Breast cancer, menopause and yes, rhubarb

by JANE ALLIN

October is National Breast Cancer Month. What better opportunity to remind women of the dangers posed by the use of HRT and the inherent cruelty foisted upon the innocent mares and their foals by the PMU industry?

Despite advances in medical technology over the years, Pfizer continues to promote their conjugated equine estrogen drugs (e.g. Premarin, Prempro, Duavee) based on antiquated science – science that has since been proven to be flawed.

In fact, the findings of the WHI study was listed as one of the top ten medical advances of the decade in an article published in 2009; “The Top 10 Medical Advances of the Decade: From genome to hormones, doctors pick the top medical advances of the decade.” [1]

“And then the world changed, the National Heart Lung and Blood Institute, which was sponsoring a placebo-controlled trial of hormone replacement therapy in more than 161,000 healthy women, announced that it was shutting down the study because HRT increased the risk of heart attack, stroke, blood clots, and breast cancer.

It was the “oops” heard round the world.” [2]

Why are these drugs still here 14 years after the fact? Why haven’t the FDA and other drug agencies around the world pulled these from the market?

Time and again the antagonistic effects of conjugated equine estrogens have proven to be potent carcinogens that give rise to a variety of cancers and other life-threatening diseases, breast cancer included.

The FDA and other governing bodies such as the European Commission in the EU continue to endorse these drugs as safe therapies for women of menopausal and post-menopausal age despite the unequivocal dire warnings on the packaging cautioning women of substantial risks that should, in any dutiful context, prevent these drugs from being marketed.

And not to forget the pitiful existence of the mares and their by-products – the innocent foals born into a precarious world where their fate is sealed if there are no takers. Now of course, this malevolent industry has moved across the globe to countries where animal welfare is decidedly worse than the loathsome state of affairs in North America.

PMU Farm in Xinyuan County, China (2012).
PMU Farm in Xinyuan County, China (2012).

But there are of course options – alternatives to the use of drugs containing equine-derived hormones. The Horse Fund has compiled a list of such options (see http://horsefund.org/pmu-alternatives-to-cee-drugs.php) as well as the safety aspects of FDA-approved prescription versions of HRT that are not derived from pregnant mare’s urine. [3]

RHUBARB

One natural alternative that crops up (pun intended) on occasion, yet is not mentioned in either of these articles, is “rhubarb”.

Rhubarb is said to be a very “old” plant, meaning that documented knowledge of the plant goes back as far as 2,700 years in China. The roots were said to have medicinal value and were a prized commodity for treating a variety of ailments. [4]

In many cultures, herbs and foods that contain so-called phytoestrogens have been used to treat symptoms of climacteric complaints – that is, complaints associated with the transition between premenopause, perimenopause and early postmenopausal stages. Examples include black cohosh, soy and red clover; rhubarb is also classified as a phytoestrogen.

Phytoestrogens are known to have distinct actions on what are known as estrogen receptors (ERs) which are activated by the hormone estrogen. As an example, estrogen receptors are over-expressed in around 70% of breast cancer cases, referred to as “ER-positive”, which can lead to proliferation of mammary cells. Moreover, estrogen metabolism creates genotoxic waste – chemical agents that damage the genetic information within a cell causing mutations which may lead to cancer.

There is growing evidence that phytoestrogens could have a protective effect on the initiation or progression of breast cancer by inhibiting pathways important for cell growth and proliferation. The characterized mode of phytoestrogen action is estrogen receptor (ER) binding which effectively blocks estrogen from binding to the ER and reduces the risk of cell propagation. Their metabolic actions are much more complicated than this simple explanation and the science behind their effectiveness is challenging to address. [5]

Essentially this is what a SERM’s (Selective Estrogen Receptor Modulator) function is.

Several reports have indicated that experimental data supports the theory that ERr from the rhubarb plant and/or its constituents do in fact exhibit(s) SERM-like properties. [6]

SERMs block the effects of estrogen in the breast tissue, for example, as well as other tissues in the body that have estrogen receptors (e.g. bones, uterus). Recall that the bazedoxifene component of Duavee is a SERM, although it is not naturally derived, nor has it been officially approved by the FDA as a stand alone drug.

