Although the well-publicized drama following the FDA denial of Provenge served as the flashpoint for this latest attack on FDA advisory panels, critics have long contended that conflicts are clearly avoidable.
In an interview with ONI, Harold J. Burstein, MD, PHD, of Dana-Farber Cancer Institute, said the suggestion that there is "no one" without ties to industry suitable for a review panel is troubling.
"It's is a sad commentary on our so-called experts that so many are tainted by relationships with industry. Patients and clinicians, along with FDA and third-party payers, should expect more from those given responsibility for developing standards of therapy for cancer patients," Dr. Burstein said.
He added that "there are, of course, many experts without conflicts of interest who would be more than capable of joining advisory panels."
Over the past several years, there have been numerous reports criticizing FDA's dependence on advisory panels. For instance, in October 2007, the Eastern Research Group, Inc. (ERG) filed its report to the FDA—Measuring Conflicts of Interest and Expertise on FDA Advisory Committees—in which the researchers found "substantial conflicts of interest for many members of FDA's advisory committees."
Ezekiel J. Emanuel, MD, PHD, chair of the Department of Bioethics at The Clinical Center of the National Institutes of Health, told ONI that FDA drug reviews must retain public trust, and if conflict of interest is influencing or is seen to influence reviews, it will undermine public trust.
Although Dr. Emanuel stressed that there are problems with the approval process, he said, "We need to be sure that we do not attack decision-makers just because we don't like the decision."
How much disclosure is necessary?
In the letter calling for an ethics hearing, the three congressmen concluded that prostate cancer activists have raised serious questions about two academic medical oncologists who voted against Provenge on an FDA panel in March— Maha Hussain, MD, professor of internal medicine, University of Michigan Medical School, and Dr. Scher.