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Science Forum Index » Medicine - Lyme Forum » Blumenthal issues report on IDSA Guidelines
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| the 3rd Man |
 Posted: Thu May 01, 2008 10:58 am |
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Attorney General's investigation reveals flawed Lyme disease guideline
process
By Attorney General's office
IDSA agrees to reasses guidelines, install independent arbiter
Attorney General Richard Blumenthal today announced that his antitrust
investigation has uncovered serious flaws in the Infectious Diseases
Society of America’s (IDSA) process for writing its 2006 Lyme disease
guidelines and the IDSA has agreed to reassess them with the
assistance of an outside arbiter.
The IDSA guidelines have sweeping and significant impacts on Lyme
disease medical care. They are commonly applied by insurance companies
in restricting coverage for long-term antibiotic treatment or other
medical care and also strongly influence physician treatment
decisions.
Insurance companies have denied coverage for long-term antibiotic
treatment relying on these guidelines as justification. The guidelines
are also widely cited for conclusions that chronic Lyme disease is
nonexistent.
“This agreement vindicates my investigation -- finding undisclosed
financial interests and forcing a reassessment of IDSA guidelines,”
Blumenthal said. “My office uncovered undisclosed financial interests
held by several of the most powerful IDSA panelists. The IDSA’s
guideline panel improperly ignored or minimized consideration of
alternative medical opinion and evidence regarding chronic Lyme
disease, potentially raising serious questions about whether the
recommendations reflected all relevant science.
“The IDSA’s Lyme guideline process lacked important procedural
safeguards requiring complete reevaluation of the 2006 Lyme disease
guidelines -- in effect a comprehensive reassessment through a new
panel. The new panel will accept and analyze all evidence, including
divergent opinion. An independent neutral ombudsman -- expert in
medical ethics and conflicts of interest, selected by both the IDSA
and my office -- will assess the new panel for conflicts of interests
and ensure its integrity.”
Blumenthal’s findings include the following:
• The IDSA failed to conduct a conflicts of interest review for any of
the panelists prior to their appointment to the 2006 Lyme
disease guideline panel;
• Subsequent disclosures demonstrate that several of the 2006
Lyme disease panelists had conflicts of interest;
• The IDSA failed to follow its own procedures for appointing the
2006 panel chairman and members, enabling the chairman, who
held a bias regarding the existence of chronic Lyme, to handpick
a likeminded panel without scrutiny by or formal approval of the
IDSA’s oversight committee;
• The IDSA’s 2000 and 2006 Lyme disease panels refused to accept
or meaningfully consider information regarding the existence of
chronic Lyme disease, once removing a panelist from the 2000
panel who dissented from the group’s position on chronic Lyme
disease to achieve “consensus”;
• The IDSA blocked appointment of scientists and physicians with
divergent views on chronic Lyme who sought to serve on the
2006 guidelines panel by informing them that the panel was fully
staffed, even though it was later expanded;
• The IDSA portrayed another medical association’s Lyme disease
guidelines as corroborating its own when it knew that the two
panels shared several authors, including the chairmen of both
groups, and were working on guidelines at the same time. In
allowing its panelists to serve on both groups at the same time,
IDSA violated its own conflicts of interest policy.
IDSA has reached an agreement with Blumenthal’s office calling for
creation of a review panel to thoroughly scrutinize the 2006 Lyme
disease guidelines and update or revise them if necessary. The panel
-- comprised of individuals without conflicts of interest -- will
comprehensively review medical and scientific evidence and hold a
scientific hearing to provide a forum for additional evidence. It will
then determine whether each recommendation in the 2006 Lyme disease
guidelines is justified by the evidence or needs revision or updating.
Blumenthal added, “The IDSA’s 2006 Lyme disease guideline panel
undercut its credibility by allowing individuals with financial
interests -- in drug companies, Lyme disease diagnostic tests, patents
and consulting arrangements with insurance companies -- to exclude
divergent medical evidence and opinion.
In today’s healthcare system, clinical practice guidelines have
tremendous influence on the marketing of medical services and
products, insurance reimbursements and treatment decisions. As a
result, medical societies that publish such guidelines have a legal
and moral duty to use exacting safeguards and scientific standards.
“Our investigation was always about the IDSA’s guidelines process --
not the science. IDSA should be recognized for its cooperation and
agreement to address the serious concerns raised by my office. Our
agreement with IDSA ensures that a new, conflicts-free panel will
collect and review all pertinent information, reassess each
recommendation and make necessary changes.
