Case 6.4: Drug Dilemma essay

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Summary

The case study is about the obligation that pharmaceutical companies have to their experimental subjects when researching the effects of a new drug. The case notes that American drug companies charge consumers too much for drugs, far more than the cost of research and development – related expenses. This is because the drug companies usually carry out their research studies in foreign countries where there are few restrictions and the overall costs are cheaper. However, companies do not sell the final product of the research in these countries because the market is not big enough to generate profits. Consequently, poor countries have become “experiment satellites” where the drug companies do their research and after they develop a new drug, abandon their subjects because they cannot afford to buy it. A case in point is CV Therapeutics of Palo Alto, California, which developed the ranolazine, a drug that treats angina. During the experimentation phase, more than 60 percent of the patient subjects were Russian. The dilemma is whether the company is under obligation to make the drug available to its experiment subjects in particular and to the Russian market in general. This is despite the fact that the company may be forced to forego profits in the process, and perhaps even incur more costs in marketing and monitoring the effect of the drug on patients.

Arising Ethical Issues

The ethical issue in this case is the obligation that businesses have to its stakeholders and the society at large. In fact, every business has a social responsibility not only to the local community within which it operates, but also to those affected by its activities. As a result, businesses usually set up schools, health centers and other social facilities as a way of giving back to the community and supporting their social responsibility. CV Therapeutics’ case, however, is unique in that the subjects used to research the drug do not constitute part of its stakeholders or the local community. Therefore, it will be far fetched to suggest that the company has any social responsibility to its experiment subjects. Moreover, even if there was expected social responsibility, it is needed to define what exactly those responsibilities are. This is because in corporate social responsibility, a company’s obligation arises from the fact that it uses the local community to access resources, labor as well as market for its services and products.

Nevertheless, CV Therapeutics is under moral obligation to give back to the subjects and community it employed to develop the drug. This obligation stems from the universal principle that doing what’s right and good is the basis of any action. The utilitarian theory espouses this principle by stating that an action is morally and ethically acceptable if it results in “the greatest good for the greatest number of people” (Beauchamp and Childress 231). By this principle, therefore, CV Therapeutics is under obligation to make the drug accessible to the Russian market. The company’s concern, therefore, should not be the profits it can potentially forego, but the number of people it can help by expanding its market to include the regions, where it carried out the experiments as well as other poor countries.

The natural rights theory also highlights the moral obligation that CV Therapeutics has to over 60 percent of patients it used as subjects for its drug research. The theory states that every human being is entitled to certain “basic rights and freedoms that are universally recognizable by virtue of human reason or nature” (Finnis 437). Accordingly, human nature and reason will determine that it is not right or morally acceptable to use human beings as subjects of a clinical experiment then deny them the benefits of that same study. This is akin to blatant exploitation of underprivileged and legally unprotected groups. As former editor in chief of the New England Journal of Medicine, Marcia Angell states, “Quite literally, the participants are used as guinea pigs, subjects of research that really should be done on experimental animals” (Angell 305). In fact, it is worth noting that the reason that CV Therapeutics used a foreign country for the research was because of the strict Food and Drugs Administration (FDA) regulations in the U.S. FDA regulations compel researchers to observe the rights of experiment subjects, such as protecting them from health risks and stating the benefits that will arise from the study. In contrast, foreign countries are less strict on these issues, which encourage American companies to carry out studies even before they are formally licensed to do so by the local authorities. In this regard, CV Therapeutics is morally obliged to observe the natural rights of its experiment subjects by making the drug accessible to the residents of a country.

Nevertheless, the utilitarian theory is best connected to my principle of doing what is right and beneficial to society. The theory espouses the desire to serve people regardless their nationality, religion, cultural background or social/economic status. This principle could have encouraged Dr. Louis Lange, founder of CV Therapeutics, to market ranolazine in Russia and other poor countries where it will greatly improve the quality of life of angina patients by easing their pain. This theory will guide my future practice by allowing me to make decisions that benefit as many people as possible. This is indeed a theory that teaches selfless service to people and society by focusing on the common good that result from an action rather than individual gain.

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