Discrimination in the KEEPS trial - Part 5 of 5

In my final installment of my 5 part series describing the discrimination in the KEEPS trial I will discuss what the future holds for the treatment of profound/advanced hypogonadism in women if trials like the KEEPS trial remain the norm.

Unless something changes then the future will be as bleak as the present. Currently, there are no published standards for the optimal levels of estradiol, testosterone or even progesterone. Instead each healthcare provider is on their own. This pits consumer against doctor in an awkward and unproductive manner where the consumer generally loses.

Why are there no standards? Primarily, because horse excrement (Premarin) has dominated the clinical trials. In clinical trials that use horse excrement it is the norm not to test any hormone levels, human or the accumulated horse estrogens in a human woman. Even without testing any hormone levels one can easily see that over the last 80 years it has been proven over and over again that horse excrement is nothing more than a slow poison. Now does it makes sense why the recommendation for its use is for as short as time as possible?

It is with 100% certainty that a woman will get sick when taking horse excrement. How can I be so sure? It is a universal truth that abnormal hormone levels always lead to poorer health. Horse excrement only creates significantly abnormal hormone levels 100% of the time. Hence, it will slowly make a woman sicker and sicker as a slow poison would.

Horse excrement makes a woman sick because it creates estrogen toxicity and androgen deprivation.

Estrogen toxicity happens when there is too much estrogen and androgen deprivation happens when there is too little androgens. Both of these conditions would be picked up if hormone testing was done.

Now does it make sense that horse hormone levels are never, ever measured, including in the KEEPS study, because it would show clearly the estrogen overdose and the severely low levels of androgens (i.e. testosterone) that always occurs when using horse excrement? Where are the bioethicists when clinical trials say they use hormone replacement and there is no hormone testing to prove it?

Why do you think the KEEPS trial used a slightly lower dose of horse excrement than previous clinical trials and now called it HT instead of HRT? To reduce the amount of estrogen toxicity and androgen deprivation in the hopes that women could tolerate it better and wouldn't mind that it reduced further what little sexual function they may have had. To what end? Why create abnormal hormone levels that will make a woman sick when you can create normal hormone levels and restore her health and her sexual function? Renaming horse excrement HT from HRT only reinforces that it was not replacement for any human hormones. The fact that horse excrement will always make a woman sick proves it is not therapeutic at all.

In my opinion, it is a win-win for the medical industry as a whole. Predictably, abnormal hormone levels are uncomfortable and unhealthy. Studies of horse excrement show that the majority of women who start on it stop it within months preferring menopausal hormone levels which is exactly what happened in the KEEPS trial. Either way the recruited women will remain and continue to be sick. The recruited women will either get sick from the abnormal hormone levels induced by the horse excrement, the inadequate bio-identical patch or profoundly low levels of ovarian hormones in the placebo arm of the KEEPS study. It's guaranteed illness that the pharmaceutical industry as well as the surgical, nursing home, hospital and internal medical industry, is happy to treat and profit from.

What the public doesn't realize is that every day that horse excrement is prescribed to women is another day a woman loses an opportunity to prevent breast cancer. The reason is that horse excrement is a potent anti-androgen. For nearly 100 years it is well known within the medical community that testosterone can prevent breast cancers and can dissolve some breast cancer tumors. Even as recently as September 2013 two studies were published that demonstrated, once again, that normal (youthful) levels of testosterone prevents breast cancer and testosterone applied locally to a breast cancer tumor dissolved it. Time will tell if it's a cure. For sure though the cancerous tumors disappeared.

Testosterone also can prevent fibroids and derivatives of testosterone are currently being given as a treatment. Disease doesn't just happen because a woman ages. It happens because her body is literally starving for what it needs.

Profound hypogonadism is a real illness and is completely treatable. Some pharmaceutical companies have tried to improve the treatment options by creating testosterone products for women. The FDA has consistently turned them down even though they are bio-identical and produce normal testosterone levels for women. Why?

Testosterone will change the face of medicine. Effective treatment of profound hypogonadism would be attainable with testosterone. Women would take testosterone, estradiol, progesterone and dhea (available over the counter) and within 6 months would have normal bone density and would significantly reduce their risk of breast cancer. In my opinion, this is why the FDA refuses to approve testosterone because along with other ovarian hormones it will eradicate osteoporosis and make a women's risk of breast cancer the same as a man's, 1 in 1000 instead of 1 in 9.

Profound hypogonadism isn't being taken seriously. It is a serious illness which will take its toll on a woman's body and a toll on her quality of life. Profound hypogonadism ends the vast majority of women's ability to become sexually aroused and have an orgasm. This is reality. Many women continue to engage in sexual activity without meaningful sexual function. As scores of women have confided in me, "you get used it", "it's your duty", "it keeps my marriage together".

Women are often told that their lack of sexual function is complicated. Not really. Genitals do not just stop working. Genitals need adult levels of ovarian hormones to work. Horse excrement only provides abnormal levels of hormones which is why in the nearly 100 years it has been used it has never claimed to improve sexual function.

The KEEPS trial as well as every other clinical trial that has used horse excrement has made it more difficult to receive treatment or even acknowledgment for profound hypogonadism. Is profound hypogonadism even listed on intake forms when women visit their doctor? It is the proverbial elephant in the room that the doctor is not empowered to treat and the woman not empowered to ask for treatment.

As it stands now only a few women will receive treatment for profound hypogonadism. The bio-ethical community could come forward and change that but has remained silent. The medical community could come forward but as a whole has not. The research community could come forward but appears to be steadfast in its need to pedal a slow poison to women. The pharmaceutical industry could boldly acknowledge that they want to produce products to treat profoundly low ovarian hormone levels in women and create bio-identical combination products to make it easier and more affordable for a greater number of women. Instead, they give up and walk away. That is what happened with the Intrinsa patch, a wonderful testosterone patch that really worked well. It was once available in Europe and now it is gone.

The only thing that can be done is for the public and those bold few in the medical community who understand an illness when they see it is to empower themselves with information.

  1. Normal hormone levels are always healthy
  2. Abnormal hormone levels are always unhealthy

My sincere hope is that these simple truths will empower those with the power to make a positive difference for women all around the world.

Here's to a better and healthier future for all women.

Beth

6/12/2014 7:00:00 AM
Beth Rosenshein
Written by
Beth Rosenshein is an electrical/bio-medical engineer and is very familiar with medical research. She holds two United States patents, one for a unique design of a vaginal speculum, and one for a clever urinary collection device specifically designed for women. Beth discovered and documented an important drug interaction...
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