USA Today - Adult anti-psychotics can worsen troubles (for children)

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Adult anti-psychotics can worsen troubles

Updated 5/2/2006

Salcido for USA TODAY

http://tinyurl.com/hcqtm

[excerpt]

There has been little carefully controlled, long-term research on

children taking most psychiatric drugs, including the atypical anti-

psychotics. The FDA is trying to get more pediatric research on the

atypicals, says Laughren, the agency's director of the

psychiatry products division.

The FDA has asked five pharmaceutical companies that make the drugs

to test them in children with schizophrenia and bipolar disorder, the

uses they're approved for in adults. Under law, they can get a six-

month extension on their patents for doing these studies.

Also, the drug companies are doing their own pediatric studies on

children with disorders as diverse as ADHD, autism, conduct disorder

and Tourette's syndrome.

Janssen LP has applied to the FDA for approval to use its atypical

anti-psychotic, Risperdal, in the treatment of symptoms of autism,

says Ramy Mahmoud, vice president of medical affairs for Janssen.

The National Institute of Mental Health also is conducting pediatric

studies, but the research is primarily funded and supervised by

pharmaceutical companies.

Even if the companies win approval, it won't guarantee safety or

effectiveness of the drugs in children, says Graham of the FDA

Office of Drug Safety, who emphasizes he doesn't speak for the

agency. " You basically know the drug isn't cyanide. You don't know

much else, " says Graham, who was the whistle-blower in the 2004 Vioxx

heart disease scandal. Industry-funded trials are four to five times

more likely than independent studies to show effectiveness for a

drug, he says.

According to a research review published in February, 90% of drug-

company-funded studies come up with findings that support the

company's drug.

In head-to-head research testing more than one atypical anti-

psychotic drug, the outcomes are contradictory, coming down on the

side of whichever company is paying for the research. (The research

included studies of Risperdal, Zyprexa, Clozaril and Geodon, but none

on Seroquel or Abilify.)

" It appears that whichever company sponsors the trial produces the

better anti-psychotic drug, " writes lead author Stephan Heres of the

Technical University of Munich in the American Journal of Psychiatry.

And the short-term, smaller studies required of companies rarely

detect any but the most glaring problems, Graham says.

" The American public is operating under the illusion that a drug is

safe just because it's approved by the FDA, " says Lieberman,

chairman of psychiatry at the Columbia College of Physicians and

Surgeons in New York. Studies lasting a few weeks to a few months,

with a couple of thousand patients total, won't reveal all that's

wrong with a drug, he says.

Laughren agrees that " it's very difficult to answer every question

we'd like to answer with these studies, because obviously they're not

huge. Sometimes bad things that happen are going to be discovered

only when a drug is used more widely. "

He says he, too, shares concern about the anti-psychotics prescribed

for children without proof of safety or effectiveness. Much more

pediatric information on the atypicals will be available within five

years, he says.