By JANE ALLIN
A recent article in Health-TODAY.com – “Angelina Jolie’s ‘bio-identical’ therapy raises hormone questions” – challenges the safety of ‘bio-identical’ hormones versus conventional therapies including those of the Premarin family that contain conjugated equine estrogens (CEEs).
The article tends to dwell on the compounded versions of these so-called ‘bioidentical’ hormones rather than FDA approved versions when the focus should be directed to the actual safety profiles of any given HRT medications.
While the term ‘bio-identical’ is indeed unscientific terminology invented by marketing strategists to promote sales of these compounded hormones as the article clearly points out, it is by no means used exclusively in this context.
Yet this article, endorsed by the medical profession, hones in on compounding pharmacies and skirts the real issues of any of the available HRTs.
‘Bio-identical’ simply refers to laboratory synthesized hormones that are molecularly analogous to hormones such as estrogen and progestin produced in women’s bodies.
Bioidentical hormone therapy is often called “natural hormone therapy” because bioidentical hormones act similar to the hormones produced in the body.
But the word natural is confusing.
Pregnant mares’ urine is natural, but Premarin is not bioidentical, nor is Cenestin, which is made from plants, at least not to human estrogen.
Bioidentical estrogens and micronized progesterone are made into a range of products, many of which are FDA-approved and available with a prescription. Commercially available bioidentical estradiol comes in several forms, including pill, patch, cream, and various vaginal preparations. Similarly micronized progesterone comes in a capsule or as a vaginal gel. 
So ‘bio-identical’ hormones are not always compounded as this article would lead you to believe.
Moreover they have launched this histrionic dialogue on Jolie’s choice of combating menopausal symptoms without the slightest clue as to what she has opted for. Despite this they do acknowledge that she is likely using an FDA approved product, not a compounded version.
“We do not know whether Ms. Jolie is on an FDA-approved product, or a compounded one,” said Pauline M. Maki, president of the North American Menopause Society. “Given that she is using a patch, it is likely an FDA-approved form.”
“In fact, when it comes to the type of patch Jolie revealed she’s wearing, compounding pharmacies cannot legally make them, said Dr. Shira Miller, a Los Angeles holistic menopause and anti-aging physician.
So what’s the point?
While there is no question that credible scientific evidence to support claims made regarding the safety and efficacy of compounded bio-identicals is lacking, shouldn’t the medical community be questioning the safety of any FDA approved hormone medications – bio-identical or otherwise, not just compounded versions – which we know come with questionable profiles?
Instead it is the same old, same old rhetoric about FDA approved therapies and the “rigorous” testing these drugs undergo before approval that make them so much safer.
“I would argue safety from the FDA products [is] more robust, and they monitor adverse outcomes,” Starck added. “Experts assert bio-identicals are not any better or safer than FDA-approved hormones.
Big Pharma Puppets
I’m not sure that informed women would disagree with the fact that compounded bio-identicals are any more effective or safer but the greater question looms as to the safety of those that are FDA approved.
The article brushes this aside in an attempt to convince the audience that anything that requires a prescription in inevitably safer.
But what can you expect from the medical community? A throng of professionals who have been brainwashed by Big Pharma and the FDA.
The simple fact is that any type of synthetic hormones formulated in laboratories carry with them risks, particularly those manufactured from the urine of pregnant mares where the risks are significantly greater.
Even the innocuous sounding drugs such as Cenestin, that contains conjugated estrogens manufactured synthetically from plant material, have potential serious side effects similar to those associated with conjugate equine estrogens (e.g. blood clots, endometrial cancer, breast cancer, dementia, etc.)
While synthetics other than those containing CEEs carry with them the same or similar warnings associated with their use, it has been repeatedly cited in scientific literature that estrogens derived from pregnant mares’ urine pose a significantly greater risk due to the conspicuous fact that equine estrogens are foreign to humans but not horses.
GASP – what a concept.
“No auto mechanic in his right mind would replace worn parts in a Mercedes with new parts made for a Chevy. Unfortunately, many physicians (and pharmaceutical companies) seem to have less common sense than the auto mechanic when it comes to treating menopausal women.”
Hormones, Enzymes and Estrogens
There are three types of hormones produced in the human body — estradiol, estrone and estriol — all regulated by human enzymes and cofactors necessary to process these hormones when they occur in natural human proportions.
In humans these estrogens occur in an approximate ratio of; 7% estradiol; 3% estrone and; 90% estriol.
In contrast Premarin® primarily consists of estrone (75-80%); equilin (6-15%) ; estradiol + two other equine estrogens (5-19%) plus quantities of other estrogens foreign to the human body.
