A rumor, not linked to any named source, is circulating (Bloomberg seems to have first reported it yesterday) that Donald Trump is likely to name Jim O'Neill to head the Food and Drug Administration (FDA).
Mithril Capital
O'Neill is currently a managing director at Mithril Capital, an investment firm co-launched by Peter Thiel, who is on Trump's transition team.
Gizmodo is hitting the panic button hard at this rumor, with its headline: "Trump is Considering an Insane Silicon Valley Libertarian to Head the FDA."
The bill of indictment against this dangerous madman, who they find "pretty freaking terrifying"?
he has advocated for the FDA to give up on vetting the efficacy of new drugs before they come to market. O'Neill, in other words, would like the FDA to stop performing one of its primary functions and let all of us act as lab mice. Such a move might allow drug makers to rake in tons of cash on untested medical treatments that might not ever work. "We should reform [the] FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk," O'Neill said in a 2014 speech at the conference Rejuvenation Biotechnology. "Let's prove efficacy after they've been legalized."
Those "insane" ideas that relate to the FDA may seem familiar to readers of Reason as they have been defended at length and intelligently here by our science correspondent Ronald Bailey, at most detail in this 2012 article.
In it Bailey presents some facts and analysis Gizmodo might not be aware of, or maybe not care about. (Gizmodo does not make the slightest attempt to actually explain why O'Neill's ideas are allegedly insane or bad for America.)
Bailey notes that "a 2010 study in the Journal of Clinical Oncology by researchers from the M.D. Anderson Cancer Center in Houston, Texas found …that the delays caused by requirements for lengthier trials have instead resulted in the loss of 300,000 patient life-years while saving only 16 life-years."
Bailey reports skyrocketing costs and time to get potentially lifesaving drugs through the FDA gantlet, and that it is Phase III trial on efficacy and potential side effects that are the largest cause of this time and money sink, "Between 1999 and 2005, clinical trials saw average increases in trial procedures by 65 percent, staff work by 67 percent, and length by 70 percent," Bailey writes.
Writing about health policy analyst Avrik Roy's call, like O'Neill's, for allowing drugs that have passed Phase I and Phase II to be conditionally marketed, Bailey notes:
Speeding up drug approvals saves lives. A 2005 National Bureau of Economic Research study found that, on balance, the faster FDA drug approvals made possible by new funding legislation passed in the 1990s saved far more lives than they endangered. In fact, new drugs saved up to 310,000 life-years compared to 55,000 life-years possibly lost to the side effects of drugs that were eventually withdrawn from the market. Conditional approval would accelerate access to more drugs, especially drugs that aim to treat the common diseases that afflict more of us. Not only would conditional approval get drugs faster to sick people willing to take a risk on a new treatment, sales of the drug would help fund the Phase III trials needed for full approval….
Roy is not alone in his advocacy for conditional approval. In a February 14 Wall Street Journal op-ed, former FDA Commissioner Andrew von Eschenbach argued that "after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."… Delaying access to new drugs kills people. As Competitive Enterprise Institute general counsel Sam Kazman has observed [PDF], "Whenever FDA announces its approval of a major new drug or device, the question that needs to be asked is: If this drug will start saving lives tomorrow, then how many people died yesterday waiting for the agency to act?"
All points that Gizmodo doesn't want to address, enjoying indulging its rampant libertarianphobia instead. Most of the points in Gizmodo about how dangerously unsuited O'Neill allegedly is to run FDA have zero to do with the FDA, but are just generic expressions of incredulity at libertarian ideas
"Here are some other reasons why it would be completely insane to let this man oversee the health and safety of all Americans," according to Gizmodo:
He's a fan of settling independent libertarian societies at sea and serves on the board of the Seasteading Institute. "If we want to achieve freedom, seasteads are by far the best prospect," he once said.
He thinks organ donors should be paid, a troubling notion that essentially turns the human body into a commodity. "There are plenty of healthy spare kidneys walking around, unused," he said in a speech at a 2009 Seasteading conference
That may be a "troubling notion" to Gizmodo for reasons they don't seem to think worth mentioning, but it is one that would also save a lot of lives, as detailed in Ronald Bailey's 2001 classic "The Case for Selling Human Organs," but fear of markets is more important than lives saved to Gizmodo no doubt.
They also poke cheap fun at O'Neill for being "surprised that people at the FDA like science" because he said in a 2014 talk "As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don't deny that… but one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics."
Said to a libertarian audience, this means O'Neill has gotten over what might be a kneejerk libertarian prejudice against FDA bureaucrats, which should rightly be seen as a good thing when considering the nexus of libertarians and FDA chieftainship.
The day before the O'Neill rumor went public on Bloomberg, Bloomberg columnist Tyler Cowen wrote somewhat admiringly of the idea of Seasteading, belief in which apparently disqualifies one for government service to Gizmodo.
I just finished reading the forthcoming book on Seasteading by Joe Quirk and Patri Friedman, and far from the instant marker of irresponsible kookoo-birdism that Gizmodo blithely assumes, the idea, when properly and soberly considered in its business and ecological promise even outside its political one (though they are all interconnected), is a likely route to nothing less than one of the most likely ways to actually solve any imaginable pile of interconnected problems such as hunger, soil depletion, fish extinction, ocean acidification, and carbon dioxide levels in the atmosphere.
FDA or no, O'Neill's association with promoting Seasteading alone should be sufficient to earn him some considered respect from anyone concerned with humanity's future on earth.
O'Neill does have previous executive branch experience under a GOP administration, having served as principal associate deputy secretary of health and human services and a speechwriter for the Department of Education during George W. Bush's administration.
Other reports on the O'Neill controversy, most at least a bit less hysterical, from The Hill, and International Business Times (which features voices upset that O'Neill doesn't have medical experience or medical doctorates), and Salon.
O'Neill, who I interviewed for my 2012 book Ron Paul's Revolution: The Man and the Movement He Inspired, has not responded to a request for any comment on the FDA rumors.
Comentários