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Clinical Practice Guideline Development and Antitrust Law

Clinical Practice Guideline Development and Antitrust Law To the Editor: The Connecticut attorney general's antitrust investigation and settlement with the Infectious Diseases Society of America (IDSA) regarding its development of clinical practice guidelines for Lyme disease offers important guidance for strengthening the integrity of clinical practice guideline development and preserving clinical discretion. I believe that in their Commentary, Mr Kraemer and Mr Gostin1 mischaracterized fact and misread the relevant law in criticizing the attorney general's intervention as political and purporting to defend the supposed positive, scientific character of clinical practice guidelines against the imposition of normative goals. Contrary to their argument, the attorney general's intervention can in fact advance evidence-based medicine. First, the authors misleadingly likened guideline development—which only faintly resembles the scientific method—to bench science.2 Guideline development has also proved vulnerable to due-process irregularities, through conduct and conflicts of interest, just as the attorney general found here. Second, Kraemer and Gostin erroneously asserted that the attorney general found an antitrust violation in the guidelines' recommendation against long-term antibiotics for chronic Lyme disease. The attorney general identified and sought to remedy process and structural abuse3—exclusionary conduct and commercial conflicts of interest—and explicitly said he was not “calling” the science. This did not promote normative, political agendas in guideline development; it sought to minimize them. Third, the authors misapplied the antitrust rule of reason balancing test when they contended that patient benefits outweigh any alleged anticompetitive effects of the Lyme disease guidelines. They assumed the scientific validity of the guidelines, took no account of alleged anticompetitive effects, and ignored the lessons from leading cases. The patient care defense is limited here: “The objective validity of a restraint has never been a defense to an antitrust charge.”4 They miss the point of Wilk v American Medical Association: the AMA's concern for patient care did not justify the exclusionary rule at issue, given the existence of a viable, less restrictive alternative—clinical discretion (which complainants also have sought here). Fourth, the authors incorrectly cited Schachar for the proposition that professional guidelines are a “medical not a legal question.” This was dictum—extraneous and not precedential. The court found no antitrust violation because it found no restraint of trade. The ophthalmology association's statement was informational only, there was no enforcement or other mandatory intent or effect, and there was no reduction in output (laser surgery). Schachar is plainly distinguishable.5 Back to top Article Information Financial Disclosure: Mr Wolfram reported being antitrust counsel to various complainants interested in the Connecticut attorney general's investigation and settlement. References 1. Kraemer JD, Gostin LO. Science, politics, and values: the politicization of professional practice guidelines. JAMA. 2009;301(6):665-66719211474PubMedGoogle ScholarCrossref 2. Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA. 2009;301(4):429-43119176446PubMedGoogle ScholarCrossref 3. An Agreement Between the Attorney General of the State of Connecticut and the Infectious Diseases Society of America. 3rd prefatory clause. State of Connecticut Web site. http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf. Accessed April 29, 2009 4. Indian Head v Allied Tube & Conduit, 2d Cir (1987), aff’d, Sup Crt (1988) 5. Wolfram R. Connecticut attorney general investigation and settlement highlights possible applicability of antitrust standard setting law to the development of clinical practice guidelines. Antitrust Health Care Chronicle. 2008;22(2):8-16Google Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Clinical Practice Guideline Development and Antitrust Law

JAMA , Volume 301 (24) – Jun 24, 2009

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Publisher
American Medical Association
Copyright
Copyright © 2009 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2009.875
Publisher site
See Article on Publisher Site

Abstract

To the Editor: The Connecticut attorney general's antitrust investigation and settlement with the Infectious Diseases Society of America (IDSA) regarding its development of clinical practice guidelines for Lyme disease offers important guidance for strengthening the integrity of clinical practice guideline development and preserving clinical discretion. I believe that in their Commentary, Mr Kraemer and Mr Gostin1 mischaracterized fact and misread the relevant law in criticizing the attorney general's intervention as political and purporting to defend the supposed positive, scientific character of clinical practice guidelines against the imposition of normative goals. Contrary to their argument, the attorney general's intervention can in fact advance evidence-based medicine. First, the authors misleadingly likened guideline development—which only faintly resembles the scientific method—to bench science.2 Guideline development has also proved vulnerable to due-process irregularities, through conduct and conflicts of interest, just as the attorney general found here. Second, Kraemer and Gostin erroneously asserted that the attorney general found an antitrust violation in the guidelines' recommendation against long-term antibiotics for chronic Lyme disease. The attorney general identified and sought to remedy process and structural abuse3—exclusionary conduct and commercial conflicts of interest—and explicitly said he was not “calling” the science. This did not promote normative, political agendas in guideline development; it sought to minimize them. Third, the authors misapplied the antitrust rule of reason balancing test when they contended that patient benefits outweigh any alleged anticompetitive effects of the Lyme disease guidelines. They assumed the scientific validity of the guidelines, took no account of alleged anticompetitive effects, and ignored the lessons from leading cases. The patient care defense is limited here: “The objective validity of a restraint has never been a defense to an antitrust charge.”4 They miss the point of Wilk v American Medical Association: the AMA's concern for patient care did not justify the exclusionary rule at issue, given the existence of a viable, less restrictive alternative—clinical discretion (which complainants also have sought here). Fourth, the authors incorrectly cited Schachar for the proposition that professional guidelines are a “medical not a legal question.” This was dictum—extraneous and not precedential. The court found no antitrust violation because it found no restraint of trade. The ophthalmology association's statement was informational only, there was no enforcement or other mandatory intent or effect, and there was no reduction in output (laser surgery). Schachar is plainly distinguishable.5 Back to top Article Information Financial Disclosure: Mr Wolfram reported being antitrust counsel to various complainants interested in the Connecticut attorney general's investigation and settlement. References 1. Kraemer JD, Gostin LO. Science, politics, and values: the politicization of professional practice guidelines. JAMA. 2009;301(6):665-66719211474PubMedGoogle ScholarCrossref 2. Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA. 2009;301(4):429-43119176446PubMedGoogle ScholarCrossref 3. An Agreement Between the Attorney General of the State of Connecticut and the Infectious Diseases Society of America. 3rd prefatory clause. State of Connecticut Web site. http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf. Accessed April 29, 2009 4. Indian Head v Allied Tube & Conduit, 2d Cir (1987), aff’d, Sup Crt (1988) 5. Wolfram R. Connecticut attorney general investigation and settlement highlights possible applicability of antitrust standard setting law to the development of clinical practice guidelines. Antitrust Health Care Chronicle. 2008;22(2):8-16Google Scholar

Journal

JAMAAmerican Medical Association

Published: Jun 24, 2009

References