"All of these aspects undermine the credibility of guidelines and permit personal bias to determine the care of patients -- the very problem that evidence-based guidelines are intended to avoid. Indeed, these deficiencies may undermine the ethical foundation of medicine, which requires 'physicians to put the needs of patients ahead of personal gain, to deal with patients honestly, competently, and compassionately, and to avoid conflicts of interest that could undermine public trust in the altruism of medicine' . "
[Show abstract][Hide abstract] ABSTRACT: Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.
Philosophy Ethics and Humanities in Medicine 06/2010; 5(1):9. DOI:10.1186/1747-5341-5-9
"Perhaps even more troubling is a study by Campbell, Weismann, Ehringhaus, Rao, Moy, Feibelmann, and Goold (2007), which found more than 60% of US medical school department chairs had relationships with the pharmaceutical industry. Furthermore, for medical school faculty the possibility of promotion and fame is tied to their research ability and to publications (Jibson, 2006; Relman, 2008; Steinman, Baron, and Marlow, 2007). And the majority of their research funding comes from pharmaceutical manufacturers. "
[Show abstract][Hide abstract] ABSTRACT: The purpose of this essay is to explore how the pharmaceutical industry’s influence impacts the drug approval process and the resulting information provided by drug manufacturers to healthcare providers and ultimately to patients. For nearly half a century, United States courts have held under the Learned Intermediary Doctrine that the makers of prescription drugs are responsible for educating prescribers, not patients, about their products. The dialectic tension between corporate profits and required prescriber education calls into question the credibility of drug information from corporate, medical, and government sources. The key question to be addressed in this paper is, how credible is the information provided to prescribers by pharmaceutical manufacturers? Numerous critics have called into question the FDA’s ability to assure that medical drugs are safe and effective and the communication about them is accurate and unbiased. But the FDA is not the only healthcare organization that collaborates with the pharmaceutical industry and creates confusion and perpetuates deceptions. Medical schools accept money for clinical trials, provide researchers, and cooperate with pharmaceutical manufacturers much to the concern of numerous critics. In addition, clinical trials data, publications, and continuing education frequently lack credibility related to researcher/author bias and conflicts of interest. Unless the influence of the pharmaceutical industry on contemporary healthcare is markedly altered or eliminated, prescribers cannot rely on the information they are provided and therefore should not be held liable by the courts as learned intermediaries.
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