August 15, 2014 — A group of researchers from the Androgen Study Group (ASG) is asking the Journal of the American Medical Association (JAMA) to retract a study linking testosterone therapy with increased cardiovascular risks.
The study prompted the U.S. Food and Drug Administration (FDA) to launch a safety review of testosterone products and sparked a wave of lawsuits and class actions.
In a 13-page complaint, the ASG asked the Journal Oversight Committee to investigate violations of “accepted standards of medical journal ethics and editorial integrity.” The group says the study is “no longer credible” due to errors, and the failure of JAMA to alert the public of the correction amounts to an “active form of deception.”
JAMA made two formal corrections involving data errors. One correction clarified that results were based on Kaplan-Meier estimates and not raw data. The other correction re-classified about 100 patients and excluded them from the study because they were women.
These corrections did not change the conclusions of the study. The authors of the study are not accused of misconduct or fabricating any data. JAMA stands by their decision to publish the study. The authors clearly stated that it was an observational study and does not conclude causality.
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