10 Years of Missing Data for Clinical Trials

Clinical trial sponsors must publish 10 years of missing data, judge rulesBy Lev Facher – Feb 2020

This shows how bad of a problem we have with scientific research, now that it’s been used and manipulated by financial interests. If a study can’t find the results the “payor” wants to “prove”, it simply disappears like it never happened.

For years, government research agencies have misinterpreted a law that requires them to collect and post clinical trial data, a federal judge ruled this week, leaving behind a 10-year gap in data that now must be made publicly available.

The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs — meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data. 

Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data.

“This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” said Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic

The plaintiffs in the lawsuit are Peter Lurie, formerly an associate FDA commissioner who worked on transparency issues, and Charles Seife, a New York University journalism professor who has written for Science and other outlets.

A STAT investigation in 2015 revealed widespread inconsistencies in how top research universities report clinical trial data. The NIH said then that the 2017 regulations, which had not been published at the time, would give it “a firmer basis for taking enforcement actions” against institutions that fail to report.

Subsequent reporting in Science magazine has revealed that despite the transparency requirements, FDA has never imposed a fine on a clinical trial’s sponsor, and the National Institutes of Health has never publicly named or withheld grant funding.

To me, it looks like financial interests now control most of healthcare, even the research, and that our health is only of concern in how it impacts their bottom line.

The same figureheads (C-suite corporate officers) cycle through powerful positions at giant global pharmaceutical companies or medical device companies and powerful positions in the regulatory agencies that are supposed to control them.

While working at public agencies they learn about the regulatory side, which then gives them the perfect “work experience” to help a private corporation navigate around the rules.

How can we expect them to look out for our health when there’s so much money at stake for them? And, apparently, with no punishment for breaking the rules, which the same corporate figureheads make when they’re running regulatory agencies.

While some clinical trial sponsors that did not post data between 2007 and 2017 are now officially out of compliance with the federal regulation, it’s unclear how quickly they’ll be required to post their results —and what the consequences might be if they don’t.

A spokeswoman for the Department of Health and Human Services said the agency was “evaluating the Court’s decision with the Department of Justice to determine our next steps.” A spokeswoman for the Food and Drug Administration declined to comment.

Author: Lev Facher, Washington Correspondent
Lev Facher covers the politics of health and life sciences.
lev.facher@statnews.co, @levfacher

3 thoughts on “10 Years of Missing Data for Clinical Trials

  1. canarensis

    A serious head-clutcher here. The word “farce” keeps bouncing around my skull…everything having to do with medical care, research, policies, enforcement, etc etc.

    Good one on Lev.

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      Politicians and law enforcement now decide our medical treatment more than medical professionals. All rules are bent toward profits, and profit reigns supreme.

      Liked by 1 person

      Reply

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