(1) NPR Discusses Testosterone & Potential Adverse Health Effects
NPR recently discussed the popularity of testosterone replacement therapies, and how the The Food and Drug Administration is reassessing the safety of testosterone products. A spokesperson reiterated the agency’s own guidelines: None of the products approved by the FDA should be prescribed unless low testosterone is associated with a medical condition.
Some doctors warn patients to stay away from low-T clinics. Dr. Bradley Anawalt is one of those doctors. He heads the Hormone Health Network, part of the professional association for endocrinologists which has released clinical guidelines for testosterone therapy.
Anawalt calls the low-T clinics “sex hormone factories” that promote all the potential virtues and great myths about how testosterone may solve all problems. “They’re really out to prescribe as much testosterone as they possibly can, and it’s not clear that all these practices are completely safe,” he says.
But there’s no evidence that the clinics are unsafe, either. State medical boards typically investigate only when patients file complaints, and there hasn’t been an outpouring of accusations against the clinics. But a review of physicians working for a number of low-T clinics found that very few specialized in urology or endocrinology. Instead, one doctor at a Chicago clinic and another in Fort Lauderdale were anesthesiologists; in Houston, an allergist; in Phoenix, an osteopath; and in Washington, D.C., an obstetrician-gynecologist.
“There is some hope that state or federal governments will start to crack down and regulate unscrupulous prescription of testosterone to men, and perhaps they will review the practices of these clinics,” says Anawalt.
The clinics themselves say they’re legitimate medical practices. Dr. Bill Reilly is the chief medical officer at Low T Center, one of the largest chains of low-T clinics, based in Southlake, Texas. His company has 45 offices and some 35,000 patients. Reilly says patients must have a diagnosed medical condition.
“Our No. 1 complaint at Low T is, ‘Why won’t you treat me?’ We just don’t see a patient, ‘Hey, here you go. Here’s some testosterone,’ ” Reilly says. “They go through a complete history, physical, thorough evaluation. We go through their symptoms.”
Reilly says some 15,000 men have been turned away from his clinics with no treatment because they don’t meet the medical definition of low testosterone. And those with sleep apnea or high blood pressure or other serious illnesses are encouraged to see their family doctor. Before joining Low T Center, Reilly was a joint surgeon. He doesn’t believe medical training in urology or endocrinology is necessary to do the job well.
“You don’t need to be an endocrinologist. You don’t need to be a urologist,” says Reilly. “We’re all doctors. And we study more about testosterone than they do. We basically follow the national endocrinology guidelines.”
Reilly says the growing criticism from others in the medical community is perhaps just ignorance and fear of competition. After all, Low T Center expects to more than double its number of sites in the next year, reaching perhaps as many as 70,000 patients.
(2) MDL Formed in Northern District Court of Illinois for TRT Litigation
Following oral arguments on May 29, 2014, an order was issued that established a federal testosterone multidistrict litigation (MLD) before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois. Testosterone Replacement Therapy (“TRT”) cases filed across the country will be transferred to Judge Kennelly for pretrial proceedings to reduce duplicative discovery, avoid conflicting rulings and serve the interests of judicial economy.
Over the remainder of 2014, the testosterone MDL is likely to be focused on the organizational structure of the proceedings, establishing processes for the rapid filing of new cases and common discovery into issues that impact all cases.
If you or a loved one has been harmed by testosterone therapy, you may be entitled to compensation. Contact our attorneys for a free consultation regarding testosterone replacement therapy or TRT.