Several scholarly articles can be found online that describe the efficacy and safety profile of rhubarb extracts in the treatment of menopausal symptoms such as hot flashes, sweating, sleep disturbances, and mood swings.

In each of these, a pill containing the extract (ERr) significantly reduced vasomotor and other menopausal symptoms. ERr was first introduced to treat menopausal symptoms in 1993 and has had no severe adverse effects reported with its use.

In an article published in Menopause in 2006 “Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731 – trade name Phytoestrol N) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.” Authored by Heger et al, the effectiveness of the rhubarb extract ERr 731 to treat menopausal symptoms was validated by a multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial on 109 women with climacteric complaints receiving either a daily dose of 4 mg of ERr 731 or a placebo. [7]

The primary outcome criterion for the efficacy of ERr 731 was the change of the Menopause Rating Scale II (MRS II) total score compared to the placebo after 12 weeks. The MRS II is a health-related quality of life developed in the early 1990’s that measures the severity of age-/menopausal-related complaints by rating a profile of 11 different symptoms. [8]

These symptoms include; hot flashes/flushes, heart discomfort, sleep problems, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, dryness of vagina and joint and muscular discomfort. [9]

Additionally, the MRS II score was accompanied by secondary outcome criteria which included physical examinations to assess the safety of ERr 731 (e.g. vaginal smear, pap smear, transvaginal ultrasound, endometrial biopsy, breast palpitation, body weight).

The treatment outcome after the intake of ERr 731 or placebo for 12 weeks was assessed by both the investigators and participants according to the Integrative Medicine Outcome Scale (IMOS) – a 4-point (investigator) and 5-point (patient) verbal rating scale ( complete recovery (patient-only), major improvement, moderate change, no change, and deterioration). Results are shown in the figure below.


imos


More detailed results, including the MRS II scores, are shown in the paper. [10]

Clearly the rhubarb ERr 731 extract is effective in significantly reducing symptomatic climacteric complaints when compared to the placebo.

Throughout the trial no abnormalities in breast tissue were observed which support those of long-term treatment with ERr 731 in everyday practice.

Moreover, women who took the ERr 731 experienced no vaginal bleeding and spotting which are common side effects due to an estrogen-dependent stimulation of the endometrium, nor was there any evidence of endometrial hyperplasia in the treated women.

CONCLUSION

Neither clinical nor experimental results detected any adverse effects of ERr 731 (e.g. uterine and endometrial growth and proliferation) which suggests that ERr 731 exerts SERM-like activites.

Overall, the trial results show that ERr 731 is a highly effective, well-tolerated, and safe herbal medicinal product in the treatment of climacteric complaints in the transition through the various stages of menopause as an alternative to traditional HRT. [11]

The demand for safe and effective estrogen-free medications is ever-increasing given the risks associated with conventional HRT, particularly those derived from conjugated equine estrogens.

In the end what matters most is that women become informed from a health and risk perspective with the realization that there is no need for PMU farming operations, whether that be here in North America or on the fledgling farms in lands far away.

PFIZER MARCHES ON

Unfortunately Pfizer, and now their counterparts in foreign jurisdictions, continue to deceitfully market these drugs as the panacea to every woman’s natural menopausal transition.

Sadly, those farms in China, India and other places where they may exist, are, in general, without the same level of oversight from advocates of animal welfare, unlike here in North America where the plight of animals, whether that be livestock or the use of animals for other human profit, such as the PMU horses, has an ever-increasing base of concerned citizens.

PMU Farm in Xinyuan County, China (2012).
PMU Farm in Xinyuan County, China (2012).

Foremost because the industry outside of North America is, relatively speaking, new, secondly because animal welfare issues appear to be less front and center and last, but not least, because many people in these countries are likely unaware of the risks associated with these drugs derived from pregnant mare’s urine.

This of course is changing as time progresses.

