The Betrayal of Menopause Research
I want your future to be better than my present
It’s good to be back.
It’s been a long time since I’ve blogged, but now I’m back. I decided to restart my blog because I’ve nearly finished my book, tentatively titled Menopause Manipulated. My book explains the reasons for the bad outcomes of clinical trials that have manipulated us into thinking a woman’s body can no longer use ovarian hormones in a healthy way as she gets older.
Our negative thinking about ovarian hormone treatments can be attributed primarily to three pharmaceutical companies, Ayerst, Wyeth, and Pfizer. Over the years, each of these companies has manufactured Premarin (pronounced PREH-ma-rin), which is the drug that has been used in pivotal clinical trials that created the guidelines for treatment for menopausal women.
To make Premarin a dominant player in menopausal research, Premarin had to be misrepresented, otherwise, it would not have been used in pivotal clinical trials. The words, ‘estrogen replacement’ to describe Premarin were chosen carefully because it softly sidesteps the fact that Premarin is not estradiol replacement. Saying ‘estrogen replacement’ sounds like it would be estradiol replacement.
You’re probably more familiar with the term ‘estrogen replacement’ because you’ve heard that more than estradiol replacement (pronounced es-TRA-di-all). However, there is only one effective estrogen hormone treatment for a menopausal woman and that is estradiol replacement because estradiol is the main estrogen of the ovary and delivers the maximum benefits of any estrogen hormone.
If Premarin were estradiol replacement, then it would be advertised as estradiol replacement.
The term, estrogen replacement, on its own, is a meaningless statement because the word ‘estrogen’ is the name of a category of hormones and not a specific hormone. The word, ‘replacement’ refers to a specific hormone. The appropriate estrogen hormone treatment for menopausal women would be estradiol replacement.
Hormone Category: Estrogen
Estradiol is the main estrogen hormone of the ovary
Hormones within a category are not interchangeable because each hormone performs very specific functions in a person’s body. Hormones fit exactly into their receptors just like a puzzle piece fits exactly into where it belongs. Anything less than a perfect fit for a hormone results in only a sliver of function with additional problems because the fit isn’t perfect. As well, you can force a puzzle piece into place to make it look like it fits, even though it still doesn’t, and the ill-fitting puzzle piece will distort the look of the entire puzzle. That’s why it is so important to use hormones that fit exactly into their receptors, like a puzzle piece fits exactly into where it belongs, so each can do what it’s supposed to do, function well.
Back in the 1930’s, a group of scientists at Ayerst Pharmaceuticals created the drug Premarin from the hormonal waste products in the urine of pregnant horses. These scientists created Premarin to contain 3 main parts. The largest part, 60% of Premarin, is the estrogen hormone estrone (pronounced es-TRONE), which is a common estrogen hormone of humans and horses. Another 30% of Premarin is the estrogen hormone equilin (pronounced EH-qwill-lin), which is not found in humans but is found in the fetus of a pregnant horse. The other 10% of Premarin is hundreds of hormones, most of which are unidentified. The function of these hundreds of hormones is to irritate a menopausal woman’s liver to encourage it to increase production of the sulfatase enzyme beyond normal limits. The sulfatase enzyme is needed to convert the equilin hormone in Premarin from an inactive to the active hormone.i
Hormone Category: Estrogen
Estradiol is the main estrogen hormone of the ovary.
Estrone is a weak estrogen hormone and can convert to estradiol.
Equilin is an estrogen hormone from the fetus of a horse.
Premarin was not created to ever be estradiol replacement which means Premarin was not created to provide the healthiest benefits to a menopausal woman. That is because Premarin contains equilin, which is a potent inhibitor of the enzyme, HSD1, which is the enzyme that estrone can use to convert to estradiol.ii Which raises an important question, what is the purpose of making Premarin 60% estrone if the estrone is effectively blocked from becoming estradiol?
To me, the reason is clear. It is to control whether the outcome of clinical research is positive or negative by manipulating the amount of equilin in Premarin which in turn manipulates the amount of estradiol formed. Typically, Premarin shows positive outcomes in short term studies and negative outcomes in long term studies. I believe smaller amounts of equilin are present in short term studies and higher amounts are present in long term studies.
For all studies, big and small, all Premarin products are supplied by its manufacturers, Ayerst, Wyeth, and Pfizer, who can manipulate the level of equilin and thereby allow equilin to partially or fully substitute itself for estradiol.
I believe Premarin was created with a combination of equilin and estrone to allow the manufacturer to manipulate the outcome of clinical research. Allowing more estradiol to form would result in more benefit and blocking estradiol from forming would result in less benefit.
A clear example of how the manufacturer manipulates the amount of equilin can be seen in FDA issued documents for Premarin tablets and Premarin vaginal cream. These documents are available to everyone on the internet and a copy is in each box of these products. The name of these documents is “Full Prescribing Information”. Even though Premarin contains hundreds of active hormones, the FDA only requires that the hormones below are listed. Both of these Premarin products are made from the urine of pregnant horses so the same hormones should be present, but that is not what happens.
Here is a list of the hormones that are expected in a woman’s bloodstream after taking Premarin tablets, according to FDA approved documents.iii
- Baseline-adjusted estrone
Here is a list of the hormones expected in a woman’s blood stream after using Premarin vaginal cream, according to FDA approved documents.iv
- Baseline-adjusted estrone
- Baseline-adjusted estradiol
Notice that estradiol is present when equilin is not.
This means that the manufacturer is capable of decreasing the amount of equilin, which in turn allows the formation of estradiol. Ayerst, Wyeth, and Pfizer have always had the ability to do this legally because the FDA allows Premarin to contain a range of equilin and not an exact amount. Manipulating the amount of equilin means having the technical capability of blocking the formation of estradiol. With estradiol completely blocked, equilin becomes the dominant estrogen hormone, substituting itself for estradiol. That means the clinical studies that showed ill health were showing what happens when equilin, an ill-fitting hormone, is the dominant estrogen hormone instead of estradiol.
In my opinion, the purpose of Premarin has always been to gaslight the public and the medical community into believing that estradiol is unhealthy and would cause serious side effects. In actuality, the pivotal studies that generated treatment guidelines are studies of equilin, a hormone from the fetus of the horse, and not of estradiol.
It’s always been a game of bait and switch. The expectation of Premarin is to produce estradiol because it contains so much estrone but in reality Premarin substitutes equilin for estradiol. The bait is the expectation of estradiol, and the switch is equilin substituting itself for estradiol.
This is what betrayal of trust looks like.
If you’re in your 20’s and reading this, you may feel very distant from the time in your life that your ovaries will run out of eggs, and you may have to endure the severe effects of multiple simultaneous hormone deficiencies. I implore you to educate yourself about the reality for women my age, 64, so you can learn what needs to be changed for better healthcare options for women when you’re my age.
I want your future to be better than my present.
For today, I want you to learn one thing. You have been betrayed by those who never spoke up and knew that Premarin was being misrepresented and never opposed the guidelines developed from it.
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i Hepatic steroid sulfatase critically determines estrogenic activities of conjugated equine estrogens in human cells in vitro and in mice Hepatic steroid sulfatase critically determines estrogenic activities of conjugated equine estrogens in human cells in vitro and in mice (sciencedirectassets.com)
ii Structure of the ternary complex of human 17b-hydroxysteroid dehydrogenase type 1 with 3-hydroxyestra-1,3,5,7-tetraen-17-one (equilin) and NADP+ pq039900840p (nih.gov)
iii label (fda.gov) Premarin conjugated tablets
iv PREMARIN (conjugated estrogens) Vaginal Cream (fda.gov)