Leah Harris Letter to the FDA — (National Association for Rights Protection and Advocacy)

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National Association for Rights Protection and Advocacy

Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee
of the Anti-Infective Drugs Advisory Committee
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0001

April, 2004

Dear Committee and Subcommittee Members:

I am here today to tell you about my experiences while taking selective seratonin reuptake inhibitor (SSRI) antidepressants as a child and teenager in the late eighties and early nineties.

I was first diagnosed with major depression in 1983 at the age of six, and started on the older form of tricyclic antidepressants. In 1988, when I was twelve years old, my doctor started me on Prozac, touting it as a miracle drug that would finally cure my stubborn feelings of depression stemming from early childhood trauma.

Once on Prozac, the relatively mild depression I felt mixed with a new and terrifying anxiety that I had never experienced previously. When I reported this anxiety to my doctor, he simply upped my dose of Prozac. I immediately began to experience insomnia, for which I was given a mild sedative to help me sleep at night. I felt a horrific inner restlessness, a feeling of wanting to jump out of my skin, that I now know is called akasthisia.

For about two years, my dosage of Prozac was continually being raised in hopes that it would finally start to work. From the beginning, I began to suffer from brief but regular periods of racing thoughts that I could not control. All this anxiety and restlessness was simply attributed to my worsening “illness.” I began to have intense thoughts of cutting myself, killing myself. It occurred to me that I should act on my thoughts of self-mutilation, and began to slice my wrists and forearms with razors. This too, was chalked up to my advancing mental illness, and I began a long downward spiral of hospitalizations, which fed the feelings of depression and anxiety. In 1991, at age sixteen, while taking Zoloft, I made my first bona fide suicide attempt, swallowing an entire bottle of painkillers. I cannot even recall the reason for doing so. I became completely unable to control feelings of terror and rage that seemed to come out of nowhere, surpassing any teen angst or depression that I had ever heard of.

In 1993, at the age of eighteen, I decided to take matters into my own hands as a legal adult, and to get off the antidepressants for good. Since stopping SSRI medications over a decade ago, I have never again self- mutilated, had suicidal thoughts, or entered the hospital. The suicidality simply vanished! For me, this is clear proof that the drugs must have played some kind of role in my suicidality and self-mutilation. In the past decade, not only am I not suicidal, but I have managed to travel the world, get an M.A. degree in political science from Georgetown University, and become an active participant in my society.

I tried to forget the past and get on with my life, but I was haunted by the bewildering experiences I had endured. A few years ago, I started to read up on everything I could find about SSRI-induced suicidality in both children and adults. When I began to hear last year about the reports coming out of Great Britain about children and SSRI medications, I felt enormously vindicated. There was finally an explanation for my experiences. If only my doctors, my family, and I had had access to this information connecting SSRIs with self-mutilation and suicidality in some children! Perhaps my complaints and behavior might have been interpreted differently. Perhaps some of the anguish that I experienced as a child could have been prevented. Despite all I went through, I know I am one of the lucky ones, because I am still alive to tell the tale of what I experienced. I have met too many grieving parents whose children were successful in their suicide attempts while on these medications.

Today I work with many organizations fighting for the rights and empowerment for people diagnosed with mental illness, and I am on the Executive Board of the National Association of Rights Protection and Advocacy, a independent organization which exists to shed light on coercive and dangerous practices in the field of mental health.

It is now incumbent upon the FDA to take seriously the British decision December 2003 banning all SSRIs (except Prozac) for under-18s. There is a growing and consistent body of research available that suggests a causal relationship between SSRIs and self-mutilation and suicidality in some children–and in some adults as well. The FDA must take action now regarding this grave issue of public health. The FDA needs to determine not only the issue of adverse events, but also that of efficacy. Do SSRIs really work better than the drugs they were designed to replace? Do the benefits of these antidepressants outweigh the risks for children, and adults, for that matter? Are medical professionals and the public adequately informed of the very serious risks that are increasingly associated with these drugs? In light of these risks, at the very least, isn’t it time for the FDA to require that these medications be labeled with clear warnings that can save lives? Yes, such warnings may negatively affect the sales of these drugs, which may not sit well with the pharmaceutical industry that makes them. But the FDA was created as an independent regulatory agency to serve the interests of the American public–not the pharmaceutical industry. I am here today with the high hopes that the FDA will take the necessary steps to prevent what happened to me and countless other American children from continuing to occur. Our children are not any less precious than British children–and they are in need of our protection.

Thank you for your attention to this matter.

Sincerely,

Leah Harris
Board Member
National Association for Rights Protection and Advocacy (NARPA)