At one point North America, and the EU for example, were in the same position. It took decades for the truth to surface and yet Pfizer still manages to market these drugs, considered carcinogens, to physicians and their patients alike without moral compass from all perspectives – horse or human.

After all, to Big Pharma it is all about corporate welfare and shareholder satisfaction no matter what the cost.

Save a horse – go out and eat some rhubarb, just don’t eat the leaves. [12]

rhubarb-leaves

END

[1] http://www.medpagetoday.com/InfectiousDisease/PublicHealth/17594
[2] http://www.medpagetoday.com/InfectiousDisease/PublicHealth/17594
[3] https://tuesdayshorse.wordpress.com/2015/11/10/fda-approved-alternatives-to-premarin-derivatives-are-they-safer/
[4] http://www.rhubarbinfo.com/history and http://www.botanical.com/botanical/mgmh/r/rhubar14.html
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074428/
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2837008/
[7] file:///M:/My%20Documents/Photography%20tutorials/Efficacy_and_safety_of_a_special_extract_of_Rheum_.pdf
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534786/
[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534786/
[10] file:///M:/My%20Documents/Photography%20tutorials/Efficacy_and_safety_of_a_special_extract_of_Rheum_.pdf
[11] file:///M:/My%20Documents/Photography%20tutorials/Efficacy_and_safety_of_a_special_extract_of_Rheum_.pdf
[12]http://www.compoundchem.com/2015/04/16/rhubarb/

© THE HORSE FUND

FEATURED IMAGE
The Health Benefits of Rhubarb“, Livestrong.com.

RELATED READING
A Look at a PMU Farm in China and It’s Not all About Pfizer; Tuesday’s Horse
Premstoppers Campaign; The Horse Fund

Premarin Horses: How many does it take to make a billion dollars? Part 3

Newest Member of the Premarin Family ― Duavee

Premarin foals.
Premarin foals.

How will this new drug impact profits and inevitably the PMU mares and their foals?

DUAVEE®, the Premarin® ― bazedoxifene combination therapy for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone hysterectomy was FDA-approved in October 2013 amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval.

Pfizer anticipates that DUAVEE® will be available in the U.S. in the first quarter of 2014.

This is the first approval of DUAVEE® in any country worldwide ― an approval of a combination drug with the component bazedoxifene yet to receive FDA approval on its own ― its approval is valid only in combination with Premarin®, at least in the US ― a conundrum in itself and worthy of further debate.

Some market analysts estimate DUAVEE®’s peak sales to reach $200 million (USD)/annum. [1]

DUAVEE® will be sold as a combination of 0.45 mg CEEs / 20 mg bazedoxifene however no pricing information is available yet as Pfizer has yet to launch it. If it sells for the same average cost per dose as Premarin® ― roughly $3.50 ― the number of mares, in addition to those currently on the pee lines, can be approximated.

Number of doses = Total Sales ($) / Cost per dose ($)
= $200,000,000 / $3.50/dose
= 57,142,857 doses
Total mg required = 57,142,857 doses x 0.45 mg/dose
= 25,714,286 mg
Number of mares = Total mg required / # of mg per mare
= 25,714,286 mg / 9466 mg/mare
= 2,716 mares

However all may not be lost on this new drug.

Despite the fact that Pfizer re-labeled this combination formula as innovative with an improved safety profile over conventional HRT it has a risk history of its own. Originally known as Aprela® Wyeth started work on it in 1999 as part of a program with Ligand anticipating a FDA approval in 2007 however it took 6 more years for the FDA to finally put its rubber stamp on it all the while citing concerns over health risks.

With the still lingering fear of developing cancers from CEE-derived HRT and the fact that there are other best-seller osteoporosis drugs currently on the market ― for example Evista® from Eli Lily which generated $1 billion last year as well and its generic to be introduced within the month ― DUAVEE® may not become the block-buster Wyeth/Pfizer once thought.

Particularly encouraging is that inside information reveals that even Pfizer is vacillating on the roll-out of this drug.

