FDA Admits Failure to Protect Public
A government watchdog has confirmed what some of us have suspected for some time
By GABE PRESSMAN
Updated 3:35 PM EST, Mon, Jan 12, 2009
A government watchdog has confirmed what some of us have suspected for some time.
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. This is disgraceful.
The physicians who conduct these trials are supposed to help decide whether or not a drug is effective in treating people. And now the inspector general of the Health and Human Services Department has concluded the FDA is falling down on the job. Indeed, the Times reports, FDA officials have told investigators that monitoring such conflicts of interest is not worth the trouble.
Dr. Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine, deplores the FDA's failure.
“Doctors who have close financial ties to the pharmaceutical industry should not be conducting clinical trials of these drugs,” Dr. Kassirer told me. “And, if you look at the committees responsible for approving drugs, you'll find that many have such ties.”
Clearly, for doctors to have a financial interest in the very companies that manufacture the drugs they're testing violates any standard of fairness or objectivity. Recently, there have been revelations of such conflicts of interest -- some involving professors at major universities. Such relationships can hardly inspire public confidence in medicine.
Kassirer said many doctors have high moral standards and it is certainly possible to assemble an impartial jury of physicians for any drug test. So why, so often, do physicians with built in conflicts get selected to conduct such trials?
A spokeswoman for the FDA said that agency opposed scrutinizing doctors' financial conflicts before trials because they represented just one possible source of bias. Does that mean there have to be at least two sources of bias before the government decides to protect us? On the face of it, that seems ridiculous.
The Obama administration should take a hard look at the ethics of the government agencies and doctors who test drugs for us.
First Published: Jan 12, 2009 1:56 PM EST
You Might Like
You have 2000 characters left
