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posted by martyb on Sunday December 24 2017, @07:02PM   Printer-friendly
from the thiel-touch dept.

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


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  • (Score: 4, Insightful) by frojack on Sunday December 24 2017, @09:17PM

    by frojack (1554) on Sunday December 24 2017, @09:17PM (#613942) Journal

    Its called regulatory capture [wikipedia.org] and its caused not only by corporate over-reach but also by common citizens demanding government "get out of the way" [reason.com].

    In fact, I suspect public demand has a lot more influence on this sort of thing than "free market capitalism". The capitalists can't simply point to an FDA approval to absolve them of all liability. They still have to face huge law suits. [governing.com]

    People tend to forget that one hard nosed lady at the FDA prevented the Thalidomide tragedy [toxipedia.org] from affecting the US. But then she didn't have to face a large body of citizens clamoring for the FDA and the DEA to remove prescription restrictions on their recreational drugs of choice.

    Every demand to legalize all drugs or voodoo cancer treatments just begs for more of this to occur in the future.

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