The veil of controversy over safety efficacy and its long and tortuous road to FDA approval seems to have cooled the hype associated with its introduction to the market. In fact speculation has it that Pfizer may never put this drug on the market – a Godsend to the horses and women alike.

Comments made by Pfizer employees on a public forum reveal a decidedly different picture from the one painted by Pfizer-proper. Here are a few interesting and illuminating remarks.

    Look into why this drug has taken so long throughout R&D phases. Wyeth Women’s Health talked about this drug coming to market by 2005.”

    Just wait until the recall. This drug will make your uterus collapse.”

    It’s the biggest joke at Pfizer. Enormous amounts of money being spent for what will be the biggest failed launch since Exubera.”

    Bingo! The cost to promote this DuaDog far exceeds the profitability for the first five years. Any CSO could sell this thing for a better ROI. It’s not rocket science but simple math. Launch is seriously being questioned and could become a no go at any moment.”

    This product is a DOG! I hear that there is debate internally as to whether or not to even launch.”

    DUAVEE: Dropped Uterus And Vaginal Equine Estrogen”.

Shareholders also understand and do not want to bear the brunt of more lawsuits, nor do the innocent women and their families. It is obvious that few have faith in the safety profile of this drug or its marketability ― two risky drugs and limited clinical data makes for a bad recipe.

It is time to stop this madness.

Big Pharma ― rotten to the core ― deception, fraud, kickbacks, price-setting, bribery and illegal sales activities ― anything to keep their profits rolling in. They will stop at nothing to expand their profit base, even if it means harming or killing countless innocents, humans and animals alike.

God bless the mares and their foals and whatever fate awaits them for they are undeniably the persecuted innocents ― without voice or choice they suffer at the hands of greed and merciless degenerates with stilted vision who fail to comprehend the difference between right and wrong ― a capitalist system where underlying principles are lost to a delinquent world that worships money.

    Where in this wide world can men find nobility without pride,
    Friendship without envy, or beauty without vanity?
    Here, where grace is laced with power and strength tempered by gentleness.
    He serves without servility, he has force without enmity.
    There is nothing so powerful, nothing less violent.
    There is nothing so quick, nothing more patient.
    Our pioneers were borne on his back,
    Our history is his industry.
    We are his heirs and he is our inheritance…
    The horse
    .’

    ― ROBERT DUNCAN

END
__________
[1] http://www.fiercebiotech.com/special-reports/duavee-pfizer-stuck-hot-flash-med-took-years-get-market

Links to All Parts of this Report

PART 1: Introduction (A billion dollars ― lots of zeros)
PART 2: Every Figure Tells a Story (Calculations and Result)
PART 3: Newest Member of the Premarin Family ― Duavee (Approved by FDA October 2013, originally submitted under the name Aprela)

March for Premarin Horses Report

Thank you to everyone participating and making this good news report possible.

March for Premarin Horses has gotten off to a tremendous start.

Last week we were stars on social media. We trended twice on Twitter last week. Great job all you re-tweeters.

We are also getting more shares on Facebook in one week than we have for a whole year. Again, great job.

Thank you. Let’s keep going. We have plenty of March left.

Please continue to like those posts, make comments and share everything. This drives important traffic. Can we trend again this week? You bet we can.

We are a few hundred dollars away from paying for the second of seven billboards we are targeting to put up in March. Can you help?

The billboards will be up for 6 to 12 months, depending on the contracts we can get.

Please make a donation to Premstoppers to reach this target.

To all of you whom have already given, we thank you so very much. We have accomplished this because of you. Every donation dollar counts greatly. It gets women off Premarin and saves the lives of mares and foals cast off and slaughtered.

Premarin horses are used on pee farms outside the US in great numbers, as far away as China.

Jane is working on a report that will give us an idea how many. From what she is discovering, the numbers will shock you. So stay tuned for that.

Women who take the Premarin family of drugs keep this deadly situation going.

Raising awareness has never been more important and what March for Premarin Horses is all about. We will not forget these horses.

Every time you donate to Premstoppers you help finance another critically important billboard.

