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We advocate nationally for quality accessible healthcare for patients with Lyme and other tick-borne diseases. We are committed to shaping health policy through advocacy, legal and ethical analysis, education, physician training and medical research. We communicate our message in print and online. We connect and educate the patient community through net- working and state online support groups. We take the pulse of the Lyme community through patient surveys. We analyze and archive information in our quarterly journal, The Lyme Times, and maintain an educational website at www.lymedisease.org. We publish regularly in peer-reviewed medical and health policy publications. Online Support Groups Participate in education and advocacy activities in your state. Learn about local resources and receive technical support for your efforts. Exchange information and patient support conveniently from your home. To find your own online state-based group, go to: health. groups.yahoo.com/group/(yourstatename)lyme. Website Visit our extensive educational website at www.ly- medisease.org. Discover the basics at Lyme 101, read news and analysis, and check the events calendar. Sign up for our free email newsletter. Facebook Keep on top of developing news and share your own experiences and opinions by joining the conversation on our Facebook page: facebook.com/lymedisease.org. Twitter • Receive our tweets on your phone or computer. Follow us at: twitter.com/lymenews. Join the Effort Participate in the Lyme community and make our col- lective voices even stronger. Visit www.lymedisease. org or complete the membership form in this issue.

The Lyme Times Contents NEWS & EVENTS COLUMNS 4 Advocates in Action 2 Editorial Patients Make a Difference “Curiouser and Curiouser” 6 Federal Legislation By Phyllis Mervine Congress Advances Lyme Agenda Back Lyme Policy Wonk 7 State Legislation Patient-Centered Research Navigating the Legislative Minefield By Lorraine Johnson 8 Advocates in Action DEPARTMENTS Lyme Education Via Public TV 3 Opinion 18 LymeDisease.org Online Advocate Disputes Anti-Science Label Spotlight on the News: ILADS Education By Sherrill Franklin Campaign, Borrelia miyamotoi 16 Legal Analysis Highlights from the Blogs: Patient CT Court to Review Jones Case Survey, IDSA on Facebook By Lorraine Johnson 20 Conferences 16 Patient Voices LDA and ILADS 2011 Proceedings My Time with Lyme FEATURES By Sally Jordan 9 Medical Board Backs Down 26 Research Review Advocates Rally Behind Beloved Lyme Doc Chemokines as Biomarkers By Monique Dubos By Bonnie Sgarro 10 Embers Monkey Study 28 Lyme Basics Spirochetes Persist in Treated Monkeys Testing for TBDs 14 National Guidelines Clearinghouse By Phyllis Mervine Petition Protests IDSA Guidelines 30 Patient Voices 17 Interview: Pollack Pursues Higher Standards Lyme Steals Singer’s Voice By Erica Xenne By Lorraine Johnson 27 Interview: Citizens Stop Texas Board 32 Ask the Expert 12 Hot Topics in 2012 By R. Timothy Haley By Jerry Simons

CALENDAR

May 6, 2012. Westin Hotel, San Diego, CA. Lyme- istration information coming soon at gibson.house.gov. Disease.org will present Richard Horowitz and a panel of Sept. 29-30, 2012. The national Association Lyme-treating doctors, including Therese Yang, MD; Erica (LDA) and Columbia University College of Physicians and Lehman, MD; and Neil Hirschenbein, MD. For more in- Surgeons will sponsor the annual Lyme & Tick-Borne Diseases formation and to register, visit lymedisease.org. scientific conference at the Hyatt at the Bellevue in Philadelphia. May 21, 2012. Skidmore College, Sarotoga Springs, NY. For more information and to register, visit lymedisease.org. "A Forum on Tick-Borne Diseases – What's NEXT?" hosted Nov. 2-4, 2012. The International Lyme and Asso- by NY Congressman Chris Gibson, a sponsor of HR 2557. ciated Diseases Society (ILADS) Annual Lyme Disease Speakers include Pamela Weintraub, Daniel Cameron, MD; Conference will be held at the Westin Boston Waterfront Lorraine Johnson, JD, MBA; Holly Ahern, Richard Horowitz, Hotel in Boston. For more information, visit ILADS. MD; David Leiby, MD; and Edward Breitschwerdt, MD. Reg- org or email Barbara Buchman at [email protected].

Volume 24 Number 1 1 DEPARTMENT - Editorial

The Lyme Times www.lymedisease.org VOLUME 24, NUMBER 1 “Curiouser and Published by LymeDisease.org Library of Congress No. 92-595999 Curiouser!” Production Staff Editor in Chief: Sometimes I feel like Alice when she Phyllis Mervine, EdM went down the rabbit hole and drank Managing Editor: the contents of a very small bottle. Pamela Cocks, MPH, MLS So we waited 11 years for the results of the Contributing Editor: Embers study to prove what we thought was true all R. Timothy Haley, MA along. The publication of the Klempner study was Mental Health Editor: expedited, if you recall, so that patients wouldn’t Sandy Berenbaum, LCSW, BCD get another extra minute of “ineffective” . Online Editor: Dorothy Kupcha Leland Unfair? Maybe. But worse is that the denialists Sponsorship Manager: are prepared to dismiss the Embers results, too. Susan N. Wolf, MBA The monkey trial, designed to parallel the Graphic Design: Jay Gamel Klempner clinical trials, proves beyond a reasonable doubt that Borrelia Graphics/Illustrators: burgdorferi spirochetes persist post-treatment. But while Klempner’s con- Michele D. Lott & Marc Ratner clusions are used to deny extended treatment to people with chronic Lyme, Embers demonstrates that the standard recommended treatment protocols Membership Correspondence: may indeed be “too little, too late,” as Lyme expert Daniel Cameron suggests. P.O. Box 5658, Marysville, CA 95901 Read Lorraine Johnson’s commentary and analysis beginning on page 10. U.S. funds only. Reasonable people might expect the new evidence of persistence to resolve Editorial Correspondence: the debate about chronic Lyme. But they would be wrong. This debate has P.O. Box 1423, Ukiah CA 95482 gone past reason. In fact at this point it’s difficult to imagine any evidence at [email protected] all that will ever convince the denialists that Lyme is a chronic infection. Original articles preferred. In fact, Gary Wormser, chief architect of the IDSA Lyme guidelines, has a whole new theory – the “amber” phenomenon – just published in Clinical LymeDisease.org Rheumatology. Based on a case study of one patient, he proposes that bacteria Chief Executive Officer: are present, but they are sequestered in some kind of matrix – like bugs em- Lorraine Johnson, JD, MBA bedded in amber – and not viable. From time to time some spirochetal material Chairman: Phyllis Mervine, EdM may be released into a joint space and cause inflammation, he suggests. Since Vice President: Dorothy Kupcha Leland there is no “active infection,” it follows that it’s no use treating with antibiotics. Secretary: Barbara Barsocchini, MBA When the results of the Fallon study were published showing that longer Treasurer: Mitch Hoggard treatment helped some patients, the Lyme denialists didn’t agree. Now they Staff: JoAnne Vidal are saying that the presence of spirochetes does not prove they are causing disease. Then what are they doing, we ask? And why are people still sick? Disclaimer It is not far-fetched to imagine this speculative “amber” hypothesis being The articles in The Lyme Times are not intended as used to postpone effective treatments for another 11 years, or longer. legal or medical advice regarding the treatment of any symptoms or disease. Medical advice of your Occam’s razor – the simplest answer is most likely correct. The desperately personal physician should be obtained before pursu- contorted theorizing of the Lyme deniers still leaves sick patients neglected and ing any course of treatment. The Lyme Times makes medicine at increased risk of loss of professional credibility and trust in doctors. no express or implied warranties as to the efficacy or The IDSA guidelines have ruined enough lives. Please put up safety of any treatment in its articles or letters and the poster in your community and ask friends and family to sign disclaims all liability for any use of any such treat- the petition on our website. See page 14-15 for details. ment. Opinions expressed in articles are those of the authors alone and are not necessarily those of The Lyme Times or LymeDisease.org. Publication of any portion of The Lyme Times without written permission is pro- hibited. Please contact the Editor in Chief if you wish to duplicate articles. © Copyright 2012 LymeDisease.org

2 The Lyme Times DEPARTMENT - Opinion Advocate Disputes Anti-Science Label Franklin calls IDSA guidelines misleading and out-of-date By Sherrill Franklin I read with interest the Infectious with H.pylori and then cured Disease Society of America’s (IDSA’s) himself with antibiotics to opinion piece, “ and prove his theory. Certainly a ethical concerns associated with ad- cross-section of IDSA Board vocacy of Lyme disease.”1 members would be willing I concede there are a few mercenaries, to follow suit by partici- quacks and outliers within the so-called pating in similar research with Lyme community – but this is an un- Lyme disease and multiple fortunate side effect of the IDSA’s bitter co-infections. If it is “hard medicine that denies the reality of tick- to catch and easy to cure” borne illness. To suggest Lyme patients as they say, why not do it? are of like mind with AIDS deniers and In the meantime, the IDSA anti-vaccine groups is bizarre at best. But need not worry that the “an- while we’re trading analogies, here’s one: noying” discoveries of the Like the Society and Lyme community are making other organizations whose best days inroads. Many physicians are are behind them, I think the IDSA is still telling patients who have sincere and they truly believe their dinner-plate size bull’s eye theories formulated 30 years ago, when rashes that they have been Lyme disease was considered a single bitten by spiders and they emerging infection. In those 30 years, should take ibuprofen and forget about the IDSA screening movies for ac- they have stayed on message, repeating it. The IDSA has made sure most phy- ceptability. The IDSA compromises the same old research, getting the same sicians are unaware that the test is no its own credibility with such antics. old answers – most of it on the tax- better than a coin toss. Most doctors Instead, they should focus on the threat payer's dime through grants from NIH. still don’t know that many people don't of the sometimes-deadly tick-borne, ma- It’s no wonder that Lyme specialists, get bull’s-eye rashes. They don't know laria-like illness – – as it slithers researchers and patients are branded that the bull’s-eye is proof positive into the U.S. blood supply, undetected. as troublemakers with their persistent of Lyme regardless of test result. Much more time, and funding questions and new discoveries that call They’ve never heard of Babesia or needs to be directed toward creating re- the original dogma into question. Bartonella and certainly have no idea liable tick-borne disease tests and into It wasn’t long ago that Nobel prize about treatment for these debilitating ill- researching comparisons of treatments, winner Dr. Barry Marshall was reviled by nesses. Persistence of the IDSA’s dogma particularly when patients have one or the medical establishment as he tried to has been successful on the grand scale. more co-infections. Fascinating discoveries discuss evidence of Helicobacter pylori as If doctors were properly informed about the role of over two dozen strains of the cause of gastritis and peptic ulcers. and patients were properly treated, Bartonella in causing human and animal In 1984, Dr. Marshall infected himself the IDSA’s concerns about illnesses also need far more support. overuse wouldn't be necessary because I think we all long for enlightened these illnesses would have been re- and visionary leadership in public life solved correctly at the outset. and in the medical arena. Sadly, we And finally, the IDSA need not spend have a long way to go on both counts. any more of its valuable time contacting The author can be reached by public broadcasting outlets and met- email at [email protected]. ropolitan newspapers trying to cut off access to documentary films like Reference “” that they don't want Auwaerter PG, et al. Personal View: Anti- science and ethical concerns associated with the public to see – as if we are naïve advocacy of Lyme disease. The Lancet In- children who can’t function without fectious Diseases, (2011, 11; 713-19)

Volume 24 Number 1 3 NEWS & EVENTS - Advocates in Action Patients in 12 States Make a Difference Arkansas Georgia Georgia Lyme Disease Association (GALDA) President Liz Schmitz was a guest on The Dr. Melanie Show on VoiceAmerica radio. New research data confirms the South- eastern United States has infectious sensu stricto strains and several other Lyme borrelia species, in- cluding the newly-identified Borrelia kurtenbachii, as well as Borrelia bissettii - species that may be human pathogens. GALDA is working to determine what tick species bite humans in the Southeastern USA by joining forces with Lyme groups in surrounding states to promote a “Save the Tick” campaign. If a tick bites you, save it in a plastic baggy in your freezer with an index card with name, date, and body location of the bite (arm, upper leg, etc.) plus the county and state name. GALDA is planning a Lyme and Tick-Borne Disease Awareness Month Program at the State Capitol on May 2, 2012. Tick-borne disease researcher Dr. Kerry Clark will be the special guest speaker.

Annette Sharp photo Kansas Six year-old Kason Henderson of Hooks, TX, grandson of ArkLATEX activist During 2011, the Lyme Association of Greater Kansas City had Annette Sharp, is a great Lyme advocate. He can tell you in a minute that Lyme information booths at 16 health fairs and 15 medical conferences is a controversy because he saw his own Nonny sick, Annette says. and gave literature packets about TBD’s and tick removers to several hundred doctors and nurses. LAGKC volunteers attended the Kansas Association of Schools and the American Academy of Family Physicians’ annual National Conference of Residents California and Students. They also gave a presentation at the Kansas As- LymeDisease.org organized LymeWalks in several cities around sociation of Osteopathic Medicine’s conference for Primary the state to raise funds for research. [see photo on next page] Care doctors. Visit the LDAGKC website at lymefight.info. In Placer County, the Mosquito and Vector Control District surveillance picked up an increase in the tick population since Maryland the late fall. After finding positive tick samples, they warned Jean Galbreath has been a volunteer educator and support the public that ticks are capable of infecting humans with the group leader for the past 16 years, says Lucy Barnes, Director of Lyme disease pathogen even when temperatures are colder. the Lyme Disease Education and Support Groups of Maryland. Volunteers with the Sierra Foothills Lyme Disease Group Galbraeth is the original founder of one of the longest-running presented a showing of “Under Our Skin” at Sutter Auburn volunteer Lyme disease groups in the country, Harford County Faith Hospital, followed by a question and answer session Lyme Disease Support Group, Inc. The non-profit group is an af- to a packed audience. In the evening, Dr. Raphael Stricker filiate of the national Lyme Disease Association. Galbreath has gave a presentation on "Controversies In Lyme Disease Di- also been a member and supporter of LymeDisease.org (formerly agnosis and Treatment” to 75 doctors and healthcare pro- CALDA) for many years. Helping people with Lyme disease not viders. Both events were well attended and appear to have only became Jean’s passion years ago, it became her way of life. This spurred further interest from the medical community. mother of three and grandmother of seven travels up and down the east coast with William, her husband of 57 years, to medical and Florida scientific conferences to learn the latest developments in the field In November, the Northeast Florida Lyme Asso- of TBD’s. She is the “go-to” person for many. No one can figure out ciation held an event at the Univ. of North Florida Fine how she does it, but after all these years, she just keeps on ticking! Arts Center. They showed Under Our Skin and raised funds for research. According to The Florida Times-Union, Massachusetts Shirley Hartman, a Jacksonville family physician. The Martha’s Vineyard Gazette reports that new surveys and has sent samples from about 150 people who came to her com- interviews on the island and on ferries indicate serious under- plaining of Lyme-like symptoms and has found Lyme antibodies reporting of TBD’s. A team of researchers presented results at the in about 75 percent. Visit NEFLA.org for more information. regional high school showing early statistical evidence of high rates of Lyme: in 2010, Island pharmacies filled an estimated 1,080 prescriptions for for new cases of Lyme. By

