The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs — and sometimes goes after such cases to send a message.

In this case, human-subject violations would be deemed especially serious given Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight, experts said.

“Since the research appears to be an effort to totally evade FDA oversight and is egregious, it makes sense the FDA would investigate it as a criminal matter,” said Patricia Zettler, a former FDA lawyer who was told of the criminal investigation by KHN. “There is a deterrent effect for others who might consider this a very brazen way to get out of human subject and FDA requirements.”

The FDA declined to comment. Rational Vaccines did not respond to requests for comment. An SIU spokeswoman said, without elaboration, “The government is investigating and we are cooperating.”

Sen. Chuck Grassley (D-Iowa), the chair of the Judiciary Committee, applauded the FDA’s action after he had called on the agency to look into the matter, citing Kaiser Health News’ investigation.

“We ought to find out if the research was done with the knowledge of those who should’ve acted to stop it instead of turning a blind eye …” he said in a statement. “This research broke just about every rule in the book and put human subjects at extreme health risk.”

Any resulting criminal prosecution from the investigation could have political ramifications.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel.

Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump’s campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.

The sources familiar with the inquiry said the FDA’s Office of Criminal Investigations, , began to aggressively pursue the case weeks ago.

The investigators have interviewed witnesses across the country, asking them to identify Halford’s associates, and have described his actions as possible violations of human-subject guidelines and of FDA regulations, the sources told KHN.

The investigators also have expressed interest in whether Halford’s former associates at the university or other researchers and medical professionals outside the university might have helped or known about his conduct, the sources said. They also have raised questions about the company’s knowledge of the violations.

Rational Vaccines helped oversee the Caribbean trial, but the 2013 hotel injections took place before the company was formed.

Under a Supreme Court , a corporate official may be prosecuted for a criminal misdemeanor offense under the even without proof that the official acted with intent or actual knowledge of the offense.

Initially, university officials and Rational Vaccines publicly defended Halford’s research. Rational Vaccines has said it considered the 2016 trial a success — though it is unclear what data it used to support that claim.

After KHN’s investigation revealed that Halford injected people in the United States, not just in the Caribbean, Rational Vaccines took down its website, although it had vowed to continue research.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently and overseas.

After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research. SIU’s medical school receives about $ 9 million a year in federal research dollars.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws. University officials have denied knowing about his misconduct, an assertion that FDA investigators are still probing, the sources said.

Halford’s actions already raised unusual legal questions because the FDA would not ordinarily have jurisdiction over clinical trials when they occur overseas and the researchers have not sought FDA approval.

It’s also unclear where Halford manufactured the vaccine.

If it was manufactured in the United States, the FDA likely has jurisdiction, said Zettler, a law professor at Georgia State University.

The OCI often goes after such cases of contaminated food, counterfeit or off-label pharmaceuticals. The office was created in the wake of a 1988 scandal in which pharmaceutical executives bribed FDA officials in exchange for speeding up generic drug approvals.

While rare, the OCI occasionally pursues research abuses as a crime. A , for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

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SIU professor William 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 safety oversight that is routinely performed by the Food and Drug Administration or an institutional review board.

Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments.

Alan Milstein, a New Jersey lawyer representing the three participants, said his clients believe they should receive compensation not only for their medical costs, but also “pain and suffering” and loss of “dignity.” Milstein said he is still exploring legal options against the university, which shared in the vaccine’s patent, set up a business account to collect donations for Halford’s research and promoted his work.

“My clients are anxious to ensure such unethical experimentation on human subjects are not repeated,” said Milstein, who specializes in such cases.

A spokesman for Rational Vaccines did not respond to a request for comment. Earlier, the company had said that it plans to continue testing the vaccine and hopes to eventually secure approval from the FDA, although it’s unclear how it could without oversight from the federal government.

Halford co-founded Rational Vaccines with Hollywood filmmaker Agustín Fernández III in 2015. The company has since received millions of dollars in private investment from billionaire Peter Thiel, who contributed to President Donald Trump’s campaign. Thiel has declined to comment on his investment.

Rational Vaccines has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim.

Another participant, Richard Mancuso, has publicly asserted the vaccine cured him of herpes.

The lawsuit comes as the university is still investigating what it now describes as Halford’s misconduct.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently. After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university. The investigation probing his research and the help he might have received by other SIU employees is ongoing.

The dean of SIU’s medical school, Jerry Kruse, has refused multiple requests by Kaiser Health News for an interview, but in a statement he said he and other university officials knew nothing about improper research methods. Sen.Chuck Grassley, an Iowa Republican who is known for pushing for accountability on such matters, demanded a response from HHS and the university about their handling of the controversy. HHS’ Office for Human Research Protections, which is supposed to monitor such violations, may not investigate the matter, HHS told Grassley.

“OHRP expects that SIU’s forthcoming report will provide sufficient information … to determine whether the office has jurisdiction,” Matthew Bassett, the HHS assistant secretary for legislation, wrote Grassley in a letter obtained by KHN.

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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 , 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, . 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 , 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.

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In sent out Thursday, Iowa Sen. Chuck Grassley also told the administration and Southern Illinois University that he wanted to be reassured that “corrective action” was being taken to prevent similar research abuses.

Southern Illinois University professor William Halford tested his experimental herpes vaccine on participants in the Caribbean and in U.S. hotel rooms without Food and Drug Administration or institutional review board oversight. After Halford died in June and Kaiser Health News raised questions about the research, the university concluded he was in “serious noncompliance with regulatory requirements and institutional policies and procedures.”

“[T]his entire episode illustrates a failure in necessary governmental oversight of vaccine research as well as a failure by SIU to properly oversee its research staff,” Grassley wrote in the letters that cited KHN’s ongoing reporting.

