Psychiatric News August 6, 2004
Volume 39 Number 15
© 2004 American Psychiatric Association
p. 35
Putting Clinical Trial Results in Perspective
With the ongoing controversy surrounding objective reporting of all
clinical trial results— both negative and positive—study results
should be viewed in context.
Many questions have been raised over potential bias based on a study's
source of funding.
The research reported here, comparing the Texas Medication Algorithm
Project (TMAP) guideline for the treatment of depression with a
"treatment as usual" approach, may be skeptically received in
light of allegations earlier this year regarding significant funding from
multiple pharmaceutical companies to the TMAP consortium of investigators.
In February it was reported, first in the New York Times, that
"10 drug companies chipped in to help underwrite the initial effort by
Texas state officials to develop the [TMAP] guidelines." The report also
noted that "other companies paid for meetings around the country at
which officials from various states were urged to follow the lead of
Texas." Indeed, these allegations are the root of a
"whistleblower" lawsuit in Pennsylvania regarding drug company
payments to state officials, allegedly aimed at getting the state to adopt the
guidelines, which the suit alleges promote the use of newer, more-expensive,
medications over older, less-expensive generics.
According to numerous reports, TMAP received a total of $285,000 from 11
pharmaceutical companies for start-up of the project. In the development of
the guidelines for depression, schizophrenia, bipolar disorder, ADHD, and
pediatric depression, TMAP to date has spent more than $6 million. The list of
funding sources is long, but is included in its entirety in the TMAP
depression study reported here.
The current study was funded by the National Institute of Mental Health,
along with numerous foundations (including the Robert Wood Johnson
Foundation—separate from Johnson & Johnson, but founded by the
estate of the long-time CEO), the Texas Department of Mental Health and Mental
Retardation, the federal Center for Mental Health Services, and the Department
of Veterans Affairs, as well as many others. Numerous pharmaceutical companies
contributed unrestricted educational grants to the TMAP depression study.
As psychiatrists and mental health professionals review the TMAP depression
algorithm report and attempt to put the results in context, they will likely
be reminded of the complexity of conducting a large, multicenter clinical
trial in today's research environment.
Related Article:
-
TMAP Shows Promise In Depression Treatment
- Jim Rosack
Psychiatr News 2004 39: 35.
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