In what critics are calling an unethical end-run around safety protocols for human drug trials, an American university and a group of wealthy libertarians teamed up to invest in an offshore trial of an experimental herpes vaccine, reports Kaiser Health News.
The libertarian businessmen (who include in their number Donald Trump supporter Peter Thiel) invested $7 million in the ongoing research, which is being overseen by a company called Rational Vaccines, KHN says. Southern Illinois University also lauded the research and parised the study's lead researcher, even though he didn't implement traditional US safety oversight in the first trial conducted April to August 2016, which was held on the Caribbean island of St. Kitts, the article adds. Neither the FDA nor any kind of IRB monitored the testing of the vaccine, and most of the 20 participants were Americans who were flown back and forth to St. Kitts to be vaccinated.
"What they're doing is patently unethical," Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center's Infectious Diseases Division, tells KHN. "There's a reason why researchers rely on these protections. People can die."
But retired Credit Suisse banker and policy adviser to the conservative Heartland Institute Bartley Madden, who is another investor in the vaccine, tells KHN that "the FDA is standing in the way."
KHN notes that American researchers have gone offshore to conduct research before, usually to save money. But in order to approve drugs for US markets, the FDA requires that clinical trials be conducted under the watchful eye of an IRB. Robert Califf, who served as FDA commissioner in the Obama administration until January, tells KHN he couldn't think of a prior instance in which American researchers doing trials offshore did not set up an IRB for oversight.
Rational Vaccines is downplaying safety concerns, saying that participants are at little risk of harm because they already have herpes, KHN reports.
Other researchers interviewed by KHN also expressed dismay at Southern Illinois University's backing of the research and what they say is its complicity in ignoring 70 years of safety protocols.
The FDA declined to comment, but spokeswoman Lauren Smith Dyer tells KHN that "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."
The vaccine's researchers tell KHN the St. Kitts trial showed the vaccine is safe and highly effective in preventing outbreaks in herpes patients. The results, howeber, have not been published in a peer-reviewed journal, as reviewers were concerned by the lack of safety.
(HT: FiercePharma)