Billionaire and Trump advisor Peter Thiel.
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The Food and Drug Administration has launched a criminal investigation into an offshore herpes research trial that began with secret injections of an unauthorized herpes vaccine in US hotel rooms, according to a report by Kaiser Health News.

The experimental herpes vaccine research, led by now-deceased Southern Illinois University professor William Halford, initially drew criticism for avoiding US protections for patients in human clinical trials by conducting tests on the Caribbean island of St. Kitts in 2016. Then last fall, Kaiser Health News reported that Halford’s early-stage research appeared to have been conducted illegally, as he injected patients with the vaccine in a Illinois hotel room in 2013. In a twist, it turned out that a group of US businessmen, including Silicon Valley billionaire Peter Thiel, had reportedly invested $7 million in the company behind the research last spring. (Thiel secretly funded Hulk Hogan’s invasion-of-privacy lawsuit that lead to the 2016 bankruptcy of Gawker Media, Gizmodo’s former owner.)

Now, Kaiser Health News reports that the FDA is taking the rare step of investigating the research:

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

In a statement to Gizmodo, the FDA said that it “can neither confirm nor deny the existence of a potential investigation.”

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A spokesperson for Rational Vaccines said, “Rational Vaccines remains committed to ending the spread of the Herpes virus. The company is currently in the process of moving forward with classical clinical development plans, including engaging established contract research organizations and contract manufacturing organizations, filing worldwide INDs—focused initially in the US—and performing clinical trials to international good clinical practice standards.”

Gizmodo reached out to Peter Thiel’s Founders Fund and Thiel Capital for comment, and we will update this article when and if we hear back. SIU declined to comment.

While the FDA does not often pursue cases of research violations, that Halford administered injections though he was not a medical doctor and appears to have deliberately avoided any agency oversight make the case especially serious. The FDA requires that clinical trials go through a rigorous process to gain regulatory approval to ensure that they are conducted safely.

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Halford died last June. His company, cofounded with Hollywood filmmaker Agustín Fernández III, received millions of dollars in private investment after the Caribbean trial, including from Thiel, who has advocated for rolling back FDA regulations. Rational Vaccines has pledged to continue its research, though it took down its website after reports about the hotel-room beginnings of the research. After that revelation, SIU acknowledged that the conduct likely violated laws and broke university rules, but denied knowing about the misconduct.

[Kaiser Health News]