much less proved to a preponderance, a theory that a glucose transporter deficiency caused Bailey‘s condition and Petitioner‘s injury. The next issue facing the Court is to determine whether the vaccine caused the ADEM from which Bailey suffered. The Court notes the Vaccine Program cases, the IOM report, and the several -19- articles of medical literature referenced by Petitioner‘s brief that have found that the MMR can directly cause ADEM. In Lodge v. Secretary of HHS, No. 92-0697V, 1994 WL 34609, 1994 US Claims LEXIS 19, 31 (Fed. Cl. Spec. Mstr. Jan. 25, 1994), Special Master French found that ADEM had been tied to natural measles, mumps, and rubella infections, as well as to measles, mumps, and rubella vaccines. As such, she ruled that the Petitioner‘s injury was ―vaccine-related and compensable under the Vaccine Program.‖ Id. at 54. In Tufo v. Secretary of HHS, No. 98-0108V, 2001 WL 286911, 2001 US Claims LEXIS 46, 33-34 (Fed. Cl. Spec. Mstr. Mar. 2, 2001), Special Master Millman found that the MMR vaccine had caused ADEM because a theory that ―measles vaccine [can cause] ADEM is biologically plausible,‖ there was a medically appropriate temporal association (2.5 weeks after vaccination), and the injured party‘s symptoms corresponded with the accepted symptomatology for ADEM. In Saunders v. Secretary of HHS, No. 97-0808V, 2001 WL 1135035, 2001 U.S. Claims

291 LEXIS 225, 9 (Fed. Cl. Spec. Mstr. Sep. 4, 2001), Special Master Hastings denied an ADEM claim, reasoning that if the injured party had suffered from ADEM, such injury ―would have been obvious upon examination of the MRI,‖ specifically through analyzing the brain‘s white matter. In reviewing these cases, the Undersigned is benefitted from the transcribed wisdom of these, my august colleagues. The first two add credence to a finding of ADEM, and establish that the time period involved in this case fits within a time frame that those cases established to support a medically plausible temporal association. It is also significant that, in the Saunders case, the Court decided on whether the injured party had suffered from ADEM based upon MRI findings, vis-a-vis nonspecific clinical indicia. All of these findings are corroborated by medical literature supplied by the Petitioner in this case (see Section II-A, supra), and the Court accepts all of these materials as persuasive in making a factual finding here. Therefore, the Court finds that the MMR vaccine can cause ADEM, and that the MMR vaccine received by Bailey did in fact cause Bailey to develop ADEM. Having suffered from ADEM, it remains to be discussed if and how the ADEM led directly to PDD as a sequela. As a preliminary matter, even though Respondent conceded during briefing that Bailey suffers from PDD, Respondent‘s expert, Dr. MacDonald characterized Bailey‘s condition as autism;

292 however, he at one point conflated the two as of one or of like kind. Tr. at 84-86. Despite his comments to that effect, the Court is inclined to view Bailey‘s condition as accurately as the medical records will allow; that is, to find that Bailey more likely than not suffers from PDD, and not from autism. When asked, Petitioner‘s expert, in explaining the connection between ADEM and PDD, stated that almost half of the people who suffer from ADEM experience sequelae such as PDD. Tr. at 108. He acknowledged that ―the majority of patients with ADEM improve significantly,‖ but added that ―the exception to this rule is when patients have been exposed to measles, just like in the case of MMR vaccine,‖ in which case ―sequela may occur in up to 50 percent of patients.‖ Tr. at 107-08. Such sequelae potentially include ―mental syndromes such as PDD.‖ Tr. at 108. -20- In response, Respondent‘s expert stated that, although ADEM may result in ―permanent neurological sequelae,‖ nevertheless ―all the medical literature is negative in that regard;‖ however, soon thereafter, he corrected this statement by clarifying, ―I can find no literature relating ADEM to autism or [PDD].‖ Tr. at 84-85. It may be that Respondent‘s research reveals a dearth of evidence linking ADEM to PDD, but that is not the same as positive proof that the two are unrelated, something Respondent was unable to produce. Therefore, the statement that ―all the medical

