The US Food and Drug Administration is taking a kicking this week after a report found its oversight of potential conflicts of interest for clinical trial researchers was really not up to scratch.
An assessment of the financial interests of researchers disclosed as part of 118 drug marketing applications approved in 2007 certainly does not reflect well on the FDA (report pdf).
The Office of Inspector General of the Department of Health and Human Services, which undertook the assessment, found that the FDA could not even determine whether clinical trial sponsors had submitted financial information for all clinical investigators. Some 42% of approved marketing applications were missing information.
In 31% of applications the FDA did not even record having done a review of financial information supplied by drug companies.
Even before this report there were claims that president-elect Barack Obama needed to seriously overhaul the FDA, so perhaps unsurprisingly, another savaging is going on in its wake.
“The Food and Drug Administration has done virtually nothing to monitor the conflicts of interests of doctors who do clinical trials of drugs and medical devices used on human subjects,” says Gabe Pressman of NBC New York. “This is disgraceful.”
The New York Times makes the point that it seems bizarre that only 1% of researchers reported any conflicts of interest: “That number seems unbelievably low given credible estimates that one-fifth to one-third of all doctors have such conflicts.”