Suppose you knew you had a terminal illness, and the doctor told you there was a drug that cost almost $100,000 a year, that had not been shown to help people with your condition live any longer; had potentially serious side effects; and might even kill you itself. However, it did seem to slow the progression of signs of your disease such as the appearance of x-rays. Would you take it? As a taxpayer or a payer of insurance premiums, would you want the government or your insurance company to use your money to pay for it?
The FDA says yes, and yes. Avastin, a so-called angiogenesis inhibitor, was just approved for use in metastatic breast cancer, even though all of the above applies, and the relevant advisory council had voted against approval. Avastin has been shown to slow the growth of tumors, but not to confer any significant survival advantage. Again, the FDA has approved a drug on the basis of a so-called "surrogate" end point, some element of a disease process or a presumed risk factor that it affects, without any evidence that the drug actually benefits patients in any subjectively meaningful way.
Unfortunately, even those new chemotherapy agents that do show a survival advantage generally extend life by only a few months, at best, at enormous cost. Do we really want to be spending a quarter of a million dollars to give a very sick person a few weeks of existence, when we aren't even willing to spend a few hundred dollars to provide primary care to low income people? This is self-evident insanity -- but it's very profitable for the drug companies, and that, apparently, is good enough for the FDA.
Monday, February 25, 2008
Through the Looking Glass
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