New study damns results of WHI report on Premarin family of drugs

by JANE ALLIN

New Study

Another new study published September 12, 2017 in the Journal of the American Medical Society (JAMA) has made headlines claiming that HRT is not the villain it was once thought to be.

Per the investigators, a statistical review of the results of the damning 2002 WHI study showed that the women taking the hormones did not die earlier or have higher incidence of chronic illness than those taking a placebo.

In fact, to the contrary, this new study asserts that these women experienced a profusion of benefits as a result of taking the HRT – improving the quality of life, preventing osteoporosis, heart disease and Alzheimer’s, and of course a satisfying sex life among other advantages.

An author who penned an article in the Huffington Post by Erika Schwartz MD, self-described as a physician who is a hormones and prevention expert, even goes so far as to tout them as miracle drugs. Laughable at best.

“Hormones are great for you. You are better off with any kind of HRT (bioidentical estradiol, testosterone, conjugated equine estrogen, etc.) than nothing. The WHI study was a most horrific insult to women’s health in recent history. It hurt and still does millions of women. Women are suffering because money was more important than pure science and honest medical discourse.” [1]

Pfizer World Headquarters. Reuters.
Pfizer World Headquarters. Reuters.

How was money more important than science and honest medical discourse? If anything, the WHI resulted in huge losses in profits for Big Pharma, notably Wyeth, now a wholly owned subsidiary of pharmaceutical giant Pfizer.

Moreover, Wyeth was guilty of covering up the truth about HRT and its link to increased incidences of cancer, heart disease and other life-threatening ailments in pursuit of higher profits at the expense of women. A classic example was the use of ghostwriters hired by Wyeth for this very reason.

“The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.” [2]

In any case, the study: “Menopausal Hormone Therapy and Long- term All-cause and Cause Specific Mortality; The Women’s Health Initiative Randomized Trials” in its entirety is available here  and a brief overview and summary of results can be found here.

The study was an observational follow-up of more than 27,000 postmenopausal women aged 50 to 79 years who were enrolled in the 2 WHI randomized clinical trials between 1993 and 1998 and followed up through December 31, 2014 – a cumulative total of 18 years.

These two trials — the original WHI study, and a second WHI study published two years later — found that taking estrogen plus progestin (Prempro) HRT increased a woman’s risk of heart disease and breast cancer while taking estrogen alone (Premarin) increased the risk of stroke, dementia, and other health dangers including endometrial cancer.

Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell
Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell.

The new study published in JAMA on September 12, 2017 strongly supports the claim that hormone therapy with CEEs (conjugated equine estrogens) in combination with progesterone (e.g. PremPro) and CEEs alone (Premarin) are not associated with “all-cause” mortality. In other words, they are trying to convince women that HRT therapy is not harmful, will not kill you nor shorten your life – those women who took the drugs to alleviate the symptoms of menopause were no more likely to be dead after 18 years than those who didn’t.

“Among postmenopausal women, hormone therapy with CEE plus Progestin (PremPro) for a median of 5.6 years or with CEE alone Premarin for a median of 7.2 years was not associated with risk of all-cause, cardiovascular, or cancer mortality during a cumulative follow-up of 18 years.”  [3]

Specifically, HRT taken for 5 to 7 years was not associated with risk of long-term “all-cause” mortality.

So they say.

Yet in the same breath, they continue to advise restrictions on its use based on the age of onset of menopause, the lowest dose possible, for the shortest duration possible, not to be taken with existing risk of cancer and heart disease, blah, blah, blah . . .

“Although these findings lend support to practice guidelines endorsing use of hormone therapy for recently menopausal women with moderate-to-severe symptoms, in the absence of contraindications, the attenuation of age differences with longer follow-up and potential health risks of treatment would not support use of hormone therapy for reducing chronic disease or mortality. Moreover, it is unclear whether benefits would outweigh risks with longer duration of treatment.” [4]

As with other prescription medications and the plethora of warnings, contraindications and precautions, how safe are these drugs, particularly given past studies other than the WHI trials have also shown them to be harbingers of heart disease, cancers and other maladies?

As a matter of fact, according to their analysis, the researchers found that there was indeed a “statistically significant” increase in breast cancer incidence in women who took the combination CEE and Progestin HRT (Prempro) – the same findings as the WHI and other independent studies of which there are many.