4 The Lyme Times NEWS & EVENTS - Advocates in Action

Texas At their February meeting, the Texas Medical Board (TMB) ap- proved a draft proposal for Continuing Medical Education (CME) and other rules related to legislation passed in the last session. When the TMB president requested that any CME be based on IDSA recommendations, the TMB executive director explained that this restriction was in conflict with the intent of the legislation. Subsequently, they accepted all the language recommended by the working group and the Texas Lyme Disease Association (TXLDA). The bold banner proclaiming “Give Lyme the Boot!” captured much attention at the colorful Fall Marketplace in Canyon Lake in October. Booths of all kinds drew a crowd of several hundred people. Many stopped by the TXLDA booth to catch a glimpse of Under Our Skin playing on a laptop, and to pick up Lyme literature. Sarah Mayhew photo Virginia Maci Mack and Jordan Christ, wearing lime-green T-shirts, carry the The Loudon County Board of Supervisors unanimously passed LymeDisease.org banner at the Sacramento Lymewalk in September 2011. the Lyme Disease Prevention Initiative, which calls for spraying County parks by May 11, creation of a Lyme Disease Com- contrast the CDC officially counted 25 cases meeting the sur- mission and a public awareness campaign to encourage private veillance definition. The researchers were upset by this dis- property owners to spray. They also agreed that the Loudoun crepancy. They also suggested allowing pharmacists to dispense a Health Council should advise physicians on how to identify single dose of doxycycline – without a prescription – as a pro- early onset of rashes and ailments. Virginia already has a Gov- phylactic. They recommended that the Island establish a ded- ernor’s Task Force, created in 2010, and legislation that perma- icated TBD health care worker to assist providers with reporting nently designates May as “Lyme Disease Awareness Month.” and to improve education in the community, particularly among high-risk workers as well as for tourists and casual visitors. Wisconsin New Jersey Teenager Deanna Warman asked that guests to her 13th birthday party forget gifts and make a donation for Lyme disease research instead. The donations of 70 party guests added up to $2,000 which the Warmans decided to give to the Uni- versity of New Haven's (UNH) Lyme Research Program. According to Deanna's mother, the teen came up with the idea for a fundraiser birthday party after watching her older sister, Alyssa, cope with Lyme. The Warmans later traveled to UNH, where Deanna presented the $2,000 to Dr. Eva Sapi, an as- sociate professor of biology and environmental sciences, who is researching better testing and treatment for Lyme disease. Oregon OLDN has been tracking numbers. Their survey found that of 67 patients clinically diagnosed with supportive laboratory evidence of Lyme, only 12 were diagnosed in Oregon. Of those 12, seven were not counted because the reference infectious disease physician decided that the ELISA tests were false positives. A 2004 OLDN survey showed that of 32 patients with positive Western blot tests and clinical symptoms of Lyme, 24 lost their full-time employment, and were either disabled or able to work only part-time. Since then, two of these pa- tients died with complications related to Lyme disease. Bonnie Fox photo The Mortality and Morbidity Weekly Report for Oregon Sisters Jessica, Jennica and Jassmyn Warner handed out candy to children while showed 38 confirmed cases of Lyme in 2008 and 2009. “Yet we the adults distributed literature. Eleven-year-old Jessie was the “Lyme Queen” support over 1,000 clinically and laboratory-positive patients because she has Lyme; the other two were princesses. The floats, sponsored by with advocacy work,” states OLDN director Theresa Denham. members of the Western Wisconsin Lyme Education & Support Group, were in parades in three rural towns.

Volume 24 Number 1 5 LEgiSLATioN - Federal Congressman Pushes Public Hearing In his March 2012 newsletter to con- (including patient groups) that deal as may be necessary” for each of the fiscal stituents, Congressman Christopher with Lyme disease policies years 2012-2016, but it does not provide Smith (NJ) announced a public hearing • Advise agencies on priorities any. According to LDA’s Ms. Smith, this on the global health problem of Lyme concerning tick-borne diseases is due to the current fiscal situation in and other tick-borne diseases to be held • Minimize overlap of activities Washington and Congress’ reluctance to “in the next couple of months.” Cong. • Ensure broad spectrum scientific provide new money in general. Both bills Smith is chairman of the US House viewpoint represented in public health provide small amounts for the operational subcommittee which includes global policies expenses of the committee itself: $250,000 health and human rights within its ju- per year in the House bill, and “such sums • Advise Health and Human Services risdiction. This will be the first hearing as may be necessary” in the Senate bill. (HHS) concerning ongoing activities in the nation’s capitol on the interna- Patients can use convenient tools at and what needs to be accomplished tional impact of tick-borne diseases. LymeDiseaseAssociation.org to ask their Days later, Senators Richard Blu- According to national Lyme Disease Representatives to co-sponsor House bill menthal (CT) and Kirsten Gillibrand Association President Pat Smith, HR 2557. Find your senators and Congressman Smith has been other legislators at contac- the US House of Representatives’ tingthecongress.org or consult Lyme Caucus Co-Chair for your local telephone directory. several years and has facilitated many meetings with Lyme ad- Money and “chronic vocates and governmental of- Lyme” language ficials and the military in DC. Some new funding for the Cong. Smith said the hearing Centers for Disease Control “will examine the scope of the and Prevention (CDC) has worldwide problem of tick-borne already been allocated toward diseases, current and emerging development of sensitive and science and technologies, more accurate Lyme tests and and impacts on patients.” other Lyme issues through Advisory Committee the 2010 Health and Human Services (HHS) appropriations, In July, 2011, Cong. Smith (NY) introduced Senate Bill 1381, es- which included $8,938,000 introduced HR 2557, the latest version for CDC, a $3,668,000 increase. of a Lyme and tick-borne diseases bill, tablishing an advisory committee using language almost identical to the House Cong. Smith developed the language, with Congressmen Frank Wolf (VA), and House Appropriations Committee Tim Holden (PA), and Chris Gibson bill. It also includes other language similar to last year’s Lyme bill. It provides Chair, David Obey (WI), along with Com- (NY) as original co-sponsors. mittee members Frank Wolf and Nita The legislation directs the Secretary (with no additional funding) for the ex- pansion of Federal efforts concerning Lowey (NY), were instrumental in its in- of Health and Human Services (HHS) clusion and passage. The Lyme community to establish a Tick-Borne Diseases Ad- the prevention, education, treatment, and research activities related to Lyme was helpful in making this happen. visory Committee within the Office of the The CDC awarded grants to a number Secretary with carefully selected mem- and other tick-borne diseases. In ad- dition, it adds this paragraph: of researchers with these funds, and edu- bership drawn from the full spectrum cational and scientific projects have been of the medical debate. It makes a special … (2) in coordination with relevant agencies within the Department of underway as a result. Both House and point of recognizing the two standards Senate Appropriations language used the of care for diagnosis and treatment by Health and Human Services, regularly review published public and private “” and “persistent requiring the HHS to ensure that the infection” language in appropriations committee members, as a group, “rep- treatment guidelines and evaluate such guidelines for effective represen- bills that year to direct federal agencies resent a diversity of scientific perspectives in their respective roles on Lyme disease. relevant to the duties of the Committee.” tation of a wide diversity of views. Unlike its predecessor, the House bill The House-Senate Conference report for The Lyme Disease Association (LDA) 2012 Health and Human Services (HHS) website summarizes the duties of the (17 co-sponsors) does not ask any new funding for Lyme research. Blumenthal’s Appropriations included the same above Committee contained in the House bill as: language and $8,773,000 for the CDC. • Communication among government Senate bill (9 co-sponsors) states there is agencies and constituency groups authorized to be appropriated “such sums

6 The Lyme Times LEgiSLATioN - State Patients Navigate Legislative Minefield Advocate groups promote good bills and work to kill bad one Physician protection chusetts, House Post Audit and Oversight year to name the members of the Com- Committee chairman David P. Linsky mission. Advocates were successful in As a result of successful advocacy called Lyme “a public health crisis.” The getting the Commission to add Bartonella efforts over the years, five states now report recommended establishing a com- as a tick-borne agent to be studied. Four have laws designed specifically to mission to investigate the incidence and other Lyme bills were introduced; one protect doctors who treat Lyme pa- impact of Lyme and other tick-borne in- of them, H.329 is broadly worded to tients: California, Connecticut, Massa- fections in Massachusetts. Linsky also in- require testing and long-term treatment chusetts, New Hampshire, and Rhode tended to create a Lyme Research Center coverage. The bill is stalled in committee. Island. Two other states have adopted at UMass Medical Center, but advocates Virginia. Advocates successfully estab- non-legislative physician protection met with him, concerned that UMass lished a task force providing a balanced measures: Minnesota and New York. would not be Lyme-friendly. Luckily assessment of the management of Lyme. Maryland. Legislators have introduced Linsky accepted several suggestions for Town hall meetings around the state several bills. Senate Bill 891 would allow the wording and agreed to drop the re- allowed patients and experts to present doctors to make a clinical diagnosis without search center. The bill was signed into testimony. A position paper was pre- support of positive tests and would prohibit law as an amendment to the 2011-2012 sented to the state executive branch. (see a negative test from being admitted as ev- fiscal year budget. The 21-person com- The Lyme Times, 23-2). Current status: idence in several contexts. Other bills allow mission established by the bill includes, The position paper is widely available certain state employees to obtain worker’s among others, two public members who to view and distribute. Potentially, the comp if they contract LD on the job. are patients or family members of patients; Governor has the ability to issue ex- Advisory committees one professional member of ILADS; and ecutive orders or recommendations. Massachusetts. In April, 2011, an- two members of advocacy organizations Pennsylvania. Advocates have been nouncing a report on Lyme in Massa- representing diverse regions of the com- trying for years to pass legislation guaran- monwealth, however they have taken all teeing insurance coverage for Lyme, giving doctors who treat chronic Lyme protection. Legislators just announced an amendment to the insurance and doctor protection bill, SB 210, transforming it into a task force bill to include members from ILADS, in- fectious disease specialists as well as others. One killed Oregon. Advocates took action against proposed legislation intended to address insurance coverage for Lyme patients. They educated their House Health Care Committee and explained the unin- tended consequences of the flawed bill. The bill was successfully killed. One of a kind Texas. Working with patient ad- vocates, legislators passed a bill em- powering the medical board to adopt rules establishing the content of and approval requirements for continuing medical education for treating TBDs. It LDA photo further specified that such rules must (L-R) A Lyme patient, LymeDisease.org CEO Lorraine Johnson, JD, MBA, and Lyme Disease Association provide for continuing medical edu- President Pat Smith, met with Cong. Smith’s Legislative Director Tim Lynagh in February. According to Pat cation courses (CME) covering a relevant Smith, Cong. Smith has been a staunch advocate for Lyme issues since the early 1990s. He introduced the spectrum of clinical treatment for TBDs. first bill devoted fully to Lyme disease in 1998 and also subsequent versions of that bill.

Volume 24 Number 1 7 NEWS & EVENTS - Advocates in Action Using TV for Lyme Education Patients can ask public channels to run Lyme DVDs Consider a community project to educate Now there is a sure-fire way for patient Your Game Plan your community about TBDs during advocates to start an educational “brush 1. Identify your local public access Lyme Disease Awareness Month in May. fire” by involving community-based cable channel and set up a meeting with Scientific evidence confirms what pa- TV outlets in a Lyme disease education the station manager or programmer. tients have known for the past 30 years: program for their communities. Quick 2. Download and print out a flier Lyme disease is complicated and per- action can make this a reality in May on Lessons in Lyme and take it sistent disease is not rare. This simple 2012 – Lyme Disease Awareness Month. with you to your meeting. Background 3. Provide the station a few facts about Written by Elizabeth Maloney, MD, TBD’s in their community and the Lessons in Lyme is an educational series importance of providing accurate on Lyme and other tick-borne illness that public information. Encourage the explains basic scientific concepts in ev- station to purchase the DVD, What eryday language. Each segment addresses Everyone Should Know about Lyme a different topic in detail – complete Disease; for $22 they will get 100 on its own. The series provides an op- minutes of programming that can portunity to develop a deeper under- be repeated as they like. Provide standing of the complexities of Lyme. them a copy of the DVD to preview, • What Everyone Should Know which they can purchase once they About Lyme Disease: a general proceed. Local groups or indi- overview of Lyme and related topics. viduals may decide to underwrite • Preventing Lyme Disease: reviews the cost of the DVD for the station. the steady increase in cases of Lyme 4. Encourage advocates to alert plus details of disease transmission. the public when the program • Borrelia burgdorferi - A Brilliant is scheduled to air. Ask local Bacterium: an in-depth look at media to run public service an- Betty Maloney, MD, author of Lessons in Lyme the bacterial cause of Lyme. nouncements for the showing. Local cable providers allow public 5. Publicly thank the station for sup- access to local markets via ded- porting your public education project. icated channels. Programmers for Please visit phhmd.com/products to message is often diluted by other media public access channels are often re- learn more and place an order. Contact priorities or drowned out by pro- sponsive to community requests to [email protected] if you have addi- ponents of the IDSA perspective. broadcast a public service message. tional questions about the series. Lyme-TAP Financial help for diagnostic testing Lyme Test Access Program (Lyme- Insurance deductibles are not covered. at IGeneX. Please consider supporting TAP) is a nationwide patient assistance Testing may be done at any CLIA/ Lyme-TAP by making a donation. program helping patients with financial Medicare-licensed laboratory of your Questions need pay for initial Lyme-related labo- choice. Funds are limited and available ratory tests. It is offered by the Ferndale on a first-come, first-served basis. Contact [email protected]. Foundation (501c3) in coordination Children under 18 are given priority. For further information, eligi- with Lyme Patients Assistance Group. The program is designed to help as bility requirements and applications If qualified and approved, patients may many patients as possible thanks to Visit www.lymetap.com be reimbursed for up to 75% of the out- a generous donation from IGeneX, a or write of-pocket costs of diagnostic testing. Pa- CLIA/ Medicare-licensed laboratory. Lyme-TAP, P.O. Box 2238, tients must demonstrate a financial need. Patients are not required to be tested McKinleyville, CA 95519

