[Mb-civic] Psychiatric Drugs' Use Drops for Children - Washington Post

[William Swiggard]

Psychiatric Drugs' Use Drops for Children
Suicide Warnings Raise Bigger Fears On Testing Process

By Shankar Vedantam
Washington Post Staff Writer
Saturday, October 8, 2005; Page A01

Warnings that drugs such as Prozac, Paxil and Effexor can increase 
suicidal behavior in some children have resulted in a nearly 20 percent 
drop in U.S. pediatric prescriptions of the widely used antidepressants 
and have triggered deep concerns about the quality of current data on 
psychiatric drugs, doctors and regulators said.

The unprecedented fall of what were once considered wonder drugs comes 
as a series of taxpayer-funded analyses have systematically undermined 
the claims of industry-funded drug trials, raising thorny questions 
about the ways in which psychiatric drugs are being tested, marketed and 
used.

No one knows the consequences of such a steep decline in children's drug 
prescriptions: Critics of the drugs say regulators ought to crack down 
further, as British health authorities did last month, but many American 
psychiatrists are worried that reduced access to medications could cause 
an increase in suicide as a result of untreated depression.

As with many disputes over these and other psychiatric drugs, opinions 
are more readily available than definitive data. The fundamental 
problem, many experts said, is that there are not enough systematic 
long-term studies about psychiatric drugs.

"The problem is we don't have enough good data," said Thomas Laughren, 
director of the division of psychiatry products at the Food and Drug 
Administration. "All of our data are focused on the short term."

As a result, he and others said, a consensus is growing that the system 
of approving psychiatric drugs based on industry-run trials that 
sometimes last just 12 weeks is not providing doctors with the 
information they need -- many physicians place patients on the drugs for 
years. Senior FDA officials say they are weighing whether companies 
should be required to conduct longer trials to reveal the true risks and 
benefits of the drugs.

Pharmaceutical makers say that profound change would increase the time 
and expense of bringing new medications to market.

http://www.washingtonpost.com/wp-dyn/content/article/2005/10/07/AR2005100701795.html?referrer=email
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