The following post is by Alan Cassels, a pharmaceutical policy researcher at the University of Victoria, British Columbia, a journalist, and author of the The Cochrane Collaboration: Medicine’s Best-Kept Secret.
It’s been on the scene for over a decade. The pharmaceutical industry has invested billions in it. Tens of millions of consumers have been exposed to it and there are proposals to try to stop it.
But the big question remaining on everyone’s mind is this: Does direct-to-consumer drug advertising actually work?
Just today a new study of direct-to-consumer ads like the one above for testosterone replacement therapy was released in the Journal of the American Medical Association. That study concluded that between 2009 and 2013, exposure to direct-to-consumer advertising (DTCA) for testosterone therapies was associated with greater testosterone testing and new use of testosterone therapies for men who likely weren’t appropriate candidates for treatment.
In other words, drug advertising appears to be an effective strategy for pharmaceutical companies to increase customers for their products. But creating more customers and sales for drug companies isn’t making the U.S. population any healthier.
Testosterone therapies are approved only to treat hypogonadism (where the body doesn’t produce enough testosterone) and other forms of pathological low testosterone. Now, however, many men take testosterone to reverse reductions that may be a normal result of aging. As we’ve seen in other conditions, such as ADHD, high cholesterol, and hormone replacement therapy, among others, once drugs are proven effective and approved for the specific population in which they are tested, they quickly end up getting prescribed to a wider body of patients than is likely needed or safe.
Certainly the prescribing and use of testosterone therapy has grown dramatically around the globe. One report from ABC News in 2012 said that the use of testosterone had doubled between 2006 and 2012 and was going to triple over the next five years. The marketing of low testosterone has expanded at a similarly rapid pace, resulting in lots of accusations of disease mongering. Many researchers and health policy experts including myself, have written about this controversial condition and the self-administered questionnaire known as the “Low-T” test which is touted as a way for men to “get their mojo back.”
In an accompanying editorial in JAMA, Dr. Richard Kravitz from the University of California in Sacramento wrote that the data provided by this study was “an important reminder that DTCA, while a potentially powerful tool in motivating patient behavior and perhaps even physician prescribing, does not necessarily serve to improve the health of patients or the public.”
I watched these ads somewhat in awe of the chutzpah being used to get men to start thinking about low testosterone and the first thing that came to mind is: How could these ads possibly work?
While the first 30 seconds or so are filled with images of virility and strength, touting the benefits of getting tested for low testosterone and the potential benefits of androgen replacement therapy, the entire last minute of the ad contains some fairly serious adverse event information–including the suggestion that androgen therapy could increase your risk of prostate cancer. Then there are the increased risks of heart attacks and strokes, according to an FDA advisory, as well as the risks of children developing premature or inappropriate sex characteristics related to testosterone (the Androgel ad says “women and children should avoid contact with application sites”). It seems odd that the advertising would be effective.
As a Canadian who doesn’t watch a lot of American TV, I’m dazzled by these ads because I don’t often get exposed to them. This kind of direct-to-consumer drug advertising is illegal in every country in the world except for the US and New Zealand, so seeing an ad blatantly promoting a drug–as opposed to just discussing the condition–is a novelty for us Canadians.
When I called Kravitz at his office in Sacramento he had just taken a look at those TV ads. I asked him the first question that came to mind: Why do these ads seem to work when it seems equally likely that they would send men running in the opposite direction? The long list of side effects, if anyone paid close attention to them, is enough to give you nightmares.
He reminded me how highly professional Madison Avenue can be when it comes to selling to consumers, even when it comes to controversial conditions and the drugs to treat them. He said, “Well, the ads are very compelling–they make use of a lot of non-verbal information. The men are handsome and virile, often with attractive women and they have described symptoms that are very common that men can relate to.” Those symptoms include a reduced energy, feeling moody or grumpy and a reduced sex drive, which are pretty common to us boomers who are now all over 50 years of age.
A drug advertisement is required by the FDA to give both the good and the bad, but one form of information may override the other. When the adverse events are listed, sotto voce, and often rapidly so they take mental energy to process, the visuals are much more powerful.
When the side effects are listed in the Androgel ad, Kravitz says: “You see he’s driving a sports car, they’re walking into a restaurant, he’s touching her neck, she takes a selfie–they’re clearly going to have sex. The visual information overcomes,” he says, “it’s like the limbic system of the brain gets turned on, and the cortex gets overrun.”
To be fair, Kravitz says that the warnings may be double-edged for some media viewers. “The commercials might prime them to worry about the adverse effects,” he says. “In practice some people do pay attention to the warnings,and those can unlock a certain amount of anxiety and questions in patients who might be good candidates for a drug and their fears are magnified–sometimes those concerns are genuine, and should be included in the risk-benefit calculation.”
He mentions antidepressants, which are also widely promoted in direct-to-consumer advertisements such as this one. “For those drugs,” he says, “they can have real benefits for clinically significant depression, but all the side effects can be a problem, especially when people are overly fearful of the treatment.”
Kravitz admits that the TV commercials don’t really do much to educate consumers, and he says the testosterone ads are “certainly starting to walk the line towards disease mongering.”
The other thing that makes drug ads different than other consumer products is that you need a “learned intermediary,” a doctor, to prescribed the drug for you. He finds it rare to have patients come in demanding a particular drug they saw advertised; “patients are more subtle about this.” He says, “I don’t see patients coming in with ads from a magazine–they might say, ‘I’m feeling tired and moody and what about testosterone?’”
This can be annoying but US doctors are primed to deliver on “patient satisfaction,” and that can mean addressing, in some way, the patient’s concerns. Kravitz says many of his colleagues ”won’t give in directly–many do give in–many go down the testing line and so they will test testosterone levels.”
He says that many other things may cause low testosterone and about “7% of men have testosterone levels below normal.” But, he adds, “just because you have low energy and moodiness doesn’t mean you’ll benefit from androgen replacement therapy.”
Kravitz admits he’s never prescribed either of the drugs discussed in this post, but he would prescribe them for the ‘right’ patient. By way of example he told me about one patient who had his pituitary gland removed, and that he had to take periodic injections of testosterone (this was before testosterone gel was on the market). “That’s someone who would have benefited–because the gel gives a pretty steady dose.”
The study’s final word seems pretty compelling: “While other studies have demonstrated associations between DTCA and increasing medication use, this study demonstrates increases in 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 bottom line, says Kravitz, is that the study raises awareness of the fact that raising awareness is not always a good thing. “People say [drug advertising] shouldn’t make any difference, and that people are smart and they won’t be influenced,” but the research shows otherwise.