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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: 4, Interesting) by BsAtHome on Sunday December 24 2017, @07:30PM (9 children)
Once you establish a no-consequence environment, it will just get worse. If someone can get away with something, then there will be someone who will try that, no matter how wrong (and I am not talking about lack of punishment). In the end, you make something despicable today into something accepted tomorrow.
The Big question is why we are so complacent about this. This is a question I am pondering for some time now. Why are we not more proactive (and reactive) to prevent obvious wrongs from becoming the new norm? This happens not only in medicine, but there are numerous areas in society where we too can observe the same attitude.
(Score: 3, Insightful) by MostCynical on Sunday December 24 2017, @07:40PM (1 child)
Where "free market capitalism" meets "anarchic free-for-all"
"I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
(Score: 4, Insightful) by frojack on Sunday December 24 2017, @09:17PM
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.
No, you are mistaken. I've always had this sig.
(Score: 3, Funny) by JoeMerchant on Sunday December 24 2017, @10:32PM
When I was considering moving to Hilo, some of what I read about Hawaiian politics might explain: "Yes, it's wrong, it's totally unfair, bad people are getting away with things and good people are suffering as a consequence..." and it's still a paradise on earth even with all that going on, so why get all worked up about making things right, when things are still pretty good anyway?
Modern life is pretty damn easy, people have enough to eat, they can mostly avoid wars, and there's lots of new shiny to put in your shed... is it really worth diminishing your personal quality of life to start some crusade for justice?
🌻🌻🌻 [google.com]
(Score: 0) by Anonymous Coward on Monday December 25 2017, @05:50AM (2 children)
How do you expect this to stop? Should it even stop?
A drug company creates a shell company for a new drug, limiting liability. That drug-specific company seeks a separate company to do the testing. One is created, owned by a testing company. That new company then contracts out... and before long it is 8 step removed. Some company located in the Cayman Islands is doing drug tests in Eritrea or Djibouti, where life is cheap and the alternative to being tested on is to go fight for a warlord or go be a sex slave. It's the kind of place where kids fight over a maggot-infested hide because they are hungry, and their mom tries to ration it. Given the alternatives in a place like that, drug testing is a pretty sweet job.
(Score: 3, Insightful) by sjames on Monday December 25 2017, @06:55AM (1 child)
Until a test leaves you with a permanent disability and the company throws you to the wolves without even a fighting chance. And keep in mind, they will make sure their offer is only SLIGHTLY better than the other terrible offers even though for the cost of a single executive luncheon, they could set up the trial participants for life. Disclosing the actual risks and then paying enough to make it worthwhile is the LAST thing they'll do.
Not so good for the eventual market either when the testing company sweeps the occasional devastating permanent side effects under the rug.
(Score: 0) by Anonymous Coward on Monday December 25 2017, @11:57AM
Sounds a lot like the ratings agencies which needed to keep giving out A+++ ratings otherwise the banks would go somewhere that would.
(Score: 1) by khallow on Monday December 25 2017, @06:23AM (2 children)
The ugly part is that testing a new treatment in a low regulation part of the developing world is a lot cheaper than doing it in the US. For example, a pharm company could secretly test a group of new drugs in the developing world and then once they have a good idea what works, use parallel construction to test only the drugs that show strong positive results officially. That alone would greatly reduce R&D costs even when the latter research continues to be done in the developed world.
Currently, whoever doesn't fully play by the rules has a significant advantage over those who do. While some of that may be unavoidable, we can veer away from regulations that make that worse.
(Score: 0) by Anonymous Coward on Monday December 25 2017, @12:01PM (1 child)
I see, so the solution is to remove regulations in order to... what now?
(Score: 1) by khallow on Monday December 25 2017, @12:40PM
Cheaper, faster, and better medical advances in our lifetimes and those of our descendants. The opportunity cost of making every medical advance subject to a lot of costly regulation is that billions of people will die prematurely. It also protects high value cartels via the creation of considerable barriers to entry.
It also encourages widespread disregard for law (via the advantages from breaking rules rather than obeying them). In this story, a dying researcher took big short cuts because there was otherwise a good chance that the research would never happen. He won't pay for the consequences of his actions because he is already dead. Other ways will be figured out.