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New Drug: Big Pharma Goes Bio-Identical

Posted Apr 02 2013 3:00am
Two themes pervade today's post: 1) perception is reality  and 2) squeaky wheel gets the grease .  I thought it a good follow up to a spate of emails I recently received regarding a new brand of estrogen, specifically Divigel (17 beta estradiol) after having discussed the Women's Health Initiative Observational Study yesterday and the Global Consensus Statement re menopausal hormone therapy last month .

After the initial release of findings from WHI, a loud outcry was heard about how synthetic hormones were bad for you while natural hormones are good.  Thus ensued another version of the long running us vs them debate.  In clothing, it's been about natural fibers vs man-made ones.  Until recently, everyone wanted natural cotton, natural silk, natural linens, etc.  However, of late, we are moving towards synthetic fibers w/more wicking power able to keep you drier & warmer regardless of your activity & ambient temperature.

Well, in the world of hormones, this argument & name calling erupted along the lines of "synthetic" conjugated equine estrogen which was considered bad because it was derived from mare's urine (hence Premarin ) and included a large number of equine estrogens not normally found in humans.  There was also concern that all women received the same dose, 0.625mg, rather than adjusted & titrated to their individual needs.

Thus compounding pharmacies came to the rescue w/bio-identical hormones made from soy, yam, clover, etc and dosed according to the patient's individual needs as determined by lab values.  As you well know, neither Big Pharma nor the compounding pharmacy industry is without sin, but we'll leave that story for another day.  
More recently, Big Pharma has responded to some of these issues by making CEE available in more (smaller) doses (see statement #9)  (my numbering) as well as offering estradiol, ostensibly bio-identical, although not necessarily synthesized from plant materials ( Alora , Climara , Elestrin , Estraderm , Estrasorb , EstroGel , Evamist , Menostar , Minivelle , and Vivelle (Dot) ),  in various transdermal forms as suggested by statement #7 (my numbering).  However, the complaint remained that these were all synthetic hormones, even though, in my opinion, the end product, estradiol is estradiol, same as that generated in humans.

To meet everyone's needs, Upsher Smith just started marketing Divigel , which they claim to be a bio-identical plant-based estradiol, as such identical to that very same estrogen hormone made in human females.  Personally, I don't consider anything natural if it's been processed.  As such, unless you're ridding yourself of vasomotor symptoms by eating clover, soy & yam plant products, you're not getting natural anything because even compounded medications derived from these plants are synthesized.  But if it makes you feel better to apply something derived from plants, then pick Divigel over the other transdermal estradiol products.  Otherwise, I think they're all the same. But then again, perception is reality.  
Taken to an extreme, if all things natural are better than synthetic for us, then I should wipe my bottom w/poison oak or poison ivy when I'm out camping.  Likewise, I should chew on willow bark daily rather than take an aspirin or foxglove rather than digoxin if so indicated.  And if those arguing against use of CEE because it's synthesized from mare's urine and contains non-human equine estrogens, then why do these same people argue for the use of desiccated porcine thyroid extract, often sold as Armour Thyroid , Nature-Throid & Westhroid , which supposedly have other porcine cofactors in addition to being a combination of T4 & T3 hormone?   Our endocrinology colleagues will be the first to tell us that most people w/hypothyroidism convert T4 into T3 just fine and don't need the fixed ratio combinations found in those 3 natural formulations (similar to buying a dress rather than blouse & skirt, I suppose).  I guess that means I should return to prescribing natural porcine-derived insulin rather than recombinant E coli derived synthetic insulin for all our diabetics, right?  Let's be consistent in our recommendations, shall we?

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