“Total cancer mortality did not differ significantly between intervention and placebo groups in either trial despite the increased incidence of breast cancer with CEE plus MPA34 and concerns about an increased risk of hormone-sensitive cancers with both regimens”. [5]

Yet this “critical finding” is obscured in the blanket statements in the many articles circulating the Internet that extol the benefits of HRT as a direct result of this study.

Sadly, often these warnings are not passed on to the unsuspecting patient and are glossed over, even by their physicians. One need only listen to the sweeping comments made by Erika Schwartz, MD, the hormone expert who authored the paper referred to above; “Principal Investigators of 2002 WHI Study Reverse Findings — HRT vindicated in new JAMA article”.

Not only does she recommend all forms of HRT to her patients, as well as making the ridiculous statement that women are suffering because money was more important than science when in fact, money had nothing to do with it — sales of Premarin and its derivatives plunged after the results were released — she has this little rant to add:

“Now oddly media coverage hasn’t really done this report justice. It has been casually covered as a ray of hope but not as the wake-up call it MUST be. While in 2002 the media frenzy killed HRT, the JAMA report was interpreted as light reassurance for HRT. That’s just not right. There is no doubt here. HORMONES DO NOT HARM WOMEN, the medical establishment dogma does.” [6]

Seriously?

The researchers themselves have underscored the limitations of the study, caution the interpretation of the results and warn that cause-specific mortality analyses should be considered exploratory. If that isn’t from the horse’s mouth what is?

So, what to make of this? What prompted these original researchers to revisit this 25 years after the fact? To right a perceived wrong in the hope that the whole debacle of the HRT debate goes away once and for all? To help lessen the stigma so that there will be a resurgence of sales of the Premarin family of drugs?

Your guess is as good as mine, but I am betting it has everything to do with Pfizer’s bottom line.

There is no reason to think that a new study is right and all the previous studies are wrong. But if they are profit driven this is exactly what the drug companies want people to believe.

Class Action Lawsuits

And what about all those class-action lawsuits? Are they suddenly moot? These were massive suits involving thousands and thousands of women, some surviving and others dying. If these drugs don’t cause cancer why on earth did Wyeth/Pfizer lose these lawsuits, many of which were unlawful death suits? Do people really think that companies such as Wyeth and Pfizer have no leverage? Money talks.

The science is there but it seems that there is always some new study funded by these mammoth pharmaceutical companies to cast doubt on the findings if they are not in support of pushing their drugs that make lucrative profits — money before patient safety. In fact, for this study, Pfizer was paid for consultancy and review activities.

Conflict of interest? You be the judge.

As Peter Gotzsche M.D., Director of The Nordic Cochrane Centre and author of “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care” points out:

“Much of what the drug industry does fulfills the criteria for organized crime in US law,” Dr. Gotzsche said in a recent interview. “And they behave in many ways like the mafia does, they corrupt everyone they can corrupt, they have bought every type of person, even including ministers of health in some countries . . . The drug industry buys the professors first, then chiefs of departments, then other chief physicians and so on, they don’t buy junior doctors.” [7]

Menopause Lane Street Sign. Author unknown.
Unattributed Google search result.

Lies, Damn Lies and Statistics

The approach to this study is not new and similar studies have been made in the past — for example, one in 2013:

Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized”. (http://jamanetwork).

One of the key points is that in these studies the results of the WHI are broken down by age groups, rather than individuals treated as a single cohort. The other principal factor is that the statistical analysis used in both the current and 2013 study was hypothesis testing (statistical significance) using “P values”. And in each case, the conclusions were the same — HRT is safe (with some restrictions).

While this age-stratified analysis is a good approach, what of the actual statistical method used to arrive at the conclusions?

Without going into detail about hypothesis testing and the use of “P values” to predict the significance of an event, this statistical method and its applicability to medical research has been shown repeatedly that conclusions based on calculating “P values” are frequently false. Just as statistical significance does not always mean a result is real, lack of statistical significance (which they are using in this study) does not mean that there is no effect.

In fact, observant experts have been pointing out serious flaws in standard statistical testing for decades. In recent years, the depth of the problem has become more apparent and better documented, yet the medical community continues to employ these methods simply because these methods have been embedded in the scientific process. In effect, it is not just medical research, but all research fields, that often draw erroneous conclusions.

