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Potential FDA Head Could Change Drug Approval Process Dramatically

One controversial aspect, O’Neill says the FDA should only regulate drugs for safety, not efficacy.   
Drugs are proven safe and effective before hitting pharmacy shelves. Jim O'Neill sees it differently.

President elect Donald Trump has had several controversial cabinet picks so far for his administration. But in the medical community many are especially concerned over the possible tapping of Jim O’Neill for head of the FDA. For the last 50 years, commissioners have all had a medical background, either as a doctor or a researcher, but not this Silicon Valley investor. He is familiar with government. In 2002 under the Bush administration, the candidate did a stint as the principal associate deputy secretary for the Department of Health and Human Services.

O’Neill has close ties with billionaire and PayPal co-founder Peter Thiel. Thiel is aiding the Trump team with its Defense Department transition. O’Neill and Thiel were colleagues at Clarium Capital Management. The possible appointee also spent some time managing the Thiel Foundation and a biotech incubator called Breakout Labs. At the latter, he helped biomedicine and food science startups develop and gain a foothold in the market.

Currently, the prospective commissioner is a managing director at Mithril Capital Management, a company owned by Thiel. An inside source close to the Trump team told Scientific American that Thiel was advocating for O’Neill. Yet, some of the investor’s past statements have raised concerns. While one of the FDA’s main jobs is approving medications, O’Neill said in a speech in 2014 that medications should be evaluated for safety only, what 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,” he said in that same speech. “Let’s prove efficacy after they’ve been legalized.”

Billionaire and PayPal founder Peter Thiel.

This is causing alarm among those in Big Pharma and the medical community. What about the placebo effect? Patients could falsely believe they are getting better, when in fact a new medication does nothing for them. What’s more, it may reveal a naiveté on the part of O’Neill, as many say it is impossible to separate safety from efficacy during the assessment process.  

President of the National Center for Health Research, Diana Zuckerman, told The Hill that such a move would toss insurance companies into limbo. Being unable to rest on FDA approval when deciding coverage, such a move would, “throw the entire U.S. healthcare system into turmoil.” In a legal sense, the 1962 Kefauver amendment would have to be repealed, a law which states that drugs must be proven safe and effective before they can make it to market.

Jettisoning effectiveness is not his most eyebrow raising idea. O’Neill along with Theil, are board members of the first sea-based enclave, known as the Seasteading Institute. Here, like-minded individuals will inhabit a series of rigged platforms floating on the ocean. Seasteaders are looking to make their own libertarian utopia in international waters, free of existing governments, or so they claim.

Conceptual design for a seasteading enclave. By JackDayton at en.wikipedia (Transferred from en.wikipedia) [CC BY 3.0] GFDL from Wikimedia Commons

The staunch libertarian says that the problem with American healthcare is that government interference has suppressed the free market, which has made the process wasteful and expensive. O’Neill has said in past statements that no one should be forced to pay for another’s obesity, and organ transplant recipients ought to pay for the organs they receive. “There are plenty of healthy spare kidneys walking around, unused,” he said, in that same 2009 speech. O’Neill is also a proponent of anti-aging medicine, and believes that medically driven immortality is not outside the realm of possibility.

FDA insiders question how O’Neill might interact with the 17,000 permanent staff at the agency. The FDA commissioner is not the sole voice in approving medications or devices. Independent reviewers are employed for that weighty task. Peter Pitts, a staffer and former FDA associate commissioner for external relations, told Forbes, that O’Neill’s lack of a medical background was “counterproductive and almost insulting.” Since federal employees have some job security, if O’Neill were appointed, senior staff under and the commissioner could be ramming heads over policy changes to the agency for the next four years.

Some conservatives argue that O’Neill could shake up the agency, and help it to branch out in new ways. In a 2009 speech, he said the free market would liberate healthcare, driving down drug prices, improving delivery systems, and sparking innovation. This may fit into what the Trump administration said they want to do, which is “reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.” But few details on how that will be done have been offered. Trump has also vowed that he’d “bring down drug prices.”

O’Neill isn’t the only prospective pick. Former FDA bigwig Dr. Scott Gottlieb is also being considered. He was at the agency under the second Bush administration and is currently the head of the American Enterprise Institute. Gottlieb is considered a more conventional GOP pick.

To hear O’Neill speak for himself, click here: 


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