Connecticut's attorney general has launched an antitrust investigation into
The Infectious Disease Society of America's new guidelines for the treatment
of Lyme disease, an
unprecedented move that raises questions about the government's role in
scientific consensus.
Attorney general Richard Blumenthal has subpoenaed IDSA records on grounds
that the guidelines, which do not recognize a chronic form of Lyme disease,
are anticompetitive. If doctors refuse to diagnose patients with chronic Lyme,
Blumenthal contends, patients will have limited access to treatment and
insurance reimbursement, a potential violation of state antitrust laws.
The attorney general's decision to weigh in on medical consensus has ruffled a
few feathers. "We're complying with the subpoena, but we're unhappy to see
this kind of political interference with what are very normal and routine
guidelines," Martin
Blaser, chairman of the department of medicine at NYU Medical Center and
president of the IDSA when the guidelines were published late last year, told
The Scientist.
Blaser added that clinical guidelines have to be based on
science, not
economics. "This is research of the literature. What does the literature
support and what does it not support," said Blaser, adding that the IDSA makes
it clear the guidelines are voluntary, and physicians should use their
discretion when treating Lyme patients. Patients can be harmed by long-term
use of antibiotics, he noted, and a misdiagnosis of chronic Lyme could halt or
delay treatment for the true cause of symptoms.
IDSA's lawyer, Alvin Dunn, said the antitrust investigation is unprecedented,
and could have more far-reaching effects. "If we have to worry each time [we
craft medical guidelines] that maybe we will be getting subpoenaed and have to
go through the time, effort, and expense of responding, then we might not take
controversial but appropriate positions," Blaser noted.
Blumenthal countered that even with disclaimers, the guidelines have a
significant impact on the clinic. "The question is whether there is a denial
of coverage to patients and doctors as a result of inflexible standards that
are then adopted by insurance companies," Blumenthal told The Scientist,
adding his office has not ruled out extending the inquiry to insurers.
According to the America's Health Insurance
Plans, a Washington trade group, major medical insurers do not cover
chronic Lyme disease, citing the IDSA guidelines in their medical coverage
statements.
Raphael Sticker, president of the
International Lyme and Associated Diseases Society (ILADS), which supports
the view that chronic Lyme exists and has published its own
guidelines, said
researchers should welcome the challenge to the power of a large, prestigious
society. "When the IDSA guidelines say that there is no chronic Lyme disease (ie
no persistent infection with the Lyme spirochete), that stifles scientific
inquiry," he said.
The most recent
IDSA treatment guidelines for Lyme disease note that "there is no
convincing biologic evidence" for chronic infection by Borrelia burgdorferi,
the causative agent in Lyme disease. However, Sticker and others who
believe chronic lyme
exists point to references that suggest the opposite conclusion.
Blumenthal's investigation is warranted, contended Lorraine Johnson, a
healthcare lawyer and member of the advisory board of the
Lyme Disease Association, Inc,
because members of the IDSA panel which wrote the new guidelines had ties to
Lyme product manufacturers that benefit from a limited definition of Lyme
disease, which makes it easier to prove efficacy in clinical trials.
Five members of the panel disclose conflicts of interest in the guidelines,
such as ties to Baxter vaccines, which is developing a
Lyme vaccine.
Tom File, who chairs IDSA's practice guidelines committee, defended the
organization. "We are very strict in making sure there is full compliance and
disclosure of conflict of interests," he said, noting corporations are most
likely to turn to scientists with strong expertise for help in developing
products. Blaser, for his part, noted that many doctors have their own
financial conflicts of interest in arguing chronic Lyme exists, since if the
IDSA recognized chronic Lyme, insurers would be more likely to pay for it.
As it stands now, the small group of Lyme specialists who treat chronic Lyme
are getting rich from patients who pay out-of-pocket, said Karen Vanderhoof,
chairwoman of the Lyme Disease Foundation.
"But if the IDSA guidelines provided some flexibility then patients could go
to any doctor. Now there's no competition for the chronic patient. IDSA throws
them out of the office."
Susan Warner
mail@the-scientist.com
Links within this article
CDC: Lyme disease
http://www.cdc.gov/ncidod/dvbid/lyme
Martin Blaser
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ILADS guidelines
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http://www.lymediseaseassociation.org/
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http://www.the-scientist.com/article/display/14828
Lyme Disease Foundation
http://www.lyme.org