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.