8 The Lyme Times FEATuRE - Advocacy Wisconsin Medical Board Backs Down Online groups help patient advocates rally behind beloved Lyme doctor By Monique Dubos This winter, over 1,000 Lyme patients attorney to begin the appeal for rein- and a hearing date was set for January 18. across the state of Wisconsin mobilized statement of his license. The new attorney Since the beginning of the ordeal, one to rescue their doctor – and themselves. required a retainer of $5000, and a defense patient had been collecting photos and Dr. John Hoffman, or “Doc” as he is fund was set up to accept donations. comments from many of Doc’s patients often called, had been treating chronic to be compiled into a scrapbook. Toward Lyme disease in rural Wisconsin for three the end of December, the scrapbook was decades, often taking patients “from given to Doc. He was “speechless and wheelchair to walking,” as one patient ad- emotional” at the outpouring of support. vocate described it. In early November As the appeal date approached and 2011, Doc got a letter that would threaten anxieties mounted, patients began phoning the well-being of hundreds of patients who medical board directors individually. The relied on his years of experience and skill. board president sent a letter to the group A prosecuting attorney from Wis- explaining that direct contact with board consin Department of Safety and Pro- members could interfere with the appeal fessional Services, responding to a less- process. A week before the appeal, rumors than-glowing assessment of Doc’s medical started to emerge about a date change, know-how from the U Madison School which proved to be false. The hearing of Public Health, was recommending that took place as scheduled, with about six the medical examining board suspend patients testifying in support of Doc. Doc’s license. Patients believed Doc was Later in the day, one of the online on the ropes for treating chronic Lyme. group moderators posted a message: Within hours their online support group – Monique Dubos photo “The WI Med Board has endorsed the where, on any given day, dozens of patients Hundreds of patients on the LymeDisease.org Agreement reached by the DSPS and trade advice or commiserate – was trans- online group WisconsinLyme rallied to defend their Dr. Hoffmann's attorney. Dr. Hoffmann formed into a campaign headquarters. “Doc” Hoffman when the medical board revoked his will be able to resume practice.” license to practice medicine. Advocates began organizing the of- There were several conditions and re- fensive aimed at the state medical board strictions, but Doc was back in the saddle – that would decide his fate. A hearing at least for now – and his patients were safe. of the board, during which a decision With Doc’s license suspended hundreds would be made about Doc’s license, of patients were left without their primary was scheduled for November 16. care physician. They needed to find another The first salvo was a petition started practitioner who would understand the LymeDisease.org on Change.org. Within nine days, 2,000 complexities of Lyme and be willing to Patient Conference Lyme patients from Wisconsin and other prescribe much-needed antibiotics. states signed the petition. Many signers Panicked patients inundated Doc’s office. Date: Sunday, May 6, 2012 pleaded with the medical board: A couple of group leaders, patients them- Location: Westin Gaslamp “We must have the freedom to have selves, began organizing, sifting through available for hope hundreds of patient files trying to connect Quarter, San Diego, CA when no one else will help,” and “My patients with other doctors around Keynote: Richard Horowitz, MD daughter would not be alive today if the region. In some cases, they tried to Dr. Horowitz, a founding member it was not for Dr. Hoffman’s care.” convince the new doctor to lower fees or of ILADS, has treated over 11,000 Days before the hearing, Doc Hoffman’s accept insurance. They emphasized that chronic Lyme patients over the patients heard that an agreement had the new doctor would need to continue been reached and he would not lose his the treatment regimen prescribed by Doc. last 20 years. He conducts re- license. Unfortunately, it wasn’t true. The At the same time, Wisconsin patients search, publishes and lectures in- next day, the group moderator posted were sending letters to the state and their ternationally on Lyme and related a message that Doc’s license had been legislators explaining why it was of utmost co-infections. For more infor- suspended. After what seemed like a importance that Doc’s license be rein- backroom betrayal, Doc enlisted a new stated. One patient filed an official appeal mation, visit lymedisease.org

Volume 24 Number 1 9 FEATuRE - Embers Monkey Study Spirochetes Persist in Treated Monkeys Study proves failure of short-term antibiotics and insensitivity of C6 antibody tests By Lorraine Johnson, JD, MBA For years, the IDSA has used the to assess the persistence of infection in The problem with proving otherwise, clinical trials by Klempner et al to monkeys infected with Bb. Their treatment however, is that some experiments cannot justify their position that long-term protocol was intentionally modeled after ethically be conducted on humans. But treatment for Lyme is ineffective and in- the Klempner trial involving humans. since animal studies allow invasive tissue fection does not persist. The IDSA also In fact, the idea of conducting such a sampling to be done, the Embers study claims that antibody tests used to di- agnose Lyme disease are accurate. But a parallel study in non-human primates by Embers finds each of these assumptions wrong. We now know that Bb persists in non-human primates after treatment. What does this mean for patients? The Embers and Klempner study were intended to be published around the same time, with Embers essentially fact checking Klempner. Instead, Embers was parallel study in monkeys was proposed was able to directly demonstrate per- published 10 years later and the findings by the advisory committee to the Kl- sistent Bb infection in monkeys. Rhesus of Klempner were used to deny Lyme empner trial to fact check the human macaques were chosen as the animal patients treatment. Why the delay? results. Carl Brenner of the National Re- model because they experience many of A summary of the LymePoli- search Fund for Tick-Borne Diseases, the key signs of human Lyme disease, cyWonk blogs on this subject follows. and Phyllis Mervine, President of Lyme- including (an in- Comments on the posts have been ex- Disease.org, were both patient members fection of the brain or nervous system). tensive, over 175 have been posted on of that advisory committee. The hope It is worth noting that persistent in- the blog. Check out the fireworks at ly- was that the results of the two studies fection, notwithstanding antibiotics, has medisease.org/news/lymepolicywonk/ would be published at the same time. previously been demonstrated in mice, lymepolicywonk-was-this-important- Study questions ponies, dogs and other animal models. lyme-study-hidden-for-12-years.html While not the same as humans, it is com- The researchers posed Background pelling that persistence has been shown three critical questions: consistently in different animal models. A study by Drs. Monica Embers, • Does the 28-day protocol for Animal studies remain our highest level Stephen Barthold, Mario Philipp and treating early-disseminated Lyme of evidence on the persistence until better colleagues was just published – 12 disease (defined as four months bio-markers for the disease are developed. years after it was conducted. It is the after inoculation) eradicate Bb or latest in a number of studies demon- does Bb persist notwithstanding this 28-day treatment failed 100% strating persistent infection in animal treatment? One portion of the study focused models. The findings hold enormous • Does the 90-day treatment protocol on whether 28 days of antibiotics can promise for patients. The original Kl- (30 days of IV Rocephin followed eradicate infection in early-disseminated empner trial, funded by the National by 60 days of oral doxycycline) for Lyme disease (defined as four months Institutes of Health (NIH), was intended treating late disseminated Lyme after inoculation). Five monkeys were to assess the efficacy of retreating pa- disease (approximately seven months inoculated with Bb, of which three were tients with chronic Lyme. NIH oversight after inoculation) eradicate Bb, or treated for 28-days with doxycycline, of the project was provided by Dr. Philip does Bb persist notwithstanding this the IDSA’s protocol for early Lyme. Baker. Using the SF-36 quality of life as- treatment? Findings: About one year after inocu- sessment, the researchers concluded that • Does the C6 antibody test accurately lation, intensive tissue sampling de- the 90-day treatment protocol did not measure active infection? termined that Bb persisted in all five significantly improve patient scores. animals notwithstanding short-term The Klempner trial and the Embers Advantages of animal model treatment – a 100% failure rate. At monkey trial were designed as tandem The IDSA guidelines deny that Bb in- four months post infection, 28 days of projects. The Embers team intended fection persists after antibiotic treatment. treatment with doxycycline appears to

10 The Lyme Times FEATuRE - Embers Monkey Study be insufficient to eradicate infection. direct measures of infection. Rather than tool since those with the infection will test 90-day protocol failed 75% detecting bacteria directly, they measure negative over time (false negative), as will antibodies produced by the patient’s anyone previously treated with antibiotics. Another portion of the study focused immune system to combat a specific germ, Embers, et al. hypothesized that the on whether 90 days of antibiotics (30 days a bacteria in the case of Lyme. When a C6 test became insensitive in the treated of IV Rocephin followed by 60 days of patient’s immune system fails to produce monkeys because the number of spiro- doxycycline) can eradicate infection in antibodies, the result is a negative lab test. chetes may have been reduced or had late-disseminated Lyme disease (defined Embers et al. evaluated whether the C6 become a dormant form of bacteria that as about seven months after inoculation). antibody test was capable of accurately de- does not produce the antigens necessary Of the 24 infected monkeys, 12 were tecting Bb infection in order to determine for accurate C6 results. No explanation treated with antibiotics for 90 days (as whether treatment cleared that infection. was offered for the insensitivity of the test in the Klempner study), and 12 were not Findings: For untreated monkeys, the on 50% of the non-treated monkeys. treated at all; one monkey in the antibiotic C6 antibody test detected active infection The insensitivity of the C6 antibody group died of unrelated causes. Of the four 100% of the time up to 27 weeks after in- test may apply to other antibody tests as uninfected control monkeys, two were oculation. Beyond 27 weeks, however, for well. It may explain why patients with treated with antibiotics and two were not. 60% of the infected monkeys antibody persistent manifestations of Lyme often After treatment, intensive tissue sampling response returned to baseline. In treated test negative. The Embers study suggests was conducted to determine whether Bb that patients may have persistent in- persisted notwithstanding treatment. fection despite negative results on an Findings: Bb persisted in approxi- “With any study, the antibody lab test. This is consistent with mately 75% of the infected monkeys in authors should separate other published evidence that com- spite of treatment with the Klempner mercial antibody lab tests for Lyme fail to protocol. This means two things. First, the findings from the detect disease roughly 50% of the time. antibiotic therapy works; not in all conclusions. Conclusions monkeys but in 25% of the monkeys Spirochetes persist with chronic Lyme disease. Second, the are interpretations The authors concluded that their studies fact that treatment fails 75% of the time of findings and “offer proof ... that intact spirochetes can suggests that other approaches should be persist in an incidental host comparable explored; for example, longer treatment interpretations are to humans, following antibiotic therapy.” durations as are used in other chronic subject to bias.” The study also found that the C6 an- infections; different antibiotics; combi- tibody test gave false negative results in nation antibiotics; and pulsed therapy. As all of those treated with antibiotics and the authors state: “[T]he use of variable monkeys, 100% returned to baseline in more than 50% of those untreated. and pulse-dosing regimens of antibiotics notwithstanding persistent infection. These findings are critical because may improve efficacy and this warrants This suggests that the C6 test is not they show that Bb infection may ac- testing in an appropriate model.” sensitive enough to detect active disease tually persist after treatment even Study allowed direct testing in those who have had the disease when antibody tests are negative. for more than a few months or who Another critical take-away from the Unlike Embers, Klempner did not es- study is that using a treatment approach tablish persistence through direct evidence have been treated for the disease. The Embers study also compared that may be efficacious for patients from tissue testing. Instead, researchers showing an EM rash is not appropriate for attempted to measure effectiveness of 90 the C6 antibody test with more direct measures of infection, including PCR, those who have had the illness for even a days of antibiotic treatment on humans short while longer, that is, four months. indirectly using the SF-36 quality of life culture, immunofluorescence (visual- ization of spirochetes in inflammatory More effective treatment options are survey. Although the Klempner study needed even for early-disseminated relied on negative blood PCR and blood lesions), and xenodiagnosis (allowing uninfected ticks to feed on the in- cases of Lyme because standard IDSA culture tests to conclude that there was protocols do not clear infection. no evidence of persistence, both tests are fected monkey and then be examined for Bb). The use of xenodiagnosis in The study concludes that “Reliable regarded as highly insensitive methods for procedures to determine that infection detecting persistence. Being able to rely humans is controversial, however, as it may transmit previously unidentified has been cleared from Lyme disease on evidence from invasive tissue sampling patients have not been established.” underscores the importance of using pathogens to the person being tested. animal models for research, since such The Embers study found that even when Policy implications sampling would be impossible in humans. there was direct evidence of persistent The conclusions drawn from the Kl- infection identified by tissue sampling, Antibody testing fails empner study and the Embers study conflict. the C6 blood test failed to detect it. The IDSA has long contended that Like the C6, all antibody tests are in- The C6 test is not a reliable diagnostic Continued on page 13

Volume 24 Number 1 11 FEATuRE - Embers Monkey Study

Embers Monkey Trials: Implications for the IDSA Guidelines The Embers trial contradicts major assumptions and conclusions that form the basis of the IDSA guidelines below:

Topic IDSA Embers Monkey Trials Mandatory use of an- Clinical findings are sufficient for the di- The C6 antibody test failed to detect Lyme in tibody tests for diagnosis agnosis of erythema migrans, but clinical 60% of monkeys with persistent infection over findings alone are not sufficient for diagnosis time despite direct evidence of persistent Bb. of extracutaneous manifestations of Lyme. Di- Meaning: the C6 test is not sensitive agnostic testing performed in laboratories with enough to be required for diagnosis. excellent quality-control procedures is required for confirmation of extracutaneous Lyme. Treatment of early- dis- Doxycycline, amoxicillin, and cefuroxime All infected monkeys treated with this protocol seminated Lyme axetil are effective for the treatment of early failed to clear the infection. Early-disseminated Lyme Lyme. Most patients respond promptly and was defined as four months after inoculation. completely. Some individuals have per- Meaning: short-term protocols are expected to fail sistent subjective complaints, despite re- in monkeys with early- disseminated Lyme. ceiving therapy that otherwise appears cu- rative. Less than 10% of individuals do not respond to antibiotic therapy, as evidenced by the presence of objective clinical mani- festations; re-treatment is rarely required. Persistence of Borellia There is no convincing biologic evidence Embers found direct evidence of persistent infection in all burdorferi (Bb) for the existence of symptomatic chronic monkeys treated with 28 days of antibiotics and also in 8 out Bb infection among patients after receipt of 11 monkeys treated with the 90-day Klempner protocol. of recommended treatment regimens. Meaning: Bb persistence is the norm in monkeys. Antibiotic therapy is not Antibiotic therapy has not proven useful Embers found that 3 of 11 infected monkeys cleared useful for chronic Lyme and is not recommended for patients with the infection using the 90-day Klempner protocol. chronic (6 months) subjective symptoms Meaning: 90 days of antibiotics was ef- after recommended treatment regimens. fective in about 25% of the monkeys. Recommended Because of a lack of biologic plausibility, Embers concluded that the use of variable treatment modalities lack of efficacy, absence of supporting data, or and pulse-dosing regimens of antibiotics might the potential for harm to the patient, the fol- improve efficacy and warrants testing. lowing are not recommended for treatment Meaning: Non-standard treatment ap- of patients with any manifestation of Lyme: proaches may improve efficacy. Note that 90 days combinations of antimicrobials, pulsed- was better than 28 days in the Embers study. dosing (i.e., dosing on some days but not others), long-term antibiotic therapy.

