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posted by janrinok on Thursday November 16 2017, @06:02PM   Printer-friendly
from the its-the-way-that-you-do-it dept.

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.

Source: https://arstechnica.com/science/2017/11/university-could-lose-millions-from-unethical-research-backed-by-peter-thiel/


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  • (Score: 4, Interesting) by khallow on Thursday November 16 2017, @06:41PM (8 children)

    by khallow (3766) Subscriber Badge on Thursday November 16 2017, @06:41PM (#597806) Journal
    It's pretty bogus to portray this as an ethical concern. This was a deliberate challenge to the current bureaucracy surrounding medical research.

    The vaccine—a live but weakened herpes virus—was first tested in a 17-person trial on the Caribbean Island of St. Kitts without federal oversight or the standard human safety requirement of an institutional review board (IRB) approval. Biomedical researchers and experts have sharply rebuked the lack of safety oversight and slammed the poor quality of the data collected, which has been rejected from scientific publication. However, investors and those running the trial say it is a direct challenge to what they see as innovation-stifling regulations by the Food and Drug Administration.

    “This is a test case,” Bartley Madden told KHN. Madden is another investor of the vaccine as well as a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

    The thing we need to remember here is that such bureaucracy delays and increases the expense of human research. It kills people too. And really what is the point of these boards? Is it for ethical concerns or to create a competitive advantage for large businesses who can buy compliant boards [slate.com]?

    Today, however, the ethics review of more than half of all new drug submissions to the Food and Drug Administration is handled by a single for-profit IRB, Western Institutional Review Board in Olympia, Wash. (according to Western's owner, Angela Bowen, as quoted in Bloomberg). At the SFBC clinic in Miami, some of the ethics review was done by a for-profit IRB owned by the wife of an SFBC vice president. At the Fabre Research Clinic in Houston where Garry Polsgrove [a human test subject mentioned earlier in story] died, the ethics review was conducted by a for-profit IRB run by Louis Fabre, the clinic owner. (The Fabre clinic and its IRB have since shut down.) If you find yourself down on your luck and are tempted to volunteer for an industry-sponsored drug study, chances are that you will be entrusting your safety to a private board that is operating with very limited government oversight, and that is being paid by the drug company whose drugs you are taking.

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  • (Score: 2, Informative) by Anonymous Coward on Thursday November 16 2017, @06:56PM

    by Anonymous Coward on Thursday November 16 2017, @06:56PM (#597816)

    Oh ho, finally you see why some things should not be for profit enterprises!

    As for why we need ethics boards: Medical War Crimes [wikipedia.org]

  • (Score: 4, Insightful) by Grishnakh on Thursday November 16 2017, @07:20PM

    by Grishnakh (2831) on Thursday November 16 2017, @07:20PM (#597836)

    The problem I see here is that the US FDA is not the global authority on what drugs are safe and can be allowed. There's many other nations out there, many of them quite advanced, that drug testing could be performed in.

    If the FDA was getting in their way, why didn't they just go to some other country like Germany or Japan and do testing there, rather than some backwater country with no real regulation of drug-testing?

  • (Score: 2) by DannyB on Thursday November 16 2017, @07:46PM (1 child)

    by DannyB (5839) Subscriber Badge on Thursday November 16 2017, @07:46PM (#597855) Journal

    It's pretty bogus to portray this as an ethical concern. This was a deliberate challenge to the current bureaucracy surrounding medical research.

    Try . . .

    It's pretty bogus to portray the dumping of radioactive waste in the drinking water as an ethical concern. This was a deliberate challenge to the current bureaucracy surrounding radioactive waste disposal. (and challenge to the cost as well)

    Some things are bureaucratic for a reason. And rightly so.

    such bureaucracy delays and increases the expense of human research. It kills people too.

    That cost of human research is because of ethics and humanity to treat other human beings as actual people. Not lab animals. People who have lives. Loved ones. Hopes, dreams, and wishes and fears. That is why early testing uses lab animals, which are cheaper. Even then, ethics and the minimizing of suffering is a concern.

    Yes, people die from diseases we don't have approved cures for. It has always happened. For all of human history. And it's sad. The work to develop a safe cure or treatment is for the end result of ending that suffering. People who have the condition for the drug being tested are the very potential candidates to participate in a scientific study. That does not relieve the obligation to make the test as safe as possible.

    But there are other ways. The Dilgar War Master Jha'dur infected the entire population of Latig IV with Stafford's Plague [wikia.com] just to see how long it would take for them all to perish.

    --
    People today are educated enough to repeat what they are taught but not to question what they are taught.
    • (Score: 1) by khallow on Friday November 17 2017, @07:44AM

      by khallow (3766) Subscriber Badge on Friday November 17 2017, @07:44AM (#598100) Journal

      It's pretty bogus to portray the dumping of radioactive waste in the drinking water as an ethical concern.