Grassley, the chair of the Judiciary Committee, is well-known for pushing U.S. agencies to account for what he describes as breakdowns or lapses in the federal bureaucracy — even when the GOP is in charge.

In this case, his letters to the Department of Health and Human Services and the Food and Drug Administration could put pressure on the Trump administration to take a more aggressive role in any investigation of Halford’s research. Grassley’s letter to SIU could also lead to the university implementing tougher reforms in the wake of the unauthorized research, which participants say occurred as early as 2013 and continued into 2017.

“The type of research conducted, apparently all under-the-radar to the Obama administration and the very university that employed [Halford], has put individuals at extreme health risk,” Grassley wrote.

Grassley also sent his letter to the federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials.

OHRP could have jurisdiction in launching an independent investigation because the university had pledged to follow human-subject safety protocols for all research, even if it was funded privately.

But experts say that the federal government has become less aggressive about pursuing human-subject research violations over the years.

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.” That number has steadily declined. In 2017, it issued one.

Further politicizing the matter, Halford’s company, Rational Vaccines, received millions of dollars for future research on the experimental vaccine from billionaire Peter Thiel, a President Donald Trump supporter and high-profile critic of the FDA.

Thiel has not commented on the matter, despite investing in Rational Vaccines after Halford’s offshore trial.

SIU, meanwhile, has previously said it had no role or responsibility for Halford’s work, which it said it didn’t know about until after it was completed.

Following a KHN report that Halford completed the 2016 trial in St. Kitts and Nevis with no independent safety oversight, HHS demanded the university account for the research. The FDA and OHRP, however, have not commented on their roles in the matter.

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Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.

But don’t expect the disclosures after Halford’s death in June to trigger significant institutional changes or government response, research experts say.

“A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they’re hurt in the trial,” said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. “These types of cases are really a black hole in terms of accountability.”

The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.

Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford’s. He recruited subjects through Facebook and in some cases didn’t require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford’s offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.

“This is experimentation in the 21st century: heavily embedded in social media and combined with a hostility to regulatory oversight,” said Arthur Caplan, director of the Division of Medical Ethics at New York University’s School of Medicine. “How is the government going to manage subjects, researchers and investors who don’t like regulations?”

SIU officials initially brushed off any questions about Halford’s methods, saying the university did not have responsibility for the offshore vaccinations of the 20 participants in the trial because he formed an independent company to conduct the trial in St. Kitts and Nevis.

SIU eventually launched an inquiry last August, more than a month after Kaiser Health News began asking questions about Halford’s methods. The investigation is ongoing, although a preliminary inquiry found Halford’s methods to be in “serious noncompliance” with university rules and U.S. regulations.

Experts say the university should contact all participants who were injected with the vaccine and offer help to those who are suffering from side effects. But they point out that the university has potential conflicts of interest when scrutinizing its role in Halford’s research. SIU shared in the vaccine patent with Halford’s company, and medical school administration officials touted his work when Rational Vaccines benefited from Thiel’s investment.

In ongoing reporting, KHN learned that Halford injected a group of people in two hotel rooms near his lab in Springfield, Ill., in 2013, three years before he began experiments offshore. According to emails and one of the participants, many email exchanges with participants were sent from Halford’s university email account. He used the university phone and referred to a graduate student as assisting in the experiment and using the lab.

One participant has told the FDA he believes he suffers from adverse effects from the vaccine.

Yet Rational Vaccines continues to assert the vaccine is safe and effective, even though Halford’s data from his human subject experiments have not been published in a reputable scientific journal. Since the controversy, the company has taken down its website.

“This researcher basically violated all of the regulatory requirements and ethical principles guiding human subject research,” said Michael Carome, a doctor who directs the health research group for the nonprofit advocacy group Public Citizen. “Unfortunately, it seems everyone is trying to distance themselves here to avoid legal liability and a public relations embarrassment.”

The FDA, which has declined to comment on this case, could have jurisdiction, but it rarely takes aggressive action on behalf of human subjects, experts said. The FDA has had limited contact with two participants who have filed complaints alleging side effects from the vaccine.

“The FDA is just not set up to handle this,” NYU’s Caplan said.

The federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials, could choose to conduct an independent investigation. The agency would have jurisdiction because the university had pledged to follow human subject safety protocols for all research, even if it was funded privately.

Experts, however, remain skeptical that OHRP, an agency in the Department of Health and Human Services, would assume a prominent role in investigating the case based on the agency’s track record.

OHRP asked the university for an explanation after KHN first reported that Halford didn’t ask for routine safety oversight from an institutional review board.

OHRP once took on human subject violations that occurred during non-federally funded research and in cases where the FDA asserted jurisdiction, Carome said.

Now, the agency often chooses to stay out of non-federally funded trials and defers to the FDA, he said.

As a result, its public response to allegations of research abuse has plummeted, experts said.

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.”  That number has steadily declined. This year, it has issued one.

“A single letter in one year is extraordinary,” said Carome, who was the agency’s associate director for regulatory affairs from 2002 to 2010. “OHRP’s compliance oversight activities are moribund.”

“The end result is the federal watchdog for human subject protections is ineffective in its role in investigating complaints” and preventing violations, he said.

OHRP maintains it has been using other “more efficient” approaches. Rather than automatically opening a case and issuing a determination letter, the agency is “working more closely with complainants and institutions to address some of the concerns raised about human subject research,” said an HHS spokesperson, who declined to be named citing agency policy.

“But … in situations where something seriously wrong occurred, or subjects were harmed, OHRP does take action,” the spokesperson said.

OHRP hasn’t taken high-profile, aggressive action in years, said experts who pointed to the government’s suspension of federally funded research at Duke University and Johns Hopkins University more than a decade ago.

The federal government’s unresponsiveness in cases of privately funded research became more pronounced under the Obama administration, experts said.

