It was recently revealed that a researcher in the United States injected people with an experimental herpes vaccine that was not approved by the Food and Drug Administration (FDA). As a result, there has been a great deal of uproar among ethicists and scientists alike. There is no way to tell whether the vaccine is safe or not.
Without a medical license to his credit or an FDA oversight for the experimental herpes vaccine, William Halford, a researcher from Southern Illinois University injected Americans offshore, as well as in hotel rooms in the U.S.. Since he performed those actions, several people who participated in his experiment have come forward to complain about side effects they are experiencing.
Halford passed away in June 2017. However, researchers don’t expect any significant changes or response from the government regarding the issue.
Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota, stated that organizations usually don’t take any responsibility or action to help participants, even when they’re injured during the course of a trial. He said such cases are a black hole in terms of accountability.
How Halford Got Test Subjects
Previously, the federal government would scrutinize and even freeze research like this at universities after learning the details of the controversies. However, now, experts report that oversight agencies avoid taking any action even in the most unbelievable cases. Further, they say that regulatory agencies are unprepared to deal with clandestine experiments such as the one Halford conducted. Many of his subjects were found on Facebook and didn’t require consent forms. Additionally, many people who participated in spite of the lack of FDA clearance. Participants were patients who suffer from bad cases of herpes and went ahead with the experiment in hopes of a cure.
Initially, SIU officials didn’t answer questions about the experiment and the methods Halford used, stating that it wasn’t responsible for offshore vaccinations within the trial. Further, they claimed Halford formed his own independent company to perform another trial in Nevis and St. Kitts.
Independent Investigation Started
However, in August, SIU started an investigation after Kaiser Health News started inquiring as to Halford’s methods. Currently, the investigation is still going, but an early inquiry determined the experiment to be noncompliant with SIU’s rules and US regulations.
According to experts, the university should contact anyone who participated in the vaccination experiment and help anyone experiencing adverse side effects. At the same time, they note that SIU possibly has conflicts of interest in looking into the research.
The FDA declined to comment on the case. However, it rarely takes action on behalf of participants and had limited contact with two people who filed complaints after experiencing negative side effects from Halford’s vaccine.
The Office for Human Research Protections (OHRP) monitors the way people are treated during trials. It could perform an investigation and has jurisdiction because SIU pledged that it would follow any subjects and ensure that all safety protocols were met during any research. However, experts are skeptical that this would happen.
Issue of Privately-Funded Research
An associate professor at Vanderbilt University’s Center for Medicine, Health and Society, Laura Stark, said that trials funded by the federal government put more of an emphasis on protecting research participants than organizations against liability, but that doesn’t necessarily affect trials that are privately funded. She explained that if studies are privately funded, they aren’t beholden to the law.
What makes things even worse is that the U.S. is the only developed country in the world that doesn’t guarantee that participants injured during clinical trials will receive medical care. Typically, when someone reports injury, they’re directed to file a claim with their insurance company, which gets them nowhere, according to Arthur Caplan, the director of the Division of Medical Ethics at NYU’s School of Medicine.
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