293 literature is negative‖ is incorrect. Also, as noted above, Respondent‘s expert ―does not see even a theoretical basis for an association between ADEM and PDD.‖ Resp. Post- Hearing Memorandum at 17. The Court notes the difference in opinion between the experts in this case, and realizes that there may not have been a specific study linking a tumultuous episode of ADEM specifically to the polymorphous category of symptoms encompassed by the term ―pervasive developmental delay.‖ That being said, the literature filed in this case is instructive: ―In children[,] recovery from the acute stage [of ADEM] is sometimes followed by a permanent disorder of behavior [or] mental retardation...‖ (Pet. Ex. 27 at 530), and 4% of the Tenembaum study group suffered ―mental handicap‖ as a residual deficit or neurologic syndrome (Pet. Ex. 46 at 1229, Table 4). Respondent disputes that these sequelae fit the ―definition‖ of PDD, and calls into question the applicability of the Tenembaum study. Respondent‘s expert averred that PDD is a ―well-defined neuro[-]behavioral disorder,‖ diagnosed using ―standard‖ categorical criteria, and should not be conflated with the more general term ‗mental handicap‘ used by the Tenembaum study authors, to which Petitioner referred. Resp. Ex. I. Both Petitioner and Respondent vouch for the credibility of the Diagnostic and Statistical Manual of Mental Disorder, referenced supra, and that source is very forthright in describing its own

294 limitations in describing PDD with both accuracy and precision. The Court does not accept the quibble posited by Respondent, and follows the caveat stated by the authors, who acknowledge the heterogeneity found in the general classification PDD. The same authors are quick to note that PDD carries no assumed etiology, and that Petitioner‘s theory of causation makes equal and greater logical sense than any other etiology that is apparent from the medical records. In sum, the Court‘s factual findings are fourfold: 1. Bailey did show evidence of ataxia in the period surrounding his seizure, following his vaccination; 2. Such ataxia, when considered in conjunction with the radiological results and some other ―soft indicia‖, together support the Court‘s finding that Bailey did, in fact, suffer from ADEM. 3. Bailey‘s ADEM was caused-in-fact and proximately caused by his vaccination. It is wellunderstood that the vaccination at issue can cause ADEM, and the Court finds, on the record filed herein, that it did actually cause the ADEM. -21- 4. Bailey‘s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. Additionally, this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay. III. CONCLUSIONS OF LAW

295 As aforementioned, the Court is authorized to award compensation for claims where the medical records or medical opinion have demonstrated by preponderant evidence that either a cognizable Table Injury occurred within the prescribed period or that an injury was actually caused by the vaccination in question. § 13(a)(1). The Petitioner has not claimed to have suffered a "Table" injury, which §13(a)(1)(A) assigns the burden of proving such by a preponderance of the evidence. While the Petitioner is not entitled to a presumption of causation afforded by the Vaccine Injury Table, this petition may prevail if it could be demonstrated to a preponderant standard of evidence that the vaccination in question, more likely than not, actually caused the injury. See § 11(c)(1)(C)(ii)(I) & (II); Grant v. Secretary of HHS, 956 F.2d 1144 (Fed. Cir. 1992); Strother v. Secretary of HHS, 21 Cl. Ct. 365, 369-70 (1990), aff‘d, 950 F.2d 731 (Fed. Cir. 1991). The Federal Circuit has indicated that, to prevail, every petitioner must: show a medical theory causally connecting the vaccination and the injury. Causation in fact requires proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury. A reputable medical or scientific explanation must support this logical sequence of cause and effect. Grant, 956 F.2d at 1148 (citations omitted); see also Strother, 21 Cl. Ct. at 370. Furthermore, the Federal Circuit recently articulated an alternative three-part causation-in-fact analysis as follows: [Petitioner's] burden is to show by preponderant evidence that the vaccination brought about [the] injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and

296 effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. Althen v. Secretary of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under this analysis, while Petitioner is not required to propose or prove definitively that a specific biological mechanism can and did cause the injury, he must still proffer a plausible medical theory that causally connects the vaccine with the injury alleged. See Knudsen v. Secretary of HHS, 35 F.3d 543, 549 (1994). -22- Of importance in this case, it is part of Petitioner's burden in proving actual causation to "prove by preponderant evidence both that [the] vaccinations were a substantial factor in causing the illness, disability, injury or condition and that the harm would not have occurred in the absence of the vaccination. Pafford v. Secretary of HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006)(emphasis added), rehearing and rehearing en banc denied, 2006 U.S. App. LEXIS 28907, cert. den., 168 L. Ed. 2d 242, 75 U.S.L.W. 3644 (2007)., citing Shyface v. Secretary of HHS, 165 F.3d 1344, 1352 (Fed. Cir.1999). This threshhold is the litmus test of the cause-in-fact (a.k.a. but-for causation) rule: that petitioner would not have sustained the damages complained of, but for the effect of the vaccine. See generally Shyface, supra. A. DETERMINING CREDIBILITY In their closing briefs, the parties discussed the respective weight to be afforded each medical

