Yesterday marked the inception of a two-day meeting of scientific advisors to the FDA who were delegated the task of assessing the safety of Avandia, a diabetes drug linked to an increased risk of cardiovascular problems.
Among the conference attendees, perhaps FDA Commissioner Margaret A. Hamburg raised the most brows, since the head of the agency rarely appears at panel advisory meetings. “Follow the science wherever it leads and the rest will fall into place,” she stated at the meeting.
“It is almost a historic event when the FDA Commissioner attends and speaks to the scientific advisory panel, and more importantly, when they remind panel members that sound science must come first,” says ACSH’s Jeff Stier.
Despite Dr. Hamburg’s wise words of caution in the Avandia investigation, the Physicians Committee for Responsible Medicine (PCRM) is now suing the FDA, faulting it for allegedly failing to alert diabetes patients to safer alternatives to Avandia. In a 2007 petition, the group asked the FDA to require warning labels informing patients that low-fat, plant-based diets are viable substitutes for diabetes drugs. PCRM is now accusing the FDA of negligence by not following their “sage” advice.
“They should be renamed the Physicians Committee for Irresponsible Medicine, for meddling in the Avandia debate. PCRM is actually an animal-rights activist group, which advocates vegan diets in a completely unscientific manner,“ ACSH’s Dr. Elizabeth Whelan pronounces.
According to PCRM’s general counsel, Daniel Kinburn, “A low-fat, vegan diet is clearly safer and at least as effective.” Dr. Whelan counters, “How dare they suggest that a dairy-free, meat-free diet is as effective as proven pharmaceuticals for diabetics?”
ACSH’s Dr. Gilbert Ross adds, “PCRM is not a ‘doctors group,’ as the media called them. Of course, sound nutrition, exercise and weight control are important in diabetes management. But it’s completely inappropriate for this group to sue the FDA on Avandia.”