After a hearing yesterday, a panel of experts strongly urged the FDA to impose strict limitations on the off-label use of testosterone replacement gels in order to avoid prescribing testosterone to millions of men who have no medical need for the drugs.
The panel voted 20-1 in recommending label changes to the FDA.
Testosterone replacement therapies – including testosterone gels like AndroGel – have been medically approved to treat a very specific, and relatively rare condition called hypogonadism. However, giant pharmaceutical companies have rapidly grown profits by promoting these drugs for off-label use for ailments as benign as fatigue, weight loss, and libido – all symptoms of the regular aging process.
“The whole idea is to try and rein in the inappropriate advertising and use of these drugs,” said Dr. Michael Domanski, the director of heart failure research at Mount Sinai School of Medicine, who was one of the 20 members on the panel who voted to change the labeling.
– Sabrina Tavernise at The New York Times
What kind of inappropriate advertising was Dr. Domanski talking about? How about the “Is it Low T” Quiz. This quiz is provided by AndroGel maker AbbVie (recently spun off from drug giant Abbott Labs) to allow men to “self-diagnose” their need for testosterone gel. This 10-question quiz was developed by a doctor who scribbled out the quiz onto a roll of toilet paper while going to the bathroom. (He then gave the toilet paper to his secretary, who he made type it up – Ewww). For this, the “author” was paid $40,000.
And the quiz is designed so that everyone will fail. Just look at the questions:
- Do you have a decrease in libido (sex drive)?
- Do you have a lack of energy?
- Do you have a decrease in strength and/or endurance?
- Have you lost height?
- Have you noticed a decrease in your enjoyment of life?
- Are you sad and/or grumpy?
- Are your erections less strong?
- Have you noticed a recent deterioration in your ability to play sports?
- Are you falling asleep after dinner?
- Has there been a recent deterioration in your work performance?
Answering “yes” to as few as one of these questions will “qualify” you as a candidate for having “Low T”.
The pharma companies selling these drugs are peddling a dangerous, foreign substance to treat a made up disease. In fact, the expert panel heard evidence that up to 25% of patients never even had a baseline test to determine their actual testosterone levels and concluded that “little evidence exists that testosterone replacement therapies are effective for treating low levels of the hormone caused by aging”.
Testosterone Gel: Side Effects and Health Risks
The expert panel also identified several noted health risks – including increased risk of heart attack and stroke.
The panel was also asked to sift through the evidence for safety risks. It concluded that the evidence of heart problems was mixed, and all but one of its members voted to require clinical trials for safety for at least some types of testosterone therapy.
A 2010 clinical trial found an elevated risk of heart attacks and strokes among men who took testosterone.
– Sabrina Tavernise at The New York Times
In fact, the risk of heart attack and stroke was so great, the study was canceled as a result.
Another study, by William D. Finkle and others – was published in January 2014. The Finkle study examined more than 55,000 men and looked at the rate of heart attack within 90 days of starting testosterone replacement therapy.
Finkle found that testosterone replacement doubled the risk of heart attack in men over 65 years old and tripled the risk of heart attack in men with a prior history of heart problems.
An earlier study, published in the November 2013 edition of the Journal of the American Medical Association (JAMA) also found that testosterone gel therapy resulted in a substantially increased risk for heart attack and stroke in men over 65.
Testosterone Lawsuits Filed
There have been a number of lawsuits filed involving men who have experienced heart attack or other heart-related events after taking AndroGel. Hundreds of additional lawsuits are expected across the country. The attorneys at Langdon & Emison are currently investigating and evaluating these claims. Contact us for a free evaluation of your case. You can also download our free e-book, which takes a closer look at the development of testosterone replacement gels and the serious side effects that have been documented in recent studies.
- F.D.A. Panel Backs Limits on Testosterone Drugs [Sabrina Tavernise at The New York Times]
- Possible Heart Risk With Testosterone Spurs Debate on Use [Caroline Chen at Bloomberg]
- New Book Explores Testosterone Link to Heart Attack and Stroke
- Testosterone Gel Linked to Increased Heart Attack Risk
- “Is It Low T” Quiz Was Written on Toilet Paper
- Testosterone Therapy: Off-Label Promotion, Dangerous Side Effects, & Stephen Colbert
© Copyright 2014 Brett A. Emison
Brett Emison is currently a partner at Langdon & Emison, a firm dedicated to helping injured victims across the country from their primary office near Kansas City. Mainly focusing on catastrophic injury and death cases as well as complex mass tort and dangerous drug cases, Mr. Emison often deals with automotive defects, automobile crashes, railroad crossing accidents (train accidents), trucking accidents, dangerous and defective drugs, defective medical devices.