UMass Boston Researcher: Clinical Practice Guidelines May Pose Health Risk


A team of researchers from the University of Massachusetts Boston, Tufts University Medical School, and the University of Alabama have found that there was not enough data to support the treatment recommendations contained in a new guideline for Major Depressive Disorder (MDD) with mixed features, and that the guideline may pose a health risk.The new guideline, published in the journal CNS Spectrums, recommends expensive patented antipsychotic medications, such as Saphris ($1,000 per month) and Latuda ($500 per month), even in children, as a first-line intervention. The research team found that the guideline did not meet any of the Institute of Medicine’s (IOM) standards for trustworthy guidelines. The researchers’ paper, “When is a guideline not a guideline? The devil is in the details,” is published in the journal BMJ Evidence-Based Medicine.

The researchers, who examined the clinical trial data, said that the recommendations were based mainly on post hoc analyses and that there was not enough data to support the recommendation for long-term treatment with an antipsychotic. The team also found significant commercial ties between the developers of the guideline and the drug companies whose products they recommended in the guideline: 13 out of 20 guideline panel members, including the first author of the guideline, had financial conflicts of interest. The lead author of the guideline is the editor-in-chief of CNS Spectrums.

“If a guideline is not evidence-based and is unduly influenced by industry, rather than enhance evidence-based practice, it could actually pose a public health risk,” said Lisa Cosgrove, PhD, a professor of counseling and school psychology at UMass Boston and lead author of the BMJ paper.

The guideline was described on Medscape as the “first ever” guideline for MDD with mixed features, but there was no information given that suggested it was vetted by any professional organization.

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