A Conversation with Carl Elliott: Shine Lecturer Hopes to Shed Light on Dark Side of Drug Trials.

Elliott, a professor of bioethics, is among a nationwide corps of physicians who have publicly questioned the ties between medicine and industry

Drug testing in clinical trials has always involved a kind of “moral trade-off” in which subjects are asked to take risks for the greater good. 

But in an age when consumerism has infiltrated medicine, regulatory protections for the so-called “guinea pigs” who volunteer for trials are flimsy, at best, with inadequate accounting of the deaths and injuries that befall test subjects.

So says Dr. Carl Elliott, a physician, author and professor at the Center for Bioethics at the University of Minnesota, who will deliver the second annual Cathy Shine Lecture on Thursday, March 8, at the BU School of Public Health. His talk, “The Dark Side of Research: Exploitation in Clinical Trials,” will draw from his controversial book, White Coat, Black Hat: Adventures on the Dark Side of Medicine. The noontime talk is free and open to the public.

“Many of these trials — especially Phase I clinical trials, which are early-stage studies done primarily to determine whether a drug is safe — exploit impoverished, vulnerable people, especially the mentally ill,” Elliott said. “Few people realize how little oversight the federal government provides for the protection of subjects in privately sponsored studies.”

Elliott has written and lectured extensively on the influence of the pharmaceutical industry in medicine, at a time when industry ties to physicians are facing increasing scrutiny. Federal health care reform legislation calls for drug companies to disclose all payments to doctors for consulting, speaking, gifts and meals by September 2013. Research funded by Big Pharma has drawn increasing criticism.

Elliott is among a nationwide corps of physicians who have publicly questioned the ties between medicine and industry, which he believes will take years to sever.

He has taken on a range of drug companies and universities in making his case against industry manipulation of clinical trials — including his own employer, the University of Minnesota, which participated in a controversial drug trial during which a 26-year-old man committed suicide. Although the university was exonerated in the case, Elliott publicly questioned its decision-making in a 2010 Mother Jones article and again in White Coat, Black Hat, published the same year.

Elliott has authored or edited seven books, including A Philosophical Disease: Bioethics, Culture and Identity (1999), and Better than Well: American Medicine Meets the American Dream (2003). Just within the past few weeks, Elliott has again come under fire for calling out what he sees as unethical conduct in the medical industry, a firestorm that may have lasting implications for patients, journalists and whistleblowers uneasy with what they’ve seen on the inside of the industry. 

Elliott talked about some of his qualms and conclusions:

Q: You write about a lack of oversight of clinical trials and the vulnerability of the “guinea pigs” who are paid to participate in drug trials. What’s the main problem with the way the drug-testing system works?

A: The main problem is the profit motive. Drug research has become an almost completely commercial enterprise. It’s funded by the drug industry; it’s managed by CROs (contract research organizations); it’s carried out in for-profit testing sites. It’s done by doctors in private practice, and it’s approved by commercial ethics boards — each of which operates as a private, commercial, for-profit enterprise. Yet it is not regulated as a commercial enterprise, so there are abuses.

Q: What should a patient know before agreeing to participate in a clinical trial?

A: Way too many things to be listed here. One thing that patients ought to know, but are never told, is how much money the investigator is getting for the trial — especially how much money per research subject.

Q: You used the image of doctors in “black hats” for your book. Did the pharmaceutical companies put those hats on physicians, or were there other culprits involved?

A: I think a lot of physicians were eagerly shopping for the black hats themselves.

Q: In just the last few years, 12 drug companies have either voluntarily or involuntarily started to publicly disclose payments to physicians — everything from meals to speaking fees. Do you think public disclosure will make a difference one way or another?

A: Initially, I was skeptical, because in academic medicine, working for Pharma is often seen as a mark of pride, not shame. But I am changing my mind. One great thing that has come from the “Dollars for Docs” database that the news organization ProPublica compiled — which lists payments to physicians — is to make it much easier for investigative reporters to look into possible cases of corruption. So disclosure is a good step.

Q: Would banning all industry gifts to doctors make for better medicine, in your view?

A: Yes, because it would put us all a step closer to a situation where a doctor’s decisions are based on scientific evidence and sound clinical judgment, not industry spin.

The Cathy Shine Lecture, sponsored by the Department of Health Law, Bioethics & Human Rights at SPH, is endowed by the family of the late Cathy Shine, who died in 1992 from a severe asthma attack and was a strong advocate for human rights. The gift recognizes the scholarly work of Department Chair George Annas, who wrote about the Shine case in 1999 in arguing for the importance of respecting patients’ rights. The lecture will be held from 12-1 p.m. in Room L-110 of the School of Medicine instructional building, 72 East Concord St. A reception will follow.

submitted by: Lisa Chedekel

chedekel@bu.edu