The Lowdown On Low Testosterone And AndroGel
14 CommentsBy Ed Silverman // June 23rd, 2010 // 9:10 am
A new study that finds low testosterone is much less common in older men than previously thought - and is closely identified with just nine specific symptoms - may cause physicians and patients to rethink their use of various elixirs. Take AndroGel, for instance. The salve is cleverly promoted on an unbranded web site called ‘Is It Low T?,’ which features a quiz. The site lists various symptoms and risks purported to be associated with the condition, although some do not match what was noted in the study, which was published last week in The New England Journal of Medicine.
The study found that only 2 percent of men aged 40 to 80 suffer from the condition, which is also called male menopause, andropause or late-onset hypogonadism. The researchers measured testosterone levels in 3,369 men between those ages and then correlated their levels with different symptoms. Of 32 possible symptoms, only nine were linked with decreased testosterone. Three were physical - unable to engage in strenuous activity, walk about a mile or to bend over or kneel - and three were psychological — low energy, sadness and fatigue. However, these six symptoms were only mildly linked to the problem, while three sexual symptoms - less frequent morning erections, low sex drive and erectile dysfunction - were closely related to low testosterone.
“Our results also highlight the substantial overlap between late-onset hypogonadism and non-specific symptoms of aging. The application of these new criteria can guard against the excessive diagnosis of hypogonadism and curb the injudicious use of testosterone therapy in older men,” conclude the researchers, who noted the condition is usually associated with advancing age, yet there is little evidence about the “exact criteria for identifying testosterone deficiency in older men.”
Meanwhile, Abbott’s Solvay Pharmaceuticals unit actively promotes on its site that low testosterone affects more than 13 million men in the US over the age of 45. An Abbott spokesman points to a pair of studies used to bolster the notion that low testosterone will increase substantially with age, including in men well past 65 years old, although these were published in 2004 and 2007 (look here and here). Yet the AndroGel prescribing info acknowledges there haven’t been enough men 65 and older who have participated in clinical trials to know whether the treatment is safe or effective. And it is now 2010. Of course, now that the NEJM study dismisses the notion that older men are more likely to develop the problem, Solvay may not have to conduct a study.
The Low T site also states that the risk of developing low testosterone is 2.4 times greater if one is obese; 2.1 times greater if is one has diabetes; 1.8 greater with high blood pressure and a 1.5 higher risk if one also has high cholesterol. The evidence for this claim comes from this 2006 study. These may be accurate, although for the record, all five authors had ties to Solvay (click on authors and disclosures in the link to the study). Similarly, six of the seven authors of the Endocrine Society Clinical Guidelines for treating low testosterone have ties to Abbott (see page 31). This may confuse some people, since the ‘Low T’ site is identified as a Solvay site. However, a summary of the older version of the guidelines lists financial ties to Solvay (see this).
Also interesting is the pop quiz….
To gauge its usefulness, we deliberately answered ‘no’ to each of the 10 questions, which asked about whether we had lost our libido, energy, strength, height, enjoyment of life, and a few other choice topics. In other words, we deliberately avoided offering any indication that a problem may exist. Just the same, we received this reply: “Your answers show that you have a lower risk for low testosterone (Low T). But it’s still important to talk with your doctor about your symptoms. They may be caused by treatable condition.” What symptoms? Hard to say. Unless one is being pushed to ask a doctor for something.
In response to questions, the spokesman tells us that the site is “designed to simply raise awareness about the condition so that men who believe they’re suffering from the problem can have a conversation with their doctor about it…The quiz is not a diagnostic tool, but is a trigger to have that dialogue with the physician. Someone who takes the quiz may be feeling something isn’t right, so this says that perhaps they should still explore that. But it’s not intended to be diagnostic.”
And what about the site? Will Solvay modify it to reflect the findings from the NEJM study? “We believe there’s plenty of data that would suggest there’s a constellation of symptoms that may be associated with Low T,” he says. “We certainly always encourage continued scientific discovery and continue to look at this, but we still feel sufficient data out there that suggests this whole array of symptoms maybe associated with Low T.”
