Wednesday, November 27, 2013

The Next Vioxx? Disease-Mongering "Low T"

Natasha Singer in the New York Times:
--writes about the campaign to convince all men over the age of maybe 25 that if they ever once felt tired or run-down or in any way lacking in manly vigor, they probably have testosterone deficiency and need one of the various products to supplement their testosterone--now a $2B annual industry. It seems that the brilliance of deciding that testosterone deficiency should be called "low T" was a major breakthrough in the public acceptability of this new supposed disease state. Two executives from AbbVie, the maker of AndroGel, were named by the trade magazine Medical Marketing & Media as "the all-star large pharma marketing team of the year" for their low-T promotional campaign.

Singer makes two major points in her article--first, that Pharma has successfully skated around the FDA by pushing the idea of "low T" through unbranded promotions. If you run an ad telling the public that low T is real and serious and they should see their doctors to find out if they have it, but don't at the same time mention your drug by name, you can get away with pushing your drug for all sorts of conditions for which it has not been granted FDA approval. (The FDA, it seems, is quite old-fashioned and still thinks that testosterone replacement products should be used for medically diagnosed cases of significant hormonal deficiency.) The second point is the widespread use of questionnaires where virtually anyone will answer "yes" to at least one question, which is then supposed to suggest that you probably have low T and could benefit from treatment.

Singer mentions along the way that the risks of taking testosterone long-term when you don't have serious hormone deficiency are essentially unknown. So why does "low T" sound like the next Vioxx waiting to happen, where drug firms convince the entire world that they all need to take a drug, and only later find out the substantial increase in adverse reactions that they have now inflicted on thousands if not millions of people? (This is what a while ago Don Light and I labeled the "Inverse Benefit Law":

1 comment:

Michael S. Altus, PhD, ELS said...

Instead, how about:
The Next Prempro? Disease-Mongering “Low T"...So why does "low T" sound like the next Prempro waiting to happen...

Another article directed to consumer readers complements the New York Times article:

RX for Change: The Low-Down on Low-T (or Menopause for Men)
By Charlea Massion and Adriane Fugh-Berman
National Women’s Health Network
The Women's Health Activist, September/October 2013; accessed Dec. 14, 2013

“Does the man in your life have ‘Low-T’ (low testosterone) Syndrome? Oh, wait; make that ‘the men in your life’ — chances are any of the men you know over age 40 qualify for a diagnosis.

“The promotion of ‘Low-T’ to consumers eerily parallels the promotion of ‘estrogen deficiency’ to women and prescribers....the benefits of hormones for preventing heart attacks, strokes, dementia, and wrinkles were extolled without scientific proof.... the Women’s Health Initiative (a large, long-term, Federally-funded randomized controlled trial) found that menopause hormone therapy increased the risk of breast cancer, blood clots, dementia, and cardiovascular disease....

“Now, pharmaceutical companies are targeting men, the women who influence them, and health care providers who can prescribe testosterone.”

Two JAMA Internal Medicine articles provide additional insight into the disease-mongering of “low-T”.

One is Schwartz LM, Woloshin S. Low "T" as in "template": how to sell disease. JAMA Intern Med. 2013 Aug 12;173(15):1460-1462. This article stated, “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 (it is one thing to tell men that Low T can make them grumpy; it is another to say that it can kill them) and spin the evidence about drug benefits and harms.

The other article is Braun SR. Promoting "Low T": A Medical Writer's Perspective. JAMA Intern Med. 2013 Aug 12;173(15):1458-1460. The article explains how the author, a medical writer, ghostwrote articles under the name of a well-known endocrinologist for consumer magazines about the “hazards” of low T and the availability of new forms of testosterone replacement therapy (TRT). I found this to be of particular interest, inasmuch as I thought of medical ghostwriting in relation to the concealed role of drug companies in the preparation of medical journal articles under the names of experts.

Braun’s article continues to explain how he prepared a patient education booklet carefully spun by a pharmaceutical company manufacturer of a TRT to be blandly accurate and effective at transmitting the company’s core messages. Finally, the article describes development of a consensus statement about TRT from panel meeting all of whose members had received support from by a pharmaceutical company manufacturer of a TRT that in turn was sponsoring the meeting. The workings of such a panel are described in interesting detail.