Last week I wrote a post about the FDA considering revoking its approval of Avastin for treatment of metastasized breast cancer, in which I wrote this:
We didn’t even have to wait until 2014 for ObamaCare to be fully implemented to see these death panels. Already the FDA is considering revoking its approval for Avastin as a treatment for women with advanced breast cancer because of issues with the drug’s cost. Determining whether a drug is or is not too expensive isn’t in the FDA’s purview. It’s job is to make sure the drugs are safe and effective.
Liberal commenters immediately came out of the woodwork to defend the FDA’s decision by arguing what the FDA did, that the drug wasn’t helping enough women with breast cancer to justify its cost.
Enter the Wall Street Journal, which wrote about the controversy on Friday and provided a lot more information about the research that went into Avastin’s use for breast cancer and the FDA’s response. It found that the FDA moved the goal posts when it came to approving Avastin for breast cancer:
The FDA later unilaterally redefined its regulatory expectations, devising a pretext to undermine Avastin. The terms of ODAC debate are set by instructions from FDA staff reviewers, and in round two they suddenly emphasized topics that had been resolved in round one, such as the lack of overall survival benefits and safety issues such as toxic side effects.
The latter can include severe bleeding and other life-threatening complications, though they are manageable. Some 812,000 patients world-wide have been treated with Avastin, 90,000 with metastatic breast cancer, and its safety characteristics are well understood. As for survival, Avastin hasn’t been shown to extend life on average–but it doesn’t impair it on average either, even as patients are enduring the savagery of traditional chemotherapy.
ODAC chairman Wyndham Wilson, a National Cancer Institute lymphoma specialist, conceded that Avastin’s side effects only affect “small numbers,” but “if you’re the one, that’s not what you want to be exposed to.” But what if you’re “the one” for whom Avastin offers massive breast cancer relief, or a reprieve of a few months at the end of life?
Few of the Avastin panelists had any first-hand clinical experience with metastatic breast cancer. Six of the 13 members sat on the ODAC panel that judged Avastin in 2007 and five of them were invited back by the FDA on an ad hoc basis as “temporary members.” They ought to have recused themselves if only to preserve the appearance of impartiality.
One of them was Natalie Compagni Portis, a member of the original panel and amazingly enough its “patient representative.” She said, “Hope is very important. But to offer hope that isn’t substantiated I don’t think is responsible.” Jean Grem of the University of Nebraska explained her anti-Avastin vote by observing, “We aren’t supposed to talk about cost, but that’s another issue.”
So here we have government-anointed medical patriarchs substituting their own subjective view of Avastin’s risks and costs for the value that doctors and patients recognize. If Avastin is rescinded, thousands of dying women will lose more than proverbial false hope in the time they have left. They will lose a genuinely useful medicine.
Read all of the Wall Street Journal’s piece. It shows that the FDA’s and ODAC’s motives aren’t as pure as they would like you to believe.