Baltimore Sun Editorial: Do No Harm
Here is an editorial and my reply.
To the Editor,
I have had a problem with having my testimony weighed against Ms. Vogel-Scibilia’s in many press reports around the world. Furthermore I fail to understand your statement that “the consequences of issuing a warning on these drugs . . . are indeed grave.” Far more serious is the failure to have issued proper warnings over the past 17 years since Prozac was first introduced.
Personally I do not believe that Ms. Vogel-Scibilia represented her story honestly and fully. She did not divulge that she was a practicing psychiatrist. Although she indicated she worked for the National Alliance for the Mentally Ill, I am not sure she stated that she was on the Board. Most importantly, she misrepresented the strong ties NAMI has with the pharmaceutical industry. NAMI receives substantial corporate donations from the pharmaceutical industry which contribute not only to its core budget but also, in some cases, fully fund special campaigns such as an antidiscrimination campaign which had a $4 million budget in 1999. NAMI has even had executives from drug companies, such as Eli Lilly, “on loan” working out of the organization’s headquarters. Many critics of NAMI argue that the group’s corporate sponsors help shape its agenda. The group is known to view mental illness as a disease which can be treated most effectively with medications. I have to ask myself whether Dr. Vogel-Scibilia’s primary motive in testifying before the FDA advisory committee was her genuine belief in the benefits antidepressants had conferred on her children or a defense of NAMI’s interests.
Dr. Vogel-Scibilia spoke of the fact two of her children were able to lead full and productive lives as a result of the medications. Yet this is simply an assertion. She gave no examples of exactly what this really means. She certainly did not bring her children along with her to have them testify on behalf of the drugs themselves. Compare this both with the factual nature of my own testimony in which I graphically represented exactly what happened to my daughter over the course of her time on Paxil and with the testimonies of several children who attended the hearing in person to speak themselves of the harm these drugs had done to them. Furthermore, even more shocking to me, is the fact that she never acknowledged her own manic depression and personal experience on the drugs. In 2001, she was quoted as saying that when she was 15 she “started therapy and was ‘on the wrong meds with the wrong diagnosis for a long time.’ When she went into her winter depressions, her doctors would put her on antidepressants, which would sometimes cause manic spells. They would then give her antipsychotic drugs.” When I came across this article quoting her I was utterly shocked. Here is someone who has experienced the very thing about which we victims are trying to get warnings and yet she is standing up defending drug industry policies as if they were her own.
Your editorial made many good points but it still seemed hesitant on the implications of issuing honest warnings about akathisia and drug-induced agitation, especially in the early weeks of treatment or when dosages are increased or stopped abruptly. What harm can honesty and education about this clearly demonstrated phenomenon possibly do? It is a strong predictor of violent behavior. If the doctors treating my daughter or myself as a parent had really been made aware of this syndrome and its seriousness, Cecily would be alive today. I am certain of that. I am not calling for a ban on these drugs, simply clear and effective warnings about a very serious side effect. If the whole truth frightens patients or doctors, that does not mean it should be hidden when lives are at stake. Untreated depression, of course, is dangerous, but let’s not assume the only or best treatment for depression is an antidepressant, especially one that is given without all the facts. I hope as you do that the FDA investigation will answer some questions about the drugs but they had the opportunity 12 years ago to act and did not do so; I hope this time will be different.
February 13, 2004
TESTIFYING BEFORE the Food and Drug Administration about the effects of antidepressants on their children, Sara Bostock and Suzanne Vogel-Scibilia graphically illustrated the dilemma facing the federal agency. Ms. Vogel-Scibilia said the medications had enabled her two children to lead full and productive lives. Ms. Bostock's daughter, Cecily, stabbed herself to death two weeks after starting on the drug Paxil.
The consequences of issuing a warning on these drugs - known as selective seratonin reuptake inhibitors (SSRIs) - are indeed grave, and the FDA has chosen wisely to proceed with caution. Its decision to seek an independent review of industry-sponsored drug trials on SSRIs should help clarify a situation beset by flawed data, emotional personal stories and doubts about the efficacy of the drugs. Until then, parents of children on the medications should keep a close eye on the children's behavior and confer routinely with their physicians or psychiatrists.
Most of us know these medications by their brand names: Prozac, Zoloft, Paxil, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron. Questions arose about suicidal tendencies in children who take the drugs over a year ago, but Britain's decision in December to restrict use of the medications in children pushed the issue to the forefront. As many as 2.1 million American children take the drugs. So why shouldn't the United States follow Britain's lead?
