A group of wealthy businessmen, including President Donald Trump's adviser Peter Thiel, are backing offshore testing of an experimental herpes vaccine that bypassed U.S. safety protocols for human clinical trials by not having FDA or institutional review board oversight, according to Kaiser Health News.
The 20 participants in the first phase of the clinical trial, taking place on St. Kitts Island in the Caribbean, were flown to the island several times to be vaccinated without any oversight.
While it is not illegal to conduct trials offshore without oversight by the FDA or an institutional review board, the FDA and various physicians argue these protections exist for good reasons.
"What they're doing is patently unethical," Jonathan Zenilman, MD, chief of Baltimore-based Johns Hopkins Bayview Medical Center's infectious diseases division, told Kaiser Health News. "There's a reason why researchers rely on these protections. People can die."
Despite the lack of oversight, American businessmen, including Mr. Thiel, poured $7 million into the ongoing vaccine research.
Supporters of the trial argue the FDA over-prioritizes consumer protection at the expense of medical innovations. "This is a test case," Bartley Madden, a retired policy adviser to the Heartland Institute and an investor in the vaccine, told Kaiser Health News. "The FDA is standing in the way, and Americans are going to hear about this and demand action."
The company that oversaw the trial, Rational Vaccines, along with its co-founder Agustín Fernández, assured Kaiser Health News that the study's former lead researcher William Halford, PhD, who recently passed away from cancer, took the necessary precautions and is not placing anyone at risk.
For the drug to be sold in the U.S., the FDA requires the clinical trial to be reviewed by an institutional review board.
Mr. Fernández is planning to submit the initial clinical trial data to the FDA for approval. If the FDA declines, Rational Vaccines will continue offshore trials, according to the report.