Peter Thiel, the eccentric tech billionaire worth 2.6 billion and supporter of President Donald Trump, is being investigated after helping to fund a controversial offshore test of an experimental herpes vaccine.
It was reported on Thursday that the St. Kitts government is now investigating the questionable trials.
An unidentified former Hollywood filmmaker was also a financial backer who has claimed that the vaccine was successful during clinical trials, according to The Daily Beast.
Peter Thiel, the eccentric tech billionaire worth 2.6 billion and supporter of President Donald Trump, is being investigated after helping to fund a controversial offshore test of an experimental herpes vaccine
From left Vice President-elect Mike Pence, PayPal founder Peter Thiel, and Apple CEO Tim Cook listen to Republican presidential-elect Donald Trump during a meeting with technology industry leaders at Trump Tower in New York
The investment group gathered at least $7 million for the research, which they hoped to run in Mexico and Australia.
The trials are part of a $7million experiment being conducted by an American university – with the backing of a group of wealthy libertarians – that is drawing criticism because of its noncompliance with traditional guidelines governing testing on humans, according to Kaiser Health News.
They were reportedly performed in St. Kitts from April to August 2016 — without the approval of the US Food and Drug Administration or the oversight of an institutional review board — on a group of 20 people.
St. Kitts officials told The Daily Beast the tests were conducted without government permission.
‘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,’ a government press release said Wednesday evening.
Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division also said: ‘You can’t just ignore human-subject protections that have evolved since the end of the Second World War.’
Thiel along with a group of wealthy libertarians is helping fund a controversial offshore test of an experimental herpes vaccine
‘What they’re doing is patently unethical. There’s a reason why researchers rely on these protections. People can die.’
The risks of conducting experimental trials with live viruses without these built-in safeguards range from infection to dangerous side effects.
Genital herpes is a sexually transmitted disease that often produces either mild symptoms or none at all, according to the Centers for Disease Control.
It is no accident that Thiel, the billionaire who struck it rich by co-founding PayPal and investing in Facebook when it was in its infancy, is aiding the effort to bypass the FDA.
Thiel has been on record criticizing the FDA for the manner in which it approves pharmaceuticals.
The trial is being done on 20 participants, most of whom are Americans who were flown to the Caribbean island of St. Kitts (above) several times in order to be vaccinated
He believes that ‘you would not be able to invent the polio vaccine today’ because of the agency’s requirements.
Trump has also long advocated for speedier approvals of medicine by the FDA, which places constraints on pharmaceutical companies in order to ensure consumer safety.
Trump’s pick for FDA commissioner, Scott Gottlieb, criticized the agency before his confirmation for what he views as a slow approval process.
Another investor in the vaccine, Bartley Madden, said that Americans are unhappy about ‘the FDA standing in the way’ of new treatments.
An increasing number of American drug researchers are conducting offshore clinical trials due to what they say is the prohibitive costs of doing these trials in the U.S.
Still, for any drug to be approved in the U.S., it must meet FDA safety standards as mandated by an IRB.
But none of the tests were monitored by the Food and Drug Administration or a safety panel known as an institutional review board. FDA headquarters is seen above in Silver Spring, Maryland
The fact that the Thiel-backed clinical trial has not set up an IRB is puzzling to some.
‘There’s a tradition of having oversight of human experimentation, and it exists for good reasons,’ said Robert Califf, who served as FDA commissioner during the Obama administration.
‘It may be legal to be doing it without oversight, but it’s wrong.’
But the company conducting the trials, Rational Vaccines, says the safety concerns are overblown because the participants already are infected with herpes.
A co-founder of Rational Vaccines is William Halford, a tenured professor at Southern Illinois University.
The school is one of the patent holders of the vaccine and it has solicited donations for the trial.
Halford died of cancer this past June.
President Trump has also long advocated for speedier approvals of medicine by the FDA, which places constraints on pharmaceutical companies in order to ensure consumer safety. Trump’s pick for FDA commissioner, Scott Gottlieb (above), criticized the agency before his confirmation for what he views as a slow approval process
The university said it has no concerns about safety risks because it believes Halford took the necessary precautions.
‘SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial,’ said Karen Carlson, the university’s spokeswoman. ‘But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial.’
This explanation will likely not assuage critics who are aghast at what they say is a reckless experimentation on humans.
Still, the vaccine’s researchers insist that safety protocols are being followed and the drug has so far been shown to be safe and effective.
Richard Mancuso, who agreed to participate in the trial, said that the vaccine has ‘saved my life.’
He said the drug has stopped his severe herpes outbreaks.
So far, there have been no peer-reviewed journal articles about the vaccine due to concerns over lack of safety.