The truth is that none of the trials in which 4,000 children participated conclusively attributed suicidal tendencies to use of the drugs. And, more to the point, clinicians and researchers have identified a series of flaws in the trials, most notably that the drug companies never determined if SSRIs were effective in children. Also, the drug trials were not designed to test whether the medications caused suicidal tendencies.
The inconsistencies, questions and conflicts in the trials require a second, more intensive review of the data, which the FDA has asked researchers at Columbia University to do. Until the teams return with their findings in the summer, parents should proceed with an abundance of caution.
Medication should be only one aspect of a treatment plan that includes therapy with a mental health professional. Physicians should engage parents and patients in a conversation about the FDA's findings to prevent hasty, uninformed decisions to stop taking their medication.
But the practice of prescribing medications - whatever they may be - that have not been tested on children needs to be re-evaluated. Changes in the health care delivery system, restrictions on mental health coverage and the limited availability of child psychiatrists (there are only 6,000 in the country) require that pediatricians and family physicians be properly trained in the use of psychotropic drugs.
Suicide remains a serious problem among youths. The FDA-sponsored review of SSRIs will help save lives, no matter its conclusion.
Copyright © 2004, The Baltimore Sun
To the Editor,
I have had a problem with having my testimony weighed against Ms. Vogel-Scibilia’s in many press reports around the world. Furthermore I fail to understand your statement that “the consequences of issuing a warning on these drugs . . . are indeed grave.” Far more serious is the failure to have issued proper warnings over the past 17 years since Prozac was first introduced.
Personally I do not believe that Ms. Vogel-Scibilia represented her story honestly and fully. She did not divulge that she was a practicing psychiatrist. Although she indicated she worked for the National Alliance for the Mentally Ill, I am not sure she stated that she was on the Board. Most importantly, she misrepresented the strong ties NAMI has with the pharmaceutical industry. NAMI receives substantial corporate donations from the pharmaceutical industry which contribute not only to its core budget but also, in some cases, fully fund special campaigns such as an antidiscrimination campaign which had a $4 million budget in 1999. NAMI has even had executives from drug companies, such as Eli Lilly, “on loan” working out of the organization’s headquarters. Many critics of NAMI argue that the group’s corporate sponsors help shape its agenda. The group is known to view mental illness as a disease which can be treated most effectively with medications. I have to ask myself whether Dr. Vogel-Scibilia’s primary motive in testifying before the FDA advisory committee was her genuine belief in the benefits antidepressants had conferred on her children or a defense of NAMI’s interests.
Dr. Vogel-Scibilia spoke of the fact two of her children were able to lead full and productive lives as a result of the medications. Yet this is simply an assertion. She gave no examples of exactly what this really means. She certainly did not bring her children along with her to have them testify on behalf of the drugs themselves. Compare this both with the factual nature of my own testimony in which I graphically represented exactly what happened to my daughter over the course of her time on Paxil and with the testimonies of several children who attended the hearing in person to speak themselves of the harm these drugs had done to them. Furthermore, even more shocking to me, is the fact that she never acknowledged her own manic depression and personal experience on the drugs. In 2001, she was quoted as saying that when she was 15 she “started therapy and was ‘on the wrong meds with the wrong diagnosis for a long time.’ When she went into her winter depressions, her doctors would put her on antidepressants, which would sometimes cause manic spells. They would then give her antipsychotic drugs.” When I came across this article quoting her I was utterly shocked. Here is someone who has experienced the very thing about which we victims are trying to get warnings and yet she is standing up defending drug industry policies as if they were her own.
Your editorial made many good points but it still seemed hesitant on the implications of issuing honest warnings about akathisia and drug-induced agitation, especially in the early weeks of treatment or when dosages are increased or stopped abruptly. What harm can honesty and education about this clearly demonstrated phenomenon possibly do? It is a strong predictor of violent behavior. If the doctors treating my daughter or myself as a parent had really been made aware of this syndrome and its seriousness, Cecily would be alive today. I am certain of that. I am not calling for a ban on these drugs, simply clear and effective warnings about a very serious side effect. If the whole truth frightens patients or doctors, that does not mean it should be hidden when lives are at stake. Untreated depression, of course, is dangerous, but let’s not assume the only or best treatment for depression is an antidepressant, especially one that is given without all the facts. I hope as you do that the FDA investigation will answer some questions about the drugs but they had the opportunity 12 years ago to act and did not do so; I hope this time will be different.
