The following testimony was submitted on February 2, 2004, to the Psychophar- macologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee U.S. Food and Drug Administration by Lydia Lewis, President of the Depression and Bipolar Support Alliance.

The Depression and Bipolar Support Alliance (DBSA) appreciates the effort by the Food and Drug Administration (FDA) to assess the occurrence of suicidality in clinical trials for antidepressant drugs in pediatric patients to determine whether federal regulatory action is needed in the clinical use of these products.

DBSA is the leading patient-directed national organization focusing on the most prevalent mental illnesses: depression and bipolar disorder. More than three million people annually request and receive information on depression and bipolar disorder from our non-profit organization. As DBSA President, I can assure the members of these committees that our organization, with more than 1,000 peer-run support groups across the country, has received numerous inquiries from those we serve about possible connections between youth suicides and the use of prescribed medications, particularly Selective Serotonin Reuptake Inhibitors or SSRIs.

We recommend to those our non-profit organization serves that individuals must have a full understanding of the kinds of medication they are taking and must become partners with their physicians in their treatment. That is also true for parents with children who are taking SSRIs.

DBSA is concerned that a premature or ill-founded conclusion about SSRIs could lead adolescent patients or their parents to discontinue them without consulting their physicians. If the FDA ultimately determines that warnings should be issued in relation to the use of certain medications, it must make clear to physicians and parents precisely why the warning was issued so that risks and benefits can be thoroughly weighed.

The FDA itself has recognized that to this point, there is no clear association between suicides and the use of antidepressants. Unfortunately, the British Medicines and Healthcare Products Regulatory Agency, in what I believe was a premature and hasty decision, late last year recommended against the use of SSRIs in patients under the age of 18. Ultimately, this decision could actually prove to be harmful for children and adolescents with depression.

Untreated or undertreated mood disorders are the leading cause of suicide in the United States. More than ninety percent of people who take their own lives have suffered from depression or bipolar disorder. Suicide will continue to be a risk for people living with depression until more effective treatments for this highly disabling disorder are found. The key, then, is not to hastily abandon treatments that can help alleviate the symptoms of depression, thus helping to prevent suicide.

The findings of the British regulatory authorities are in direct contrast to recent studies by the American College of Neuropsychopharmacology (ACNP). Among the clinical trials of more than 2,000 youth reviewed by their task force, there were no findings of any statistically significant increases in suicide attempts, self-harm or suicidal thinking related to SSRI use.

This task force, comprised of highly respected medical doctors, psychiatrists and clinicians, further concluded, based on autopsy reports, that suicide was more likely to occur in patients who failed to take their prescribed SSRIs rather than when they were taking their medication properly.

As patients we know the danger of our illness, medication is one of the important tools we use to stay alive in the face of this disabling disease.

In many cases, the use of SSRIs has served to completely turn lives from despair to hope. Take the case of one DBSA constituent, a 22-year-old woman, who wrote this about her SSRI medication:

"I have lived with depression since I was nine years old. In fact, I was placed in a child psychiatric hospital when I was 14. I have been on and off different medications throughout the years and still have good and bad days. I have tried most of the antidepressants out there, and know that it is through this medication that I can survive on a day to day basis. While I still have problems focusing and concentrating on even simple tasks, I have the ability to get up in the morning through my antidepressant."

I believe this advisory committee’s review will be more detailed than that conducted in the United Kingdom. The FDA’s re-examination of twenty studies of eight antidepressants involves more than 4,100 children. This analysis, coupled with the findings of the ACNP, hopefully will assuage any concerns in the medical and patient communities about the use of SSRIs.

In the meantime, there is much more that we can do as a nation to combat depression and bipolar disorder as causal factors in suicide. We must significantly increase available services to meet the needs of at-risk youth and those with mood disorders. The existing level of these services is woefully inadequate. We need to encourage the growth of the number of child psychiatrists in the country and fund a mental health infrastructure that spans primary care, schools, mental health facilities, foster care, social services and the juvenile justice system. We need to better fund research at the National Institutes of Health to find causes and cures for depression and bipolar disorder. We need to remove the barriers that stand in the way of research specifically for Adolescents and Children.

I recognize these issues are not the purview of this advisory committee, but this current review and any ultimate decision by FDA on the use of SSRIs will have a significant impact on an already inadequate mental health care system in this country.

Should treatment options for youth with mood disorders be reduced, particularly if based on unreliable or incomplete data, I fear the effect on the suicide rate among this population.

I urge the advisory committee to reach a sound conclusion with an appreciation of the significant impact that its recommendations will have on treatments available to our youth who live with depression.