Former Food and Drug Administration (FDA) Commissioner David Kessler told jurors in the first bellwether trial over alleged testosterone side effects that in his opinion manufacturers of the male hormone overstepped federal regulatory boundaries when they aggressively marketed the treatment directly to consumers without proper testing, according to Law360.
Kessler was called as the first witness in the case of Jeffrey Konrad, who claims that he was lured by AbbVie’s ads for the testosterone gel AndroGel for a condition the drug company made up called “Low T.” The ads claimed that Low T could cause low libido, weight gain, muscle loss and mood swings, but AndroGel could reverse those effects.
Allegedly prompted by the ads, Konrad asked his doctor to prescribe him AndroGel. Two months later, Konrad suffered a heart attack. He later learned that testosterone replacement therapy had been linked to adverse cardiovascular effects including heart attacks, strokes, blood clots and death.
Konrad’s case is the first to be tried among about 4,200 that blame several testosterone treatment manufacturers for aggressively marketing their products without fully disclosing the risks. AbbVie faces the bulk of the suits from its top-selling AndroGel. Other manufacturers named in the suits include Eli Lily & Co. and Endo Pharmaceuticals.
Kessler said that when AndroGel was approved by the FDA for sale in 2000, it was only intended for a limited number of diseases that led to hypogonadism, a condition in which the body does not produce enough testosterone. It was never intended for age-related hypogonadism. Yet, AndroGel manufacturers marketed the drug to doctors and consumers as being a beneficial treatment for aging men with naturally declining testosterone, Kessler said.