297 expert. Respondent seized the initiative in his Post-Hearing Memorandum. After referencing general authority for undisputed rules, Respondent argues that Dr. Lopez‘s opinion ―cannot be viewed as reliable or credible,‖ and that, even though ―Dr. Lopez is certainly qualified to testify in this case,‖ nevertheless, his opinion ―should be afforded little weight.‖ Id. at 8. Respondent bases this strong assertion primarily on the fact that Dr. Lopez believes Bailey suffered from ADEM, in disagreement with Dr. Philbrook, another treating neurologist. Id. Respondent seeks to bolster Dr. Philbrook, and to give him alone the credibility of a treating doctor, exclusive of Dr. Sleight as a contemporaneously treating radiologist (―radiologists are not directly involved with the care of the patients whose scans they interpret‖) and Dr. Lopez as another treating neurologist at a later time (―the opinions of Dr. Lopez also do not merit consideration commensurate with that of a treating physician‖ as his treatment of Bailey ―occurred more than three years after Bailey was treated for a seizure‖). Id. at 13-14. In undercutting Dr. Lopez‘s opinion, Respondent states, ―In order to draw his conclusion about the etiology of Bailey‘s PDD, Dr. Lopez would have been forced to rely upon the same reports and medical records available to any other physician.‖ Id. at 14. Petitioner attacked this position of Respondent in his surresponsive post-hearing brief. Petitioner first points out, ―Respondent erroneously states that Dr. Lopez‘s diagnosis of ADEM

298 contradicts the diagnosis of the neurologist that was treating Bailey at the time of his first seizure, Dr. Philbrook.‖ Id. at 2. Petitioner rebuts Respondent‘s position by countering that Dr. Philbrook ―never diagnosed Bailey,‖ such that ―[t]here are no inconsistencies between Dr. Lopez‘s and Dr. Philbrook‘s opinions.‖ Id. Secondly, Petitioner takes issue with Respondent‘s criticism that Dr. Lopez examined Bailey too late to adequately diagnose an etiology for the PDD: ―The passage of time in this case, however, only strengthens Dr. Lopez‘s conclusions. Dr. Lopez‘s ability to view Bailey‘s three year clinical and radiological history, which both support a diagnosis of ADEM, adds more weight to his opinion.‖ Id. at 2-3 (emphasis added). Next, Petitioner turned the spotlight back towards Respondent, and Respondent‘s expert: ―If little weight is to be afforded to a witness that testified in this matter, it should be the testimony of Respondent‘s witness, Dr. MacDonald,‖ because he ―never physically examined Bailey, but has In Daubert, the Court was interpreting Federal Rule of Evidence 702, 13 which allows expert opinion testimony regarding ―scientific, technical, or other specialized knowledge.‖ 509 U.S. at 589. -23- merely reviewed his medical records, ruled out a diagnosis of ADEM, which was never excluded by any other of Bailey‘s treating physicians.‖ Id. at 3. The Court briefly pauses to point out the similarities between this case, and the case of

299 Walther v. Secretary of HHS, __ F.3d. __, 2007 WL 1247047, 2007 U.S. App. LEXIS 10006, (Fed. Cir. May 1, 2007) (slip opinion), another case where a petitioner alleged that the alleged injury was caused by a vaccine-related bout of ADEM. In that case, as here, there was no dispute that the vaccination at issue could cause ADEM, but Respondent disputed whether the petitioner did actually suffer from ADEM. The Special Master initially hearing the case ruled that the petitioner‘s expert ―was not credible on the causation issue‖ and rejected the expert testimony (as Respondent advocates here) ―because he harbored significant concerns regarding the quality and the substance‖ of such testimony. Id., Slip Opinion at 4. According to the Federal Circuit‘s interpretation, the Special Master excluded that testimony because of its probative weight, rather than its admissibility. Id. The Federal Circuit vacated that Decision, and remanded the case for further proceedings. Respondent has argued, as it has in other cases, that this Court should apply de facto the standards set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), even if this Court is not technically bound to apply the analysis followed there de jure. This Court has indeed done so upon occasion, to the approval of the Federal Circuit. See Terran v. Secretary of HHS, 41 Fed. Cl. 330 (1998), aff‘d, 195 F.3d 1302 (Fed Cir. 1999), rehearing and rehearing en banc denied, (2000). Specifically, Respondent states that ―the Supreme Court crafted four proposed