Oh, and please remember to send the Dear Physician letter to your local women’s health doctors too. We have gotten off to a great start too.

One of our local staffing agencies who had people on standby that didn’t get called out but got paid anyway were “donated” to us for a day. They got 600 letters sent out to 9 States. Hooray!

Thank you everyone. March for Premarin Horses!

Hayworth and Molly Premarin flyer.
Remember this from 2010? That figure is even higher now. March for Premarin Horses everyone. Download it and share it.

Big Pharma wins again: FDA approves Aprela under new name

BY JANE ALLIN

Despite government shutdown, on October 3, 2013 the FDA approved the dual-acting drug formerly known as Aprela for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy.[1]

Aprela, approved under the new name Duavee.

It’s new name is fittingly ugly — DUAVEE® — for an ugly vile drug that robs life from the pregnant mares, their foals and unsuspecting women who have faith in Big Pharma and the propaganda they continue to spew regarding the purported benefits of hormone replacement therapy (HRT) derived from pregnant mare’s urine. Pfizer anticipates that DUAVEE® will be available in the U.S. in the first quarter of 2014. This is the first approval of DUAVEE® in any country worldwide.

DUAVEE® is a combination of Premarin® and bazedoxifene, a selective estrogen receptor modulator or SERM known as Viviant® specifically developed to help prevent postmenopausal osteoporosis. Amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval, Big Pharma has yet again overridden barriers seemingly insurmountable.

Given the tainted history of the Premarin® family of drugs and their contribution to a plethora of cancers and other maladies attributed to the use of conjugated equine estrogens (CEEs) it is inconceivable how another such drug containing a known carcinogen can possibly make its way into the Doctor’s office and onto the shelves of pharmacies across the nation.

While studies have confirmed that DUAVEE® is effective in relieving moderate to severe vasomotor symptoms (VMS), vulvar and vaginal atrophy (VVA) associated with menopause as well as the prevention of postmenopausal osteoporosis, the jury is still out on the safety aspect. Most alarming is the fact that Viviant® has failed to receive approval from the FDA and is itself not without issues. Clinical trials have indicated an increased risk of stroke in addition to higher incidences of deep vein thrombosis, retinal thrombosis, hot flushes and leg cramps compared to placebo-treated subjects. These are well-known side effects of SERMs which can also include increased risk of endometrial cancer. [2]

This together with limited safety data on DUAVEE® does not bode well — cancer is an insidious disease and can take years to develop. This is exactly what happened with the Premarin® family of drugs — not just the combination Prempro® therapy.

As far back as the 1970’s there was damaging evidence about the risk of cancers and cardio vascular disorders using CEEs, long before the arrival of Prempro® in 1995 and finally the WHI which undisputedly linked HRT with increased cancer and cardio risks among others. Yet Big Pharma continues to peddle its dangerous wares with the blessing of the FDA.

But true to the manipulative and contemptible reputation of Pfizer there is a seemingly logical scientific explanation as to why two wrongs make a right.

DUAVEE® is categorized as a tissue-selective estrogen complex (TSEC) with dosages of 0.45 mg CEEs and 20 mg bazedoxifene. The overall strategy for the combination drug is that a SERM functions to selectively stimulate or inhibit estrogen receptors in various target tissues (e.g. breast tissue) — either stimulating cell proliferation (i.e. estrogen active) or inhibiting it (i.e. estrogen inactive). In short a SERM that blocks the effect of estrogen in breast tissue, for example, does so by taking up residence in the breast cell estrogen receptors. However other tissue cells in the body also have estrogen receptors which have different chemical structures dependent on the type of cell and as their name implies they are “selective”. Consequently a SERM that blocks the activity of estrogen in breast cells can potentially activate estrogen’s activity in other cells (e.g. bone, liver, uterine).

