Peter Thiel is a polarizing tech giant who has come under fire for funding the demise of Gawker, supporting Donald Trump, and possibly being an IRL vampire. The latest controversy to befall the billionaire founder of PayPal is his involvement with a company whose drug research methods on a genital herpes vaccine violated federal regulations meant to ensure patient safety.
Thiel is one of a handful of other investors who backed Rational Vaccines, a company that is working to develop a herpes vaccine using viruses that are weakened but not dead — something doctors consider especially risky. Rational Vaccines was co-founded by now-deceased Southern Illinois University (SIU) researcher William Halford and former Hollywood filmmaker Agustín Fernández III, and because the company is still affiliated with SIU, the school now stands to lose $15 million in federal funding for being complicit in violating research rules.
In 2016, Halford and Fernández tested the vaccine on themselves to “prove” its safety before conducting a small-scale clinical trial on 17 patients in the Caribbean nation of St. Kitts and Nevis.
A recent inquiry has surfaced many problems with the way this research was conducted.
Rational Vaccines conducted its research without oversight from the U.S. Food and Drug Administration or approval from an institutional review board. FDA monitoring and IRB approval are essential to medical research, and as such, mainstream scientific journals rejected the research from publication.
“What they’re doing is patently unethical,” Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Division of Infectious Diseases, told Kaiser Health News in August. “There’s a reason why researchers rely on these protections. People can die.”
Now, based on documents obtained by The State Journal-Register, it seems that Halford’s former employer, SIU, may risk losing millions in federal grants for failing to ensure safe and ethical trials:
The initial investigation by SIU’s institutional review board “has determined that serious noncompliance with regulatory requirements and institutional policies and procedures occurred,” SIU School of Medicine dean and provost Dr. Jerry Kruse wrote in an Oct. 6 response to a federal inquiry about William Halford’s genital herpes vaccine research.
The federal inquiry, conducted by the Office for Human Research Protections, a division of the U.S. Department of Health and Human Services (HHS), came on the heels of reports by Kaiser Health News and the State Journal-Register on Rational Vaccines’ questionable drug trials. Following the HHS inquiry, SIU began its own investigation.
SIU had initially downplayed the fact that the company conducted drug trials that seemed to intentionally skirt federal and university regulations, saying that Halford was acting as an agent of Rational Vaccines and not as a university researcher. But now HHS maintains that the university had committed to ensuring patient safety in the drug trial.
If the HHS investigation finds that the university was indeed responsible for the oversight failure, it could cost the university $15 million in ongoing federal funds for research. Furthermore, local doctors in St. Kitts and Nevis were kept in the dark regarding what the researchers were doing. So even if what happened was not illegal, it appears to have been highly unethical.