Stephany
The patient self-quiz ran by a drug company promoting their drugs such as Solvay’s - Is it Low T? –is just another disease-creating fear mongering ad campaign for profit.The DTC ad on TV directs viewers to go take the Solvay website quiz….
A few other articles about the Low T: which include good commentary and some great humor:
http://pharmamkting.blogspot.com/2010/05/omg-do-i-have-ed-or-low-t-or-both.html
http://bipolar-stanscroniclesandnarritive.blogspot.com/2010/05/male-hormone-replacement-big-pharma-and.html
http://www.healthnewsreview.org/blog/2010/06/the-lowdown-on-low-t-hint-disease-mongering.html
pharmavet
Assays of testosterone and of bioavailable testosterone are highly method-dependent and show wide temporal variability. Based on my reading of the linked article, they are essentially worthless. I would therefore base my prescribing decisions on clinical symptomatology rather than serum levels of these analytes.
http://www.ncbi.nlm.nih.gov/pubmed/11979385
SteveM
Re: “The Low T site also states that the risk of developing low testosterone is 2.4 times greater if one is obese; 2.1 times greater if is one has diabetes; 1.8 greater with high blood pressure and a 1.5 higher risk if one also has high cholesterol.”
Of course like the gamed and loaded psycho-pharm depression surveys, the initial solution is never a modified life-style of exercise, proper diet and meditative practices - it’s “talking to your doctor” - about a drug. Their drug…
Justice in MI
Great report, Ed. As I read the study, the authors are also (as Vet suggests) advocating that the three sexual symptoms need to be present _as well as_ lab correlation to consider “replacement” therapy. So the treatment guidelines suggested are much narrower than one would imagine from Abbott/Solvay’s Low T site, and certainly not dependent on labs alone.
This is in light of the risks, of course. The current Androgel label lists the risks of development of prostate cancer within 3 years–with clear causal connection to treatment–to 1.2%. The worsening of BPH, including urinary retention, is over 11%. This appears to be independent of dose.
Of course, a “help seeking” ad like the Low T one doesn’t need to include risk information. Just think of how mopey some of those guys would look if, along with low T, they also had prostate cancer and/or could no longer urinate.
Justice in MI
Took a look at the 2004 and 2007 studies linked. Very weak indeed and, if anything, support the conclusions of the NEJM study.
This is shaping up to be one more classic battle between marketing and science. It will be interesting to see whether new guidelines, re: disclosure, access to data, ghostwriting, off-label promo, etc. make any difference.
(Solvay, of course, is part of Abbott now.)
pharmavet
JiM is correct. Consider this: We’re talking about an age group at higher risk for prostate cancer. Take two highly variable assays, PSA and testosterone, misinterpret the results, give the androgen and you could easily wind up lighting a fire under an othwise indolent prostate carcinoma. Add to this the fact that many of these same doctors also prescribe Human Growth Hormone as part of the “anti-aging therapy, and we know that HGH stimulates tumor growth. Taken together this is a recipe for disaster.
MsPiggy
I have received a verified secret rumor and mumbling communication on Twitter that the APA (American Psycho-actric Association) has recently added LTDS “Low T Denial Syndrome” to the new and unimproved DSM-V edition of the Holy Pharmacological Bible.
I believe many commenting in this forum above may meet this broad and overreaching diagnostic criteria.This in theory and practice will allow the Courts to place each of you here under an Assisted Outpatient Treatment (AOT) order to keep this developing epidemic under reasonable control and profitable.
As a legally deemed danger to self, that little willy wonker, and to greater society as a whole.
You will be placed on a monitored daily forced medication regiment of T-Gel and seroquelXR until it has been determined by a court ordered quack MD of AstraZeneca or Abbott Pharmaceuticals choice, that you have totally submitted to their advertising campaign, propaganda disease mongering, and have been deemed chemically back in balance and genetically hygienically cleansed of this life long ailment and treatable condition.
I’m sorry I had to be the one to break this good news, but someone had to take the magic bullet.
Further developments: NAMI has signed on to be the national advocacy and educational center for LTDS support to families of those who are in Low T denial.
