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Herpes trial on Americans without FDA oversight gets little response so far

U.S. regulators once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even for the most outrageous abuses.

Recent revelations that a U.S. researcher injected Americans with his experimental herpes vaccine without routine safety oversight raised an uproar among scientists and ethicists.

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, which came after Halford's death in June, to trigger significant changes, 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 bioethics professor 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, agencies tend to avoid action even for the worst abuses.

Experts said the U.S. regulators are especially unprepared for off-the-grid experiments like Halford's. He recruited subjects through Facebook and didn't always require signed consent forms, or inform participants outright that the experiments flouted FDA oversight. These patients, many of whom struggle with painful herpes, proceeded anyway. After Halford's offshore trial, Peter Thiel, a libertarian and adviser to President Trump, gave millions 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 questions about Halford's methods, saying the university had no responsibility for the offshore vaccinations of the trial's 20 participants because he formed an independent company to conduct the trial in St. Kitts-Nevis.

SIU eventually launched an inquiry last August, more than a month after Kaiser Health News (KHN) 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 suffering from side effects. But they also point out that SIU shared in the vaccine patent with Halford's company, and school officials touted his work when Rational Vaccines attracted Thiel's investment.

KHN later 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. Many email exchanges with participants came from Halford's university email account. He used the university phone and described a graduate student as assisting.

The FDA, which has declined comment, could have jurisdiction, but rarely takes aggressive action on behalf of human subjects, experts said. "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 conduct an independent investigation. Experts, however, remain skeptical. The agency's public assessments of research misconduct peaked in 2002 when it issued over 100 "determination letters."  This year, it issued one, showing how its oversight activities "are moribund," said Carome, the agency's associate director for regulatory affairs from 2002 to 2010.

OHRP's unresponsiveness to privately funded research became more pronounced under the Obama administration, experts said. Its compliance staff dwindled from six employees in 2008 to two in 2017.

Compounding the problem, the U.S. is the only developed nation that does not guarantee care for those injured in trials, experts 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," said NYU's Caplan. Their only route then is to sue."

Kaiser Health News is a nonprofit news service covering health issues.