While it is firmly established that the most clinically effective treatment for menopausal symptoms is hormone replacement, one common distinction that too many fail to make is that “conventional” hormone replacement and “bioidentical” hormone replacement are not one and the same. It amazes me how often patients tell me their physician has said to them “hormones are hormones”– even the OB/GYN who really should know better. My own personal research, and that of countless other scientists and physicians in this area of medicine, tells us that all hormones are NOT created equally.
The Women’s Health Initiative study looked at two very specific drugs, namely Premarin and Prempro. Premarin is a distillation of various non-human hormones derived from pregnant mares’ urine. The drug’s package insert vaguely describes the pill’s content of “conjugated estrogens” without providing much more detail of the assorted components or their chemical structure. But, if one is able to examine with an understanding of chemistry and physiology the specific make-up of the non-human hormones in Premarin, it becomes inconceivable that these chemicals could possibly behave identically to the body’s own innate forms of estrogen. Likewise, in the case of Prempro, the other drug studied by the WHI, it is actually a combination of two drugs–Premarin and Provera. Provera, or medroxyprogesterone acetate (MPA) is a potent progestin(a progesterone-like substance) that is very “sticky” with regard to its target cell receptors, meaning it stays engaged longer and more stubbornly than the body’s own naturally produced progesterone. Though it has progesterone in its name, MPA is not nearly identical to natural human progesterone
The chemical differences between the body’s own hormones and those foreign hormones described above are unquestionably very subtle. But, if one looks at the chemical structure of the three main ovarian hormones, progesterone, estrogen and testosterone, each of these differ only slightly from the other by the arrangement and placement of hydrogen here, a carbon there, and double-bonded oxygen there. Obviously, these three hormones behave and have very different effects from each other on the tissues and organs of the body—nobody in his right mind would question this. But, somehow people, scientists, and yes, even physicians quite easily assume these other chemicals, since they all have estrogenic and/or progestin-like properties and appear very structurally similar, will all produce the same short and long term effects, one just the same as the other. This is where the erroneous thinking begins in the minds of those inclined to make over-generalizing conclusions from the results of the WHIstudy. First, whatever was found to be true in the WHIstudy of conjugated estrogens, must also be true of all estrogens, even those made in the human body’s own organs and glands. Similarly, the resulting long-term effects of years of exposure to MPA must also be expected to follow from supplementation with bio-identical progesterone. This is just wrong thinking! Why properly educated and esteemed doctors and scientist make this clumsy leap, I cannot figure.
Bioidentical hormone replacement therapy (BHRT) has enjoyed some prime-time publicity and increased popularity over the last several years. Suzanne Summers, Oprah Winfrey, Robin McGraw (Dr. Phil’s wife), and even Dr. Oz have endorsed the use and practice of BHRT. In other words, it’s alternative therapy that has now become mainstream. Does this mean everybody should jump on the bandwagon and start slathering with hormone creams to feel young again? I think not. Obviously, as a compounding pharmacist whose most profitable niche is BHRT compounding, I have a strong bias in favor of this therapy—complete transparency here, folks. But, I promise you, I am not in it only for the money. I truly believe it is the best therapy. I recommend it for my wife, my mom, my grandmother– every woman I think could benefit from it, because it is the right therapy. It is, very simply stated, putting back into the body exactly what it is deficient in. Bio-identical hormones are molecularly indistinguishable– exactly the same substances that Mother Nature has helped you make your entire life.
So, let’s talk about the FDA and its non-approval as well as the varying quality and strength issues related to compounded hormone replacement. Does FDA approval mean a drug or food or device is unquestionably safe? No. It means that a company has proven that it’s patented product is safe enough to meet with the FDA’s approval to proceed with marketing that product for specific indication(s) or use(s)—plain and simple. The FDA gets all of its revenue, millions and millions of dollars, from drug companies’ participation in their approval process. Bio-identical hormones are not patent-able. Therefore, they are not a potential revenue source for the FDA. Furthermore, they stand, potentially and actually, to compete with other products out there the big Pharma companies produce. Products the big Pharma companies have gone through all the FDA’s expensive hoops in order to be able to market to the public and its medical professionals. Let’s not be naive, big Pharma owns the FDA with all the revenue it provides, and devotes enormous amounts of additional dollars in lobbying efforts to help shape the FDA’s stance on such “public health threats” as pharmacy compounding. This is how we little compounding pharmacists see the playing field—sound a little paranoid and conspiracy theorist? Well, you can be the judge on that one.
So,what about quality and strength? I will agree one hundred percent that there is undoubtedly going to be a lot of varying quality and consistency out there when you take into account all the thousands of different pharmacies across the nation performing various levels and scales of compounding. Each pharmacy is inspected and held accountable to the standards determined by their own state’s board of pharmacy. And, what it boils down to, really, is the skill-level, the expertise, the infrastructure and the integrity of each particular operation. I know, firsthand, there are operations out there that are really sub-par as far as professional and industry standards go. That being said, there exist others who hold themselves to a standard higher than what is expected of a plant subject to FDA inspection. Lucky for me, I was professionally trained and personally instilled with the mindset and practice approach of one of these very top-notch operations.
At the end of the day, my advice to anyone receiving or even considering receiving a compounded preparation, is to first establish with a presciber who has substantial experience in BHRT practice, so that you will be prescribed appropriate doses to treat your symptoms with minimal exposure to risk. Secondly, by doing so, you will presumably be referred to a pharmacy or, better yet, choice of pharmacies, with which the presciber has had consistent reliable experience and results. Next, though it may be tempting to price shop once one has begun using compounds in order to get the “best deal”, I strongly advise against changing compounding pharmacies too frequently. Not all will use the same bases and inactives, hence the results may vary significantly as well. Also, saving a few dollars here or there doesn’t necessarily ensure the best quality of compounded preparation. Go see the pharmacy, ask the pharmacist questions, ask for referrals. Who are his/her big prescribers? How long as he/she been in practice? It’s your body, it’s your health. Do the right thing.
John Ortego, PharmD