Taking a contrarian, libertarian tack on the recent move by the FDA to be more conservative about patient safety, Hoover Institution fellow Dr. Henry Miller writes in the Washington Times
As more breakthrough drugs come before FDA for approval, the agency must curb its paternalistic instincts and find a way to more sensibly balance safety with patients’ right to assume responsibility for their own medical decisions. This would be a sea change for FDA, which in many areas — “off-label” prescribing, and disseminating new information about drug therapy, among others — has sought repeatedly to limit physicians’ and patients’ discretion on treatment decisions.
The notion FDA should “err on the side of safety” must be qualified for patients with incurable or poorly treatable diseases: For them, there is no safety in the status quo, and they are only damaged further by paternalistic public policies that prevent them from exercising their own judgment about risks and benefits. If FDA must err, it should be on the side of patients’ freedom to choose.
I’m sympathetic to Dr. Miller’s view, although in typical Hoover Institution style he veers toward ideological purity rather than practicality. If the FDA did a better job of making sure risks and benefits were well understood and if physicians exercised more independence from pharmaceutical company influence, I’d be comfortable with lowering the bar for drug approval.
I’ve written before about my dismay at seeing drugs pulled from the market that end up reducing options for patients.August 2, 2005