In the waning days of the Obama administration, the federal government approved the first major overhaul of regulations surrounding human trials in 40 years. The resulting changes to federally funded trials included making consent forms more concise and clear.

, associate professor at Vanderbilt University’s Center for Medicine, Health and Society, said that in federally funded trials the measure “shifts the balance towards protecting research participants rather than protect[ing] institutions against liability.”

However, the rule does not address privately funded trials.

“If [the] organization and studies are privately funded, then they are not beholden to the law,” Stark said

As more universities began dropping their pledges to follow safety protocols for all research, it had already become difficult for the agency to assert jurisdiction. Meanwhile, OHRP’s compliance staff dwindled from six employees in 2008 to two in 2017. The lack of accountability for privately funded research is unlikely to change, experts say.

Stark called Halford’s research “a potential harbinger of the future of medical research given the increase in private funding and the unlikely prospect of updating the regulations again anytime soon.”

Compounding the problem, the United States is the only developed nation that does not guarantee medical care for those injured in clinical trials, experts said.

When participants claim injury, they often are told to file claims with their insurance companies, an impossible endeavor, said NYU’s Caplan.

“We still haven’t figured out how to compensate people who say they are injured in research,” he said. “In cases like these, in which subjects are claiming harm from a cuckoo experiment, the system is set up to punish the institution rather than give redress to the subject. Their only route then is to sue.”

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Last week, Kaiser Health News reported that Halford conducted an experiment in which he vaccinated patients in U.S. hotel rooms in 2013 without any safety oversight and in violation of U.S. laws, according to patients and emails they provided to KHN to support their allegations.

They told KHN those injections occurred three years before Halford tested a herpes vaccine he created on human subjects in a house in St. Kitts in 2016, again without routine safety oversight. Halford died of cancer at the end of June.

While the university has refused to respond to questions about the 2013 injections, an Oct. 16 memo to the federal government obtained by KHN under open-records law shows that SIU learned of such possible activity at the end of July. According to the memo, Rational Vaccines, the company that Halford co-founded, and another SIU professor disclosed that “human subjects research might have occurred prior to the … clinical trial in St. Kitts.”

SIU reported in the memo to the Department of Health and Human Services and the Food and Drug Administration that its institutional review board, or IRB, found Halford’s activities to be a “serious noncompliance” and said it recommended the university conduct a “confidential” investigation to determine if he committed any other misconduct.

“Dr. Halford willfully and intentionally engaged in human subjects research without the approval and oversight of the IRB, in violation of IRB policies and in violation of applicable law and regulation,” SIU wrote in the memo.

Previously, the university had said it was not responsible for Halford’s St. Kitts trial because he conducted it independently through Rational Vaccines.

Before releasing the memo to KHN, the university blacked out some of the details. It’s unclear whether the “serious noncompliance” involved the 2013 injections or some other unauthorized human subject research.

“This is a very serious matter for the university,” said Robert Klitzman, a doctor and director of the master’s program in bioethics at Columbia University in New York.

Klitzman said the (OHRP), the HHS division that oversees compliance with rules on human trials, could halt all of the university’s research as a result of the finding. The National Institutes of Health could also freeze its funding to SIU, he added, even though Halford’s research was not federally funded.

OHRP and the FDA said they have policies of not discussing potential or ongoing investigations. SIU did not respond to questions.

Several participants from both trials told KHN they have asked SIU for help. They said Tuesday that they felt the university should be informing them of its investigation into unauthorized experiments and its findings.

“Halford tested his vaccine on humans using SIU’s facilities and resources,” said one Colorado woman who has tried to talk to the university about her experience in the St. Kitts trial. “They [SIU] deny knowing anything about it. SIU hasn’t been very forthcoming.”

Klitzman said the university did have a responsibility to the participants who were injected with Halford’s vaccine. Two of them — including the Colorado woman — have filed so-called adverse event complaints with the FDA, saying that Halford’s vaccine may have caused side effects.

“Ethically, the university should contact the participants to let them know that some participants have developed adverse events,” he said.

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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.

The 2013 experiments raise further questions of misconduct by Halford, who pursued a herpes vaccine for years while working at Southern Illinois University, which claims to have been unaware of his unorthodox research practices.

Halford, who died this summer from cancer, ran a clinical trial out of a house on St. Kitts in 2016 to test the experimental vaccine and did not alert U.S. or St. Kitts and Nevis authorities.

Following a KHN report that Halford completed the 2016 trial with no independent safety oversight, the Department of Health and Human Services demanded the university account for the research.

SIU, in an initial response to U.S. authorities, said the university’s institutional review board found “serious noncompliance with regulatory requirements and institutional policies and procedures.”

SIU, like many universities receiving federal research funds, pledged to follow U.S. standards for all clinical trials.

In 2013, Halford, who was a microbiologist not a physician, noted a need for secrecy in one email to a participant, writing that it would be “suicide” if he became too public about how he was conducting his research.

Many email exchanges with 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.

“Furtive unregulated live virus vaccine injections in a Holiday Inn? This is really, really out there,” said Jonathan Zenilman, a doctor and an expert on sexually transmitted diseases at Johns Hopkins University. “Someone in the university had to know that this stuff was going on. If they didn’t, they should have.”

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, Zenilman said.

SIU refused to comment on revelations about Halford’s 2013 experiments.

It has previously said it had no role or responsibility for Halford’s work in 2016 in the Caribbean. The university has maintained it didn’t know about the offshore trial because he pursued that through Rational Vaccines, a company the professor co-founded in 2015.

But criticism has been raised about the university’s ties to Halford’s commercial venture.

