Friday, November 1, 2013

Pharma Issues at the American Society for Bioethics and Humanities Annual Meeting

I began writing this post from Atlanta where I was (as usual this time of year) attending the annual meeting of the American Society for Bioethics and Humanities. In past years there has been maybe one session per year on something directly related to Pharma issues, so I was impressed to see at least three sessions on this year’s program. Here I report on a panel, “Bioethics Capacity Building in a Corporate Setting: One Pharmaceutical Company’s Experience,” presented by two folks from Eli Lilly and two distinguished academic bioethicists who have served for 15 years on the company’s bioethics advisory panel. The panel moderator was Luann E. Van Campen, PhD, head of the Bioethics Program at Lilly, and one of the panelists was Donald G. Therasse, MD, VP for Global Patient Safety and Bioethics at the firm, to whom Dr. Van Campen reports.

I gather from the presentation that Lilly has had an advisory committee on bioethics for 15 years, but that the internal bioethics program was inaugurated in 2008. You can find out more at: http://www.lilly.com/research-development/approach/research-ethics/Pages/bioethics.aspx
The two academic bioethicists on the panel were indeed heavy hitters—Tom Beauchamp, PhD of the Kennedy Institute of Ethics at Georgetown, co-author of what most regard as the canonical textbook in the field, Principles of Biomedical Ethics; and Robert Levine, MD, of Yale.  I’ll focus mostly on what Dr. Beauchamp said as Dr. Levine indicated he endorsed almost all the former’s comments.

The academics reminded us that the bioethics advisory board at Lilly has so far concentrated its work in only one area—the ethics of research on human subjects. (The case study Dr. Levine discussed had to do with clinical trials in a poor country of a drug that might then be unaffordable to the population of that country.) Organizational or business ethics related to Lilly as a corporation was simply not on the agenda. Therefore, the academics said, apparently with justification, that they saw very little difference between being a paid consultant for Lilly and consulting on any bioethics body within their own university or in the academic world.
In response to an audience question, Dr. Therasse made an interesting comment. He said that perhaps in a few years, the bioethics program at Lilly would branch out and start to address these wider ethical issues. However, Lilly right now, like many of the large drug firms, is under a corporate integrity agreement with the U.S. Department of Justice. Until that agreement expires, the staff people who might work on that wider ethical inquiry have their hands completely full doing all the required compliance tasks with the corporate integrity. When the agreement expires, those people will presumably be freed up.

Dr. Therasse did not tell the audience what the corporate integrity agreement was triggered by, so I can’t be sure that it relates to this previous post:
http://brodyhooked.blogspot.com/2009/01/lilly-fine-for-zyprexa-off-label.html
But consider what’s apparently being said. Lilly was forced by a legal settlement to improve its corporate ethics behavior. They now say that they don’t have enough staff to attend to a full bioethical inquiry into their company’s activities because they are too busy complying with that settlement. But as soon as the settlement ends, then they can take the time and trouble to think more about ethics. Everybody got that? (I’m pretty sure that Lilly monitors this blog, so if I’ve been unfair to you guys, tell me, OK?)

My main concern, however, was not with Lilly but with my academic bioethics colleagues. Dr. Beauchamp began his talk by noting that some in our field criticize him for consorting with industry in this fashion. He then characterized their criticism using a series of straw-man arguments, such as they thought it was bad to make profits. He failed to address a single substantive argument made against close relations with Pharma based on actual patterns of industry behavior. So far as Beauchamp was concerned, there simply was all upside and no downside to consulting with drug firms. We recently reviewed the new book by Peter G√łtzsche that was highly critical of the industry:
http://brodyhooked.blogspot.com/2013/11/deadly-medicines-over-top-or-overdue.html
If you were to listen to Dr. Beauchamp’s talk, you’d have no idea that such a book ever could have been written.

What was embarrassing about this presentation was that if a physician/scientist had given such a talk, explaining why he was a paid consultant to Eli Lilly, anyone with any familiarity with the industry would have labeled the talk as the typical rationalization that people with their hands in the till give when in denial of their actual conflict of interest. Here we have one of the bright lights of the field of bioethics imagining that he is giving a presentation that defends his role as a paid industry consultant, apparently not even realizing that he is merely giving that much more ammunition to critics of current financial entanglements.
To elaborate further on a theme that I have stressed repeatedly here, I want to contrast the positions of my academic colleagues with that of Dr. Van Campen. I may agree or I may disagree with her ethical thinking on a variety of issues, but at least we know fully where her loyalties lie. She’s a paid Lilly employee, and we must imagine that the minute that her activities were judged by Lilly to be bad for business, she’d be out the door. My concern rather is for people like me who imagine that we are independent, objective scholars, but that we can accept a role as a paid consultant to Lilly or any similar company while still adhering with full integrity to our independent stance. This panel, if anything, further demonstrated the fallacy of that view.

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