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U of M bioethicist takes U.S. to task for not protecting research subjects

Carl Elliott
umn.edu
Carl Elliott

University of Minnesota bioethicist Dr. Carl Elliott has written a scathing commentary in the New England Journal of Medicine (NEJM) about the serious lack of protection given research subjects in U.S. clinical trials.

“If a research subject is seriously injured, neither the researcher nor the sponsor has any legal obligation to pay for that subject’s medical care,” he writes.

In fact, only 16% of academic medical centers in the United States make it a policy to pay for the care of injured subjects. If a subject is permanently disabled and unable to work, sponsors have no obligation to pay compensation for his or her lost income. If a subject dies, sponsors have no financial obligations to his or her family. Not a single academic medical center in the United States makes it a policy to compensate injured subjects or their families for lost wages or suffering. These policies do not change even if a subject is injured in a study that is scientifically worthless, deceptive, or exploitative.

Whether pharmaceutical, medical device or other companies are better about picking up the costs of medical care for people who are injured during the studies is an open question, Elliot adds. But don’t count on it.

“Typically the consent document may say the [industry] sponsor will pay for medical expenses to treat adverse events caused by the study drug,” an attorney for injured study participants told Elliott. “But therein lies the rub. They frequently maintain the condition was not caused by the drug but by the underlying condition or by a freak coincidence.”

As Elliott points out, people have been trying to call attention to this unfairness for decades. A string of national commissions have issued reports on the topic, including one in 2011, which (once again) concluded that “human subjects should not individually bear the costs of care required to treat harms resulting directly from that research.”

“This report,” writes Elliott, “seems likely to produce approximately the same results as the ones that have preceded it.”

No results, that is.

Alone among developed countries

Yet other countries seem to have figured out how to protect their research volunteers.

“Virtually every other developed country requires researchers or sponsors to provide treatment or compensation to injured subjects,” writes Elliott. Some countries have no-fault compensation schemes; others require sponsors to provide insurance before a study can begin.”

Elliott believes similar protective measures should be set up in the United States. But three factors, he says, are holding us back from such reform: 1) much of the workings of the institutional review boards “is so secretive that it is difficult for watchdog organizations or journalists to investigate potential wrongdoing,” 2) tort law “has been largely ineffective in forcing political change,” and 3) research subjects are not a coherent community and, thus, cannot effectively “demand their civil rights.”

“In theory, Elliott adds, “patient advocacy groups might have played a role in organizing support, but today many such groups are financially dependent on the pharmaceutical industry and other research sponsors.”

‘How to exploit a research subject’

On his blog, Fear and Loathing in Bioethics, Elliott provides an even more scorching (and much shorter) summary of the United States’ ongoing failure to protect research subjects:

How to exploit a research subject:

Step 1: Design a risky, deceptive or scientifically worthless study.

Step 2: Injure subjects.

Step 3: Bankrupt the injured subjects by forcing them to pay for their medical care.

You can read Elliott’s NEJM commentary in full on the journal’s website.

Comments (2)

  1. Submitted by Bill Gleason on 07/09/2012 - 11:19 am.

    Action in this area is long overdue…

    Thanks to Professor Elliott for his courageous stands over the years in the area of patient protection and to MinnPost for important work in reporting on this and other health related matters of this type.

    Bill Gleason, U of M faculty and alum

  2. Submitted by Ginny Martin on 07/09/2012 - 09:40 pm.

    More thank yous

    This is alarming–and who knew? A friend volunteered to test a a shingles medication, which was eventually released. But she got shingles. And she didn’t get a whole lot of help from the clinical test people. She finally got help from her own doctor. The clinical team was pretty indifferent.

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