A Republican senator is demanding that the Trump administration and a university scrutinize how a researcher was able to inject an experimental herpes vaccine into human subjects without routine safety oversight.
In letters 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.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.
This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.