Great catch by Jonathon Cohn yesterday. The FDA is pulling its approval of a drug called Avastin for use in treating late-stage breast cancer citing an increase in heart failure in patients using it along with other negative side effects.
Conservatives are calling it Obamacare death panel rationing.
[D]uring the debate over the Affordable Care Act,…conservative critics claimed that the initiative would create “death panels” charged with making decisions to stop treatments for people deemed too old to save. Now it’s happening again in the wake of a controversial regulatory ruling about a cancer drug.
The drug is Avastin, manufactured by Genentech. Last month, the Food and Drug Administration announced that it was withdrawing approval of the drug for treatment of late stage breast cancer. The move was not unexpected or without grounding. In September, an FDA advisory committee that includes not just physicians but also patient advocates had recommended the change by a 12-to-1 vote.
Why did the FDA remove Avastin from the market? Here’s why:
At the time, plenty of oncologists were skeptical about the drug’s promise. And it looks like those skeptics were right. In two subsequent clinical studies, Avastin did not prolong life expectancy for late-stage breast cancer victims. Avastin did stop tumor growth for a few months, thus extending what oncologists call “progression-free survival.” But the delay was shorter than the initial study had suggested and the studies did not show that a higher quality of life followed. On the contrary, patients were more likely to suffer from the drug’s many painful and potentially toxic side effects, which include gastrointestinal tract perforations, kidney damage and heart failure.
Here’s where the GOPocrisy gets involved:
[C]onservative critics have been pouncing anyway. Sen. David Vitter, R-La., calls the decision “the beginning of a slippery slope leading to more and more rationing under the government takeover of health care.” Breitbart’s “Big Government” deems it “the result of ObamaCare” and its determination “to ration care to the sick and elderly.”
Here’s Rush Limbaugh (sorry, I won’t link him):
Why should the government be the ones to make this call? Why should the Obama administration, why should the Department of Health and Human Services, why should Kathleen Sebelius, why should those people be able to make the call as to whether or not this drug is made available to Americans? Why shouldn’t some women be able to sign up for a health plan that covers Avastin? Because it’s used for breast cancer. It’s having the same kind of demonstrable positive impact on breast cancer as it is on brain cancer. Whose choice is it here? It’s clear. The story yesterday was the FDA is going to ban this because it’s too expensive. The theory is, “Well, not everybody can have it, so nobody should have it.” It’s what we were talking about yesterday with a “peasant society,” a peasant culture.
Now, they’re running around scaring everybody into thinking Republicans are gonna take away your Social Security, and here they are actively close to removing a drug from the market by disapproving it, simply because of its cost.
Of course, Limbaugh’s assertion is completely off-base since cost is not the issue. Breast cancer patients’ health and safety IS.
The Wall Street Journal got in on the act last August:
If there’s an American precedent for the medical central planning of ObamaCare, it’s the Food and Drug Administration. Witness a looming FDA ruling that may deplete the drug arsenal for terminally ill cancer patients…
The Avastin mugging is really an attempt to undermine regulatory modernization like accelerated approval that offends the FDA’s institutional culture of control and delay. It is also meant to discourage innovations like Avastin that the political and medical left has decided are too costly, with damaging implications for the next generation of cancer drugs.
The FDA is doing its job: removing unsafe drugs from the market. That’s what they are supposed to do. That’s what we want them to do. But, true to form, the conservatives hate them some regulation. It gets in the way of corporate profit-taking, don’tchya know. Too bad if a few women with breast cancer get run over on the way to the bank.
UPDATE: I should have made this a bit more clear the first time around. The FDA is only withdrawing its approval for use in treating late-stage breast cancer. Other uses (treating other forms of cancer, eye conditions, etc.) are still approved. Which, of course, makes the conservative’s hue & cry that much more idiotic.
UPDATE 2: For some really great background, discussion of the science behind the FDA’s decision, and insight into the politics of the whole affair, I commend your attention to this comment on the Daily Kos version of this blog entry. It’s worth a read.
I’m just sayin’…
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