Watchdogs or Show Dogs 3: Eli Lilly

Do bioethicists make pharmaceutical companies more ethical?

This is a central question motivating my interview with Jenny Dyck Brian, an Arizona State University professor who wrote her doctoral dissertation on corporate bioethics boards. (See parts one and two of the interview.) Today we turn to Eli Lilly, a company that has had its share of ethical scandal: the recruitment of homeless alcoholics for drug-safety trials, the suicide of a healthy volunteer in a Cymbalta study, the company’s controversial promotion of Xigris, a sepsis drug that was later taken off the market, and most recently, a record-setting penalty for fraudulent marketing of its antipsychotic drug, Zyprexa. Throughout it all, Lilly has been guided by a group of bioethicists that includes some of the most prominent names in the field. As Brian says, Lilly has a bioethics consultation service that offers “specific advice and guidance to research scientists about the ethics of their work.”

Q: How did Lilly decide to set up an advisory board?

A: The Lilly board grew out of an initial proposal from the Hastings Center to conduct a study on the ethics of using homeless persons in clinical trials following a story in The Wall Street Journal about Lilly’s clinical trial recruitment practices. Lilly rejected their proposal, but did hire bioethicists—one of them from the Hastings Center and three others. Following the study, Lilly retained the services of two of those bioethicists, and would occasionally seek the help of other ethics consultants.

Q: And yet Lilly has had some pretty spectacular research scandals, even by the standards of other pharma companies.

A: Yes. They argue that—at this point—they do not have the capacity or capability to deal with the business division (and that tends to be where many, though not all, of the scandals come from). The Chief Medical Officer admitted that they will always have a credibility problem if they cannot deal with ethical problems across the company.

Q: Were any of the members of the committee willing to discuss those scandals? The Tracy Johnson suicide, for example, or the Zyprexa scandal?

A: Not specifically, no.

Q: I’m also curious about disclosure issues. It seems to me that bioethicists are often very reluctant to disclose their corporate ties. For example, just looking at the timing, it appears as if Robert Levine was working as a consultant for Eli Lilly while also editing IRB, a research-ethics journal. Tom Beauchamp does not appear to disclose his Lilly ties in publications such as this recent article in the Journal of Internal Medicine, or this one in the American Journal of Bioethics. Did you discuss this issue?

A: We discussed it only peripherally. The three academics who work with Lilly have slightly different ideas about disclosure. Tom Beauchamp told me he believes he needs to disclose only when he is presenting or writing about topics directly related to Lilly. I did not ask Robert Levine—and he did not mention anything. Eric Meslin stopped consulting for Lilly when he had a conflict that could not be resolved, but few people knew he was a consultant at all.

One of the SmithKline Beecham people wrote an article about industry funding of science shortly after his tenure on the board ended and never disclosed his affiliation. The others do not disclose, as far as I can tell. Advanced Cell Technology people always disclose. I feel like they are trying very hard to show that private-sector bioethics committees can be very productive and meaningful.

Coming up soon: the final part of the interview, on Advanced Cell Technology and the way bioethicists see pharma.