Altha Stewart, M.D., chair of the Steering Committee to Reduce
Disparities in Access to Psychiatric Care, discusses the committee's final
report with former APA president Richard Harding, M.D., at last month's Board
of Trustees meeting.
See page 13 for
coverage of the meeting.
The AMA will prepare an independent and comprehensive review of the
scientific data pertaining to safety and efficacy of using selective serotonin
reuptake inhibitor (SSRI) antidepressants in the treatment of child and
adolescent psychiatric disorders.
In response to a resolution introduced by APA and the American Academy of
Child and Adolescent Psychiatry (AACAP), the AMA's Council on Scientific
Affairs will be preparing a report in an attempt to mitigate some of the
confusion surrounding the Food and Drug Administration's (FDA) recent"
black box warning" about the risk of suicidality in children and
adolescents being treated with SSRIs (Psychiatric News, November 19,
The resolution was approved by the AMA's House of Delegates at last month's
interim meeting in Atlanta. Testimony in reference committee hearings
preceding the vote was overwhelmingly supportive.
(Prior to any action taken by the House of Delegates, all resolutions are
brought before a reference committee and debated; based on testimony provided
during that hearing, the reference committee then makes a recommendation to
the house to approve the resolution or not, with or without amendments.)
John McIntryre, M.D., chair of the AMA Section Council on Psychiatry and
chair of the reference committee that heard testimony on the issue of children
and SSRIs, told Psychiatric News that the FDA action had created much
confusion around the use of medications that have proven successful in the
treatment of some children and adolescents.
"It was clear to the House of Delegates that the FDA black-box
warning was confusing both to the public and parents with kids on
antidepressants, but also to physicians who prescribe these
medications," McIntyre said. "The house approved the resolution
asking for a prompt study by the AMA's Council on Scientific
Child psychiatrist David Fassler, M.D., vice chair of the Section Council
on Psychiatry, AACAP delegate, and author of the resolution, told the
reference committee that the data on which the FDA based its action were far
"Data on children and SSRI antidepressants are inconsistent and
inconclusive," Fassler said. "In particular, it's important to
underscore that there have been no actual suicides in any of the clinical
trials, which have now included close to 5,000 subjects. Second, the public is
confused by inaccurate and contradictory media reports. And finally,
physicians are confused by the recent FDA decision to require black-box
warnings on all antidepressants used in the treatment of children and
adolescents with psychiatric disorders. We very much need an independent,
authoritative scientific review of this topic."
In October the FDA ordered drug companies to label all antidepressants
distributed in the United States with strongly worded warnings that the
medications "increase the risk of suicidal thinking and behavior
(suicidality) in children and adolescents with major depressive disorder (MDD)
or other psychiatric disorders."
The FDA decision has not been without controversy. In a joint statement,
APA President Michelle Riba M.D., M.S., and President-elect Steven Sharfstein
M.D., said, "The American Psychiatric Association believes
antidepressants save lives.... We restate our continued deep concern that a
`black-box' warning on antidepressants may have a chilling effect on
appropriate prescribing for patients. This would put seriously ill patients at
Riba and Sharfstein said that APA is "working to help mitigate such
an impact by collaborating with nonpsychiatric physicians—including
pediatricians and general practitioners—to help them better understand
their patients' needs and properly diagnose, treat, and monitor
patients" (Psychiatric News, November 5, 2004). ▪