SIU, based in Springfield, Ill., shared in a patent on the prospective vaccine with Rational Vaccines, which was formed to market and research the product. The university promoted Halford’s vaccine research on its website. And when a company owned by Peter Thiel, a supporter of President Donald Trump’s, invested millions of dollars into the research this April, SIU publicly trumpeted Halford and Rational Vaccines.

The Food and Drug Administration, which oversees the safety of vaccine research in the U.S., declined to comment on the 2013 experiments. It previously declined comment on the 2016 trial.

Since Halford’s death in June, several participants who received the vaccine in 2013 and 2016 have told KHN they have informed the university about what they fear may be side effects from the vaccine.

One participant who says he received the injections in Illinois fears that the vaccine, which contains a live virus, may have given him a new and different type of herpes he did not have, a scenario that experts who reviewed his medical details for KHN said was possible.

In recent weeks, that participant from Texas and a woman from Colorado who took part in the St. Kitts trial have separately electronically reported to the FDA their possible side effects, also known as “adverse events.”

They said SIU and the FDA have not adequately addressed their inquiries.

“It makes me angry that Halford went ahead with the offshore trial anyway,” said the man from Texas who did not want to be publicly identified because of the sensitive nature of his disease. “I hope more people weren’t hurt.”

Rational Vaccines has vowed to proceed with the research. The company, founded by Halford and Hollywood filmmaker Agustín Fernández III, has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim. In a statement, Rational Vaccines said that Fernández was not involved with Halford’s work before the company was formed but that Fernández was aware of “individuals who experienced positive outcomes from the vaccine.”

“Their stories are what sparked Mr. [Fernández’] future involvement,” the company stated. It did not address specific questions from KHN about the 2013 injections.

A representative for billionaire PayPal co-founder Thiel did not respond to questions about his investment in the vaccine. Thiel and other backers share libertarian political views that are critical of the FDA’s regulations.

The 2013 emails and interview with a participant show Halford began unregulated human experiments while working as an associate professor in the medical school’s department of microbiology.

The Texas patient said he first learned of Halford’s work through a members-only Facebook account. According to the emails, one woman helped Halford recruit patients and organize injections. This woman identified herself to KHN in an email as a herpes patient who was injected with Halford’s vaccine. She claims she was cured as a result.

KHN attempted to contact the other participants who received injections in 2013. They either declined to comment or did not respond.

In the emails, Halford describes some of his methods, including that he was varying the doses — as well as the number of shots. He communicated regularly with participants using a familiar tone.

“Just wanted to pass along that I immunized someone with the higher dose of the HSV-2 vaccine on Monday, and I attach the photos of the injection site at 48 hours to give you and everyone else an idea of what to expect …” he wrote on Sept. 19, 2013. “This individual requested that I give him two immunizations to double the effect … one immunization per leg.”

“Everyone’s vaccines contained ~150 million infectious units of the HSV-2 vaccine strain …” Halford wrote four days later, on Sept. 23, saying the first injection of the group represented about a thirty- to fortyfold increase over what others had received in August 2013.

In the same email, Halford said he believed the experiments were important to demonstrating that his vaccine worked.

“Saturday Sept. 21 definitely represents a milestone in my career,” he wrote. “Don’t know how it will turn out, but I undoubtedly feel like this was a real test of the (a) safety / tolerability of the HSV-2 vaccine and (b) an opportunity to see if it has any therapeutic potential.

“I am indebted to all of you.”

Halford also refers to using his university’s resources in the emails.

“My lab currently consists of myself and 1 graduate student and anything I do with you guys or your blood is extra and on top of what I get paid to do …,” he wrote in a Nov. 3, 2013, email. “If my graduate student gets to it before I do, I will pass along the results.” Attempts by KHN to reach the graduate student, who was not named in the email, were unsuccessful.

When discussing the possible effects of the vaccine in emails dated Oct. 2, 2013, Halford openly speculated about possible results, calling his analysis “nothing more than an educated guess.”

“The proof is in the pudding … let’s see if your problems with outbreaks dial back or not.”

The participants treated Halford with deference and were eager to receive the injections, the emails show.

The Texas man said he did not know how the trial was financially supported, adding that Halford wouldn’t accept money from participants because, as he told them, “it would get him in more trouble if he was ever caught.”

But Halford told participants they could donate money to SIU for his research, the Texas man said. SIU has confirmed that it set up a business account for donations to Halford, but the university has refused to say how the money was used.

When Halford invited them for dinner and drinks at his house, they agreed.  “I’ll do whatever he wants,” the Dallas man wrote about the dinner.

In the emails, the participants, who ranged in age from their 20s to 50s, were enthusiastic about the potential for the vaccine and freedom from often excruciating chronic symptoms. “I do believe [it’s] safe,” the Texas man wrote Halford on Sept. 15.

But months later, on Feb. 24, 2014, he said, he was frightened by a reaction to the vaccine, after his second shot. “I got a large rash on my leg and it burned and swelled,” he wrote to Halford. “… then a blister popped up.”

The Texas man has HSV-1, which usually emerges in sores on the face. Halford’s vaccine was a weakened version of HSV-2, which is genital herpes, according to descriptions he uses in the emails. “I did not think the HSV-2 vaccine strain would be capable of reactivation, but perhaps I will have to reconsider that,” Halford wrote in response in an email.

Anna Wald, a leading herpes expert at the University of Washington, said Halford should have informed the Texas man before testing that he was vulnerable to having side effects because he had a different herpes virus type than the vaccine Halford prepared.

Wald said Halford’s research — without oversight — jeopardized the patients.

“We’re not allowed to do this to guinea pigs in this country let alone human subjects,” Wald said.

But Wald said she could understand the participants’ desire for a chance at a cure. “People underestimate how desperate people with genital HSV are,” she said. “This is what drives even the possibility of a study such as Halford’s.”

