The frequently recommended antidepressant Paxil (paroxetine) is actually powerless and unsafe for teenagers, a recent study has shown. This contradicts previous findings published in 2001 which had deemed the drug “generally well tolerated and effective”.
The paper was published on Thursday in The BMJ, as part of the “Restoring Invisible and Abandoned Trials”(RIAT) initiative, which tests the accuracy of already published studies. It has been proven that none of the 22 experts who were believed to have written the study actually contributed to it.
Instead, the supposed findings were ghostwritten by a medical consultant appointed by GlaxoSmirthKline (GSK), the antidepressant’s manufacturer. Multiple transcription errors were identified, as well as the violation of protocols related to statistical analysis.
In addition, the antidepressant was proven to be as ineffective as a placebo, but much more harmful: throughout the years there have been several lawsuits filed against the company by parents of teenagers who had experienced serious adverse reactions to the drug.
As a result, the BMJ urges for the misleading paper to be retracted, but so far no comment was made by the American Academy of Child and Adolescent Psychiatry, which first published the findings in its journal.
The original experiment included 275 clinically depressed people, aged 12 to 18, and the aim was to compare the effectiveness of paroxetine and imipramine (sold as Tofranil) against a placebo. Each subject took one of the drugs or the placebo for a period of 8 weeks and eventually it was found that paroxitine was indeed beneficial and fit for use.
However, in 2002, when the U.S. Food and Drug Administration (FDA) verified the findings, it concluded that the study had been unsuccessful, because there wasn’t a noteworthy improvement for the group of patients who took Paxil versus the control group who received a placebo.
Moreover, the review pointed out that paroxetine users were significantly more emotionally labile, suicidal and inclined to harm themselves, while those who took imipramine experienced cardiovascular issues.
Despite these warnings, millions of children and teenagers were prescribed the controversial drug, which remained in demand, until 2012 when its popularity was dented.
That year, GSK was fined $3 billion for advertising the antidepressant despite its severe side effects, but the pharmaceutical company defended itself, claiming that all such drugs come with a warning of increased suicide risk.
Indeed, Paxil is a selective serotonin reuptake inhibitor (SSRI), and such drugs have been known to increase suicide ideation among children and adolescents, especially within the first months of treatment.
Nevertheless, according to Dr.Fiona Godlee, editor-in-chief of the BMJ, the fact that manufacturers have continued to make this potentially harmful antidepressant available is proof of “the extent to which drug regulation is failing us”.
Instead of being handled objectively, many studies are sponsored by companies that sway results, in order to reflect their own economic interests. As a result of more scrutiny from consumer rights organizations, the number of retracted studies is ten times higher now than in 1975.
Experts who analyzed 2,046 retractions in 2012 showed that more than half of these (67.4%) were as a result of fraud, misconduct or plagiarism.
Due to this worrying trend, it becomes apparent that more published studies should be replicated to test their validity. Otherwise, they might perpetuate potentially dangerous behavior, with unpredictable consequences.
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