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‘Low T’ Called a Big-Time Fraud by Insurer Class

CHICAGO (CN) - Deceptive marketing "duped" insurers into paying billions for ineffective and unsafe drugs to treat low testosterone, one claims in Federal Court.

Medical Mutual of Ohio sued Abbvie, Abbott Laboratories, Solvay America, Eli Lilly and Company, Auxilium Pharmaceutical, Actavis Pharma and various subsidiaries on Wednesdays.

The complaint comes in the wake of hundreds of product-liability lawsuits against Abbott Labs, the maker of AndroGel, and others over an aggressive disease-awareness campaign that led millions of men to think that their lack of energy was low-testosterone, or "low-T," problem.

Many men who took AndroGel claim that the drug gave them serious medical problems, including life-threatening cardiac events, strokes and thrombolytic problems.

Medical Mutual of Ohio, an insurance company, joined the chorus of individual complaints Wednesday with a class action purporting to represent all insurers that paid for the costs of AndroGel, Testopel, Axiron, Androderm and Fortesta Gel.

"These TRT [testosterone-replacement therapy] drugs were marketed as part of a decade-long deceptive marketing scheme to transform the male aging process into a curable disease state defendants variously called 'Andropause,' 'ate-onset male hypogonadism,' 'age-related hypogonadism,' or simply 'Low T, which were invented from whole cloth," the 341-page complaint states.

But the U.S. Food and Drug Administration never approved promotion of the TRT drugs to third-party payors like insurance companies, as well as to patients and physicians, "for 'Andropause' and as a treatment for a host of medical problems,"

Medical Mutual says.

In addition to unapproved, such "off-label" were also ineffective, the complaint says.

The FDA has approved TRT drugs only to treat hypogonadism, but pharmaceutical companies allegedly applied off-label use to other age-related ills, such as erectile dysfunction, diabetes, depression, and obesity.

Medical Mutual says many of these afflictions already come with a higher risk for heart disease.

"Defendants succeeded in polluting the medical discourse and medical literature concerning testosterone therapy to such a degree that the contours of the entire disease state and diagnosis were blurred," according to the complaint.

Paying doctors and researchers to inflate the prevalence of hypogonadism created the false impression that "almost half of the middle-aged male population in the world was hypogonadal and now needed TRT drugs," the insurer claims.

Sales of TRT drugs allegedly grew by 90 percent from 2007 to 2012. Sales of AndroGel topped $1 billion in the U.S. by 2012, and Testim sales account for nearly 80 percent of Auxilium's revenues in 2011, according to the complaint.

"With their respective schemes now exposed, estimates are that the vast majority of TRT drug use is for ineffective, unsafe, and/or unuseful off-label purposes," the complaint states, citing studies published in respected medical journals. "For once-daily TRT drugs, estimates are that such off-label use is even higher."

Emphasizing "the serious adverse health effects associated with the off-label use of TRT drugs" that the drugmakers allegedly concealed intentionally, the insurer notes that "there is up to a 500 percent increased risk of such adverse events" among some patient populations.

"As part of Defendants' illegal schemes to increase sales of their TRT drug(s), these known safety risks were and continue to be systematically concealed and minimized from the public and from TPPs," the complaint states.

Insurers that pay the cost of TRT drug prescriptions are the "financial victims" of this scheme, and have been "duped" into paying billions of dollars for ineffective and unsafe prescriptions that endanger patients' lives, according to the complaint.

The class seeks damages for violations of federal anti-racketeering law, conspiracy and fraud. It is represented by Conlee Whiteley with Kanner & Whiteley in New Orleans.

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