Republican Senator Chuck Grassley of Iowa, chairman of the Senate Judiciary Committee, is calling on regulators and Southern Illinois University to account for reports that a researcher conducted rogue trials of an experimental herpes vaccine.
Republican Senator Chuck Grassley of Iowa, chairman of the Senate Judiciary Committee, is calling on regulators and Southern Illinois University (SIU) to account for reports that a researcher conducted rogue trials of an experimental herpes vaccine.
As Kaiser Health News reported in October 2017, a now-deceased SIU professor, William Halford, PhD, admitted to injecting patients who had herpes with a live, attenuated herpes vaccine that Halford called “Theravax.” Halford injected the patients—who signed consent forms that stated that the vaccine had not been manufactured according to good manufacturing practice criteria and that Halford and his partners at the startup Rational Vaccines “feel the FDA’s one-size-fits-all approach to drug approval does not address the needs of millions of HSV-2 genital herpes sufferers”—with the experimental product in hotel rooms in St. Kitts and Nevis. Halford was also found to have injected subjects in the United States at hotel sites near the SIU laboratory.
Grassley, in letters addressed to Eric Hargan, acting secretary of HHS; Scott Gottlieb, MD, commissioner of the FDA; and Jerry Menikoff, MD, JD, director of the Office for Human Research Protections (OHRP), called Halford’s action a violation of “The Common Rule,” or Title 45 of the Code of Federal Regulations, Part 46.
“William Halford…may have violated almost every requirement of the Common Rule,” wrote Grassley. Under the rule, risks to participants must be minimized and reasonable in relation to anticipated benefits, selection of subjects must be equitable, informed consent must be sought and documented, researchers must monitor data to ensure participants’ safety, and participants’ privacy must be maintained. Grassley wrote that Halford did not have appropriate patient protections in place for his unapproved study, and that the researcher’s own emails “…stated that it would be ‘suicide’ if the manner in which he conducted the research were to be made public.”
Grassley has requested written responses from HHS, FDA, and OHRP detailing what—if any—investigations the agencies have launched into Halford’s conduct, and what corrective actions the agencies are taking to prevent similar violations from occurring.
Also in Grassley’s sights is SIU, itself. In a letter to the institution’s president, Randy Dunn, EdD, the senator asked for details of corrective action taken by the institution to prevent further noncompliance with regulatory requirements, the process SIU follows once a complaint about potentially unapproved research is received, the number of reports of unapproved research SIU has fielded over the past 5 years, and how many internal reviews and referrals to law enforcement were made during that period.
SIU’s official position, released in a November 2017 statement, is that, because Rational Vaccines had licensed SIU’s intellectual property and was therefore the party responsible for upholding applicable laws and regulations, “SIU did not feel that any discussion with Dr. Halford about the trial was warranted.” The statement added that it was undertaking an investigation related to the trial, and that it will provide more information after the inquiry has been completed and evaluated.
Grassley requested written responses to the questions posed in his letters by tomorrow, January 18, 2018.