A FDA advisory expert panel voted yesterday to impose strict limitations on the multibillion-dollar testosterone drug industry. The panel recommended that the agency change warning labels for the medicines so they are not prescribed for men who only have normal aging issues, such as low energy and low sex drive.
Testosterone drugs are currently taken by over two million American men, mainly for symptoms related to normal aging. By 2011, nearly one in 25 men in their 60s was taking testosterone. The rate was much higher in the 45-60 age group, accounting for 60% of prescriptions.
According to experts, should the F.D.A. accept the panel’s recommendations, there could be a significant reduction in testosterone prescriptions and blunting of the aggressive direct to consumer advertising and marketing by drug companies.
According to Consumer Reports magazine, drugmakers’ big-time spending on marketing the products, with promotional expenses increased up to $100 million in 2012 from $14 million in 2011. For the first half of 2013, AbbVie spent more than $45 million promoting Androgel, which is now its second-best-selling drug.
According to AbbVie, Lilly and other manufacturers, they only market their testosterone products for men whose hormone levels are clinically low.
FDA: Testosterone Replacement Unproven
According to the FDA, the benefits of testosterone treatments for healthy, aging men are unproven, and that the drugs could be risky. Men who take them have been found to have higher rates of heart problems in some studies.
Testosterone Low T Huge Business
Testosterone usage has increased 500% since the early 2000s for men in their 40s, because of aggressive marketing that touts the drugs as a universal panacea, a fountain of youth for low energy, low sex drive and moodiness in aging men. The ads play on men’s insecurities regarding the normal aging process.
FDA: Testosterone Replacements Increased Heart Attacks, Strokes
Earlier in the year, the F.D.A. said it was reassessing the safety of testosterone products in view of recent studies and would investigate rates of stroke, heart attack and death in men using the drugs.
Experts said the label should be limited to men with serious medical conditions, such as pituitary gland problems. A 2010 clinical trial found an elevated risk of heart attacks and strokes among men who took testosterone, and it was stopped early as a result.
The panel heard surprising facts: Almost 25% of the men who are prescribed testosterone have not had a baseline test of their testosterone level. And 60% of the prescribing is done by primary care doctors, while just 20% of the drugs are prescribed by specialists like endocrinologists and urologists.
Low T “Misleading Advertisments”
According to one FDA official, the agency had issued warning letters to sponsors over inappropriate and misleading promotions.
One concerned an ad claiming that patients who had taken a particular testosterone drug “start chasing their wives around the room a little bit — they just feel like guys again,” implying that the product can be used to successfully treat sexual dysfunction, when there is no data to support that, he said.
According to one expert, Dr. Schwartz said the marketing of what is popularly known as Low-T, or low testosterone, was “eerily reminiscent” of the aggressive promotion of hormone replacement for post-menopausal women.
For years, physicians were convinced the treatment protected women from heart disease, and they promoted it as a long-term preventive regimen to treat symptoms such as hot flashes, mood swings and low sexual desire.
But a randomized trial, the Women’s Health Initiative, found that the popular treatment actually increased risks of blood clots, strokes and breast cancer, and did not protect against heart disease.
New NIH Testosterone Trial
The National Institutes of Health is sponsoring a large randomized trial, called the T trial, to see whether older men who take testosterone have improved physical, sexual and cognitive function, and whether the hormone reduces risks for heart disease and diabetes. Results are expected next year.
But the largest group of men being treated is actually younger than those represented in the trial.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.