[NVIC] Drug Companies Manipulate Study Data

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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 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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