Attack of the Chronic Lyme Denialists

by: CTPatriot

Mon Nov 12, 2007 at 04:36:31 AM EST

For more than a decade, a battle royale has been waged over the diagnosis and treatment of Lyme disease. An excellent overview of the controversy is provided by Dr. Raphael Stricker, President of the International Lyme and Associated Diseases Society (ILADS), and his associate, Lorraine Johnson in an article published by the medical journal, Expert Review of Anti-infective Therapy:

Lyme disease is one of the most controversial illnesses in the history of medicine [1,2]. Over the past decade, two opposing camps have emerged in the controversy over this tick-borne illness. One camp is represented by the Infectious Diseases Society of America (IDSA), which maintains that Lyme disease is a rare illness localized to well-defined areas of the world. According to the IDSA, the disease is ‘hard to catch and easy to cure’ because the infection is rarely encountered, easily diagnosed in its early stage by means of accurate commercial laboratory tests and effectively treated with a short course of antibiotics over 2–4 weeks. Chronic infection with the Lyme spirochete, Borrelia burgdorferi, is rare or nonexistent [3].

The opposing camp is represented by the International Lyme and Associated Diseases Society (ILADS), which argues that Lyme disease is not rare and, because its spread is facilitated by rodents, deer and birds, it can be found in an unpredictable distribution around the world accompanied by other tick-borne coinfections that may complicate the clinical picture. According to the ILADS, tick bites often go unnoticed and commercial laboratory testing for Lyme disease is inaccurate [1,4]. Consequently, the disease is often not recognized and may persist in a large number of patients, requiring prolonged antibiotic therapy to eradicate persistent infection with the evasive Lyme spirochete [1,4].

The battle over chronic Lyme disease has taken some unprecedented turns. As of 2007, more than 19,000 scientific articles about tick-borne diseases have been published, and the dichotomy between basic science studies and clinical research articles is striking: while basic science studies continue to highlight the invasiveness and elusiveness of B. burgdorferi in culture systems and animal models, clinical research articles adhere to the dogma that B. burgdorferi produces a limited infection that is eradicated easily [5,6]. Patients with persistent symptoms are labeled as having ‘post-Lyme syndrome’, hypothesized to be an autoimmune response to the previously eradicated infection. To date, attempts to elucidate the autoimmune mechanism of post-Lyme syndrome have been unsuccessful [7,8].

While IDSA followers have embraced the post-Lyme syndrome concept and foresworn long-term antibiotic treatment, followers of the ILADS have continued to use antibiotics to treat persistently symptomatic Lyme patients for chronic infection with B. burgdorferi and coinfecting tick-borne agents. They cite animal studies that demonstrate persistent infection by a complex organism, as well as numerous clinical reports that document failure of the standard 2–4 weeks of antibiotic therapy recommended by the IDSA [1,9–12].

The corporate media often portrays this war as one between equally powerful sides posing equally valid arguments, but that is far from the case. It has never really been a fair fight, nor has it ever really been about making sure the best science wins.

The academics on the IDSA side of the battle, who I will refer to as "chronic Lyme denialists", have chosen to forego the rigors of scientific debate, opting instead to dominate the marketplace through the use of sheer political force. They have accomplished this by seeking out positions of influence both inside and outside of government, and using those powerful positions to further their particular ideology to the exclusion of all others. In so doing, they have established control over every aspect of Lyme disease -- research, testing methods, diagnostic standards, treatment standards, insurance reimbursement and even over the livelihoods of those doctors who dare to treat outside the denialists' protocols.

Through their connections at NIH and CDC, they have gobbled up most of the public grant money available for Lyme disease research, and expended far too much of it on poorly conceived studies designed to substantiate their long-held beliefs that long-term antibiotic therapy is unwarranted and that chronic Lyme disease is a myth. Their sphere of influence extends to America's most prestigious medical journals, where they are able to impact which studies get published, which studies don't, and how quickly such decisions are made. Invariably, studies whose conclusions contradict those of the chronic Lyme denialists have a harder time passing through the journals' peer review process.

