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.”