August 15, 2014 — A complaint has been filed against the Journal of American Medical Association (JAMA) for publishing a study linking testosterone therapy with a 30% increased risk of heart attack, stroke, and death.
When the study was published in November 2013, it set off a firestorm in the medical community, prompted the U.S. Food and Drug Administration (FDA) to launch a safety review, and spawned dozens of lawsuits and class actions.
The 13-page complaint was filed by a group of researchers and doctors affiliated with the Androgen Study Group (ASG). It is the second time the group has asked for the study’s retraction this year.
The group is calling on the Journal Oversight Committee to investigate “a major breach of editorial ethics” and violations of “accepted standards of medical journal ethics and editorial integrity.”
The complaint cites two corrections JAMA made to the study. One correction clarified that the results were not based on raw data, but rather Kaplan-Meier estimates. The other correction excluded about 100 patients who were women.
Neither of the two corrections changed the results of the study or its conclusions. The researchers are not accused of fabricating any data or misconduct. Both JAMA and the authors stand by the study. They have also reiterated that it is an observational study and has not concluded cause-and-effect.
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