Tuesday, May 26, 2015

"It will sicken you"

Have a look at this comment posted on my editorial about psychiatric research scandals in today's :
New York Times

I monitor clinical trials for a living, I can tell you that none of the suggestions here will work unless there are additional changes. These changes need to be 1) fully fund the FDA, including inspections with the power to immediately halt research at sites AND impose criminal sanctions. 2) tie the validity of the medical license of the physician to their behavior as a PI or Co-PI on a clinical trial. If they are debarred by the FDA, they should lose their medical license.

When physicians sign the FDA Form 1572, that is a contract with the federal government to run the trial on an ethical basis. When they fail to do that, time after time, nothing happens except "retraining". Guess what counts as "retraining"? Reminding them not to do it again. What is repulsive and shameful to me, is to take a name from the FDA's list of debarred investigators and then do a Google search on them. Without fail, they are still practicing medicine even if they were debarred for placing experimental devices into patients without their consent. The debarment often has no effect on whether or not they can continue to practice medicine, and often the public knows nothing about this. And these practitioners are making tons of money. 

Here is the FDA Debarment List:

http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm2005408.htm

Read through some of the Debarment letters describing the findings by the FDA. It will sicken you. Then tell me if we give a damn about ethics in this country.

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