[NVIC] Drug Companies Manipulate Study Data

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"Protecting the health and informed consent rights of children since 1982."

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BL Fisher Note:

    If drug companies manipulate study data on psychiatric drugs, it is a
given that they manipulate study data on vaccines created for the lucrative
child population in America. The CDC has never met a vaccine for children it
did not want to recommend for universal use in order to guarantee drug
companies a stable, assured market and big profits. The psychiatric drug
business pales in comparison with the multi-billion dollar child vaccine
business in America. Other than the FDA staff, nobody is independently
checking the integrity of vaccine safety data provided to the FDA by drug
companies when they seek licensure of a new vaccine. The public is asked to
"trust" that the drug companies are telling the truth about vaccine safety.
Sure they are.

http://www.usatoday.com/news/health/2006-05-24-drug-studies_x.htm?POE=NEWISV
A
USA Today
Posted 5/24/2006 11:37 PM ET

Psychiatric drugs fare favorably when companies pay for studies

By Marilyn Elias, USA TODAY
Drug companies fund a growing number of the studies in leading psychiatric
journals, and drugs fare much better in these company-funded studies than in
trials done independently or by competitors, researchers reported Wednesday.
About 57% of published studies were paid for by drug companies in 2002,
compared with 25% in 1992, says psychiatrist Igor Galynker of Beth Israel
Medical Center in New York City.

His team looked at clinical research in four influential journals: American
Journal of Psychiatry, Archives of General Psychiatry, Journal of Clinical
Psychiatry and Journal of Clinical Psychopharmacology.

In the report, released at the American Psychiatric Association meeting in
Toronto, reviewers did not know who paid for the studies they evaluated,
Galynker says. There were favorable outcomes for a medication in about:

. Eight out of 10 studies paid for by the company that makes the drug.

. Five out of 10 studies done with no industry support.

. Three out of 10 studies done by competitors of the firm making the drug.

The findings don't prove the companies are knowingly biasing studies, says
co-author Robert Kelly Jr., also with Beth Israel. The report didn't look at
the evidence for bias in design of the studies.

As drug companies increasingly fund research that yields favorable outcomes
for their drugs, there may be a built-in bias because journals are reluctant
to publish studies with negative or inconclusive findings, Galynker says.

In October 2004, the pharmaceutical industry set up a database to allow
publication of all studies, positive and negative, says Alan Goldhammer of
the Pharmaceutical Research and Manufacturers of America, trade group for
the drug companies. "We want to improve transparency," he says.

Because drug studies are very expensive, pharmaceutical companies fund those
most likely to have a positive outcome, Goldhammer says. The firms weed out
drugs that don't work and consult with the Food and Drug Administration to
design trials that will pass muster with the FDA. "We're constantly trying
to develop new drugs to treat mental illness," he says.

Posting a negative study on the database is voluntary. "And common sense
dictates that the worse the drug does, the less likely you are to volunteer
to beat yourself up publicly by sharing that," says Sidney Wolfe of Public
Citizen, the Washington-based consumer advocacy group.

"We're seeing a huge tilting in the education of psychiatrists toward the
industry point of view on psychiatric drugs," Wolfe says. "And that point of
view is, 'Prescribe my drug, it's better.' "

The government should be funding more of this research because public
programs, such as Medicare, pay so much for psychiatric drugs, Wolfe says.



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