Allopathic programs train you to look askance at anything that could be construed as a natural therapy.  “We have a drug for that” is a mantra that is entrenched, at least in clinical rotations, but, by golly, they made the mistake of teaching me biochemistry, pharmacology and physiology first.  Some of that, more than I anticipated, came flooding back at the most appropriate times, such as when the Women’s Health Initiative Study came out.  I was beyond dismayed by this study and vowed not to prescribe synthetic hormones.  Shelving hormone therapy in favor of, I shudder to admit, anti-depressants, supplements, and soy (shudder again), it didn’t take long for this gynecologist to discover, duh, women need hormones.  However, my quest to bring real answers to real clinical problems forced me to return to the basic sciences, in search of a more excellent way.  As with anything worth doing, it brings its share of naysayers, to which I say, bring them on, I love bio-identicals and I’m never going back!

1.  Hormones are all the same. – I love this one!  Especially since we bend over backwards to differentiate between things like Human insulin and Bovine insulin.  No, I’m sorry, synthetic hormones are not the same as bio-identical ones (the same chemical structure as in the human body), although the naysayers want to quibble about the term “bio-identical”.  They want to do that because everyone knows what “synthetic” means and if given a choice, most would choose a therapy that is NOT synthetic.  Now, that doesn’t mean it is not manufactured.  No, you cannot rub a yam on your arm and get hormones.  Hormones must be extracted in a lab, even the bio-identical ones.  But this process does not warrant the conspiracy theory that “bio-identical” is not an accurate term.  The fact is, Big Pharma/ACOG/NAMS are all scared of this term so they figure if they throw up a big hand-waving smoke screen about the name, people will start to doubt its value.  Too late people, the cat is out of the bag!  A hormone fits in a receptor and that receptor responds to a hormone that it recognizes better than one that it doesn’t.  My favorite example:  synthetic progestins (most commonly Provera, medroxy progesterone acetate) while they may stop bleeding, and “stabilize the endometrium,” that’s where any similarity ends.  Progestins make people feel bad, moody, anxious, etc.  Natural progesterone is the “mood-stabilizer” hormone.  Progestins are pregnancy category X (causes birth defects), while natural progesterone is a PRO-GESTATION agent, without which a normal pregnancy cannot progress.  And jumping ahead to Number 2:  BIG LIE that came out of WHI:  these results should be applied to natural hormones, to the extent that the FDA actually put the same risks identified for Prempro (heart attack, blood clot, stroke, breast cancer) on Prometrium, micronized bioidentical progesterone.  INSANE!

2.  All hormones have the same risks:  Uh, yeah, how many times do we have to say this?  Natural progesterone has no pro-clotting properties.  Oral estrogens and some types of synthetic progestins can cause very serious clotting problems.  Oral estrogens (even bioidentical estrogen) have to be metabolized by the liver, which is where clotting and inflammatory factors are made.   Numerous journal articles back this up, but it is physiology not rocket science.  Since transdermal estrogen bypasses the liver, there is no increased clotting risk.  Don’t believe me?  Read the ESTHER trial.  This study (which naturally was not conducted in the US) followed women who had a VTE (venous thromboembolism/blood clot), for the types of subsequent HRT they took.  Those women who took transdermal estrogen (in this study, patches) and/or bio-identical progesterone did not have an increased risk of subsequent VTE. 

3.  Transdermal hormones are not absorbed well.  I don’t really get this one either.  Apparently the people saying this don’t understand physiology very well.  Oral administration of hormones requires that the hormones make it through the GI tract and are metabolized by the liver (first pass effect) which is why the doses have to be so much higher.  Transdermal absorption is much better (think low dose hydrocortisone cream) and bypasses the liver, which is helpful for those with elevated liver enzymes, high risk for clotting because of smoking, obesity or family history, those with GI problems like gastric bypass, malabsorption, chronic bowel problems.  For some reason, most people have no trouble accepting excellent transdermal absorption of estrogen, but they don’t think progesterone creams are absorbed well.  Wrong!  It has been wonderful to see just how low dose we can get hormones and still get a clinical effect, just by utilizing the proper routes of administration.  Doctors have routinely used vaginal progesterone to support early pregnancies because it is quickly absorbed into the uterus.

4.  Bio-identical hormones are very expensive (only Suzanne Somers can afford them).  Many insurances do pay for hormones if you have a compounding pharmacy which files with insurance for compounded preparations.  They’ve been paying for compounded vaginal progesterone suppositories in early pregnancy for a long time (and these are way cheaper compounded than the retail products).  If your insurance does not cover compounds, the average monthly price with the pharmacies I use is around $40-$45, which usually is for multiple hormones.  Not bad for hormone balance!

5.  Patients do not require customized hormone therapy.  The American College of OB/GYN wants to make it very clear to you.  WOMEN DO NOT REQUIRE CUSTOMIZED HORMONE THERAPY.  Do you hear that!?!   Women are all the same, the only distinction you need to make is, do you have a uterus or not?  Beyond that, listen you women, THERE IS NO NEED TO “INDIVIDUALIZE, TAYLOR OR CUSTOMIZE” THERAPY!  See, the modern approach to hormone therapy is based upon guessing, mono-therapy if you’ve had a hysterectomy because “all you need is estrogen,” synthetic progestins if you have a uterus, no options for testosterone, and no attention paid to your diet, your supplements, your metabolic status, your thyroid and adrenal function, etc.  And that’s the way ACOG intends it to stay, no matter how many women Suzanne Somers tries to convince to demand otherwise.

