Androgel Testosterone Replacement Trials Begin

Androgel Testosterone Replacement Trials Begin

More than 4,000 men line up for a legal challenge against AbbVie this month, as trials related to the company’s Androgel testosterone replacement drug get underway.

The first testimony was heard this week in a class action case being heard in a U.S. District Court in Illinois. Concerns about the drug relate predominantly to cardiovascular problems, but the allegations against AbbVie are more concerned with fraudulent marketing practices.

The company could have focused on the specific subset of patients who legitimately need the drug, who suffer from hypogonadism. This is a limited condition that causes a rapid drop in testosterone and requires immediate treatment to restore healthy levels. The lawsuit concerns AbbVie’s expanded efforts to inflate usage of Androgel by creating a questionable medical condition – ”

The lawsuit concerns AbbVie’s expanded efforts to inflate usage of Androgel by creating a questionable medical condition – “Low T” – are what critics of the drug believe lead to heart issues. 2012 is held up as the banner year for this promotion, as the drug maker launched a broad marketing campaign that cost some $80 million to implement and achieved sales of $1.1 billion the same year. Unsurprisingly, many ads that speak to low testosterone focus on the emotional draw of being “less of a man,” which strikes at the heart of male health concerns (and, of course, sells a huge amount of drugs in the process).

As a result, Androgel and several other testosterone replacement drugs are now in the line of legal fire. Patients feel like testosterone drugs have been falsely sold to them as a solution for a condition that is questionable at best.

Regulators seem to agree with that sentiment, having slapped multiple subsequent warnings on Androgel and similar products. Sales have declined significantly since that overblown promotion, as AbbVie and its competitors, including Eli Lilly and Endo, deal with the fallout of their Low-T campaigns.

With Androgel testosterone replacement the first of many to face legal proceedings, the outcome of this lawsuit will go a long way to determining how other pharmaceutical companies address the issue. As always, a settlement is the most likely outcome. Drug makers will be watching closely to see just how much this latest case of alleged marketing malpractice is going to cost them.

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