in May, FDA extended approval AbbVie’s SSRI escitalopram (Lexapro) is administered to children aged 7 and older with anxiety. The basis for the approval was clinical trials conducted by AbbVie employees and included articles authored by AbbVie’s ghostwriting firm.
Researchers randomly assigned 275 children aged 7 to 17 years diagnosed with generalized anxiety disorder (GAD) to either Lexapro or placebo. The trial lasted eight weeks.
The survey results were mixed. On the 30-point PARS-GAD anxiety scale, there was a mean difference of 1.42 points between the drug and placebo groups (p<0.05 statistically significant, p<0.01 not significant). This is a finding that supports FDA approval.
But researchers also No difference between groups drug response, remission from anxiety, and overall functioning. That is, approximately the same number of children experienced clinical improvement (“Response”) or their anxiety disappeared (“Remission”) regardless of whether they were taking the drug or the placebo. Also, the drug did not improve overall function.
Worryingly, Lexapro also increased suicide rates six-fold. 9.5% of children in the escitalopram group had suicidal thoughts compared to 1.5% in the placebo group. One patient in the escitalopram group actually attempted suicide (none in the placebo group).
This is particularly noteworthy as having a diagnosis of depression and suicidal thoughts were exclusion criteria for this study. no Depression or suicidal ideation at study entry.
What did the researchers conclude?Even though the same number of children who received the drug or placebo improved their symptoms and the suicide rate increased six times People who have taken this drug write:
“This large, multicenter study replicates previous studies demonstrating the efficacy of escitalopram for adolescents with GAD and extends these findings to children aged 7 to 11 years. Furthermore, this study suggests that escitalopram is generally well tolerated in children and adolescents.”
SSRIs (such as Lexapro) have been repeatedly shown to increase the risk of suicide, especially in children and adolescents, even though they are often prescribed to people at risk of suicide. That’s why the FDA mandated “black box warnings” on SSRIs to inform consumers that SSRIs are driving children and teens to suicide.
Forest Labs (later acquired by Allergan, then merged with AbbVie) Paid $313 million in 2010 Obstruction of justice, illegal marketing, kickbacks, and false insurance claims related to Lexapro and other drugs.
AbbVie was forced to pay, among other controversies $24 million in 2018 and another $25 million in 2020 To resolve lawsuits relating to illegal kickbacks and the illegal sale of various drugs. Additionally, Allergan was one of the major companies accused of triggering the opioid crisis by illegally selling opioids. Last year, AbbVie agreed to: pay $2.37 billion to settle these allegations.
Current research Journal of Child and Adolescent Psychopharmacology. Like most current published reports on clinical trials of drugs, the company’s own employees were named as authors, and the medical writing firm Prescott Medical Communications Group was paid to write the articles. Indeed, AbbVie clarifies that it controls all aspects of the trial, writing that it “financed this study and participated in study design, research, analysis, data collection, data interpretation, and review and approval for publication.”
The original author was Jeffrey R. Strawn of the University of Cincinnati Medical Center. Although he is not an employee of AbbVie or the company AbbVie paid to conduct the research, disclosures in his paper state that he received research funding from AbbVie.
Authors Edward Greenberg, Chengcheng Liu, and Mallika Gopalkrishnan are direct employees of AbbVie. Authors Leslie Moldauer, Rebecca D. Hahn, Alexandria Wise, Christina Bertzos, and Beth Eisenberg are all employees of Syneos Health, the company AbbVie funds to conduct the study. The paper’s last author, James A. Nutson, also owns a similar company, Core Clinical Research. Author Molly McVoy received a grant from the Hartwell Foundation, which focuses on expanding biomedical interventions for children.
Carol Brown, a Prescott Medical Communications employee who wrote this article, is not listed as an author. now as usual She is not such a “ghost writer” and is credited for “helping with writing and editing.”
Articles are usually expected to indicate what work has been done in the research and writing of each listed author. Here’s that paragraph from the study:
“All authors contributed to the interpretation of the data and provided critical reviews for all draft papers.”
As can be seen from this acknowledgment, there is no claim that the named author designed and conducted the research or wrote the paper. The published paper is an AbbVie study report, and not surprisingly, it concludes that escitalopram is safe and effective in children, even though the data published in the same paper state that the drug is ineffective in children and increases the likelihood of suicide. Of course, this is the conclusion AbbVie uses to market escitalopram for children.
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Strawn, JR, Moldauer, L., Hahn, RD, Wise, A., Bertzos, K., Eisenberg, B., and Knutson, JA (2023). A multicenter, double-blind, placebo-controlled trial of escitalopram in children and adolescents with generalized anxiety disorder. Journal of Child and Adolescent Psychopharmacology, 33(3), 91-100. http://doi.org/10.1089/cap.2023.0004 (Link)
