FDA orders drug companies to start studying suicide risk during trials. Wha? When?
Who'da' noticed?
After decades of inattention to the possible
psychiatric side effects of experimental medicines, the U.S. Food and Drug
Administration is requiring drug makers to study closely whether patients become
suicidal during clinical
trials…
The drug industry is keenly aware of the change. For the first time, the agency is asking makers of drugs dealing with obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions to put comprehensive suicide assessments into their clinical trials…
The seeds for the new U.S. effort were planted four years ago with the discovery that antidepressants might cause some children and teenagers to become suicidal. Top agency officials at first discounted the finding but commissioned researchers to reanalyze the drugs’ clinical trials. This work led the drug agency and its experts to view the risk as real.
Suddenly, agency officials realized that multiple classes of medicines might cause dangerous psychiatric problems.
These are civil servants charged with keeping us from being killed by the latest nostrums cobbled together by the legal drug trade.
Yes, they’re not often doctors; but, wouldn’t you think something about medicine and possible side-effects might have rubbed off over time? Eh?
The drug industry is keenly aware of the change. For the first time, the agency is asking makers of drugs dealing with obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions to put comprehensive suicide assessments into their clinical trials…
The seeds for the new U.S. effort were planted four years ago with the discovery that antidepressants might cause some children and teenagers to become suicidal. Top agency officials at first discounted the finding but commissioned researchers to reanalyze the drugs’ clinical trials. This work led the drug agency and its experts to view the risk as real.
Suddenly, agency officials realized that multiple classes of medicines might cause dangerous psychiatric problems.
These are civil servants charged with keeping us from being killed by the latest nostrums cobbled together by the legal drug trade.
Yes, they’re not often doctors; but, wouldn’t you think something about medicine and possible side-effects might have rubbed off over time? Eh?
Posted: Sun - January 27, 2008 at 08:02 AM