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Low T Marketing Part 2

Wednesday, June 5, 2013 // Uncategorized

The following is an editorial in JAMA from the same edition that hasd the essay by the medical ghostwrite.  It outlines the marketing of a treatment for a pseudodisease.  It’s worth a billion dollars.

Invited Commentary | ONLINE FIRST

Low “T” as in “Template”: How to Sell Disease:  Comment on “Promoting ‘Low T’” ONLINE FIRST

Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS
[+-] Author Affiliations

Author Affiliations: VA Outcomes Group, Department of Veterans Affairs Medical Center, White River Junction, Vermont; the Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice; and the Norris Cotton Cancer Center, Lebanon, New Hampshire (Drs Schwartz and Woloshin).

 

JAMA Intern Med. 2013;():1-3. doi:10.1001/jamainternmed.2013.7579.
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Published online June 3, 2013
 
 
 

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.
The Colbert Report,1 December 2012

Mr Ferguson, a healthy 55-year-old man without active problems, is in your office for his annual checkup. He tells you that he has no problems and feels fine.

“Well,” his wife chimes in, “he has been a little grumpy. Especially since Sammy—our son—starting beating Shaun here in their one-on-one basketball games.”

“Of course, I’m grumpy. We bet on a game and now I have to do the lawn,” Shaun says, shaking his head. “Takes forever, and it’s exhausting.”

“I understand,” you reply, laughing. “So, are you still off cigarettes?”

“Wait,” his wife blurts out before Shaun answers. She stares. “Don’t you think he needs a blood test? Could this be . . . Low T?” She hands you a paper—Shaun has completed the Low T question quiz from the Is It [Low T]? website.2

Testosterone usually brings sex to mind. Curiously, only 2 of 10 quiz questions are about sex: Decreased libido? Erections less strong? Your patient did not check either. But he checked 3 about energy, mood, and sports performance, enough for the quiz to suggest asking his doctor about “Low T” (low testosterone level, aka hypogonadism).

The site also offers strategies for spouses to “motivate the men in their lives to talk to their doctors.” For example, if the man says “I don’t have much energy anymore,” “[his spouse might think] he’s just making excuses.” But the site tells her that Low T may be the real issue because it can affect energy levels—never suggesting other explanations such as stress, depression, or other medical problems.

The Low T website is part of a broader disease awareness campaign run by Abbott Laboratories, maker of Androgel, the leading testosterone replacement product (>3 million prescriptions and >$1 billion in sales in the United States in 20123).

Whereas traditional drug promotion such as direct-to-consumer ads, physician samples, gifts, and detailing has received much attention, 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.

The article by Braun4 on the promotion of Low T is a fascinating and troubling first-hand look inside the kitchen of industry disease awareness campaigns. Braun exposes how industry used ghostwritten magazine articles under a celebrity physician’s byline. This is on top of educational campaigns, television and magazine ads, and mobilizing industry-funded advocacy groups. The campaigns also target physicians through special journal supplements, consensus statements, and continuing medical education, as Braun also highlights.

The Low T campaign provides a template for understanding how disease awareness campaigns work. Like other campaigns (eg, Bipolar Disorder and Restless Legs Syndrome), the Low T campaign uses 3 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.

Health exists along a spectrum. At one end, people are clearly well; at the other, clearly sick. What about the big gray zone in between? When do bothersome experiences become symptoms? Where do you draw the line? For Low T, the location of the line is implausible. Everyone feels a little tired—or sad or grumpy—sometimes. And everyone slows down a bit over time (it is called aging). Recent US endocrinology5 and European urology6 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.”5(p2543)

Interpreting laboratory values is all about lines—often determined statistically: lines are typically drawn, for example, 2 standard deviations beyond the mean, defining 5% of the population as abnormal. If the lines are drawn closer to the mean of normally distributed values, the proportion defined as abnormal expands rapidly. For testosterone, a serum level of 230 ng/dL (to convert to nanomoles per liter, multiply by 0.0347) defines 7% of men 50 years and older as abnormal; moving the line to 350 ng/dL (the cutoff for “normal” used in the consensus recommendation coauthored by Braun4) increases the abnormal proportion to 26%.

Ideally, the line would be drawn to maximize benefit and minimize harm. Unfortunately, lines are often drawn not because of evidence but to expand the market. Whether or not broad disease definitions are in the public’s interest, they do serve the financial and professional interests of industry, specialists, and advocacy groups.

