SoylentNews is people
SoylentNews
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: 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.