300 criteria‖ to determine the admissibility of expert opinion evidence: ―testing; peer review and publication; known or potential error rate; and, general acceptance in the scientific community.‖ Respondent‘s Post-Hearing Memorandum at 6. The Daubert opinion addresses a trial court‘s ―gatekeeper‖ function, to protect the fact-finder from unreliable testimony that will confuse, rather than inform, the fact-finding process. 509 U.S. at 595-597. The Supreme Court there connected the precondition that testimony comport as ―scientific knowledge‖13 to ―a standard of evidentiary reliability.‖ Id. at 590. The Court then linked evidentiary reliability to a supportive foundation of scientific validity. Id., note 9. A proposition or theory is scientifically valid where it supports the conclusion that ―it purports to show.‖ Id. The Court in Daubert readily distinguished, as a separate component, the issue of relevance. Id. at 591. Unsurprisingly, evidence is only admissible in the first place when it is relevant, but even potentially relevant testimony is excluded as inadmissible under the Daubert analysis of FRE 702 whenever it is not reliable. Id. at 592-93. Therefore, the two are distinct, and not to be conflated. The Daubert opinion states that, prior to determining the relevance of expert opinion evidence, a trial judge must first assess ―whether the reasoning or methodology underlying the testimony is scientifically valid and [] whether the reasoning or methodology properly can be applied

301 to the facts in issue.‖ Id. at 592-93. The Court gives guidance for this determination by way of some factorial examples, but leaves the determinative process to the logic and reason of the trial judge: -24- We are confident that federal judges possess the capacity to undertake this review. Many factors will bear on the inquiry, and we do not presume to set out a definitive checklist or test. But some general observations are appropriate. Id. at 593. The Court proceeds to list the four examples referenced by Respondent above (Id. at 593- 94), but reiterates such an inquiry remains ―a flexible one,‖ focused not on a mechanistic weighing of predetermined factors, but on the scientific validity of the opinion offered. Id. at 594-95. Later in the decision, the Daubert Court assuaged the fear that such a result would allow materials to be considered which might technically comport to the reliability standard, but which are only minimally relevant (i.e., of slight probative value). Id. at 595-96. The Court‘s assurance was that the assaying process of trial would sufficiently test, weigh, and prove the proper amount of weight to be afforded to such testimony. This reassuring concept makes clear that even if a proffered theory is not ―generally accepted‖, it may still be admissible, and will be left to the winnowing analytical process of the fact-finder to assign an ultimate probative value. Applying these rules, it appears that Respondent‘s argument conflates two very distinct

302 concerns: admissibility and probative weight. Respondent seems to argue that, by Respondent‘s estimation, Petitioner‘s expert‘s theory is not convincing, and should therefore be excluded in toto. The cases discussed above militate against this result. So long as the testimony from Dr. Lopez is relevant, it is admissible, unless some concern of evidentiary reliability requires its exclusion. As Dr. Lopez gave the perspective of a physician who actually treated Bailey, who is commenting on Bailey‘s condition in light of the medical record extant, and who argues that such condition is vaccine-related, it is eminently relevant. If believed, such testimony covers much distance in carrying Petitioner‘s burden of proof. Moreover, his testimony follows the scientific method. If the Court as fact-finder accepts the premises proffered by Petitioner, the logical theory offered by Petitioner‘s expert supports a conclusion that Bailey‘s injury is vaccine-related, the conclusion such theory seeks to prove. There is nothing inherently unreliable or nonsensical in Petitioner‘s theory, and hence, nothing to require the Court to exclude from the appropriate body of evidence in this case. Therefore, the Court will not exclude the testimony of Dr. Lopez, and moves on to assign a degree of relative probative weight in determining the final conclusion of this case. As Respondent references at page 6 of his prehearing memorandum, the Federal Circuit has ruled that ―treating physicians are likely to be in the best position to determine whether ‗a logical

