Steven Woloshin and Lisa M. Schwartz are professors of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and co-chairs of the steering committee of Preventing Overdiagnosis, an international conference to be held at the National Institutes of Health in September.
Seven years, at least 25 million prescriptions and $9.7 billion in sales too late, the Food and Drug Administration is finally pushing back against the over-prescribing of testosterone.
Last month, in response to new FDA rules, testosterone manufacturers released new instructions for doctors making it clear that testosterone is not approved for “low-T” — a marketing term developed by drug companies to describe men with low testosterone levels caused by aging. Companies must now warn doctors about a possible increased risk of heart attack and stroke in men who take these drugs.
The FDA rules came about after the agency announced in March that it “has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”
Why are so many men taking testosterone for an unapproved use? The nearly tenfold increase in testosterone prescriptions began in 2007 when Abbott Laboratories (now AbbVie) launched its award-winning “Is It Low-T?” disease awareness campaign. The campaign has urged countless middle-age men who would like to become thinner, more muscular, more energetic and more sexually satisfied to ask their doctors whether low testosterone could be the reason they have gained weight, sometimes feel sad or grumpy, or get sleepy after meals.
A quiz on the “Is It Low-T?” Web site — which, perhaps in a positive sign, was taken down for unspecified “upgrades” last month — told men if they should have their testosterone level checked. (A company spokeswoman said last week that she could not answer our questions about the status of the site.) One of us — feeling grumpy, low energy and a little sleepy after dinner — took the quiz in the days before the site was removed and was told to talk his doctor about having a blood test. The Web site even instructed visitors in how to ask. Suggested questions included, “Considering my symptoms, should I be tested for Low T?” — helpful if your doctor is a little slow or happens to read the New England Journal of Medicine, which in 2010 published a study debunking the value of symptoms besides those related to sexual activity, like those covered by seven of the 10 quiz questions, in making a diagnosis (the question on loss of height was not tested).
Company-funded disease awareness campaigns often blur the line between public health messages that increase awareness about important diseases and infomercials meant to sell a disease to sell a drug. It’s a simple formula: The more diagnoses doctors make, the more prescriptions they can write. The “Is It Low-T?” campaign appears to be about getting as many men as possible diagnosed.
The problem is that it’s not about getting the right men (and boys) diagnosed, such as those who have low testosterone because of trauma, chemotherapy, genetic abnormalities, undescended testes or some other serious underlying problem. These patients need testosterone to develop normally or to restore “malenesss” and sexual function. They don’t need an awareness campaign, because treating them is standard medical practice.
As the FDA now acknowledges, the benefits and harms of treating men for “low-T” related to aging are unknown. For many men, the symptoms highlighted in the ads may not even be related to their level of testosterone. That’s why the FDA’s endocrine advisory committee questioned whether “low-T” of aging is even a disease at all. Or whether, in the words of comedian Stephen Colbert, “low-T” is simply “a pharmaceutical company-recognized condition affecting millions of men with low testosterone, previously known as getting older.”
According to the FDA, the dramatic rise in testosterone use is overwhelmingly in men with “low-T” of aging. If testosterone is not approved for these men — the target of “Is It Low-T?” — then why didn’t the FDA stop the campaign years ago?
The FDA acknowledges that it has received complaints about the campaign but told the endocrine advisory committee it could not act. The agency maintains that it can only regulate a disease awareness campaign if the campaign mentions a specific drug by name. But it can regulate campaigns when an unnamed drug is uniquely identified, as is the case with “low-T.” Here, the treatment is testosterone. The campaign has specifically mentioned “testosterone” in all its available forms (tablet, patch, roll-on, gel, etc.) as the recommended treatment.
And even if the FDA were powerless, it could still refer the matter to the Federal Trade Commission. It’s not clear how often the FDA makes such referrals, and the Federal Trade Commission declined to comment when asked whether the FDA had referred the low-T campaign. But the bottom line is: Neither the FDA nor the Federal Trade Commission has taken public action to limit or eliminate the “low-T” campaign. For years, consumers have been subjected to so-called disease awareness advertising and marketing that clearly crossed the line into off-label drug promotion.
Unfortunately, “Is It Low-T?” is not unique. It’s just a particularly bulked-up example of what has become standard operating procedure for drug companies. Regulators must be vigilant about such campaigns and act right away when they cross the line. They must not let manufacturers exploit what is essentially a regulatory blind spot.
The FDA’s recent action changing the official prescribing information for doctors may help reduce inappropriate prescriptions for “low T” related to aging — and that’s a good thing. But it’s not enough. The agency needs to flex its regulatory muscle and eliminate any so-called “disease-awareness” campaigns that promote drugs for off-label uses. Otherwise, how much of a dent can the FDA’s action really make when millions of men have been told that aging is optional?
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