Ethical relativism provides a flimsy moral gloss condoning questionable activities of global pharmaceuticals in developing nations. But the Emperor has no clothes. Ultimately, there’s no such thing as a little bit of ethics.
Medical ethics became an area of concern in the wake of the Nuremberg Trials. The Nuremberg Code was developed in response to the outrages perpetrated by Nazi researchers in the 1930s and 1940s. As medical research expanded in the United States, legislators recognized a need to codify a set of principles and regulations in the wake of publicity surrounding the Tuskegee Syphilis Study. The National Research Act of 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission’s findings, known as the Belmont Report, are a statement of the basic ethical principles and guidelines governing the conduct of research.
However, case-by-case interpretations of the Belmont Report principles and the context of their practical applications can create a lot of wiggle room. Conflicts of interest are easy to overlook in the rush to approve new, important “research”.
The rush to do so is very real. In the last 20 years clinical trials have become big business. And, most clinical trials are now largely controlled and conducted by the pharmaceutical industry.1 Even more alarming, much of the work of these trials is outsourced to contract research organizations (CROs). In 2004, more than 40% of pharmaceutical drug development expenditures had been committed to outsourcing.2 In 2001, CROs generated $7 billion in revenues.
The implications are clear. Clinical trials can no longer be accurately categorized as research. Clinical trials are a business activity, items on the balance sheet of global pharmaceutical corporations.
And when money comes in the front door, ethics are thrown out the window. Developing nations are attractive sites for drug trials — standards of care are less demanding or nonexistent, regulatory oversight is rudimentary or absent, and local governments are notoriously pliable.
But the bright light of ethical inquiry is beginning to shine on international drug trials, brought to public attention by such studies as those involving perinatal transmission of HIV in developing nations3 and the infamous Trovan trial in Nigeria.4 The overarching question in evaluating the conduct of international drug trials is whether universal or local ethical standards and standards of care should be applied.
Is it all a game or do we as a people and a nation take ethical guidelines and principles seriously? It seems so obvious that money – tangible, bankable money – holds sway when contrasted with intangible abstract principles of rightness and goodness. Front page and business section headlines prove this every day.
1Relman A, Angell M: America’s Other Drug Problem. The New Republic, 12-16-02, pp 27-41
2Petryna A, et al: Global Pharmaceuticals: Ethics, Markets, Practices. Duke University Press, 2006, p 57
3Lurie P, Wolfe S: Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. N Engl J Med 337(12):853-856, 1997
4Lowenberg S: Drug company trials come under increasing scrutiny. Lancet 371(9608):191-192, 2008
The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.
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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.