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Too many clinical trials still exploit the poor and other vulnerable people, says U of M bioethics professor

Researchers can still unethically take advantage of study subjects, but today’s exploitation has taken a different form — often involving marketing, says Dr. Carl Elliott.

This week, the directors of the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) joined President Obama and other administration officials in condemning a human syphilis/gonorrhea experiment conducted by U.S. researchers on unsuspecting Guatemalan prisoners, soldiers and mentally ill patients in the late 1940s.

Writing in the Journal of the American Medical Association (JAMA), Dr. Thomas Frieden, director of the CDC, and Dr. Francis Collins, director of NIH, called the Guatemalan experiment “regrettable and deeply saddening.”

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The two men also insisted that such unethical studies could not be done today because of the myriad safeguards that have been put in place during the past 60 years to protect study participants, especially those drawn from vulnerable populations, such as the poor, the imprisoned and the mentally ill.

Is that true? Are there enough protections in place?

No, says Dr. Carl Elliott, a professor of bioethics at the University of Minnesota and author of the just-published “White Coat, Black Hat: Adventures on the Dark Side of Medicine.” (Last month, Elliott also published a Mother Jones article that focused on the 2004 suicide of a young mentally ill man who was enrolled at the time in a U of M industry-funded clinical trial of the antipsychotic drug Seroquel.)

Dr. Carl Elliott
Dr. Carl Elliott

Clinical trials can still exploit study subjects, only the exploitation has taken a different form, Elliott told me in a phone interview earlier this week. Medical researchers may no longer be going out and intentionally making people sick, as they did in the Guatemala study (and in the infamous Tuskegee syphilis study), but they still can — and do — recruit vulnerable people (the uninsured, the poor) and often fail to give them adequate treatment while the subjects are in the trial.

“In a lot of ways, what’s going on now is even worse,” said Elliott. No one apparently died in the Guatemalan trial, he noted, but that wasn’t the case in a clinical trial conducted by the pharmaceutical giant Pfizer during a meningitis outbreak in Nigeria in 1996. Pfizer tested an experimental antibiotic, Trovan, on 200 children during that epidemic without, according to the children’s families, proper consent. (The families say they didn’t realize their children were receiving an experimental treatment.) Eleven children died and many more were permanently disabled. (Trovan has been banned in Europe and can be prescribed in the United States only to adults and in limited medical situations.)

The Trovan study is an example of the increasing number of clinical trials being conducted solely for marketing rather than for scientific purposes (to advance our knowledge about a disease or a treatment), said Elliott. “They’re being done to make a drug look good so it can be approved and marketed. … It’s totally driven by the market.”

To beat the competition to market, drug companies need to get their studies completed quickly.

“The thing that slows them down is recruiting subjects,” said Elliott. The faster a company can recruit people to participate in a clinical trial, he said, the faster it can do the study, get the drugs approved, stay on the market — and make money.

“It all starts with patients,” said Elliott. And the easiest patients to recruit, he added, are those without health insurance and/or who are poor. They need the money.

For Phase I trials, which are conducted to determine if a drug is safe, researchers must recruit healthy people. Yet what healthy person is going to volunteer to be the first to take an experimental drug? The unemployed and the poor, said Elliott.

Later-Phase trials, which test a drug’s effectiveness, need to recruit sick people. “A lot of those patients are in America because we don’t have universal health coverage,” he said, “but it also means people in the developing world. There are a lot of sick people in the developing world who are happy to sign up for a trial.”

“We rich people with health insurance in the developing world can depend on poor people without health care to test our drugs for us, and nobody sees that as a problem,” he added.

As for safeguards, Elliott pointed out that many of the 6,000-plus institutional review boards (IRBs) that are supposed to oversee the methodology, safety and ethics of clinical trials in the United States are for-profit entities whose existence depends on the drug companies that they’re evaluating — a troubling conflict of interest.

“IRBs essentially have extremely little oversight in this country,” said Elliott. Indeed, just last year, a sting operation conducted by a congressional committee and the General Accountability Office uncovered a Colorado IRB that was willing to rubberstamp a clinical trial for a fake and unproven medical product from a fake company. The IRB hadn’t checked anything.

“What depresses me more than anything else is that I can see so little avenue for action, for striking back on the part of the people who are bearing the burden of this,” said Elliott. “Unlike, for example, the civil rights movement where you actually had a community that could organize and strike back for power, sick people and poor people are so vulnerable and so easily exploited that there is little opportunity for some kind of collective action.”