First note the disparities between the concentrations of estrone and estradiol and of course the presence of the equine estrogens found exclusively in horses – clearly problematic in relation to the safety profile of these drugs.
Obviously the ratios of the common estrogens and the presence of equine estrogens can without doubt induce hormonal imbalances that can have far-reaching adverse effects on human hormonal regulation mechanisms.
Not only do these estrogens contribute to imbalances but they are also associated with increased risks for a variety of cancers.
A closer look renders CEE-derived HRT products even more sinister.
Premarin® contains at least 10 estrogens that are the sulfate esters of the ring B saturated estrogens: estrone, 17beta-estradiol, 17alpha-estradiol, and the ring B unsaturated estrogens: equilin, 17beta-dihydroequilin, 17alpha-dihydroequilin, equilenin, 17beta-dihydroequilenin, 17alpha-dihydroequilenin, and delta-8-estrone. Bioassays and estrogen receptor binding studies indicate that all 10 estrogens are biologically active. Moreover, individual components, such as equilin sulfate, delta-8-estrone sulfate, 17beta-dihydroequilin sulfate and estrone sulfate, have potent estrogenic effects. Since all of the estrogens present in Premarin have estrogenic activity, the pharmacological effects of Premarin are a result of the sum of these individual activities.
As two leading reproductive physiologists point out, when women take Premarin, “Levels of [equilin] can remain elevated for 13 weeks or more post-treatment due to storage and slow release from adipose [fat] tissue. In addition, metabolism of equilin to equilenin and 17-hydroxyequilenin may contribute greatly to the estrogen stimulatory effect of [conjugated estrogen] therapy”. Another metabolite of equilin, 17-dihydroequlin has been found to be eight times more potent that equilin for inducing endometrial growth, a possible precursor to cancer.
There has been recent interest in oestrogen metabolites because there are indications that they can be involved in the development of hormone-dependent tumours, e.g. breast cancer. Zhang et al. have shown that equilin metabolites have toxic properties with carcinogenic potential through the formation of quinones. A special carcinogenic risk factor may be the formation of semiquinone-adducts with DNA.
But there is more:
“In women, a recent study has evaluated the potential of HRT to induce DNA damage in peripheral blood leukocytes of postmenopausal women using the comet assay (Ozcagli et al. 2005). Significant increases in DNA damage were observed among women receiving 0.625 mg/day conjugated equine estrogens or conjugated equine estrogens plus medroxyprogesterone acetate as compared to the control group that had never received HRT. Finally, the excessive production of ROS in breast cancer tissue has been linked to metastasis of tumors in women with breast cancer (Malins et al. 1996; Malins et al. 2006; Karihtala and Soini 2007; Benz and Yau 2008). These and other data provide a mechanism of estrogen-linked tumor initiation/promotion by redox cycling of estrogen metabolites generating ROS, which damage DNA.”
ROS stands for “Reactive Oxygen Species”.
Various carcinogens, such as CEEs, may partly exert the effect of oxygen derived species (e.g. superoxide radical) by generating reactive oxygen species (ROS) during their metabolism. Oxidative damage to cellular DNA can lead to mutations and may, therefore, play an important role in the initiation and progression of multistage carcinogenesis.
Cancer is ugly, so are CEEs.
Sadly, most conventional physicians, in addition to the self-serving Pfizer, are quick to rationalize the cancer and other risks of ingesting horse estrogens in favor of preventing age-related heart attacks or strokes rather than the undeniable life-threatening dangers proven to be associated with CEE-containing HRT.
Clearly not all HRT is created equally.
Yet this article, in its single-minded evaluation of compounded bio-identicals, downplays or simply fails to acknowledge the risks associated with other forms of HRT, particularly the Premarin family of drugs – blindly claiming that FDA approved prescription drugs are safer.
The risk of any hormonal product depends on its hormonal components and how it is manufactured. FDA approved bio-identicals do not contain the myriad estrogens in Premarin – estrogens primarily foreign substances that clearly carry with them greater risks than those endogenous to the human body.
I’ll take bets that even these compounded bio-identicals are safer than Premarin. In fact there have been a limited number of studies that support this opinion.
However what is paramount to any of this discussion is the disturbing notion that this concoction of CEEs — a regularly prescribed drug for menopausal women, not a life-saving one — is still on the market given that it is a known carcinogen as proclaimed by the World Health Organization and the National Toxicology Program.
I doubt that any such drug would survive if it was prescribed for the other gender.
And last, but not least, thank you Angelina Jolie for your courage and your willingness to share your story so that others may learn from it.
And a special thank you from the horses for not choosing Premarin® and its vile sister drugs including the recent Duavee.
 Same as 2.
 Same as 4.