“A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel… for treating something called Low-T, a pharmaceutical company recognized condition affecting millions of men with low testosterone, previously known as getting older.”
– Colbert Report, December 2012
Lebanon, NH (June 3, 2013) – Pharmaceutical companies and their “disease awareness” campaigns have become great fodder for one American comedian. And, rightfully so, say Drs. Lisa Schwartz and Steven Woloshin of The Dartmouth Institute for Health Policy & Clinical Practice in an editorial published online in JAMA Internal Medicine.
Traditional drug promotions – such as direct-to-consumer ads, physician samples and gifts – have morphed into well-coordinated and more subtle campaigns, which herald the selling of disease, they say.
The Low-T(estosterone) campaign can be used as the perfect template for the campaigns, complete with a quiz to determine if you have the “disease,” the editorial says. The Low-T website is part of a broader disease awareness campaign run by Abbott Laboratories, maker of Androgel, the leading testosterone-replacement product, which saw approximately 3 million prescriptions filled and $1.4 billion in sales in the U.S. in 2012.
The “disease awareness” campaigns are part of a broad effort to influence how doctors and the public think about what constitutes disease and when drugs are “needed,” and blur the line between public health or professional education and marketing, according to the authors.
An analysis of the the Low-T campaign provides an understanding of how the campaigns work with its three basic strategies: lower the bar for diagnosis, raise the stakes so people want to get tested, and spin the evidence about drug benefits and harms.
By Lowering the Bar, pharmaceutical companies target people in the “big grey zone” between being clearly well or clearly sick. “There are a lot of American men. Some are grumpy. Some are tired. Some may not be interested in sex at the moment. And all of them are aging,” say Schwartz and Woloshin. “This is the intended target of the campaign.”
Furthermore, the authors point to recent guidelines from the U.S. Endocrine Society and the European Association of Urology, which recommend against using Low-T-type quizzes because they are unreliable and unvalidated. The U.S. guideline goes even further, recommending against general population screening for Low-T “because of the lack of consensus on case definition and to the extent to which androgen deficiency is an important health problem.”
As to Raising the Stakes, the authors say messages are out there in scientific meeting reports and journal articles, and even the news, which say that Low-T can kill you. “But these associations come from inherently weak observational studies, which cannot exclude residual confounding or establish causality,” Schwartz and Woloshin say.
The final leg of the “disease awareness” campaign is to Spin the Evidence. “The implicit message of the Low-T awareness campaign is that testosterone replacement will improve men’s energy, mood and sex life,” the authors say. But the campaign does not tell that replacement therapy results in only small improvements in lean body mass and body fat, libido and sexual satisfaction, and has inconsistent (or no) effect on weight, depression and lower extremity strength. “The focus is on getting diagnosed and on which form of treatment to take,” the authors say.
The analogy between the marketing testosterone replacement therapy for men and estrogren replacement therapy for menopausal women should not go unheeded, say the authors. “Before anyone makes millions of men aware of Low-T, they should be required to do a large-scale randomized trial to demonstrate that testosterone replacement for healthy aging men does more good than harm.”
The campaign should be recognized for what it is, the authors say. “A mass, uncontrolled experiment, which invites men to expose themselves to the harms of a treatment unlikely to fix problems which they may not really have.”
Drs. Schwartz and Woloshin are members of the steering committee for the Preventing Overdiagnosis Conference, hosted at Dartmouth College Sept. 10-12 in Hanover, NH, and co-directors of the VA Outcomes Group, VA Medical Center, White River Junction, VT, and the Center for Medicine and the Media at the Dartmouth Institute for Health Policy & Clinical Practice.