SIU continues to be under scrutiny. Jerry Kruse, the dean of SIU’s medical school, responded to the HHS inquiry into the 2016 trial on Oct. 6 and indicated that the university has more to discover.

In his letter, obtained by KHN under the Freedom of Information Act, the dean said “if deemed necessary, SIU will develop an effective corrective action plan.” Some of the letter is redacted.

Several participants from both trials told KHN they have asked SIU for help.

The Colorado woman from the 2016 trial who reported a possible side effect from the vaccine to the FDA said she found university officials “dismissive.”

One participant, a Californian in his 30s, said he wanted the university to continue the vaccine work with safety oversight while “taking responsibility” for any improprieties.

SIU did not adequately address his questions, and he said: “It was obvious they want nothing to do with us.”

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The lead U.S. researcher, William Halford, openly acknowledged he was flouting Food and Drug Administration regulations in the consent forms they signed. He would be injecting them with a live, though weakened, herpes virus without U.S. safety oversight.

Still, many of them felt upbeat when they arrived on St. Kitts and Nevis in the spring of 2016. They had struggled for years with debilitating, painful herpes. Halford, the creator of the vaccine, sounded confident.

Maybe they could be cured.

“It felt like paradise,” one of the participants recalled. “Or therapy combined with vacation.”

A year later, their optimism has turned to uncertainty. Memories of kicking back in a Caribbean hotel during the trial have been overshadowed by the dread of side effects and renewed outbreaks.

They also can’t rely on his university, which shares in the vaccine’s patent but says it was unaware of the trial until after it was over. Because the didn’t monitor the research, it can’t provide guidance. Indeed, there is little independent information about what was in the vaccine or even where it was manufactured, since Halford created it himself.

At a time when the Trump administration is pushing to speed drug development, the saga of the St. Kitts trial underscores the troubling risks of ambitious researchers making their own rules without conventional oversight.

“This is exactly the problem with the way the trial was conducted,” said , an expert on sexually transmitted diseases at Johns Hopkins Bayview Medical Center in Baltimore. “These people are supposed to have rights as human subjects, but now there’s nowhere for them to go. We may never know if this vaccine worked, didn’t work or, even worse, harmed anyone.”

, the U.S. company co-founded by Halford, still hopes to market the vaccine. It touted success online and to other researchers, prompting millions of dollars of recent investment, including from a company run by Peter Thiel, a backer of President Donald Trump.

Thiel, a PayPal co-founder who has the FDA as too bureaucratic, declined to answer questions about his investment, which occurred after the trial had ended.

Kaiser Health News interviewed five of the 20 participants in the clinical trial and several associates of Halford.

The participants agreed to speak on condition of anonymity because they don’t want to be known as having herpes. Most also said they feared retaliation from Halford’s company but hoped by speaking out some of their concerns might be addressed.

Their accounts, along with documents, and emails obtained by KHN from the offshore trial, pointed to what experts said were serious irregularities:

• Halford did not rely on an institutional review board, or an “IRB,” which monitors the safety of research trials.
• The company has said it doesn’t know where Halford manufactured the vaccine, so it isn’t known whether he followed U.S. government guidelines when transporting it.
• Halford offered booster shots of the unapproved vaccine inside the United States. FDA regulations prohibit such injections.

“The FDA goes after these ,” said , a lawyer and assistant professor who specializes in medical ethics at the University of Pennsylvania’s Perelman School of Medicine. “[Researchers] can be prosecuted.”

SIU, however, did little to discourage Halford. The university, which has a financial interest in the patent, said it learned of “the concerns” only after his death. In August, after KHN asked about the trial, the medical school’s IRB launched an investigation into whether Halford violated U.S. regulations or university rules.

In a statement to KHN, Rational Vaccines acknowledged that Halford “discussed a myriad of concerns … including the potential need for booster shots.”

“Unfortunately, Dr. Halford is no longer with us to address all the ways in which he may have investigated his concerns …,” stated the company. It added, “We nevertheless wholeheartedly intend to continue his line of investigation in a clinical setting to international good clinical practice standards.”

Racing Against Time

Halford first broke with scientific protocols in 2011, shortly after he was diagnosed with nasal cancer and treated with chemotherapy and radiation, according to an account he later posted on his blog.

By then, Halford was in his 40s and had worked almost a decade at SIU’s

Halford, who did not have herpes, realized his cancer might not give him much time. If he submitted to the FDA’s oversight, it would take years, he reasoned in his account.

He decided to become his own research subject, injecting himself more than two dozen times with the vaccine.

“There is an ongoing herpes pandemic that demands the scientific community’s attention today, not tomorrow,” he wrote in his blog, which by his count received thousands of hits.

The experiments on himself, Halford believed, demonstrated the vaccine was safe.

In 2015, Halford set his sights on launching an offshore clinical trial.

However, his unorthodox approach made some of his peers recoil.

“He sat in my kitchen and tried to convince me to join him,” said Terri Warren, a nurse practitioner in Oregon who was approached by Halford in 2016 to help with the trial. “He believed so firmly in his vaccine. He said, ‘Think of all of the herpes patients who are suffering.’”

Warren had previously worked with Halford on a different, IRB-approved trial studying a new blood test to diagnose herpes. This time, she said, she became concerned about his methods, including how he was selecting his participants.

“I told him absolutely not,” she recalled. “I didn’t want anything to do with it. I felt bad for him because he was dying, but I thought he had lost perspective.”

But Halford did find backers, including Hollywood filmmaker , whose credits include action films and an award-winning documentary.

Fernández recently declined to respond to questions. But in an earlier interview this year with KHN, he said he initially contacted Halford to try to help someone he knew who was battling the disease. He said he didn’t have herpes, or a background in science.

Fernández, however, became such a believer in Halford, he said, he allowed Halford to inject him with the vaccine. In 2015, he co-founded Rational Vaccines with Halford and invested his own money into the company. That same year, the company licensed two patents related to the vaccine from SIU.

