Psychiatric News July 15, 2005
Volume 40 Number 14
© 2005 American Psychiatric Association
p. 1
AMA Opposes Restrictions On SSRI Use In Youngsters
Mark Moran
The House of Delegates adopts an APA-AACAP resolution endorsing the
training of investigators to study the effects of psychotropic drugs in
children, adolescents, and young adults.
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Carolyn Robinowitz, M.D. (left), greets well-wishers at a reception in
her honor after she was reelected to AMA's prestigious Council on Scientific
Affairs (now the Council on Science and Public Health). Robinowitz is APA's
secretary-treasurer. Capuccino Catering Chicago
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Selective serotonin reuptake inhibitors (SSRIs) should remain available for
use in children and adolescents, including for unlabeled uses, according to a
report adopted by the AMA House of Delegates at the organization's annual
policy-making meeting in Chicago last month.
The report was written by the AMA's Council on Scientific Affairs (CSA) in
response to a resolution brought to the house at last year's meeting by APA
and the American Academy of Child and Adolescent Psychiatry (AACAP).
The report also states that current clinical evidence indicates that
fluoxetine is an effective SSRI in children and adolescents with major
depressive disorder, and it calls for a review of how FDA regulatory actions
impact prescribing patterns, patient compliance, and access to
medications.
"A causal role for antidepressants in increasing suicides in children
and adolescents has not been established," the CSA report states.
The council's report was adopted without debate on the floor of the house
and had widespread support from pediatricians and other physicians during
reference committee hearings. Along with several other actions that originated
with the APA Section Council on Psychiatry and were approved virtually without
opposition (see story on page
8), the council's report on SSRIs is evidence of the growing
influence of psychiatry within the house of medicine, APA leaders say.
"This is an excellent example of the importance of psychiatry's
involvement in the house of medicine," said John McIntyre, M.D., chair
of the Section Council on Psychiatry and head of APA's delegation. "This
issue was identified by APA and AACAP last year, and as the report was being
prepared, there was dialogue between the AMA and APA around the content of the
report.
"This is a major issue for our patients," he added. "We
are now at a level of participation that when issues come up that involve our
patients, we can be confident that we will be part of the solution."
David Fassler, M.D., vice chair of the Section Council on Psychiatry and
AACAP's delegate, was the author of the original resolution calling for the
report. He said during reference committee hearings that the report would
likely do much to dispel public and professional confusion that has surrounded
the FDA's action regarding antidepressants and children.
"The conclusions and recommendations... confirm that medication can
be an effective and important component of treatment for children and
adolescents with depression," Fassler said. "The report also
acknowledges the importance of continued access to the full range of these
medications, and it calls for ongoing research with an emphasis on larger
studies and long-term follow-up, which will ultimately give us more clinically
relevant data regarding both the safety and efficacy of these
medications."
(Reference committee hearings are held prior to the convening of the House
of Delegates and offer an opportunity for any AMA member and invited public
representatives to voice opinions on all reports and resolutions brought to
the House. On the basis of testimony heard at the reference committee, a
recommendation is made to the full house to adopt, amend, or not adopt those
reports and resolutions; a decision is also sometimes made to refer an item
for deliberation to the AMA Board of Trustees or to an appropriate
council.)
Melvyn Sterling, M.D., an internist and chair of the CSA, urged adoption of
the report during reference committee hearings, saying the issue was one of
the most important facing physicians who treat children and adolescents.
"As director of an emergency department of a university medical
center, I have treated thousands" of people who have made suicide
attempts, Sterling said. "I view this as one of the most important
conditions that we as physicians and a society have to deal with. We have to
deal with suicidality and with the awesome social and economic impact of
depression on our society. For us to deny patients access to what could be the
most important medication in their lives, when the data [about suicide] are
actually equivocal, I think would be very, very sad."
The CSA report summarizes recent regulatory actions related to the labeling
of antidepressants and their use in children and adolescents; evaluates the
apparent safety and efficacy of antidepressants, particularly the SSRIs in
children and adolescents; and reviews the evidence on whether these drugs may
have a causal role in the emergence of suicidality or other harmful behavior
during treatment.
The report concludes with four recommendations:
- That SSRIs should remain available for use in children and adolescents,
including unlabeled uses, subject to the exercise of prudent clinical judgment
and development of clinical guidelines for treatment. Current clinical
evidence indicates that fluoxetine is an effective SSRI in children and
adolescents with major depressive disorder, the report states.
- That the AMA urge the Food and Drug Administration (FDA) to ensure that
studies conducted by sponsors in pursuit of pediatric exclusivity be
adequately designed and of sufficient duration to answer clinically relevant
efficacy and/or safety questions that have evolved in a particular therapeutic
area.
- That the AMA recognize that the current product labeling (package insert)
of antidepressant drugs, including the black-box warnings, is a precautionary
statement intended to reinforce the need for careful monitoring of patients
with depression and other psychiatric disorders during the initiation of
treatment. This product labeling should not be interpreted in a way that would
decrease access for patients who may benefit from these drugs, the report
states.
- That the FDA evaluate the impact of labeling changes it mandates for
antidepressants, including the black-box warnings and patient medication guide
on treatment patterns, patient compliance, and patient access.
In related action, the House of Delegates adopted, without debate, a second
resolution put forward by APA and AACAP that asks the AMA to endorse efforts
to train additional qualified clinical investigators in pediatrics, child
psychiatry, and therapeutics to conduct studies related to the effects of
psychotropic drugs in children, adolescents, and young adults.
That resolution also asks the AMA to promote efforts to educate physicians
about the appropriate use of psychotropic medications for children,
adolescents, and young adults.
More information about these and other actions taken at the AMA's
2005 annual meeting are posted online at
<www.ama-assn.org/ama/pub/category/14887.html>.
Related Article:
-
AMA Endorses Several APA-Sponsored Proposals
- Mark Moran
Psychiatr News 2005 40: 8.
[Full Text]
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