303 sequence of cause and effect show[s] that the vaccination was the reason for the injury.‘‖ Cappizano v. Secretary of HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006), quoting Althen v, Secretary of HHS, 418 F.3d at 1280. Dr. Lopez was indeed a treating physician, and rendered an opinion supporting the Petition in his contemporaneous medical notations. He did so well before this Petition was filed, presumably with no knowledge that such a cause of action would be brought before this Court. Unlike the other treating neurologists that treated Bailey, he did render a diagnosis for Bailey‘s condition as well as a likely etiology to explain his diagnosis. His position on these matters has remained unchanged since that initial treating diagnosis, and the Court can see no reason to gainsay such medical opinion from a treating physician. The Court therefore takes quite seriously the opinion testimony given by Dr. Lopez. -25- B. APPORTIONING PROCEDURAL BURDENS Respondent argues at length that a burden should be borne by Petitioner to disprove all other potential causata as a component of proving the causa proffered by Petitioner: namely, the MMR vaccine. Respondent argues that, ―in an actual causation case, the question of whether a factor other than the vaccinations was responsible for the condition is necessarily subsumed in petitioner‘s basic burden: proving that the vaccine was the most likely cause of the condition. Respondent‘s Post-

304 Hearing Memorandum at 5. Respondent reads Pafford, supra, to collapse subsections (A) and (B) of 42 U.S.C. § 300aa–13(a)(1), the general rule for recovery in actual causation cases in the Vaccine Program, such that Petitioner‘s burden is, in essence, to prove that the vaccine actually caused the injury suffered by also proving that such injury was not caused by factors unrelated to the vaccine. On 1 May 2007, in the case of Walther v. Secretary of HHS, supra, the Federal Circuit clarified the rule in Pafford so as to correspond squarely with the Vaccine Statute, which is the only authority conferring jurisdiction upon this Court. The Vaccine Statue text reads as follows: (a) General rule (1) Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole— (A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 300aa–11 (c)(1) of this title, and (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition. The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion. 42 U.S.C. § 300aa–13(a)(1)(A)-(B). Vaccine cases follow the Restatement (2d) of Torts, which requires a petitioner to prove actual causation, which is bifurcated into causation in fact, also known as ―but-for‖ causation; and proximate or non-remote causation, sometimes referenced as ―substantial

305 factor‖ causation. Walther, slip op. at 8-9; see also Shyface v. Secretary of HHS, 165 F.3d 1344 (Fed. Cir.1999). If a petitioner proves actual causation thus defined, Respondent is shouldered with task of proving a ―factor unrelated‖ under subsection (B), above. Id. The Federal Circuit in Walther states a general legal principle, and a common- sensical truth: that ―our legal system rarely requires a party to prove a negative,‖ and therefore, it is not a component of a petitioner‘s burden ―to prove that ‗there is not a preponderance of the evidence.‘‖ Id., slip op. at 9. Applying traditional legal techniques of statutory interpretation the Federal Circuit also resolved that the reading urged by Respondent would render § 300aa– 13(a)(1)(B) a legal See Pafford v. Secretary of HHS, No. 01-0 14 165V, 2004 U.S. Claims LEXIS 179, *16, slip op. at 7 (Fed. Cl. Spec. Mstr. Jul. 16, 2004), aff‘d, 64 Fed. Cl. 19, 2005 U.S. Claims LEXIS 31 (2005), aff‘d 451 F.3d 1352, 1356 (2006) (―this court perceives no significant difference between the Special Master's test and that established by this court in Althen and Shyface‖), rehearing and rehearing en banc denied, 2006 U.S. App. LEXIS 28907, cert. den., 168 L. Ed. 2d 242, 75 U.S.L.W. 3644 (2007). -26- redundancy or superfluity, which is contradicted by the interpretive canon against reading statutory text as redundant or superfluous. Id. at 9-10. In stating the general rule for the case, the Walther court explained that ―[Respondent] bears

