University Under Fire For Off-The-Grid Herpes Vaccine Experiments
WASHINGTON â Southern Illinois Universityâs medical school has halted all herpes research, one of its most high-profile projects, amid growing controversy over a researcherâs unauthorized methods offshore and in the U.S.
SIUâs ethics panel launched a âfullâ investigation Dec. 5 of the herpes vaccine experiments by university professor William Halford, according to a memo obtained by Kaiser Health News.
Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without routine safety oversight from the Food and Drug Administration or an institutional review board, according to ongoing reporting by KHN. Some of the participants say they are experiencing side effects.
The panel, known as the Misconduct in Science Committee, told SIUâs medical school dean that the inquiry should not only investigate the extent of Halfordâs alleged wrongdoing, but also scrutinize âmembers of his research team,â according to the Dec. 5 memo obtained through a Freedom of Information Act request.
âThe Misconduct in Science Committee is now in its investigative stage and the School anticipates this investigation will take approximately 120 days,â SIU spokeswoman Karen Carlson told KHN in an emailed response. âHowever, the investigation could take longer.â
The panelâs inquiry marks the second one to be launched by SIU since Halfordâs methods were detailed in a KHN report in 2017.
The Department of Health and Human Services asked the university to determine whether Halfordâs activities violated the institutionâs pledge to HHS. SIU, a state university, had pledged to follow human-subject safety protocols for all research, even if privately funded.
In October, SIU medical schoolâs institutional review board determined Halfordâs activities were in âserious noncomplianceâ with university rules and U.S. regulations and recommended that the misconduct committee investigate, according to records obtained by KHN under open-records laws.
Now, the committee has taken up the case, putting more pressure on SIUâs medical school, which initially said it bore no responsibility for the experiments.
The committee, which is made up of five faculty members, holds hearings about such misconduct and can call witnesses before reaching a conclusion.
The university is required to have such a committee to assure the federal government that it will examine allegations of research misconduct, said , a professor of health law at SIUâs medical school in Springfield,Ill. The medical school receives about $ 9 million a year in federal research dollars.
âPart of the reason this committee exists is to keep the federal funding clean and flowing,â said Spielman, who specializes in bioethics. âAny university that does research, especially with human subjects, wants to be trusted by the federal government and the public.â
In SIUâs response to KHNâs open-records request, the university excised the names of the committee members.
Carlson said that after the committeeâs investigation is complete âin conjunction with recommendations from the appropriate federal agencies, we will address our policies and procedures and anything else that arises from the investigation.â
âCurrently, no herpes research is being conducted at SIU,â she said.
SIU had said Halford conducted his research on human subjects independently in the Caribbean in 2016 with a company he co-founded with a Hollywood filmmaker. Yet, SIUâs medical school shared in a patent on a prospective vaccine with Halfordâs company, Rational Vaccines, and promoted Halfordâs vaccine research on its website.
The university has not responded to questions about its role in earlier experiments on human experiments by Halford. According to emails obtained by KHN and an account by one of the participants in the herpes vaccine experiment, Halford injected patients with the vaccine in 2013 in Illinois hotel rooms.
Many of the email exchanges with the participants in 2013 â asking them to send photographs of rashes, blisters and other reactions â were sent from Halfordâs university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab, which ethics experts said could constitute an improper use of state funds.
It is unclear whether the committee will have access to Halfordâs or his former colleaguesâ emails for its inquiry. An SIU colleague who had worked with him on his research took a job with Rational Vaccines, according to his online profile. Edward Gershburg, a former SIU professor, describes himself as the companyâs chief technology officer, . Gershburg, who is no longer with the university, could not be reached for comment, and the company did not respond to questions about him.
In the Dec. 5 memo obtained by KHN, the misconduct committee pointed out that Halford received federal funding for his research on animals from the National Institutes of Health. In such cases, universities are supposed to ensure that researchers donât use federal funding for unauthorized research, ethics experts told KHN. SIUâs Carlson said Halfordâs NIH funds stopped in 2012.
âIt is unclear at this time whether that grant is affected by the alleged misconduct,â stated the memo, which was sent to the medical school dean, Jerry Kruse, who assumed that role on Jan. 1, 2016.
In a reference to Halfordâs nasal cancer, which was diagnosed before the human-subject experiments, the committee added: âWe can only speculate as to [Halfordâs] motivation, which may have been related to his terminal illness.â
NIH declined comment and HHS did not respond to questions.
The pressure on the university has intensified with attention from Capitol Hill and a high-profile lawyer.
In letters sent out earlier this month, Iowa Sen. Chuck Grassley, the Republican chair of the Judiciary Committee, told the Trump administration and Southern Illinois University that he wanted to be reassured that âcorrective actionâ was being taken to prevent similar research abuses.
In a separate development, three participants injected with an unauthorized herpes vaccine by Halford are demanding compensation from SIU for alleged side effects from the vaccine.
The participants recently hired , a New Jersey lawyer who specializes in litigating research abuses. In late December, Milstein notified SIU that the participants hired him to pursue litigation. Milstein asked for a meeting to discuss the participantsâ fears about the vaccine and possible side effects.
âThey 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,â Milstein said in an interview.
The participants, who have herpes, have requested anonymity to protect the privacy of their health.
Milstein sent a similar letter to Halfordâs company, Rational Vaccines.
Rational Vaccines was co-founded with Hollywood filmmaker AgustĂn FernĂĄndez III and has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trumpâs campaign.
SIU declined to comment, and the company did not respond to questions about Milsteinâs letter.
While critics have accused Milstein of relying on overly aggressive tactics that obstruct legitimate research, he is widely known to pursue research misconduct cases, even those involving some of the nationâs most prominent research institutions.
Over the past decade, Milstein has represented plaintiffs alleging research abuses committed by drug companies and prestigious universities, including Stanford University and the University of Pennsylvania. The complaints often have led to confidential settlements.
Regardless of whether SIU can be found negligent in court, Spielman of SIU said she believed the university owed the participants an âinstitutional apologyâ for how the research was conducted.
âThe university should acknowledge that there must have been some kind of breakdown in the system,â she said.