Statement of Suzanne Vogel-Scibilia, M.D. On Behalf of NAMI
Before the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee
February 2, 2004
Good morning. The National Alliance on Mentally Illness (NAMI) greatly appreciates this opportunity to provide a statement on the critically important issue of the use of selective serotonin reuptake inhibitors (SSRIs) for children and adolescents with depression – specifically focused on reports of suicidality (ideation and attempts) in clinical trials and approaches to analyzing data from these trials and further research needs to address these issues.
NAMI was founded as a grassroots family advocacy movement 25 years ago in Madison, Wisconsin. Today, NAMI has more than 220,000 consumer and family members nationwide dedicated to improving the lives of children and adults living with mental illnesses.
My name is Suzanne Vogel-Scibilia and I am a member of the NAMI Board of Directors. As a person diagnosed with bipolar disorder, I am proud to serve on the NAMI Board and proud that NAMI is the nation’s "voice on mental illness" representing both consumers and family members. I am also proud to be the mother of five children, two of who are diagnosed with mental illnesses and one of who is currently being treated with an SSRI.
I am also a psychiatrist with board certification in general psychiatry, addiction psychiatry and geriatric psychiatry and have additional board certification from the American Board of Adolescent Psychiatry. I have a thriving practice in Beaver, Pennsylvania.
My son, Anthony, has had severe mental illness primarily depression and attention deficit disorder as a manifestation of his bipolar disorder and another son has had treatment with numerous antidepressant medications including several SSRIs. My children have had tremendous improvement with their illnesses and lead very full and functional lives because of SSRI medication, along with other psychotropic medications. I shudder to think of their plight if these medications were not available.
One of my sons has had suicide attempts and violent incidents with knives. He has also run out of our house – in a fit of terror -- in subzero weather only to be found freezing and hypothermic by our local police department in the next township. These incidents all occurred when his illness was not adequately treated with antidepressant medication. My other son suffers from disabling obsessive-compulsive disorder symptoms and depression and has had his life improve dramatically from treatment with SSRIs.
Many of my patients, as well as my children, have had severe symptoms from their illness that others may claim is from the treatment. I, as a mother and a psychiatrist, realize that the evidence linking suicidal behavior to SSRIs is weak and I will not draw conclusions lightly based on anecdotal information and isolated case reports. As a psychiatrist, I question whether some of the cases where a child worsened on SSRIs may have been because the child had bipolar disorder instead of unipolar depression. This has been posited by authorities in the field as well (American College of Neuropsychopharmacology Report to the FDA, dated January 21, 2004).
Upon review of the research, which confirms the experience of many NAMI families, NAMI believes that SSRI access for young people should be maintained.
NAMI Calls for Increased Research on Early Onset Mental Illnesses
The prevalence of mental illnesses in children and adolescents is significant and on the rise. Research shows that early identification and comprehensive treatment can improve the long-term prognosis of children with mental illnesses. Research on the effectiveness of treatments -- including SSRIs and other psychotropic medications -- is our best hope for the future.
With so many children and adolescents being prescribed psychotropic medications, we need research and science to help guide the safe and effective use of these medications. There is an essential need for more data on the long-term effects and safety of psychotropic medication use in children. NAMI calls on NIMH to make a significant investment in research on early onset mental disorders and the use of psychotropic medications – including SSRIs -- for children and adolescents. This promises to help us understand the safety and effectiveness of SSRIs and other psychotropic medications in treating mental illnesses in children.
The discussion about children and adolescents and the use of SSRIs to treat depression must also address the critical need to ensure that all children and adolescents with mental illnesses have access to evidence-based assessments and interventions – with quality clinical care as an integral part of all aspects of the service delivery system. An expanded reporting system is necessary so that data from the pharmaceutical industry and other studies is available to the public.
For children with mental illnesses – especially those with persistent and serious mental illnesses -- the ability to access psychiatric medications when needed is vital. NAMI believes that many children with mental illnesses need access to medication as part of a comprehensive treatment plan. NAMI is concerned that any limitations on the ability of knowledgeable practitioners to treat children with SSRIs, when needed, could be damaging to children in our country especially those with serious life altering illnesses.
The Efficacy of Psychotropic Medications for Children
Parents’ or caregivers’ decisions about whether to use SSRIs or other psychotropic medications for their child can be extremely difficult. Psychotropic medications for young children with mental illnesses should be used only when the anticipated benefits outweigh the risks. Parents and family members should be fully informed of the risks and expected benefits associated with medications prescribed for children and decisions about whether to use medication for a child should only be made after carefully weighing these factors. Children and adolescents who are taking psychotropic medications must be closely monitored and frequently evaluated by qualified mental health providers.
