The experimental herpes vaccine first drew criticism for flouting US protections for patients in human clinical trials by conducting it on the British West Indies island of St. Kitts. In a twist, it turned out that a group of US businessmen, including Silicon Valley billionaire Peter Thiel, had reportedly invested $7 million in the company behind the research in April 2017. (Thiel had secretly funded a lawsuit that lead to the bankruptcy of Gizmodo’s former owner Gawker Media.)
Now, Kaiser Health News reports that the research wasn’t just shady, some of William Halford’s research appears to have been conducted illegally, specifically trials in 2013:
Southern Illinois University associate professor William Halford administered the shots himself at a Holiday Inn Express and a Crowne Plaza Hotel that were a 15-minute drive from the researcher’s SIU lab. Halford injected at least eight herpes patients on four separate occasions in the summer and fall of 2013 with a virus that he created, according to emails from seven participants and interviews with one participant.
Yep. You read that right. He was injecting live virus vaccines into people at a Holiday Inn. Kaiser Health News:
According to the emails between Halford and the patients and extensive interviews with the participant, Halford did not procure written informed consent as required by federal law when testing a live virus on humans. Medical researchers, such as Halford, may not inject patients without oversight by a physician or a nurse practitioner, [Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division] said.
Kaiser Health News reported that Southern Illinois University claims it was initially unaware of the concerning research practices, but upon investigation found “serious noncompliance with regulatory requirements and institutional policies and procedures.” Halford died this summer from cancer, but the company he founded in 2015, Rational Vaccines, plans to move ahead with the work.
SIU, by the way, shared a patent on the developing vaccine with Rational Vaccines and tweeted about the work, even though it claimed it was not hip to the questionable research ethos.
The vaccine in question is designed to treat HSV-2, a more aggressive but less common strain of the usually sexually transmitted virus that typically causes genital herpes. While there is no cure, there are drugs to help keep it in check. In addition to outbreaks of painful genital sores, it can put people at increased risk for contracting other illnesses, such as HIV.
In a press release issued when the initial story broke in August, Halford said that he had chosen to conduct the trial in the Caribbean because of cumbersome American regulations.
In the US, Trump and FDA Commissioner Scott Gottlieb have pledged to speed up the drug approval process. But Halford’s unorthodox practices make a good case for why those regulations are in place to begin with: One trial participant who said he received the injections in Illinois told Kaiser Health News that he was afraid the vaccine may have given him a new type of herpes that he didn’t previously have.
We reached out to Peter Thiel for comment and will update the post should we hear back.