The U.S. FDA has been all over the news in the past year and none of it has been good news for us. Recalls of tainted peanut butter, baby beds and swings, weight loss drugs, tainted pet food and toys with lead paint have all been lead stories for the nightly news. Each and every one of those products were approved for use or consumption by the FDA until very bad things began to surface resulting in the recalls.
Is it any wonder that government investigators have found that the FDA does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in real life people? In 42% of those clinical trials the conducting doctors had previously received money from the sponsoring company according to the inspector general of the Department of Health and Human Services (DHHS). Here is the report.
Those financial conflicts were ignored and the FDA did nothing about the problem. Perhaps more ominously, in 31% of the trials in which the required forms were submitted, the FDA reviewers did not document that they even looked at the information. The New York Times quoted FDA spokeswoman Karen Riley as actually saying the agency opposed reviewing doctors’ financial conflicts before clinical trials. Unbelievable!
The Inspector General recommended the FDA do a better job of making sure the companies follow the rules to insure patients are protected. I wholeheartedly agree and urge everyone concerned to contact your legislators to push for an overhaul of the FDA. Then we can have some confidence in the very agency set up to protect us before these products hit our store aisles.
Richard J. Arsenault, 2011
