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Hormone Replacement Therapy and Bio-Identical Hormones
By Diane Petersen, M.D.
Hormone replacement therapy is a controversial and much-talked-about topic today in thefield of gynecology. There is much confusion regarding the safety of various hormonepreparations as well as debate over the effectiveness of hormone therapy to preventserious diseases associated with aging. A generation ago the menopausal woman didn’tget much attention from pharmaceutical companies and the popular press. Wow, what adifference the baby boom generation has had on this area of medicine.
Before delving into the controversies of Premarin/Provera, bio-identical or synthetic, etc.,I would like to address some of what the popular press, pharmaceutical companies, andentrepreneurial pharmacies and physicians don’t want to talk about. They don’t want toreveal that half of the population will eventually become potential customers and they allwant a piece of that pie. Think of it, if women can be convinced that life will be betterwith some sort of hormone therapy, the profit would be huge. I don’t mean to be cynical,but it is important to realize that in large part the controversy stems from greed. Thepharmaceutical companies are obviously in it for profit (or else their stockholderswouldn’t be very happy). Then there are the compounding pharmacies that can placehormones into creams, ointments, lozenges and market them to you as “bio-identical”hormones. The hormones are manufactured from plants and the process for producingthese hormones is not patent-protected, meaning these “generically” produced hormonescan be purchased by the compounding pharmacies for use in their products. Thesesmaller operations rely on building your trust and a personal relationship, a nice touch,but there aren’t many controls in place to guarantee that you are getting exactly what youhave paid for and your insurance company will likely not cover the cost of theseproducts. The pharmaceutical companies are often using the same “bio-identical”hormones, but they have patented the delivery system (patches, gels, creams, vaginalinserts). It is important for the patient to realize that there isn’t any difference in thesafety profile of compounding pharmacy products and pharmaceutical company productsif they are using the same hormones (most commonly estradiol). There are somehormones that may be beneficial to a patient that are not available from pharmaceuticalcompanies; therefore the compounding pharmacies have filled the void with theirproducts.
Another aspect to the “free market” mentality to hormone replacement therapy is the useof various laboratory evaluations to determine what replacement is perfect for the patient.
There are saliva, urine a blood tests available and labs that will do some or all of these fora price. You can always find someone to facilitate having these test performed if you arewilling to pay the price. Physicians that have their own laboratories running these tests orsend them to laboratories that give the physician part of the profit are in a precariousposition. Some would consider this a conflict of interest. Laboratory results are only asaccurate as the quality of the laboratory. Laboratory results are only useful when we havecontrolled studies that guide our interpretation of the results and we apply the results tothe individual patient’s set of symptoms and signs of menopause. Tests that areperformed in my medical practice are sent to a standard laboratory. We bill a fee for
drawing and handling the blood only. The laboratory bills the insurance company or thepatient.
The term “bio-identical” seems to be all over the news lately. To many of my colleagues,this is a dirty word. It implies quackery to many gynecologists because it has been usedby those who would capitalize on the present controversy surrounding hormonereplacement therapy. I have welcomed the use of this phrase because it emphasizes theneed to strive for hormone replacement therapy that replicates the human ovarianfunction as closely as possible. I would compare this goal to the replacement of insulinand thyroid hormone in the body.
When I went through my residency training, there were standard levels of estrogen
hormone that were given. Those doses were based primarily upon the minimum dose
required to maintain optimal bone density. The most widely prescribed was Premarin, the
first available estrogen hormone and produced from pre
therapy by itself without progesterone therapy was found to cause endometrial cancer
(the ovary makes estrogens, progesterone, and testosterone). In the early days of hormone
replacement therapy natural progesterone initially couldn’t be formulated in a way that
we could get into our bodies, therefore medroxyprogesterone “Provera” was the main
progestin (synthetic progesterone). Premarin and Provera cornered the market for
decades. Gradually scientific advances in the pharmaceutical industry brought us
estrogens that were exactly like the ones that the ovary makes and micronized
progesterone that could be absorbed into the body. Patients gradually began to demand
that hormone replacement therapy be individualized to their needs, not based on what
might be best “on average” or to necessarily avoid one long-term consequence of
menopause. The explosion of different products all touting their advantages over their
competition fueled on by these demands of the baby boom generation has made hormone
replacement therapy big industry. Let the turf battle begin!
The shear number of products and services available to navigate menopause isstaggering. The news and quasi-news media has taken notice. Just recently I was linkedto “Bio-identical Hormones” by way of a news dimension report that linked to acompounding pharmacy’s site that listed me as an “expert” in bio-identical hormones(without my permission, might I add). The flood of phone calls has been amazing andprompted me to write this brief explanation on this topic. I cannot possibly see all thepatients that want to come in and talk about hormones. Also, I am no more of an expertthan any of my partners at Women’s Health Consultants. I believe that I achieved this“distinction” because I am willing to work with a patient and if they decide to use acompounding pharmacy I will then work with the pharmacy to give that patient the bestcare that is possible.
Much of the controversy in HRT arises from the medical industries honest effort to findthe truth. Medical research is an essential and quite difficult part of our industry. It is notlike having a diagnostic study on your car, the human body has many mysteries that wehave yet to solve. Studies come out month after month with new and often conflictingconclusions about the safety or risks of these various products. Reports on Premarin and
Provera, synthetic products, should not be extrapolated to describe the risks of productsthe contain estradiol and micronized natural progesterone. But when will the report cameout that looks at exactly how and when you as an individual are taking hormone therapy?Unfortunately,that will probably be a long time from now. Large randomized, well-designed studies are very expensive and difficult to conduct. In the mean time, how doyou decide if hormone replacement therapy is right for you? Finding an expert to helpyou with this decision might be a good idea. Realistically, some physicians do not wantthe potential liability of advising patients regarding hormone therapy because of thesafety controversy particularly after the Women’s Health Initiative (WHI) study. Otherphysicians may simply have decided that they do not want to keep up with the ever-growing amount of information in this field of medicine. Many patients are capable andmotivated to do some of their own research. I would recommend using the NationalLibrary of Medicine at www.nlm.nih.gov if you are interested in doing your own researchinto the literature. There are many books that have been written for the public on thissubject. While I have read many of them, I simply cannot keep up with them all. In thisforum I will not endorse any specific book(s) because I have not found one that I canrecommend to all patients.
I hope that you have found this to be a useful introduction to hormone replacementtherapy. If you were directed to this page because you called our office to make anappointment as a new patient, please consider discussing your needs with your primaryphysician again. If you can start the discussion with more than “Bio-identical hormones”as the introduction, you may be pleasantly surprised how very well informed and helpfulyour physician can be on this subject. Good luck.
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