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Experts Accuse Testosterone Manufacturers of “Disease Mongering”

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At the beginning of April 2015, over 1,300 lawsuits had been filed in the testosterone therapy MDL taking place in the U.S. District Court for the Northern District of Illinois. The plaintiffs are typically men who suffered serious side effects, such as heart attack or stroke, after taking testosterone replacement drugs.

There is also quite a bit of talk that testosterone replacement manufacturers “made up” a fake disease and then offered the drugs to treat it, misleading thousands of men into asking for prescriptions they didn’t need. A recent editorial in the Journal of the American Geriatrics Society goes so far as to say that testosterone direct-to-consumer product advertising (DTCPA) “is the mass marketing component of disease mongering of age-related declines in testosterone.”

Testosterone Manufacturers Offer Anti-Aging Solution

You’ve probably seen the advertisements. There’s a tired middle-aged or older gentlemen who can’t keep up with his beautiful partner, can’t shoot hoops as well as he used to, or just lacks energy. He uses a testosterone replacement product and immediately gets “back into the game,” acting like he did in his 20s.

The FDA approved the use of testosterone replacement products only for men who don’t produce enough of the hormone because of a medical condition (called “hypogonadism”). Doctors could prescribe it “off-label” if men tested low for testosterone levels, but drug companies took it way beyond that with their marketing efforts.

According to a recent report in Forbes, direct-to-consumer ads attributed symptoms like fatigue, reduced sex drive, and lack of focus to a condition they named “Low-T,” and offered testosterone replacement drugs as solutions. In truth, the advertisements made these drugs look like anti-aging solutions. AbbVie, which manufactures AndroGel, spent $75.6 million on direct-to-consumer marketing in 2012, and nearly that much in 2013.

The problem is that these advertisements downplayed potential side effects, which didn’t really come to light until a couple of studies made it clear that some men may be at risk.

Studies Raise Concerns About Testosterone-Related Heart Attack and Stroke

In 2013, for example, a study published in JAMA reported that older men using testosterone after receiving a coronary angiography were more likely to suffer from heart attack, stroke, and death than those who didn’t take the drugs. A later 2014 study published in PLoS One reported that in men 65 years and older, as well as in younger men with pre-existing heart disease, risk of heart disease and heart attack increased substantially after they started taking testosterone therapy drugs.

In January 2014, the FDA announced they were investigating the risk of stroke, heart attack, and death in men taking testosterone products, and in June, they required all manufacturers to include a general warning on their labels about testosterone and the risk of blood clots. In March 2015, they announced they were requiring drug makers to warn that testosterone products may increase risk for heart attacks and strokes.

Age-Related Low-T is Not a Disease

Doctors Thomas Perls and David J. Handelsman note in their journal editorial that over the past decade, testosterone advertising has led to an increase in sales of testosterone from $324 million in 2002 to $2 billion in 2012. Yet the advertisements were part of the “disease mongering” the authors accuse the manufacturers of, which they define as “the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments.”

Marketers of Low-T, the authors continue, encouraged men to take questionnaires focusing on common age-related complaints like low energy, sleep problems, feeling sad, putting on the pounds, or experiencing decreased physical performance. Yet at a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committees, experts concluded that age-related hypogonadism had not been established as a disease, and that testosterone was indicated “only for classical hypogonadism and not age-related hypogonadism.”

The next status conference in the testosterone MDL is scheduled for April 21, 2015. Plaintiffs who have suffered serious side effects after taking testosterone replacement drugs may be eligible to join the litigation.