June 9, 2017 — Former FDA Commissioner Dr. David Kessler testified that the testosterone gel AndroGel was marketed by AbbVie Inc. for off-label uses, according to Law360.
Attorneys called Dr. Kessler to the stand as the first witness in the trial of Jeffrey Konrad, a man who suffered a heart attack in 2009 after taking Androgel for “Low T.”
At the time, Androgel was widely marketed for age-related symptoms like depressed mood, sagging muscles, and flagging libido, yet it was only approved for a rare disorder known as hypogonadism that primarily affects men without testicles and causes low testosterone.
According to Dr. Kessler:
“What the companies in essence did was to take those indications of low testosterone in men for specific reasons [and] the company in essence broke that link.”
He said AndroGel “was no longer [being marketed] for specific diseases; it was for low testosterone for a broad range of issues.”
AbbVie is embroiled in a federal litigation involving around 4,200 plaintiffs nationwide who accuse the drug-maker of aggressively promoting AndroGel for unapproved uses while downplaying risks.
AndroGel was not approved for age-related testosterone loss, which naturally occurs at a rate of 1-2% per year after age 40. The FDA did not order AbbVie to clarify the approved indications until March 2015.
AndroGel was already a blockbuster drug by 2015, with sales that year estimated at $2 billion — all despite research linking testosterone therapy with higher rates of stroke, heart attack, and death.
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