Protecting scientific integrity: the commercial speech doctrine applied to industry publications.

1. INTRODUCTION The pharmaceutical industry is a competitive business. Companies spend billions of dollars researching and developing new drugs.1 Many drugs never make it to market. For the limited drugs that make it through the experimental, regulatory, and clinical rigors of drug development, companies recoup their lost expenditures for the drugs that previously failed. Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company's decision-making process regarding full disclosure on a particular new drug. An example of this type of conflict was seen in the silicone breast implant fiasco in the 1970s, 1980s, and 1990s. Dow Corning, the manufacturer of the implants, withheld important data from long-term animal models that demonstrated adverse effects from the breast implants.2 Further, Dow failed to conduct long-term studies on breast implants, even when armed with data indicating that such studies were necessary to ensure the continued health of the patients.3 Presumably, Dow stood to lose large sums of money if it conducted the long-term studies because it might establish the implants were harmful. It took litigation to expose Dow's failure to conduct the proper studies of the long-term effects of its implants. Pharmaceutical companies are experts in marketing their new drugs. To do this in the medical and scientific literature, companies will publish positive results of their clinical trials.4 They tend not, however, to disclose negative results of clinical trials in scientific publications, or they down-play the negative results. Further, pharmaceutical companies may suppress negative results, change design studies, or halt studies early if they think the results may not be positive.5 No regulation requires that industry publish negative results, and the scientific community, the public, and policymakers may never be aware of such negative results.6 Pharmaceutical companies expend enormous resources promoting new drugs. In addition to direct-to-consumer advertisements, they publish results in non-peer reviewed scientific/medical journals, host symposiums, and write multiple articles citing their own work. They use these tactics to flood the medical and scientific literature with positive information about their drug. This might not be so harmful if it were not often intertwined with strategies of suppressing negative results in clinical trials. That is, some of the publications are misleading because they only tell half the story- but the other half, i.e., the negative consequences from the drug, is not reported. This selective reporting causes harm because doctors may be misled into using an inferior or harmful treatment. Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter "industry") and explains how some of the publications promote misleading information. In recent years, an entire sector has arisen to assist in the publication and promotion of pharmaceutical drugs. This section also introduces the Lanham Act, which prohibits false advertising. Claims against some industry tactics may be brought under the Lanham Act. It is unclear, however, whether the Lanham Act can adequately address the issues with biased or misleading industry publications. For this reason, Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. As previously called for by me and others, a national registry of all clinical trials would provide, in part, the needed transparency. The reader of any publication reporting the results of a clinical study could cross-check the accuracy of the data with a national registry. Another recommendation is to enact a regulation called the Truth in Marketing (TIM) Act. …