306 the burden of establishing alternative causation by a preponderance of the evidence once the petitioner has established a prima facie case....[T]he text and structure of the Vaccine Act separates the inquiry for alternative etiologies from the inquiry for causation,‖ and so ―[t]hese are two separate inquiries under the statute.‖ Id. at 11, quoting Grant v. Secretary of HHS, 956 F.2d 1144, 1149 (Fed. Cir. 1992) (internal marks omitted). In a footnote, the court in Walther noted that, for the purpose of proving proximate causation (a.k.a. ―substantial factor‖ causation), a petitioner may still bear a burden to address other potential causata, if significant, but that such a petitioner need not disprove that these other factors caused the injury suffered: ―Where multiple causes act in concert to cause the injury, proof that the particular vaccine was a substantial cause may require the petitioner to establish that the other causes did not overwhelm the causative effect of the vaccine.‖ Slip Op. at 11, note 4; see also Whitecotton v. Secretary of HHS, 81 F.3d 1099 (Fed. Cir. 1996). The Federal Circuit concluded the Walther decision by holding ―that the petitioner does not bear the burden of eliminating alternative independent causes.‖ Id. at 12. That holding directly applies in this case. In light of the clear explanation given by the Federal Circuit to aid in reading the operative portions of the controlling statutory provisions, this Court now holds that Petitioner bears no burden

307 to disprove, as a component of his case in chief, the glucose transporter deficiency hypothesis raised by Respondent. Petitioner‘s burden under the Vaccine Act, as well as the controlling cases interpreting the Act, is to prove that, ―but for‖ the consequential effect(s) of the vaccine, the alleged injury would not have been suffered, and that the vaccine‘s effect was a substantial, proximate (i.e., non-remote) cause of that injury. C. APPLYING THE LAW TO THE FACTS As a matter of elucidation, the Undersigned takes note of the following two-part test, which has been viewed with approval by the Federal Circuit,14 and which guides the Court‘s practical approach to analyzing the Althen elements: -27- The Undersigned has often bifurcated the issue of actual causation into the "can it" prong and the "did it" prong: (1) whether there is a scientifically plausible theory which explains that such injury could follow directly from vaccination; and (2) whether that theory's process was at work in the instant case, based on the factual evidentiary record extant. Weeks v. Secretary of HHS, No. 05-0295V, 2007 U.S. Claims LEXIS 127, *64, slip op. at 25, n. 15 (Fed. Cl. Spec. Mstr. Apr. 13, 2007). The Court found, supra, that Bailey‘s ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it

308 did actually cause the ADEM. Furthermore, Bailey‘s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay. Based upon that finding of fact, it follows as a natural conclusion that Petitioner has carried his burden of proving to a preponderance that the MMR vaccine at issue actually caused the condition(s) from which Bailey suffered and continues to suffer. Inasmuch as the other elements of § 300aa–11 (b) and (c) have already been satisfied, the Court holds that Petitioner has met his burden on his case in chief. These facts likewise satisfy the Althen test set forth above. Petitioner‘s theory of PDD caused by vaccine-related ADEM causally connects the vaccination and the ultimate injury, and does so by explaining a logical sequence of cause and effect showing that the vaccination was the ultimate reason for the injury. Also, the timetable in this case for the onset of ADEM fits within the range found to be reasonable in the cases addressing the same question. See Lodge v. Secretary of HHS, No. 92-0697V, 1994 WL 34609, 1994 US Claims LEXIS 19, 31 (Fed. Cl. Spec. Mstr. Jan. 25, 1994),

309 Tufo v. Secretary of HHS, No. 98-0108V, 2001 WL 286911, 2001 US Claims LEXIS 46, 33-34 (Fed. Cl. Spec. Mstr. Mar. 2, 2001), and Saunders v. Secretary of HHS, No. 97- 0808V, 2001 WL 1135035, 2001 U.S. Claims LEXIS 225, 9 (Fed. Cl. Spec. Mstr. Sep. 4, 2001). In contrast, the Court found, as a matter of fact, that Bailey did not suffer from glucose transporter deficiency, or any other factor unrelated to vaccination. Without such a finding, based upon preponderant proof, Respondent has not satisfied his burden under § 300aa–13(a)(1)(B). To paraphrase a citation provided in Respondent‘s own Prehearing Memorandum, the ―possibility‖ of a causal relationship between a factor unrelated and a condition does not support a finding in Respondent‘s favor. Duncan v. Secretary of HHS, No 90-3809V, 1997 WL 75429 *4, 1997 U.S. Claims LEXIS 73 (Fed. Cl. Spec. Mstr. Feb. 6, 1997). -28- III. CONCLUSION Therefore, in light of the foregoing, the Court rules in favor of entitlement in this matter. The parties are to contact the Court as soon as practicable to schedule a status conference on the issue of damages. IT IS SO ORDERED. Richard B. Abell-Special Master