They have similarly used their powerful connections to encourage and support investigations by state medical boards against doctors who treat chronic Lyme disease in order to drive the "competition" out of business. And they have used their consulting relationships with insurance companies to deprive patients of access to extended antibiotic therapy and/or insurance reimbursement, even when that therapy has been shown to improve the patients' health.

Stacking the Deck

Last year, determined to put an end once and for all to the debate over chronic Lyme disease, the denialists, under the rubric of the Infectious Diseases Society of America (IDSA), published an updated set of diagnostic and treatment guidelines that literally defined chronic Lyme disease out of existence.

While the IDSA authors' ideology was reason enough to doubt the scientific objectivity of the guidelines, suspicions of bias grew even deeper when it was revealed that the authors had relied on only a small subset (405) of the "more than 19,000 scientific studies on tick-borne diseases" in formulating their conclusions, and that they had largely disregarded contradictory research. As further evidence of the ideological echo chamber within which IDSA's guidelines were created, a significant percentage (close to 40% by my count) of the 405 studies were authored by the very same people who had authored the IDSA guidelines.

Because of the serious public health consequences which could result from adherence to erroneous diagnostic and treatment protocols, and because evidence suggested that bias in the creation of IDSA's guidelines had corrupted its conclusions, and finally because the financial ties of IDSA authors to insurance companies, labs, and Lyme related patents, royalties, etc. might have provided motivation for such bias, Connecticut Attorney General, Richard Blumenthal decided to investigate:

The controversy came to a head in November 2006 when the IDSA released new guidelines severely limiting treatment options for patients with persistent Lyme symptoms [3]. The guidelines were so restrictive that the Attorney General of Connecticut (USA) initiated an unprecedented investigation into possible antitrust violations by the IDSA, the dominant infectious disease society in the USA, in its formulation of the guidelines [13,101].

Although these new guidelines were trumpeted as independent scientific corroboration of the IDSA guidelines' pronouncements, nothing could be further from the truth. Because, as it turns out, the AAN guidelines were authored by 3 of the same people who had authored the IDSA guidelines (Wormser, Shapiro, Halperin) and who therefore had a vested interest in arriving at identical conclusions. Thus, the professed independence of AAN's guidelines is likely nothing more than an illusion. Attorney General Blumenthal apparently agrees with that observation, as he recently subpoenaed related documents from AAN (as inferred from the title of a firewalled article, available to paid subscribers only, "Guidelines on Trial: AAN Subpoenaed as Part of Investigation into Treatment Parameters for Lyme Disease", which can be found in the October 16th, 2007 AAN publication, Neurology Today).

That wasn't the end of the politically motivated "scientific" onslaught. On October 4, 2007, barely over a month ago, the prestigious New England Journal of Medicine (NEJM) became the latest to join the fray with their publication of a research review titled, 'A Critical Appraisal of "Chronic Lyme Disease"'. That article, whose primary author is long time chronic Lyme denialist Dr. Henry Feder of Connecticut Children's Hospital, reached virtually the same conclusions as the previously released IDSA and AAN guidelines (my emphasis):

Chronic Lyme disease is the latest in a series of syndromes that have been postulated in an attempt to attribute medically unexplained symptoms to particular infections. Other examples that have now lost credibility are "chronic candida syndrome" and "chronic Epstein–Barr virus infection."57,58 The assumption that chronic, subjective symptoms are caused by persistent infection with B. burgdorferi is not supported by carefully conducted laboratory studies or by controlled treatment trials. Chronic Lyme disease, which is equated with chronic B. burgdorferi infection, is a misnomer, and the use of prolonged, dangerous, and expensive antibiotic treatments for it is not warranted.2

Those commonalities alone would be enough to cast doubt on the originality and independence of Feder's work. But that's not all. The NEJM study's collaborators included a whopping 11 out of the 14 IDSA guideline authors (IDSA's Wormser, Shapiro and Steere were listed as NEJM lead authors, while IDSA's Klempner, Bakken, Bockenstedt, Nadelman, Dattwyler, Dumler, Halperin and Krause were listed as NEJM ad-hoc committee members). Remarkably, there were only 3 IDSA authors, Durland Fish, Gerold Stanek and Franc Strle, who had no discernable involvement with the NEJM article.

