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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: 0, Offtopic) by Anonymous Coward on Thursday November 16 2017, @10:02PM (1 child)
When conducting a clinical trial, whose laws should apply? The US has the most strict laws around this, with Europe and Japan being much lighter, and Africa and South America being far less stringent. The US is also the most expensive place to perform a trial since it has a high cost of living. So if a US company wants to release a vaccine in Europe, but perform the clinical trial in Africa, whose laws should govern the way the trial is run? The FDA and related regulatory bodies will based the decision to permit the vaccine solely based on the data from the trials. But they have no jurisdiction over the treatment of those people. In practice, a company probably will apply the greater of: its own moral standards, and the standards set by the laws of the nation the trial is conducted in.
(Score: 2) by All Your Lawn Are Belong To Us on Friday November 17 2017, @04:38PM
You raise a really good question that gets to the heart of the ethical dilemma, AC. To me, there are three approaches which should control (and in this case were apparently ignored). The first is that an Illinois institution was involved as the patent holder and academic home of the principal investigator. Whether it was actually connected or not is an open question that has much bearing - the article seems to paint it both ways a little. We can also take a remove and ask under what jurisdiction is Rational Vaccines chartered? Either, or both, should immediately dictate the minimum level of concern applied. If Rational Vaccines was chartered out of St. Kitts and Nevis, then it is the Kittian standards that should be used at minimum. If a university in the United States has any kind of sponsorship (or is the patent holder in this case,) then their standards should apply if stricter.
I say "minimum" because a second approach could be the California approach.... simply make sure that all regulations of all jurisdictions are satisfied during the process. That may the most restrictive requirements of all stakeholding jurisdictions are satisfied.
But lastly, the notion that patients were actually FLOWN IN to the region where testing was done seems to say that the jurisdiction was shopped for regulatory dodging. It's not like this is some rare condition where the number of available patients would be so scarce that patients needed to be imported to obtain a sample size. (At least, I assume not). Further, as I've been trained, it is perfectly normal to expect to have to get an IRB signoff before one conducts research on human subjects and the story portrays that they tried and failed to get a signoff. So they proceeded to find a way to ignore the way research is normally conducted in the US and circumvent what are intended to be safety controls. And this was done willingly and apparently in full knowledge of what correct procedure should be, anywhere in the United States.
To me, the whole thing reeks of trying to forum shop. It's not only ethically wrong, but morally bankrupt. The company should be investigated to the full extent the law allows, and if it really was that they tried to pull a fast one, be punished accordingly.
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