A Push to Sell Testosterone Gels Troubles Doctors

October 18, 2013

(NEW YORK TIMES) – The barrage of advertisements targets older men. “Have you noticed a recent deterioration of your ability to play sports?” “Do you have a decrease in sex drive?” “Do you have a lack of energy?” If so, the ads warn, you should “talk to your doctor about whether you have low testosterone” — “Low T,” as they put it.

DRUGS1-popupIn the view of many physicians, that is in large part an invented condition. Last year, drug makers in the United States spent $3.47 billion on advertising directly to consumers, according to FiercePharma.com. And while ever-present ads like those from AbbVie Pharmaceuticals have buoyed sales of testosterone gels, that may be bad for patients as well as the United States’ $2.7 trillion annual health care bill, experts say.

Sales of prescription testosterone gels that are absorbed through the skin generated over $2 billion in American sales last year, a number that is expected to more than double by 2017. Abbott Laboratories — which owned AbbVie until Jan. 1 — spent $80 million advertising its version, AndroGel, last year.

Once a niche treatment for people suffering from hormonal deficiencies caused by medical problems like endocrine tumors or the disruptive effects of chemotherapy, the prescription gels are increasingly being sold as lifestyle products, to raise dipping levels of the male sex hormone as men age.

“The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” said Dr. Joel Finkelstein, an associate professor at Harvard Medical School who is studying male hormone changes with aging. “The problem is that no one has proved that it works and we don’t know the risks.”

DRUGS2-articleInlineDr. Eric Topol, a cardiologist and chief academic officer at Scripps Health in San Diego, is alarmed by the high percentage of patients he sees who use the roll-on prescription products, achieving testosterone levels that he described as “ridiculously high.”

The gels are of questionable medical benefit for many of the millions of men who now take them, he and other doctors say, and their side effects may well prove dangerous.

These medicines come with a risk of coronary artery disease,” Dr. Topol said. When I ask patients why they’re on it, the instant response, is, ‘I have low T.’ I ask, ‘Why would you even get tested for that?’ There isn’t really a normal,” he said. Other side effects include an enlarged prostate, he added.

Nevertheless, many insurers cover the cost of the high-priced hormone treatments, requiring only a small co-payment from patients. AndroGel and another popular testosterone gel, Axiron, by Eli Lilly & Company, sell for more than $500 a month retail, and about $400 with pharmacy coupons.  Many experts say that pharmaceutical advertising promotes excessive and inappropriate drug use by convincing patients that they are ill — or have a more serious condition than is genuinely the case — and need medicine to treat it.

While television viewers are barraged with advertising warning men they may have “low T,”Dr. Finkelstein said,

“There is no such disease.”

Such advertising also leads patients to seek out more expensive treatments, rather than cheaper ones that are often equally effective. Drugs that are advertised are almost always the ones that are costly.  In response to an article Sunday in The New York Times on prescription drug costs for asthma medicines in the United States, a number of readers complained about the high price of inhalers, and that the costs were inflated by the millions of dollars pharmaceutical companies spend on advertising for them.

Jack D. from Philadelphia, for example, wrote that he mail-ordered his prescription steroid nasal spray from overseas, for 20 percent of the price in the United States.

I refuse to pay for ads featuring talking bees with Spanish accents,” he wrote.

Merck spent $46.3 million last year advertising Nasonex, its popular steroid spray.

Patients of any age may benefit from testosterone replacement if their levels are severely low because of serious medical problems, experts say. But testosterone normally declines as men age — just as estrogen does in women.

The F.D.A. has approved the gels

for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts.”

But that directive is ambiguous, and the F.D.A. office did not respond to questions because of the government shutdown. Should testosterone be replaced in older men, and will it safely redress frequent ordinary symptoms of male aging, like decreased muscle mass and libido? And what constitutes a very low amount?

Dr. Finkelstein said,

Until there are big long-term studies to address the issues of testosterone replacement, we’re not ready to make recommendations on that.”

But drug companies defend their efforts to reach out to potential users. Testosterone deficiency is

“a recognized clinical condition, with signs/symptoms that can impact millions of patients,” said Morry B. Smulevitz, a director of communications for Lilly, which makes Axiron.

While he said the company did not condone the use of medicine for purposes other than those approved by the F.D.A., it

“encouraged patients to talk to their physicians to weigh the risks and benefits.”

David Freundel, director of public affairs for AbbVie, which makes AndroGel, said the company’s

low testosterone efforts” were “developed to educate men who may be at risk for, or have, low testosterone, so they can have the appropriate dialogue with their physician to determine if testing and treatment may be appropriate.”

Studies are just beginning to yield results to address the appropriate use of the drug in older men. For example, scientists have found that age-related male changes in body fat depend on a different hormone, estradiol, which also decreases with age. Likewise, while strength and libido do decrease with falling testosterone levels, that effect may not be significant until testosterone levels are very low, Dr. Finkelstein said. Low testosterone is rarely the main cause of erectile dysfunction.  Finally, he added, no one has really defined what is a “normal” or “physiological” testosterone level. And yet, physicians often order tests for “low T.”

A survey this year by CMI/Compass found that more than half of physicians felt that pharmaceutical advertising to consumers should be scaled back, and 63 percent said it misinformed patients.

I really don’t understand why it’s tolerated at a time we’re struggling with health care costs,” Dr. Topol said. “A lot of people bounce their legs in meetings, but that doesn’t mean you have restless leg syndrome, and you shouldn’t be taking drugs for that.”