Two commentaries published Monday in the journal JAMA Internal Medicine — one by two physicians, the other by a medical writer — examine the subtle but deeply troubling “disease awareness campaigns” being run by Big Pharma.
“Whereas traditional drug promotion such as direct-to-consumer ads, physician samples, gifts, and detailing [physician office visits by drug company salespeople] has received much attention,” write Drs. Lisa M. Schwartz and Steven Wiloshim, co-directors of Dartmouth College’s Center for Medicine and the Media, “far less is known about disease awareness campaigns’ much broader efforts to influence how physicians and the public think about what constitutes disease and when drugs are needed. These well-coordinated campaigns are more subtle than drug-specific campaigns, and they blur the line between public health or professional education and marketing.”
Schwartz and Wiloshim and the author of the other commentary, medical writer Stephen Braun, specifically discuss campaigns to promote testosterone replacement therapy (TRT) for so-called Low T, or low testosterone levels in men. But you don’t have to look far to find plenty of other examples of such disease mongering (the stretching of diagnostic definition of an illness to include healthy people). Leading examples include osteoporosis, bipolar disorder, mild cognitive impairment, attention deficit hyperactivity disorder (ADHD), restless legs syndrome, social shyness, irritable bowel syndrome and balding.
Disease mongering is hugely profitable. As Schwartz and Wiloshim point out, U.S. sales of the best-selling TRT product, Abbott Laboratories’ Androgel, topped $1 billion in 2012.
There is a medical condition called hypogonadism, in which the testes (or the ovaries in women) do not function properly. But that condition is relatively rare. The vast majority of TRT sales are to healthy men — men who are being told by TV ads, magazine articles (often written by physicians with ties to the drug industry), and online websites (also tied to the drug industry) that their dips in energy, mood, sex drive and sports performance can be explained by low testosterone levels.
Such advertising seldom suggests other possible explanations, like stress, depression or an undiagnosed (and non-testosterone-related) medical problem.
Or just plain aging.
“Everyone feels a little tired or sad or grumpy sometimes,” write Schwartz and Woloshin. “And everyone slows down a bit over time (it is called aging). Recent US endocrinology and European urology guidelines actually recommend against using such Low T type quizzes because they are unreliable and unvalidated. The Endocrine Society guideline goes even further, recommending against general population screening for Low T because of the lack of consensus on a case definition and the extent to which androgen deficiency is an important health problem.”
Like other disease-mongering campaigns, explain Schwartz and Woloshim, the one for Low T uses three basic strategies: “lower the bar for diagnosis (turning ordinary life experiences into conditions that require medical diagnoses), raise the stakes so that people want to get tested, and spin the evidence about drug benefits and harms.”
The Low T campaign has lowered the bar for diagnosis, they note, by defining “abnormal” testosterone levels as anything below 350 ng/dL.
Under that definition, 26 percent of U.S. men would need “treatment.”
The campaign has raised the stakes by suggesting that Low T not only makes you irritable and lethargic, it may also kill you. But, as Schwartz and Woloshim point out, “Because Low T becomes more common with aging, associations with death are inevitable.”
As for spinning the evidence, the Low T campaign does that by simply ignoring it.
“Physicians and patients who assume that treatment has an important effect on all or most symptoms may be surprised by the evidence from randomized trials,” write Schwartz and Woloshim. “Testosterone 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.”
A view from the writing trenches
In his commentary, the Boston-based Braun offers a frank, insider’s look at how that spinning is done. He describes how he ghosted a series of magazine articles (under a physician’s byline), patient-education materials and physician “consensus statements” that were carefully worded to portray only positive or neutral information about TRT.
Braun tells, for example, of how a public-relations firm under the direction of a pharmaceutical company approached a “well-known endocrinologist” to place articles on TRT in popular consumer magazines. That endocrinologist hired Braun to ghostwrite the articles, which eventually appeared in such publications as Woman’s Day, Business Week, and Life After 50.
“Although these articles were relatively neutral in tone and did not mention specific products, none were skeptical, none questioned the reliability of the data on which claims were being made, and none included the views of clinicians who dissented from the emerging paradigm about Low T,” Braun writes in his commentary. “In part, that was because I was just learning about the issue myself and had not dug deeply into the literature. But I also knew what I was getting paid to do: trumpet the party line. As a result, the articles adhered nicely to the new paradigm of Low T as a potentially serious condition for which new treatments were available.”
Braun offers his experience with the writing of these materials as a cautionary tale.
“Everyone involved in the creation of drug company sponsored educational materials for physicians or consumers, myself most certainly included, must constantly guard against these kinds of influences,” he warns. “We must do our own research, ask hard questions, be skeptical about all claims, and question whether our judgment and our words are being subtle skewed by the knowledge that the funder is watching.”
‘A mass, uncontrolled experiment’
Schwartz and Woloshin agree, of course, but their caution goes even further.
“Before anyone makes millions of men aware of Low T,” the two doctors stress, “they should be required to do a large-scale randomized trial to demonstrate that testosterone therapy for healthy aging men does more good than harm.”
“There are a lot of American men. Some are grumpy. Some are tired. Some may not even be interested in sex at the moment,” they conclude. “And all of them are aging. This is the intended audience for the Low T campaign. Whether the campaign is motivated by a sincere desire to help men or simply by greed, we should recognize it for what it is: a mass, uncontrolled experiment that invites men to expose themselves to the harms of a treatment unlikely to fix problems that may be wholly unrelated to testosterone levels.”