Peter Thiel–Backed 'Unethical' Herpes Vaccine Could Gouge $15 Million From Research Into Serious Diseases

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Peter Thiel in Washington, D.C., on October 31, 2016. Thiel, the co-founder of PayPal and an outspoken critic of current FDA regulations, invested $7 million in Rational Vaccines, the company that developed a herpes vaccine and carried out the drug’s trial in the Caribbean without scientific oversight. Alex Wong/Getty Images

Links between a university researcher and a controversial clinical trial for a herpes vaccine carried out in the Caribbean could determine if an Illinois medical school will lose $15 million of federal research funding. The results of that trial were announced months before venture capitalist Peter Thiel, the co-founder of PayPal and an outspoken critic of current FDA regulations, invested $7 million in the company that developed the vaccine and carried out the experiment.

The trial of Theravax was run by the company that owns it, Rational Vaccines, at a hospital in the Caribbean country of St. Kitts and Nevis. The location is not the problem. It's the apparent lack of oversight from the FDA, local authorities, or a scientific oversight committee known as an Institutional Review Board that's proving worrisome for some observers.

"What they're doing is patently unethical," Jonathan Zenilman, chief of the infectious diseases division at Johns Hopkins Bayview Medical Center, told Kaiser Health News, one of the outlets that first broke the story.

Vaccines are usually made with tiny pieces of some of the proteins found on a bacteria's or a virus's surface. Vaccine trials do carry risks—which is why there are oversight protocols. People may be allergic to the vaccine, for example, or have a stronger-than-expected immune response to the vaccine.

"There's a reason why researchers rely on these protections. People can die," Zenilman said.

No one did die in this trial. In late 2016, the company issued a press release with preliminary results and by January, CEO Agustín Fernández was promoting the vaccine in the media. The data, however, has not been published.

However, while the trial was ongoing, Rational Vaccines' co-founder, Dr. William Halford, also was a professor at Southern Illinois University School of Medicine. Beyond that, Southern Illinois stated, they had no knowledge or involvement in the trial. If the government thinks the university was involved, however, it could face serious consequences. Like most universities doing medical research, Southern Illinois receives federal grant money—and the federal government has rules about what you can and cannot do in human research.

On November 8, The State Journal-Register, a local newspaper in Springfield, Illinois, reported that the U.S. Department of Health and Human Services (HHS) had asked Southern Illinois for details about why the university felt the clinical trial was outside its jurisdiction.

The herpes virus. Genital herpes is a common sexually transmitted disease that affects about one in six Americans. Yale Rosen/Flickr

While the FDA is perhaps the more obvious agency to bring up when discussing clinical trials, HHS also has an interest in the situation. The department is home to the Office for Human Research Protections, which keeps up regulations about what can and cannot be done by researchers working with humans and human samples. (Specifically, HHS is responsible for The Common Rule, which was just revised in January.)

In its response to HHS, Dr. Jerry Kruse, dean and provost of Southern Illinois University School of Medicine, said that an initial investigation "has determined that serious non-compliance with regulatory requirements and institutional policies and procedures occurred."

Halford died in June from cancer at the age of 48. After his death, his co-founders vowed to continue work on the vaccine, the Journal-Register reported.

Since the ethics of the trial were first called into question in October, the company's leadership has also stated that it will follow FDA guidelines from now on, CNBC reported.

Two types of viruses cause herpes. Genital herpes is a common sexually-transmitted disease that affects about one in six Americans, according to the CDC. The virus can cause blisters and sores, which can be painful. Another strain of the herpes virus is the one responsible for the cold sores that are characteristic of oral herpes infections.