Tech billionaire and informal Donald Trump adviserPeter Thiel is bankrolling ongoing research that began with a herpes vaccine trial in the Caribbean that not only flouted United States safety laws, but also potentially put human clinical trial participants at risk.
Thiel was part of a group of investors that sank $7 million into the biotech company Rational Vaccines, which ran experimental herpes vaccine testing from April to August 2016. The testing wasn’t monitored by the U.S. Food and Drug Administration, nor was it approved by an institutional review board, both of which ensure that human subjects’ rights and well-being are protected, and can reject research that doesn’t meet safety standards. (Thiel’s representatives did not respond to HuffPost’s request for comment.)
The trial was conducted by William Halford of Southern Illinois University School of Medicine, who is also the scientist who developed the vaccine. Although SIU is one of the vaccine’s patent holders, the school said it has no legal responsibility for the vaccine and did not know the trial occurred until after it ended. Halford died of cancer in June.
“Bill had long interviews with these people. He gave them an informed consent form. He wanted to do it as close to the FDA guidelines as possible,” Agustín Fernández III, who co-founded Rational Vaccines with Halford, told HuffPost.
“Two things really pushed Bill to do this trial in an expedited way. There are people who are really afflicted with [herpes] and they’re ignored. The people calling Bill repeatedly got on his conscience. That coupled with his terminal diagnosis,” Fernández said.
“SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial,” Karen Carlson, the university’s spokesperson, told Kaiser Health News. “But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial.”
Public health experts disagreed with that assessment.
“In short, this is a sham and a fraud,” Dr. Christopher Gill, an associate professor of global health at Boston University’s Center for Global Health and Development, told HuffPost.
“What’s most astonishing is not that we have discovered another huckster peddling snake oil to the desperate and unwary, but that SIU has not seen fit to step in and deal with the risk to humans imposed by this sham research, or to see that their failure to fulfill their oversight role exposes them to significant liability should any serious adverse events befall the participants in the trial.”
Why human trials are so regulated
The trial involved 20 study participants from the U.S. and Britain with herpes who traveled to St. Kitts and Nevis in the Caribbean several times to receive the experimental vaccine. According to the SIU website, all of the 17 participants who received the three-shot vaccination reported it was more effective than antiviral drugs in reducing their symptoms.
But an admiring report from SIU, which called the vaccine a “game-changer,” doesn’t mean the results were ethical or accurate.
“There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” Robert Califf, FDA commissioner under President Barack Obama, told Kaiser Health News. “It may be legal to be doing it without oversight, but it’s wrong.”
Califf said he could not recall a prior instance when U.S. researchers conducted research outside the country without IRB approval.
The reason clinical research is so regulated is because the stakes are high. Humans can be ― and have been ― hurt by unregulated research, which has a dark history, including U.S. medical research that deliberately infected Guatemalans with sexually transmitted disease without their consent in the 1940s and the infamous Tuskegee experiment, during which researchers withheld treatment from poor African-American men in Alabama with syphilis.
The experiment itself had problems
In the end, the scientific process may prove a bigger deterrent to the vaccine’s future than regulations or ethics.
The trial’s results, which have not been published in a peer-reviewed journal, received scathing criticism from peer reviewers at Future Virology, where Halford submitted the paper before he died.
“This manuscript is partly a vision, partly science, and partly wishful thinking,” one reviewer wrote. “The author has taken his construct of HSV‐2 vaccine into human subjects, and believes, based on little data, that this vaccine will provide both a therapeutic and a prophylactic benefit.”
Importantly, the experiment relied on self-reported data from participants about whether their herpes symptoms improved after they were vaccinated and did not include control subjects.
“This means that the ‘self-reported improvements’ by a subset of vaccinees is uninterpretable,” Gill said. “We have no way of knowing what response would have occurred had they received an injection of salt water instead.”
Gill didn’t think regulatory bodies outside of the U.S. would be more accepting of Halford’s unregulated human research, either.
“There is precisely zero chance that other reputable regulator bodies would feel any more charitable,” he said. “That means it won’t be used in Australia, Canada, the E.U. or South America. Where then is the market that they are targeting?”
Fernández sees things differently.
“I think [Bill] understood that there would be a firestorm,” he said. “My hope is that now with the investment, that we can take the science and really do things in a way that the critics can’t poke holes in it.”
CORRECTION: A previous version of this article stated that U.S. researchers infected African-American men with syphilis as part of the Tuskegee experiment. In fact, the researchers withheld treatment from men who had already contracted the disease. This article has also been updated with additional information from Agustín Fernández of Rational Vaccines to clarify that while Thiel did not fund the initial vaccine trial in the Caribbean, he is funding the company’s ongoing research, which continues to operate outside of institutional review board oversight.
- This article originally appeared on HuffPost.