Photo 1 – Sen. Chuck Grassley
By: E. Williams
Washington DC, USA –A United States senator is now asking questions about the illegal and unethical herpes vaccine trial that took place in the United States and the Federation of St. Kitts and Nevis.
United States Sen. Chuck Grassley, R-Iowa is reported to have sent letters last week about the late William Halford’s research activities to SIU system president Randy Dunn and officials from the Food and Drug Administration and the U.S. Department of Health and Human Services’ office for human research protections.
Grassley asked for responses by Jan. 18 to his questions about what the FDA, HHS and SIU found through inquiries by the federal agencies and an ongoing internal investigation at SIU School of Medicine into Halford’s research.
At issue, according to the letters from Grassley, were news accounts, first reported by Kaiser Health News, that suggested Halford injected at least eight herpes patients with his experimental, therapeutic herpes vaccine in two different Springfield hotels in the summer and fall of 2013.
The testing didn’t have supervision from SIU’s “institutional review board” or any other governmental bodies and apparently didn’t follow widely accepted ethical and legal standards, according to Grassley’s letters.
SIU officials have said they didn’t know the unauthorized research was going on.
Halford, 48, a Springfield resident, died in June from a rare form of nasal cancer.
Halford also has been criticized for lack of IRB oversight when the company he helped to form, Rational Vaccines, conducted a clinical trial of his therapeutic herpes vaccine in 2016 on 17 U.S. and British patients in the Caribbean island nation of St. Kitts and Nevis. Research in animals that contributed to the development of Halford’s experimental therapeutic and preventive herpes vaccines took place as part of Halford’s work as an SIU faculty member.
In Grassley’s letter to Dunn, the senator said Halford’s alleged injections in volunteers at Springfield’s Crowne Plaza Hotel and a Holiday Inn Express “may have violated almost every requirement” of a federal policy known as the “Common Rule” that is designed to protect the safety of human research subjects.
Grassley, chairman of the Senate Judiciary Committee, asked Dunn what corrective action has been taken to prevent further abuses and the results of SIU’s internal review.
The federal agencies and SIU haven’t provided answers to those questions from the news media. The federal government has the power to sanction SIU and withdraw federal research funding.
SIU officials said in November that it will comment on the results once its investigation is done.
Officials from the medical school’s IRB said in an Oct. 16 report for federal officials that 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 spokeswoman Karen Carlson said Monday that SIU’s investigation continues and that Dunn will respond to Grassley’s letter but hasn’t done so yet.
Carlson said the FDA and HHS office for human research protections haven’t made any decisions on whether SIU will be sanctioned. SIU officials submitted information to those agencies in October, and SIU has had “frequent communication” with the HHS office since then, she said.