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FDA stinks at policing conflicts

Just when you thought nobody could be worse than the National Institutes of Health at managing financial conflicts of interest among trial investigators... The Inspector General of the Department of Health and Human Services released a linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf today that indicates a pretty severe lack of oversight over at the Food and Drug Administration. The report found that only one percent of the almost 27,000 clinical investigators contracted by

By | January 12, 2009

Just when you thought nobody could be worse than the National Institutes of Health at managing financial conflicts of interest among trial investigators... The Inspector General of the Department of Health and Human Services released a linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf today that indicates a pretty severe lack of oversight over at the Food and Drug Administration. The report found that only one percent of the almost 27,000 clinical investigators contracted by the agency in 2007 disclosed a financial interest. In 42% of clinical trials, the FDA never even received the financial disclosure forms from participating investigators that the agency mandates. The FDA not only failed to address these shortcomings, in 20% of the trials where investigators did report a financial conflict, the FDA took no action. In 31% of trials where researchers did submit financial conflict documentation, FDA reviewers didn't even indicate that they read the forms. If this isn't enough to make you smack your forehead and send your morning coffee spraying from one nostril, the FDA also apparently told the inspector general that it wasn't that interested in requiring drug makers to collect and report accurate financial disclosure information from investigators prior to the commencement of clinical trials. "FDA asserted that this additional effort would not be worthwhile because financial interests are only one form of potential bias," the report reads. All of this doesn't appear to be bothering potential clinical trial participants searching to wring a buck out of our foundering economy, though. The __Boston Globe__ linkurl:reported;http://www.boston.com/news/world/europe/articles/2009/01/05/paid_studies_draw_more_interest_in_sour_economy/?page=1 last week that the number of Americans seeking to become paid clinical trial subjects has skyrocketed since the economy went south.
**__Related stories:__***linkurl:Should conflicts mean no NIH grant?;http://www.the-scientist.com/blog/display/55058/
[29th September 2008]*linkurl:Report faults NIH on conflicts;http://www.the-scientist.com/blog/display/54183/
[18th January 2008]*linkurl:CSPI: FDA can manage conflicts better;http://www.the-scientist.com/blog/display/53953/
[3rd December 2007]
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Comments

Avatar of: Ellen Hunt

Ellen Hunt

Posts: 199

January 12, 2009

I am absolutely an advocate for transparency and proper policing. I am quite aware that conflict of interest has invaded biosciences like a cancer going metastatic. \n\nHowever, FDA is quite correct that financial interest is only one form of bias. I don't think that the kind of financial interest that is tracked is anywhere near the top priority that should concern us. \n\nWhat should concern us is scientific falsehood. Scientific falsehood by omission and commission is driven by need for grants primarily, and grant need is driven by need to advance and publish. Publications saying "the right thing" are driven by the need to get grants. That's the feedback loop that is driving the cancer in our midst. \n\nIf we crack that nut, then the business interests will take care of themselves, because academia will provide the function, much as the press (4th estate) does. \n\nGeorge Soros had a very cogent observation about such matters. He said that "Real freedom requires viable choices." Most people (the center of the bell curve) become criminal when they feel they have no other choice, or when their choices are extremely narrow and there is no oversight, so they don't expect to be caught or if caught to be punished. \n\nThe major problem in science today is in the foundations, where scientists feel that they have no viable choices. They see one person doing something unethical and succeeding because of it, and so they do it too. \n\nI think the way to address this is NOT with more reporting of business interests, NOT with more ticking off boxes. The way to address this is to establish a separate agency run by DOJ that investigates and rules on ALL academic misconduct at universities. Bluntly, we at universities are not policing ourselves, and so we are educating students into a culture of acceptance of fraud and chicanery. Academia is no better at policing itself than Wall Street. \n\nDoing this will be the equivalent of going after the squeegee-men in New York City. Zero tolerance for low level chicanery will get rid of most of the major stuff, and it will change our culture to empower voices that don't speak up now. This morass of low level fudging, hedging and retaliatory action is like a neighborhood with broken windows, graffiti and trash in the streets. Clean that up, and most everything else will go away.

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