Restoring Confidence in the Pharmaceutical Industry

Abstract

LACK OF TRUST IN THE PHARMACEUTICAL INDUSTRY threatens the future of biomedical research. Although more than half of funded clinical trials in the United States are supported by industry and many scientists, clinicians, and others in industry are committed to advancing biomedical science and improving the health of patients, there is a need to restore confidence in pharmaceutical companies and the research they sponsor. As editors of a journal that publishes articles supported by industry, we are familiar with many of the complicated issues related to industry-supported and industry-analyzed studies. We have had discussions with leaders of the pharmaceutical industry about concerns they have regarding the erosion of trust in their companies. We also have had discussions with academic leaders and leading scientists about ways to improve the reputation of pharmaceutical industry research and have participated in initiatives to harmonize reporting by physicians, investigators, and others who have financial relationships with industry and other conflicts of interest. The last 2 decades have seen major changes in the pharmaceutical industry. Consolidation among companies has occurred; revenues and profit margins have increased; and until recently, many “blockbuster” drugs had entered the marketplace. However, in more recent years, innovation leading to new product development has declined, resulting in limited numbers of new drugs and other agents in the once robust pharmaceutical pipeline. In 2013, the industry will face substantial drug patent expirations, with more than 40 brand-name products losing patent protection with an estimated value of $35 billion in annual sales. To maintain market share, some companies have proposed new uses for or minor modifications to existing products. At the same time, the credibility of pharmaceutical company research has declined. Numerous high-profile reports involving some of the world’s largest and previously most well-respected companies have detailed serious concerns about manipulation and misrepresentation of data from industry-sponsored research. One report that compared information from efficacy trials included in US Food and Drug Administration (FDA) documents for approved new drug applications (NDAs) with information published in journal articles found that many clinical trials included in the NDAs were not published 5 years after drug approval had been granted. The study also found important discrepancies between the primary outcomes, statistical analyses, and conclusions reported in NDAs compared with that information reported in journal articles. The information found in published trials was often more favorable than the data reported in the NDAs. Moreover, some companies have incurred substantial fines for unethical and illegal marketing practices of approved products. In addition, a recent study suggested that clinicians devalue the credibility of industryfunded trials, as compared with the same trials characterized as having National Institutes of Health funding or having no source of support listed, and were less likely to prescribe a drug evaluated in a clinical trial that was supported by industry, even if the study was of high quality. The pharmaceutical industry is confronted by other challenges. Society has become increasingly risk adverse, and patients are less tolerant of even rare adverse outcomes, which may not be detected even in large-scale randomized clinical trials designed as “efficacy studies,” with highly selective populations. But because virtually no drug is entirely safe, rare adverse events are inevitable, and some serious adverse events might not manifest until the drug is used in less carefully selected “effectiveness” patient populations that characterize clinical practice. Should industry be held accountable for these adverse events? The health sector is viewed differently from other sectors of the economy. Virtually everyone seeks health care at some point in his or her life, and because of the unique importance of health, more is expected of all entities and individuals in the health care system, including manufacturers and suppliers of medications and medical devices, to ensure the safety of their products. Yet the majority of pharmaceutical companies are publicly traded and for most companies, generating profit is an important and reasonable priority. This creates substantial tension for the leaders of pharmaceutical companies. Despite these challenges, several options are available to pharmaceutical companies to help restore credibility and trust in their sponsored research.