Mechanisms of persistence Finally, Lyme disease lacks character- “The nature of the persistent organisms and the acqui- istics of other infections that justify longer sition of tolerance to antibiotics are questions that need to treatment courses, such as infections in be addressed. The Bb spirochete is known to invade col- immunodeficient hosts, infections in which a lagenous tissue as a possible mechanism of immune evasion.” pathogen is inhibited but not killed by antimi- . . .”The fact that organisms can persist in the presence crobial therapy or in which available antimi- of antibiotics such as penicillin and cephalosporins (cef- crobials are minimally active in vitro, in- triaxone) that interfere with cell wall synthesis appears to stem fections caused by an intracellular pathogen, from their ability to enter a dormant, non-dividing state, thus infections involving a biofilm, infections on a avoiding the need for cell wall synthesis to continue growth.” heart valve, or infections involving a clinical …”A ‘‘persister’’ phenotype may possibly be responsible for the site in which there is ischemia, a foreign recalcitrance of persisting spirochetes made evident by previous body, a sequestrum, or frank pus. The “cystic” studies in mice and dogs, and by those presented in this report.” forms of Bb that have been seen under certain Meaning: there are lots of plausible mech- growth conditions in vitro have not been anisms for persistence. shown to have any clinical significance. Antibody level decline Additional compelling evidence against In all of the infected animals, the C6 antibody index rose the hypothesis that persistent symptoms steeply within the first 5–8 weeks post-inoculation (PI). are the result of persistent infection is Thereafter, the responses fit into three patterns, depending the fact that the concentrations of anti- on whether the animals were or were not treated with anti- bodies against Bb in many of these pa- biotics. In the treated group, the response declined steadily tients diminish to undetectable levels. The during the treatment period and reached background panel is unaware of any chronic infection levels at the endpoint in all animals. In contrast, the re- in which antibody titers diminish despite sponses of the untreated group remained either largely un- persistence of the causative organism. changed (5 out of 12 animals, or returned to background levels (7 out of 12 animals) but not in parallel with the ki- netics of the treated group’s decline in specific antibody.

12 The Lyme Times FEATuRE - Embers Monkey Study the Klempner study showed that ex- the water and wastes precious resources rested entirely with the authors. While tended antibiotic treatment does not vital for patient care and research. Further, there are several possible explanations work and that persistent infection it can form the basis for seriously mis- for the delay, it is possible that after the does not exist. This premise is used to leading recommendations leading to Klempner trial was published, the po- justify its denial of treatment to pa- unnecessary suffering and death. litical headwinds against publication of tients with chronic Lyme disease. A recent edi- If – as the Embers study proves – Bb torial in the infection persists despite 90 days of British Medical treatment, however, the IDSA premise is Journal calls the false. Rather than 90 days of treatment crisis of missing being ineffective, perhaps 90 days is research data a insufficient to clear the infection. threat to the in- Similarly, the IDSA 28 day protocol tegrity of evidence- for treating early-disseminated based medicine. Lyme disease may also be insuf- They conclude ficient, as all monkeys treated with that “[a] current this protocol remained infected. culture of hap- Furthermore, if lab tests like the C6 are hazard publication so insensitive, they should not be required and incomplete for diagnosis, as the IDSA guidelines data disclosure require. Doing so will leave many Lyme make the proper patients undiagnosed and untreated.: analysis of the harms and benefits of contradictory results became too chal- common interventions almost im- lenging. If so, the recent publication Persistent and pathogenic? possible for systematic reviewers.” might be regarded as an act of courage on One way that Embers demon- How does this apply to Lyme disease? the part of the authors. There can be no strated persistence was through the Imagine that a scientific result has a doubt, however, that the delay in publi- use of xenodiagnoses – placing un- bearing on treatment of a disease that cation caused patients considerable harm. infected ticks on infected monkeys may relieve human suffering. Imagine References and examining the ticks for bacteria that those results are not published Embers ME, et al. Persistence of Borrelia burg- after feeding to repletion. The question for a decade and so are not reflected dorferi in Rhesus Macaques following An- remains whether the harvested bacteria in clinical guidelines. As a result of tibiotic Treatment of Disseminated In- were pathogenic (causing disease), and the delay, patients are inappropriately fection. PLoS ONE. 2012;7(1):e29914. whether previously uninfected monkeys treated for want of knowledge of that Dickersin K, Chalmers I. Recognizing, investi- scientific result. And that is what essen- gating and dealing with incomplete and biased re- could develop the type of pathology porting of clinical research: from Francis Bacon to that the study monkeys developed. tially happened with the Embers study. the WHO. J R Soc Med. 2011 Dec;104(12):532-8. The Klempner and Embers studies Whether ticks infected through xeno- Klempner M, et al. Two controlled trials of antibiotic diagnoses can infect other animals has were funded within two years of each treatment in patients with persistent symptoms been answered, however, in a study by other. But while the results of the Kl- and a history of Lyme disease. The New England Barthold et al. using a mouse model. It empner human trial were rushed to Journal of Medicine. 2001 Jul 12;345(2):85-92. remains to be proven whether persistent press, those of the companion monkey Lehman R, Loder E. Missing clinical trial bacteria can cause disease, however. trial languished for another decade. data. BMJ. 2012 2012-01-03 00:00:00;344. During this period, seriously ill pa- The “imagine” exercise is adapted from an article by Downside of delaying data tients were told there was no persistent Valentine Cawley: An Analysis of the Ethics of Peer This would be old news except that infection to treat, and physicians who Review and Other Traditional Academic Publishing the results of the monkey study – funded Practices. International Journal of Social Science treated patients for persistent infection and Humanity, Vol. 1, No. 3, September 2011. in 1998 – were not published until 2012. were brought before medical boards. Weintraub Pam. Cure Unknown: Inside Does that delay matter? You bet it does. Where were the NIH, which funded the Lyme Endemic (Paperback: 2009) Science builds upon published research. and oversaw the Embers study, and Sir Iain Chalmers, James Lind Ini- New research incorporates the previous the NIH project manager, Dr. Phil tiative (PR 47) written evidence sub- work of others into a new hypothesis, Baker, during those years? Dr. Baker, mitted to Parliament, Peer Review. refines it, and sometimes transforms it. now retired from the NIH, advocates Wormser GP, et al. The clinical assessment, As leaders in evidence-based medicine against Lyme patients on behalf of the treatment, and prevention of lyme disease, point out, “Peer review cannot take American Lyme Disease Foundation. human granulocytic anaplasmosis, and babe- account of what cannot be seen.” Dr. Iain siosis: clinical practice guidelines by the In- Baker denies allegations that the NIH fectious Diseases Society of America. Clin Chalmers explains that unreported re- suppressed publication of the study and Infect Dis. 2006 Nov 1;43(9):1089-134. search stops scientific progress dead in claims the decision to delay publication

Volume 24 Number 1 13 FEATuRE - National Guidelines Clearinghouse Petition Protests IDSA Guidelines Congressmen request removal from NGC website In September 2011, LymeDisease. for them in the settlement agreement, final report specifically states that the task org became aware that the controversial that is, whether the guidelines were of guideline revision would be conducted 2006 IDSA Lyme guidelines, listed with “medically and scientifically justified,” by a separate IDSA group. the National Guidelines Clearinghouse a legal goal that falls far short of the In December, ILADS wrote the NGC (NGC), were more than five years old. goal of guideline revision. The review asking them to retire the 2006 guidelines The NGC, part of the U.S. Department process cannot be used to establish from the NGC list “until a formal re- of Health and Human Services’ (HHS) currency of the 2006 guidelines. evaluation has been generated.” They Agency for Healthcare Research and • The IDSA claims that it reviewed noted the “ever-changing breadth Quality (AHQR), publishes all im- the guidelines internally in 2011, of evidence constantly being gen- portant treatment guidelines. The NGC deciding that no change was required. erated,” a fact that underscores the im- requires that guidelines posted on their Such a “review” is not listed on their portance of the NGC requirement for website be reviewed and updated every NGC application, however, nor is regular guideline review and revision. five years to ensure that they reflect the process or methodology used for In their letter, ILADS referenced the current evidence-based research. such a review disclosed, as the NGC IDSA settlement agreement, including Medical guidelines are tremendously requires. inaccurate statements made in the IDSA important in determining treatment • The IDSA antitrust review panel 2006 guidelines based on low-quality options for patients. It’s the govern- recommended over 25 important evidence and mere “expert opinion.” It ment’s way of providing updated infor- revisions to their guidelines, none is important to recall that physicians mation about different diseases to health of which have been implemented. who treat chronic Lyme were excluded care professionals. Revisions significantly Further, the panel did not reach from the (hardly independent) 2009 an- effect diagnosis and treatment and are consensus on which lab test(s) should titrust hearing panel, “a fact that severely essential to the quality of patient care. be mandatory for a diagnosis of Lyme limited the scope of the proceeding.” Given the NGC policy, it was assumed disease. Federal intervention that the IDSA was indeed updating their • The 2006 guidelines are not current LymeDisease.org and other advocates 2006 guidelines. When LymeDisease. since they do not reflect new science org asked whether they were in the have appealed to legislators to address including the Barthold mouse study the problem. In response, Congressmen process of doing so, the IDSA merely and the Embers monkey study. Both referred us to their website that said its Smith, Wolf and Gibson asked the NGC studies found persistent infection, a to remove the outdated IDSA guidelines guidelines were current. They refused fact denied in the 2006 guidelines. to provide any further information. from their website. Shortly thereafter, Subsequently, we learned that the Advocates in action Senators Blumenthal and Gillibrand ex- NGC was planning to continue listing Since this situation with NGC surfaced, pressed similar concerns. New York State the 2006 guidelines until 2015 - without LymeDisease.org has been working Assemblyman Richard Gottfried, who updating them. The NGC based their behind the scenes with advocacy and chairs the Assembly Health Committee, decision on the IDSA’s claim that the patient groups - including Time for also requested that the guidelines be Connecticut Attorney General’s an- Lyme, ILADS and other individuals - removed pending a review for currency. titrust settlement process in 2008-2009 to focus attention on the problem. constituted an update that qualified In November, LymeDisease.org their 2006 guidelines for continued wrote to the IDSA asking about the publication on the NGC website. status of their treatment guidelines, of- Pass the Petition! This is wrong fering to speak on behalf of the patient perspective in their revision process, The campaign to dissuade the NGC The NGC’s decision to continue to and was quickly stonewalled. from listing the IDSA guidelines post the IDSA 2006 guidelines is un- LymeDisease.org also wrote to the NGC needs your help. Copy and print the justified for several reasons: explaining that the legally mandated IDSA flier on page 15 and post it in shops, • The IDSA 2009 antitrust review panel antitrust review panel was not empowered clinics, offices, places of worship was expressly NOT empowered to to update their 2006 guidelines. In fact, and libraries your community. update or revise their 2006 guidelines. the final report of that panel states that the Visit lymedisease.org to add your The review panel ONLY had settlement agreement specifically provides name to the petition, and remind authority to review the guidelines for that they were NOT charged with updating friends and family to sign it, too. compliance with the legal standard set or rewriting the guidelines. Instead, the

14 The Lyme Times FEATuRE - National Guidelines Clearinghouse

Volume 24 Number 1 15 DEPARTMENT - Legal Analysis Dr. Jones Saved My Life By Sally Jordan My Time With Lyme

I never know when I awake which part of my body will ache, My words are jumbled my minds a blur, how I wish there was a cure. My joints are stiff, my head is throbbing. My life, the Lyme is robbing. Why didn't my doctors here see what was deep inside of me. I felt like they didn't even care about all the symptoms I had to share. Sometimes I can't even go to school because the Lyme likes to rule. My body has felt like this for years, I often go to sleep in tears. By God's hands, I met Dr. Jones. He's my hero, he didn't leave me alone. Editor’s Note: As part of a recent Tick Talk at the Brewer Com- munity School in Brewer, Maine, 11-year old Sally Jordan bravely Bangor Daily News photo faced a large audience – including legislators and the media – Sally says Dr. Jones told her, “You’re fixable.” The hours she spent with him were as her poem about Lyme was read. After years of undiagnosed painful, “but he’s the one who actually saved my life,” she says. “So I’m very thankful for that.” illness, she is determined to change public awareness of Lyme. CT Court to Review Jones’ Case Important precedent rests on outcome of the appeal The Connecticut Supreme Court has Proof based on a “preponderance pending the outcome of the appeal. agreed to hear a key aspect of Dr. Charles of evidence” is less stringent than the Dr. Jones continues to train others Ray Jones’ legal appeal. Among other standard used in criminal proceedings through preceptorships and presen- points, Attorney Elliott Pollack asked – “beyond a reasonable doubt.” It is also tations. He participated in the 2012 the Court to review whether the Con- less stringent than the standard used in ILADS conference in Toronto, and necticut Department of Public Health proceedings against attorneys brought spoke at a workshop in February on (CDPH) should have been required to before their own disciplinary body. The the topic of autism and Lyme. prove its case to the Connecticut Medical preponderance of evidence standard The continuing defense for Dr. Jones Examining Board (CMEB) by a “clear and makes it easier to obtain a finding of will require many hours of legal represen- convincing standard of evidence” instead guilty for physicians who are the subject tation. Contributions to his legal defense of by the “preponderance of evidence.” of complaints brought before the MEB. fund may be sent to: Pullman and Comley The outcome of this appeal could Until the appeal is settled, the Trust Account for Dr. Charles Ray Jones set an important precedent for all phy- 83-year-old Dr. Jones continues to Please note “Gift/Legal Defense sicians. The fact that the Connecticut work five or six days a week on behalf Fund” in the memo section of Supreme Court has agreed to consider of children with tick-borne diseases. the check and mail to: this issue – called a “certification pe- He will practice medicine free from Elliott B. Pollack, Esq. tition” – constitutes a victory for Dr. a stringent requirement previously Pullman and Comley, LLC Jones. The Court grants only about nine imposed upon him by the CMEB for 90 State House Square percent of these requests. Oral arguments diagnosing and treating Lyme. These Hartford, CT 06103-3702 are expected to be heard before Fall. requirements have been suspended,

16 The Lyme Times FEATuRE - Interview with Elliott Pollack Pollack Pushes for Higher Standard of Proof By Lorraine Johnson, JD, MBA TLT: Why did the Connecticut Supreme propriate benchmark Court accept the appeal? to be satisfied in dis- Pollack: It is difficult to know exactly. ciplining attorneys. However, I believe it is because of the In doing so, they burden of proof question. We assert that emphasized that the it was not decided correctly by the CMEB, right to practice one’s the trial court and the Appellate Court and profession (i.e., law) also because there is no Supreme Court is a constitutionally ruling on the issue. Time, of course, will protected property tell if I am accurate in this judgment. interest. TLT: The primary issues concern bias For some reason, and burden of proof. Why are these issues Connecticut’s legal important in Dr. Jones’ case? system – and that of Pollack: The issue being addressed in many other states – the appeal is that of the proper burden has treated the right of proof to be satisfied by the DPH when to practice medicine it prosecutes physicians before the MEB. as inferior by not ap- Unfortunately, the Supreme Court refused plying the “clear and to consider the bias of one of the three convincing” con- hearing officers as an important part of the stitutionally-based burden of proof needed to overcome bias. test but, rather, al- Hartford Courant photo Currently established rules call for DPH lowing authorities to Attorney Elliott Pollack (left) confers with his client, C. Ray Jones, MD, during to prove cases against doctors based upon obtain discipline if one of the hearings before the Connecticut Medical Board, where Dr. Jones the “preponderance of the evidence,” a the evidence met the was defending his right to practice medicine. “It is an honor to be Dr. Jones’s attorney,” says Pollack. standard applicable to personal injury “preponderance of cases, contract disputes and other civil the evidence” rule. litigation. Connecticut attorneys, for Our claim here example, cannot be sanctioned unless is that doctors should be treated no dif- Jones case? the evidence against them meets the ferently from lawyers, and that their Pollack: Should the Supreme Court “clear and convincing” standard, which constitutionally protected property right sustain Dr. Jones’s appeal, all Connecticut presents a more demanding test than to practice medicine is at least equal to physicians would be entitled to the pro- the “preponderance of the evidence. and probably more important than that tection of a higher proof standard when TLT: What is a burden of proof and why of lawyers, given the role doctors play in facing discipline proceedings filed against is it important? Why is there more than our society and the time and effort we them by the DPH in the future. one burden of proof standard for different invest in educating and training them. It can be expected that the DPH will legal cases? TLT: Do other states use the “clear and argue that it would be inappropriate to Pollack: The burden of proof is im- convincing” standard of proof for phy- impose a weightier burden on it due to the portant because it describes the height of sicians in medical board actions? allegedly additional expense associated the hurdle a plaintiff (here the DPH) must Pollack: The state of Washington, with establishing that a physician breached surmount to establish its claim. In this in- among others, requires the “clear and the applicable standard of care by “clear stance, the DPH sought discipline against convincing” standard as well as Wyoming, and convincing” evidence. This claim Dr. Jones. We argued from the beginning Oklahoma and Nebraska. should fail because they are wrong and that the “clear and convincing” standard TLT: If you prevail at the Supreme make little sense, when measured against was required. Court, what happens next for Dr. Jones? the constitutional rights of physicians to TLT: In your brief, you state that the Pollack: If the Supreme Court sustains be protected in their licenses and the fact burden of proof for attorneys and for the appeal, it has the option of cancelling that Connecticut lawyers already enjoy physicians has been applied differently in the discipline brought against Dr. Jones; or- the same level of evidentiary protection. Connecticut. How are attorneys treated dering the case back to the MEB for a new Should the appeal be sustained, hopefully differently from physicians? hearing (which would be unfortunate); or the Connecticut Supreme Court’s de- Pollack: Many years ago, the Con- crafting other relief at its discretion. cision will also be read favorably by other necticut Supreme Court established the TLT: What is the significance of these state courts which have not adopted “clear and convincing” standard as the ap- issues for other physicians beyond the Dr. the “clear and convincing” standard.

