The Case against Testosterone Maintains Its MOJO

Cincinnati, OHAttorney Joseph Lyon is more committed than ever to litigating against makers of testosterone gels. “There are a lot of issues that we as trial lawyers could explore these days. We picked this because we don’t think Low T is a disease.

It’s a marketing creation and it’s doing more harm than good,” says Lyon from his office in Cincinnati, Ohio.

Lyon currently represents dozens of men who have suffered blood clots, strokes, heart attacks and similar adverse events after using testosterone therapy such as AndroGel marketed by AbbVie (formerly Abbott Labs) or other similarly designed drugs.

More than five million prescriptions for AndroGel and similar-use testosterone therapy products, including AndroDerm, Axiron, Bio-T Gel, Foresta, and Testim, were sold in the US in 2011 to treat a condition known as Low T, or low testosterone.

The testosterone therapies are licensed for use by the FDA to treat patients with lower than normal levels of testosterone accompanied by fatigue, depression, decreased sexual drive, sleeplessness, and other changes in mood and behavior.

Lyon is undeterred by a group of medical doctors and researchers, known as the Androgen Study Group, that has been fighting back against a study published in the January 2014 edition of JAMA (Journal of the American Medical Association) that reported men over the age of 65 using testosterone gels have an increased risk of adverse cardiovascular events, like heart attack and stroke. The group argues that not only is testosterone not dangerous, it actual improves men’s health.

“The Androgen Study Group is not affecting anything we do at all,” adds Lyon, the founding partner at The Lyon Firm, in Cincinnati. “The argument that all the scientific study done around testosterone has never shown a connection to heart disease is just wrong.

“We are very confident that the literature supports the causation of heart attack and stroke at this point,” says Lyon, who has been studying the testosterone research for months and months now. He points to a study done by a Hong Kong research team led by Dr. Lin Xu that compared industry-funded studies with non-industry-funded studies and published its findings last April in a journal called BioMed Central.

Dr. Xu’s team reported that “The effects of testosterone on cardiovascular-related events varied with source of funding. Nevertheless, overall and particularly in trials not funded by the pharmaceutical industry, exogenous testosterone increased the risk of cardiovascular-related events, with corresponding implications for the use of testosterone therapy.

Bottom line, testosterone creams and gels raised the risk level for heart and stroke.

The makers of AndroGel alone spend $80 million raising awareness about Low T syndrome, and creating demand by marketing directly to consumers through television and print advertising.

“Doctors are prescribing it and people are taking it because they think it makes them feel better,” says Lyon. “But they are not thinking this through. This is a hormone. This is not hand lotion. This is not some supplement from the drugstore made from plants or vitamin E. This is an active hormone that is being added to your endocrine system and it is going to affect it.”

One of Lyon’s clients was an apparently otherwise healthy man who had no idea he had an underlying blood-clotting condition called 4G/4G. Seven days after he began using AndroGel, he developed a blood clot that traveled to his spinal cord. He is now paralyzed.

“The company warns about blood clots in your legs,” says Lyon. “It talks about swelling or redness. The average consumer has no idea that these clots can travel and form in other parts of your body. When they market directly to consumers like they have been doing, they have a responsibility to warn to the fullest extent.”

Androgen and similarly designed testosterone therapies Lyon argues are so dangerous he anticipates that the FDA will have no option but to soon slap an extra warning on the packaging.

“I see a very high risk with this medication and not much benefit,” says Lyon. “We can have the legal debate, but in the meantime, I think there is sufficient evidence to start warning people and telling them there are studies out there that tell us this is not a risk-free, all-benefit medication.”