Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.