Volume 24 Number 1 17 NEWS & EVENTS - LymeDisease.org Online Spotlight on the News Visit lymedisease.org for breaking news, political action alerts, event listings, book reviews and regular blogs by Lorraine Johnson and Dorothy Leland. a powerful public service campaign to Burgess Communications partnered ILADS initiates create greater awareness of Lyme disease. to create a pro bono spot using footage “Lyme disease is a silent epidemic in from Under Our Skin. In February, a America,” Shea said. “We want to alert and message was posted at the Daytona 500. campaign educate consumers about this disease, which ILADS is dedicated to the diagnosis is often misdiagnosed. Left untreated, it and appropriate treatment of Lyme and to increase will become chronic and debilitating.” its associated diseases and knows how On New Year’s Eve 2011, the campaign elusive diagnosis and treatment can be awareness kicked off with a JumboTron message unless a physician is Lyme-literate. Their International Lyme and Associated in New York City Times Square. For message sends viewers to their website Diseases Society (ILADS) President Super Bowl X, Open Eye Pictures and (www.ilads.org) for more information. Leo J. Shea, III, PhD, has announced Lyme Message on Times Square NIH study may increase risk of patient exposure Researchers recently discovered that Borrelia miyamotoi (Bm) – a species of corkscrew-shaped bacteria previously found in Asia, Europe and North America – causes human illness similar to Lyme disease. A new study shows that tick larvae can transmit Bm to newly hatched larvae. This highlights the risk in a current NIH study in which live tick larvae – that may not have been screened for this pathogen - are allowed to feed directly on patients. The NIH says their ticks are “clean.” Last year LymeDisease.org asked the NIH to pull the plug on this study because of the risk that unidentified pathogens pose for patients enrolled in the study. Although the NIH claimed that this risk was considered during the study approval review, their documentation failed to show that it was either carefully considered or that adequate precautions were taken. So as LymeDisease.org continues to monitor Patricia Lesyk photo this situation, they have again asked the Members and friends of the New York City Lyme Disease Support group handed out Lyme information in NIH to demonstrate that the study is Times Square near the ILADS JumboTron in December. The giant video screen is 26 feet tall and 20 feet safe or, if not, to stop the study entirely. across. The spot ran every 20 minutes for 3 months.

18 The Lyme Times NEWS & EVENTS - LymeDisease.org Online Highlights from the Blogs Lyme Policy Wonk IDSA view is not ignorance. Rather these respondents were Macauda survey misinterprets saying that the IDSA guidelines are out of sync with reality. findings Another conclusion could have been drawn from the study: By Lorraine Johnson, JD, MBA Given that Lyme is a serious illness that can persist and destroy lives, it should be treated aggressively like other serious A majority of residents surveyed by infectious diseases (e.g., tuberculosis). Inaccurate infor- Dr. Macauda and colleagues in the New mation that does not reflect the experiences of those with the England area believe: Lyme disease disease is not likely to be persuasive to an educated public. can persist after antibiotic treatment; Lorraine is CEO of LymeDisease.org. Contact Lorraine at standard courses of antibiotics are often [email protected] not curative; and treatment beyond two months can be useful. These findings are highly significant and confirm the Touched By Lyme experience of patients with Lyme. Lorraine Johnson Findings Serving up IDSA Facebook The survey was conducted in comments to Congress highly endemic areas of Con- necticut and Rhode Island. The findings are remarkable: By Dorothy Kupcha Leland • Information Sources: Contrary to the belief that the Lyme On January 4, 2012, the Infectious controversy arises from misinformation on the Internet and Diseases Society of America (IDSA) patient support groups, respondents relied upon friends posted a question on its Facebook and family (64%), physicians (24%), or experience with the page: “What would you like to see disease themselves (34%-54%). Few subjects reported the from your society in the coming Internet or support groups as a source of information. year?” The organization’s PR people • Persistence: More than 75% of respondents agreed that Lyme intended the question for their pro- bacteria can remain in their body even after treatment with fessional membership. Instead, those antibiotics. with Lyme and related chronic in- • Treatment Duration: 67% agreed that treatment beyond two fections throughout the U.S. and around months was sometimes or always useful. Dorothy Kupcha Leland the world took notice and leaped at • Personal Experience: 24% had Lyme within the past five years; the opportunity to speak out against over 75% knew on average six people with Lyme, two of the IDSA’s Lyme treatment guidelines. whom were “very ill.” Word of this unique opportunity traveled swiftly. Within • Rates of Lyme: The rates of Lyme in the survey were “several days they had posted 1,000 comments - within the first magnitudes higher than” officially reported. The authors week, it went viral within the Lyme community globally. concluded that the problem is misdiagnosis. Or … is it As many of their posts began being removed, possible that the official rates of Lyme are vastly under- they created a parallel Facebook wall and mon- reported as Lyme patients have been saying for decades? itored the IDSA’s wall 24/7 for several weeks. In the aftermath, they compiled 2350 postings to create Conclusion a 274-page document (with minimal editing) entitled “The Because of the extreme controversy and rigid dogma involving Devastation of Lives and Lies.” They released it to the public Lyme, it is important to separate findings from conclusions since and have been distributing it to various media and public of- such interpretations are subject to researcher bias. One of the ficials including members of Congress, Congressional Com- study authors was also an author on the IDSA 2006 guidelines. mittees, the CDC, State Legislators, the President. Given the potential harm from unnecessary prolonged Why, you may ask? Because they need answers, they need the therapy, the authors concluded that more accurate information truth, and they need their dignity restored. Too many lives have needs to reach the Lyme community to curtail the “wide- been devastated. The despair in this document is palpable. spread belief in chronic Lyme.” This is a faulty assumption. The Visit lymedisease.org to read the document in its entirety. survey population had extensive knowledge about Lyme and were highly educated, almost half having a graduate degree Dorothy is LymeDisease.org’s V.P. for Education and and an additional third with a BA. Disagreement with the Outreach. She may be contacted at [email protected].

Volume 24 Number 1 19 NEWS & EVENTS - LDA Conference Bb Biofilms Evade Immune System Researchers offer new strategies to address infection Editor’s note: Condensed from a report on Anaplasma phagocytophilum (Ap), the of the nucleotide inhibit the ability of Bb of the 2011 Columbia and LDA Lyme and agent of human granulocytic anaplasmosis to pass from ticks to mammals while low Tick-Borne Diseases Annual Conference on (HGA). This emerging tick-borne pathogen levels interfere with the passage of spi- the website of Columbia University Medical demonstrates stealth trickery, enabling it rochetes from mammals to ticks. These Center Lyme and Tick-Borne Diseases Re- to avoid and even subvert immune cells. In studies provide unique insight into the search Center. For full report, visit http:// molecular mechanisms that control columbia-lyme.org/research/scientific.html. the ability of the Lyme disease spiro- This year’s conference was once again chetes to complete the enzootic cycle. an exciting and stimulating meeting Dr. CHRIS EARNHART described bringing together researchers, cli- work developing a novel next-generation nicians, community leaders, patients, Lyme disease vaccine based on outer and public health officials. Below is a surface protein C. OspC is expressed by all summary of the talks for the benefit of Bb species and strains and is expressed in those who were not able to attend. the human host for several weeks before Dr. J. WILLIAM COSTERTON re- being down-regulated. The first gen- viewed the history of the discovery of eration OspA vaccine killed Bb in the biofilms, demonstrating that these biofilms mid-gut of the tick and was only 68-76% enable micro-organisms to resist host de- effective, requiring very high antibody fenses and antibiotics, enabling infections titers in the human to maintain its effect, to become chronic. Over 500 bacterial thus requiring frequent boosters. There species have been identified in typical were fears that the OspA vaccine might dental plaque biofilms. Dr. Costerton de- trigger a type of . Dr. Earnhart’s scribed how the capillary bed in the knee is work may soon lead to animal trials. LDA photo Dr. ROBERT LANE gave an overview a trap for bacteria, pointing out that septic Brian Fallon, MD, was co-director of the LDA arthritis in children settles in the knee (not Conference course held in Philadelphia in of his research team's long-term studies the hip) and Treponema denticola (from September. of the ecology and epidemiology of Lyme periodontitis) also settles in the osteoar- disease in California, and then sum- thritic knee (not the hip). For more infor- the USA, HGA is endemic in the Northeast, marized some exciting recent findings re- mation about biofilms, check out www.erc. the upper Midwest, and Northern Cali- garding the genospecies and genotypes of montana.edu.[And see article on page 24] fornia, where the disease’s tick vector is Bb s.l. that infect the western black-legged Dr. EVA SAPI’s talk on “Killling Borrelia prevalent. HGA presentation varies from tick and humans in this region. He and – an impossible job?” addressed mech- sub-clinical to mild or severe disease. members of his research team reported in anisms associated with Borrelia burgdorferi Though rare, HGA can be fatal. Symptoms the March issue of the Journal of Clinical (Bb) that may help it to survive despite an- include fever, chills, headache, myalgia, leu- Microbiology that Borrelia bissettii-like tibiotic treatment. Bb can adopt alternative, copenia, thrombocytopenia, and elevated spirochetes occasionally infect humans. defensive forms to evade the immune re- serum levels of liver enzymes. Patients gen- This is the first time that this Lyme sponse and perhaps to increase antibiotic erally respond to the antibiotic doxycycline. disease-group spirochete has been dem- resistance. The cyst form may be resistant Ap effectively invades and subverts the onstrated to infect people in North to the front line antibiotic treatment. very cell meant to destroy microorganisms. America. Previously, it was known as Another possible explanation for per- Ap converts its host cell into a Trojan horse a human pathogen only in central and sistent symptoms might be the formation by tricking the cell into engulfing it into a southern Europe. Dr. Lane also pointed of a biofilm. Dr. Sapi’s group is examining vacuolar compartment. Once inside, the out that northwestern California is highly different agents that may help to reduce pathogen hijacks disguises itself by masking endemic for Lyme disease, that the tick biofilms, such as the antibiotics doxy- itself as a “recycling compartment.” The Ixodes pacificus has at least 108 vertebrate cycline and tinidazole as well as the herb Ap-occupied vacuole remains undetected hosts, and that some of the highly invasive Banderol. Dr. Sapi concluded with the hy- within host cells. Understanding how the strains of Bb found in the Northeast have pothesis that the Bb biofilm likely provides pathogen works can lead to new treatments. not been detected in California ticks. a refuge for chronic Lyme infection, and Dr. RICHARD MARCONI described Dr. KAREN NEWELL ROGERS dis- offers an additional avenue of attack for research about a cyclic nucleotide which cussed novel ways to target chronic in- potential treatments for Lyme disease. plays a critical role in regulating several flammation and chronic immune ac- Dr. JASON CARLYON’s talk focused important cellular processes. High levels tivation among patients with chronic

20 The Lyme Times NEWS & EVENTS - LDA Conference

LDA photo Brian A. Fallon, MD, Director, Lyme & Tick-Borne Diseases Research Center, Columbia University surprises Pat Smith, LDA President (left of podium), with the "Outstanding Leadership Award." In the background are LDA affiliate, chapter and support group leaders.

