In May, the FDA expanded the approval of drug giant AbbVie’s SSRI escitalopram (Lexapro) to include children ages seven and older who suffer from anxiety. The basis for the approval was a clinical trial conducted by AbbVie employees, with an article written by AbbVie’s ghostwriting company.
Researchers randomly assigned 275 children aged 7 to 17 with a diagnosis of generalized anxiety disorder (GAD) to receive either Lexapro or a placebo. The trial lasted eight weeks.
The results were mixed. On the 30-point PARS-GAD anxiety measure, there was a mean difference of 1.42 points between the drug group and the placebo group (statistically significant p < 0.05, but not significant p < 0.01). This is the finding that supports the FDA approval.
However, the researchers also found that there was no difference between groups in response to medication, remission from anxiety, and general functioning. That is, roughly the same number of children, on both the drug and the placebo, experienced clinical improvement (“response”) or no longer had anxiety (“remission”). Neither drug improved overall functioning.
Worryingly, Lexapro also increased suicidal tendencies six-fold. In the escitalopram group, 9.5% of the children were suicidal compared with 1.5% in the placebo group. One patient actually attempted suicide in the escitalopram group (versus none in the placebo group).
This is particularly notable since having a diagnosis of depression or suicidal ideation were exclusion criteria for the study, meaning that children were Not depressed or suicidal when they started drug trials.
The conclusions of the researchers? Although the same number of children are improving whether they received the drug or the placebo and the tendency to commit suicide is increasing six times in those who took the drug, they write:
“This large, multi-center study replicates previous studies demonstrating the efficacy of escitalopram in adolescents with GAD and extends these findings to children aged 711 years. Furthermore, the study suggests that escitalopram is generally well tolerated in children and adolescents.
SSRIs (such as Lexapro), while often prescribed to people at risk of suicide, have repeatedly been shown to increase the risk of suicide, particularly for children and adolescents. That’s why the FDA has required a “black box warning” on SSRIs to let consumers know that the drugs make children and adolescents suicidal.
Forest Labs (which has since been bought by Allergan, which has since merged with AbbVie) paid out $313 million in 2010 for obstruction of justice, illegal marketing, kickbacks and false insurance claims related to Lexapro and other drugs.
Among other controversies, AbbVie was forced to pay $24 million in 2018 and another $25 million in 2020 to settle lawsuits related to illegal kickback practices and illegal marketing for its various drugs. Additionally, Allergan was one of the major companies accused of creating the opioid crisis by illegally marketing opioids. Last year, AbbVie agreed to pay $2.37 billion to settle these allegations.
This study was published inJournal of Child and Adolescent Psychopharmacology. Like most published reports on clinical trials of drugs today, the drug company’s employees were listed as the authors and it paid a medical writing firm, Prescott Medical Communications Group, to write the article. In fact, AbbVie clarified that it controlled all aspects of the process, writing that it “funded this study and participated in the study design, research, analysis, data collection, data interpretation, and publication review and approval.”
The first author was Jeffrey R. Strawn of the University of Cincinnati Medical Center. While he is not an employee of AbbVie or the companies AbbVie paid to conduct the study, the document’s disclosures state that he received research funding from Abbvie.
The authors Edward Greenberg, Chengcheng Liu and Mallika Gopalkrishnan are direct employees of AbbVie. The authors Leslie Moldauer, Rebekah D. Hahn, Alexandria Wise, Kristina Bertzos and Beth Eisenberg all employed Syneos Health, an AbbVie-funded company, to conduct the study. James A. Knutson, the article’s last author, owns Core Clinical Research, another such company. Author Molly McVoy has received a grant from the Hartwell Foundation, which focuses on expanding biomedical interventions in children.
Carol Brown, the Prescott Medical Communications employee who wrote the article, is not listed as the author. As is now commonplace for such “ghost authors,” she is instead recognized for her “writing and editorial assistance” of hers.
It is usually necessary for an article to specify what work each individual listed author did on studying and writing the article. Here is that paragraph in this study:
“All authors contributed to data interpretation and provided critical reviews of all draft articles.”
As can be seen from this acknowledgment, there is no claim that the named authors designed and conducted the study or wrote the article. The published article is AbbVie’s report on its trial and, not surprisingly, the article comes to the conclusion that escitalopram is safe and effective in children, even though in the same article the published data speak of a drug treatment that is ineffective in children and increases the likelihood of them becoming suicidal. It is, of course, the conclusion that AbbVie will now use to market escitalopram for use in children.
Strawn, JR, Moldauer, L., Hahn, R.D., Wise, A., Bertzos, K., Eisenberg, B., and Knutson, JA (2023). A double-blind, placebo-controlled, multicenter study 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)
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