Beyond Government Intervention: Drug Companies and Bioethics

In their analysis of the Cipro case, David Resnik and Kenneth De Ville (2002) propose conditions that should be met before the federal government overrides drug patents. A separate set of ethical and policy issues concerns the conduct of the drug company. The analysis of the Cipro case should address whether the private sector shares with public officials a responsibility for promoting the common good.

Resnik and De Ville note that in responding to the anthrax attacks Bayer "has been careful to avoid creating the impression that it is exploiting the attacks for its own benefit." Accordingly, the company has voluntarily cut prices and increased production of Cipro. Bayer has also exercised restraint in marketing the drug by refraining from claiming that Cipro is the sole or superior anthrax treatment.

How should we regard this behavior? Is it purely self-serving, part of a general strategy to defeat the threat to Bayer's patent rights? Is it designed more to improve public relations than to serve society?

Although I do not know the Bayer executives' actual motivations, I believe that at minimum their actions reveal a desire to meet public expectations of corporate social responsibility. Although the Bayer executives themselves might not be convinced of their duty to behave ethically, they apparently are aware that others would condemn them for taking undue advantage of the sudden demand for anthrax drugs.

The anthrax incident is just one of many situations in which the morality of drug company conduct is under scrutiny. Companies are being criticized for their high prices, above-average profit margins, and massive lobbying efforts. Also under attack are direct-to-consumer advertising campaigns aimed at stimulating demand for expensive, patent-protected, and sometimes questionably necessary drugs. Critics say that this corporate profit-seeking underlies recent increases in healthcare spending. Other targets are the companies' responses to the HIV/AIDS crisis in poor nations and the quality of their studies on drug safety and efficacy. Many questions are raised as well about whether participants are adequately informed and protected in drug trials, particularly in trials conducted by contract research organizations. And there are ongoing worries about whether companies put a positive slant on the data they submit when applying for U.S. Food and Drug Administration approval to market their products.

These criticisms would carry more weight if they were backed by a robust account of industry responsibility. Bioethicists have an opportunity to contribute to such an account. Scholars should consider ethical principles for companies developing and marketing healthcare products. They should examine whether this industry has any special ethical duties because of the nature of the products it offers. Should companies whose business goals are related to human health be obliged to temper profit-seeking behavior more than companies whose offerings matter less to human flourishing? Do any of the fiduciary duties we assign to medical professionals extend to corporations that create the tools of medicine? Should industry researchers be held to the same standards as academic researchers with regard to study design, publication of results (including ones unfavorable to their products), and protection of trial participants' rights and interests?

Another focus of this inquiry should be the ethical issues that arise when bioethicists seek to influence corporate behavior. Carl Elliott (2001) has taken a strong stand against bioethicists accepting funds for consulting or other services furnished to drug companies. He contends that industry support threatens the bioethicist's actual and apparent independence. This is a central question for our field and is likely to become even more prominent in the coming years. As bioethicists we must confront how our own financial conflicts of interest could undermine our ability to be effective advisers and critics of corporate organizations.

The current debates over human embryonic stem cell research and embryo cloning for research highlight the social and practical importance of developing a richer analysis of private-sector bioethics. Government regulation...