Andrew C. Leon, Ph.D.
My name is Dr. Andrew C. Leon. I know that this is clearly an emotional issue. My family has been profoundly impacted by mental illness - so much so, that I have devoted my career to the field of psychiatry. I am Professor of Biostatistics in Psychiatry and Public Health at Weill Cornell Medical College, where I have been on the faculty for over 20 years. I have published over 200 peer-reviewed scientific manuscripts. Nearly all of my research has been funded by NIH. I have served as a consultant to FDA, NIMH and to industry, primarily to monitor the safety of participants in clinical trials.
All of us here today share a common goal: to do the very best for our veterans. My perspective is that doing the best requires the discipline to use empirical methods to understand optimal mental heath care and prevention of suicide.
I was the biostatistician on the FDA’s Psychopharmacologic Drug Advisory Committee from 2003-2008 and participated in FDA hearings on the topic of antidepressants and suicidality. The class of medications that I will discuss is antidepressants. Depression is a life threatening illnesses. Suicidality is a symptom of depression, whether treated or untreated.
My main points today are paraphrased from the FDA Black Box Warning on all antidepressants: 1) Depression increases risk of suicide 2) To reduce suicide risk, clinicians must carefully monitor veterans with depression, whether treated or untreated.
I will discuss three types of scientific studies: randomized controlled clinical trials (comparing antidepressants and placebo), observational studies, and post-mortem studies. Three types of suicidality are reported in these studies: suicidal thinking, suicide attempts and suicide deaths.
In 2004, the FDA reviewed 25 pediatric clinical trials for antidepressants involving over 4400 subjects and found that patients randomized to antidepressants were about twice as likely to report suicidality. However only 3 percent reported suicidality – mostly suicidal thinking. There were no suicide deaths.
In 2006 the FDA reviewed 295 clinical trials of antidepressants for adults involving over 75,000 participants. Less than 1 percent reported suicidality, mostly suicidal thinking. Unlike pediatric trials, adults randomized to antidepressants were NOT more likely to report suicidality. In fact, antidepressants conveyed significant protection from suicidality for ages 65 and higher.
At least one, large longitudinal observational study of mood disorders, funded by the NIMH, extended the clinical trial conclusions, finding that antidepressants significantly reduced risk of suicide attempts and suicide deaths in adults.
Our research group at Cornell conducted post-mortem studies of suicide deaths in New York City. 95 percent of the youth suicides and 77 percent of adult suicides had NOT taken antidepressants immediately before their deaths. This suggests that prevention of suicide requires intervention primarily among patients who are not receiving antidepressants.
A cause and effect relationship has not been established between antidepressants and suicide. In light of the suicide risk in depression, a prudent recommendation is that veterans, whether treated or untreated, must be appropriately monitored by clinicians. In conclusion, I would like the committee to recognize that depression is itself a risk factor for suicide. To leave these men and women untreated is to accept suffering from the disorder itself.