It is one thing to tell men that Low T can make them grumpy; it is another to say that it can kill them. Messages raising the stakes about Low T have appeared regularly in scientific meeting reports and journal articles7 and often make their way into the news (“Low testosterone could kill you,” according to ABC News8).

Because Low T becomes more common with aging, associations with death are inevitable. But these associations come from inherently weak observational studies that cannot exclude residual confounding or establish causality. To his credit, Braun4 was able to highlight these fundamental limitations in the consensus recommendations that he coauthored. Ironically, the same report asserts that Low T increases the risk of heart disease even though this finding is based on similarly limited research (in fact, a randomized trial of testosterone therapy in elderly men was stopped early because it increased the risk of cardiovascular disease9).

The implicit message of the Low T awareness campaign is that testosterone therapy will improve men’s energy, mood, and sex life. Neither the Low T website, nor the consensus recommendation, nor the magazine articles published using unnamed ghostwriters4 tell readers which outcomes are likely to improve with testosterone therapy—let alone the magnitude of the changes. The focus is on getting a diagnosis and on which form of treatment to take.

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 (Table): 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. Whether these effects are big enough to matter to patients is unknown. Nor is it known whether they are big enough to outweigh the harms of testosterone therapy, ie, polycythemia that may increase thromboembolic events, edema, serious hepatotoxic effects, gynecomastia, worsening of sleep apnea, prostate enlargement, and rise in prostate-specific antigen level (and potential increased risk of prostate cancer).10

Table Grahic Jump LocationTable. Claims and Supporting Evidence About Testosterone Therapy for Low T

There are a lot of American men. Some are grumpy. Some are tired. Some may not even be interested in sex at the moment. 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.

We agree with Braun that there is a strong analogy between the marketing of testosterone therapy for men and estrogen therapy for menopausal women. Ignoring the lessons of estrogen therapy is scandalous. 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 therapy for healthy aging men does more good than harm.

Correspondence: Dr Woloshin, Department of Veterans Affairs Medical Center, White River Junction, VT 05009 ([email protected]).

Published Online: June 3, 2013. doi:10.1001/jamainternmed.2013.7579

Conflict of Interest Disclosures: None reported.

Disclaimer: The opinions expressed by the authors of this Invited Commentary are their own, and they should not be interpreted as official positions of the Department of Veterans Affairs.

Additional Information: Drs Schwartz and Woloshin are members of the Steering Committee for the Preventing Overdiagnosis conference cosponsored by the Geisel School of Medicine at Dartmouth in September 2013.

Additional Contributions: We thank Stephen Colbert for bringing needed attention to the selling of Low T and Victor Montori, MD, for reviewing the Table.

REFERENCES

1 +

 Low-T and Low-O. The Colbert Report. Comedy Central television. December 4, 2012. http://www.colbertnation.com/the-colbert-report-videos/421822/december-04-2012/low-t—low-o. Accessed April 21, 2013
2 +
 Abbott Laboratories. Is It [LowT]? http://www.isitlowt.com. Accessed April 12, 2013
3 +
Dobrow L. All-star large pharma marketing team of the year: AndroGel. Medical Marketing & Media. January 2, 2013. http://www.mmm-online.com/all-star-large-pharma-marketing-team-of-the-year-androgel/article/273242/. Accessed April 29, 2013
4 +
Braun SR. Promoting “Low T”: a medical writer’s perspective [published online June 3, 2013].  JAMA Intern MedLink to Article
5 +
Bhasin S, Cunningham GR, Hayes FJ,  et al; Task Force, Endocrine Society.  Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline.  J Clin Endocrinol Metab. 2010;95(6):2536-2559
PubMed   |  Link to Article
6 +
Dohle GR, Arver S, Bettocchi C, Kliesch S, Punab M, de Ronde W. Guideline on Male Hypogonadism. Anhem, The Netherlands: European Association of Urology; 2012
7 +
Lewis BH, Legato M, Fisch H. Medical implications of the male biological clock.  JAMA. 2006;296(19):2369-2371
PubMed   |  Link to Article
8 +
Bunyavanich S. Low testosterone could kill you. ABC News. June 6, 2007. http://abcnews.go.com/Health/ActiveAging/story?id=3247773#.UXGsoErTDFc. Accessed April 21, 2013
9 +
Basaria S, Coviello AD, Travison TG,  et al.  Adverse events associated with testosterone administration.  N Engl J Med. 2010;363(2):109-122
PubMed   |  Link to Article
10 +
 AndroGel 1.62% [package insert]. North Chicago, IL: Abbott Laboratories; 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf
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