I wrote a post back in 2013 that quoted the average cost of drug development: $1.2 billion over 15 years. Four years later, it’s probably more than that, but the point is still the same: it would appear to cost way too much and take way too long to come up with the next wonder drug to fight Parkinson’s.
But be careful what you wish for. Would you buy a drug that was safe but you didn’t know whether it worked? Perhaps more critically, would your insurance cover it? This is the reported philosophy of Jim O’Neill, one of President Trump’s potential candidates to lead the Food and Drug Administration. During the George W. Bush administration, Mr. O’Neill held various posts at Health and Human Services Department. Currently, he is managing director at Peter Thiel’s Mithril Capital Management. O’Neill would be an unconventional pick, since he doesn’t have a medical background. The head of the FDA for the last five decades has either been a trained physician or a prominent scientific researcher.
In a 2014 speech, O’Neill said he supported reforming FDA approval rules so that drugs could hit the market after they’ve been proven safe, but without any proof that they worked, something he called “progressive approval.” “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety — and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”
That phrase “at their own risk” gives me considerable pause — especially since the major legislative strengthening of FDA occurred as a result of thalidomide birth defects in the 1960s. No drug is risk free — but at the same time I have some qualms about suddenly growing a flipper. I also wonder where my insurance company would put “pixie dust” on its formulary.