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Unregulated herpes experiments expose 'black hole' of accountability
Recent revelations that a U.S. researcher injected Americans with his experimental herpes vaccine without routine safety oversight raised an uproar among scientists and ethicists. Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.
But don't expect the disclosures after Halford's death in June to trigger significant institutional changes or government response, research experts say. "A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they're hurt in the trial," said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. "These types of cases are really a black hole in terms of accountability." The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.
Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford's. He recruited subjects through Facebook and in some cases didn't require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford's offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.
Previously: Hopes of Extended Lifespans Using Transfusions of Young People's Blood
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
(Score: 2) by JoeMerchant on Thursday December 28 2017, @06:13PM (2 children)
And, trusting the profit makers to execute the development process "in the dark..." I don't like those odds.
Also, what lots of people are willing to pay high prices for, and what is long-term valuable to society are not usually the same things - drug makers are targeting the former, while wearing the mantle of the latter.
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(Score: 1) by khallow on Thursday December 28 2017, @06:28PM (1 child)
As I noted earlier, you could have nipped this whole thing in the bud by advocating for revealing all such research data after approval or final rejection (sigh, "permission to market") by the FDA and related regulators. It's still quite timely for the public and any lawsuits to come from bad faith medical research (which already can access such data via the discovery phase of a lawsuit). Meanwhile I don't see the reason you should be informed prior to that point. The unintended consequences of such a regulation (such as most medical development moving to countries without such regulations, leaving the US years behind in medical research) certainly aren't worth any slight knowledge you might gain by this.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @07:58PM
for what it's worth, that one is called "denial," with the implication that the denied party is (usually) free to apply again once having addressed the listed reasons for denial of application.
As for "revealing all such research data after" - that's the enforcement paradox: beyond the veil of secrecy, one can never know how much data was collected, how many trials were terminated in the dark. Discovery won't happen when the lawyers have no knowledge of the other (drug) trials. In a perfect world where everybody does what they are supposed to, sure, this could work. In a world of secrets and liars? Not as well.
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