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 uncoverred 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 ddivergent 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:
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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; |
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Subsequent disclosures demonstrate that several of the 2006
Lyme disease panelists had conflicts of interest; |
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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; |
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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"; |
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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; |
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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 resultting 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 undder the
direction of Assistant Attorney General Michael Cole, Chief of
the Attorney General's Antitrust Department.
