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Antidepressant Ban for Kids Puts Pressure On U.S. / Canada
he British government ban for use of all but one SSRI antidepressant drug in children and teens (Dec 10, 2003) is reverberating wherever these drugs are widely prescribed. The action was taken after an independent committee of experts examined the raw data from controlled clinical trials that had been conducted by these drugs' manufacturers. The evidence shows that contrary to the claims made by their promoters, SSRIs are neither effective against depression in children, nor safe. The hazards posed by SSRIs--of which the most serious is self-harm and aggression toward others--had been detected during company controlled clinical trials, but the hazards were concealed--even in published reports in academic journals. Thus, doctors who prescribed the drugs and patients and families for whom they have been prescribed were kept in the dark.
Neither the leading experts in psychiatry nor officials of the FDA (or equivalents in the UK) noticed these suicide findings. A British journalist not trained in science readily detected the problem and brought it to public attention.
* How do officials in the UK and US regulatory agencies explain their failure to protect children from hazardous drugs that are no more effective than placebo? * How do regulators explain their role in helping drug companies conceal the evidence by not even examining the efficacy and safety data from clinical trials submitted to them 7 years ago? * How do regulators explain their failure to read the published reports and to inform the public about findings of potential hazards? * How do regulators explain their failure to request long-term studies to ensure that these problematic drugs don't pose irreversible damage?
The regulatory agencies failed to examine the data even as a body of evidence accumulated from case reports of drug-induced adverse reactions. Only after the manufacturers sought to obtain a marketing license for depressed children did the British authority convene an expert panel to examine the raw data from previous pediatric trials. On Dec. 11, Health Canada announced it will review the data as well. See: www.cbc.ca/cgi-bin/templates/print.cgi?/2003/12/12/Consumers/ssri031212
A two part article in the Canadian Sterling News Service reports that warnings by the British authority in June, prompted Canadian doctors to ask serious questions and to re-examine the wisdom of prescribing antidepressant drugs for children, inasmuch as the evidence from clinical trials clearly shows that children may be helped equally by the placebo effect without the drug-related risks.
For example, Dr. Jane Garland, director of the mood disorders clinic at British Columbia Children's Hospital, and one of the investigators who tested SSRIs in clinical trials, put it this way: "As physicians, we want to be helpful, but we often suffer individually and collectively from a pharmacological imperative: If we have a drug, we feel compelled to prescribe it." Dr. Garland acknowledges, "We suffer from excessive therapeutic optimism."
But a re-examination of the data led her to conclude: "If it were ethical, placebo treatment would be the recommended first step. Alternatively, supplements such as omega-3 fatty acids could be plausible and inexpensive 'active' placebos."
Antidepressant Ban for Kids Puts Pressure On U.S. / Canada
he British government ban for use of all but one SSRI antidepressant drug in children and teens (Dec 10, 2003) is reverberating wherever these drugs are widely prescribed. The action was taken after an independent committee of experts examined the raw data from controlled clinical trials that had been conducted by these drugs' manufacturers. The evidence shows that contrary to the claims made by their promoters, SSRIs are neither effective against depression in children, nor safe. The hazards posed by SSRIs--of which the most serious is self-harm and aggression toward others--had been detected during company controlled clinical trials, but the hazards were concealed--even in published reports in academic journals. Thus, doctors who prescribed the drugs and patients and families for whom they have been prescribed were kept in the dark.
Neither the leading experts in psychiatry nor officials of the FDA (or equivalents in the UK) noticed these suicide findings. A British journalist not trained in science readily detected the problem and brought it to public attention.
* How do officials in the UK and US regulatory agencies explain their failure to protect children from hazardous drugs that are no more effective than placebo? * How do regulators explain their role in helping drug companies conceal the evidence by not even examining the efficacy and safety data from clinical trials submitted to them 7 years ago? * How do regulators explain their failure to read the published reports and to inform the public about findings of potential hazards? * How do regulators explain their failure to request long-term studies to ensure that these problematic drugs don't pose irreversible damage?
The regulatory agencies failed to examine the data even as a body of evidence accumulated from case reports of drug-induced adverse reactions. Only after the manufacturers sought to obtain a marketing license for depressed children did the British authority convene an expert panel to examine the raw data from previous pediatric trials. On Dec. 11, Health Canada announced it will review the data as well. See: www.cbc.ca/cgi-bin/templates/print.cgi?/2003/12/12/Consumers/ssri031212
A two part article in the Canadian Sterling News Service reports that warnings by the British authority in June, prompted Canadian doctors to ask serious questions and to re-examine the wisdom of prescribing antidepressant drugs for children, inasmuch as the evidence from clinical trials clearly shows that children may be helped equally by the placebo effect without the drug-related risks.
For example, Dr. Jane Garland, director of the mood disorders clinic at British Columbia Children's Hospital, and one of the investigators who tested SSRIs in clinical trials, put it this way: "As physicians, we want to be helpful, but we often suffer individually and collectively from a pharmacological imperative: If we have a drug, we feel compelled to prescribe it." Dr. Garland acknowledges, "We suffer from excessive therapeutic optimism."
But a re-examination of the data led her to conclude: "If it were ethical, placebo treatment would be the recommended first step. Alternatively, supplements such as omega-3 fatty acids could be plausible and inexpensive 'active' placebos."
Antidepressant Ban for Kids Puts Pressure On U.S. / Canada
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