October 25, 2006
Sherwood Gorbach, M.D., Editor
Lyme Expert Defends North Carolina Infection Expert, Blasts AP for Many Errors and Takes On Drs. Shapiro and Mead
To the Associated Press,
The story entitled "Doctor Disciplined over Lyme Disease Treatment" (4/14/06) has numerous inaccuracies. First, the title makes it sound like Dr. Jemsek has already been convicted of some crime. Nothing could be further from the truth, as the story finally acknowledges in the fourth paragraph. By then the casual reader has been totally misled.
The story quotes Dr. Paul Mead of the Centers for Disease Control and Prevention (CDC), who makes comments about the treatment of chronic Lyme disease. Dr. Mead is a research epidemiologist at the CDC. He is not involved in direct patient care, and he has no expertise in the clinical management of patients with chronic Lyme disease. His comments are irrelevant to the thousands of patients suffering from chronic Lyme disease, and his uninformed clinical views are irrelevant to Dr. Jemsek's case.
The story also quotes Dr. Eugene Shapiro, a pediatric researcher from Yale University who helped formulate the now-obsolete Lyme guidelines of the Infectious Diseases Society of America. Dr, Shapiro makes another one of his nihilistic comments for which he is notorious:
"It's not that the people diagnosed with chronic Lyme disease don't have problems," he said. "It's that chronic Lyme disease is not the problem."
Over the past decade, it has become obvious that a major problem for people with chronic Lyme disease is Dr. Shapiro himself, who has used his stature as a university professor to spread misinformation about Lyme disease around the country. Sadly there are gullible reporters who blindly print his dismissive statements while ignoring the immense problems with chronic Lyme disease, which confers disability similar to congestive heart failure. Dr. Jemsek is trying to solve those problems. Dr. Shapiro is making them worse.
A story like this one should have included comments from more enlightened physician groups such as the International Lyme and Associated Diseases Society (ILADS, www.ilads.org) and from patient advocacy groups such as the national Lyme Disease Association (LDA, www.lymediseaseassociation.org). Let's hope that the Associated Press does a better job next time.
Raphael Stricker, MD
Clinical Infectious Diseases
Tufts University School of Medicine
200 Harrison Avenue
Boston, Massachusetts 02111
Subject: Retraction of "The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America."
Dear Dr. Gorbach:
On behalf of the membership of the International Lyme and Associated Diseases Society (ILADS), I am submitting a formal request for retraction of the article, "The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America" (hereafter referred to as the "Lyme guidelines article"), which has been published electronically in your journal (1).
ILADS is requesting retraction of the Lyme guidelines article because the authors of the article employed exclusionary data selection that substantially biased the resulting diagnosis and treatment recommendations while ignoring opposing or dissenting views about these recommendations. As with research articles tainted by data selection, the Lyme guidelines article threatens to harm patients and patient care due to the biased methodology used by the authors, and this threat can only be avoided by formal retraction of the article.
The attached analysis of key points in the Lyme guidelines article demonstrates that the authors of the article made statements that either reflected significant selection bias of published data or ignored published evidence that conflicted with their opinions. Nowhere is this more apparent than in Dr. Klempner's analysis of the three NIH-funded Lyme treatment studies, which elevates and relies on the findings of his own study while dismissing the results of two other studies that conflict with his findings. Other statements about the erythema migrans (EM) rash, Lyme testing methodology, antibiotic treatment of chronic Lyme disease, Lyme disease in pregnancy and Lyme disease in Southern states all reflect a biased view of Lyme disease that is either unsubstantiated or refuted by available peer-reviewed published literature.
It is disturbing that ten of the central recommendations in the guidelines are supported by evidence ranked E-III–that is, "very strong" recommendations based on the weakest level of evidence–opinion. In light of the controversy surrounding Lyme disease diagnosis and treatment and our evolving understanding of the disease, it is inappropriate to dictate medical care based on such weak evidence. The panel of authors was selected to exclude divergent points of view from patients, from treating physicians in other medical societies, and even from physicians within IDSA itself. The failure of the authors to disclose dissenting views presents a false sense of consensus on an issue that is in fact highly controversial, misinforming patients and physicians alike about available treatment options and denying the exercise of clinical discretion and individualized medical decision-making that is central to any complex illness.
Although the Lyme guidelines article boasts 405 references, many of the dissenting references are either glossed over or ignored in the text. In addition, as of the date of publication of the Lyme guidelines article there were 18,537 articles about tick-borne diseases listed on Medline, so the referenced articles represent only 2% of the available literature. The remaining 98% of these articles often present opposing or conflicting views of Lyme disease, and thus the data selection by the authors is even more striking.
We are aware that retraction of medical publications is generally reserved for research articles that violate principles of scientific integrity (2). Scientific integrity has been defined as "commitment to truthfulness, to personal accountability and to vigorous adherence to standards of professional conduct (eg, accuracy, fairness, collegiality, transparency)" (3). Clinical guidelines from societies as powerful as IDSA are generally accepted as accurate, fair, collegial and transparent, and they rapidly become the standard of medical care in our country. It is wholly inappropriate and dangerous for guidelines to be formulated using exclusionary tactics, flagrant data selection, biased opinions and sweepingly "strong" recommendations based on the weakest category III evidence. We feel that the same principles of scientific integrity that apply to medical research should also apply to practice guidelines. In our opinion, the Lyme guidelines article does not reflect accuracy, fairness, collegiality or transparency and should be retracted.
We propose the following:
2. Formal notification of the CDC and other medical societies that the guidelines article has been retracted.
3. Formation of a widely diversified Lyme guidelines committee that bases its recommendations on the strength of the underlying evidence.
4. Reformulation of the Lyme guidelines article to reflect a more balanced view of tick-borne diseases, taking into account the existing evidence-based ILADS guidelines article listed by the National Guidelines Clearinghouse (4).
5. Submission of the reformulated guidelines article for outside peer review to a medical journal that is independent of IDSA.
Raphael Stricker, MD
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Nadelman RB. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the
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NIH, National Institute of Health; CDC, Centers for Disease Control & Prevention; FDA, Food & Drug Administration; ELISA, enzyme-linked immunosorbent assay
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cc: Julie L. Gerberding, MD, MPH, Director, CDC
Michael O. Leavitt, Secretary, U.S. Department of Health and Human Services
Elias A. Zerhouni, MD, Director, NIH
Anthony S. Fauci, MD, Director, NIAID
Andrew C. von Eschenbach, MD, Director, FDA
Jesse L. Goodman, MD, Director, CBER
Jay E. Berkelhamer, MD, FAAP, President, American Academy of Pediatrics
Mary K. Crow, MD, President, American College of Rheumatology
Lynne M. Kirk, MD, FACP, President, American College of Physicians
Larry S. Fields, MD, FAAFP, President, American Academy of Family Physicians
Martin J. Blaser, MD, FIDSA, President, Infectious Diseases Society of America