F.D.A. Requiring Suicide Studies in Drug Trials

By GARDINER HARRIS
Published: January 24, 2008

Source: The New York Times

After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.

The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.

The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.

In recent months, the agency has sent letters — it would not say how many — to drug makers requiring that they use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clinical trials being conducted now.

A MUST READ STORY - HERE

Too little too late if you ask me.

- For years there have been denials from both the medicines regulator and Pharma.
- More and more deaths (suicides) have occurred
- Public outcry
- Pharma suppressing data
- Regulators not asking for raw data

..and now, some 15 or so years after the launch of Seroxat in the UK, patients are having to go to trial to get some form of justice. See here, here, here, here, here and here.

The FDA's equivalent in the UK are called the MHRA or The Medicines and Healthcare products Regulatory Agency. Despite emails and yellow card reports sent to them from worried patients, they have failed to act, failed to protect, failed in every department. To employ former members of GlaxoSmithKline and to use these two members as spokespersons to defend Seroxat is like sticking two fingers up to the British public. WE ARE THE MHRA AND WE CAN DO AS WE PLEASE.

Your time is running out Prof. Woods (MHRA CEO) - No closing down of small Internet Viagra sites is going to save you.

Collectively you are all an utter disgrace.

Fid