“I felt like Bill had the answer, and we had to make sure he got a chance to prove it,” Fernández said.

‘Finally … Someone Who Cared’

As soon as news began spreading in the tight-knit herpes online community that Halford may have a cure, he began hearing from the most desperate who asked to be included in any future research.

For many, herpes is a mild disease that can be controlled by antiviral medicines. However, for some, it becomes a life-altering disease that destroys any hope of intimate relationships.

To several of the participants, Halford was an empathetic scientist who refused to give up on finding a cure.

“After dealing with doctors who had no answers, it felt like you were finally talking to someone who cared and could help,” said a participant in his 30s from the South who had described the trial as “paradise.”

There were other perks as well.

Rational Vaccines told some participants they would be reimbursed for their flight and hotel expenses. If they got through the entire trial, they would be given an extra $500.

As Halford organized two groups of 10 participants, he instructed them on drawing their own blood for the trial, according to a filmed in a medical lab.

He proceeded with the trial from April to August 2016, giving participants three shots over three months.

Once in St. Kitts, many of them quickly bonded with one another and Halford. Even though they ranged in age from their 20s to 40s and came from different regions, they had the disease in common. They commiserated about how herpes had wreaked havoc on their lives.

“It was a relief to meet people who understood what we were talking about,” the Southerner said.

But other participants now say they noticed some troubling signs.

They received the injection in a house in St. Kitts, not a medical clinic.

Halford, whose gaunt frame made his cancer apparent by then, at times appeared disoriented.

Fernández, a constant presence, was introduced to them by name and made some of them uncomfortable when they socialized over drinks and dinner.

Some patients became anxious about their participation soon after receiving the vaccine.

One, a web developer in his 20s, felt ill after receiving just one dose.

“I experienced tiredness and ringing in my ears,” said the web developer, who reported the feelings along with “disequilibrium and slurred speech” continue to this day.

He said he decided not to return to St. Kitts for follow-up shots after Halford dismissed his symptoms as arising from a common cold.

Another participant, a Colorado woman in her 40s, said she told Halford she experienced flu-like aches and pains and tingling and numbness soon after the second shot. The symptoms were followed by an “excruciating” 30-day outbreak of herpes.

“I have new symptoms every day,” that woman later wrote Halford in an email exchange provided to KHN. “This is terrifying.”

Halford initially dismissed her symptoms, speculating they were caused by a mosquito-borne virus, she said.

She returned for the third shot but had her doubts. Halford and Fernández met her at a café to talk about her concerns, she recalled.

“[Fernández] kept saying, ‘You signed the consent form. You knew the risks,’” said the Colorado woman, who said Halford then removed her from the trial.

Another participant, a Californian in his 30s, said he went through with all three shots despite feeling a “terrible pain in my stomach.”

Halford then told him he had noticed in his research of mice that another version of the virus entered the gut of the mice and killed them, the participant said.

“I then thought maybe this is dangerous,” said the Californian, whose pain went away but his outbreaks did not.

Warren, the nurse practitioner in Oregon, said two participants tracked her down as a . She said that they described possible side effects from the vaccine.

Halford had told participants he would follow up on their reactions to the vaccine for a year, according to the consent form. But he stopped sending questionnaires to the two participants who said they had been dropped from the trial.

Warren said that even when researchers stop administering a vaccine because of possible side effects, known as adverse events, they have a duty to track the subjects’ reactions.

“There is no doubt that these were adverse events that should have been reported,” Warren said.

Rational Vaccines did not respond to questions about the complaints. In previous public statements, it acknowledged that one of the 20 participants was concerned about possible side effects.

Some participants also wonder where Halford made the vaccine and how he transported it to St. Kitts.

Halford told his business partner he had made it outside of the United States, without disclosing where.

After the trial ended, some participants began complaining that the vaccine hadn’t worked. Halford and Fernández offered booster shots, according to four participants.

One participant, a man in his 40s who was also from California, declined to get the booster. He said he decided to go back to antiviral drugs when his outbreaks returned.

The Southerner said he agreed to allow Halford to give him booster shots at an office in Springfield, Ill., where Halford worked.

“It was between me and him,” said the participant. “He was doing me a favor.”

“I don’t know if it was a different strain or what, but he gave me a set of double boosters at the same time, one in each leg,” recalled the Southerner, who said he didn’t have records of the injections. He said he received them as Halford continued to collect data for the trial.

Months later, he said, he returned a second time for another set of boosters.

Courting Support Without Results

Halford, meanwhile, tried to persuade a U.S. scientific journal to publish a lengthy manuscript detailing the results of both his experiments on himself and his offshore trial. Halford put the cover letter on SIU letterhead.

In December 2016, only months after the trial had ended, Halford’s paper was rejected by the journal.

“This manuscript is partly a vision, partly science, and partly wishful thinking …,” said one reviewer for the journal. “Neither safety nor efficacy has been demonstrated by the data presented.”

Halford asked his former doctoral adviser, Daniel Carr, to attend a Rational Vaccines advisory board meeting. Carr, a University of Oklahoma Health Services Center professor, said he and other invitees heard glowing reports about the trial.

Carr agreed in May to present the trial data at a of herpes experts in Colorado.

A published summary of the event listed Carr as a lead author, though he said he wasn’t involved in the research.

“I just did it to help him out,” said Carr, who asked for his university’s permission to be on Rational Vaccines’ advisory board and is waiting for word on federal funding to study another version of Halford’s vaccine. “I also presented it because I thought that the scientific community would find it interesting.”

Despite its patent agreement reached in 2015, SIU said it was in the dark about Halford’s offshore activities until October 2016 — months after the trial had ended.

Halford, meanwhile, promoted his work at events attended by university officials.

