| Topic: |
Sociology > Depression |
| User: |
"Pharma Nation" |
| Date: |
21 Oct 2004 10:23:05 AM |
| Object: |
Depression: Prozac, therapy or both? |
Decoding Psychiatric Propaganda
http://groups.msn.com/psychbusters
--
Prozac, therapy or both?
Fred Gardner
Counterpunch
Just about every newspaper and TV station in America reported August
18 2004 that a study in the Journal of the American Medical
Association showed Prozac and cognitive behavior therapy, in
combination, to be the most effective treatment of depression in
adolescents. Here are some of the headlines with which we were
bombarded: "Drugs and therapy aid depressed kids, study says." "Drug +
Therapy Combo Best for Teen Depression." "Combined Approach Better
Than Drugs or Therapy Alone." "Depressed Teens Need Drug + Therapy."
Etc., Etc.
The research, conducted over three years at 12 medical centers, was
funded and coordinated by the National Institute of Mental Health at a
cost to US taxpayers of $17 million. A total of 439 adolescents aged
12-17 were given Prozac, Prozac plus cognitive behavior therapy,
placebo plus CBT, or placebo alone. After 12 weeks, 71% of those
treated with Prozac and CBT showed improvement (defined by the
therapists and the subjects' responses to questionnaires). Improvement
was reported by 60% of those taking Prozac without CBT, 43% getting
CBT alone, and 35% taking placebo alone.
NIMH Director Thomas Insel told the media it was a "landmark study"
because "it's the largest publicly funded study and the only study
this size that doesn't have pharmaceutical funding." Insel would have
been accurate if he'd said the NIMH study didn't get direct funding
from the pharmaceutical industry. But lead investigator John March of
Duke University Medical Center is on the Eli Lilly payroll, and five
of his 10 co-authors also get drug-company grants.
Data to which March et al did not draw attention -and few stories
about the study even mentioned- showed a higher incidence of harmful
behavior among teens taking Prozac (11.9%) compared to those on
placebo (5.4%) and CBT alone (4.5%). Few stories mentioned that
teenagers to whom suicidal thoughts had occurred had been excluded
from the study before it began. A summary of the study by Jeanne
Lenzer in the British Medical Journal pointed out a structural flaw:
two"arms" were blinded (neither subject nor investigator knew whether
Prozac or placebo was being given), but the two arms involving CBT
were not. The BMJ also quoted a succinct criticism of the study by
David Antonuccio of the University of Nevada School of Medicine: "The
authors' value judgment is that the benefit of a few extra improved
patients is worth the cost of a few extra harmed patients."
Reports in the popular media failed to mention the ominous bottom-line
conclusion of the NIMH study:"the identification of depressed
adolescents and provision of evidence-based treatment should be
mandatory in health care systems." In other words, if Lilly has its
way, screening by a doctor or a school, followed by mandatory Prozac
(with a few hours of talk therapy thrown in for the Colin Powell
effect), may be coming soon to a teenager near you.
The NIMH has played a "handmaiden" role at every key juncture in the
peddling of Prozac. In 1987, as Lilly was gearing up to market it,
NIMH launched its Depression Awareness, Recognition and Treatment
(D/ART) Program to convince the American people that they suffered
from "clinical depression" en masse and could get help from a
prescription drug. The rationale for D/ART was laid out in an article
in the American Journal of Psychiatry whose authors included past and
future NIMH directors Lewis Judd and Fred Goodwin. "Today, 80% to 90%
of persons with a major depressive order can be treated successfully,"
they wrote. "Yet only about one person in three who suffers from a
depressive order ever seeks treatment... Even when people do seek
help, current evidence suggests that too often depression is poorly
recognized, undertreated, or inappropriately treated by the health
care system."
The NIMH D/ART Program had three objectives: "1. To increase public
knowledge of the symptoms of depressive disorders and the availability
of effective treatment. 2. To change public attitudes about depression
so that there is a greater acceptance of depression as a disorder
rather than a weakness. To motivate changes in behavior among the
public and treatment professionals." D/ART produced "depression
awareness" materials -drafted by private sector "campaign consultants"
on the Eli Lilly payroll - that were distributed at government
expense. It also launched a "community partnership program" involving
the nonprofit National Mental Health Association to "identify sources
of private support to distribute print and electronic materials and...
to host talk shows, to encourage the development of professional
seminars on depression, and to make referrals to treatment
facilities."
