FDA Laxity in Clinical Trial Oversight

Nancy Muller Health Pro
  • The Food and Drug Administration (FDA) does virtually nothing to police the financial conflicts of doctors conducting trials involving new drugs and medical devices, an investigation conducted by the inspector general of the Department of Health and Human Services (DHHS) concluded in a report made public in January.


    The New York Times (January 12, 2009) reported that in 42% of the clinical trials reviewed by DHHS, the agency did not even receive standard forms disclosing financial interests of the doctors and did nothing to pursue obtaining them. And even in a third of the trials for which there were such forms provided, agency reviewers admitted that they had not looked at the information. In 20% of the cases in which doctors revealed what was considered significant financial conflicts, neither the FDA nor the sponsoring companies took action to address the conflicts, much less replace the doctors as investigators.

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    On the heels of a literal meltdown of Wall Street and the global financial community largely for lack of transparency and inadequate surveillance and regulation, this "look the other way" attitude by authorities in the healthcare sector does nothing to protect the public from a potential source of bias in recruiting and screening patients and reporting and interpreting research results. In fact, fewer than one percent of the doctors who helped oversee clinical trials actually registered with the agency and filed the required financial disclosure forms reported they had a significant conflict of interest, when studies find that at least one-fifth of all doctors have such conflicts. The current rules of the FDA allow drug and device manufacturers to avoid reporting such conflicts if they certify that they tried to get the information and could not. Should there not be some teeth in what a clinical investigator has to provide in order to get paid by the company for his research data?


    The New York Times reported that a similar investigation last year found a parallel set of circumstances between the huge, federal grant-giving machine in healthcare, namely the National Institutes of Health (NIH), and university professors receiving federal money. The NIH refrained from wanting to collect such information, much less look at it. While university professors may be less likely to fall in the same wealth bracket, on average, as clinical specialists - who are usually in an academic institution as well - the same requirements for disclosure should apply.


    Don't misunderstand me. I've grateful for the private sector's role in research. If it weren't for private sector investment, there would be precious little applications research bringing much needed innovation to improve our everyday lives. The point is we deserve for financial relationships to be disclosed so that an appropriate judgment can be made on the weight it may carry in potentially contaminating data and conclusions generated by clinical investigators. The answer is transparency, and we need a heavier dose of it for our wellness and our future health.


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    At the National Association For Continence (NAFC), we are also eager for consumers to participate in clinical trials. Greater participation speeds the time and investment it takes to bring a new drug or device to market. But we want people to be informed about the process, assured the process has integrity, and be mindful of the risks of participation. To gain a better insight, go to http://www.nafc.org/bladder-bowel-health/finding-help/the-clinical-trial-process/

Published On: January 21, 2009