[Ip-health] Lyme disease guidelines may violate antitrust laws

[James Love]

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[ Picked text/plain from multipart/alternative ]
*  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.

* Blaser added that clinical guidelines have to be based on science,
not economics.

* 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.


http://www.the-scientist.com/news/home/49605/
The Scientist

By Susan Warner
NEWS

State official subpoenas infectious disease group
Connecticut's attorney general probes whether the professional
society=92s Lyme disease guidelines violate antitrust laws

[Published 7th February 2007 02:56 PM GMT]

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
http://www.med.nyu.edu/people/blasem01.html

I Oransky, "Hate ticks? Save deer," The Scientist, January 1, 2007.
http://www.the-scientist.com/article/display/38020

America's Health Insurance Plans
http://www.ahip.org/

International Lyme and Associated Diseases Society
http://www.ilads.org/

ILADS guidelines
http://www.ilads.org/files/ILADS_Guidelines.pdf

GP Wormser et al, "The clinical assessment, treatment, and prevention
of lyme disease, human granulocytic anaplasmosis, and babesiosis:
Clinical practice guidelines by the infectious diseases society of
America," Clinical Infectious Diseases 2006;43:1089-1134.
http://www.journals.uchicago.edu/CID/journal/issues/
v43n9/40897/40897.html

M Frey et al, "Detection of Borrelia burgdorferi DNA in muscle of
patients with chronic myalgia related to lyme disease," Am J Med
1998;104, 591-594.
http://www.the-scientist.com/pubmed/9674723

RB Stricker et al, "Lyme disease: Point/Counterpoint," Expert Rev
Anti Infect Ther. 2005 Apr;3(2):155-65
http://www.the-scientist.com/pubmed/15918774

Lyme Disease Association
http://www.lymediseaseassociation.org/

R. Lewis, "Vaccines: Victims of their own success?" The Scientist,
July 19, 2004.
http://www.the-scientist.com/article/display/14828

Lyme Disease Foundation
http://www.lyme.org




---------------------------------
James Packard Love
Knowledge Ecology International
mailto:james.love@keionline.org
tel. +1.202.332.2670 / mobile+1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton"