The government of St. Kitts and Nevis has launched an investigation into the clinical trial for a herpes vaccine by an American company because it said its officials were not notified about the experiments.
The vaccine research has sparked controversy because the lead investigator, a professor with Southern Illinois University, and the U.S. company he co-founded did not rely on traditional U.S. safety oversight while testing the vaccine last year on mostly American participants on the Caribbean island of St. Kitts.
The trial received financial backing from a former Hollywood filmmaker who has asserted the vaccine was highly successful in stopping herpes outbreaks. Since then, a group of investors, including Donald Trump supporter Peter Thiel, have backed the ongoing vaccine research with a $7 million investment that could include additional clinical trials in Mexico and Australia.
Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an "IRB," monitored the testing on the 20 human subjects. Now, the government of St. Kitts and Nevis says that the researchers also did not officially seek permission to test the vaccine, which took place from April to August 2016.
"The Ministry of Health states categorically that neither the Cabinet, the Ministry of Health, the office of Chief Medical Officer (CMO) nor the St. Kitts and Nevis Medical Board has ever been approached on this project," said the government press release sent out Wednesday night. "By extension, none of these agencies has approved such a venture."
Agustín Fernández III, the co-founder of Rational Vaccines, the company that oversaw the vaccine testing, said his partner, William Halford, told him that he notified the St. Kitts government. Halford, who was the lead investigator on the research, died of cancer in June and Fernández said he did not have any other details about whom Halford might have talked to.
"I don't know exactly," Fernández wrote in an email Thursday. "[Halford] said he spoke to local authorities."
Southern Illinois University did not immediately respond Thursday to questions about the research but told a reporter previously that Halford was not doing the research as part of his job at the university.
U.S. 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.
In the St. Kitts press release, the Ministry of Health and Social Services said it "will always ensure that all research involving human participants follow international standards which protect the safety and security of persons involved."
To ensure this happens, an ethics review committee is supposed to vet medical research protocols "in keeping with international best practices."
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 the skin.
However, Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Fernández has said Halford took the necessary precautions during the trial. Halford also told him he manufactured the vaccine outside the United States, Fernández said Thursday.
"I don't know how he [got] it there," Fernández said in the email. He added that the doses were already in St. Kitts when he agreed to fund the trial.
SIU did not immediately respond to questions about whether it knew if Halford sought permission from St. Kitts officials.
Rational Vaccines was established in February 2015 and the company entered into its patent agreement with the university later that year, Fernández said.
A university spokeswoman earlier said the university first learned about the trial in October 2016 — after it had ended. The spokeswoman added that Halford didn't need to bring the trial to SIU's IRB because the trial wasn't overseen by the university.
However, after a reporter raised questions about the lack of an IRB, the university launched a review of "internal processes to assure we are following best practices."
Depending on how Halford transported the vaccine, he might have been required to seek approval from St. Kitts customs officials, said Dr. Patrick Martin, St. Kitts and Nevis' chief medical officer until June 2016. Martin, who had been in that position since 2004, said he never heard from Halford or any other member of the company, although he should have been notified.
"Where did the testing of the herpes vaccine take place?" Martin asked. "Where [were] the material, the drugs, the storage equipment for these vaccines housed? Were there appropriate customs declarations?”
Martin said he had to shut down another unauthorized research site, which was testing a stem cell product around the same time.
"We are a country of rules and regulations," he said. "Researchers can't just do whatever they like without notifying the government or going to an IRB."
The St. Kitts official now in charge of such matters, Dr. Hazel Laws, did not return repeated phone calls. An employee who answered the phone said it was unlikely she or any other official would call back because "the press release spoke for itself."
American scientists called for more rigorous clinical trial oversight in the wake of Nazi atrocities involving human experiments but the U.S. did not require IRBs until the 1970s.
Steven Joffe, chief of the division of medical ethics at the University of Pennsylvania Perelman School of Medicine, said for research to be considered ethical "the study must be conducted in accordance with international standards for human subjects research."
That includes approval by an institutional review board, research ethics committee or the equivalent.
"Legally, it must comply with the laws and regulations of the country," he added.
KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.