The controversy has also since brought in PayPal founder Peter Thiel, whose investment firm later invested millions into the project.
The research, led by the late Dr William Halford, involved testing out an experimental genital herpes vaccine on 20 humans on the quiet Caribbean island of St Kitts between March and August 2016. The patient's consent forms openly stated that the trial was ignoring regulations of the US Food and Drug Administration (FDA).
The medical trial was run by the private company Rational Vaccines, co-founded by Dr William Halford, who also independently worked at the Southern Illinois University School of Medicine (SIU). He died on June 22 of this year, after a battle with cancer. In his account, he wanted to defy the regulations of US clinical trials because he was desperate to fast-track the herpes vaccine following his diagnosis of cancer.
In his own words, Dr Halford wrote: “Some readers may find this course of action reckless... I would suggest the opposite… The risk I accepted by self-injecting the live HSV-2 vaccine pales in comparison to the morbidity that actually occurred in the 1.5 billion people who were newly infected with HSV-1 or HSV-2 whilst FDA sanctioned herpes subunit vaccine trials have failed for three decades.”
In August, Kaiser Health News reported that controversial Paypal founder Peter Thiel and a “group of wealthy libertarians” had invested $7 million into Rational Vaccines. This money was reportedly invested after Dr Halford and Rational Vaccines had carried out the human trial in the Caribbean.
In the past, Silicon Valley billionaire Thiel has expressed disdain for the overly bureaucratic nature of the FDA, once saying“you would not be able to invent the polio vaccine today” due to their regulations.
Halford attempted to submit the findings of his studies on the genital herpes vaccine into the journal Future Virology, however the editors rejected the study. One reviewer said: “This manuscript is partly a vision, partly science, and partly wishful thinking.”
Whether SIU loses their $15 million funding pot depends on the ongoing federal inquiry, conducted by an arm of the US Department of Health and Human Services.
“This researcher went rogue,” Holly Fernandez Lynch, a lawyer who specializes in medical ethics, told Kaiser Health News. “It’s true that universities can’t stand behind their researchers watching their every move. But when one of their own goes rogue, a university should launch an aggressive investigation, interview the participants, and make sure it never happens again.”
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