Lyme disease. Toll Like Receptors (TLR) led to the identification of new mech- panied by fever, chills, and muscular pain. appear to be the “gate-keepers” of an anisms of disease, as well as treatments Preliminary evaluation of immunologic inflammatory response. Bacteria, in- for some previously untreatable diseases. responses to early infection with Borrelia cluding Borrelia, produce products that He showed stunning videotapes of pa- show interesting patterns of cellular promote leukocyte activation, cytokine tients with limbic encephalitis with immune response. These may eventually production, and acute inflammation. In profound neurobehavioral disturbances shed light on the differing clinical outcomes some genetic backgrounds of mice, acute (e.g., extreme terror) whose symptoms that are seen during the two-year study inflammation is sufficient to fight off in- reversed after receiving treatment that in- follow up after initial antibiotic therapy. fection and resolve disease. In other mouse terfered with the autoimmune process. Dr. REINHARD STRAUBINGER strains, the bacteria get past the inflam- Most of these patients are first seen by focused on Lyme borreliosis in animals, mation and remain symptomatically un- psychiatrists (23% by neurologists); 88% especially in dogs and horses. There is no detectable in cells and tissues. Dr. Newell’s are eventually admitted to the ICU and transfer of Borrelia from pets to humans. research is aimed at determining how 90% have a CSF pleocytosis. Dr. Dalmau’s Epidemiological data generated with Borrelia infection is influenced by TLR. work may be of relevance in the field of animal populations can help to monitor Dr. ROBERT YOLKEN talked about Lyme disease given findings that pa- the geographical distribution of Lyme infections and human neuropsychiatric tients with chronic Lyme disease have borreliosis (e.g., dogs are excellent sen- diseases. Epidemiological studies suggest elevated levels of anti-neuronal anti- tinels). In experimentally induced in- that infectious agents may contribute bodies which have been shown in vitro fections, not all animals develop disease; to many cases of schizophrenia, often to target neurons in the cerebral cortex for example, in one study up to 75 % in individuals who are susceptible due and dorsal root ganglia. It remains to be of all infected dogs developed disease, to genetic factors. Toxoplasma gondii is demonstrated however whether these while none of the experimentally of particular interest. He concluded by antineuronal antibodies are associated exposed ponies showed clinical signs. emphasizing that an increased under- with the chronic clinical symptoms in The presence of antibodies does not cor- standing of the role of infectious agents post-antibiotic treatment Lyme disease. relate with clinical signs and infected dogs might lead to new methods for the pre- Dr. JOHN AUCOTT reported that 75% can seroconvert and stay asymptomatic. In vention and treatment of severe neuropsy- of patients with early Lyme disease will dogs and horses the first signs of clinical chiatric disorders, such as schizophrenia. have the telltale skin lesion within the first disease are mild fever, general malaise, Dr. JOSEP DALMAU’s pioneering 1-4 weeks of infection. He emphasized lameness and swelling of local lymph work on autoimmunity shows how an that the classic description of a “bull’s-eye nodes; this stage may go unnoticed, waning immune response triggered by a tumor rash” occurs only 20% of the time – it is after a few days. An erythema migrans has or an infectious process results in anti- not the most common manifestation of not been described in dogs and horses. bodies that can attack components of the Lyme rash. Rather, a uniformly red With dissemination, local inflammatory the central nervous system involved in or reddish-blue rash, round or oval in reactions can cause pain, swelling and memory, behavior, cognition, and psy- shape, with sharply demarcated borders is chosis. Dr. Dalmau’s recent work has most common. The rash is usually accom- Continued on next page

Volume 24 Number 1 21 NEWS & EVENTS - LDA Conference

Continued from page 21 to be an aberrantly functioning immune system in both disorders, compared to lameness. In certain breeds renal disease normals; and c) compared to controls, can also occur, with death or euthanasia PTLS patients had reduced levels of one day to eight weeks after onset of the proteins considered important for the disease without demonstration of viable Bb. maintenance of CNS cellular architecture, Dogs and horses may develop as- such as axon, neurite, and dendritic spine ymptomatic encephalitis, mild peri- growth and organization, supporting the neuritis or meningitis. The two-tiered neurologic basis for chronic Lyme en- ELISA and immunoblotting system is cephalopathy. Dr. Fallon said that these the method of choice for diagnosis. discovery phase results require repli- Dr. JAMES MOELLER presented a talk cation before conclusions can be drawn. on “Immunologic aspects of neuropsy- Dr. ANDREW WALTER reported that chiatric illness: Lyme disease as model.” ehrlichiosis is an uncommon tick borne He reported analyses demonstrating that LDA photo disease seen in the mid-Atlantic area and the level of anxiety and depression among UC Berkeley entomologist Robert Lane, PhD, told therefore clinicians need to maintain a patients with chronic Lyme encepha- the audience that Borrelia changes the behavior of heightened vigilance. Ticks in the MD/ lopathy was highly correlated with a clinical host-seeking ticks. More infected ticks are found up DE/PA area carry Ap which causes human index combining Bb-specific serologic and on logs – where they are more likely to find lizards, granulocytic ehrlichiosis (HGA). Am- CSF status and brain metabolism. This their favored hosts – than are on the ground. blyomma americanum ticks in the mid- represents the first time that psychiatric west carry E chaffeenis which causes symptoms in Lyme disease have been di- that there are approximately 700 unique human monocytic ehrlichiosis (HME). rectly linked to objective measures of Bb- proteins distinguishing the patients with Doxycycline is the drug of choice. specific immunity and brain function. chronic neurologic post-Lyme syndrome Hemophagocytic lymphohistiocytosis Dr. BRIAN FALLON reviewed the from the patients with chronic fatigue (HLH) is a rare complication of infectious evidence regarding models of persistent syndrome, clearly demarcating them as diseases including ehrlichiosis. Primary infection and/or persistent immune ac- different disorders; b) both PTLS and CFS HLH is fatal with a median survival among tivation. A recent collaborative study had elevated levels of complement in the infants of less than two months. Sec- revealed several important findings: a) CSF proteome, highlighting what appears ondary HLH may result from a strong immunological reaction from a severe infection. Patients who are very ill with SAVE THE DATE ehrlichiosis or other infection should be immediately screened for HLH. Dr. ANDREA GAITO reported that Lyme arthritis occurs in 60 % of patients with untreated Lyme disease. The ar- thritis may affect one or multiple joints. It is frequently migratory. The spirochetes rapidly disseminate to joints by inducing the production of cytokines which then promote vascular permeability, allowing further infiltration of spirochetes into the synovial tissue. The presence of the bacteria can then trigger an autoimmune response in susceptible patients. Both se- Lyme Disease Association 2012 rologic tests and diagnostic X-rays are The national Lyme Disease Association's 2012 annual Lyme & Tick-Borne often required to access the joint pathology. Diseases scientific conference will be held at the Hyatt at the Bellevue in Phila- Evaluation of joint fluid for blood count, delphia, PA, on Saturday (8am-5pm) and Sunday (8am-2pm), September 29 & 30. viscosity and cell type, along with testing Columbia University College of Physicians and Surgeons for the presence of the Lyme bacteria, is will again jointly sponsor the conference. essential if an effusion is present. MRIs The conference is designed for physicians and scientists, but the public and synovial biopsies may be helpful in is invited to register to attend. Continue to check the LDA website advanced cases. Many rheumatologic for future registration, information about the conference, and ex- disorders may be associated with Lyme hibitor opportunities. www.LymeDiseaseAssociation.org disease. The management of autoimmune disorders in a Lyme patient may require

22 The Lyme Times NEWS & EVENTS - LDA Conference additional therapy with disease-modifying Dr. ELIZABETH MALONEY re- a Type II error in a study sample of this agents along with an antibiotic regimen. viewed the literature to identify lessons, size. Additionally, the review called at- The use of steroids should be limited due gaps and future research needs. She ex- tention to the fact that the retreatment to concerns of immunosuppression. amined the evidence from prospective trials by both Krupp and Fallon dem- Dr. INGEBORG DZIEDZIC discussed studies conducted in the U.S. with regards onstrated positive treatment effects. how Lyme disease impacts the eye, empha- to adequacy of design, success rates sizing that the eye is in part like the skin and lessons learned. The evidence from and in part like the brain. Eye manifes- many clinical trials was found to be in- tations that relate to infection with Bb tend adequate due to small sample sizes with SAVE THE DATE to be acute and can be recurrent: conjunc- high non-completion rates, poor trial ILADS 2012 tivitis, keratitis, iritis, retinal vasculitis, designs and limited antibiotic regimens; retinitis, and optic neuritis. Lyme disease success rates were unacceptably low. The International Lyme and eye-related symptoms are as varied as they The review also found that the efficacy Associated Diseases Society are seen systemically. These issues should of prophylaxis studied in the single dose be taken seriously and treated so the patient doxycycline trial pertained only to the annual conference will be held at can function better and recover sooner. development of an EM at the bite site; the Westin Boston Waterfront Hotel Dr. VIJAY THADANI presented an success rates in the EM trials ranged from in Boston, MA, November 2-4, overview of seizures and non-epileptic 60 – 80%. The design of the largest of the 2012. Watch the ILADS website seizures, showing videos of both. Brain chronic post-treatment Lyme trials (Kl- for further information or contact infections such as Lyme disease can lead empner et al, 2001 study – reporting no to the development of epilepsy due to in- benefit from retreatment) was limited Barbara Buchman, flammation of the surface of the brain and in that the high bar set for clinical im- [email protected]. the formation of scar tissue. Such damaged provement increased the likelihood of areas of brain can act as foci from which seizures begin and spread through the brain. Epilepsy is not however a common complication of Lyme disease, and if it occurs it can usually be treated successfully with anti-epileptic drugs. Epilepsy that is resistant to drugs can occur, but other causes of seizures should be ruled out. The consequences of any brain disease, or any traumatic life experience, include mental stress that can manifest as a con- version disorder with non-epileptic psy- chogenic seizures. About 25% of patients with seizures refractory to anti-epileptic medication do not have epilepsy but have non-epileptic psychogenic seizures. A few patients have both. Long-term video-EEG recording is the best way to capture events and make a definite diagnosis. Correct treatment depends on correct diagnosis. Dr. STEVE BOCK proposed that the treatment needs to address multiple symptoms of the “Chronic Lyme Disease Complex” as well as the accompanying dys- function. He then reviewed the “Wheel of Function,” which included a multisystem assessment approach – inflammation, GI Missed Toronto 2011? function, endocrinology, immune defi- The 2011 ILADS Conference brought professionals together to examine ciency, nutritional deficiency, stress, sleep cutting edge research and state-of-the-art clinical applications for the diagnosis disturbance, neurotransmitter disturbance, and treatment of Lyme disease. Access to the presentations by medical profes- food allergies, heavy metal toxicity, co-in- sionals and Lyme disease leaders is available through the ILADS Media Center. fections. Dr. Bock concluded by discussing various testing and treatment approaches. Visit ILADS.org

Volume 24 Number 1 23 NEWS & EVENTS - LDA Conference Biofilms Protect “Bad Guys” Microbial communities share DNA and resist attack Reviewed by Christine Green, MD “Biofilms explain chronicity,” declared Dr. Costerton in his talk at the LDA conference. Biofilms are not aggressive but are extremely protective of the bacteria in them. When phagocytes detect a biofilm they go berserk, he said, and produce fantastic amounts of antibody – in fact “dangerous levels.” But they are not able to clear the bacteria. Biofilm can also withstand huge concentrations of antibiotics, as studies on pacemakers has shown.. Essentially all organisms live in community; free- floating – or “planktonic” – bacteria are rare. In the microscopic world we call these communities biofilms. A biofilm is made up of components from microbes (bacteria, fungi and flagellates) and com- ponents from the world in which the microbe lives. A biofilm is a sticky, almost cement-like mucus. Under a microscope you can see the immune anti- bodies stuck looking in at the bacteria they want – Alan MacDonald photo but apparently not able to move into the biofilm. The Dark field microscopic image of biofilm containing Borrelia burgdorferi spirochetes. wall of antibodies gives another layer to the biofilm that also seems to protect the pathogenic bacteria. The neu- trophils and natural killer cells are unable to get through the thick the community of bugs helps members survive. biofilm to engulf, or “eat up” the bacteria. Instead they release Finally Dr. Costerton showed remarkable pictures that, if they their cytokines into neighboring tissue, provoking a huge inflam- were human-sized, would be a sci-fi nightmare. These biofilms matory response in the host. are slimy masses with a bunch of different-shaped organisms Based on his findings, Dr Costerton’s conclusion is: if bacteria in them. They are connected by filaments that probably allow are free in the blood or tissues (so called “planktonic” bacteria), communication between different species of bacteria, between they are easy to kill with a targeted short course of antibiotics. bacteria and fungi, and between bacteria, fungi and flagellates. But if they are living in a biofilm, protected by that “cement wall” They are also connected by electrical impulses and by nanotubes and the “front yard and their friends and neighbors,” then a short where they can exchange material – including DNA. course of antibiotic will eradicate only free bacteria that have Dr. Costerton noted that Eva Sapi’s approach was spot on in left the biofilm, and terms of trying to figure out how to address the Borrelia burg- perhaps some in the dorferi (Bb) in community and what this might have to do biofilm, but it is un- with treatment and eradication of infection. Dr. Sapi has been likely to eradicate all researching biofilms at the University of New Haven in Con- of them in the biofilm. necticut. She has shown that Bb can form a biofilm all by itself Dr Costerton growing in a test tube. In fact it forms biofilms on the surface of further noted that certain plastics in which they were trying to grow it. Bb starts sometimes biofilms forming biofilm after about 10-14 days. Dr Costerton has looked have members largely at implanted joints and devices. Catheters develop a that create a toxic biofilm within three months. chemical, for instance Biofilms may explain why continual antibiotics are required butyrate. Another to keep an active Borrelia patient functional, with reduced or member in the biofilm absent symptoms. Perhaps researchers will eventually understand – for instance spiro- the signaling in these communities and use that knowledge to LDA photo chetes – might like eradicate the pathogens. If we know how these bacteria, flagellates Calling Borrelia the “King of slime,” Dr. J. William to eat butyrate. Many and molds talk to each other, we may be able to interrupt the con- Costerson says biofilm is a thousand times more biofilms have spiro- versation and inhibit their growth. resistant than free-floating planktonic cells. chetes as a partner. So

24 The Lyme Times NEWS & EVENTS - ILADS Conference ILADS Attracts Hundreds of Physicians Toronto conference examines diverse Lyme-related topics Microscope Aids Diagnoses Morgellons patients often become agitated and unruly at their derma- tology appointments, said Cindy Casey, RN, Director of The Charles E. Holman Foundation, who presented the work of her colleague Ginger Savely, DNP on this controversial disease. Casey told The Lyme Times that the reason may have something to do with the tendency of dermatologists to label such patients "delusional." Many of the doctors who attended Casey's lecture already had several ILADS photo Morgellons patients in their practices. Drs. Leo Shea, Warren Levin, Daniel Cameron, and Andrea Gaito attend the ILADS conference in Toronto in They were interested in learning October 2011. Dr. Shea is President of ILADS. Dr. Gaito was ILADS’ first president and is currenly treasurer. more about the complex and distinct Dr. Cameron is a past president and serves on the Board. For more information, visit ILADS.org. manifestations of the disease. "Many of them had actually examined their patients’ skin with 100X magnifi- patient's 'delusion' and prolonging their and look at the evidence instead of cation light dermoscopy, unlike derma- office visit," Casey said. She added that catering to insurance companies and tology specialists whose reliance upon many dermatologists employ the "match stakeholders with no medical expe- ancient medical folklore has prohibited box sign," which she termed "ridiculous." rience will lead to better treatments a skin examination with lighted mi- Casey is hopeful that medical pro- for people with Morgellons. croscopy for fear of feeding into their fessionals who listen to their patients Co-infections Suppress Immune System “Parasitic illness is spreading are “cesspools of organisms,” he said. But Treatment of multiple co-infections worldwide,” said New York internist you will not necessarily find it on testing may involve multiple drugs which Richard Horowitz, MD, who has treated because they are intracellular, so you may may cause side-effects. “We only use 11,000 patients with tick-borne diseases have to do multiple PCRs, he advised. He clindamycin for patients we don’t like,” in the past 20 years. An expert on co-in- also strongly recommended testing for dif- he joked. He recommended that doctors fections, he gave a long list of the health ferent forms of Babesia. When LabCorp must know their pharmacology. problems his patients suffer from – started offering the WA1 he did 137 tests, The patient may have multiple over- babesia, Lyme disease, pyroplasma, rick- resulting in more than a 19% positivity rate. lapping etiologies. Missing the di- ettsiae - as well as immune system and nu- Horowitz considers the immuno- agnosis of a co-infection may consign tritional deficiencies, Candida, viruses and suppressive effects of the infections. him to a lifetime of sickness. more. But his talk focused on parasites. Some patients become chronic “It’s like having 10 nails in your Parasites are widespread. A tick survey carriers. Drug resistance may also foot. You pull out one nail, but you in his area showed that 71% had one or- be a problem but hardly anyone is still have pain,” he quipped. ganism, 30% had two, 5% had three. Ticks talking about persistence, he said.

Volume 24 Number 1 25 DEPARTMENT - Research Review Chemokines as Biomarkers Researchers look for ways to identify active neuroborreliosis By Bonnie Sgarro, MLS Chemokines The authors claim these results confirm thus causing damage. CD4+ lymphocytes belong to the larger CXCL13 in CSF fluid to be a reliable have been implicated in the pathogenesis family of cytokines, marker for LNB, and should be added of Lyme disease. … CD4+ T-cells spe- all produced pri- to the diagnostic armamentarium. cifically responding to the Bb lysate have marily by the Another study (5) compared CXCL13 been present in the CSF of patients with liver, but also in levels in the CSF of children and adults acute Lyme encephalitis. …[We will] in- the spleen, lymph with Lyme – one group with LNB and vestigate the CD4+ cells, … [hypothe- nodes and in- a control group without neurological sizing] that the molecular basis for this re- testines (1). They play a central role in symptoms. CXCL13 was significantly cruitment is the SDF-1α/CXCR4 pathway.” orchestrating immune response. Some elevated in the group with neurobor- Editors Note: Chemokines are part of chemokines are pro-inflammatory, re- reliosis. They also found elevated levels the immune system that can cause damage cruiting immune cells to the site of of CXCL13 in controls with other neuro- to the body when activated against an an infection or injury, while others inflammatory diseases, although not as infection like Lyme. Certain chemokines are homeostatic, controlling the mi- high aas in the LNB subjects. Treatment are elevated in peopel with neuroLyme. gration of cells during normal pro- of LNB vastly reduces CXCL13 levels in cesses of tissue formation or repair. CSF, making measurement of this che- Further Reading CXCL13 and IgG in infected tissue mokine a valuable tool for ascertaining 1. Anthony DC, et al. The systemic active disease and effective clearance response to brain injury and Chemokine CXCL13 is a small cy- of the pathogen following treatment. disease (Article in Press). Brain, tokine belonging to the CXC chemokine Behavior and Immunity (2011). family. Recently, this chemokine has 2. Rupprecht TA, et al. The che- been promoted as a potential diagnostic Because a positive anti- mokine CXCL13 is a key regulator biomarker for the presence of neurobor- borrelia antibody index of B cell recruitment to the ce- reliosis having been discovered in 1998 rebrospinal fluid in acute Lyme (2). A 2005 study (3) concluded that the may persist even after neuroborreliosis. Journal of Neu- persistent production of CXCL13 and antibiotic treatment, roinflammation (2009, 6:42). IgG within infected tissue is a definitive 3. Narayan K, et al. The nervous system feature of Lyme neuroborreliosis (LNB). additional markers as ectopic germinal center: CXCL13 A strong up-regulation of CXCL13 are needed to identify and IgG in Lyme neuroborreliosis. has been observed in acute bacterial in- Annals of Neurology (2005, 57:6). fection, as spirochetes invade the cere- ongoing LNB. 4. Tjernberg I, et al. Diagnostic per- brospinal fluid (CSF). The host’s immune formance of cerebrospinal fluid system reacts to the invading organism chemokine CXCL13 and an- with a local inflammation, leading to an CXCL12 The Lyme Neuroborreliosis Re- tibodies to the C6-peptide in accumulation of leucocytes and activated Lyme neuroborrliosis. Journal B cells. B cells in the CSF of neurobor- search Program at New York University is looking into another chemokine, of Infection (2010, 62:2). reliosis patients can reach 80%, higher 5. Van Burgel ND, et al. Discrimi- than in other central nervous system in- CXCL12, also known as SDF-1 alpha. CXCL12 is a ligand of the chemokine nating Lyme neuroborreliosis from fections. Only a few chemokines attract other neuroinflammatory diseases B cells, and CXCL13 is one of them. receptor, CXCR4. SDF-1alpha and CXCR4 are required for normal em- by levels of CXCL13 in cerebro- CXCL13 and C6 antibodies bryonic development of the nervous, spinal fluid. Journal of Clinical Because a positive anti-borrelia an- gastro-intestinal, hematopoietic and Microbiology (2011, 49:5). tibody index may persist even after an- cardiovascular systems. According to 6. www.lymeneuroborreliosis- tibiotic treatment, additional markers one of their ongoing studies (6): program.org/html/current-research/ are needed to identify ongoing LNB. A “We hypothesize that the upregulation current-studies/study-no-2.html. study done in Sweden looked at CSF- of SDF-1α in pathological tissues of the Bonnie Sgarro is a librarian at Bard serum for combinations of CXCL13 central and peripheral nervous system College’s Stevenson Library in New York. and C6 antibodies, and found a sensi- (CNS, PNS) tissue is responsible for the She may be reached at [email protected]. tivity of 99% and a specificity of 98% (4). attraction of CXCR4 inflammatory cells,

26 The Lyme Times FEATuRE - Interview with Andrew Schlafly Citizens Can Stop Secretive Boards Schlafly asserts anonymous sources can’t finger LLMDs in Texas any more By R. Timothy Haley, MA State medical • Allow recording the informal continuing medical education (CME). boards are settlement conferences with Board According to Schlafly, this is no relief thought of as officials, an action that will reduce for Lyme doctors at all. He suggests that protecting pa- abuse and lack of justice occurring a more coordinated effort between AAPS tients from un- behind closed doors. and concerned Lyme groups who seek scrupulous or • Require the medical board to accept transparency on all these medical boards incompetent the findings of fact and law by the might help protect physicians from boards physicians, administrative law judge – a change that overreach their powers in any state. but Lyme that defenders of the medical boards The Texas legislation was successful, Andrew Schlafly groups have resisted most. he believes, through a coordinated come to realize Schlafly also confirmed that, as of attack that began with holding com- these same boards are under the in- January 2012, a federal judge has ordered mittee hearings in the state legislature. fluence of factions who don't think that the Texas Medical Board hand over Schlafly asserted what they did in chronic Lyme disease exists. a number of confidential complaints Texas could be done in other states. Lyme physicians caught under medical about doctors it has held secretly for Any chairman of the committee having board scrutiny after confidential or even years. This is the first time confidential some jurisdiction over these medical anonymous complaints about their efforts complaints have been so ordered in any boards may call hearings. Any elected to help Lyme patients have discovered state at any time, Schlafly believes. state official (a local Assembly person that there is no such thing as due process Strikingly, AAPS was effective in just or State Senator) will know who is in the investigations. Now an organi- two cycles of the convening Texas Leg- chairman of a committee that may call zation of independent physicians has islature in a coordinated effort to get hearings about these medical boards, in- come up with an effective political strategy the law passed. So compelling were cluding, but not limited to, a budgetary, against the Texas Medical Board that their efforts legislatively that in the health or jurisprudence committee. could be applied in any of the 50 states. Texas assembly they got a resounding He further outlined that a chairman of Efforts by the Association of American 147-0 vote for a full set of reforms. any related committee may hold hearings Physicians and Surgeons (AAPS) While some of their demands were into the activities of these various state stripped the Texas Medical Board of waylaid in the Texas Senate, according to medical boards. Then witnesses need to powers it felt the board had long abused, Schlafly, more could have been accom- be lined up and questioned not just about including ending anonymous com- plished if other groups had joined in the Lyme disease improprieties but about the plaints against Texas physicians. fight. For instance, while they were able whole broad-spectrum of transparency in In landmark legislation and spanning to end anonymous complaints – com- medical board procedure. Board members four years of activist participation from plaints with no name at all – the state did should be asked about why a doctor may 2007 to 2011, there has been a fun- not resolve the larger problem of con- not know who his/her accuser is and damental change in how the Texas fidential complaints. Complaints can other pointed questions under oath. Medical Board may review com- still be filed and the TMB does not have “All of this is relatively inexpensive plaints about individual physicians. to reveal the source of a complaint. and hugely beneficial even if nothing According to Andrew Schlafly, general Interested Lyme disease groups were else gets done,” Schlafly said, “because counsel for the AAPS, this most no- pushing a medical reform bill in the if they have been acting badly they will torious of state medical boards must now Texas Legislature at the same time. This think twice about doing it again.” conform to the following procedures: was a bill intended to protect physicians Once there is political momentum from • Establish a seven-year statute of who treat chronic Lyme disease and was well-attended hearings, then a bill needs to limitations on complaints filed with under the legislative guidance of Rep. be framed that will protect all physicians the medical board. Tod Hunter. However, the bill, HB 2975, from these boards. Schlafly feels educating • End anonymous complaints. came out at the other end of the legis- the rank-and-file is crucial. Standing up to • Require disclosure to the physician lative process not protecting Lyme phy- be counted by calling their elected officials when a complaint is filed by an sicians who go before the Texas Medical and attending any hearings is essential. insurance or pharmaceutical company Board but only “advising” the board about “Without all three components – legal, or third-party administrator. medical education coursework they think political and educational – meaningful Lyme doctors ought to take under the change is not likely,” Schlafly said.

Volume 24 Number 1 27 DEPARTMENT - Lyme Basics Testing for Lyme Understanding the Western Blot Editor’s Note: Many Lyme patients are denied diagnosis ten proteins, he plans “to test patient sera against the entire and treatment for years because of inadequate tests. The array of 1,800 Bb proteins in all their variability.” This is a far Western blot is one of the “indirect” testing methods, which cry from the 10 proteins utilized as definitive by the CDC. assesses the patient’s immune response to the infection. Connecticut pediatric Lyme specialist Dr. C. Ray Jones com- Lyme disease is a controversial diagnosis. Doctors generally plains that the CDC Western blot criteria don’t even make prefer confirming a case with a lab test rather than relying on a sense. They include non-specific, cross-reacting antibodies and clinical diagnosis without testing. The Centers for Disease Control exclude specific Bb antibodies. One can have a CDC surveillance- and Prevention (CDC) and the Infectious Diseases Society of positive IgG Lyme Western blot with the five non-specific anti- America (IDSA) recommend a two-tier testing system: an ELISA bodies, he says, without having any Bb species-specific antibodies. (which stands for Enzyme-Linked ImmunoSorbent Assay) or Requiring different bands on the IgM and IgG doesn't make an IFA (ImmunoFluorescent Assay) as the first – or screening – sense either, he adds. IgM converts to IgG in about two months test, followed by a Western blot. If your ELISA or IFA is negative, unless there is a persisting infection driving the IgM reaction. they don’t recommend further testing – and they don’t count your case of Lyme disease, even if you have other positive tests. Requiring a “sensitive” ELISA sounds good on paper, but studies CDC Case Surveillance Definition show it actually is not; it misses up to 70% or more of cases con- • A two-test approach for active disease and previous firmed by other methods. Experts have criticized the ELISA as infection using a sensitive enzyme immunoassay not being sensitive enough for a screening test. For example, the (EIA) or immunofluorescent assay (IFA) followed by a World Health Organization recently condemned a TB test with Western immunoblot (WB). 50% sensitivity as “unethical.” When the CDC first adopted the • All specimens positive or equivocal by a sensitive two-tier testing criteria in 1995 they emphasized that these criteria EIA or IFA should be tested by a standardized WB. were for surveillance, not diagnosis. At the time this seemed rea- Specimens negative by a sensitive EIA or IFA need not sonable, but since then the IDSA has adopted the two-tier sur- be tested further. veillance case definition for their clinical guidelines, and many • During the first four weeks of disease onset both IgM doctors rely on it completely. As a result, they miss many cases. and IgG should be performed. For the CDC to count your case, both tests must be positive. • IgM is positive if two of the following three bands are Doctors often insist on both tests being positive before they present: 21 (OspC), 39 (BmpA), and 41 (Fla) and the will diagnose and treat you. The two-tier method misses many patient has been sick less than one month. true cases. Fortunately, many Lyme-literate physicians skip the • IgG is positive if five of the following 10 bands are ELISA and go directly to a Western blot. LymeDisease.org rec- present: 18, 21 (OspC), 28, 30, 39 (BmpA), 41 (Fla), ommends you choose a CLIA- and Medicare-approved lab 45, 58 (not GroEL), 66, and 93 and if the patient has that reports all the bands, not just the CDC-approved ones. been sick more than one month. The Right Bands The Western blot provides more detailed information about your antibody profile than the ELISA. The test result looks Part of the problem is that the CDC criteria were developed like a barcode, with “bands” corresponding to different an- using blood samples from people with early Lyme disease. tigens presented by the Lyme spirochete. The bands represent They don’t work as well for people with late or chronic Lyme. outer surface proteins, flagella, and other proteins. The test Lyme-literate physicians will often accept non-CDC-compliant may be divided into two parts, IgM (Ig stands for immuno- blots as evidence of Lyme disease. Outer surface protein A (OspA), globulin) for early Lyme; IgG for late Lyme (after one month). for example, is one of the proteins found on the surface of Bb. It The CDC has defined certain bands and a minimum number is such a characteristic protein that vaccine developers chose it as of bands they will accept as positive for Lyme on each test. For the basis for the discontinued Lyme vaccine, LYMErix®. Ironically, the IgM, the magic number is two out of three; for the IgG test, this is the reason OspA was excluded from the CDC surveillance it’s five out of ten. If you don’t have the minimum number of case definition, that is, because vaccinated people would have a bands or the right ones, the CDC won’t count your case, and strong response to it and appear to have Lyme when they did not. doctors following the IDSA guidelines won’t diagnose you either. But what if you have not been vaccinated? The CDC still According to journalist Pam Weintraub, author of Cure doesn’t count OspA, but knowledgeable physicians know that Unknown, the CDC/IDSA method is, in a word, crude. In it is a significant sign of infection. This is why it’s important to an interview she recounts in her book, Dr. Ben Luft of Stony choose a lab that reports all the bands, not just the CDC ones. Brook University said that instead of testing for antibodies to

