A critical mass of patients, clinicians, researchers, and other mental health advocates successfully delivers a clear message to an FDA advisory committee.

The goal was the delivery of a unified and cogent message, based upon existing scientific evidence and bolstered by researcher, clinician, and patient experience. The target was the long-anticipated public release of the U.S. Food and Drug Administration's (FDA) report on suicidality in adult antidepressant clinical trials (see articles on page 1 and above).

The message was delivered by a coalition of 15 national mental health advocacy and professional specialty organizations, including APA. The coalition's “Open Letter on Antidepressants” was released at the coalition's lunch briefing on the same December day that the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) held a public hearing to discuss the report.

“As advocates for people living with depression and other mental illnesses,” the letter began, “we strongly urge the FDA to carefully consider the potential impact of the agency's public statements on the risks and benefits of antidepressants. Access to effective treatments for depression is pivotal in improving the lives of the 19 million Americans that face this devastating illness each year.”

The coalition's efforts were led at the December 13 briefing by David Shern, Ph.D., president and CEO of Mental Health America (MHA). He noted that“ without treatment, this disorder can be fatal—15 percent of people who live with untreated depression take their own lives.

“Any knee-jerk or pressure-based actions by the FDA may put an untold number of Americans at risk of the tragedy the agency aims to avoid—suicide,” Shern stressed. “The risk associated with not treating depression is far greater than any potential risk of adverse effects of medication,” he added, echoing his testimony before the PDAC during the public-comment section of the panel's hearing.

In addition to Shern, the briefing featured APA President-elect Carolyn Robinowitz, M.D.; Carl Salzman, M.D., a professor of psychiatry at Harvard who represented the American College of Neuropsychopharmacology; and patient/consumer advocate Sheri Walton, who also represented MHA.

However, what had a greater impact than the briefing and its packaged presentations were the more than 20 coalition-affiliated speakers who testified during the public-comment period of the PDAC hearing. Over and over again, panel members heard the coalition messages that “untreated depression itself kills,” “antidepressant medications are safe and highly effective treatments when monitored appropriately,” and“ any extension of the existing ill-conceived warnings is likely to create further barriers to access to care.”

What seemed to resonate the most with the panel, however, was not the consistency of the points, but rather the variety of the speakers making them—patients and family members, advocates, clinicians, and noted researchers.

In summarizing the long day's hearing, Daniel Pine, M.D., chief of Child and Adolescent Research at the National Institute of Mental Health, who served as the PDAC's acting chair for the meeting, noted, “We've heard today from a lot of speakers who believe these medications can cause someone to commit suicide. We've also heard from a number of speakers who have testified to the benefits of these medications. It is certainly possible that the black-box warning this committee voted for two years ago has led to unintended, negative outcomes. Perhaps it is time we reach for more balance in these labels.

“Above all, I think we all agree we need better science to help us answer some hard questions. In the interim, however, we need appropriate labeling that fosters cautious prescribing and close monitoring, without unduly restricting access to these effective medications.”

These are the 15 members of the coalition:

• American Academy of Child and Adolescent Psychiatry

• American Association for Geriatric Psychiatry

• American Association of Suicidology

• American College of Neuropsychopharmacology

• American Foundation for Suicide Prevention

• American Psychiatric Association

• American Psychotherapy Association

• Children and Adults With Attention-Deficit/Hyperactivity Disorder

• Families for Depression Awareness

• Kristin Brooks Hope Center

• Mental Health America

• National Alliance on Mental Illness

• Suicide Awareness Voices of Education

• Suicide Prevention Action Network

• The Jason Foundation Inc. ▪