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CARTWRIGHT ANNIVERSARY SEMINAR 5Th August 2008 Presented by Lynda Williams

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CARTWRIGHT ANNIVERSARY SEMINAR 5Th August 2008 Presented by Lynda Williams CARTWRIGHT ANNIVERSARY SEMINAR 5th August 2008 Presented by Lynda Williams “GARDASIL – CARTWRIGHT’S DAUGHTER?” My involvement in the issue of HPV vaccines formally began on 20 February 2006 when a representative from CSL, the manufacturer of Gardasil, came to meet with members of the Auckland Women’s Health Council and Women’s Health Action. Her visit rang alarm bells. When drug company reps want to come and visit with women’s health groups my alarm bells always start ringing, but this visit was particularly worrying. For a start the young woman couldn’t answer many of the questions we had about the research results. She also made claims about there being a reduction in the timeframe between infection with the human papilloma virus (HPV) and the development of cervical cell abnormalities which she said would be substantiated when new research results were published in 2 – 3 months time – this didn’t happen. And she was obviously hoping that we would support CSL’s endeavours to get the vaccine introduced into the school-based vaccination programme. We made it quite clear that we wouldn’t. We also had major issues around how long the vaccine would last and the need to include males in any anti-HPV vaccination programme. We had other concerns as well and I will come to these later. But before I say any more about Gardasil, we need to go back and set the scene for why this particular issue is the topic of today’s Cartwright lunch time seminar and is one that women’s groups are examining through what we refer to as a “Cartwright lens.” Cervical Cancer Inquiry It is exactly 20 years today since the report of Judge Silvia Cartwright’s Inquiry into the treatment of cervical cancer at National Women’s Hospital was released. The report marked a watershed in medical history in this country and women’s groups have continued to commemorate this special day in various ways every year since 1988. This annual luncheon is one of them. Judge Cartwright’s report recommended sweeping changes in both the practice of medicine and research, as well as various measures for protecting patient rights. The report also recommended the establishment of a national cervical screening programme. When releasing the report the government of the day promptly made a very public commitment to implementing all of the recommendations in the Cartwright Report. However some of the changes took a lot longer to get off the ground than others. It took six years before the Office of the Health & Disability Commissioner was established with Robyn Stent appointed as the first Commissioner, and two more years before the Code of Consumers’ Rights came into effect on 1 July 1996. The Auckland Women’s Health Council and Women’s Health Action took a very active role in the two major consultation exercises that took place in 1995 during the development of the Code of Consumers’ Rights and produced extensive submissions on the proposed Code. For me personally, the lynch pins of the Code of Rights have always been Right 6: the right to be fully informed , and Right 7: the right to make an informed choice and give informed consent . The other rights sit around these two essential aspects of the Code. Cervical Cancer We now know a lot more about cervical cancer and how and why it develops than we did 20 years ago. We know that the vast majority of cervical cancers occur as a result of the body failing to heal itself from infection by one of dozens of human papillomaviruses (HPV) that women become vulnerable to once they become sexually active. We know that most HPV infections clear spontaneously – 70% of infected women have got rid of the infection within one year, and 90% have got rid of it within two years. We know that two types of the virus are responsible for about 70% of cases of cervical cancer – HPV16 and HPV18 . We also know that it takes around 15 years for cervical cancer to develop if the body fails to deal with the infection. When the National Cervical Screening programme was established in the early 1990s around 90 women died of cervical cancer in New Zealand every year. Over the past 18 years that figure has dropped to 60. 2 HPV Vaccines The HPV vaccine is one of the most expensive vaccines ever to come onto the market. It is one of the first vaccines to be designed to prevent a cancer that is caused by a virus – the Hepatitis B vaccine was the first. In this case both the HPV vaccines now on the market have been shown to be effective against HPV16 and 18 – the two that are responsible for around 70% of all cervical cancers. Until Friday 1 August 2008 I was under the misconception that to be effective the vaccine needed to be given before teenagers become sexually active. On Friday I listened to an interview with Dr Diane Harper, one of the lead researchers on the vaccine who said the vaccine is just as effective when given after a woman has become sexually active, and even if she has already got infected by one of HP viruses. The difference between the two HPV vaccines is that Gardasil which was developed by CSL and marketed by pharmaceutical company Merck has been shown to be effective against HPV16 and 18 as well as two others, HPV6 and 11 which cause genital warts, while Cervarix which is marketed by another pharmaceutical giant, GSK, is effective against HPV16 and 18 alone. The New Zealand government has opted to use Gardasil rather than Cervarix. In the UK the Department of Health recently announced that it had decided to use Cervarix for their HPV vaccination programme which is scheduled to begin in September. It says it will save up to £18.6 million by using Cervarix which is equally effective against HPV16 and 18, but doesn’t include the two types that cause around 90% of cases of genital warts. The Cartwright Issues Surrounding Gardasil I now propose to examine the introduction of Gardasil into a vaccination programme for young teenage girls from a Cartwright perspective. • Informed Consent As I have already mentioned I regard informed consent as a key issue: - in what happened during the “unfortunate experiment” at National Women’s Hospital in the 1960s and 1970s, - in the recommendations contained in the Cartwright Report, - in the establishment of the Office of the Health & Disability Commissioner, - in the development and enshrining in legislation of the Code of Consumers’ Rights. And before we go any further I first want to acknowledge that women paid a very high price what we have in place today – the Cartwright Inquiry revealed 3 that many women died needlessly of cervical cancer, not knowing they had been part of an experiment at NWH. So how does informed consent work in the current medical and social environment? And how will the need to obtain informed consent be met with respect to this particular vaccination campaign? Of major concern to me is the Ministry of Health’s history when it comes to vaccination campaigns. This is one area where the Ministry has repeatedly abandoned any pretence of adhering to the legal requirement to obtain informed consent. Let me give you a recent example. The MeNZB vaccination campaign which the Ministry recently announced was now officially over. As a mother of a primary school- aged boy, I got the Ministry’s information on meningococcal B and the MeNZB vaccine. Three and a half years ago I attempted to find out as much as I could about this particular vaccine and what the risks of my son catching meningococcal B actually were. I must admit my efforts to obtain the information I needed to make an informed decision were spectacularly unsuccessful. So I made an uninformed decision. Several weeks ago I stumbled upon some information on the University of Auckland’s Immunisation Advisory Centre’s website about the MeNZB vaccine that shocked me. The one-page information sheet for health professionals was put on the website two or three months ago. I learned that only 75% of young children developed a successful immune response after 3 doses of the vaccine; that only 53% of babies who start their 3-dose MeNZB vaccinations at 6 weeks developed the level of immunity needed to protect them from the disease, that the immunity lasted for less than 7 months in young children and only slightly longer than that in older children. In other words all those under 20-year-olds who were vaccinated with the MeNZB vaccine between 2004 and 2007 no longer have any immunity to the disease. It has been estimated that the hundreds of millions of dollars spent on this vaccine prevented 54 cases of meningococcal B disease and 1.7 deaths. In consulting with a number of parents who had had their children vaccinated with MeNZB I discovered that all of them believed that their children were protected from getting this disease for decades – if not for life. My point is this – how long the immunity that a vaccine provides lasts is an important piece of information parents should be told and it should be part of the informed consent process. For MeNZB it could mean the difference between life and death if a parent saw signs of the disease in their child but did not seek medical help soon enough because they believed their child was still protected by the vaccine. 4 But how long vaccine-induced immunity lasts is not usually part of the information that the Ministry is prepared to divulge.
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