October 26, 2007 Blumenthal: He doesn't know when to quit Neurology Today [an excerpt] Volume 7(20), 16 October 2007, pp 1,12-13
Guidelines on Trial: AAN Subpoenaed as Part of Investigation into Treatment Parameters for Lyme Disease.
by Lisa Philips
The AAN is not a target of the investigation. Rather, the Connecticut Attorney General subpoenaed the Academy for information on how its guidelines for Lyme disease were developed and its relationship, if any, with the IDSA, said AAN General Counsel Murray G. Sagveen.
The investigation specifically seeks to determine whether the effect of the IDSA guidelines is ``constraining choices by patients or doctors in a way that could be anticompetitive,'' Attorney General Blumenthal told Neurology Today.
``If the effect of the guidelines is to deny medical coverage for other kinds of treatment, there might be a violation of antitrust law.''
The investigation, launched last November, is also looking into possible conflicts of interest among the members of the panel that developed the IDSA guidelines, Blumenthal said.
Blumenthal launched the investigation at the request of Lyme disease patients and physicians who believe in the efficacy of long-term use of intravenous antibiotics for the treatment of PLS.
The International Lyme and Associated Diseases Society (ILADS) has its own treatment guidelines, which recommend extended antibiotic use for chronic Lyme disease.
A RESTRAINT OF TRADE
AAN General Counsel Sagsveen said he has submitted the requested information about the AAN guidelines. But, he added, he is baffled by the idea that the IDSA guidelines restrain physicians from making their own choices -- and that the IDSA guidelines are the target of an antitrust investigation.
``If the IDSA guidelines are a restraint of trade, then by logical extension isn't any set of medical guidelines a restraint of trade?'' he asked.
Henry Allen, a Holland & Knight partner who teaches law at Northwestern University and serves as counsel for the AAN on the Blumenthal investigation, said that the antitrust laws prohibit restraints of trade that are unreasonable in the sense they injure consumers.
He noted that ``non-coercive clinical guidelines do not even amount to a restraint, much less one that might be deemed unreasonable.''
Moreover, both the Federal Trade Commission and the Supreme Court have recognized that guidelines for clinical patient care are reasonable because they have major consumer advantages, Allen said.
``The biggest advantage is that providing information to consumers saves physicians, on behalf of patients, the trouble of doing their own investigation,'' Allen said. ``Insurance companies, being consumers too, are also advantaged.''
At the same time, he added, ``those who are opposed to these voluntary guidelines have an opportunity to express their ideas as well. The remedy for any mistake is, as one antitrust tribunal put it, not antitrust litigation but more speech -- the marketplace of ideas.''
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"Insurance companies, being consumers too, are also advantaged.''
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