Peter Thiel and a group of libertarians are funding an offshore human clinical trial of a herpes vaccine, skirting FDA regulations and sparking a heated debate over U.S. safety rules.
The tech billionaire and Trump advisor has reportedly poured $7 million into the experimental trial being held on the Caribbean island of St. Kitts without any oversight from the FDA or monitoring from a safety panel known as an institutional review board (IRB).
Some in the political arena, including Trump, have been critical of the slow nature of U.S. regulatory approval and a herpes vaccine would potentially save millions of lives — the disease affects one in every six Americans, according to the Centers for Disease Control.
However, several medical experts have come forward condemning the offshore trial, called the Rational Vaccine, saying it was “unethical.”
“There’s a reason why researchers rely on these protections. People can die,” Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division told Kaiser Health News, which first reported the trial.
Thiel, on the other hand, is known for his disdain of regulations and has repeatedly tried to make the case that the FDA is getting in the way of progress. “You would not be able to invent the polio vaccine today,” due to FDA regulations, Thiel said.
To be clear, Thiel’s herpes trial is legal as the Caribbean is not held to the same standards as a human clinical trial would be on American soil. It’s also increasingly common for a drug company to support an offshore trial before making a case for a U.S. trial.
However, most of these trials are at the very least attached to an IRB. Robert Califf, who served as FDA commissioner in the Obama administration, told Kaiser Health news that “he couldn’t think of a prior instance in which American researchers did not set up an IRB abroad.”
“It may be legal to be doing it without oversight, but it’s wrong,” Califf said.
The company behind Rational Vaccine has downplayed the concerns, telling critics the lead investigator and tenured SIU professor William Halford, who passed away in June, took the necessary safety precautions to conduct the trial.
Regardless, critics have clobbered Southern Illinois University (SIU), which is one of the vaccine patent holders, for its involvement in the trial. Despite safety claims, SIU has said publicly it has no legal responsibility to ensure those same safety measures in the trial.
The FDA has so far declined comment, but a spokesperson for the FDA told Kaiser Health News, “the FDA believes that the oversight of clinical investigations, including review by an IRB, is critically important and is a regulatory requirement for clinical investigations subject to FDA regulations.”