“This Action Plan -- incorporating a conflicts screen by an
independent neutral expert and a public hearing to receive additional
evidence -- can serve as a model for all medical organizations and
societies that publish medical guidelines. This review should
strengthen the public’s confidence in such critical standards.”
THE GUIDELINE REVIEW PROCESS
Under its agreement with the Attorney General’s Office, the IDSA will
create a review panel of eight to 12 members, none of whom served on
the 2006 IDSA guideline panel. The IDSA must conduct an open
application process and consider all applicants.
The agreement calls for the ombudsman selected by Blumenthal’s office
and the IDSA to ensure that the review panel and its chairperson are
free of conflicts of interest.
Blumenthal and IDSA agreed to appoint Dr. Howard A. Brody as the
ombudsman. Dr. Brody is a recognized expert and author on medical
ethics and conflicts of interest and the director of the Institute for
Medical Humanities at the University of Texas Medical Branch. Brody
authored the book, “Hooked: Ethics, the Medical Profession and the
Pharmaceutical Industry.”
To assure that the review panel obtains divergent information, the
panel will conduct an open scientific hearing at which it will hear
scientific and medical presentations from interested parties. The
agreement requires the hearing to be broadcast live to the public on
the Internet via the IDSA’s website. The Attorney General’s Office,
Dr. Brody and the review panel will together finalize the list of
presenters at the hearing.
Once it has collected information from its review and open hearing,
the panel will assess the information and determine whether the data
and evidence supports each of the recommendations in the 2006 Lyme
disease guidelines.
The panel will then vote on each recommendation in the IDSA’s 2006
Lyme disease guidelines on whether it is supported by the scientific
evidence. At least 75 percent of panel members must vote to sustain
each recommendation or it will be revised.
Once the panel has acted on each recommendation, it will have three
options: make no changes, modify the guidelines in part or replace
them entirely. The panel’s final report will be published on the
IDSA’s website.
ADDITIONAL FINDINGS OF BLUMENTHAL’S INVESTIGATION
IDSA convened panels in 2000 and 2006 to research and publish
guidelines for the diagnosis and treatment of Lyme disease.
Blumenthal’s office found that the IDSA disregarded a 2000 panel
member who argued that chronic and persistent Lyme disease exists. The
2000 panel pressured the panelist to conform to the group consensus
and removed him as an author when he refused.
IDSA sought to portray a second set of Lyme disease guidelines issued
by the American Academy of Neurology (AAN) as independently
corroborating its findings. In fact, IDSA knew that the two panels
shared key members, including the respective panel chairmen and were
working on both sets of guidelines a the same time -- a violation of
IDSA’s conflicts of interest policy.
The resulting IDSA and AAN guidelines not only reached the same
conclusions regarding the non-existence of chronic Lyme disease, their
reasoning at times used strikingly similar language. Both entities,
for example, dubbed symptoms persisting after treatment “Post-Lyme
Syndrome” and defined it the same way.
When IDSA learned of the improper links between its panel and the
AAN’s panel, instead of enforcing its conflict of interest policy, it
aggressively sought the AAN’s endorsement to “strengthen” its
guidelines’ impact. The AAN panel -- particularly members who also
served on the IDSA panel -- worked equally hard to win AAN’s backing
of IDSA’s conclusions.
The two entities sought to portray each other’s guidelines as separate
and independent when the facts call into question that contention.
The IDSA subsequently cited AAN’s supposed independent corroboration
of its findings as part of its attempts to defeat federal legislation
to create a Lyme disease advisory committee and state legislation
supporting antibiotic therapy for chronic Lyme disease.
In a step that the British Medical Journal deemed “unusual,” the IDSA
included in its Lyme guidelines a statement calling them “voluntary”
with “the ultimate determination of their application to be made by
the physician in light of each patient’s individual circumstances.” In
fact, United Healthcare, Health Net, Blue Cross of California, Kaiser
Foundation Health Plan and other insurers have used the guidelines as
justification to deny reimbursement for long-term antibiotic
treatment.
Blumenthal thanked members his office who worked on the investigation
-- Assistant Attorney General Thomas Ryan, former Assistant Attorney
General Steven Rutstein and Paralegal Lorraine Measer under the
direction of Assistant Attorney General Michael Cole, Chief of the
Attorney General's Antitrust Department. |
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