      If only sarcasm were a reliable test for fake problems. We have at least two examples of the above. People spazzing over trace leaks of tritium and of course, the drama over leaking of the Fukushima site into the ocean.

      That cost of human research is because of ethics and humanity to treat other human beings as actual people.

      Or at least, theater resembling such concern.

      Yes, people die from diseases we don't have approved cures for. It has always happened. For all of human history. And it's sad. The work to develop a safe cure or treatment is for the end result of ending that suffering. People who have the condition for the drug being tested are the very potential candidates to participate in a scientific study. That does not relieve the obligation to make the test as safe as possible.

      The difference is that we can do something about it now.

  • (Score: 4, Informative) by edIII on Thursday November 16 2017, @08:14PM (1 child)

    by edIII (791) on Thursday November 16 2017, @08:14PM (#597865)

    Yeah, it's not bogus at all. It's absolutely a concern over ethics, and you just proved our point by showing a rather stark lack of ethics and a for-profit infection in the bureaucracy we have. Already know that, tell us something new. But we do appreciate you posting it.

    Investors always challenge everything, because they only have ONE concern: profitability. Ethics, humanity, accountability, all go out the window, and are subjugated by Capitalism. As ethics and accountability nearly always hurts profit, at least in the eyes of the sociopathic avaricious parasites infecting humanity (aka investors). It's like mob mentality where a person might normally be fine, but when presented with decisions over an investment, promptly lose their humanity in the face of lost profits.

    You love competition and the myth of the free market so much, so why did they choose the Caribbean again? That's right, to make their principled stand against the problematic ethics and their application in the U.S? Bullshit. Like somebody else pointed out, they could just choose a more progressive country. Instead of going to any other major 1st world country, they decide to go to a backwater island with the tiniest fraction of medical bureaucracy to be found. Then they lied to that tiny bureaucracy to be freed from it.

    If they had a legitimate case, especially as investors, they would've chosen a country where they could actually bring a product to market after enough proper science that convinced a 1st world country. This was just a waste of fucking money while they "tilt at windmills" fighting the FDA.

    “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

    Yeah, only if they can show a real product, done with real science, within a medical community that could be trusted. Otherwise, the American people are just going to see a pharma drug produced under almost no oversight beyond the oversight of the investors themselves. Uh huh, the American people are just so trusting of pharma companies and their investors right? If they had anything to begin with, they could have a European pharma company bring it to market in the EU. When Americans consistently hear of friends and relatives "across the pond" living better lives with a good treatment for herpes, THAT will motivate them to demand action. Although as I say that, I giggle a little bit in a morbidly depressed way, at the very idea that anybody in power gives a shit what the people think anymore.

    No, this was an issue of ethics from the very beginning, and specifically, the ethics that should be able to constrain investors, and that investors don't want constraints when going after profits. After all, anything that reduces profits is wrong when the predominant ethics on the planet are driven by Capitalism. It's not might makes right, but profits make right.

    --
    Technically, lunchtime is at any moment. It's just a wave function.
    • (Score: 1) by khallow on Friday November 17 2017, @12:53AM

      by khallow (3766) Subscriber Badge on Friday November 17 2017, @12:53AM (#598001) Journal

      You love competition and the myth of the free market so much, so why did they choose the Caribbean again? That's right, to make their principled stand against the problematic ethics and their application in the U.S? Bullshit.

      It's cheap, near the US by vicinity, and not subject to US regulation.

  • (Score: 2) by meustrus on Thursday November 16 2017, @09:10PM (1 child)

    by meustrus (4961) on Thursday November 16 2017, @09:10PM (#597900)

    Premise: The processes in place fail at their purpose (ensuring research is ethical and methodologically sound) because of institutional corruption.

    Peter Thiel's response: Burn it all down, those processes don't need to exist anyway.

    If the premise is correct, the response makes things better. But it doesn't make things right.

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    If there isn't at least one reference or primary source, it's not +1 Informative. Maybe the underused +1 Interesting?
    • (Score: 1) by khallow on Friday November 17 2017, @01:07AM

      by khallow (3766) Subscriber Badge on Friday November 17 2017, @01:07AM (#598004) Journal

      If the premise is correct, the response makes things better. But it doesn't make things right.

      It does however underline an important point. Medical research doesn't have to happen in the US. It doesn't have to honor US regulations. And it doesn't have to benefit US citizens. When you create rules that only the "ethical" have to follow and which cost many lives and generate huge costs, then you create enormous incentives for behavior that doesn't follow those rules.