Psychiatr News September 2, 2005
Volume 40, Number 17, page 1
© 2005 American Psychiatric Association
New Data Show Declines In Antidepressant Prescribing
Jim Rosack
Whichever way the data are analyzed, no one is questioning the trends
they depict. However, their significance and implications are the subject of
much debate, and NIMH's director finds them alarming.
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Closed in 1996, Fairfield State Hospital in Newtown, Conn., recalls the
period in American psychiatry when mentally ill people were cared for in
architecturally impressive—and imposing—asylums. See story on
page 24. ©
Chris Payne
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Newly released data show that the number of antidepressant prescriptions
dispensed to patients aged 18 and under has dropped nearly 20 percent since
the Food and Drug Administration (FDA) issued its public health advisory on
March 22, 2004, warning that the drugs might be associated with an increased
risk of suicidality in both children and adults.
The number of antidepressant prescriptions dispensed to adults has held
fairly steady over the last two years.
The changes in dispensing were calculated based on the number of
prescriptions dispensed from March 31, 2004, to June 30, 2005, compared with
the anticipated number of prescriptions that would have been dispensed over
that same time had the number of prescriptions dispensed each month remained
constant at the March 2004 level.
The trends were revealed in data requested by Psychiatric News
from Atlanta-based NDC Health Inc. The company, which says it processes 5
billion health care transactions annually, tracks prescription-dispensing data
nationally through electronic connections with "more than 90 percent of
U.S. pharmacies."
NDC Health provided Psychiatric News exclusively with two years'
worth of monthly prescription data, showing the total number of prescriptions
dispensed each month and the total cost of those prescriptions from July 2003
through June 2005. The data were reported as monthly total numbers and costs
for patients aged 18 and under and for patients over age 18. The data cover
all antidepressants, including SSRIs, SNRIs, atypical antidepressants,
tricyclics, and MAOIs.
Psychiatric News analyzed the data to determine whether the rate
of dispensing prescriptions for the two populations had changed in that time
period.
The dataset begins seven months before the FDA's first public meeting on
antidepressant use in children by the Psychopharmacologic Advisory Committee
and Pediatric Subcommittee in February 2004 (Psychiatric News, March
5, 2004; March 19, 2004; April 16, 2004) and cover the ensuing 17 months of
turmoil, which included Congressional hearings and additional advisory
committee meetings. Those public meetings resulted in the FDA's announcement
of, and eventual implementation of, black-box warnings on labels of all
antidepressants marketed in the United States (Psychiatric News,
October 15, 2004; November 5, 2004; March 5, 2005).
"These data demonstrate a dramatic shift in practice patterns over a
very brief period of time," David Fassler, M.D., told Psychiatric
News.
Fassler is an APA trustee and a clinical professor of psychiatry at the
University of Vermont. A child and adolescent psychiatrist, he has been at the
forefront of APA's involvement with the regulatory process concerning
antidepressant medication use in children and adolescents and testified on
APA's and AACAP's behalf at the Congressional hearings and APA's behalf at FDA
advisory committee meetings. (At the FDA hearings AACAP was represented by
Laurence Greenhill, M.D.)
Darrel Regier, M.D., M.P.H., executive director of the American Psychiatric
Institute for Research and Education and director of APA's Division of
Research, commented, "It looks like the earlier warning in February 2004
clearly had an effect on prescribing, in contrast to the FDA's report at the
September 2004 hearings," after which a much smaller decline in
prescribing occurred (see chart at right)."
John March, M.D., M.P.H., a professor of psychiatry at Duke University,
told Psychiatric News, "These data confirm what others have
seen—namely, that the FDA process has resulted in a decrease in the
number of prescriptions for antidepressants written for children and
adolescents."
March was the principal investigator on the National Institute of Mental
Health's Treatment of Adolescents With Depression Study (TADS)
(Psychiatric News, September 3, 2004; July 1).
Prescriptions Decline Significantly
All of those contacted by Psychiatric News agreed with its
analysis, whether the data are shown as total number of prescriptions
dispensed each month over the two-year period beginning with July 2003 or as a
percentage change in the number of prescriptions dispensed each month
calculated from the base month of March 2004, when the number of prescriptions
peaked (see chart at right).
A third analysis (not depicted here) showed similar trends. That analysis
looked at the percentage of change in the number of prescriptions written by
quarter, compared with the same quarter in the previous year.
The number of antidepressant prescriptions dispensed was increasing from
the beginning of July 2003 through March 2004, in both pediatric and adult
populations—an upward trend confirmed by previously published data
showing steadily increasing annual sales figures for the antidepressant class
over the last several years.
