I wrote this letter to Dr. Thomas A. M. Kramer at the University of Chicago who wrote an article in Medscape entitled "Talking Points About Antidepressants and Suicide." He never acknowledged it but subsequently he wrote another somewhat more cautionary article entitled "All the Things They Taught Us That Were Wrong."
Dear Dr. Kramer,
Your recent article in Medscape has been brought to my attention. You are a doctor and a professor. I am just the mother of a wonderful young woman who died from a Paxil induced suicide. Yet from just two years of intensive study of the subject as well as communication with countless victims of SSRI induced suicide and harm, I feel I have a better understanding of some of the issues than you demonstrate in your article.
You do not cite any scientific evidence for your assertion that there have been “numerous satisfied patients and practitioners.” Like the evidence for suicide and harm, this is largely “anecdotal.” Professionals do attest to seeing benefit in their patients but clinical trials indicate that at least some, if not all, of this benefit could be attributed to the placebo effect. Beyond that antidepressants are known to be stimulants and undoubtedly do change mood as a result of this effect, but the long term impact of taking a stimulant has not been properly studied. The chemical dependency created by antidepressants is rarely explained to patients commencing treatment and when they stop the rebound from this dependency is often mistaken for a relapse of disease.
There are several reasons why questions about SSRIs are finally getting the attention they deserve. First of all the huge increase in their use has finally resulted in a critical mass of victims who previously thought that they were alone. The rise of the Internet has enabled them to find each other and the small group of dedicated professionals who are trying to understand what is going on. It has also opened up access to what little research there is on the issue.
The fact that Prozac was exonerated after the first hearing on the subject in 1991 greatly slowed the process of uncovering the truth. A research study was proposed at the time of that hearing but was never undertaken. Lawsuits were filed against Eli Lilly and documents had to be handed over revealing the company’s awareness of the issue even before approval and their effort to control it. In Germany, Lilly was required by the regulatory agency to include in their package insert a warning for the possible need for a concomitant sedative in the initial weeks of treatment. This was not on the label in the U.S.
Many other antidepressants came on the market in the next ten years and sales skyrocketed. Paxil, as I’m sure you are aware, causes more problems in withdrawal or with missed doses. It became the number one selling antidepressant in Britain and awareness of problems with withdrawal became widespread prompting an investigation by BBC reporters. After a documentary was aired on national television the BBC received an unprecedented response from over 65,000 people. Included in the many responses were stories of at least two dozen suicides linked to Paxil. This led to another documentary on the suicide issue. Pressure mounted on the regulatory authority in Britain to do further investigation and when they did, they found a number of clinical trials which had never been published showing “inconvenient” results about both the risk and benefit of the drug. Last year the MHRA (the British equivalent of the FDA) issued a ban on all antidepressants except Prozac for use in children. Shortly afterward Eli Lilly changed their doctor’s fact sheet in the U.K. to state that Prozac was not recommended for use in children. They have not made this change in the U.S. A pdf file of the U.K. doctor’s fact sheet is available on ahrp.org.
This is some of the background to the February hearing and recent advisory. Two major articles were published this month, one in the British Medical Journal and one in Lancet, attesting to a lower benefit and higher risk demonstrated in several unpublished trials. Only trials that help with approval are usually published. This does not make for a very objective process. The FDA simply does not have the means at its disposal to keep rigorous control especially in the field of psychiatry where symptom diagnosis and improvement are subjective. Most antidepressant trials only run for 8-10 weeks and no follow-up on long-term use has ever been done. Yet patients are being put on these drugs and left on them for years. Furthermore no study of suicidal effects has been undertaken. In general every effort is made to rule out suicidal patients in clinical trials. No objective way of measuring degrees of suicidality has ever been defined. Despite this, suicidal acts have still been shown to increase in patients taking antidepressants over those on placebo when they are compared in clinical trials.
The FDA has not issued the advisory lightly on the basis of a cursory reading of misrepresented data or on claims of bereaved and, some would say, misguided families. To say this is dangerous and naïve. While it is true that no child has committed suicide out of the 1700 in the few trials that are under immediate review of the Columbia project now, in a much wider review by Dr. Arif Khan that covered over 71,000 adult trial participants the number of suicides on antidepressants was substantial and higher than in untreated patients. Over 60 families testified at the hearing on February 2nd and the stories were chilling as well as highly repetitive. The people who are dying are not ones, in most cases, who were given the drug for major depression or people who had ever expressed suicidal thoughts. This was a refrain heard over and over again. These were not people anyone was expecting to commit suicide, not people who needed to be watched for suicidality. This is a very important point. These suicides are not ones committed out of a sense of hopelessness and despair as we so often assume suicides are. They are impulsive, violent, and out of character. People who have survived suicide attempts on the drugs describe an out of body, intensely dissociative state. No one should underestimate the ability of these drugs to do this. Even if there is only one in a thousand chance that the drug would do this to any one individual, it is such a catastrophic effect that everyone needs to be aware of the possibility, especially when benefits have been exaggerated.
