The use of the word” bioidentical” is brilliant. It’s catchy. It sounds “natural.” It sounds like something different than a hormone product produced and distributed by commercial pharmacies.
Promoters of bioidentical hormones claim that these products reverse aging, enhance sex and prevent cancer. They also allege that, unlike FDA-approved commercial hormones, compounded hormones have no risks and no side effects. It all sounds pretty good, until you look closer.
Myth #1: Bioidentical Hormones are “natural.” The only thing that is natural is to drink the horse urine or eat the soy plant. All hormone preparations are synthesized and require a chemical process to achieve a product, which can be put into a cream, a spray, a patch or a pill.
Promoters of compounded drugs use the term “natural” because it is appealing to consumers and implies that bioidentical products have an advantage over manufactured pharmaceutical products. “Natural” does not equal “safer.” We can all name many things that are natural but hardly safe. Arsenic comes to mind.
Natural products do not always work better than synthetic products. There is no scientific evidence that “Bio-identical H ormones” provide more symptom relief than commercial hormone replacement.
Myth #2: Unlike commercially produced hormones, “Bioidentical Hormones” are identical to the hormones in our bodies. Plant-derived estrogen from soybeans or yams is molecularly very similar, but not identical to human hormones. Is what you get from the compounding pharmacy closer to the hormones we produce, “more human-like”… than what you get in an FDA-approved product?
This is the interesting part. Compounding pharmacies don’t manufacture hormones, they just mix them.
Once the hormone is extracted from the plant, it is synthesized to a usable form. The active ingredients are sold to both commercial pharmaceutical companies and compounding pharmacies. It is then that the active ingredient is used to make lotions, pills, sprays or patches.
The active ingredient, estradiol, is extracted from the same plants by the same factories. So you are getting the identical estradiol molecule, whether you get your hormones from a compounding pharmacy or your corner Walgreen’s.
Myth #3: Bioidentical hormones are safer than other hormones. Since bio-identical hormones are nothing more than custom-made compounded alternatives to FDA-approved estrogen and progestin formulations, and thus have the same active ingredients as commercial hormones, they obviously are going to have the same benefits and the same safety concerns. But unlike marketers of commercial hormones, the distributors and promoters of bioidentical hormones deny these risks. And that’s really misleading.
How do they get away with it? Since the FDA does not regulate compounding pharmacies, they can make whatever claims they want. They tell women what they want to hear — namely, that bioidentical hormones have fewer risks, fewer side effects and are more effective than standard hormones, even though there is no evidence to prove that claim. No package inserts for the clinician or patient, documenting safety and efficacy, are required in order to sell these mixtures.
While women generally distrust the pharmaceutical industry — which is legally obligated to back up their claims, do testing and report all safety risks and negative findings — the general population seems to have little problem placing their trust in companies that have no such efficacy or safety standards. This fact, combined with wider and more aggressive advertising and marketing via the Internet, has resulted in women believing that compounded products are safer than standard products.
Are bioidentical hormones at least as safe as commercial hormones? No reason to think they are not. It’s the dosages and protocols, which are commonly recommended, that have never been shown to be safe, much less safer or more effective than conventional prescription estrogen products.
Myth #4: Saliva levels are a useful way to determine dosage. Salivary hormone-level testing is used to create the illusion of individualized therapy but is actually a merchandising tool.
It would be great if estrogen and progesterone levels were detectable in saliva, and therefore a drop of spit could actually unravel the mysteries of menopause. Unfortunately, salivary hormone levels have not been proven useful in any scientific studies to determine the necessity or appropriate dosage for hormone replacement.
In fact, hormone levels in saliva are not biologically meaningful. There is no relationship between serum hormone levels and saliva levels. Saliva levels vary depending on diet, time of day and other variables. And most importantly, there is no specific therapeutic window to aim for. It’s not as if an estradiol level of say, 100, were known to alleviate symptoms. The number doesn’t matter because there is a huge range of what works.
What matters is not the number, but how someone feels.
