The Business Ethics Blog

A couple of days ago, MSNBC featured a commentary by Art Caplan (director of the Center for Bioethics at the University of Pennsylvania), on a couple of recent clinical drug trials that went very wrong. One of them happened in London, and the other in Montreal.

Caplan writes:

Last week, six very healthy men suddenly wound up in a London hospital in critical condition. Earlier this month, 11 otherwise well people tested positive for tuberculosis, according to Montreal’s health department. What do these people have in common? All were human subjects in research paid for and conducted by private companies. These mishaps mean that the time has come to take a closer look at how commercialized research involving human subjects is being conducted all over the world.

Caplan’s very reasonable conclusion is to call for tighter regulation of the companies that now conduct so many drug trials for pharmaceutical corporations:

The recent events in London and Montreal make it clear that it is time for Congress and other regulatory bodies here and overseas to take a hard look at how clinical research is being done these days. Many of those in the for-profit business of conducting clinical research may be doing their best, but they and their sponsors had best be putting the safety and welfare of their subjects first. Otherwise they should have no business doing clinical research.

Tighter regulation is of course a great idea here. This is a situation where vulnerable lives are being put in the hands of the lowest bidder, and research subjects are being recruited by physicians who often receive finder’s fees that place them in a very, very serious conflict of interest. But I can’t help wondering if a public-policy response is the only response available.
From the point of view of business ethics, we might ask the following questions:

• What can the industry do to towards better self-regulation? (And what moves on the part of government — legislative, exhortative, or financial — could inspire better self-regulation?)
• What factors have resulted in the failure of leadership in these corporations? We all know that the tone is set at the top. What are pharma CEO’s doing wrong?
• Has anyone, either in academia or industry, written up anything like a set of ‘best practices’ for the business side of commercial clinical trials?
• Is there anything peculiar (or just inadequate) about the ownership structure or governance structures of the pharmaceutical industry that makes failures of this kind more likely? (There is a literature on these issues for corporations in general. See, for example: “Why do corporations become criminals? Ownership, hidden actions, and crime as an agency cost”)

(See also my previous posting on “What Causes Unethical Behaviour.”)