F.D.A. Panel Backs Limits on Testosterone Drugs

September 18, 2014 | SPH in the News


September 18, 2014

An expert panel voted overwhelmingly on Wednesday for the Food and Drug Administration to impose strict new limitations on the multibillion-dollar testosterone drug industry, recommending that the agency tighten labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy and libido. The F.D.A. often takes the advice of such panels.

Once used only to treat serious medical conditions, testosterone drugs are now taken by over two million American men, mostly for symptoms that are largely a result of aging, a pattern that has alarmed some medical experts. If the F.D.A. adopts the panel’s recommendations, it could sharply reduce the number of men prescribed the medicines and clamp down on marketing of them by drug companies. It could also limit coverage from insurance companies for their use, experts said.

“The whole idea is to try to 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 20 members on the panel who voted to change the labeling. Just one member voted against the change.

Still, some experts were skeptical that usage would change much, because doctors can prescribe the drugs as they see fit, despite indications on the label.

One factor driving treatment is a larger number of easy-to-use testosterone drugs like gels, experts say. One of the items on the F.D.A.’s agenda for Thursday is to ask its expert panel whether it should approve a new oral testosterone drug. AbbVie, the company that makes AndroGel, a testosterone treatment, said: “Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients, and we will work with the F.D.A. during its review.”

The F.D.A. has said that 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 usage has quadrupled since the early 2000s for men in their 40s, driven in part by marketing that suggests the drugs are a solution for low energy, low libido and other ills, many of them associated with aging. By 2011, nearly one in 25 men in their 60s was taking testosterone. In 2013, 2.3 million Americans were being treated with testosterone therapy, according to material distributed at the panel meeting.

“People are looking for the fountain of youth,” said Dr. Aaron Katz, chairman of the Department of Urology at Winthrop-University Hospital in Mineola, N.Y.

Many experts began raising alarms, saying that the benefits and longer-term risks of the drugs were unknown.

This year, the F.D.A. said it was reassessing the safety of testosterone products in light of recent studies and would investigate rates of stroke, heart attack and death in men using the drugs.

One of the stickiest problems had been the vagueness of testosterone drug labels, which many doctors have interpreted to include any man with low testosterone. Panelists said the label should be limited to men with serious medical conditions, such as pituitary gland problems. It was not clear what share of men that represented, though officials said it was a small minority of users.

The panel was also asked to sift through the evidence for safety risks. It concluded that the evidence for risks 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, and it was stopped early as a result. Other trials have found no increased risk.

The panel heard surprising facts: A fifth to a quarter of men who are prescribed testosterone have not had a baseline test of their testosterone level. And 60 percent of the prescribing is done by primary care doctors, while just 20 percent of the drugs are prescribed by specialists like endocrinologists and urologists.

“Why did the F.D.A. allow this huge push for the creation and the selling of ‘aging is optional for men,’ when we don’t know the benefits or harms?” said Dr. Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice.

Trung-Hieu Brian Tran, an F.D.A. official, said 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.

One potentially major effect of Wednesday’s vote would be to give the F.D.A. more control over the marketing of the drugs, allowing the agency to draw a narrower definition of whom drug companies could target.

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.

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, and some experts pointed out that the trial may not give all the answers the medical community is seeking. F.D.A. data show that men ages 45 to 64 receive about 60 percent of all testosterone treatment; men over 65 represent just 20 percent.

The label changes will ultimately be up to the F.D.A., which has discretion over wording and application.

“Exactly how the wording will be changed is not yet known,” said Mary Schooling, a professor of public health at Hunter College.

Originally published by The New York Times