However, according to the NDC Health data, during April 2004—just
after the FDA's March 22 Public Health Advisory that resulted from the
February meeting of the advisory committees—the number of prescriptions
dispensed to both adults and to children dropped precipitously. Indeed, in
just one month, the number of antidepressant prescriptions for those over the
age of 18 declined by 10.7 percent, while prescriptions for those aged 18 and
under declined 12.6 percent.
The dataset that NDC Health gave to Psychiatric News for this
article indicates that the decline in dispensing of antidepressant
prescriptions that began in April 2004 has continued for those aged 18 and
under. Depending on whether one looks at the trend over the entire two-year
period, or the trend since the peak in March 2004, the rate of dispensing to
adults has either leveled off or declined.
As a percentage of change in antidepressant prescribing relative to the
dataset's July 31, 2003, baseline, the number of prescriptions for adults was
on the upswing. Though there were wide monthly fluctuations in the number of
prescriptions dispensed to adults between July 31, 2003, and March 31, 2004,
the number of prescriptions rose an average of about 4 percent. During the
same period, the number of prescriptions for those 18 and under rose an
average of just over 10 percent. However, between March 31, 2004, and June 30,
2005, prescribing to adults (again as a percentage change relative to the same
July 31, 2003, baseline) held fairly stable, ending the month of June 2005 at
5 percent above the end of July 2003. In contrast, prescribing to children
ended 10 percent below where it stood at the end of July 2003.
Data Provoke Many Questions
Regardless of how the decline is measured, however, for those aged 18 and
under the drop is statistically significant (p=0.01). For adults, the
prescribing pattern over the two-year period does not change significantly.
However, the clinical implications of these data, particularly of the decline
in pediatric antidepressant prescriptions, appears to be in the eye of the
beholder.
"These data clearly suggest that there are children and adolescents
with depression who no longer have access to the full range of effective and
appropriate treatment options," Fassler told Psychiatric
News.
"This picture is disastrous," said Gail Griffith, who sat on
the FDA's advisory panel as a patient representative (Psychiatric
News, May 20). "The real question I want answered is,
Why?"
If the decline is coming from "physician reluctance," Griffith
said, "it may be due to lack of education or fear of liability or
malpractice [associated with prescribing the drugs]." However, she
continued, "if the reluctance is coming from the public, then we have an
opportunity here to provide evidence and educate."
Thomas Laughren, M.D., acting director of the FDA's Division of Psychiatry
Products, reiterated in an e-mail to Psychiatric News that "the
intent of the strong warning statements was not to discourage appropriate
prescribing of these drugs to pediatric patients, but rather to alert
prescribers, patients, and their families to the increased risk" (see
box).
"We do not know whether the impact is positive, neutral, or
negative," said Duke's March. "It will be important to evaluate
the outcome of this natural experiment on suicide attempts and on completed
suicide to know whether the appropriate caution in prescribing and call for
increased monitoring is a net plus or not."
If Not Drugs, Then What?
Nearly every one Psychiatric News interviewed agreed that the 20
percent drop in antidepressant prescriptions for children between April 2004
and June 2005 does not indicate any significant remission rate. Quite the
opposite.
Adelaide Robb, M.D., who directs the adolescent inpatient unit at
Children's National Medical Center in Washington, D.C., said the data are
"worrisome." She told Psychiatric News, "You have
to ask, Is there a corresponding increase in use of treatments like
cognitive-behavioral therapy or interpersonal therapy, treatments that have
proven effective with adults? Without medications, though, are these kids
getting any treatment at all?"
"Our sense from this and similar data is that at the same time that
there's been this drop in use of antidepressants, there has been a
compensatory increase in the use of atypical antipsychotics in this
population," added Thomas Insel, M.D., director of the National
Institute of Mental Health (NIMH). "And that is of great concern because
we have very little safety data and very little evidence of efficacy, for that
matter. These drugs simply haven't been studied much in children."
Insel added that although he thought the data were "entirely
predictable," he is bothered by the fact that the the decline "is
entirely driven by a focus on risk and a neglect of benefit."
Insel noted that NIMH has large studies under way "looking at whether
the decrease in SSRI utilization might be associated with an increase in
suicidality rather than a drop in suicide, and my expectation is that we may
see an increase."
Insel said that he thinks psychiatrists will be concerned when they see the
information presented in this article. "We must use this as a wake-up
call," he said. 
Related Articles:
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Rational Buildings Designed To `Calm the Disorderly Mind'
- Aaron Levin
Psychiatr News 2005 40: 24-25.
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FDA Official Comments on Data
Psychiatr News 2005 40: 39.
[Full Text]
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