The Dark Side of Drug Trials !!!

Drug testing in clinical trials has always involved a kind of moral trade-off—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 to test subjects.

So says physician and author Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota, who recently delivered the second annual Cathy Shine Lecture at the School of Public Health. Sponsored by the health law, bioethics, and human rights department, the lecture is endowed by the family of the late Cathy Shine, a strong advocate for human rights who died in 1992 from a severe asthma attack, in recognition of the scholarly work of George Annas, a William Fairfield Warren Distinguished Professor and department chair. Annas wrote about the Shine case and the importance of respecting patients’ rights in a much-cited article in the New England Journal of Medicine.

Elliott’s talk, titled The Dark Side of Research: Exploitation in Clinical Trials, drew from his controversial book, White Coat, Black Hat: Adventures on the Dark Side of Medicine.

“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,” says Elliott (left). “Few people realize how little oversight the federal government provides for the protection of subjects in privately sponsored studies.”

At a time when industry ties to physicians are facing increasing scrutiny, Elliott has written and lectured extensively on the influence of the pharmaceutical industry in medicine. Federal health care reform legislation calls for drug companies to disclose, by September 2013, all payments to doctors for consulting, speaking, gifts, and meals. Research funded by Big Pharma has drawn increasing criticism.Elliott is one of a corps of physicians nationally who have publicly questioned the ties between medicine and industry, ties that he believes will take years to sever.

He has taken on 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 inWhite Coat, Black Hat, published the same year.Elliott has written or edited seven books, including A Philosophical Disease: Bioethics, Culture and Identity (1999) and Better Than Well: American Medicine Meets the American Dream (2003).

He spoke with Bostonia about his qualms and his conclusions:

Bostonia: You write about lack of oversight of clinical trials and the vulnerability of the “guinea pigs” paid to participate. What’s the main problem with the drug-testing system?

Elliott: 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.

What should a patient know before participating in a clinical trial?

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.

Your book uses the image of doctors in black hats. Did the pharmaceutical companies put those hats on physicians, or are other culprits involved?

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

In the last few years, 12 drug companies have publicly disclosed payments—from meals to speaking fees—to physicians, either voluntarily, or not. Do you think public disclosure will make a difference?

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.

Do you think banning all industry gifts to doctors makes for better medicine?

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.