A Wall Street Journal op-ed on today’s upcoming vote on the drug Avastin by a Food and Drug Administration panel of bureaucrats has an arresting headline:
Race Against the Cure
The op-ed explains what is going on:
Avastin is a biologic that chokes off the flow of blood to tumors, and the FDA provisionally approved it for breast cancer in 2008. Last year, the agency decided that the drug did not offer terminally ill women “sufficient benefit.” The agency has never withdrawn a treatment option for such a serious disease. In an unprecedented move, Avastin’s maker, Genentech, has appealed to the FDA leadership above the drugs division. Thus this week’s trial, with FDA bureaucrats as de facto prosecutors and Genentech scientists defending their medicine….
What Genentech is really challenging is the FDA’s statistical purism that blinds it to the benefits that accrue to some patients amid the averages of randomized controlled trials. Avastin offers some terminally ill women months or years of life. For others, it delays the onset of symptoms, improves their quality of life and gives their doctors another tool to better control disease. No treatment in late-stage oncology is perfect, but a good definition of insanity is denying all patients an option because it may only help some of them.
In other words, Avastin works for some patients and not for others. A few extra months of my life may not seem like much to a bureaucrat. But it could matter immensely to me. Instead of leaving the decision to the patient and physician, the FDA is seeking to ensure that nobody gets a shot at using Avastin. An FDA ban on payments for Avastin would have an effect not just on patients who might benefit from Avasin today but on innovation in the future.
I realize Genentech is trying to make a profit, but this is one time I am definitely siding with the pharmaceutical giants who (along with other productive elements of society) are pilloried in contemporary Washington.