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
Related Stories
Questionable herpes vaccine research backed by tech heavyweight Peter Thiel may have jeopardized $15 million in federal research funding to Southern Illinois University School of Medicine. That's according to documents obtained by a Freedom of Information Act request by The State Journal Register.
In August, Kaiser Health News reported that Thiel and other conservative investors had contributed $7 million for the live-but-weakened herpes virus vaccine, developed by the late SIU researcher William Halford. The investments came after Halford and his private company, Rational Vaccines, had begun conducting small clinical trials in the Caribbean nation of St. Kitts and Nevis. With the off-shore location, Rational Vaccines' trial skirted federal regulations and standard safety protocols for human trials, including having approval and oversight from an institutional review board (IRB).
Experts were quick to call the unapproved trial "patently unethical," and researchers rejected the data from publication, calling the handling of safety issues "reckless." The government of St. Kitts opened an investigation into the trial and reported that health authorities there had been kept in the dark.
(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.
(Score: 3, Funny) by aristarchus on Wednesday April 18 2018, @08:38AM (2 children)
Avast! He blows! After him, Starbuck! T'is the White Whale! If only this could have been an Ismael submission! Peter the Thielon, swimming in the oceans of cash the sprunged from the anus of the Paypal. Well to be that it lay to windward. The stench was unbearable, like unto a Sperm Whale dead these many weeks, but not so ripe as the Honey Tun is not to be tapped! Oh, sail on, me hearties! There is much to be on this sea of medical research, many isolated fortresses, and lonely ships, and theories with no collaboration. They will be ours!
(Oh, when I say "Ismael submission", you should substitute "aristarchus submission", for purposes of rhyme and metronics. Otherwise the Pentatic Hexameter will not work, and Homer shall be very cross. )
(Score: 3, Funny) by RamiK on Wednesday April 18 2018, @02:46PM (1 child)
Tell me this isn't a reference to Diomedes' Ars Grammatica' list of dactylic hexameters...
compiling...
(Score: 2) by aristarchus on Thursday April 19 2018, @12:24AM
Would it bother you if it was not?
(Score: 2) by DannyB on Wednesday April 18 2018, @02:55PM
Just don't let them create Biotics.
To transfer files: right-click on file, pick Copy. Unplug mouse, plug mouse into other computer. Right-click, paste.
(Score: 2) by Snow on Wednesday April 18 2018, @04:59PM (1 child)
I would love a herpes vaccine. Although herpes it self is a very minor inconvenience, the social stigma is huge. STD tests (or STI tests) do not typically look for herpes because it's so common and minor. So you could be about to sleep with someone, they say they were tested last month, but they could still have herpes.
Combine that with the fact that MOST adults do have herpes (Type 1 Oral). They didn't get it from sex, but rather their mother/father/aunt/uncle kissing them as a baby.
The stigma around herpes is ridiculous. It's just because it can happen on the 'taboo' parts of the body.
(Score: 3, Informative) by HiThere on Wednesday April 18 2018, @06:05PM
Herpes is also implicated in the development of at least *some* cancers. So it *can* have quite harmful results.
But, yes, it's usually trivial.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.