The drug's first clinical trial was done overseas without traditional safety oversights.
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Peter Thiel, the billionaire libertarian and prominent Donald Trump supporter, is among a group of wealthy investors backing an experimental herpes vaccine that's being tested offshore, beyond the reach of government-mandated safety protections for human trials.
Thiel co-founded PayPal and took an early stake in Facebook; he's used his resulting wealth on pet projects including life-extension research using the blood of young people and seasteading experiments. (Seasteading, for those not well versed in libertarian utopias, is the idea of building a new society in international waters, outside the reach of terrestrial government. Thiel thinks the necessary technology isn't quite there yet.) He was the money behind the lawsuit that bankrupted Gawker, and he donated more than $1 million to Trump's campaign, making him one of Silicon Valley's few vocal Trump supporters, though that relationship seems to have soured in the months after Thiel was named a transition team member.
According to a report from Kaiser Health News, Thiel has also invested $7 million in a company called Rational Vaccines, which tested an experimental herpes vaccine on the Caribbean island of St. Kitts last year. The vaccine is designed to prevent herpes outbreaks; the testing involved 20 participants who already had the disease, most of them Americans, being flown to the island for treatment. Yet the trial did not include monitoring by the Food and Drug Administration, or the oversight of an institutional review board (IRB), a committee designated to oversee safety in human medical testing. Review by an IRB is a prerequisite for drugmakers seeking FDA approval to sell their products in the US.
"What they're doing is patently unethical," Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center's Infectious Diseases Division, told KHN. "There's a reason why researchers rely on these protections. People can die." Rational Vaccines did not return an emailed request for comment, but the company downplayed the trial's risks to KHN by noting that participants were already infected with herpes. Still, experimental trials involving live, weakened viruses like Rational Vaccines' product, could lead to side effects even in people already infected with the virus. A representative for Thiel told KHN he was not available for comment.
Despite the ethical concerns, the trial was touted by Southern Illinois University, as one of its professors, William Halford, developed the vaccine and led the study. (Halford, who cofounded Rational Vaccines with former Hollywood filmmaker Agustín Fernández III, died of cancer in June.) The SIU press release read: "The results were impressive, suggesting a functional cure for the disease may be on the horizon."
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The outside-the-lines approach to medicine fits Thiel's libertarian philosophy—and that of the FDA he's helping to reshape. KHN notes that Scott Gottlieb, who Trump tapped to run the FDA, has long opposed the agency's rigorous safety requirements. Trump himself has complained about the time it takes to bring new drugs to market, promising to streamline the process. Trump's proposed changes, not surprisingly, will more likely benefit corporations than consumers.
Rational Vaccines is hoping that the FDA will approve its vaccine despite the fact that its trial didn't have oversight from an IRB. If the FDA denies the request, the company will do more testing in Mexico and Australia and "hopes" to set up an IRB for these trials. The results of the first trial have yet to be published in a peer-reviewed journal, and the first attempt to do so was rejected in part because of concerns over lack of safety and skepticism about Halford's scientific approach.
And one investor in the company says the herpes trial is at least partly a political maneuver, designed to force the issue of medical testing regulation into the public eye. "This is a test case," Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, told KHN. "The FDA is standing in the way, and Americans are going to hear about this and demand action."
Robert Califf, the most recent FDA Commissioner before Gottlieb, told KHN that he couldn't think of a single instance where American researchers operating abroad didn't set up an IRB, and doubted the FDA was getting in the way of herpes vaccines, saying the cost of bringing new treatments to market is high because treatments often don't work or are shown to be unsafe. "The FDA is not the problem," Califf said. "The issue is that there are so many failures."
Meanwhile, there are at least three other herpes vaccines currently in development, including one that's already in phase three clinical trials and one that's being tested by the National Institutes of Health.
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