On December 13 the U.S. Food and Drug Administration held hearings on its proposal to place a black box warning on antidepressants for adults indicating that these medications increase the likelihood of suicidal thoughts. Roger Peele, MD and Louis Kopolow, MD testified against placing such a warning on antidepressants. Following are the testimonies of Drs. Peele and Kopolow.
Chief Psychiatrist, Montgomery County, Maryland Clinical Professor of Psychiatry, George Washington University Member, American Psychiatric Association Board of Trustees, Member, Washington Psychiatric Society Board of Directors
I come before you as Chief Psychiatrist, Montgomery County government, I come before you as someone who has been responsible for the care and treatment of people with psychiatric illnesses in public or academic settings in Washington, Virginia, or Maryland for the past 46 years, and I come before you as someone who has had four uncles, one aunt, and three cousins commit suicide in the years before we had SSRIs.
In thinking about preventing suicides, are we interested in blocking patient’s willingness to talk about suicidal thoughts? We are not. None of my 8 relatives who killed themselves talked about suicidal thoughts. Many of us have had patients who are alive today because they had become willing to talk about their suicidal thoughts.
In thinking about suicide prevention, are we interested in blocking pts self-injurious behavior? None of my 8 relatives who killed themselves had self-injurious behaviors. We certainly do not want patients injuring themselves, but it remains that many a clinician has had patients who cut themselves as a way of reducing unbearable anxiety, and in reviewing their histories, one can conclude that if they had not cut themselves, they might well have done something more drastic. We need to remember that the emotion just prior to committing suicide is often not sadness, but an excruciating anxiety in which the only escape seem to be to end one’s life.
In thinking about preventing suicides, are we interested in preventing plea-for-help gestures? None of my 8 relatives who killed themselves had a history of plea-for-help gestures. We certainly do not want patients to have to resort to such gestures, but it remains that for many a patient, such a gesture is not suicidal but an alternative to suicide.
Using a term like 'suicidal' for willingness to talk about suicidal thoughts, for cutting oneself, or for plea-for-help gestures, then basing a black box on the word 'suicidal' would lead the FDA to make a promulgation that the experienced clinician knows is based on a fallacious understanding of word 'suicidal.'"
I am Dr. Louis Kopolow. Am currently president of the Suburban Maryland Psychiatric Society. I will be speaking today from the perspective of a psychiatrist who has treated thousands of patients for depression over the course of my 30 year career. I will be making three points for the committee’s consideration: 1. Depression can be a lethal disease; 2. There is a significant link between untreated depression and physical illness; 3. Depression is an illness that is already under-diagnosed and under-treated in this country.
1. Depression is a disease with a high likelihood of severe, unalterable consequences if not treated promptly and successfully. People with untreated depression face up to a 15% greater lifetime risk of dying by suicide.
2. Depression is not only an illness affecting an individual’s emotional state but physical health as well. Patients suffering from Major Depressive Illness have 1 ½ to 2 times greater risk than the general public of developing hypertension, cardiovascular disease, and diabetes. The World Health Organization has identified depression as the leading cause of disability in the world.
3. The Surgeon General’s report in 1999 noted that more than half of all people with a mental disorder, such as depression, do not get the help they need. I am concerned that a black box label will lead to an actual increase in untreated depression and suicide by discouraging physicians from recommending antidepressant medication and causing patients to discontinue the treatments that are helping them. Data show that the number of antidepressant prescriptions dispensed to patients aged 18 and under dropped nearly 20% in the wake of the FDA’s pediatric black box hearings. This may set a precedent for what will happen if a black box label is required fro antidepressants for adults. Another consequence of greater hesitancy of avoidance in prescribing antidepressants may be a decrease in the chances of a person achieving recovery. In a NIMH collaborative study, Dr. Marty Keller found that the chances of recover diminished the longer depressive symptoms persisted. At 6 months the rate was 54%; at 1 year it was 16%, and when an individual had been depressed for 5 years the possibility for recovery decreased to a stunning 1%.
In conclusion, this committee must weigh the lethal consequences of untreated Major Depressive Illness versus the questionable significance of an increase of risk in suicidal thoughts and gestures which already is an inherent part of the disease. An unfortunate consequence of a black box label is that many doctors will be reluctant to prescribe antidepressants for their patients and their patients will face needless suffering.
References:
1. Goodwin, FK, Jamison KR: Suicide in Manic-Depressive Illness. New York, Oxford University Press, 1990 pp. 227-244
2. Guze SB, Robins E.: Suicide and primary affective disorders. Br J of Psychiatry 1970; 117: 437-438.