According to Pfizer:

“Bazedoxifene was specifically selected to be studied as the SERM in DUAVEE because of its unique pharmacologic profile and mechanism of action, as demonstrated by pre-clinical studies that looked at a number of different SERMs. The pairing of CE with bazedoxifene enables DUAVEE to work selectively in different tissues to activate estrogen receptors in some while inhibiting estrogen activity in others (the uterus). This pairing allows DUAVEE to offer estrogen efficacy in treating moderate-to-severe hot flashes and preventing postmenopausal osteoporosis while providing an alternative way to help protect the uterine lining from hyperplasia.”

See Pfizer News Release at http://goo.gl/yjb2qq >>

As it happens this is not necessarily a good thing.

Tamoxifin was the first SERM to be studied for its capacity to block the action of estrogen in breast cells effectively inhibiting cell proliferation and therefore useful in treating breast cancer. However Tamoxifin has the serious side effect of increasing the risk of uterine cancer as it mimics the actions of estrogen and stimulates cell proliferation in the uterus.[3]

This concept was further explored with the combination estrogen-progestin therapies Prempro® and Premphase®. Studies in the 1980s suggested that the progesterone hormone tended to counteract the increased risk of uterine cancer. As the public well knows, this combined HRT resulted in increased risks of breast cancer, strokes, heart attacks and blood clots.[4]

Theoretically isn’t this the same premise as DUAVEE®? Instead of progestin DUAVEE® uses bazedoxifene – a drug not approved by the FDA here in NA – to help protect the uterine lining against hyperplasia that may result from estrogen-alone treatment according to Pfizer. Moreover if bazedoxifene is inhibiting estrogens in the uterus what tissues is it activating estrogen in?

No one ever imagined the nightmare Prempro® became, or Premarin for that matter; it’s like a game of Russian Roulette — taking chances without knowing or understanding the odds — risk at its worst. Will DUAVEE® be any different?

Time and again SERMs have proven to be unsafe with much controversy in the scientific community purely from a safety aspect. Together with the established risks of CEEs it’s anyone’s guess as to the ramifications over the longer-term.

Pfizer has taken two questionable drugs with well-established serious side effects and re-labeled this combination formula as innovative, new and improved and safer than conventional HRT anticipating that the public will buy into their marketing ruse. But wait, the packaging reveals a different story — it carries with it the same boxed warnings as Premarin® and Prempro® and more[5]:

  • blood clots
  • stroke
  • heart attack
  • cancer of the lining of the uterus (endometrial cancer)
  • breast cancer
  • ovarian cancer
  • dementia
  • gallbladder problems
  • loss of vision
  • high blood pressure
  • increased fats in your blood
  • liver problems
  • thyroid problems
  • fluid retention
  • low calcium
  • swelling of the mouth or tongue
  • worsening of other medical problems such as asthma, diabetes, epilepsy, migraines, a genetic problem called porphyria, lupus and liver problems

Who are they kidding?

Unfortunately, with the FDA as the central driving force of its depravity and deception, the corruption and addiction to fraud by Big Pharma continues to poison consumers. Pfizer has a proven track record of promoting drugs in ways not necessarily backed up by medical science. The usual tactic employed is one in which insufficient details of clinical trials are published, frequently authored by individuals who will benefit financially from the companies whose drugs they are writing about – often these articles are deficient to the point of being misleading.

Publication bias, or selectively publishing results of trials, is nothing new. Years ago in the 1990s and early 2000s concern arose over the practice of “cherry-picking” Pharma-funded positive-sounding clinical trial results while negative results were never reported.

Sadly this is deliberate, widespread and prolific — there are no watchdogs when it comes to Big Pharma, only lapdogs. Big Pharma simply hides its failures and the FDA looks the other way. And in their wake, the innocent suffer — money and power at the dire detriment of all creatures on earth.

“Corruption in the pharmaceutical sector occurs throughout all stages of the medicine chain, from research and development to dispensing and promotion”

~ World Health Organization (WHO) fact sheet. See http://www.naturalnews.com/028686_Big_Pharma_corruption.html

© Int’l Fund for Horses

To learn more about Premarin Horses, please read our Fact Sheet. Note: DUAVEE is a sister drug to Premarin and Prempro, all of which are produced using the estrogen rich urine of pregnant mares.