A decade later Lilly used an NIMH study (Emslie, et al, published in
Archives of General Psychiatry) to get FDA approval to market Prozac
to children. The Emslie study was also used by Lilly to get their
Prozac patent extended in 2001. According to Vera Sharav of the
Alliance for Human Research Protection, " At least two of 48 children
treated with Prozac in the NIMH-sponsored trial attempted suicide...
In the single published report of this trial, however, there is no
mention of any children attempting suicide. Instead, the published
report states: 'Side effects, as a reason for discontinuation, were
minimal, affecting only 4 patients who were receiving Prozac. (Emslie
et al., 1997, p. 1033)...'
"The NIMH posted an announcement on its website entitled
'Antidepressant Medications for Children: Information for Parents and
Caregivers.' This announcement... makes no mention of suicide attempts
among Prozac-treated children. Instead, parents were merely told: 'The
studies found that [Prozac] reduced depression for many children
better than a placebo and it did not increase suicide or suicidal
thinking.''
According to Sharav, the FDA reviewers in 2001 examined Lilly's
integrated safety data summaries (ISS) from three pooled Prozac
pediatric trials and determined that "22 children dropped out because
of adverse reactions in the Prozac-treated group compared to five in
the placebo groups. The FDA review also states that there were three
suicide attempts among the Prozac-treated group versus one such
attempt among the placebo group. FDA's review refers to additional
children being hospitalized for suicidal events...
"Furthermore, the ISS summaries indicate that six of the
Prozac-treated children, but none on placebo, developed mania or
hypomania."
http://www.counterpunch.org/gardner09112004.html
* * *
BMJ 2004;329:529 (4 September), doi:10.1136/bmj.329.7465.529 (British
Medical Journal)
Specialists challenge claim that fluoxetine plus talk therapy works
best for depressed adolescents
Jeanne Lenzer
New York
A US study of clinically depressed adolescents, showing that a
combination of fluoxetine (Prozac) and cognitive behaviour therapy
(CBT) works best, has sparked concerns over the interpretation of the
data.
The multicentre trial randomised 439 depressed adolescents aged 12-17
years to four arms: fluoxetine alone, CBT alone, CBT plus fluoxetine,
or placebo. The results showed that at 12 weeks, 71% of those treated
with CBT plus fluoxetine had improved, compared with just over 60% of
those taking fluoxetine alone, 43% treated with CBT alone, and 35%
taking placebo alone (JAMA 2004;292: 807-20 [Abstract/Free Full
Text]).
Fluoxetine is the only anti-depressant in its class to be approved by
the US Food and Drug Administration for depression in adolescents.
Dr Thomas Insel, director of the National Institute of Mental Health,
which sponsored the $17m (£9.5m; 14m) research, described it as a
"landmark study" because "it's the largest publicly funded study and
the only study this size that doesn't have pharmaceutical funding."
But six of the 11 authors, including the lead author, John March, have
received funding from Eli Lilly, the manufacturer of fluoxetine.
Dr March, from Duke University Medical Center, Durham, North Carolina,
said that between 1 in 20 and 1 in 40 US adolescents developed severe
depression. "In some cases it's fatal. Now that we can identify it and
treat it, it seems common sense that you ought to provide the
resources to [do so]," he said. He stood by the authors'
recommendation for mandatory screening and treatment of depressed
adolescents and for fluoxetine to "be made widely available, not
discouraged."
But the study fails to blind two of the four study arms—those which
included CBT alone and CBT plus fluoxetine—which raises questions
about the validity of the research, says Dr Michael Wilkes, director
of adolescent medicine at the University of California at Davis: "Most
methodologists would say combining blinded and unblinded arms is less
than ideal. You can't mix apples and oranges and have confidence in
the results."
Critics say the authors focused on only one of the study's two primary
end point scales—the one with the positive result. The other primary
end point showed that fluoxetine performed no better than placebo.
Harmful behaviour, including suicidal tendencies, was twice as high in
adolescents taking fluoxetine (12%) as it was in those receiving
placebo (5%).
Concerns about the authors' interpretation of the data have prompted
Professor David Antonuccio of the department of psychiatry and
behavioural sciences at the University of Nevada School of Medicine to
request the raw data under the terms of the Freedom of Information
Act.
"The authors' value judgment is that the benefit of a few extra
improved patients is worth the cost of a few extra harmed patients,"
said Professor Antonuccio. "My own risk-benefit analysis leads me to a
different conclusion." He suggested that CBT alone, or exercise,
should be offered as the first line treatment because of the lower
risk of side effects.
http://bmj.bmjjournals.com/cgi/content/full/329/7465/529?ehom
--
Decoding Psychiatric Propaganda
http://groups.msn.com/psychbusters
.
|
|
|
Related Articles |
|
|