In October 2016, Halford was a keynote speaker at an to discuss his vaccine work.

Then, in April 2017, Halford and Rational Vaccines held a press conference to trumpet an investment pledge by Thiel’s company, according to materials handed out at the event. University officials, including SIU’s medical school dean, were invited speakers.

The university’s IRB is continuing its investigation, which includes scrutinizing whether Halford used university resources.

“If there are areas of concern, SIU will report those findings promptly to Department of Health and Human Services,” said SIU spokeswoman Karen Carlson. “We will also communicate our findings with the scientific community and the public.”

FDA spokeswoman Lauren Smith Dyer declined to comment on the trial except to say the FDA does not have jurisdiction over offshore trials that don’t seek agency approval.

Dyer, however, added that the export from the United States of an unapproved vaccine for research use and the injection of it on U.S. soil would be within the agency’s jurisdiction.

Even so, some participants don’t regret taking part in the trial.

“When you feel like a disease has ruined your life, you become desperate,” said the Southerner, who believes the boosters have lessened his outbreaks. “Some people contemplate suicide. You’re willing to do almost anything.”

Other participants still hope for some sort of accountability.

“I feel like without a doubt that my symptoms were vaccine-related,” said the Colorado woman. “I feel like it triggered something that I’ll have for the rest of my life.”

No matter what, experts said, the university has a responsibility to conduct an in-depth investigation. So far, the university has not reached out to participants who spoke to KHN.

“This researcher went rogue,” said Fernandez Lynch, the lawyer who specializes in medical ethics. “It’s true that universities can’t stand behind their researchers watching their every move. But when one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again.”

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The vaccine research has because the lead investigator, a professor with Southern Illinois University, and the U.S. company he co-founded did not rely on traditional U.S. safety oversight while testing the vaccine last year on mostly American participants on the Caribbean island of St. Kitts.

The trial received financial backing from a former Hollywood filmmaker who has asserted the vaccine was highly successful in stopping herpes outbreaks. Since then, a group of investors, including Donald Trump supporter Peter Thiel, have backed the ongoing vaccine research with a $7 million investment that could include additional clinical trials in Mexico and Australia.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing on the 20 human subjects. Now, the government of St. Kitts and Nevis says that the researchers also did not officially seek permission to test the vaccine, which took place from April to August 2016.

Agustín Fernández III, the co-founder of Rational Vaccines, the company that oversaw the vaccine testing, said his partner, William Halford, told him that he notified the St. Kitts government. Halford, who was the lead investigator on the research, died of cancer in June and Fernández said he did not have any other details about whom Halford might have talked to.

“I don’t know exactly,” Fernández wrote in an email Thursday. “[Halford] said he spoke to local authorities.”

Southern Illinois University did not immediately respond Thursday to questions about the research but told a reporter previously that Halford was not doing the research as part of his job at the university.

Read our first story on the offshore human trial of herpes vaccine that skirted FDA regulations.

U.S. researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

In the St. Kitts press release, the Ministry of Health and Social Services said it “will always ensure that all research involving human participants follow international standards which protect the safety and security of persons involved.”

To ensure this happens, an ethics review committee is supposed to vet medical research protocols “in keeping with international best practices.”

Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact but also can be released through the skin.

However, Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Fernández has said Halford took the necessary precautions during the trial. Halford also told him he manufactured the vaccine outside the United States, Fernández said Thursday.

“I don’t know how he [got] it there,” Fernández said in the email. He added that the doses were already in St. Kitts when he agreed to fund the trial.

SIU did not immediately respond to questions about whether it knew if Halford sought permission from St. Kitts officials.

Rational Vaccines was established in February 2015 and the company entered into its patent agreement with the university later that year, Fernández said.

A university spokeswoman earlier said the university first learned about the trial in October 2016 — after it had ended. The spokeswoman added that Halford didn’t need to bring the trial to SIU’s IRB because the trial wasn’t overseen by the university.

However, after a reporter raised questions about the lack of an IRB, the university launched a review of “internal processes to assure we are following best practices.”

Depending on how Halford transported the vaccine, he might have been required to seek approval from St. Kitts customs officials, said Dr. Patrick Martin, St. Kitts and Nevis’ chief medical officer until June 2016. Martin, who had been in that position since 2004, said he never heard from Halford or any other member of the company, although he should have been notified. “Where did the testing of the herpes vaccine take place?” Martin asked.

Such questions reverberated after news broke of the vaccine trial. The former St. Kitts and Nevis prime minister, Dr. Denzil Douglas, in a press release said: “Where [were] the materials, the drugs, the storage equipment for these vaccines housed? Were there appropriate customs declarations?”

Martin said he had to shut down another unauthorized research site, which was testing a stem cell product around the same time.

“We are a country of rules and regulations,” he said. ”Researchers can’t just do whatever they like without notifying the government or going to an IRB.”

The St. Kitts official now in charge of such matters, Dr. Hazel Laws, did not return repeated phone calls. An employee who answered the phone said it was unlikely she or any other official would call back because “the press release spoke for itself.”

American scientists called for more rigorous clinical trial oversight in the wake of Nazi atrocities involving human experiments but the U.S. did not require IRBs until the 1970s.

Steven Joffe, chief of the division of medical ethics at the University of Pennsylvania Perelman School of Medicine, said for research to be considered ethical “the study must be conducted in accordance with international standards for human subjects research.”

That includes approval by an institutional review board, research ethics committee or the equivalent.

“Legally, it must comply with the laws and regulations of the country,” he added.

Correction: This story was updated Aug. 31 to reflect that a statement attributed to Dr. Patrick Martin came from Dr. Denzil Douglas.

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The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.

