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Science Forum Index » Medicine - Lyme Forum » IDSA Statement regarding Treatment Guidelines
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| the 3rd Man |
 Posted: Thu May 01, 2008 11:04 am |
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Guest
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Agreement Ends Lyme Disease Investigation By Connecticut Attorney
General
Medical Validity of IDSA Guidelines Not Challenged
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.”
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.. |
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