ICYMI: Blake Masters, Peter Thiel sought new FDA boss, new approach to clinical trials as Trump took office [Arizona Republic]

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Arizona Republic: Blake Masters, Peter Thiel sought new FDA boss, new approach to clinical trials as Trump took office
By Ronald J. Hansen
September 23, 2022

Key Points:

• The closest U.S. Senate candidate Blake Masters has come to working in government in recent years were the few months he spent with President-elect Donald Trump’s transition team beginning in late 2016.

• But even when he was working for Trump, Masters’ effort aligned closely with his mentor, billionaire Peter Thiel.

• Trump’s transition team featured a half-dozen people from Thiel’s orbit, headed by Masters. For a time, the incoming president’s team considered having the federal agency that screens pharmaceutical drugs headed by two men with no medical training,  including Jim O’Neill, who worked for Thiel.

• O’Neill notably wanted the public to be able to access experimental drugs before they completed clinical trials, a costly, multiphase process that measures whether any potential drug is safe and effective. It is the kind of significant shift in policy also favored by Thiel and Masters.

• The O’Neill recommendation came as a company Thiel’s foundation backed was nearing a phase of that testing with a drug intended to treat Alzheimer’s disease.

• O’Neill didn’t get the job, and the Alzheimer’s drug failed its test. The company’s finances crashed with it.

• For Masters, the story of the FDA recommendation and a company called Cortexyme offers a glimpse of his free-market preferences and the public risks and private profits that can go with it. As is often the case for Masters, Thiel looms large over it.

• Masters was the signatory for the Thiel Foundation’s 2014 investment in Cortexyme, according to records with the Securities and Exchange Commission. That South San Francisco-based company was developing atuzaginstat, a drug intended to help slow the progression of Alzheimer’s.

• First, Cortexyme had to get its drug approved by the Food and Drug Administration. To do so, it had to pass clinical trials.

• Experimental drugs go through internal testing, then face scrutiny from the FDA. The FDA reviews tests on humans to determine if the proposed drugs are safe and effective for specific diseases and helps set dosage levels.

• Thiel’s top pick for the FDA was Balaji Srinivasan, an electrical engineer and entrepreneur who had created businesses ranging from cryptocurrency mining to genetic testing.

• He had no medical background, and Chafkin reported Srinivasan deleted tweets reflecting a hostility to the FDA ahead of his recommendation to head the agency… Thiel’s other pick was O’Neill.

• By early December 2016, Trump’s team considered both to head the FDA. It was a provocative possibility and widely was seen as reflecting Thiel’s influence on Trump’s incoming administration.

• “We should reform (the) F.D.A. so there is approving drugs after their sponsors have demonstrated safety — and let people start using them, at their own risk,” he said in a 2014 speech to a biotechnology group according to Gizmodo. “Let’s prove efficacy after they’ve been legalized.”

• That’s a process that many in medicine think would do more harm than good.

• Masters has also complained about an FDA drug-development regime that stifles innovation to the detriment of the public. “I think that all of the FDA’s regulatory processes are probably just way too bureaucratic and way too expensive and take way too long,” Masters said in an April interview with Hidden Things, a podcast with David Gornoski.

• In February 2021, the FDA ordered Cortexyme to limit its testing of the Alzheimer’s drug after some of those receiving it saw side effects to their liver.

• Eight months later, in October, the company disclosed even more disappointing results… The results meant the company failed the kind of efficacy testing that O’Neill wanted to end.

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