Financial Conflicts Largely Ignored By FDA Report Finds

Conflicting interests between drug companies and researchers conducting clinical drug/device trials is a story that makes the headlines almost weekly, especially since the research generated often dictates the prescriptions doctors write nationwide.  

Now a federal inquiry into the practice sheds some light on the appalling lack of oversight that may be allowing that to happen.

A Department of Health and Human Services (HHS) inspector general report issued Monday reviewed 118 clinical trials marketing applications approved by the FDA in 2007.

The Food and Drug Administration (FDA) has a hands-off policy over conflicts admitting that the efforts to try and protect patients from such conflicts is, “not worth the effort” reports the New York Times.

Here are some of the findings:

• Only one percent of clinical investigators disclose a financial interest.
  
• 42 percent of FDA-approved marketing applications were missing financial disclosures. Companies are required to disclose any financial interests with the companies they are conducting trials for, but the HHS report found that in 42 percent of the trials, the FDA did not receive the required forms.
  
• In 31 percent of marketing application, the FDA did not document reviewing financial disclosures.
  
• When there were financial conflicts, in 20 percent of applications, the FDA reviewers did not take action
  

In 1999, the FDA required drug and device makers to divulge any conflicting interests with doctors who oversee patients involved in clinical trials. The companies are supposed to disclose that information to the FDA, but the inspector general found there was almost no enforcement of those rules.

Part of the problem is that the FDA does not have a complete list of all clinical investigators, therefore cannot check whether every doctor is complying with the rules. The agency reported that collecting and checking that information, though required, was not worth the effort for either the companies or the FDA.

Karen Riley, a spokeswoman for the FDA told the Times that the agency “opposed reviewing doctors’ financial conflicts before trials because they represented just one possible source of bias.”

The Office of Inspector General’s mission is to protect the integrity of the Department of Health and Human Services programs and the people they serve.  The office is calling for consistency in both disclosure and in FDA follow-up. #