Questionable herpes vaccine research done in St.Kitts and Nevis and backed by tech heavyweight Peter Thiel may have jeopardized $15 million in federal research funding to Southern Illinois University School of Medicine. That’s according to documents obtained by a Freedom of Information Act request by The State Journal Register newspaper, Springfield, Illinois.
In August, Kaiser Health News reported that Thiel and other conservative investors had contributed $7 million for the live-but-weakened herpes virus vaccine, developed by the late SIU researcher William Halford. The investments came after Halford and his private company, Rational Vaccines, had begun conducting small clinical trials in the Caribbean nation of St. Kitts and Nevis.
With the off-shore location, Rational Vaccines’ trial skirted federal regulations and standard safety protocols for human trials, including having approval and oversight from an institutional review board. (IRB).
Experts were quick to call the unapproved trial “patently unethical,” and researchers rejected the data from publication, calling the handling of safety issues “reckless.” The government of St. Kitts opened an investigation into the trial and reported that health authorities there had been kept in the dark.
Yet the regulatory evasion may have been key to drawing interest from the conservative backers, including Thiel, who view FDA oversight and rules as innovation-stifling. One investor called the trial a “test case” and argued that “the FDA is standing in the way, and Americans are going to hear about this and demand action.”
Now, however, the Department of Health and Human Services and Southern Illinois University’s IRB are the ones hearing about it and taking action.
According to the documents SJR obtained, SIU’s IRB has opened an investigation into the trial and “determined that serious noncompliance with regulatory requirements and institutional policies and procedures occurred.”
Moreover, that piece of information was included in an October 6 statement from SIU School of Medicine dean Dr. Jerry Kruse. He was responding to an inquiry from Lisa Buchanan of the Federal Office for Human Research Protections, which is part of the HHS. In September, Buchanan had reached out to Kruse, asking essentially why an SIU researcher was conducting a clinical trial without following HHS regulations.
According to HHS records, SIU had committed to following all HHS regulations—including safety requirements and having IRB approval and oversight—for all clinical trials, regardless of who funded the trials. If SIU fails to do so, it could jeopardize the $15 million in federal grant money the university receives for its other research.
Earlier, an SIU spokesperson had claimed that the school didn’t need to follow HHS regulations in this case because Halford was acting as an independent researcher with Rational Vaccines. Thus, SIU had no legal responsibility to ensure proper safety protocols and wasn’t risking its federal funding.
In her e-mail, Buchanan asked for the “results of SIU’s evaluation of its jurisdiction over this research.”
In his response, Kruse noted that SIU was not aware of the St. Kitts trial until October 2016, two months after the trial was completed. But, he wrote, the university had opened an investigation into it following Halford’s death in June of this year. The decision to investigate was also based on disclosures from American filmmaker Agustín Fernández III, who co-founded Rational Vaccines with Halford, Kruse noted.
Rational Vaccines responded to some questions over e-mail. When asked if the company disputes the finding that its trial was not in compliance with federal or institutional regulations, it simply responded that it:
Is not aware of the specific findings of Southern Illinois University (SIU) in regards to SIU’s investigation into the actions of the late Dr. William Halford, in his capacity as an associate professor of immunology at SIU.
The company went on to say that it is pursuing an investigational new drug application through the FDA for its herpes vaccine.
Peter Thiel and SIU’s medical school did not respond to Ars’ request for comment.
In his response to Buchanan at the HHS, SIU’s Kruse stated that the internal investigations into the trial are ongoing and it would report results to HHS and the FDA.
“I assure you that SIU takes this situation very seriously,” Dr. Kruse wrote. “I am committed to identifying any missing controls that facilitated the conduct of a human subject trial without appropriate oversight.”