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)

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)

As health care coverage gets more and more unfair by international standards, “Improving Fairness in Coverage Decisions” (Wynia et al. 2004) shows that the best of America's employers, unions, heal...

Mary Ann Baily's points are important, but they are largely accounted for by the analysis we provided. -/- .

This chapter contains sections titled: Introduction The Shipwreck of the Richmond and the Duty to Rescue The Ethics of Global Access to Essential Medicines Conclusion References.

In a new and important book entitled TheManagedCareBluesandHowtoCureThem, a lifetime consumer advocate and a surgeon who witnessed the excesses and unaccountable errors of his colleagues under fee for service explain with deft hands the promise of managed care, its problems, and solutions to them. Walter Zelman and Robert Berenson show empathy for the consumer backlash, provider resentment, and the patients' rights movement that has spawned a thousand bills to prevent possibly unethical actions. Yet they believe these efforts to regulate managed (...) care are misdirected and will prevent it from realizing its potential. (shrink)