The medical school at Southern Illinois University in Springfield has pulled the plug on its herpes research project after the school’s ethics panel opened a high-profile investigation into unauthorized human experiments.
Participants injected with prototype concoctions “are demanding compensation from SIU for alleged side effects.”
According to their attorney, Alan Milstein, “they realize now they were used as guinea pigs in outrageously unethical experiments that defied and flouted the most basic requirements of human-subject research in this country.”
Patients who go to hotel rooms for injections of experimental drugs should have a pretty good idea that there won’t be any “routine safety oversight from the Food and Drug Administration or an institutional review board,” especially when they have to travel offshore for the treatment.
That isn’t stopping the patients’ lawyer from arguing that they were preventably injured.
Unable to get approval for human trials, professor William Halford decided to continue his research anyway. He wasn’t afraid of any consequences, Dr. Halford suffered from terminal nasal cancer and is now deceased.
SIU medical school is still around though and they find themselves fighting to justify continued federal research grants. “$9 million a year in federal research dollars” are riding on the outcome of an internal investigation.”
What everyone, including Iowa Sen. Chuck Grassley, wants to know, is what “corrective action” has been taken to prevent abuses like this from ever happening again.
Three participants, who hired New Jersey’s top specialist in research abuse litigation, are among a group of several patients who were either injected with “an unauthorized herpes vaccine” in Illinois hotel rooms in 2013 or in similar rooms on the offshore islands of Nevis and St. Kitts in 2016. Now they claim they have “side effects.”
After Halford’s research hit a brick wall, he decided to move his human subject studies to the Caribbean in 2016. He teamed up with Hollywood filmmaker Agustín Fernández III and SIU university co-worker Edward Gershburg to form “Rational Vaccines.”
The startup got a huge infusion of cash when they “received millions of dollars in private investment from billionaire Peter Thiel.” Gershburg became the chief technology officer and remained with the company after Halford’s death in June of 2017.
The university, Milstein insists, should have had more control. Emails obtained as part of the case show that Halford advised participants of the 2013 study to “send photographs of rashes, blisters, and other reactions.”
The ethics panel didn’t like the fact that all the emails were sent from Halford’s account at the university. They also weren’t happy that “he used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab.” That is a no-no, they said. It “could constitute an improper use of state funds.”
Bethany Spielman is a professor of health law, specializing in bioethics. She also serves on the ethics committee probing Halford. “Part of the reason this committee exists is to keep the federal funding clean and flowing,” she admits. ”
Any university that does research, especially with human subjects, wants to be trusted by the federal government and the public.” She wants to make clear that whether SIU can be found negligent in court or not, the university owed the participants an apology. “The university should acknowledge that there must have been some kind of breakdown in the system.”
The misconduct committee has really turned up the heat on medical school administrators, who at first claimed they “bore no responsibility for the experiments.”
One of the biggest things connecting SIU with Halford’s illicit experiments is that “SIU’s medical school shared in a patent on a prospective vaccine” with Rational Vaccines and promoted Halford’s vaccine research on its website.”
Karen Carlson, a spokesperson for SIU released a statement about the controversy. “The Misconduct in Science Committee is now in its investigative stage and the School anticipates this investigation will take approximately 120 days. However, the investigation could take longer.”
Carlson explains that the program is on ice until the panel concludes its recommendations.
“Currently, no herpes research is being conducted at SIU. In conjunction with recommendations from the appropriate federal agencies, we will address our policies and procedures and anything else that arises from the investigation.”