Tuesday, September 28, 2010

Drug Regulation, Sort Of


According to Rush Limbaugh (9/23), the Big, Bad Democratic Party is at it again:

However, the Democrats run the FDA, and the FDA is now threatening to ban this drug Avastin that can help women with breast cancer and shrink the tumor and extend life. And the reason they are doing this is because the drug's too expensive. Pure and simple. The results of this drug have been excellent. Any ban is due to the high cost of the regimen of the treatment.

So this to me is a little ironic. They are running around saying evil insurance, evil insurance, they can't cancel you if you're sick. But we in the government are going to make sure you don't get this drug if you have breast cancer because we think it's too expensive.


Go to the RedState post to which the transcript of this segment links and you could conclude (except that, well, it is redstate.com) that this is the beginning of death panels. Blogger Brian Darling claims "should the FDA agree with the advisory panel’s recommendation, private insurers and Medicare will drop coverage for the drug for breast cancer patients, despite the fact that the drug extends life for an average of six months."

The truth, not surprisingly, bears little resemblance to the tale spun by Limbaugh and arguably the blogosphere's leading conservative site. Avastin, developed by the South San Francisco California-Genetech facility of Roche Holding AC, is approved by the Food and Drug Administration for brain, lung, and colon tumors. In 2008 the FDA granted the drugmaker conditional approval for use of the drug (alongside a chemotherapy drug) for breast cancer following a clinical trial which showed tumor growth stalled for 5.5 months (apparently the source of the claim of "the fact that the drug extends life for an average of six months")compared to chemotherapy alone.

But a clinical test later that year showed showed no significant benefit of Avastin, wherein it stalled the disease for a mere .9 months when paired with the chemotherapy drug, compared to sole use of the latter. The FDA advisory panel thus concluded that the benefit of the drug did not compensate for its side effects, including headache, irritated nose, protein in the urine, taste alteration, dry skin, rectal bleeding, tear production disorder, and inflammation of the skin. (Less likely: bleeding/hemorrhage, high blood pressure, nose bleeds, blood clots in veins or arteries, holes (perforations) in the stomach or intestines, and wound-healing complications.)

Although it generally does not do so, the FDA overruled the recommendation of its advisory panel, granting through its accelerated approval process acceptance of conditional use of the drug in patients with breast cancer. Genetech agreed to conduct more tests.

In 2009 a clinical test showed greater benefit than the immediate prior test, but only a reduction in tumor growth of 1.2 months. This past July, an advisory panel voted to recommend rescission of conditional approval, apparently because Avastin failed to show significant improvement in survival rates for breast cancer. Using the generic term, American Cancer Society deputy chief medical officer Len Lichtenfeld, MD observed: "The benefits of taking bevacizumab were clearly less impressive—and the side effects considerable—compared to previous reports.”

On September 17, the FDA announced it would delay until December 17 its decision regarding whether to accept the recommendation of its advisory panel and withdraw approval of Avastin for breath cancer. Genetech's own press release noted "There are no data available showing that Avastin improves disease-related symptoms or survival in advanced HER2-negative breast cancer" (this quote from a short, interesting, and oddly objective post on forbes.com).

The FDA still, in December, may choose to give Roche the go-ahead on its division's drug for use in breast cancer. In the interim, it can be used, with government approval, for brain, lung, and colon tumors. And without government support, it can be prescribed by doctors for breast cancer, though insurers- private insurance companies- would be reticent to pay for it.

Rush Limbaugh, a steadfast and enthusiastic supporter of the pharmaceutical industry (insert joke here), complains that the federal government won't permit use of a drug because of its cost. It thus far is a finding and recommendation, not a decision. It was based not on cost, but on lack of false hope. And the irony: the drug company will continue to manufacture the drug and private insurance companies can, if they choose, pay for it. That sounds a lot like the free market at work, with the insurance company at liberty to pay for use of a product if it finds the benefits outweigh the costs.

But Limbaugh is no dope. If, based on corroborating evidence, the FDA rescinds its approval, the system has worked- the system of the free market working effectively when it is sensibly regulated by the federal government. That brings into doubt- nay, refutes- one of the core principles of conservativism, the evil of regulation. And that is something Limbaugh, RedState, and Repub politicians fear.




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