FDA decisions on Avastin, Actos raise eyebrows

Two Food and Drug Administration decisions that came down late last week are raising eyebrows. The agency postponed until December a final decision on whether to withdraw Avastin’s approval for breast cancer. An advisory committee that looked at the clinical trial data in August found it didn’t prolong life, and voted 7-1 to pull the labeling (it would still be available for off-label use because Avastin has been approved for use against other cancers).

And, in a press release issued around 4 p.m. on Friday, the FDA announced it was investigating whether the diabetes drug Actos elevates the rate of bladder cancer among chronic users. This drug is the alternative to Avandia, which a minority of outside advisors said in July said ought to be pulled from the market because it increases cardiovascular deaths in diabetics who take it to lower blood sugar.

We all know that the bad old days of the Food and Drug Administration being influenced by politics is over. There’s a new public health sheriff in town and there will be no more Plan B fiascos, where White House meddlers and Capitol Hill factotums overrule sound science.

So what did the FiercePharma blog (this is a headline service published by an industry trade journal, not exactly the place where one expects to find idle speculation about politics influencing FDA decisions) have to say about this Avastin “postponement”?

The new decision date conveniently comes after the November elections. Congressional types are among those lobbying FDA to keep the breast cancer indication–and accusing it of “rationing” healthcare if it doesn’t.

The FDA told the New York Times that it had to carefully weigh all the data. There’s more data? According to FiercePharma, Roche has submitted new information to the agency. I wasn’t going to write about this until I ran into a close observer of the oncology drugs division of the FDA this evening. He insisted “there is no new data.”

If Roche/Genentech, which makes Avastin, has produced new information in a last minute attempt to sway the agency, it would make a mockery of the advisory committee process. I’d rather believe the FDA wants to put off a politically troubling decision.

Meanwhile, no conspiracy theories have surfaced to explain the Actos bladder cancer investigation. But it sure raised my eyebrows. This is the one drug in this class that FDA insider and safety advocate David Graham said every diabetic should take since it would be unethical to allow people to be randomized to Avandia in a clinical trial comparing the two drugs because of its heart attack risk.

The patient guide for Actos already says there may be a risk of bladder cancer based on animal studies. Takeda, its manufacturer, is in the midst of a ten year study attempting to figure out if it happens in humans. The latest data, five years in, shows a small elevation in the very low rate of cancer. But it is still too early to tell if it is statistically significant. The company, whose drug has seized market share from Avandia because of that drug’s bad publicity, said it will take at least five more years to figure it out.

The FDA doesn’t have that long to figure out what it’s going to do on Avandia. Will it be pulled from the market, or will it get stronger warnings on the label with a stringent patient education program for prescribers (they’re called risk evaluation and mitigation strategies or REMS at FDA)? I can’t imagine there are electoral implications to this decision. My speculation? The Actos announcement — at 4 p.m. on Friday no less — is a smokescreen to cover up real division inside the agency over what to do about Avandia.