The United States Food and Drug Administration (FDA) is investigating an international herpes scandal, which involves St. Kitts and Nevis.
Reportedly, the FDA is looking into allegations leading to an unauthorized Herpes Vaccine test trial conducted in St. Kitts and Nevis and in the United States, Illinois.
The FDA’s investigation will look at William Halford, former professor at Southern Illinois University, who allegedly administered experimental vaccines to patients without any safety oversight from the organization or an institutional review board.
Halford was allegedly granted access to perform the test in St. Kitts by someone in the Timothy Harris-led government. A major payout was also said to be involved in the transaction between Halford and the government official.
Halford, who died in June 2017, gave 20 herpes patients the vaccine in St. Kitts and Nevis in 2016, and at least eight herpes patients in an Illinois hotel rooms in 2013.
The FDA’s Office of Criminal Investigations is looking into whether staff at Halford’s former company, Rational Vaccines, or Southern Illinois University had knowledge of his actions and violated FDA regulations by assisting him in unauthorized research.
Although the FDA rarely prosecutes research violations, the agency may move forward with this case and pursue the unauthorized development of the vaccine as a crime.
FDA highlighted that these violations are severe because Halford is not a medical doctor and provided an experimental vaccine without supervision, which is a violation of human-subject guidelines.
In January 2018, United States Senator Chuck Grassley, reportedly sent a number of letters to Southern Illinois University’s (SIU) President, Mr. Randy Dunn, concerning the illegal practices and research of the late William Halford.
Grassley also sent letters to officials from the Food and Drug Administration (FDA) and the U.S Department of Health and Human Services’ (HHS) Office for Human Research Protections.
In his inquiry into the ordeal, Grassley asked for responses by Jan 18th 2018, 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.
Grassley’s letters referenced news highlights from Kaiser Health News, which suggested that 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.
Those experiments and tests did not 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.
In response, SIU officials have said they did not know the unauthorized research was going on.
However, Halford went on to conduct a clinical trial of his therapeutic herpes vaccine in 2016 on 17 U.S. and British patients in St. Kitts.
In Grassley’s letter to Dunn, the senator said Halford’s alleged injections in volunteers “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 2017, that it will comment on the results once its investigation is done.
Officials from the medical school’s IRB said in an Oct. 16th 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.