If saliva is worthless…what about blood tests? That brings us to …
Myth #5: Blood tests are useful to determine dosage. During the peri-menopausal roller coaster, hormone levels fluctuate day to day. Once menopause has occurred, and the ovaries have shut down, you don’t need a blood test to know what the estrogen level is.
Doing an estrogen level on a menopausal woman is like doing a pregnancy test on a woman just before she gives birth. The result is hardly shocking.
Again, if a woman is taking hormones, clinical response is what matters anyway…not a number. There is a wide range of normal, and a target hormone level is rarely useful.
Myth #6: Bioidentical hormones prevent cancer. The evidence clearly does not support this claim. In fact, endometrial hyperplasia, a precancerous condition that commonly is a direct result of taking estrogen without the proper progesterone to balance it, is caused by hormone therapy.
There is no uterine safety data in compounded progesterone, and in fact there is good data that shows that progesterone creams don’t achieve the protection needed. So, far from preventing cancer, compounded hormones are putting women at increased risk.
Myth #7: The experts that prescribe bioidentical hormones know more than my doctor. The majority of the people that present themselves as being authorities in the field of hormones and menopause would not be considered to be experts by any academic institution or knowledgeable physician. The majority are not board-certified in anything.
Most don’t have hospital affiliations. The few that are board-certified are certified not in gynecology or endocrinology but, inexplicably. in emergency room medicine.
Why does it matter if someone is board-certified? This is your assurance from the scientific community that a physician is qualified and has the requisite training to put your life in their hands. If you needed brain surgery, would you choose the surgeon who went to an accredited residency program and was board-certified, or would you choose the ER doc who decides that he’d always wanted to do brain surgery and so goes to a weekend course and gives it a whirl?
Many bioidentical hormone experts are board-certified in “anti-aging.” I wasn’t familiar with this particular board certification and had never heard of a residency in anti-aging, so I Googled it. And this is what I learned: Unlike actual board certifications that require a four- to six-year residency in an approved program, followed by written and oral examinations, an Anti-Aging board certification — complete with a very impressive-looking diploma — only requires a weekend course (usually in a sunny location ) and a check for a few thousand dollars.
Myth #8: Compounding pharmacies custom-design hormone therapy. Most compounded hormones are actually manufactured in large volumes and not individually compounded.
Most refugees from the world of compounded pharmacies arrive in my office holding a bag of products that are all the exact same dosage, even though they have supposedly been compounded “just for them.” And again, many of these hormone preparations are exact copies of those produced commercially.
Myth #9: Compounding pharmacies are as good as commercial pharmacies. Prescription drugs are federally regulated and tested for purity, potency, safety and efficacy, but compounded products are not. Millions of women are using these prescription drugs that have never gone through the testing and approval process needed to substantiate safety, efficacy, quality or purity.
A 2001 study looked at 29 products from 12 compounding pharmacies. Since there is no monitoring about cleaning and maintenance of production equipment, it is hardly shocking that 34 percent of those products failed at least one standard quality-control test, while 25 percent failed potency standards as a direct result of the lack of uniform manufacturing standards.
Myth #10: Big Pharma is only in it for the money. Of course pharmaceutical companies are profit-motivated; this is America. And that is what the Food and Drug Administration is for: to make sure greed does not get in the way of patients getting safe, effective drugs.
Guess what? The compounding pharmacies are also profit-motivated, except that there is no one around to make sure that they don’t let their greed get in the way of distributing safe, effective drugs. They don’t need to spend their profits on research, development or providing information to patients and doctors.
Women are looking for answers, and their own doctors are not providing them. I don’t blame the women who choose bioidenticals from unregulated compounding pharmacies.
I blame the medical profession. We as physicians have failed. Most physicians don’t know much about menopause, they aren’t interested in menopause, and they don’t help their menopausal patients.
Lauren Streicher, M.D., is a Clinical Professor of Obstetrics and Gynecology at Northwestern University’s medical school, The Feinberg School of Medicine. Her column, “Ask the Ob-Gyn,” appears in The Chicago Sun-Times. She has appeared on The McNeil Lehrer Hour, ABC News Now, 20/20, Chicago Now and World News Tonight. She is a host of The Answered Patient, and appears on NBC’s In The Loop with iVillage.