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from the who-needs-clinical-trials-anyway dept.
FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research
The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned. SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.
According to four people with knowledge about the inquiry, the FDA's Office of Criminal Investigations is looking into whether anyone from SIU or Halford's former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.
The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs—and sometimes goes after such cases to send a message.
[...] Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III, and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel. Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump's campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.
Three people have sued Rational Vaccines over the experimental injections.
Also at STLtoday.com.
See also: Can We Gene-Edit Herpes Away?
Previously: University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
(Score: 3, Insightful) by Anonymous Coward on Wednesday April 18 2018, @06:31AM (3 children)
To prevent this https://en.wikipedia.org/wiki/Unethical_human_experimentation#United_States [wikipedia.org]
Even today people are mostly categorized as a renewable resource, something I find pretty disturbing.
(Score: 2, Insightful) by Anonymous Coward on Wednesday April 18 2018, @10:22AM (1 child)
What should be regulated is experiments with humans (and animals), not research of specific topics.
For example, imagine someone develops a great computer model that completely explains how Herpes works, and uses that computer model to develop Herpes vaccines in silico, however without first getting authorization. I think everyone would agree that there's absolutely nothing unethical in that research; the ethical questions only arise as soon as that development is finished and the researcher wants to actually test the Herpes vaccine in humans, which certainly would need authorization.
But if you regulate the research topic this means that this researcher would be guilty of unauthorized research, despite doing nothing but programming computers and feeding them with data.
Now I didn't read the details, so it's well possible that in reality only the experimentation needs approval, but I consider already the formulation in the title of the story as harmful, and also the claim in the title of the comment I'm replying to.
Don't get me wrong, there are certainly many things in health research that should be regulated, but not because it's health research, but because of the nature of the research.
(Score: 0) by Anonymous Coward on Wednesday April 18 2018, @06:58PM
i don't need some useless, authoritarian sack of shit trying to protect me from my own decisions. I am not a client or a slave of the state, even though the state says otherwise. you either have a right or you don't. you are either free or you are not. you are either committing fraud or using force or you are not.
(Score: 0) by Anonymous Coward on Wednesday April 18 2018, @12:39PM
No need to prevent truly informed consent, though.