The ends aren’t supposed to justify the means, and people shouldn’t be unnecessarily risked for the sake of medical progress. But if paying patients to risk themselves would accelerate progress, is it okay?

That dilemma is raised in a solution proposed by two University of Chicago health policy experts to a paradox of drug development: If moderately effective drugs are already available, patients will have little reason to volunteer for tests of drugs that could be better, but might not work at all.

The policy experts, Anup Malani and Tomas Philipson, illustrate the paradox with data from the early days of HAART, the anti-HIV drug cocktail that hit the market in 1996. Compared to existing drug regimens, HAART was genuinely revolutionary, and has allowed many people to live with the virus for decades rather than years. But HAART still has limitations: Not everyone responds, the side effects can be vicious, and it’s a delay rather than a cure.

Using data from a survey of more than 1,000 HIV-positive men involved in the Multicenter AIDS Cohort Study, Malani and Philipson found a massive decline in clinical drug trial participation after HAART’s debut. Many people with AIDS, happy with the new treatment, wouldn’t participate in clinical trials.

It was a completely understandable decision, of course. But the basic pattern, extrapolated to drug development at large, may represent a problem. And while not everyone agrees with the pharmaceutical industry’s own take on drug development difficulties, it stands to reason that new drugs won’t be approved if they can’t be tested.

Malani and Philipson’s proposal, contained in a paper published in May by the National Bureau of Economic Research, is straightforward: Pay patients an attractive wage to participate in experimental drug trials.

Under existing rules, patients can receive only small stipends. Anything more could be coercive, an anathema to ethical standards established to prevent people from being lured into risking their lives for cash. But Malani and Philipson say that, as long as people are educated about risks, they should be able to take them — especially when withholding payment prevents the development of better, life-saving drugs.

“So long as consenting subjects understand the risks of research, there is nothing special about compensating for health risks in trials,” wrote Malani and Philipson, noting that paying people to take risks is the essence of modern military service.

Over at the University of Minnesota’s Fear and Loathing in Bioethics Blog, the response was harsh. “The patient is desperately ill. She needs treatment right away. But you need research subjects for your clinical trial, and she wants proven therapy,” wrote a poster identified as Carl. “What’s a clinical investigator to do? The answer is simple: pay her to sign up for the trial. You get a research subject; she gets a paycheck; and if the experimental treatment doesn’t work, well, you warned her.”

Image: Woman on hospital bed. (Hamed Saber/Flickr)

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