When men see television ads for testosterone products, they are significantly more likely to ask their doctors to be tested for low testosterone (or “low T”) and to start taking the drugs, a study published Tuesday in the Journal of the American Medical Association (JAMA) has found.
The study’s authors — led by a team of researchers from the University of North Carolina — analyzed health insurance claims of about 17.2 million American men living in 75 metropolitan television markets from 2009 to 2013. During that period, about 1 million of those men underwent testosterone tests and about 283,000 started treatment with testosterone products, mostly gels and injections.
Using Nielson data on ad viewership, the researchers determined that a single TV ad for products aimed at treating “low T” was associated with 14 new tests, five new testosterone prescriptions following the tests and two new prescriptions without testing for each million men who saw the ad.
“Although the average increase in testosterone rates associated with a single ad exposure was less than 1 percent, advertisements were widespread and frequent during the study period,” write the study’s authors.
Some market areas saw as many as 200 ads for testosterone during that period, they add.
Potential for harm
The findings add to concerns about the use of direct-to-consumer drug advertising, which has been permitted in the United States since 1997. Much of the medical community has been opposed to such marketing, in part because it drives consumer demand for expensive treatments when less costly alternatives are available. In 2015, the American Medical Association called for an outright ban of direct-to-consumer advertising of prescription drugs and medical devices.
But, as the authors of the JAMA study point out, the problem with the testosterone ads goes beyond just the drugs’ cost. Their findings link the ads to “potentially inappropriate use and increasing initiation during a time when most testosterone use was of questionable value for age-related testosterone decreases without strong evidence of benefit.”
The only condition for which testosterone supplements are indicated is hypogonadism, a disorder of the hypothalamus, pituitary gland or testes that results in abnormally low levels of the hormone. “Low T,” on the other hand, is a condition created by the pharmaceutical industry two decades ago to broaden the market for its testosterone products. In a classic case of disease-mongering, the industry set about persuading men that the natural decline in the body’s testosterone levels that comes with aging is something that requires medical treatment.
A series of studies published earlier this year found that testosterone supplements offer older men little benefit — and significant risk. The drugs may help with bone density and with reducing the risk of anemia, those studies found, but they do not improve memory — and may increase the risk of heart disease. Previous studies in have also linked the supplements to heart disease, which led the Food and Drug Administration to change the warning labels on the products early in 2014.
According to background information in the current study, that FDA action caused sales of the drugs to plummet by up to 6 percent in the first half of 2014. But the market for testosterone products remains strong — well over $2 billion a year.
The pharmaceutical industry’s “low T” campaign has been “startlingly effective,” says Dr. Richard Kravitz, an epidemiologist at the University of California, Davis, in an editorial that runs with the study.
Part of the reason for that effectiveness is the fact — as other research has shown — that patient queries and requests regarding drugs and other treatments strongly influences what doctors prescribe.
“Physicians are supposed to protect consumers from the potential adverse effects of drug advertisements,” writes Kravitz. “However, when clinical indications are weak or uncertain, signals of harm are suggestive but unproven, and patient demand is strong, physicians may not be able to provide that protection.”
The JAMA study’s findings are an important reminder, he adds, that while direct-to-consumer-advertising may be “a potentially powerful tool in motivating patient behavior and perhaps even physician prescribing, [it] does not necessarily serve to improve the health of patients or the public.”
The United States and New Zealand are the only developed countries that allow the direct marketing of prescription drugs to consumers.
FMI: Abstracts of the study and the editorial can be found on the JAMA website.