WASHINGTON—Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.
The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.
Neither the Food and Drug Administration nor a safety panel known as an institutional review board (IRB) monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.
"What they’re doing is patently unethical," said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. "There’s a reason why researchers rely on these protections. People can die."
The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.
The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for overprioritizing consumer protection to the detriment of medical innovations.
"This is a test case," said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. "The FDA is standing in the way, and Americans are going to hear about this and demand action."
American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.
Robert Califf, who served as FDA commissioner in the Obama administration until January, said he couldn’t think of a prior instance in which American researchers did not set up an IRB abroad.
"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."
However, Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Agustín Fernández III co-founded Rational Vaccines with tenured SIU professor William Halford. He said Halford, the lead investigator, took the necessary precautions during the trial conducted from April to August 2016. Halford died of cancer in June.
The university backed its professor’s work by posting a glowing article on its website about the vaccine. SIU is one of the patent holders of the vaccine and set up a business account to collect donations for the work.
Nonetheless, Southern Illinois University officials said they had no legal responsibility to ensure safety measures were in place because the university has an arms-length relationship with Rational Vaccines. Fernández said the company licensed two patents related to the vaccine from the university.
"SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial," said Karen Carlson, the university’s spokeswoman. "But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial."
But other researchers said they were appalled by what they des...
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