310

Appendix 4 Industry revenues

For the first time ever, in 2006, global spending on prescription drugs topped $643 billion, even as growth slowed somewhat in Europe and North America. The United States accounts for almost half of the global pharmaceutical market, with $289 billion in annual sales followed by the EU and Japan.(pdf) Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent.[16]

US profit growth was maintained even whilst other top industries saw little or no growth.[17] Despite this, "..the pharmaceutical industry is — and has been for years — the most profitable of all businesses in the U.S. In the annual Fortune 500 survey, the pharmaceutical industry topped the list of the most profitable industries, with a return of 17% on revenue."[18]

Pfizer's cholesterol pill Lipitor remains a best-selling drug world wide. Its annual sales were $12.9 billion, more than twice as much as its closest competitors: Plavix, the blood thinner from Bristol- Myers Squibb and Sanofi-Aventis; Nexium, the heartburn pill from AstraZeneca; and Advair, the asthma inhaler from GlaxoSmithKline.[16]

IMS Health publishes an analysis of trends expected in the pharmaceutical industry in 2007, including increasing profits in most sectors despite loss of some patents, and new 'blockbuster' drugs on the horizon.[19]

Teradata Magazine predicted that by 2007, $40 billion in U.S. sales could be lost at the top 10 pharmaceutical companies as a result of slowdown in R&D innovation and the expiry of patents on major products, with 19 blockbuster drugs losing patent.[20] [edit]Market leaders in terms of revenue Main article: List of pharmaceutical companies

The following is a list of the 20 largest pharmaceutical and biotech companies ranked by healthcare revenue. Some companies (e.g., Bayer,Johnson and Johnson and Procter & Gamble) have additional revenue not included here. The phrase Big Pharma is often used to refer to companies with revenue in excess of $3 billion, and/or R&D expenditure in excess of $500 million.

311

Healthcare Net income/ Revenu Total Country R&D (loss) Employe e Rank Company Revenues(USD millions 2006(USD millions) 2006(USD millions) es 2006 2008 )

Switzerlan 1 Novartis 53,324 7,125 11,053 138,000 d 2 Pfizer USA 48,371 7,599 19,337 122,200 3 Bayer Germany 44,200 1,791 6,450 106,200 GlaxoSmithKli United 4 42,813 6,373 10,135 106,000 ne Kingdom Johnson and 5 USA 37,020 5,349 7,202 102,695 Johnson 6 Sanofi-Aventis France 35,645 5,565 5,033 100,735 Hoffmann–La Switzerlan 7 33,547 5,258 7,318 100,289 Roche d UK/Swed 8 AstraZeneca 26,475 3,902 6,063 50,000+ en 9 Merck & Co. USA 22,636 4,783 4,434 74,372 Abbott 10 USA 22,476 2,255 1,717 66,800 Laboratories 11 Wyeth USA 20,351 3,109 4,197 66,663 Bristol-Myers 12 USA 17,914 3,067 1,585 60,000 Squibb Eli Lilly and 13 USA 15,691 3,129 2,663 50,060 Company 14 Amgen USA 14,268 3,366 2,950 48,000 Boehringer 15 Germany 13,284 1,977 2,163 43,000 Ingelheim Schering- 16 USA 10,594 2,188 1,057 41,500 Plough Baxter 17 USA 10,378 614 1,397 38,428 International Takeda 18 Pharmaceutical Japan 10,284 1,620 2,870 15,000 Co. 19 Genentech USA 9,284 1,773 2,113 33,500 Procter & 20 USA 8,964 n/a 10,340 29,258 Gamble

Source: Top 50 Pharmaceutical Companies Charts & Lists, Med Ad News, September 2007[21]

312 see also E-Books

1. In Harm’s Way : www.horne-roberts.co.uk/ebook/mmr10.doc

2. Access to Justice: www.horne-roberts.co.uk/ebook/access_to_justice.html

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