Agreement Ends Investigation
Agreement Ends Lyme Disease Investigation
By Connecticut Attorney General
Medical Validity of IDSA Guidelines Not Challenged
May 1, 2008—The Infectious Diseases Society of America (IDSA) has entered into an agreement with the Attorney General of Connecticut ending his investigation of the Society’s Lyme disease guidelines. Under the agreement, the guidelines remain in effect; but in an effort to clear the air, IDSA is voluntarily agreeing to an extra step: a one-time special review of the Lyme disease guidelines.
The agreement ends the investigation of IDSA and its volunteer guideline panel members without the filing of a complaint or the entry by a court of factual or legal findings, without IDSA paying any fines or penalties, and without imposing on IDSA any restrictions on its right to promulgate guidelines for Lyme disease or any other disease or condition in the manner it believes best serves public health.
“IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” said IDSA President Donald Poretz, MD. “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by the Society, and we look forward to the opportunity to put to rest any questions about them.”
The IDSA Lyme disease guidelines recommend against long-term antibiotic therapy, an unproven and potentially dangerous treatment. A small group of physicians outside the medical mainstream and their patients endorse such long-term treatment, despite the compelling medical evidence that it is ineffective and can have serious, life-threatening complications—and, furthermore, is extremely expensive. This agreement does not change the medical advice to patients: The 2006 Lyme disease guidelines remain in place.
Under the terms of the agreement announced today, IDSA will convene a review panel to conduct a comprehensive review of the Lyme-related literature to determine whether the 2006 guidelines should be revised or updated. While IDSA periodically reviews all of its treatment guidelines in order to keep them current, the agreement allows for an expanded process that includes an opportunity for public presentation and submission of information to ensure that all points of view are presented to and considered by the review panel.
IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines. This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.
The main actions of the agreement include:
- Complete resolution of the Attorney General’s investigations, issues, and potential claims and causes of action against IDSA and its volunteer panel members.
- The current Lyme disease guidelines remain in effect. The medical and scientific basis of the 2006 guidelines remains in place and unchallenged.
- IDSA will convene a review panel to determine whether the 2006 Lyme disease guidelines should be revised or updated. Howard Brody, MD, PhD, who has been jointly selected by the Office of the Attorney General and IDSA, will serve as an ombudsman who will have a limited role that will focus on screening potential conflicts of interest. The ombudsman will not be involved in the operation of the review panel. Any proposed changes to the guidelines would require a supermajority vote of 75 percent of the panel.
IDSA strongly disagrees with the Attorney General’s assertion that panel members had significant conflicts of interest. Panel members had no financial interests that would have affected, or been affected by, recommendations in the guidelines. The guidelines recommend generic drugs and generic diagnostic tests. Panel members do not stand to profit from any recommendation in the guidelines. In fact, the panel members denied themselves and their colleagues an opportunity to generate a significant amount of revenue when they recommended against expensive, repeated, long-term antibiotic therapy.
IDSA also strongly disagrees with the Attorney General’s allegation that the Lyme disease guideline panel excluded competing viewpoints. In fact, the panel offered an opportunity for other organizations and individuals to submit additional evidence and carefully considered all information provided. In 2000, a single member of the panel voluntarily stopped participating. He was not removed from the panel, as the Attorney General has alleged. Furthermore, all IDSA guidelines are subjected to a rigorous, multi-level review and approval process before they are published, which allows other clinicians who did not serve on the panel that developed the guidelines to ensure that the guidelines are relevant, accurate, useable, and balanced.
IDSA’s guidelines—like all medical societies’ guidelines—are voluntary. They are for the benefit of physicians seeking the best possible advice from experts in the field. Medical societies do not have the authority or the desire to dictate to physicians how to practice medicine. Nor do they have the ability to dictate to insurance companies how to reimburse for services. No ties exist between IDSA and any insurance company.
The physicians who wrote IDSA’s 2006 guidelines concluded that, for nearly all patients, a short course of antibiotics is an effective treatment for Lyme disease. Studies have proven that long-term antibiotic treatment, which is usually given through a needle and a catheter, is ineffective, expensive, and potentially harmful. The overuse of antibiotics also contributes to an important public health threat: the development of drug-resistant infections that are difficult if not impossible to treat.
“We recognize that medicine is always evolving, and we welcome the opportunity that the review panel provides to examine any new evidence and vet our earlier findings,” said Dr. Poretz. “We are pleased that under this agreement, the proper diagnosis and treatment for Lyme disease will be decided in a medical forum, not a courtroom. We hope this special review of the guidelines will help quell the unfortunate controversy surrounding the treatment of Lyme disease and ensure that patients receive advice and treatment based on the best available scientific and medical evidence.”
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IDSA is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has more than 8,000 members, was founded in 1963 and is based in Arlington, VA. For more information, visit www.idsociety.org.