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The Dark Side of Drug Trials

Physician, bioethicist addresses topic in Shine Lecture tomorrow


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 will deliver the second annual Cathy Shine Lecture tomorrow at noon 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.

Carl Elliot, White Coat, Black Hat: Adventures on the Dark Side of Medicine

Elliott’s talk, titled The Dark Side of Research: Exploitation in Clinical Trials, draws 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.

White Coat, Black Hat: Adventures on the Dark Side of Medicine book by Carl Elliott

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 in White 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 BU Today about his qualms and his conclusions:

BU Today: 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.

The 2012 Cathy Shine Lecture, The Dark Side of Research: Exploitation in Clinical Trials, by Carl Elliott, is tomorrow, Thursday, March 8, at noon in the School of Medicine Instructional Building, Room L-110, 72 East Concord St. It is free and open to the public and will be followed by a reception.

Lisa Chedekel can be reached at chedekel@bu.edu.


6 Comments on The Dark Side of Drug Trials

  • AHs on 03.07.2012 at 5:32 am

    why is it that gifts to doctors are considered not good?

    when two companies make the same product with the same ingredients with only different packaging and different brand names, a doctor maybe indifferent to prescribing either to the deserving/needy patient. why is it that the drug manufacturers are criticized for building a relationship with the doctors so the doctors can prescribe their products when (if the company hadn’t reached the doctor) the doctor would just be prescribing either or both with no preference.

    in distinguishing its brand from another company’s, a company would spend on its packaging and advertising, does it not make sense to spend a little less of that amount on building a stronger relationship with the doctor instead?

    • Duh on 03.07.2012 at 10:20 am

      Because,it starts doctors to make decisions on profit motive instead of being based on scientific evidence and sound clinical judgment.

      Unless you are denying that that is happening, or that it is a problem? But that would be a personal problem

    • C on 03.07.2012 at 11:40 am

      Well I guess it depends if your goal is to make money, or to help people (although the two don’t have to be mutually exclusive.) If your goal was first and foremost to improve the health of others, it would make more sense to invest your resources into making a product that is not only DIFFERENT than those on the market, but also BETTER. If you were more interested in making money, you would invest your resources into better marketing (either by advertising or “building a stronger relationship with the doctor”) of your existing mediocre product. Prescribing decisions should be based on the merits of the drug, not the patient’s interest in getting the drug he or she saw in a commercial, and not the relationship a physician has with a pharm company.

  • F on 03.07.2012 at 6:48 pm

    This is exactly why AHs said that the products are similar to eachother and have the same ingredients.

    I own a pharmaceutical company and my company comes under the top 5 cleanest companies I’m the region.
    Even though I make excellent products, not always is it enough since you have to give the doctors an incentive to sell your product.
    Yes, the doctor should always care about the patient first and foremost but is there any harm in competing with my direct competitors that are also in the top 5 in the region by “building stronger ties” with the doctor than the other company manages to?

    Do you think we prefer having to gift doctors? But don’t you think it’s unfair for me if I don’t gift the doctors and the doctors instead chose to prescribe drugs manufactured by companies that are not producing the quality drugs we are? Don’t you think in order for companies to stay in the market, they have to do this? If we don’t, then another company (in the case in my region: a company not nearly close to being as clean as we are) will take the market share.

    If theres a way this can be done then it’s the doctors that should be blamed for it since they’re the ones who pledge to save lives the best they can

    Why do pharma companies have to suffer.

    It would be better for us if the doctors didn’t want these gifts since we know we’re good and we don’t need to gift the doctors but the way the doctors are doing their jobs right now there is no way a Pharma company can survive without cooperating with the doctors.

    I use the word cooperating because we are forced to do so. No one likes spending money in things they don’t have to.

    • AM on 03.01.2013 at 9:11 am

      Good lord! “Why do pharma companies have to suffer?” Why do people who aren’t rich have to bear the burden of experimentation and not have access to expensive drugs such as AIDS treatments so that some greedy capitalist can have a second house?

      And your quote “you have to give the doctors an incentive to sell your product” is exactly the problem in this industry. You do NOT want to give doctors incentives to do anything except give their patient the cheapest, most effective treatments for health.

      • MH on 03.04.2013 at 4:06 am

        And the answer to this is to make it illegal for pharma co’s to gift the doctors. Level the playing field, if you will. Then, the pharma co’s that ARE doing the right thing by producing a better, cleaner, cheaper product will have the upper hand with the doctors who care for their patients. At that point, they can build their second home in the Hamptons with my blessing. Capitalism at its finest, right? Greed is the great distortionist. It induces people who may have started out with the right intentions to do things they may not have otherwise. Call a spade a spade, these gifts are thinly veiled bribery. However, until they are made illegal, as they should be, small pharma co’s cannot compete unless they participate. A tragic catch-22. This bribery interrupts the natural system of captitalism. Don’t blame capitalism, blame the system that allows those companies to bypass what is right, and allows the docs the opportunity to be swayed. Hold them all accountable for doing what is right, not what is easy.

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