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"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?

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

takyon writes:

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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Original Submission

• Re:Wild dog in the Gorillas' nest(Score: 1) by khallow on Tuesday December 26 2017, @04:06PM

  by khallow (3766) on Tuesday December 26 2017, @04:06PM (#614330) Journal

  Isn't that what patents and copyrights are for?

  In part, but security through obscurity doesn't have to be perfect in order to work.

  and your would-be competitor better be operating solely in third world countries if they hope to continue.

  Plenty of them already do.

  If you do it all in secret, you can still get ripped off, and while it's a bit harder to do in the end you have no public evidence and can't do a damn thing about it.

  They won't be able to do a damn thing [raps.org] about it in most cases anyway.

  Despite some recent revisions, the USTR [US Trade Representative] says that industry “generally reports only partial progress as a result of the change, and that continued unjustified denials of patent applications and invalidations of existing patents create great uncertainty and potentially undermine incentives to innovate."
  
  In addition, undisclosed trial data used to obtain marketing approvals in China is also drawing the ire of the USTR.
  
  The US also continues to express concerns about the extent to which China provides "effective protection against unfair commercial use of, as well as unauthorized disclosure of, and reliance on, undisclosed test or other data generated to obtain marketing approval for pharmaceutical products,” the report says.
  
  And although China has committed to the practice of not allowing subsequent applicants to rely on undisclosed test or other data submitted in support of an application for marketing approval of new pharmaceutical products for a period of at least six years from the date of marketing approval in China, “there are reports that generic manufacturers have, in fact, been granted marketing approvals by the China Food and Drug Administration (CFDA) prior to the expiration of this period, and in some cases, even before the originator’s product has been approved.”

  So notice that there are already vigorous generic producers competing in US markets and often producing generic versions of medications before the US creator can legally enter a market. That won't get better, if the creator of a medication has to telegraph their discovery years before they can get approval in any market.

  Parent