State official subpoenas infectious disease group

Connecticut's attorney general probes whether the professional society?s Lyme disease guidelines violate antitrust laws

By | February 7, 2007

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

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