28 The Lyme Times DEPARTMENT - Lyme Basics

, CFS, MS, Parkinson's, ALS, ADD, depression, What do the Western blot bands mean? etc. – when in fact Lyme disease is the underlying culprit. Treatment for those conditions will not address the source of 18: Flagellin fragment the problem. 21: OspC?* 22: Immunogenic integral membrane lipoproteins • False-negative tests provide your health insurer another 23-25: Outer surface protein C (OspC) * reason to deny your medications as well as any further testing 28: outer surface protein D (OspD) or treatment for Lyme and TBDs. 30: OspA substrate binding protein While no test can rule out Lyme disease, a negative 31: Outer surface protein A (OspA) test result still suggests to your doctor that you do not 34: Outer surface protein B (OspB) have Lyme and makes diagnosis more difficult. 37: FlagellinA gene product. Which blot is best? 39: Bacterial membrane protein A The best blot is a sensitive blot. Many commercial labs (e.g. 41: Flagella Quest, Lab Corps, ARUP) use a test kit based on a single strain of 45: Heat shock protein, appears for HGE Bb native to Long Island, NY. The test will not be as sensitive if you 58: Heat shock protein picked up Lyme in a different part of the country. For instance, 66: Heat shock protein, outer/integral membrane protein in a group of patients infected with CA5, a California strain, 20% 73: Heat shock protein. were negative when tested against the B31 New York strain. 83: High molecular mass protein It is best to use a lab approved by CLIA and Medicare 93: Immunodominant protoplasmic cylinder that specializes in testing for TBDs. IGeneX Lab in Cali- antigen, associated with the flagellum fornia is unique in using two strains of Bb in its blot and * The CDC calls the 24 and 21 kDa proteins the same. also reports all bands, including 31 and 34. Medical Diag- nostic Laboratory in New Jersey and Stony Brook lab in New York will report all bands if your doctor requests them. It is important to order the most sensitive test you can What do the Western blot bands mean? find. In fact, if you can afford a panel – blot, urine antigen Each band on the blot indicates the presence of an antibody to and PCR – having all three will increase your chances a spirochetal antigen with a certain molecular weight expressed of getting a true positive to 98%. Early diagnosis is the in kiloDaltons (kDa). You will often see, for example, 18kDa, surest way to prevent late, chronic Lyme disease. 31kDa, etc. In this article, to keep it simple, we are dropping the People in financial difficulty can consider applying for a kDa. See the box for what each band is thought to represent. testing grant from Lyme-TAP (Lyme Test Access Program), The first to show positive is usually the 41 band followed a nationwide patient assistance program offered by Ferndale by the 23 band. Dr. Jones thinks that the presence of the 41 Foundation in coordination with Lyme Patients As- band, along with one of the specific bands, is sufficient to in- sistance Group. Visit Lyme-tap.com for information. dicate that a person has been exposed to the Lyme bacteria. Interestingly, the IgM is often positive in late Lyme disease as well. Some experts think this is because of the relapsing-remitting nature of the disease. Hidden spirochetes re-emerge, perhaps with a new protein coat, and trick the immune system into thinking Why do I have a negative test? it is a new infection. The IDSA does not recognize this phe- Here are some of the reasons your test nomenon as legitimate and calls such tests “false positives.” result might be falsely negative. What about false negative tests? • Specimen improperly handled • Test run too soon There are significant disadvantages for a patient re- ceiving a false-negative Lyme test. The website Maryland • WB criteria fail to include most significant antigens Lyme summarizes the downsides as follows: • Test does not detect the strain of Bb you are infected • Your health care professional may not realize you have Lyme with disease and, as a result, not treat you. • Immune suppression by recent antibiotics, steroids, or • False-negative tests can cause a delay in obtaining a proper co-infections diagnosis. Not receiving proper treatment in the early stages • Lab tests standardized for early, not late-stage disease of Lyme allows the infection to spread throughout your • Antibodies may decline over time body, worsening your condition and allowing the disease to • Antibodies are bound up in immune complexes (tests advance to later stages. Late-stage or chronic Lyme disease is detect free antibodies) more difficult for the patient and much more complex and • Spirochetes may be hidden or dormant or in a cell expensive to treat. wall-deficient form • You may be improperly diagnosed with other disorders –

Volume 24 Number 1 29 DEPARTMENT - Patient Voices Lyme Disease Steals Singer’s Voice Giving up music felt like she had lost herself By Erica Xenne

People ask, “What do you do?” “What are you into?” Lyme disease doesn’t do that; it must be something else!” The underlying question is, “Who are you?” That is what Although I avoided music, songs kept writing themselves people want to know. Childhood is a time to explore these through me. During the ten years that I was not doing music, questions. But for me there was no question. I knew who I I built up a repertoire of about 20 songs. Little by little, I began was and what I loved to do for as long as I can remember. sharing my songs and was encouraged to write for other singers. Before Lyme disease, I was a professional singer, pianist But it didn’t feel right. I love singing and was born to sing on stage. and composer. When people asked, “What do you want I started performing with a backup band, singing through my to be when you grow up?” the answer was: A singer. whispery voice. Most shows were tough. When I played solo, my I started piano lessons at four – acting and singing at eleven. I voice seemed haunting and angelic. With a band, my voice was practiced in the school music room during lunch. I was usually drowned out. But a few good shows kept me going. in two or three musicals. By age 13, I began playing piano and Exiled from my passion [Eros] – singing – I call my band singing at restaurants for tips. Erosian Exile. When I I saved my money because I perform, I wear white, which dreamed of buying a mobile reflects colors around me home and traveling around but never absorbs them. the country with my keyboard I have lost my ability to speak to sing all over America. above a whisper and my oppor- Before my sixteenth birthday, tunity to be on Broadway. But I was preparing to audition for I have gained faith in myself the Broadway show “Les Mis- and the power of my dreams. erables,” recording an original Beyond any doubt, nothing is album in New York City and going to change the essence considering other major pro- of who I am. My struggles are fessional opportunities. reflected in my songs. Al- But on my birthday I woke though I may be a changed up hoarse. I couldn’t sing and person, the act of reflecting had to cancel one event after my emotions through music – another. The laryngitis per- even grieving for what I have sisted for months. Nobody lost – strengthens my essence. knew why. Doctors put me on This year, Erosian Exile re- steroids hoping to reduce in- leased a rock and roll album flammation in my vocal cords. called Slave to Freedom. I After my second course of recently directed, shot and steroids, I couldn’t move. My edited my first music video long, wavy hair fell out rapidly. for the song, Born in a Box. I couldn’t feed myself or put on I am recording an acoustic clothes. Sometimes I didn’t know who I was. I spoke in a whisper. album, playing my songs on piano and sing lead with cello and Once I was diagnosed with Lyme disease and began antibiotic backup vocals. I’m preparing my band for the next rock album, treatment, I improved. After a few years I went from being unable and slowly chipping away at an electronic album. Though I to move to being able to walk. Despite my continuing illness, I often sing with backup singers, I sing lead on all of my songs. was able to graduate from college. But my voice never recovered. Because my voice comes and goes as my Lyme fluctuates, it Even after four vocal chord surgeries, I still speak in a whisper. takes a long time to record vocals, but it is worth the struggle. I felt lost. I stopped playing music. I could not play piano All my life I have sung for the love of singing, but now I sing for without crying for my missing voice. I did not know what I hope. I sing because nobody should give up on their dreams. Yes, wanted to do or who I was. I wanted to say, “I was a singer, I have Lyme. I speak in a whisper and have scar tissue where my but now I’m nobody.” People made rude comments – “What’s vocal cords once were. But a singer is who I am. I will not give up. wrong with your voice?” If I took the risk of telling them The author may be reached at erosianexile.com. that I had Lyme disease, I got unjustified remarks like, “Well,

30 The Lyme Times Putting Lyme Behind You Cutting Edge Ways to Heal from Tick-Borne Disease Joseph Burrascano, MD The 2-disk 150-minute DVD set is available from LymeDisease.org • Suggested minimum donation: $40 SPECIAL OFFER One year LymeDisease.org membership + DVD: $50 Members receive quarterly issues of The Lyme Times plus online access to archived issues at lymedisease.org All proceeds from the sale of the DVD go towards supporting LymeDisease.org’s re- search, education and advocacy projects. Dr. Joseph Burrascano is one of the world's leading experts on diag- nosing and treating Lyme disease. The 2011 patient education program in Santa Rosa, CA, also featured a panel of Lyme-treating physicians, including Drs. Eric Gordon, Ray Stricker, AzRa MaEl, Christine Green, Neil Nathan and Wayne Anderson.

" Clip and Mail Make our voice even stronger Join LymeDisease.org today! A national advocacy organization supporting Lyme patients in all states. All members receive four quarterly issues of The Lyme Times plus online access to archived issues on the website. YES! Please begin a 1-year membership in LymeDisease.org! Send form below or visit our website at www.lymedisease.org. MEMBERShiP CATEgoRiES $35 – Basic $250 – Patron $2,500 & up - Platinum $50 – Supporting $500 – Champion $15 - Special Needs $100 – Sustaining $1000 - Gold Circle $45 - International MEMBERShiP SPECiAL Join at the $50 level or above and receive our 2-DVD set “Putting Lyme Behind You” with Joseph Burrascano, MD I enclose an additional $ ______as a tax-deductible contribution to the Education and Research Fund. I enclose my check or money order for the total amount of $ ______Please consider donating to honor family and friends at important occasions – anniversaries, birthdays, holidays, graduations, memorials. Make your check payable to LymeDisease.org and mail with this form to: P.O. Box 5658, Marysville, CA 95901. Please Print Clearly Name: ______Street Address: ______Email Address ______Phone Number ( ) ______Help us save resources by providing your email address. We’ll send renewal notices and payment receipts directly to your email account. Your confidential information will be used only for our membership purposes.

Volume 24 Number 1 31 DEPARTMENT - Ask the Expert 12 Hot Topics in 2012 Watch for new antibiotics, tests and alternative therapies By Jerry Simons, PA Wondering about the hot topics for 2012? Trifortify (liposomal glutathione), LDN and Questran. Below are some that I think everyone will be 9. GCMAF. This is an immune system regulator that talking about! How many are you fluent in? works as a vitamin D binding program. It has worked well 1. New antibiotics. A new, strong 5th gen- in cancer and HIV patients. Many Lyme patients are re- eration cephalosporin-type antibiotic is porting positive changes with this blood product. available: Ceftaroline, works on a similar 10. Candida. Many Lyme patients suffer from poor immune pathway to Rocephin (a 3rd generation function. The Jeffrey Modell foundation has encouraged candida antibiotic). I have observed a positive provocation skin testing to better assess body tissue load and early response in patients who have hit a plateau on Rocephin. sensitivity. If candida levels are high, antibiotic therapy will Great when combined with Zithromax, flagyl and teasel root. fail. Remember to address candida first. As candida is de- 2. Lipid therapy. Lipid replacement therapy helps to restore the stroyed, many classic Lyme or TBD symptoms may appear! healthy lipids found in all of our cells, which are destroyed by 11. Mold hypersensitivity. Mold sensitivity is a drain on the illness and toxins. Phosphatidylcholines (PC) (lecithin), found immune system and can hamper Lyme therapy and exacerbate in egg yolks and soy, is available in oral formulations or IV. symptoms. VCS vision testing, C4A complement level, and Often as little as six PC treatments can show positive benefit. MMP9 blood levels help us assess the degree of mold exposure. 3. Low-Dose Naltrexone. This immune system favorite has been Get a mold test kit and remember to test under your bed. shown to be beneficial for autoimmune disease as well as per- 12. Glutathione. This is an amazing immune booster, anti- sistent infections. As an immune stimulant it helps to rebuild oxidant and detoxifier. Many patients would prefer a daily in- the system and battle infectious agents. In many patients, Lyme jection of this over B12. I have many on long-term oral liquids. is clearly an autoimmune disease, and this is a great remedy. Note: Look for more detailed information on each 4. Lyme culture. Advanced Lab Services is now offering a of these items in future issues of The Lyme Times. spirochete culture test. This is a major advancement, since in Jerry Simon, PA-C, a physician assistant, worked with the world of infectious disease there is no better test than to Dr. Joseph Burrascano, Jr., MD, from 1995 to 2006. culture the actual germ. Some questions still remain though, i.e., would an infection in the tissue (brain, knee car- tilage, etc) still be detected in the blood culture? 5. Persistence. We were all delighted to read the Cornell University study published in Clinical Im- Got Lyme? munology/Nature Magazine stating that “patients diagnosed with “post-Lyme disease syndrome” Join an Online Support Group [chronic Lyme] have antibodies that suggest they Want to learn more about Lyme disease? carried the infection for an unusually long time.” Want to connect with other patients? 6. Complement proteins. Found in the blood, Your state online support group allows you to connect with other Lyme they help the immune system with inflammatory patients in your area — a virtual meeting place — a source of infor- cascades. High levels often indicate acute infection mation and emotional support for people with tick-borne diseases. while low levels hint at a more long-term in- fection. C3A and C4A are especially good at moni- For help finding your state support group, visit toring for mold and Lyme exposure/activity. lymedisease.org 7. Biofilms. It is well known that many in- fectious diseases - including Lyme - can Click on “Activism” and choose “Not in California” produce a biofilm making antibiotic therapy dif- Or visit your state site directly. ficult. There are several products available Enter your state name into the following url: to treat biofilms while treating Lyme. health.groups.yahoo.com/group/(YOURSTATENAME)Lyme 8. Low-dose minocycline. The Road Back (all sites include a state name run together with “lyme”) Foundation has endorsed low dose, long- term Minocin for years to help control inflam- e.g., Maryland: health.groups.yahoo.com/group/marylandLyme mation. I have seen many patients benefit from In South Carolina, insert a hyphen between state name and Lyme this, and have observed a slow gradual increase (southcarolina-lyme) in the CD57 levels. Great when combined with For Washington DC, go to DCLyme

32 The Lyme Times

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LYMEPOLICYWONK

Patient-Centered Research An idea whose time has come for Lyme By Lorraine Johnson, JD, MBA CEO, LymeDisease.org

A friend forwarded me the audio link of an interview with Dr. Iain Chalmers of the Cochrane Collaboration — a leading voice in evidence-based medicine. Dr. Chalmers, who focuses on the patient perspective in evidence-based medicine, made a number of points that I think you will find of interest. First, he said, research agendas should be driven by patient concerns rather than by researchers’ preferences. There’s an interesting idea. Then he said that physicians have to make a decision today and cannot wait for the research of tomorrow. That sounds right, too. He went on to say that when looking at outcomes, the clinical experiences of those who receive the intervention or treatment are the key — these experiences are not the soft data, they are, in fact, the “hard” evidence. Finally, he noted the difficulty of getting “disappointing” results pub- lished. Disappointing results can be trials that don’t turn out as planned or that contradict what the researcher expected. His last quote regarding academic researchers in particular stuck with me and should resonate with the Lyme com- munity: “If you have a cherished hypothesis which your career has ridden on for the past 20 years, and someone does a really killer experiment which actually shows that you have been wrong all that time, the natural reaction — the human reaction — is to say “there must be something wrong with it … I can’t have been wrong all these years.” It all sort of takes me back to the Embers monkey study (featured in this issue) where they found persistence of the Lyme bacteria in monkeys despite antibiotic treatment protocols. In the comment section of one of my blog posts (which drew 175 comments), Dr. Phil Baker goes head to head with patients. Formerly with the NIH, Baker now heads the American Lyme Disease Foundation, which many patients believe is a front for the Infectious Diseases Society of America (IDSA). Rather than embracing the new science, Baker’s responses sound more dogmatic than impartial. Like maybe he has a strong interest in showing that “he can’t have been wrong all these years.” What do you think? If you’ve missed the fireworks, visit lymedisease.org/news/lymepolicywonk/lyme- policywonk-was-this-important-lyme-study-hidden-for-12-years.html. If you want to listen to Dr. Chalmers’ interview, visit bbc.co.uk/programmes/b01cjwtd. For subsequent updates on this topic as well as commentary on other medical-legal issues impacting the Lyme community, follow Lorraine’s blog at lymedisease.org/news/lymepolicywonk. You may contact her at [email protected].