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After Going to Market

Ruth Faden and her colleagues, who were part of an Institute of Medicine committee, examine the ethics of postmarketing research in a New England Journal of Medicine essay. Back in 2008, the US Food and Drug Administration told GlaxoSmithKline to look into whether its drug Avandia (rosiglitazone) was associated with a higher risk of heart attack and death as compared to placebo or other, unrelated drug therapies. In 2010, after receiving letters from Congress that asked for the trial's justifications and that raised concerns regarding whether the consent forms provided enough risk information, FDA stopped the trial and restricted the use of the drug.

As Katherine Harmon at Scientific American points out, in the clinic, patients and their doctors could weigh the risks of whether or not to take the drug, but if those patients enrolled in the trial, they would be assigned randomly to take one particular therapy, not knowing the risks. "Now you've got this heightened ethical obligation toward these people," Faden tells her. "They need to understand why this particular trial is being conducted."

The Institute of Medicine committee was convened to examine the ethics of postmarketing research required by FDA in light of the Avandia trial, and Faden and her colleagues write that the committee found that when FDA requires a postmarketing study, "it assumes a measure of ethical responsibility for the welfare of the study participants; exercise of that responsibility cannot be handed off to contractors or the industry sponsor. The responsibility is particularly strong when the patients' treatment is determined by the study, such as in a randomized trial." Further, they say that the committee found that FDA should only require a randomized trial when an observational one will not provided the needed information. The IOM report was issued in May.

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