Does FDA have a special obligation to patients who sign up for post-marketing safety studies? An article in the latest New England Journal of Medicine suggests it does. And with new legislation setting up the prospect of more fast-track approvals, the authors point out, post-marketing studies will be more common--and more important--than ever.
After analyzing a head-to-head safety trial pitting GlaxoSmithKline's ($GSK) diabetes drug Avandia against Takeda Pharmaceuticals' Actos, three ethics experts concluded that the usual informed consent doesn't cut it in such studies. The very reason that FDA called for the trial--the questions about Avandia's cardiovascular safety--set a higher bar for disclosure, the authors said.
FDA called for the Avandia-Actos safety trial, dubbed TIDE, after meta-analyses uncovered some red flags about the GSK drug, namely hints of increased risk of heart attack and cardiovascular death. The idea was to check out Avandia's risks, and determine whether Actos came with the same potential for problems. Some FDA staffers protested, saying that the safety signals on Avandia were strong enough to make that trial unethical, but the agency determined that the risks were still uncertain and needed to be assessed, the NEJM article states.
After some criticism from Congress, FDA Commissioner Margaret Hamburg asked for advice from an advisory committee--which recommended that TIDE go on if Avandia remained on the market--and requested that the Institute of Medicine weigh in.
The NEJM essay, written by three IOM committee members, is based on those recommendations. The gist: FDA should be doubly careful about the design of these safety studies and their governance. Trial participants have to be crystal-clear on the risks they're taking by enrolling, and to make sure of that, FDA should set up stricter guidelines for informed consent in these trials. Plus, the committee determined, if FDA orders a post-marketing safety study, then it must be prepared to act quickly on its outcome.
- read the NEJM piece
- get more from Scientific American
GSK wraps up another 25,000 Avandia suits
Takeda's Actos era ends with generic launches
Watson sues FDA for delay of generic Actos launch