Rational Vaccines, a startup founded by a microbiologist at Southern Illinois University, Dr. William Halford, is being sued by three subjects from experimental trials of a live herpes virus vaccine conducted in 2013 and 2016. The plaintiffs are seeking compensation for adverse side effects associated with the vaccine, which was administered both in a Holiday Inn room in 2013 and on the islands of St. Kitts and Nevis in 2016 without formal written consent. Neither of these trials had a physician present and were conducted without the approval of either an independent institutional review board or the Food and Drug Administration. Though Rational Vaccines has said it plans to seek FDA approval, this lawsuit alleges that the company violated U.S. and international laws protecting the rights of patients.
The human subjects involved in this trial are likely to be left with many questions as to why the trial was conducted in such a shoddy fashion. There was no formal written consent. None of the usual regulating agencies were involved in the vaccine trial. After an auspicious start in a hotel room, the location of the trials was moved to an international location to better avoid these regulating industries, although subjects were given booster shots upon their return to the United States.
The findings from the 2013 and 2016 trials of the vaccine have not been published, yet Rational Vaccines considers the last one a success. Now they’re being sued. According to Alan Milstein, the New Jersey lawyer retained by the plaintiffs, “My clients are anxious to ensure such unethical experimentation on human subjects are not repeated…”
What about the University? The Southern Illinois University School of Medicine, where Dr. Halford was employed for 10 years, is still investigating his research methods on the request of the Department of Health and Human Services. While they acknowledge that his conduct violated both University code and U.S. law, the dean of the medical school, Jerry Kruse, maintains that Dr. Halford’s research was kept hidden. This contradicts quotes from an article in The State Journal Registrar of Springfield that stated “I hope this works… The initial results are astounding…Halford is “an outstanding scientist — a genius, actually…” Denying knowledge of Dr. Halford’s shady practices also seems disingenuous considering the University owns the patent for Dr. Halford’s technology and admitting to any wrongdoing stands to lose the University 15 million dollars in federal research grants.
But It’s Profit
In cases like this, it helps to go straight to the source – Dr. Halford. Unfortunately (or conveniently, if you prefer a touch of conspiracy with your vaccine news), he died of cancer in June 2017. But the company is continuing on. In fact, they’re thriving, receiving 7 million dollars in funding from billionaire businessman, FDA critic, and Trump supporter, Peter Thiel.
Is this the tale of a rogue scientist, going off the rails, trying desperately to finish his life’s work before he’s cruelly struck down by cancer? Or do we believe the university’s narrative, willing to turn a blind eye to unorthodox and frankly dangerous research practices in the hopes of new achievements and increased fundraising? How about the story of a scrappy startup with a dream, willing to find a way past any and all obstacles to bring the world something it needs at any cost? Maybe it’s all three.
One of the trial subjects, Richard Mancuso, has gone on record stating that the vaccine cured his herpes. Rational Vaccines now has a powerful backer with a proven track record of disruption at a time when patients are no longer taking doctors and researchers at their word. Many of the medical community’s common practices are out of date and actively degrading the world we live in.
But is injecting people with live vaccines in a hotel room and a startling lack of transparency really the precedent we want to set for new medical research going forward?
- Participants In Rogue Herpes Vaccine Research Take Legal Action – Kaiser
- Criminal Conduct By Rational Vaccines Co-Founder? – American Council on Science and Health
- Peter Thiel-Backed ‘Unethical’ Herpes Vaccine Could Gouge $15 Million from Research Into Serious Diseases – Newsweek
- Herpes vaccine company backed by Peter Thiel vows future testing will follow FDA guidelines after offshore trial sparks ethics furor – CNBC
- Scientist with ties to SIU reports positive results for genital herpes vaccine – State Journal Registrar