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."
