Independent Clinical Trials to Test Drugs: The Neglected Reform
Marc A. Rodwin
Suffolk University Law School; Harvard University - Edmond J. Safra Center for Ethics
January 8, 2013
Saint Louis University Journal of Health Law & Policy, Vol. 6, p. 113, 2012
Suffolk University Law School Research Paper No. 12-58
Drug manufacturers face a fundamental conflict of interest. Pursuit of profit compromises their impartial assessment of their drugs’ benefits and risks. Their biased evaluation can corrupt public knowledge of drugs, lead to marketing unsafe and/or ineffective drugs, compromise medical practice and undermine rational physician prescribing. Over the last century, federal regulation has mitigated this problem through FDA regulation of clinical research used to support applications to market new drugs. Nevertheless, the conflicts of interest persist because the firm that seeks to market a drug designs and controls the clinical trials that the FDA relies upon when it decides whether or not to authorize marketing the drug. An ample record reveals that drug firms can design clinical trials in ways that bias the conclusions.
This article analyzes a reform proposal that precludes bias in clinical trials used to test drugs and compares its pros and cons to alternative regulatory strategies. The proposal would remove all drug firm influence on the design and conduct of clinical trials used to decide whether to allow marketing of a drug. In fact, between the late 1950s and 1980s, reformers and congressional leaders championed this idea, but pharmaceutical industry opposition blocked its enactment and so the federal government pursued alternative strategies, which have proved ineffective. By the mid-1990s, scandals prompted several leaders in drug policy and research to again advocate legislation to require independent drug testing. It would not be surprising if Congress opts for stricter regulation of clinical trials using the existing regulatory paradigm. However, to be effective, reforms need to eliminate the corruption that lies at the root: drug firm control over clinical trials.
Number of Pages in PDF File: 55
Date posted: December 30, 2012 ; Last revised: August 19, 2013