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posted by Fnord666 on Wednesday April 18 2018, @04:22AM   Printer-friendly
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


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  • (Score: 3, Funny) by aristarchus on Wednesday April 18 2018, @08:38AM (2 children)

    by aristarchus (2645) on Wednesday April 18 2018, @08:38AM (#668497) Journal

    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. )

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  • (Score: 3, Funny) by RamiK on Wednesday April 18 2018, @02:46PM (1 child)

    by RamiK (1813) on Wednesday April 18 2018, @02:46PM (#668594)

    Pentatic Hexameter

    Tell me this isn't a reference to Diomedes' Ars Grammatica' list of dactylic hexameters...

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