It’s Legal. Is It Ethical? Billionaire Facebook Board Member Funds Offshore Herpes Trial Vaccine Without FDA Oversight

Written by Dana Sanchez

Silicon Valley tech entrepreneur Peter Thiel, who ardently supported Donald Trump for his promise to revive American innovation, has funded experimental vaccine trials for herpes outside the U.S., attracting some criticism for testing humans without the oversight of Food and Drug Administration regulations.

Thiel is one of a group of wealthy libertarians and institutions including Southern Illinois University that invested $7 million in ongoing herpes vaccine research.

The criticism stems from concerns that experimental trials with live viruses could lead to infection if not handled properly or cause side effects in those already infected, Marisa Taylor reported for Kaiser Health News:

“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 (institutional review board, also known as an independent ethics committee) or an international equivalent. The IRB can reject research based on safety concerns.”

Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Most infected people are asymptomatic, but can unknowingly spread this common sexually transmitted disease. The virus is primarily spread through sexual contact, but also can be released through skin, according to the CDC. Neonatal herpes is devastating for newborn infants. About one in six people aged 14 to 49 years have genital herpes.

Southern Illinois University promoted the experimental herpes 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, Marisa Taylor reported.

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.

Rational Vaccines downplayed safety concerns, saying there was little risk the participants would be harmed because they already had herpes.

Agustín Fernández III co-founded Rational Vaccines with tenured Southern Illinois University Professor William Halford, who died of cancer in June. Halford took the necessary precautions during the trial conducted from April to August in 2016, Fernández said, according to the Kaiser Health report.

Several medical experts say the offshore trial is unethical.

“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.”

Thiel, on the other hand, is known for his disdain of regulations and has repeatedly tried to make the case that the FDA is getting in the way of progress, TechCrunch, reported. “You would not be able to invent the polio vaccine today,” due to FDA regulations, Thiel said.

The reason clinical research is so regulated is because the stakes are high, Huffington Post reported. Humans have been hurt by unregulated research, as happened during Nazi experimentation. In the U.S., medical researchers withheld treatment from poor African-American men in Alabama with syphilis in the infamous Tuskegee experiment. U.S. researchers also deliberately infected Guatemalans with sexually transmitted disease without their consent in the 1940s.

“There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” said Robert Califf, FDA commissioner under President Barack Obama, in a Kaiser Health News interview. “It may be legal to be doing it without oversight, but it’s wrong.”

Califf said he could not think of a prior example when U.S. researchers conducted research outside the country without IRB approval.

Backing Donald Trump cost Thiel $1.25 million in campaign contributions — less than 0.05 percent of Thiel’s net worth. Reputationally, it was expensive, Jeff Bercovici wrote in an Inc editorial piece:

“It has made Thiel persona non grata in many quarters of Silicon Valley. Worse, perhaps, it has cost him a chunk of his reputation as a man who sees into the future.

“… I viewed Thiel’s backing of Trump as a specific kind of bet … that people like him should have near-absolute license to build “the machinery of freedom that makes the world safe for capitalism.” For Thiel to privilege his hypothetical libertarian utopia in the stars above the welfare of everyone now alive represents, I believe, a profound moral blindness…”

 

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