Trump's rumored FDA candidate strikes nerve

Trump's rumored FDA candidate strikes nerve
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The possibility that President-elect Donald TrumpDonald TrumpTrump cheers on Senate GOP ahead of 'skinny' ObamaCare repeal vote Live Coverage: Senate votes down 'skinny' ObamaCare repeal Pete King defends ‘unorthodox’ Scaramucci after attacks on Priebus MORE could nominate Jim O’Neill, a Silicon Valley investor with no medical background and controversial views, as head of the Food and Drug Administration (FDA) is setting off alarm bells among some healthcare experts.

Bloomberg News reported Wednesday that O’Neill, a libertarian and associate of billionaire Peter Thiel, who is close to the Trump team, is under consideration for the FDA position. The agency oversees the approval of new drugs and is responsible for ensuring their safety. 

O’Neill lacks a medical background, traditionally a prerequisite for the job, and has raised eyebrows with his past comments about overhauling the agency.

The most attention has fallen on O’Neill’s comments in a 2014 speech, where he called for changing the FDA’s mission so that it no longer considers whether drugs are effective when deciding whether to approve them. Instead, O’Neill said the agency should only consider whether drugs are safe.

“We should reform FDA so that it’s 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. “But let’s prove efficacy after they’ve been legalized.”

Experts expressed alarm at those remarks, saying that they demonstrated a lack of knowledge of how the FDA’s review process works, and that it is all but impossible to separate the questions of safety and efficacy. 

“People need to understand that safety doesn’t exist without the balance of risk,” said Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner under President George W. Bush. 

He said that “every drug has risks,” so the important consideration is balancing the risks against how effective the drug will be. Side effects that would never be approved for Aspirin might be approved for a lung cancer drug, he noted. 

Pitts said he hopes O’Neill clarifies his views if he is selected. 

O'Neill has also suggested that people should be allowed to be paid to donate their organs. “There are plenty of healthy spare kidneys walking around, unused,” he said in a speech in 2009, according to Stat News. 

Dr. Michael Carome, director of Public Citizen’s health research group, said he was “just stunned” when he heard O’Neill’s name reported to be in consideration for FDA.

He said O’Neill’s proposals would bring the country back to 19th century “snake oil salesmen” being able to fool people into using ineffective products.

Beyond his view on the FDA’s mission, O’Neill has also been on the board of the Seasteading Institute, which seeks to set up floating cities on the ocean to test out new ideas for how government should function.

He also has an interest in anti-aging products and has spoken of “immortality” as a possibility. 

“You can tell a lot about an era by listening to what people whine about,” O’Neill said in the same 2014 speech. “If we invest wisely in life extension technologies, in 40 years, we’ll all be able to annoy our friends with complaints like ‘immortality almost never works.’”

On a more basic level, experts expressed concern that O’Neill has no medical background. He was a Principal Associate Deputy Secretary of the Department of Health and Human Services under President George W. Bush.

“He is stunningly unqualified in terms of his understanding of medicine,” Carome said.

It is far from clear that O’Neill will even be selected. Dr. Scott Gottlieb, a former FDA official under Bush now at the American Enterprise Institute, is also reportedly under consideration and would be a more conventional Republican choice. 

O’Neill would also have to be confirmed by the Senate if he were chosen.

But there is still concern about the possibility that he could become FDA commissioner.

Diana Zuckerman, president of the National Center for Health Research, said that O’Neill’s idea of having the FDA no longer consider whether a drug is effective would cause chaos because insurance companies would no longer be able to use FDA approval to decide which drugs they would cover, and possibly could have to start making those determinations on their own.

“It would throw the entire U.S. healthcare system into turmoil,” she said.