TESTOSTERONE THERAPY: ADS DIRECTED TO CONSUMERS PROMISE MUCH
By Maryann Napoli

"Take this quick test to find out if you might benefit from treatment." The new drug ad campaign goes on to ask four brief questions: Are you losing your sexual desire? Are you experiencing reduced sexual function? Are you losing muscle mass? Are you feeling less like yourself?

The ad might have gone on to ask, Are you a man over 70? But no, this is the latest example of a drug ad aimed at consumers in which aging becomes an illness that can be treated with lifelong drug therapy. The headline announces how prevalent the problem is: "One in five American men over 50 suffers from low testosterone." And just in case we miss the point, the ad features an enlarged version of the male symbol with the usually straight arrow gone limp.

Auxilium Pharmaceuticals, Inc. is advertising its new 1% testosterone gel now available by prescription under the brand name Testim 1%. (An ad aimed at doctors says, "Test him. Then Testim 1%," illustrating the natural progression of things.) The drug is described as "highly tested," an overly optimistic claim given the fact that the one and only FDA-required clinical trial lasted 90 days. Any drug billed as "replacement" therapy is likely to be prescribed indefinitely.

The ad campaign, as seen in the August 24 issue of The New York Times Sunday magazine, never comes right out and says that Testim 1% can overcome erectile dysfunction (ED) because the FDA approved the drug solely on the basis that it can increase blood levels of testosterone. But everything that surrounds Auxilium's ad implies that it is a proven treatment for ED.

This ad campaign is an example of how drug companies can get around FDA regulations against false advertising--just mount an expensive, multi-page advertisement complete with an article about the latest treatments for ED, and people will, no doubt, get the message. The format and typeface of the article match the rest of the magazine so many readers might not notice it is part of the sales pitch, though the word "advertisement" appears in fine print at the top of each page.

Testim 1% was approved by the FDA as a treatment for men with hypogonadism, or low testosterone, which can be attributed to a wide range of causes, including chemotherapy, alcoholism, pituitary tumors, radiation damage, and congenital abnormalities. But low testosterone can also be a non-problem for many men, according to Alvaro Morales, MD, professor of urology at Queens University, Kingston, Ontario, Canada, and author of several research papers on testosterone.
In a telephone interview, Dr. Morales said that a majority of men will have low levels of testosterone if they live long enough, but that doesn't mean that all will be bothered by symptoms.

He does, however, see a clear role for testosterone therapy in certain men with symptoms, such as decreased sexual desire, ED, irritability, lack of sleep, while acknowledging that it is hard to differentiate these symptoms from those associated with normal aging. "We tend to focus on sexual dysfunction, but anemia, loss of muscle mass, osteoporosis, fatigue, and depression are also symptoms of hypogonadism," said Dr. Morales. "We urologists castrate men to treat [advanced] prostate cancer, and we see all those symptoms in men after the testicles are removed, but this is artificial [whereas,] the natural version [of testosterone deprivation] is more subtle."

Not all the symptoms must be present, according to Dr. Morales. "When a man comes to me, I get a clinical picture of the signs and symptoms and send him for a blood test. If the blood test documents his levels as below normal, then the patient should have a three-month trial of testosterone supplementation. As for the choice of testosterone therapy, that depends on patient preference, cost, and efficacy--it doesn't matter which type--skin patch, rub-on gel, injectable--of testosterone." Each has advantages and drawbacks, he said. "In the USA, you don't have a safe oral version that other countries do."

There are five topical testosterone prescription drugs now on the market in the U.S.: AndroGel, Androderm, Testoderm, with Testim 1% and Striant as the newest entries. The latter is a tablet that is placed on the surface of the gums. No clinical studies of Striant, however, have been published, according to The Medical Letter (9/1/03), which lists the cost of all five topical drugs as ranging from $116 to $190 for a one-month supply.

One of the concerns about these products is the transmission of testosterone to the female partner through skin-to-skin contact, which can result in unpleasant side effects like acne, facial hair, and hair loss. Transmission to pregnant women could harm the fetus. None of the topical testosterone products have been evaluated for safety or efficacy in women, though some researchers are pursuing the idea that androgen (testosterone) deficiency causes female sexual dysfunction.

These topical products are approved by the FDA on the basis of how well they increase blood levels of testosterone, but many men will be interested in how effective they are at increasing sexual activity. The FDA-approved drug labels are vague on this important point. For example, the Testim 1% label refers to the 90-day trial in which men taking this drug reported a 59% increase in sexual activity compared to baseline, but nowhere is it explained what the baseline was for any of the study participants.

We can only guess that the sexual activity level of men entering such a trial was low. Here's what 59% increase in sexuality activity can mean: If the men in the Testim group reported an average of three days of sexual activity in three months before starting the clinical trial, then the 59% increase would mean that they went from three days of sexual activity in the three-month period to four or five days.

"Testosterone is a safe, natural compound," said Dr. Morales, though he followed this statement with cautions. "Once you start replacing it in older men, there is potential for adverse effects, and physicians should monitor them very carefully. I follow them every three months in the first year,' he said. "If anything bad is going to happen, it is usually in the first year, and prostate safety is the biggest concern," he continued, referring to evidence that increasing testosterone levels could stimulate the growth of a latent prostate cancer in elderly men or cause the prostate to enlarge.

Another condition to be monitored for is polycythemia, which is an abnormally large number of red blood cells in the circulatory system. Furthermore, testosterone therapy could aggravate symptoms of sleep apnea. Men should be monitored not only for these potential adverse effects, Dr. Morales said, but also to see whether the treatment makes any difference. "If there is no response, there is no point in continuing therapy."

For More Information:

Prescription drug labels can be read at the FDA web site (www.fda.gov) click into the word "Drug," then "Drug Approvals," click into the first initial of drug you want to look up, and then click into the date under "Label Posted" in right hand column. Or, call 1(888) 463-6332 to have the label mailed to you.