Monday, September 10, 2012

Associated Press re Testosterone (Marketing)

A colleague pointed out an article about testosterone promulgated by the Associated Press (AP) yesterday for use by any means of news distribution, whether print or online.  The author specifically reviewed the advertisement by Abbott Laboratories regarding its Androgel.  But he also discussed Watson Pharmaceutical's Androderm patch & Eli Lilly's underarm Axiron.  And let's not forget Fortesta & Testim, too, as well as injectable testosterone cypionate.

Several concerns were made, one of which is long safety.  Citing the decade old Women's Health Initiative (WHI) as an example, the author rightly pointed that we have no (randomized, controlled trial) proof of testosterone's safety beyond its use for a few months.  The concern is that we might end up with another WHI fiasco which used a single RCT to overturn the conventional wisdom regarding estrogen & progestogen previously supported by only observational studies.

Beyond safety, researchers still ponder the benefit of testosterone.  While the true believers will gladly extol its virtues, obtaining statistical proof hasn't been as easy nor the data as clear cut & consistent.  We're still waiting for yet another government funded study to be published in 2 years.

More importantly, how do you decide who needs testosterone when we can't even agree upon the definition of low testosterone or hypogonadism.  Each lab, some using several different techniques, has different reference ranges for normal, which begs the question, who's normal?  Just because two-thirds of the population is overweight & obese doesn't make this condition "normal".

Finally, the author asks about medicalization, such that Big Pharma is turning every condition into one for which we can pop a pill and fix it.  I must admit that I have a tough time with this one.  At what point does a condition become an illness to be treated rather than just another part of growing older?  Perhaps if we weren't growing older, we wouldn't be complaining about these symptoms.  

But what do we do in the here & now?  First, I would posit that we don't draw screening labs in asymptomatic patients. However, given the non-specific nature of the complaints, the requirement to test only symptomatic patients is rather loose.  Second, I think it's reasonable to offer a trial in someone who's symptomatic (even if just low normal) and has no other cause to explain his symptom complex, then monitor closely for benefit, stopping if there's no benefit after optimizing one's T level.  Third, we need to monitor our patients closely.  Prescribing T is not like a late night commercial for some device that you set & then forget.  We need to keep a close eye on our patients, monitoring both emotional, mental & physical response.



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