Conflicts of Interest

It is common practice for medical journal articles to include a disclosure statement describing the potential conflicts of interest of each author. But there is never any guarantee that all relevant conflicts will be included in that disclosure. According to ILADS, there was one one very important omission from the NEJM article's conflict disclosure (my emphasis):

• The article was written by a group of researchers who have consistently voiced a narrow viewpoint on the existence of chronic Lyme disease and appropriate treatment. Eleven of the authors were members of the panel that formulated the 2006 Infectious Diseases Society of America (IDSA) Lyme guidelines. The panel is currently under investigation by the Connecticut Attorney General for exclusionary practices in formulating the IDSA guidelines.
• The authors of the article failed to disclose that they are under investigation by the Connecticut Attorney General. This omission violates the "full disclosure" policy of the journal and creates a conflict of interest by calling into question the authors' motives for writing the article.
• Several authors of the current article also participated in formulation of copycat Lyme guidelines for the American Academy of Neurology. Those guidelines were presented as "independent corroboration" of the IDSA Lyme guidelines, when in fact the same individuals were involved with both guidelines and employed the same exclusionary tactics that prompted the Connecticut Attorney General's investigation.

And if that's not serious enough, NEJM also neglected to mention the fact that IDSA guideline author Dr. Mark Klempner not only served as an ad-hoc committee member for the NEJM article but at the very same time served as an associate editor at NEJM, a position which may well have afforded him undue influence over the publication of an article whose conclusions stood to greatly benefit both himself and his IDSA colleagues.

Equally noteworthy are the conflicts of interest that did get mentioned:

Dr. Feder reports receiving lecture fees from Merck and serving as an expert witness in medical-malpractice cases related to Lyme disease. Dr. Johnson reports holding patents on diagnostic antigens for Lyme disease. Dr. O'Connell reports serving as an expert witness related to Lyme disease issues in civil and criminal cases in England. Dr. Shapiro reports serving as an expert witness in medical-malpractice cases related to Lyme disease, reviewing claims of disability related to Lyme disease for Metropolitan Life Insurance Company, and receiving speaker's fees from Merck and Sanofi-Aventis. Dr. Steere reports receiving a research grant from Viramed and fees from Novartis. Dr. Wormser reports receiving research grants related to Lyme disease from Immunetics, Bio-Rad, and Biopeptides and education grants from Merck and AstraZeneca to New York Medical College for visiting lecturers for infectious-disease grand rounds, being part owner of Diaspex (a company that is now inactive with no products or services), owning equity in Abbott, serving as an expert witness in a medical-malpractice case, and being retained in other medical-malpractice cases involving Lyme disease. He may become a consultant to Biopeptides. No other potential conflict of interest relevant to this article was reported.

No doubt, similar conflicts of interest are shared by other members of NEJM's ad-hoc panel, which reads like a veritable who's who of chronic Lyme denialists:

The following were members of the Ad Hoc International Lyme Disease Group: Gundersen Lutheran Medical Foundation, La Crosse, WI — W.A. Agger; National Microbiology Laboratory, Health Canada, Winnipeg, MB, Canada — H. Artsob; Johns Hopkins Medical Institutions, Baltimore — P. Auwaerter, J.S. Dumler; St. Luke's Hospital, Duluth, MN — J.S. Bakken; Yale University School of Medicine, New Haven, CT — L.K. Bockenstedt, J. Green; New York Medical College, Valhalla — R.J. Dattwyler, J. Munoz, R.B. Nadelman, I. Schwartz; Danbury Hospital, Danbury, CT — T. Draper; Johns Hopkins Medical Institutions, Crofton, MD — E. McSweegan; Atlantic Neuroscience Institute, Summit, NJ, and the New York University School of Medicine, New York — J.J. Halperin; Boston University School of Medicine and Boston Medical Center, Boston — M.S. Klempner; University of Connecticut School of Medicine and Connecticut Children's Medical Center, Farmington — P.J. Krause; Centers for Disease Control and Prevention, Fort Collins, CO — P. Mead; University of British Columbia, Vancouver, Canada — M. Morshed; University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, Piscataway — R. Porwancher; University of Connecticut Health Center, Farmington — J.D. Radolf; Maine Medical Center, Portland, ME — R.P. Smith, Jr.; Schneider Children's Hospital at North Shore, Manhasset, NY — S. Sood; Washington Hospital Center and Georgetown University Medical Center, Washington, DC — A. Weinstein; Wadsworth Center, New York State Department of Health, Albany — S.J. Wong; and Connecticut Children's Medical Center, University of Connecticut, Hartford — L. Zemel.

