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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, @06:24PM (2 children)
Note all you like, it's just semantics, and you are indeed in the majority of the population with equating FDA permission to market as "FDA approval."
What I am telling you is that for the last 25+ years, in face-to-face meetings with FDA officials in Rockville, Maryland, face to face with FDA field agents on inspections, and countless ex-FDA employees turned consultant, they all explicitly state "the FDA does not approve anything, the agency is adamant about that point."
If you want to go on equating "permission to market is just the same as approval" then, you're one of the millions that the FDA has been trying, ineffectively, for decades to reframe their semantics. I work in a larger medical device company today, and the majority of employees in R&D still believe "FDA approval" is a thing, it's only the ones who deal directly with FDA who have gotten the message.
FDA is _almost_ as good at getting this message out as they are enforcing the spirit of the regulations they are charged with. Which is a large part of my basis for believing that FDA regulation of the drug industry is, in its current manifestation, insufficient and dangerous to the general population. Not calling the industry as a whole detrimental, but operating with a level of risk of death and injury that is too high for the benefits they proffer. Too willing to take those risks in the pursuit of monetary profits, because monetary profits are the driver - benefits to society are incidental.
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(Score: 1) by khallow on Thursday December 28 2017, @06:46PM (1 child)
You should be as well.
Words have meaning. I get the game that is being played here. No doubt there is some conflicting rules where the FDA are supposed to approve, but not approve stuff at the same time. This is their legal out whereby approval goes by another name. It is nothing more. Social Security does the same legal fig leaf with its pay-as-you-go system which is supposed to have a treasury bond fund backing its payments, but it doesn't. That doesn't stop them from yacking about the fund as if it were a real thing. So does US intelligence which isn't supposed to spy on residents of the US.
The FDA can "reframe" all they want. Meaning doesn't change.
I get you have a problem with this, but so what? There has to be a large monetary benefit to the medical industry in order for it to do its job at this scale. They can't run off of good feelings.
(Score: 2) by JoeMerchant on Thursday December 28 2017, @08:02PM
What I also hope you get is that I don't mind them making large profits, but I want those profits to derive from truth, transparent actions, and tangible benefits to society - not fast and loose "science" with a fig leaf of regulatory permission to market.
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