Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe (...) and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. (shrink)

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. A key (...) source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others. (shrink)

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's (...) prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. (shrink)

Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of (...) harms and the paucity of benefits. (shrink)

This paper explains how the current architecture of the pharmaceutical markets has created a misalignment of financial incentives and public health that is a central cause of harmful practices. It explores three possible solutions to address that misalignment: taxes, increased financial penalties, and drug pricing based on value. Each proposal could help to partly realign financial incentives and public health. However, because of the limits of each proposal, there is no easy solution to fixing the problem of financial incentives.

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied — though by no means solved — in financial accounting than in medicine. This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information (...) manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information. (shrink)

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply ambiguous information that (...) requires sophisticated judgment to interpret reasonably. (shrink)