A.G. Underwood Announces Settlement With Ageless Men’s Health for Misleading Patients in Diagnosing and Treating Low Testosterone

NEW YORK, June 1 -- New York Acting Attorney General Barbara D. Underwood issued the following news release:

Attorney General Barbara D. Underwood today announced an agreement with Ageless Men's Health, P.C. ("Ageless"), requiring Ageless to make complete and accurate disclosures to its patients and prospective patients concerning the diagnosis of low testosterone and the risks associated with testosterone replacement therapy ("TRT"). TRT is an increasingly common treatment for men with low levels of testosterone, sometimes called hypogonadism or "Low T."

Ageless and its affiliates provide TRT to men at 36 clinics across the United States, including three in New York City. Ageless failed to inform patients that in diagnosing low testosterone and addressing potential side effects of treatment, it was not following evidence-based practices recommended by leading medical organizations. Additionally, Ageless prominently featured a deceptive "Low T quiz" on its website that misled patients regarding the diagnosis of low testosterone.

"Every New Yorker is entitled to full and honest disclosures about the limitations and risks of any health related diagnosis or treatment," said Attorney General Underwood. "Our office will continue to hold accountable clinics that mislead New Yorkers."

Ageless' misleading practices included the following:

* Ageless' website contained a misleading "Low T Quiz" in which checking off even a single potential symptom out of eleven options - such as "I have a lack of energy," "I often fall asleep after dinner," and "I often have trouble keeping my mind on task," among others - brought the viewer to a webpage reading: "Based on your answers, you could be a candidate for testosterone replacement therapy. Please contact Ageless Men's Health for a consultation and accurate test." The Low T Quiz is not a recommended method to screen patients as potential candidates for TRT.

* Medical guidelines, such as the guidelines of the Endocrine Society and the American Urological Association, recommend that two morning blood tests, on different days, should be performed to confirm a diagnosis of low testosterone before starting TRT. This is because men's testosterone levels are generally higher in the morning than at other times of day, normal ranges for testosterone are established by reference to morning levels, and men's testosterone levels can vary significantly from day to day. Ageless was aware of this recommended practice, which even appeared in an article in Ageless' own Clinical Operations Manual. Nonetheless, Ageless' practice has been to perform only a single diagnostic blood test, at any time during business hours -- more often than not in the afternoon -- without informing patients that diagnosing low testosterone in this manner is contrary to these guidelines. Instead, without informing patients, Ageless relied on different guidelines that do not contain a recommendation one way or the other concerning the time of day of testing or the number of tests that should be performed. In so doing, Ageless led patients to believe that they require treatment when they may not.

* Ageless offered TRT to men whose diagnostic testosterone levels are above the thresholds for treatment set out in medical guidelines, including those collected in its own Clinical Operations Manual, without informing patients of that fact. This also led patients to believe that they require treatment when they may not.

* Decreased fertility is a scientifically-established side effect of TRT, as recognized by generally accepted medical authorities. However, Ageless' consent form, which lists certain potential side effects of TRT, did not include fertility-related side effects.

Under the agreement, Ageless has committed to (1) remove the misleading "Low T Quiz" from its website; (2) inform patients that according to medical guidelines, blood tests for purposes of diagnosing low testosterone should be performed in the morning, and two morning tests should be performed before starting TRT; (3) inform patients about the thresholds for treatment set out in the relevant medical guidelines; and (4) inform patients in writing about the fertility-related side effects of TRT.

Consumers who believe that they have been treated unfairly by a health care provider, HMO or insurance plan, or health-related business should call the Attorney General's Health Care Helpline at 1-800-428-9071.

This case was handled by Assistant Attorney General Jonathan Zweig, former volunteer Assistant Attorney General Matthew Reisman, and Assistant Attorney General Sika Yeboah-Sampong. The Health Care Bureau is led by Bureau Chief Lisa Landau, together with Deputy Bureau Chief Susan J. Cameron. The Health Care Bureau is part of the Social Justice Division, which is led by Executive Deputy Attorney General Matthew Colangelo.