Heavyweight tech investor and FDA-critic Peter Thiel is among conservative funders and American researchers backing an offshore herpes vaccine trial that blatantly flouts US safety regulations, according to a Monday report by Kaiser Health News.

The vaccine—a live but weakened herpes virus—was first tested in a 17-person trial on the Caribbean Island of St. Kitts without federal oversight or the standard human safety requirement of an institutional review board (IRB) approval. Biomedical researchers and experts have sharply rebuked the lack of safety oversight and slammed the poor quality of the data collected, which has been rejected from scientific publication. However, investors and those running the trial say it is a direct challenge to what they see as innovation-stifling regulations by the Food and Drug Administration.

“This is a test case,” Bartley Madden told KHN. Madden is another investor of the vaccine as well as a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

Madden, Thiel , and other investors have invested $7 million into the vaccine’s development, according to Rational Vaccines, the company orchestrating the trial. Though Thiel could not be reached for comment, he has been openly critical of the FDA’s review process. At one point, he claimed that the agency’s processes were so overbearing that “you would not be able to invent the polio vaccine today.”

The lead researcher behind the vaccine, William Halford, formerly of Southern Illinois University, made similar claims. In a positive university press release, Halford was quoted as saying: “Many of the virus vaccines we currently put in our kids—chickenpox, mumps, measles, and rubella—were developed using live-attenuated viruses in the ’50s, ’60s and ’70s when the regulatory landscape was more relaxed… and they have worked remarkably well.”

He went on to suggest that the FDA has made “barriers too high” and that countries with less regulation were better for vaccine and drug development. “There are governments around the world that the WHO [World Health Organization] has approved for vaccine development,” he said. “We’re talking to those types of governments.”

Halford, who co-founded Rational Vaccines with former Hollywood filmmaker Agustín Fernández III, died of cancer in June.

Wishful thinking

Other researchers and experts strongly disagreed with Halford's stance and handling of a live, attenuated virus vaccine, which can cause infections in the uninfected or severe side-effects in those already infected. “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.”

Robert Califf, who served as FDA commissioner during the Obama era, agreed. “There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” he said. “It may be legal to be doing it without oversight, but it’s wrong.”

For the initial trial, Halford and Rational Vaccines co-founder Fernández were unable to get federal funding or IRB approval, which oversees human safety. After testing out the vaccine on themselves for safety, they moved the trial to the Caribbean island. They flew 17 patients with pre-existing genital herpes cases there to get three shots of the vaccine. Halford reported that they experienced on average a three-fold reduction in days with symptoms on followup at four to six months after vaccination. Overall, the pair claimed that the trial and self-tests proved the safety and promise of the vaccine.

But when Halford attempted to publish the results, scientific reviewers were ruthlessly critical of the data and lack of safety precautions. One reviewer concluded: “This manuscript is partly a vision, partly science, and partly wishful thinking.”

Another criticized the safety data, calling reported side effects of large patches of inflamed skin “not acceptable.” The reviewer also called out Halford’s discussion of safety issues, writing:

“The author dismisses the safety issues of live attenuated HSV as vaccines. To say that the previous trials violate the Hippocratic Oath (p. 11, line 37) because there has not been more rapid testing is unwarranted criticism. To say that “the world has little to lose” (p. 19, line 35) by more rapid testing of live HSV viruses is reckless.”

Nevertheless, in an interview with KHN, Fernández said he was on a personal mission to keep going with the vaccine for herpes, which affects more than one out of six people in the US between 14 and 49 years old. “I will not stop,” he said. “Too many people are suffering.”

A spokesperson for Southern Illinois University, one of the vaccine’s patent holders, said that the university has no legal responsibility to ensure proper safety protocols for the trial. However, after questions about the lack of IRB approval (a federal requirement), the spokesperson said that the university would “take this opportunity to review our internal processes to ensure we are following best practices.”