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‘Low T’ campaign and other disease mongering can do harm, doctors say

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.

Two commentaries published Monday in the journal JAMA Internal Medicineone 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.”

Campaign strategies

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.”

Comments (1)

  1. Submitted by Paul Molinaro on 04/22/2014 - 08:01 pm.

    “Disease Monger” I like that term

    According to its manufacturer, AbbVie, “AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.” The AndroGel website offers the following ten question yes-no quiz to see whether a man “should talk to” his “doctor about Low Testosterone:”

    1. Do you have a decrease in libido (sex drive)?
    2. Do you have a lack of energy?
    3. Do you have a decrease in strength and/or endurance?
    4. Have you lost height?
    5. Have you noticed a decrease in your enjoyment of life?
    6. Are you sad and/or grumpy?
    7. Are your erections less strong?
    8. Have you noticed a recent deterioration in your ability to play sports?
    9. Are you falling asleep after dinner?
    10. Has there been a recent deterioration in your work performance?

    The ten questions might just as well ask, “Are you getting old?” or “Are you naturally aging?” Snake oil salesmen have been selling fountain of youth elixirs since people starting getting old. Fortunately, most snake oils are only harmful to the purchaser’s wallet as many of the alleged aging cures are harmless. However, once in a while a potion does contain harmful ingredients or actual medicinal compounds which have major physiological effects. AndroGel seems to be promoted as the cure for a newly discovered disease called, “Low T.” However, its safety is in question.

    On January 31, 2014, the United States Food and Drug Administration (FDA) issued a Safety Announcement regarding testosterone products. This communication stated, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.” While the beginning of this Safety Announcement might not seem alarming, the FDA further states, “None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.”

    What is “an associated medical condition?” The manufacturers of some testosterone products would have one believe that Low T (the condition of having low testosterone levels) is an associated medical condition to the condition of having low testosterone. If you think this is strange logic, you would be correct. There are some who feel that the manufacturers of some testosterone products, realizing that they had a profitable “cure” for a disease that did not exist, simply invented a disease with ten associated symptoms (see quiz above). Recent studies have shown that certain groups of men taking testosterone will have increased risks of stroke and heart attack. Lawsuits are now being filed against the manufacturers of some testosterone products and for failing to warn consumers about the deadly harm that testosterone can cause. Without getting technical, testosterone has been shown to increase the red blood count (thickening of the blood) which can cause clotting issues leading to stroke and heart attack.

    If your physician has prescribed testosterone for you, you should immediately discuss whether you truly need it and whether there are safer alternative drugs. After weighing the risks and benefits, you and your physician can determine what drug, if any, is best for you.

    If you or a loved one, have taken AndroGel, and have suffered a stroke, you should immediately consult with his physician and then consult with an attorney who is experienced in handling such a matter.

    – Paul

    Paul J. Molinaro, M.D., J.D.
    Attorney at Law, Physician

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