Is the FDA's Breast Cancer Committee Really an Obama Death Panel?

(MoneyWatch)  Conservatives believe they have finally found President Obama's healthcare reform Death Panel, and it's the FDA's advisory committee on Avastin, a cancer drug marketed by Roche (ROG.VX) and Genentech. They're wrong, of course, and it's telling that Andrew Breitbart (responsible for the phony Shirley Sherrod scandal) is in part behind this nonsense

That FDA panel voted 12-1 on July 20 to remove Avastin's official designation as a breast cancer drug (it keeps its other cancer treatment indications). While the drug showed a small benefit for patients it came with so many serious side effects that panelists believe it should not be used for breast cancer. Earlier studies showed Avastin had a 6 month survival benefit, but the new studies revealed it's much smaller than that, 2.9 months.

Sen. David Vitter, R-Louisiana, said the vote amounts to death panels by the backdoor:

"I shudder at the thought of a government panel assigning a value to a day of a person's life," Vitter said in the news release. "It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough. I fear this is the beginning of a slippery slope leading to more and more rationing under the government takeover of health care that is being forced on the American people."

Vitter and Breitbart aren't just wrong, they're scientifically illiterate. Lack of interest or outright disbelief in science is a dangerous trend that's very much alive in conservative America, and it's going to harm us all if left unchecked (and not just because cancer patients would end up receiving dangerous drugs that don't work very well if we followed their advice).

Here's why the FDA panel voted against Avastin, according to a socialist propaganda sheet known as the Wall Street Journal:

The new studies show a smaller impact on progression-free survival of less than a month to 2.9 months depending on the treatment group. The studies showed more side effects among women being treated with Avastin. None of the studies showed a survival benefit in favor of Avastin. The panel unanimously said the follow-up studies didn't confirm the clinical benefit seen in the original study.

No survival benefit. That's pretty unambiguous. Now take a look at the source material the FDA used to make its decision. Among other things, it says:

Overall, the incidence of grade 3-5 AEs [adverse events] and serious AEs were almost twice as high in the bevacizumab [Avastin] arms compared to placebo arms in both cohorts. In the taxane/anthracycline cohort, taxane subgroup, there was slightly more deaths in the bevacizumab containing arm than placebo arm (49.8 % versus 43.1 %). The vast majority of the deaths were attributed to breast cancer.

The drug doesn't work very well for breast cancer, and even when it does it harms patients through other side effects -- that's why the FDA voted 12-1 against it.

Here's how Breitbart interprets the same data:

The FDA created a subjective standard they call "clinically meaningful." Sounds impressive but what does that mean? In the case of Avastin, which has been shown to actually work, the FDA is just saying that the average extension of life of 6 months just isn't meaningful enough. That is the new rules of the game. The dealer always wins.

When you're questioning whether drugs should be judged on "clinically meaningful" data, then you're entering a world in which medicine is on the same level as religion, witchcraft and politics.

To be clear, the FDA isn't rationing the drug. It's still on the market for a range of other cancer indications. Doctors and patients are still entitled to use it for breast cancer if they want to. All the FDA is doing is making it clear that a majority of experts don't believe it's effective or safe for one type of cancer. Vitter and Breitbart are assuming that some government programs will now stop paying for Avastin in breast cancer patients. But that's a good thing. Why would we want tax money wasted on a drug that doesn't have data showing it works?

Many private insurers will drop the drug for breast cancer coverage. Again, that's a good thing: Why would you want your premiums to go on drugs that don't work?

Neither Breitbart nor Vitter mentioned that the FDA would have made this decision regardless of the fate of healthcare reform. The vote, in fact, has absolutely nothing to do with coverage. The FDA doesn't even control how reimbursers pay for drugs (although obviously it influences them).

There's a scientific and statistical debate to be had about the Avastin study data and the FDA's decision, but that requires literacy in those fields. Vitter and Breitbart have neither.

Related:

• Why a Charity for the Blind Opposes a Cheap Drug for Sight Loss (Hint: Big Pharma Cash Is Involved)
• $500M Verdict Against Teva Exposes Drug Industry Secret: Dose Packaging Manipulation
• Genentech Finds No Friends in Lucentis Pricing Flap

Image by Flickr user spbutterworth, CC.