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Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Plaintiff Responds

By Paul J. Pennock
'Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing ever happened.' In this author's opinion, Winston Churchill's keen observation of human nature is an apt description for how the pharmaceutical industry deals with dangers revealed or at least signaled in clinical trials. For years, plaintiffs' lawyers have honed in on clinical trials conducted by pharmaceutical companies when preparing for and trying cases. These studies, often the banner touted by defendants as evidence of their innocence, are a natural place to begin the search for what went wrong when a drug is subsequently pulled from the market despite the supposed 'rigors' of clinical testing. While there is nothing new about plaintiffs' lawyers reviewing clinical trials with a fine-toothed comb, there has been a radical and bold step taken in the world of medical/science academia. Specifically, major publications such as the New England Journal of Medicine ('NEJM') and the Journal of the American Medical Association ('JAMA') are ensuring that industry-sponsored studies do not merely contain partial truths.

In the wake of several scandals related to industry-sponsored clinical trials tainted by shoddy practices and incomplete disclosure, these prominent publications are acting to save their long-standing reputations in the world of science and medicine. While Merck's handling of the VIGOR trial data was appalling, Merck is by no means alone in improperly dealing with clinical trial risk data. Baycol', Rezulin', Accutane', Paxil' and PPA are just a few of the litigations where plaintiffs have focused on incomplete and slow disclosure of clinical trial data to both the Food and Drug Administration ('FDA') and publications. Recently yet another scandal has developed regarding the clinical trials for the antibiotic Ketek'. Through investigative work by The Wall Street Journal, it came to light that Sanofi-Aventis may have allowed clinical trials of Ketek to be severely undermined by the very doctors hired to conduct the study (The Wall Street Journal, May 1, 2006). The allegations in the Ketek scandal are so sordid it seems like they could fill the plot of some daytime television soap, except that real people have died as a result of this clinical trial disaster.

The NEJM and JAMA are not alone in their frustration with pharmaceutical companies being less than truthful about their clinical trials. The International Committee of Medical Journal Editors ('ICMJE') has mandated that its journals will not publish results from any trials that are not appropriately registered in Clinical Trials.gov or another registry. This type of full disclosure for NEJM, JAMA, and their fellow publications is viewed as a necessary step to creating more transparency in the world of big pharmaceuticals and as a way of protecting the integrity of the medical establishment. It also safeguards the lives of patients seeking enrollment in the studies and the patients who might ultimately use the medication being studied. An editorial in the NEJM, commenting on why full disclosure of clinical trials is necessary for publication in the journal, stated that full disclosure made 'moral sense.' As NEJM succinctly stated, 'When patients put themselves at risk to participate in clinical trials, they do so with the tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor.' (NEJM, Dec. 29, 2005). In clinical trials, patients know there is some potential for risk; however, the average doctor who reads these publications relies upon the truth of their contents to prescribe medications to his or her patients. Doctors and patients alike deserve to know the truth, the whole truth, and nothing but the truth.

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