6.  Compounded hormones are not effective.  Yes, which is why women drive sometimes more than 2-3 hours to find someone who will prescribe them.  If they didn’t work, this whole thing would have fizzled on its own by now.  The FDA tried to discredit compounders by stating that certain batches of hormones at some pharmacies were not potent.  My advice is to only use a compounding pharmacy who is a member of the International Academy of Compounding Pharmacists (who oversee and randomly test products for potency) and the Professional Compounding Centers of America (which supply rigorously tested high potency ingredients for compounds).

7.  There is no scientific evidence to support their use.  As one “expert,” stated, bioidenticals are “data-free.”  Which is false.  First of all, there are lots of journal articles about bioidentical estrogen patches/gel/spray and bioidentical micronized progesterone which are available through retail pharmacies; see this wonderful review for literature support of bioidenticals.   As for compounds, the data is limited but promising, see here and here.  Clinically speaking, compounds have completely transformed my practice in terms of the positive impact they have made on my patients’ lives. 

8.  They are not FDA-approved.  We’ve established that even if you don’t want to use compounds, there are still plenty of FDA-approved bio-identical products currently on the market:  Climara estrogen patch, Vivelle Dot estrogen patch (one of my favorites), Evamist estrogen spray, Estrogel, Estrasorb, Prometrium (oral natural progesterone), Crinone (natural vaginal progesterone gel), oral estradiol (I avoid oral estrogen if I can, even bioidentical), Androgel (natural testosterone, for men only).  However, compounds cannot be FDA approved because they are individually prepared for each patient.  But the INGREDIENTS that are used in compounds are FDA approved because they have what is called a USP (United States Pharmacopia) monograph.  That means they are registered as able to be prescribed by doctors and taken by patients.  The whole FDA push to make the weak naturally occuring estrogen estriol a big bad hormone target, was simply to try to strengthen their attack on compounding pharmacies which in turn was only done as an orchestrated attack by then-pharmaceutical giant Wyeth in response to their plummeting Premarin/Prempro sales in the wake of WHI.  And don’t forget how Wyeth paid money to Wulf Utian, the head of the North American Menopause Society, which then put out their recommendations to continue using synthetics for ob/gyns to follow (like lemmings over the cliff).  I’ve got a whole blog brewing on Dr. Utian and how he’s in bed with the pharmaceutical industry.  He’s since dropped his affiliation with Wyeth/Pfizer like a hot potato but it doesn’t take much research into his past to find it.

9.  Saliva testing to determine what a patient needs hormonally is not valid or reliable.  Yes, we know this is the mantra of mainstream Ob/Gyn.  But the real point in all this is how they do not care about the science.   Actually, if you listen closely, you will hear them say things like, “It’s not reliable due to time of cycle, time of day, what you ate, etc., etc.”  All true, hormone levels are influenced by these factors, which is why, in a cycling woman, hormones are tested on Day 20, fasting first thing in the morning.  A post-menopausal woman doesn’t have the same fluctuations as a pre-menopausal woman, so she can test anytime, as long as it is morning and fasting.  Serum hormone testing measures bound (to protein carriers and thus inactive) and unbound hormones (free or active).  Bound hormones cannot pass through cell membranes into saliva like small free hormones can, thus saliva is reflective of the free or active level of hormones in the body.  When a woman is using transdermal hormones, the hormones quickly exit the bloodstream and are deposited into target tissues.  Thus they are not accurately measurable in serum, but are detectable in saliva.  Saliva can be more problematic in a woman with irregular cycles.  However, we are testing women using a standardized process, the ranges of normal are based on averages of women with no hormonal symptoms and regular cycles, and it is a tool that is used in conjunction with clinical assessment.  Saliva testing is not perfect, but when it is used as an adjunctive tool, it is certainly superior to guessing.  And in the post-menopausal woman, it is very reliable.  It is interesting that Dr. David Zava, the founder of ZRT labs, tried to present his data to Dr. Leon Speroff, well-known leader in the OB/GYN world, author of the hormone bible “Clinical Gynecologic Endocrinology and Infertility,” and out-spoken defender of synthetic hormones (as well as recepient of Big Pharma dollars).  Dr. Speroff, who up to then had been quite friendly, simply did not want to hear any of the scientific evidence.  Why?  Well, because, it would change everything.  See, it’s easier for these guys to say, “Oh, that doesn’t work,” rather than to actually find out if it does.  They have no incentive and they have a lot of power so if they say it doesn’t work, then all the other people under them (the lemmings), will just parrot what they said.  You know, if Drs. Speroff and Utian said it, it must be true.  Except maybe people should question their patently obvious financial conflicts of interest.

10.  Bioidenticals are really just on the fringe of medicine and can be ignored.  We have Oprah, Dr. Phil, and Suzanne Somers to thank for blowing this myth to bits.  As much as Big Pharma/FDA/NAMS/ACOG wish the “bioidentical” problem would just die off and go away, they KNOW it is not.  Demand is higher than ever (it’s not just my phone is ringing off the hook for women seeking this therapy).  Add in organizations like Women in Balance, BodyLogicMD and excellent well-trained docs like Erika Schwartz, Christine Northrup, David Brownstein, Kent Holtorf, Kenna Stephenson, Rebecca Glaser, and many more who have been helping women hormonally, and you begin to see that bioidenticals have become an established presence in medicine, and much to many women’s relief, is not going away any time soon.