NAMI is expected to make this statement in press release today: “we are willing to accept millions from any Pharmaceutical Corporation that will help us get rich and promote made up diseases”
harpy
“Someone who takes the quiz may be feeling something isn’t right, so this says that perhaps they should still explore that.”
obviously by taking the quiz you’re admitting there’s something wrong with you. btw - have you stopped beating your wife?
MachoBadTasteMan
Now that you mention it, “Have you stopped beating your wife?” might have been a good question to include in the low T quiz…..
Greg
I am HIV+ and therefore have to be aware of my t-cell count (as well other more telling indicators). Therefore, when I saw ads talking about “low t,” I thought it was an ad regarding HIV/AIDS. So Abbott may have further confused adult males regarding a more threatening illness than low testosterone.
But wait, there’s more! As prescribed by my doc, I used Androgel for about five years because many men with HIV/AIDS suffer from low testosterone. Yet during the time I used Androgel, I saw no increase in testosterone. As time progressed in about year 3 of Androgel usage, I became frustrated with applying that yucky mess to my somewhat-hairy chest and increasingly “fell off the Androgel wagon.”
When I finally confessed to my physician about no longer taking it (at the fifth year), he thought that made sense as at least for me, Androgel just didn’t work, and wasn’t worth the hassle.
I wonder how many other folks found this out and thus Abbott/Solvay decided “what we need is a new marketing tactic.
Is this why we have the “Low T” message? And will folks grow increasingly tired and wise to stop paying attention to every new “plague” drummed up by over-the-counter and pharmaceutical drug manufacturers? Perhaps the numbers and letters game has groaned too much!
pharmavet
Greg, I empathize with you about Abbott, a company that I once worked for. To this day I still believe that their price hike on Norvir a few years ago was reprehensible.
G-Force
Completely naive responses!
Talk to actual physicians/patients treating and/or being treated regardless of the media driven information that typically sours most things..majority would debate these comments. And to comment on implementing a lifestyle plan including exercise and nutrition…I agree 100% and actually train individuals to achieve both fitness & nutrition goals….realisticly for the masses I will say men are lazy and unwilling to push their bodies consistently to naturally impact those associated conditions/symptoms associated with Hypogonadism…..Primary or Secondary for that matter!
Decreases in testosterone levels among us men take place over a longer period of time (starting around 25-26 years of age) at a rate of 1-3% each year….even more pronounced if other co-morbided conditions exist…referenced in a few studies actually referenced in this article. I agree that androgens can be “fuel to the fire” if prostate/breast carcinomas exist however if not the benefits of restoring testosterone levels to normal within the wide range…300-1000 ng/dL (according to Endocrine Guidelines)can and will continue to provide proven benefits.
The assays when drawn in a typical clinical setting may present inconsistent results which is why it is recommended to repeat the assay in the early AM hours to confirm that an individual is truly hypogonadal…based on symptoms (that majority of men are clueless and/or embarrassed to admit) and yes the lab results. FYI…..As men age (>50) the Free Testosterone levels decrease with age…this is the most active form of testosterone. The Free Testosterone tightly binds to Sex Hormone Binding Globulin in turn creates a misdiagnosis of having Normal Testosterone levels in most cases…If you don’t remain active and maintain proper nutrition as men age their natural production decreases significantly. Now for the obese…Waist circumference >40….an enzyme called Aromatase lives in the adipose tissues (visceral fat) and converts the natural Testosterone production to Estradiol via a process called Aromatazation…Now consistent exercise and nutrition can be vital part to changing this however for majority of men and/or women…WE WANT RESULTS FAST WITHOUT MUCH WORK AND/OR EFFORT! We will always get older but it’s our daily choice of consistent exercise/nutrition to help maintain the natural production of hormones to balance our quality of life….if not able/willing…products such as AndroGel plays an important role for restoring Testosterone levels into normal ranges….
Keep debating and not feeling/making a difference…Hyponadism, Low Testosterone, Males Menopause, Androgen Deficiency, etc. is REAL….
G-Force
Tom
Is Androgel going generic?
Bingo
In August 2015 unless the FTC has its way and the settlements between Solvay Watson, Par, and Paddock are overturned. The FTC lost at the district court level in February.