Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Plaintiff Responds

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.

In this setting, therefore, any 'increased scrutiny' should be viewed as a welcome improvement for the public at large as well as for science and medicine. Pharmaceutical companies should see this as an opportunity to reclaim and restate their dedication to enhancing the world of medical and scientific discovery and discourse, not something on which to seek legal advice. Trust has been broken by too many questionable practices used during clinical trials and too many harmful conflicts of interest represented by study authors. It is time for companies to restore that trust rather than construct a 'proprietary information' defense for their clinical trial practices. In any event, it is doubtful that the courts will find proprietary information arguments very compelling. Many drug companies already disclose all information regarding their clinical trials through the current clinical trial registry, and they have not suffered competitively.

The bottom line is that correct scientific practices and truthful disclosure that errs on the side of caution should be the standard set by pharmaceutical companies. It is what the American public and the American medical and scientific community expect of them. Pharmaceutical companies not only have injured patients by failing to adhere to full and rapid disclosure of safety risks, but they have injured themselves in the eyes of the American public. It is time for this industry to realize the legal, ethical, and moral duties it has and accordingly stop viewing its clinical trials through the lens of future litigation threats and start viewing them through the lens of truth and quality. In sum, when they stumble over the truth, they should stop hurrying off, but instead should stop and point it out to all who might walk that way.

Paul J. Pennock is the chief of the Pharmaceutical and Medical Device Department at Weitz & Luxenberg P.C., New York and has headed and successfully litigated the firm's breast implant, Fen-Phen, Propulsid, and Rezulin litigations. He is currently in charge of the firm's litigation involving Vioxx, Bextra, Celebrex, Accutane, Zyprexa, Arava, Medicaid fraud, welding rods, and several other products.

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.

In this setting, therefore, any 'increased scrutiny' should be viewed as a welcome improvement for the public at large as well as for science and medicine. Pharmaceutical companies should see this as an opportunity to reclaim and restate their dedication to enhancing the world of medical and scientific discovery and discourse, not something on which to seek legal advice. Trust has been broken by too many questionable practices used during clinical trials and too many harmful conflicts of interest represented by study authors. It is time for companies to restore that trust rather than construct a 'proprietary information' defense for their clinical trial practices. In any event, it is doubtful that the courts will find proprietary information arguments very compelling. Many drug companies already disclose all information regarding their clinical trials through the current clinical trial registry, and they have not suffered competitively.

The bottom line is that correct scientific practices and truthful disclosure that errs on the side of caution should be the standard set by pharmaceutical companies. It is what the American public and the American medical and scientific community expect of them. Pharmaceutical companies not only have injured patients by failing to adhere to full and rapid disclosure of safety risks, but they have injured themselves in the eyes of the American public. It is time for this industry to realize the legal, ethical, and moral duties it has and accordingly stop viewing its clinical trials through the lens of future litigation threats and start viewing them through the lens of truth and quality. In sum, when they stumble over the truth, they should stop hurrying off, but instead should stop and point it out to all who might walk that way.

Paul J. Pennock is the chief of the Pharmaceutical and Medical Device Department at Weitz & Luxenberg P.C., New York and has headed and successfully litigated the firm's breast implant, Fen-Phen, Propulsid, and Rezulin litigations. He is currently in charge of the firm's litigation involving Vioxx, Bextra, Celebrex, Accutane, Zyprexa, Arava, Medicaid fraud, welding rods, and several other products.