University under fire for off-the-grid herpes vaccine experiments

Jan 23 2018

SIU's ethics panel launched a "full" 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 SIU's medical school dean that the inquiry should not only investigate the extent of Halford's alleged wrongdoing, but also scrutinize "members of his research team," according to the Dec. 5 memo obtained through a Freedom of Information Act request.

"The Misconduct in Science Committee is now in its investigative stage and the School anticipates this investigation will take approximately 120 days," SIU spokeswoman Karen Carlson told KHN in an emailed response. "However, the investigation could take longer."

The panel's inquiry marks the second one to be launched by SIU since Halford's methods were detailed in a KHN report in 2017.

The Department of Health and Human Services asked the university to determine whether Halford's activities violated the institution's 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 school's institutional review board determined Halford's activities were in "serious noncompliance" 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 SIU's 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 Bethany Spielman, a professor of health law at SIU's medical school in Springfield,Ill. The medical school receives about $ 9 million a year in federal research dollars.

"Part of the reason this committee exists is to keep the federal funding clean and flowing," said Spielman, who specializes in bioethics. "Any university that does research, especially with human subjects, wants to be trusted by the federal government and the public."

In SIU's response to KHN's open-records request, the university excised the names of the committee members.

Carlson said that after the committee's investigation is complete "in conjunction with recommendations from the appropriate federal agencies, we will address our policies and procedures and anything else that arises from the investigation."

"Currently, no herpes research is being conducted at SIU," 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, SIU's medical school shared in a patent on a prospective vaccine with Halford's company, Rational Vaccines, and promoted Halford's 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 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford's 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 Halford's or his former colleagues' 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 company's chief technology officer, according to his LinkedIn account. 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 don't use federal funding for unauthorized research, ethics experts told KHN. SIU's Carlson said Halford's NIH funds stopped in 2012.

"It is unclear at this time whether that grant is affected by the alleged misconduct," 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 Halford's nasal cancer, which was diagnosed before the human-subject experiments, the committee added: "We can only speculate as to [Halford's] motivation, which may have been related to his terminal illness."

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 "corrective action" 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 Alan Milstein, 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 participants' fears about the vaccine and possible side effects.

"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," 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 Halford's company, Rational Vaccines.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump's campaign.

SIU declined to comment, and the company did not respond to questions about Milstein's 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 nation's 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 "institutional apology" for how the research was conducted.

"The university should acknowledge that there must have been some kind of breakdown in the system," she said.

KHN's coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.