Forty Thousand Deaths a Year

Some 40,000 women died from breast cancer in 2007. Almost unbelievably, the federal government may block one of the disease's more promising therapies for no other reason than the Food and Drug Administration's obsolete, even antimodern, regulations and approval models.

You can -- and I do -- complain about marginal tax rates, tariffs, free trade, and civil liberties. But at the end of the day, no intrusion on our freedoms matches that of the FDA. Locke and Jefferson both put life first when enumerating our birthright liberties.

These 40,000 might have wanted to try Avastin. Certainly the people at Genentech would have loved to sell it to them. Yet our government, with the thinnest Constitutional purview, forbids the sale of lifesaving drugs. The Wall Street Journal Editorial Page calls it "A Moral Test for the FDA"

In February, Genentech also released the preliminary findings of a more rigorous follow-up study, including the FDA's "gold standard" of randomized and placebo-controlled clinical trials. It again confirmed that Avastin improves progression-free survival, though the full results have not yet been made public.

In other words, dying patients live nearly twice as long on average before their disease gets worse, and maybe longer. It translates into an improvement in quality of life by delaying the onset of symptoms. But only in a few isolated contemporary cases has the FDA deemed progression-free survival as a relevant "end point" for approval. There's no reason besides the FDA's complacency and archaic procedures; a recent review by the agency's own Science Board concluded that "evaluation methods have remained largely unchanged over the last half-century."

Extending life is the FDA's acid test for any anticancer agent, but studies designed to prove it take years and thousands of patients to get large average effects. In the Avastin study, women lived slightly longer, a median of 26.5 months compared with 24.8 with Taxol alone. But those results weren't proved statistically significant to FDA satisfaction.

It works. It helps. It just doesn't work they way we like it to work well enough. So we will proscribe its sale. Next year's 40,000? Drop dead.

Pharmaceuticals Posted by jk at February 21, 2008 1:06 PM