At the same time, psychotropic medications, including SSRIs, have been lifesaving for many children with mental illnesses. Families often report that the use of medication, either alone or along with other treatment modalities, has allowed their child to participate in school like other children, to live at home and to develop friendships with peers. We also know that the lack of effective treatment for a child or adolescent who needs it will adversely affect the child’s overall physical and mental development, including the ability to learn, develop self-esteem, socialize and function in the community.
I have seen, along with many other clinicians, children respond positively to SSRIs -- some dramatically. Moreover, there is little research on the outcomes that result from an absence of treatment, although lack of treatment undoubtedly leads to a greater number of preventable tragedies. SSRIs have actually been found to be effective in several recent reports (Emslie, G, et. al., Journal of the American Academy of Child Psychiatry 41(10) 1205-1215 and Archives of General Psychiatry 54:1031-7) while a large meta-analysis of an older alternative antidepressant family, the tricyclic antidepressants failed to show the same improvements (Hazell P, Cochrane Database of Systemic Reviews 2002 (3):CD002317).
Another possible treatment alternative to SSRIs is cognitive-behavioral therapy (CBT), a form of psychotherapy. However, CBT has had a high treatment non-response rate for some children with depression, which provides yet another reason to have alternative treatments, like medications, available for children (Clarke, G, Journal of the American Academy of Child Psychiatry, March 1999, 38(3) 272-9 and Brent, D, Archives of General Psychiatry, Sept. 1997 54(9) 877-85).
Many long-term studies show that the treatment of childhood onset depression with psychotherapy, medication or both improves the social and educational outcomes and emotional health of our children (Rutter and Hersov, Child and Adolescent Psychiatry).
Suicide and Consequences of Untreated Mental Illnesses
We are pleased that the FDA is looking closely at the data related to SSRI use and suicidality. NAMI is deeply concerned with the public health crisis in the number of youth who commit suicide. We are also alarmed by the high number of youth with mental illnesses that fail to receive any treatment or services. The U.S. Surgeon General reports that up to 80% of youth who need mental health treatment fail to receive any treatment.
NAMI families are well aware of the tragic consequences of untreated mental illnesses in youth. Suicide is the third leading cause of death in adolescents aged 15 to 24. (Centers for Disease Control, 1999). Evidence strongly suggests that as many as 90% of those who commit suicide have a diagnosable mental disorder. (Institute of Medicine Report, 2002 and Surgeon General, 1999).
Youth with untreated mental illnesses also tragically end up in jails and prisons – research shows that 65% of boys and 75% of girls in juvenile detention have at least one psychiatric diagnosis (Teplin, L. Archives of General Psychiatry, Vol. 59, December 2002). They fail or drop out of school – leading to a greatly diminished future as citizens and productive workers.
Educators have found that children with a mental health disability – including depression -- are most likely to flounder in the educational system and have lifelong complications from the lack of education if not adequately treated for their depressive symptoms. The risk of conduct problems and addictive behavior increases dramatically if any person with mental illness is not adequately treated (Rutter and Hersov, Child and Adolescent Psychiatry).
Crisis in the Shortage of Child and Adolescent Mental Health Providers
Families across the country also struggle with accessing mental health treatment for their child because of the crisis in the shortage of child and adolescent mental health providers – especially child-trained psychiatrists. The importance of a strong relationship between families and clinicians cannot be overstated; it is especially imperative in cases involving children and adolescents with depression.
The tragic reality is that the shortage of child and adolescent psychiatrists in this country – especially in rural communities -- makes it extremely difficult for families to access appropriate and effective treatment for their child with a mental illness. These issues must be considered in the context of this discussion on the safety and efficacy of SSRIs to treat children and adolescents with depression.
In summary, I would like to thank the committee for allowing NAMI to share our views on these critically important issues. The families that we represent from across the country call for increased research and data to understand the long- and short-term safety and efficacy of SSRIs to treat children and adolescents with depression. Let us not forget that medications have been shown to be effective and no studies have proven that SSRIs cause suicide or suicidal behavior in young people. In fact, data suggest that SSRI use may have decreased suicides among young people, which is a critical public health problem.
NAMI is aware that not all of the data concerning the impact of SSRIs in children and adolescents has been made available to the public and independent researchers. It is critical that all such data be made available so that families everywhere can make decisions about treatment based on full knowledge of the risks and benefits.
But we cannot stop there. Even if families and clinicians could make fully informed decisions about the use of SSRIs in a child, many families do not have access to providers. Services are woefully inadequate around the nation. And the current state of knowledge is simply inadequate – we need to understand mental illnesses in children much better and we need better treatments. If the FDA and U.S. federal government truly cares about the well being of American children with mental illnesses, it would address all of these issues.
For further information related to this statement or to learn more about NAMI, please contact Darcy E. Gruttadaro, J.D., Director of the NAMI Child & Adolescent Action Center.