Sydney “Syd” Wolfe, director of Public Citizen’s health research group, is scratching his head. Tequin (gatifloxacin)—an antibiotic that Public Citizen had campaigned against—was pulled from the market by its manufacturer, Bristol-Meyers Squibb (BMS). But BMS said that was because of lagging sales. That was two years ago.

In September of this year, the FDA formally announced that Tequin was withdrawn from the market for efficacy or safety reasons. (Here’s that statement.) Public Citizen had provided an early warning about the drug causing dangerously (sometimes fatally) low blood sugar.

Score one for Public Citizen, a drug safety advocacy group that, thanks to Wolfe and his staff, has repeatedly sounded an early alarm about drugs that were eventually withdrawn from the market. Public Citizen is one element of a new, informal regulatory system of medical journals and academic physicians that operates in parallel to the official, legal one. The informal system communicates effectively, unlike industry, and has fanned concerns about the integrity of drug safety data among physicians and the public.

Wolfe says it’s unusual for the FDA to issue a statement about Tequin when it didn’t have any regulatory obligation to do so, especially so long after the data have arrived and the drug has left pharmacies. “Maybe they realized they had some obligation to clear the water,” he says.

Change Afoot?

Does the letter signal any sort of sea change within the agency that’s responsible for drug approval and drug safety? Likely not, says Wolfe. 

“We’ve had to continually sue the FDA. In the old days, when we’d ask them to do something, or we’d send a petition, they’d respond. More recently, we’ve filed a number of lawsuits” about drugs Public Citizen thinks should be off the market, because the FDA has stopped responding to such petitions, Wolfe says.

Financial Tug

He added that, because the FDA gets a large chunk of its funding from drug makers, he’d be shocked to see any changes that involved more openness or cooperation with groups like Public Citizen.

“Two thirds of the agency’s funding comes in direct cash payments from the [pharmaceutical] industry. It would be hard for a sea change to occur, for them to go in a more patient-health direction, for them to overcome that kind of financial tug,” says Wolfe, referring to the user-fee arrangements mandated by Congress.

Might the FDA’s culture shift at all with a new presidential administration? No, says Wolfe. New administrations typically bring very little change to the FDA.

Change Unlikely

“Change is limited to the commissioner, general counsel and people in the office of the commissioner,” Wolfe explains. “The direction and power of the agency is determined mainly by the center directors, and they almost never change in a new administration.”

“And there are serious problems with the center directors,” he says. As one might expect, Wolfe makes it clear that he is not a fan of the man he has sued and petitioned on occasion, FDA commissioner Andrew von Eschenbach. Is there any chance things will improve at the FDA? None? Possibly, says Wolfe, “if there’s a really strong, excellent new FDA commissioner, which is possible, but I don’t know if that will be at the top of the priority list of the new president.”

We asked Wolfe if he could pick one drug on the market today which most glaringly shows the weakness of the current system from a public safety standpoint. His answer: “No—there are too many. There are a couple of hundred drugs” that show that, he said. 

Avandia Angst

Apparently, though, Avandia is one of them. After we spoke with Wolfe, Public Citizen filed a petition with the FDA to remove the already controversial diabetes drug from the market, citing the FDA’s own data. Last year Avandia, made by GlaxoSmithKline, was shown in a study published in the New England Journal of Medicine to be linked to heart attack risk.

This time, Public Citizen is working closely with formerly neutral patient advocacy groups to get the drug pulled, potentially raising the stakes for future battles between the industry and FDA (on one side) and medical journals and academic physicians (on the other). In a statement, GSK said it does not believe there to be any liver toxicity risk related to Avandia. No response yet from the FDA.

by Suz Redfearn

d9A2t49mkex