The push behind the vaccine is as much political as medical. President Trump has of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

Robert Califf, who served as FDA commissioner in the Obama administration until January, said he couldn’t think of a prior instance in which American researchers did not set up an IRB abroad.

“There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” he said. “It may be legal to be doing it without oversight, but it’s wrong.”

However, Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Agustín Fernández III co-founded­ Rational Vaccines with tenured SIU professor William Halford. He said Halford, the lead investigator, took the necessary precautions during the trial conducted from April to August in 2016. Halford died of cancer in June.

The university backed its professor’s by posting a on its website about the vaccine. SIU is one of the patent holders of the vaccine and set up a business account to collect donations for the work.

Nonetheless, Southern Illinois University officials said they had no legal responsibility to ensure safety measures were in place because the university has an arms-length relationship with Rational Vaccines. Fernández said the company licensed two patents related to the vaccine from the university.

“SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial,” said Karen Carlson, the university’s spokeswoman. “But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial.”

But other researchers said they were appalled by what they described as the university’s complicity in ignoring more than 70 years of safety protocols. Scientists called for more rigorous clinical trial oversight in the wake of Nazi atrocities involving human experiments in the 1940s.

“You can’t just ignore human-subject protections that have evolved since the end of the Second World War,” said Zenilman, who served as a technical consultant to the presidential commission on bioethical issues during the Obama administration.

Zenilman, an expert on sexually transmitted diseases, cited U.S. government research in the late 1940s that with sexually transmitted diseases without their consent.

Congress passed sweeping regulations aimed at protecting human subjects, requiring IRBs in government-funded research. Later, an advisory committee to the U.S. government wrote of the need for safety review committees to ensure that “basic ethical principles” were in place to protect human subjects from harm. The 1979 Belmont Report also urged researchers to balance the risk to the human subject against the benefit of any breakthrough in medicine.

While the FDA declined to comment on the herpes vaccine trial, spokeswoman Lauren Smith Dyer said “the FDA believes that the oversight of clinical investigations, including review by an IRB, is critically important and is a regulatory requirement for clinical investigations subject to FDA regulations.”

Despite Gottlieb’s stance on the need for FDA streamlining, many researchers are skeptical that he would approve a vaccine based on trials that did not follow American regulations or traditional safety rules for its experiments.

Even so, Fernández, a former Hollywood filmmaker, said he and his investors plan to submit the trial data to the FDA in hopes of getting the vaccine approved for treatment. If the FDA does not respond favorably, he said, the company will continue its trials in Mexico and Australia. Fernández said he hopes to set up an IRB for these next trials. No matter what, he plans to manufacture the vaccine offshore. However, without U.S. approval, the challenges to market such a vaccine in the United States remain significant.

A Thiel representative said the billionaire was not available to answer questions by email or in an interview. Thiel, who rose to prominence as co-founder of PayPal, reportedly on possible FDA nominees after donating $1.25 million to his presidential campaign. Thiel has been a vocal critic of the FDA, claiming in an interview that its approval process was so unwieldy

Fernández said he hoped the trials would put political pressure on the FDA to give the vaccine a closer look. He said his vaccine would be initially aimed at helping patients who experience the “worst of the worst” symptoms. He believed the vaccine eventually would be shown to be effective in preventing the spread of the disease. According to the CDC, about.

“I will not stop,” said Fernández, who described the trials as his personal mission. “Too many people are suffering.” Before the trial, Halford tested the vaccine on himself and Fernández. After he failed to secure federal funding and an IRB, Halford moved ahead with the trial offshore.

Other researchers said they feared that desperate herpes patients would seek to be test participants or get the vaccine without being informed properly of the risk.

Researchers at several universities and private clinical research centers are working on two different herpes vaccines under FDA and IRB oversight. One is expected to undergo final trials by 2018 before being submitted to the FDA for final approval. In addition, the National Institutes of Health has conducted a first trial of a third potential vaccine.

Califf said drugs and vaccines are often costly to bring to market simply because they initially don’t work or are shown to be unsafe.

“The FDA is not the problem,” Califf said. “The issue is that there are so many failures.”

The vaccine’s researchers told KHN the St. Kitts trial showed the vaccine is safe and highly effective in preventing outbreaks in herpes patients.

The have not been published in a peer-reviewed journal and Halford’s previous attempt to publish was rejected. of the paper said they were concerned by the lack of safety and said they were skeptical about his scientific approach.

Yet some herpes patients, who are part of a tight-knit online community, have followed the project with hope and enthusiasm.

One American participant said he decided to go public with his experience despite the condition’s stigma. Richard Mancuso said he was recruited for the trial on Facebook and grew to be friends with Halford, whom he described as a “hero.”

Mancuso said the vaccine has stopped his severe outbreaks. “This has saved my life,” he said.

Fernández of Rational Vaccines said another SIU professor, Edward Gershburg, an associate professor in the university’s Department of Medical Microbiology, Immunology and Cell Biology, has agreed to become the company’s chief technical officer.

But Kayte Spector-Bagdady, who leads the University of Michigan Medical School’s Research Ethics Service, said the St. Kitts trial could be seen as a violation of SIU’s commitment to the Department of Health and Human Services.

SIU voluntarily agreed to follow U.S. safety requirements and set up an IRB for all research involving human subjects, according to records. Many universities make such a commitment to HHS, even if the experiments are abroad and don’t rely on federal grants.

Rational Vaccines was established in February 2015 and the company entered into its patent agreement with the university later that year, Fernández said.

But when asked about its commitment to HHS, Carlson, the university spokeswoman, said the university first learned about the trial in October 2016 — after it had ended. Carlson said Halford didn’t need to bring the trial to SIU’s IRB because the trial wasn’t overseen by the university.

However, after a reporter raised questions about the lack of an IRB, Carlson added that the university would “take this opportunity to review our internal processes to assure we are following best practices.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the .

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