Sun. Feb 5th, 2023
Entrepreneur Peter Thiel.
Enlarge / Entrepreneur Peter Thiel.

Heavyweight tech investor and FDA critic Peter Thiel is among conservative funders and US researchers backing an offshore herpes vaccination trial that blatantly flouts US safety regulations, according to a report Monday by Kaiser health news.

The vaccine – a live but attenuated herpes virus – was first tested in a 17-person trial on the Caribbean island of St. Kitts without federal oversight or the standard human safety requirement of an institutional review board (IRB) approval. Biomedical researchers and experts have sharply rebuked the lack of safety oversight and criticized the poor quality of the data collected, which has been rejected for scientific publications. However, investors and those conducting the trial say it is a direct challenge to what they see as innovation-suffocating regulations from the Food and Drug Administration.

“This is a test case,” Bartley told Madden KHN. Madden is another investor in the vaccine, as well as a retired Credit Suisse banker and policy advisor to the conservative Heartland Institute. “The FDA is standing in the way, and Americans will hear about this and demand action.”

Madden, Thiel and other investors have invested $7 million in developing the vaccine, according to Rational Vaccines, the company orchestrating the trial. While Thiel could not be reached for comment, he was openly critical of the FDA’s review process. At one point, he claimed that the agency’s processes were so presumptuous that “you couldn’t invent the polio vaccine today.”

The lead researcher behind the vaccine, William Halford, formerly of Southern Illinois University, made similar claims. A positive press release from the university quoted Halford as saying, “Many of the virus vaccines we are currently putting into our children – chickenpox, mumps, measles and rubella – were developed using live attenuated viruses in the 1950s, 1960s and the 1970s, when the regulatory landscape was more relaxed… and they’ve worked remarkably well.”

He further suggested that the FDA has made “barriers too high” and that countries with less regulation are better for developing vaccines and drugs. “There are governments around the world that support the WHO [World Health Organization] has approved for vaccine development,” he said. “We talk to those kinds of governments.”

Halford, who co-founded Rational Vaccines with former Hollywood filmmaker Agustín Fernández III, died of cancer in June.

Wishful thinking

Other researchers and experts strongly disagreed with Halford’s position and handling of a live, attenuated virus vaccine, which can cause infections in the uninfected or cause serious side effects in those already infected. “What they’re doing is patently unethical,” said Jonathan Zenilman, chief of the infectious disease division at Johns Hopkins Bayview Medical Center. KHN. “There is a reason why researchers rely on this protection. People can die.”

Robert Califf, who served as FDA commissioner during the Obama era, agreed. “There is a tradition of overseeing human experimentation, and it exists for good reasons,” he said. “It may be legal to do it unsupervised, but it’s wrong.”

For the first trial, Halford and Rational Vaccines co-founder Fernández were unable to secure federal funding or IRB approval, which oversees human safety. After testing the vaccine on themselves for safety, they moved the trial to the Caribbean island. They flew 17 patients with pre-existing cases of genital herpes there to receive three injections of the vaccine. Halford reported that, at follow-up four to six months after vaccination, they experienced an average 3-fold reduction in the number of days with symptoms. Overall, the pair claimed the trial and self-tests proved the vaccine’s safety and promise.

But when Halford tried to publish the results, scientific reviewers were relentlessly critical of the data and the lack of safety precautions. One reviewer concluded: “This manuscript is part vision, part science, and part wishful thinking.”

Another criticized the safety data, calling the reported side effects of large patches of inflamed skin “not acceptable.” The reviewer also evoked Halford’s discussion of security issues, writing:

“The author rejects the safety issues of live attenuated HSV as vaccines. To say that the earlier trials violate the Hippocratic Oath (p. 11, line 37) because testing was not done faster is an unwarranted criticism. To say that “the world has little to lose” (p. 19, line 35) by testing faster-living HSV viruses is reckless.”

Yet in an interview with KHN, Fernández said he was on a personal mission to continue the vaccine against herpes, which affects more than one in six people in the US between the ages of 14 and 49. “I will not stop,” he said. “Too many people are suffering.”

A spokesperson for Southern Illinois University, one of the vaccine’s patent holders, said the university has no legal responsibility to ensure proper safety protocols are in place for the trial. However, after questions about the lack of IRB approval (a federal requirement), the spokesperson said the university would “take this opportunity to review our internal processes to ensure we follow best practices.”

By akfire1

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