If Trump Taps O’Neill for FDA Commissioner, Consider It an Rx for Bad Health | Pharmaguy's Insights Into Drug Industry News | Scoop.it

One of two people that Trump is considering as the next Food and Drug Administration commissioner gave a speech two years ago in which he suggested the agency require only safety testing for new drugs. After that, good luck.


“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” said Jim O’Neill, a managing director at Mithril Capital Management, a venture capital firm run by Peter Thiel, the billionaire Trump donor and transition team advisor. “Let’s prove efficacy after they’ve been legalized.”


He is not the right person for the job. O’Neill is not a scientist or physician. Most FDA commissioners have had such a background, because the training involved in both careers makes it easier to understand the myriad issues involved in moving medicine forward.


So what does he offer? Basically, O’Neill is a policy wonk with good connections and a steadfast belief in the power of free markets. A former policy adviser at the Department of Health and Human Services, he now funds early-stage biotech companies and likes to lambaste the “cartelized” health care system for hindering the development of health care products.


“Waiting to figure out whether a drug works after it’s available is naive, because drugs don’t work like the markets for pens or so many other products,” said Daniel Carpenter, a political scientist at Harvard University who has studied the FDA. “We would be turning the clock back nearly a century, and the legitimacy of the American medicine cabinet would crater.”


Indeed, O’Neill’s notion would be like letting the proverbial genie out of the bottle. In some cases, patients may benefit from the famous placebo effect — maybe they think a drug is working simply because they took it. More important, it is likely to be very difficult to organize proper clinical trials to determine effectiveness once a drug is widely used.


But you may ask, ‘What’s the harm? If the drug is safe, why not let people try it?’


Well, most drugs are not safe, actually. They’re approved because clinical trials have shown that on balance, they help more than they hurt.


Keep in mind that even if Trump appoints O’Neill and he’s confirmed as the new FDA chief, he cannot unilaterally overhaul the drug approval process.


The 1962 Kefauver-Harris amendments to federal law require trials to demonstrate adequate safety and effectiveness. So Congress would have to get involved to change the system. Still, that seems entirely possible given the Republican penchant for deregulation.


Naming someone with such radical ideas as FDA commissioner would not serve the public.