http://www.alternet.org/story/77800/
Posted on February 28, 2008
Are Antidepressants Faith-Based Treatment?
By Bruce E. Levine, AlterNet
<snip>
On Jan. 17, 2008, the New England Journal of Medicine analyzed both
published and unpublished antidepressant studies registered with the
FDA between 1987-2004. Examining 12 antidepressants, Dr. Erick H.
Turner, a former FDA medical reviewer, and his research team included
data gained via the Freedom of Information Act.
Dr. Turner discovered that most studies with negative results were
never published in journals, and so doctors had no way of knowing how
poorly antidepressants have actually fared. While 94 percent of
antidepressant studies published in journals show antidepressants to be
more effective than placebos, only 51 percent of all registered studies
were determined by the FDA to show antidepressants superior to
placebos.
Why are most negative results not published in journals? Drug studies
are routinely funded by the drug's manufacturer, which has no interest
in the publication of negative results. Also, medical journals are
increasingly dependent on advertising revenue from drug companies,
which results in a disincentive to publish negative results.
Antidepressant advocates point out that when comparing all research
subjects, antidepressants retain an advantage -- albeit a modest one --
over placebos. However, that belief is based on studies funded by drug
companies, utilizing research designs biased in favor of
antidepressants.
One such research-design bias is the use of depression measurements
that weigh heavily depression symptoms most likely to improve with
antidepressants (such as sleep problems and agitation), and weigh less
heavily depression symptoms not as likely to improve with
antidepressants (such as suicidal thoughts and joylessness).
Why does the FDA allow measurement bias and other dice loading that
favors antidepressants? Marcia Angell, former editor in chief of the
New England Journal of Medicine, concludes that the FDA has been
compromised by drug companies. Dr. Angell reports that, for example, in
the majority of FDA drug-approval advisory meetings through 2000, half
or more of the FDA advisers had conflicts of interest -- financial
relationships with drug companies.
A critical scientific standard in drug studies is the double-blind
control (neither subject nor experimenter knows who is getting the drug
and who is getting the placebo), but drug-company antidepressant
studies use blinds that can be peeked through. How? Inactive placebos
such as sugar pills, which don't create side effects, are used, and so
subjects can more easily guess if they are getting the actual drug. In
order to make it more difficult to penetrate the blind, an active
placebo, which creates side effects, should be used. In 2000, a
Psychiatric Times article concluded: "In fact, when antidepressants are
compared with active placebos, there appear to be no differences in
clinical effectiveness."
In addition to biased depression measurements and an absence of a true
double blind control, the FDA also accepts antidepressant research in
which subjects who respond favorably to placebos are weeded out from
final trials.
Thus, it is especially embarrassing for antidepressant manufacturers
that despite research-design biases in favor of antidepressants, these
drugs achieve superiority to placebos in only 51 percent of the
studies.
In a widely covered announcement in March 2006, NIMH reported that 50
percent of depressed people experience remission of symptoms in a
two-step treatment study (which ultimately would include four steps)
called Sequential Treatment Alternatives to Relieve Depression
(STAR*D). Unannounced by NIMH and STAR*D researchers -- who had
financial relationships with antidepressant manufacturers -- was that
for each of these antidepressant treatment steps, remission rates were
lower than or equal to the customary placebo performance in other
antidepressant studies (there was no placebo control in this $35
million U.S. taxpayer-funded STAR*D study).
Moreover, NIMH and STAR*D researchers neglected to mention that in the
same time it took to complete steps one and two of STAR*D (slightly
over six months), previous research shows that depressed people
receiving no treatment at all have a spontaneous remission rate of 50
percent -- this identical to STAR*D results over that same time span.
Worse yet, by the time all four STAR*D's treatment steps had been
completed, relapse rates were so high that the November 2006 American
Journal of Psychiatry calculated the actual cumulative remission rate
to be, at best, 43 percent.
The most benign thing that one can say about drug companies' efforts in
creating faith in antidepressants is that faith is a significant reason
these antidepressants are effective at all. In 2004, the Journal of
Clinical Psychiatry reported that among those depressed patients
expecting an experimental antidepressant to be "very effective," 90
percent had a positive response (not necessarily remission); while
among those expecting the medication to be "somewhat effective," only
33 percent had a positive response. Depressed people with "no faith" in
antidepressants were not included in this study, but such nonbelievers
rarely tell me about having a positive response with antidepressants.
As one might expect, drug companies do nothing to ensure that depressed
people who have little or no faith in antidepressants are
proportionately included in studies.
<snip>
Bruce E. Levine, Ph.D., is a clinical psychologist and author of
Surviving America's Depression Epidemic: How to Find Morale, Energy,
and Community in a World Gone Crazy (Chelsea Green, 2007).
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Full at: http://www.alternet.org/story/77800/