The Public Impact

Before the NEJM article could even hit the presses, its PR machine had cranked into hyper-drive, scoring articles in the Hartford Courant, Danbury News-Times, New Haven Register, Washington Post, as well as securing TV reports on at least 2 Connecticut stations. The news media universally trumpeted "important new findings", and included numerous quotes from Dr. Feder, featuring such fraudulent claims as:

"But the hard science says chronic Lyme does not exist.''

Stricker's reaction to the NEJM article was appropriately outraged:

"It's a disaster for people with chronic Lyme Disease,'' said Dr. Raphael Stricker, president of the International Lyme Disease Association. "Since it appeared in the New England Journal of Medicine, everyone will take it as dogma and nobody will want to pay for treatment.''

It's truly a shame to see a respected organization like NEJM allow itself to be hijacked by medical experts for the furtherance of a political agenda. That's really what this latest pseudo-scientific article is about -- insulating the IDSA authors from prosecution while simultaneously further cementing the chronic Lyme denialists' control over the definition of Lyme disease (thereby also guaranteeing that their insurance benefactors will never again have to pay for long-term antibiotic treatment).

Moreover, through their participation in the NEJM article, the IDSA authors have arrogantly and brazenly thumbed their noses at Connecticut's attorney general, as well as at the many patients who depend on lengthy courses of antibiotics to recover from Lyme disease along with the doctors who risk their careers to treat them. If there is a silver lining at all to be found here, it's that the IDSA authors appear to have unwittingly provided Attorney General Blumenthal with yet more evidence of anti-competitive behavior.

Evidence of Chronic Lyme

Just when it seemed as though the denialist foxes had completely taken over the chronic Lyme henhouse, a new study in the journal Neurology, "A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy", concluded that lengthier courses of antibiotics are helpful in reducing neurologic symptoms related to chronic Lyme disease. This study was conducted by Dr. Brian Fallon et al at Columbia University (possibly the only major American medical school that is not under the thumb of chronic Lyme denialists).

The Columbia study, while confirming the effectiveness of lengthier courses of antibiotics for at least temporarily improving symptoms, was unable to draw any conclusions as to whether lengthier courses of antibiotics might have produced a more permanent improvement in health:

Conclusion: IV ceftriaxone therapy results in short-term cognitive improvement for patients with posttreatment Lyme encephalopathy, but relapse in cognition occurs after the antibiotic is discontinued. Treatment strategies that result in sustained cognitive improvement are needed.

Such evasive ability and potential chronicity was never more clearly illustrated than in a 1995 case report published in the Journal of Neuropsychiatry & Clinical Neurosciences titled "Rapidly progressive frontal-type dementia associated with Lyme disease." The following Hartford Courant "letter to the editor" penned by this author explains the significance:

Evidence Of Chronic Lyme

October 11, 2007

In the Oct. 4 Courant article "Lyme Disease Diagnosis Challenged" [Page 1], Dr. Henry M. Feder Jr. is quoted as saying that "the hard science says chronic Lyme does not exist." Dr. Feder seems to have a unique definition of "hard science," one that ignores the wealth of peer-reviewed science whose conclusions disagree with his entrenched ideology.

