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June 18, 2011 | Posted By David Lemberg, M.S., D.C.

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.

4 comments | Topics: Bioethics and Public Policy, Ethics in Clinical Trials, Reproductive Medicine

Comments

Richard R. Pesce

Richard R. Pesce wrote on 06/19/11 10:57 AM

The smaller the world gets, the more obvious it is there is , or should be, no support for ethical relativism. We are all human with no racial differentiation because the concept of race is a fiction. There are different cultures and this does need to be recognized. It is perhaps better to think in terms of cosmopolitanism as per Kwame Appiah's description instead. There needs to be a separation of the medical industrial complex back into its separate components. Oversight of pharma is not working. Too much money is involved. Companies do NeEd to make a profit but perhaps the marketing budgets need to be less than the research budgets.

The concept of ethical living applies to the conduct and treatment of all peplos. We are not experimental preparations. Although research will become more difficult anything worth doing is worth doing correctly. Taking advantage of poor populations and countries is not right and is unethical. Whenever, it seems, money flows easily into research and the race for patents ensue consideration of human good goes to the wayside. This should not be allowed to continue and perhaps the international courts should look into the issue.
aidel

aidel wrote on 06/22/11 10:05 AM

There is an obvious conflict of interest when Big Pharma funds research which investigates it's own products. The result is cherry-picking data and a fuzzy line between a scientific yield of information and advertising. I suggest all pharmaceutical companies be required to pay a percentage of their profits (let's say 20%) that goes into a general fund used for medical/pharmaceutical research. Once the money goes into the pot, no particular drug company will have any say in tweaking the results to fit a profit motive. Data will be clean and published via open access. There are plenty of solid science writers (including bloggers, many of whom are scientists) who understand research and can explain it to a more general audience. I wish I could say as much for MDs...they are ready to whip out the prescription pad based on a cursory glance at a paper's abstract and conclusion. Too many (MDs) do not have the ability to distinguish good, solid research from poorly designed experiments and data cherry-picking.
David

David wrote on 06/25/11 3:13 PM

Richard - Agreed. Global pharmaceutical companies do take advantage of poor populations in developing nations. Their minions rationalize these tactics by invoking ethical relativism. But the more rigorous ethical mores - those of the developed nation - should take precedence.

Companies using poor populations as experimental subjects for off-shore clinical trials should significantly compensate those communities and the host countries by various forms of substantial investment in their economy and infrastructure.
David

David wrote on 06/25/11 3:21 PM

Aidel - Conflicts of interest between pharmaceutical companies, hospitals, and physicians are deeply entrenched and corrupt medical practice.

Many physicians rely on pharmaceutical sales reps for information on which drugs to prescribe. Patients who rely on their doctors for best practices are very susceptible to market forces involving promotion of the latest and greatest new drug. Harmful drug side effects and other unexpected outcomes are the common result.

Medicine needs to return to being a profession rather than a business.

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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.
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