Pharma marketed antidepressants to children after hiding the risk of suicide and aggression revealed by clinical trials
by: Evelyn Pringle
A BMJ press release reported, "Children and adolescents have a doubled risk of aggression and suicide when taking one of the five most commonly prescribed antidepressants," according to a study published in The BMJ on January 28, 2016.
Selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) are the most commonly prescribed antidepressants, the release notes.
Researchers from the Nordic Cochrane Centre in Denmark carried out a systematic review and meta-analysis of 68 clinical study reports of 70 trials involving 18,526 patients to examine use of antidepressants and associated serious harms, including "deaths, suicidal thoughts and attempts as well as aggression and akathisia, a form of restlessness that may increase suicide and violence."
But "because of the poor design of clinical trials that assess these antidepressants, and the misreporting of findings in published articles," the experts report, "the true risk for all associated serious harms—such as deaths, aggression, akathisia and suicidal thoughts and attempts—remains unknown for children, adolescents and adults."
The researchers examined "trials that contained patient narratives or individual patient listings of associated harms," the authors explained, that "are often not included in published trial reports." They also "analysed clinical study reports, prepared by pharmaceutical companies for market authorisation, and summary trial reports, both of which usually include more information."
Clinical study reports for duloxetine (Cymbalta), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft) and venlafaxine (Effexor) were from regulatory agencies in the UK and Europe. Reports for duloxetine and fluoxetine were also taken from Eli Lilly's website.
"However, clinical study reports could not be obtained for all trials and all antidepressants, and individual listings of adverse outcomes for all patients were available for only 32 trials," the release noted.
"The true risk for serious harms is still unknown [because] the low incidence of these rare events, and the poor design and reporting of the trials, makes it difficult to get accurate effect estimates," the study's authors explained.
The researcher's found limitations in trial designs and reporting that may have lead to "serious under-estimation of the harms," the authors wrote.
They compared the results from the study reports with individual patient listings or narratives of adverse effects. "This revealed misclassification of deaths and suicidal events in people taking antidepressants. For example, four deaths were misreported by a pharmaceutical company, in all cases favouring the antidepressant, and more than half of the suicide attempts and suicidal ideation, for example, were coded as 'emotional lability' [sic] or 'worsening of depression,'" the press release reported.
"In the summary trial reports on Eli Lilly's website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was incomplete," the authors wrote in the BJM study.
"Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms could not be estimated accurately," they concluded.
"Many cases of aggressive behaviour have been reported," they wrote, "but, unlike with suicidality, little systematic research has been undertaken." Perpetrators of school shootings and similar events have often been reported to be users of antidepressants and the courts have in many cases found them not guilty as a result of drug induced insanity, they point out in the study.
"We believe our study shows that, despite using clinical study reports, the true risk for serious harms is still uncertain," they wrote. "The low incidence of these rare events and the poor design and reporting of the trials makes it difficult to get accurate effect estimates."
Therefore, the authors "suggest minimal use of antidepressants in children, adolescents, and young adults, as the serious harms seem to be greater, and as their effect seems to be below what is clinically relevant," they advised in the study.
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