For example, in 1995, the Journal of Neuropsychiatry & Clinical Neurosciences published a study rooted in hard science titled "Rapidly progressive frontal-type dementia associated with Lyme disease." To summarize, a seriously ill man was diagnosed with Lyme disease and treated with the recommended course of antibiotics. He improved during treatment but rapidly deteriorated afterward. He was re-diagnosed with incurable progressive dementia and institutionalized. He soon died. An autopsy found his brain to be inhabited by the bacteria that causes Lyme disease, the same bacteria that Dr. Feder insists could not possibly have survived the amount of antibiotics given that patient.

In the real world, autopsies, cultures and biopsies are considered hard science. Apparently, in Dr. Feder's alternate universe, that of the chronic-Lyme denialists, such studies can simply be dismissed. And as you can see, the consequences to patients are potentially quite deadly.

While published case reports of deaths due to chronic Lyme disease are relatively rare, the one highlighted above provides dramatic proof of the Lyme disease bacteria's ability to persist, not to mention the devastating consequences which can result from failure to recognize such persistence. There are many more less dramatic but equally conclusive peer reviewed studies which have also proven the Lyme bacteria's ability to persist. A representative list was compiled by the LymeInfo website in 2003 and can be found here: "Relapse/Persistence of Lyme Disease Despite Antibiotic Therapy".

The More Things Change...

Though the Columbia study noted above provides a major breakthrough, its conclusions will likely have little to no influence over the national treatment standards for Lyme disease. The chronic Lyme denialists, who control those standards, will simply denigrate and reject Columbia's work, as IDSA guideline author Dr. John J Halperin already demonstrated with his editorial rebuttal, "Prolonged Lyme Disease Treatment" (complete version of article found here requires paid subscription) that was published in the very same issue of the Journal Neurology as the Columbia study.

Meanwhile, as the battle rages on, a growing number of chronically ill Lyme disease patients find themselves victimized not only by a debilitating disease whose cause and cure remain uncertain, but also by a cabal of academics, the "chronic Lyme denialists", for whom power, money and ideology would appear to trump the commitment to "first do no harm."

Petition Against IDSA Guidelines: http://www.lymediseaseassociation.org/referral/Petitions/Petition.php?id=1

References and Recommended Reading/Viewing:

• Lyme Disease: Does It Really Linger? (Elisabeth Rosenthal, NY Times, August 24, 1993)
• The Lyme Controversy - Part 3 (WSET-13 ABC TV, Virginia)
• Health insurer tied bonuses to dropping sick policyholders (Lisa Girion, Los Angeles Times)
• No Basis For Chronic Lyme Disease (William Hathaway, Hartford Courant)
• ILADS Members Question Motives of New England Journal of Medicine Article on Lyme Disease Treatment -- Article in New England Journal of Medicine Fails to Disclose Conflicts of Interest of Overlapping Panel Members (PRWeb)
• Lyme disease: a turning point (Raphael B Stricker and Lorraine Johnson, ILADS)
• A Critical Appraisal of "Chronic Lyme Disease" (Feder et al, New England Journal of Medicine)
• First Placebo-Controlled Study of Cognitive Impairment Due to Chronic Lyme Disease (Columbia Univ. Press Release)
• A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy (Fallon et al, Journal Neurology)

• LymeInfo: http://www.lymeinfo.net/
• Lymenet: http://www.lymenet.org/
• LymeBlog: http://lymeblog.com/
• The Lyme Times Magazine: http://www.lymedisease.org/lymetime.htm
• Public Health Alert Online Magazine: http://www.publichealthalert.org/
• Tick Tips for Kids: http://ticktips4kids.com/

• ILADS: http://www.ilads.org/
• Lyme Disease Association: http://www.lymediseaseassociation.org/
• Lyme Disease Foundation: http://www.lyme.org/
• CALDA: http://www.lymedisease.org/
• National Research Fund for Tick-Borne Diseases: http://www.nrftd.org/
• Time for Lyme: http://www.timeforlyme.org/
• Turn the Corner Foundation: http://www.turnthecorner.org/
• Columbia Univ. Lyme Disease Center: http://www.columbia-lyme.org/

• CDC: http://www.cdc.gov/ncidod/dvbid/lyme/
• NIH: http://www3.niaid.nih.gov/healthscience/healthtopics/Tickborne/