Regulatory Weblog: Manage the risks that REALLY matter

January 17, 2008


Ethics and drug-trial recruitment by health professionals

Filed under: Professions — Richard Page @ 12:20 pm

Ethics and drug-trial recruitment

A recent article in The New Yorker by Carl Elliott, a professor at the Centre for Bioethics at the University of Minnesota, asks questions about the ethics of recruiting healthy and cash-hungry “guinea pigs” to support the drug testing economy. In recent years, pharmaceutical companies have moved drug trials to the private sector where more than seventy percent are now conducted. There’s a lot of money on the table (thousands of dollars per subject) for recruitment and the potential to attract health professionals to participate in an area of questionable ethics. Specifically, Elliot discusses the situation of Frank Abuzzahab, a de-licensed physician in the U.S who now operates as a psychopharmacology researcher. He lost his licence through disciplinary action: he was deemed to be responsible for the injuries or deaths of forty-six patients under his care who he recruited for drug trials.

Health professionals are in a position of authority when dealing with clients, or even the public. Their codes of ethics place the interests of the client ahead of their own.

What’s your view on the ethics of this situation? Is it appropriate for doctors, nurses or other health professionals to do some moonlighting on the side like this or not?

2 Comments »

  1. I enjoyed your articles on risk management. However, I am interested in risk management as it relates to a self regulatory body, particularly as it relates to investigations into complaints against physicians. Can you direct or advise me on same.

    Comment by Veronica Livingstone — May 1, 2008 @ 12:25 pm

  2. Thanks for reading and leaving your comments. Our view of regulation is that it’s the method by which society manages its most serious risks. I think it’s important to acknowledge that regulators have more of a supervisory role; and that regulatees are fundamentally responsible for their own actions–for operating within terms of their license, or, however compliance is measured. So the regulator is really looking for the exceptions–activities that are outside the boundaries that have been established by statute, regulation, standards, principles, ethics and, more generally, by expectations.
    These “expectations” are the expectations of performance: the expectations about performance held by reasonable stakeholders. Establish the expectations, make it clear to regulatees what the expectations are, and then measure the failures (and the successes) in relation to expectations. Various methods, consistent with your objectives, can be used to measure risk — the variance from expectations.
    In the end, what you want is a clear/transparent, objective, consistent, efficient and effective way of evaluating the matters that come to your attention. This is a risk-based, decision-support approach to regulation.
    Good luck.

    Comment by Richard Page — May 1, 2008 @ 1:54 pm

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