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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: 5, Insightful) by Runaway1956 on Thursday November 16 2017, @06:23PM (10 children)
That's all well and good. But, ethics remain an important issue. If you don't have the time, or the compassion, to ensure that your test subjects don't drop dead from your tests, then you don't need to be testing medical stuff at all. Can't bear the thought of any kind of ethical oversight? You need to keep local health officials in the dark? There's something bad wrong with your methodology. If your methodology sucks, there is every reason to suspect that your results are bad too.
How many drugs have we seen come to market in the past decade or two, only to learn much later that the side effects are worse than the problems for which they were prescribed?
Ahhh, to hell with recent decades - how 'bout some nice, relaxing thalidomide? Have a truckload, so you can share it with all of your child bearing age female friends and relatives.
https://www.youtube.com/watch?v=eFTLKWw542g [youtube.com]
(Score: 3, Insightful) by Anonymous Coward on Thursday November 16 2017, @07:05PM (3 children)
see, this is why i don't mind runaway.
he's principled even if he does lean quite rightward.
conservatives do not have to be 100% profit and revenue maximizng at the expense of the actual customers they depend on.
the very fact that the topic had '"unethical" in quotes led me to believe we'd be biased right from the start--which we were with the academic witchhunt comment--but runaway helped set the proper tone.
ethics matter to everyone. you dont have to be red or blue to do unto others as you'd want done to you.
(Score: 3, Insightful) by aristarchus on Thursday November 16 2017, @08:06PM (2 children)
I totally agree. I even had to mod Runaway up. It hurt, but I did it anyway, because he's right. For once.
(Score: 1, Funny) by Anonymous Coward on Thursday November 16 2017, @09:24PM (1 child)
got your mod points back, eh?
(Score: 2) by aristarchus on Friday November 17 2017, @12:33AM
Twice as many, it seems.
(Score: 3, Insightful) by wisnoskij on Thursday November 16 2017, @10:47PM (2 children)
The story seems to be saying that a company is developing a drug in the Caribbean , that would greatly help the Caribbean, while following all Caribbean guidelines and requirements.
I don't see what concern it is to us what laws and regulations the Caribbean decides are necessary to restrict life saving medical research.
(Score: 0) by Anonymous Coward on Thursday November 16 2017, @11:07PM
It involves Peter Thiel! Hate!
(Score: 3, Informative) by Runaway1956 on Friday November 17 2017, @02:25AM
You might want to follow the links within the summary? Seems to be saying:
"An “active investigation” has begun in St Kitts and Nevis over allegations that a US-backed vaccine test took place in the federation to evade American safety oversight.
In a statement this evening, the country’s chief medical officer said in a statement via the Ministry of Health and Social Services, that a number of organisations have been kept in the dark over clinical trials.
“The Ministry of Health states categorically that neither the cabinet, the Ministry of Health, the office of chief medical officer nor the St Kitts and Nevis Medical Board has ever been approached on this project,” the statement read.
http://wicnews.com/caribbean/investigation-underway-clinical-trials-st-kitts-nevis-51245133/ [wicnews.com]
So, obviously, guidelines and requirements of St. Kitts and Nevis were evaded, right along with all pertinent US guidelines and requirements.
(Score: 2) by TheRaven on Friday November 17 2017, @10:17AM (2 children)
Thalidomide is an interesting example, because it's also a case of unintended consequences for reactionary regulation. In the wake of the Thalidomide trials, the restrictions on women participating in clinical trials were tightened up a lot to the point that some drugs made it to market without any testing on women at all. This came to light recently in the context of sleeping pills, some of which are significantly more effective on women to the point where the recommended dose can leave women dangerously sleepy in the mornings when they try to drive to work.
Oh, and Thalidomide is still used and is quite effective, doctors just have to be very careful about who they prescribe it to.
sudo mod me up
(Score: 2) by Runaway1956 on Friday November 17 2017, @02:45PM (1 child)
Those unintended consequences you mention are more a result of over reaction, than a proper reaction. IMHO, women should be included in any and all research and tests. But, women should be properly INFORMED. To lazy to go in search of thes story again, but some dude in Toronto was earning money in collge through some of these clinical tests. They gave him some stuff that caused some pretty serious side effects. The thing is, he wasn't properly informed. He didn't know to watch for the symptoms he developed. At his next scheduled appointment, he told the researchers about his symptoms, and basically, he was kicked out of the clinical test program. Blackballed. He couldn't get any more work for that group, or any similar group.
People, male or female, should have the opportunity to participate in research. But, both male and female should be fully informed. If Jenny Freshman understands that a clinical trial has a chance in thousand/million/billion of causing birth defects, then she can decide whether she wants to take that risk. A bunch of politicians shouldn't be making that decision for her. So long as Jenny is fully informed, it's her decision.
(Score: 2) by FatPhil on Saturday November 18 2017, @01:05AM
Great minds discuss ideas; average minds discuss events; small minds discuss people; the smallest discuss themselves