An epidemiological decrease in suicides has been noted in the last ten to fifteen years since antidepressants have been on the market. In fact this has been extremely slight overall and not consistent across age groups most affected by antidepressant usage. An article published last year in World Biological Psychiatry (4: 184-190) is entitled “A Stubborn Behavior: the Failure of Antidepressants to Reduce Suicide Rates.” There was a dramatic increase in the suicide rate between the 1950’s and 1980’s from a much lower rate that had preceded it for decades. The very slight decrease which has occurred in the last years of the ‘90’s could be attributed to other causes and still has not brought us back to where we were before the great increase of the past two generations (which -- perhaps randomly -- happens to coincide with the introduction of older classes of psychotropic drugs). To use epidemiological evidence as proof of benefit is poor science and poor logic.
According to Kay Redfield Jamison, at least 40% of the people who commit suicide have in fact been treated with psychiatric drugs or perhaps “mistreated” is more accurate. The failure of government authorities to collect data on suicides and suicide attempts is hindering a resolution of this issue. Coroners and emergency rooms should be investigating every suicide and suicide attempt for a link to psychiatric drugs. There should be a thorough documentation of the treatment history and analysis of the blood levels of prescription medications should be as routine as it is for illegal drugs and alcohol. This information should be in the public domain. It could be preserved anonymously to protect privacy but it should be collected. Public health and safety are at stake.
Suicide has never been taken seriously as an adverse effect and, even though
de novo suicidal behavior was first described in the early 90’s, the pharmaceutical industry with the unfortunate complicity of the medical profession has shown great determination in suppressing this as an issue. The general public has great faith in our drug approval and safety procedures that is gravely misplaced. Many victims have no idea, in fact, that a drug reaction is the source of their misfortune. I don’t think you can appreciate the strength and courage it takes to face something as horrific as the fact one’s child or loved one has died because of the very treatment that was supposed to help, unless it happened to you. Doctors too are naturally very reluctant to face the truth. No wonder it has taken so long. It is easier to believe it’s the disease even when it makes no apparent sense that it could have been. Many medical professionals, including yourself, tout the great safety of these drugs in overdose, but, in fact, dosing is critical to a safe reaction and many people who die were given doses too large for their metabolic abilities. See medicationsense.com. The risk of suicide from these drugs does not come from the risk of overdose but from something far more sinister and mysterious -- the ways in which they affect brain chemistry.
You mention only two biologically plausible mechanisms for inducing suicide but in fact as long ago as 1993, Martin Teicher and Jonathan Cole in Drug Safety (8:13 pp. 186-212) describe nine different mechanism, including akathisia, switching patients into manic or mixed states, interfering with sleep architecture, and inducing an organic obsessional state. The so called rollback phenomenon which you describe at length is in fact very rare in the case of antidepressant induced suicide. Many victims of antidepressant induced suicide have no history whatsoever of suicidal ideation and were not even given the drugs for a major depressive disorder but rather for such things as anxiety, insomnia, migraine headaches, minor psychosocial ills. Very few of the victims were actually getting better; most of them were getting dramatically worse from the moment they started the medications but were told by their doctors to stop whining and be patient for the several weeks they take to work.
Furthermore what I consider egregious in your article is your failure to mention the grave danger of giving these drugs to someone who may be manic or potentially manic. Dr. Dimitri Papolos refers to this danger several times in his book The Bipolar Child. He says that “the introduction of antidepressants may cause an earlier onset and possibly more virulent course of the illness.” He mentions this as a problem for both children and adults.
Are you aware that many school shooters in the past decade were on antidepressant medication? Eric Harris, the Columbine shooter, was one. He had been on Luvox, now withdrawn from the market, for a year. Three months before the shooting his dose was doubled. Before Luvox, he was on Zoloft and he told his doctor he was having trouble with it. He was unable to concentrate and felt restless. This information about Eric would have been lost from public view forever if a Harris neighbor had not been aware that Eric’s application to the military was rejected because of his treatment with an antidepressant. It took a special request to get the coroner to test his blood level for the presence of the drug. No one should blithely assume that his behavior was not influenced by an adverse reaction to his medication.
Dr. Kramer, I think it is irresponsible of you to say that supposedly mysterious deaths like my daughter’s should be kept quiet so as not to scare other depressed people. People need to take medication with a complete and full understanding of what it can do; they also need to realize that treating depression is more complicated than simply taking a pill. I urge you to do a lot more reading on this subject and educate yourself fully about what antidepressants can really do.
Yours sincerely,