Even the researchers warn of caution when interpreting these results:

“Finally, the nominal P values presented here should be interpreted cautiously, as multiple outcomes and subgroups were examined. Thus, cause-specific mortality analyses should be considered exploratory.” [8]

And yet, this new study is being promoted as leading-edge “feel-good” news for menopausal women across the globe via social media without recognition of the caveats associated with the results. Reckless endangerment at its best.

Yes, ladies, you can breathe a sigh of relief. Or not.

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” [9]

In truth, the best solution to determine the safety of HRT on the health of menopausal women would be to repeat the experiment without the flaws that existed in the original WHI studies. Unfortunately, often studies are too complicated, lengthy or expensive to repeat.

Or, as in this case perhaps, the drug company does not want to pursue a wholly comprehensive study as it will further affect sales if found to negatively impact the health of patients, just as it did originally – why take the time and money if only to find that HRT does in fact cause heart disease, cancer and the like.

That is both a financial risk and a precarious risk where damning results could leave a stain on the brand name and negatively affect profits if the results are published. However, drug companies publish only a fraction of the studies they fund — the ones that promote their drugs. Unwanted results are not published.

Sadly, doctors must rely on academic peer-reviewed medical journals to learn about prescription drugs and pass these findings onto their patients in the way of prescription medications. What choice do they have?

“Pharmaceutical companies know this and have worked hard to sway the leadership. Now the question comes up if we can trust the data that the leadership relies on. One wonders how deep the deception goes. In fact, the heavy influence of pharmaceutical dollars inspired the former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell, to conclude, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”  [10]

In the News

It is always tempting for journalists and scientists alike to report a finding that is contrary to popular belief. This is no exception.

For years after the damning result of the WHI study, and to this day forward, HRT has been a controversial subject. When a study emerges that defies previous findings, often the magnitude of the effect is overstated and the less likely the research findings are to be true.

Then there is the enticing phrase “Contrary to previous scientific belief . . .”.

“Ordinarily, “contrary to previous belief” should be a warning flag that the result being reported is likely to be wrong. Instead it is usually a green light to go with the story. So the general criteria of newsworthiness—a first report, in a hot field, producing findings contrary to previous belief—seem designed specifically to select the scientific papers most likely to be bogus.” [11]

Add to this, the HRT media campaigns by Pfizer and others that underplay the dangers of cancer and heart disease. These types of studies that shine a positive light on the use of HRT to control symptoms of menopause clearly add more arsenal to their strategy. Billions are spent on direct-to-consumer ads promoting drugs that Big Pharma say are intended to raise awareness of treatment options.
The truth is, direct-to-consumer advertising is used to drive choice rather than inform it – the ‘driving’ typically in the direction of expensive brand-name drugs. [12]

The only two countries in the world that allow direct-to-consumer advertising are the U.S. and New Zealand.

Survey’s carried out in both countries have shown that when a patient asks for a specific drug their family physician is likely to prescribe that drug over others such as generics or alternatives, for example.

But it is more insidious than this since the ugly truth is that doctors are being enticed by pharmaceutical companies to prescribe their drugs.

In a gullible nation that has been brainwashed by Big Pharma, and their physicians who receive 95% of their information from this very source, there is little difficulty persuading the masses that drugs are the answer to any “condition” although many of these so-called illnesses are treatable by lifestyle changes or, in effect, are not diseases at all. [13]

Such is the case for the ubiquitous Premarin family of drugs.

Prescription drugs are killing us. Arnold Seymour Relman. Image Source: True Activist.
“The medical profession is being bought by the pharmaceutical industry, not only in terms of practice of medicine but also in terms of teaching and research.” Arnold Seymour Relman. Image Source: True Activist.

So, I leave you with this.

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.” – Arnold Seymour Relman (1923-2014), Harvard Professor of Medicine and former Editor-in-Chief of the New England Medical Journal [14]

[1] [6] http://www.huffingtonpost.com/entry/principal-investigators-of-2002-whi-study-reverse-findings_us_59bf0771e4b06b71800c3aed

[2] http://www.nytimes.com/2009/08/05/health/research/05ghost.html?pagewanted=all

[3] [4] [5] [8] https://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/483786.pdf

[7] [10] https://www.thedailybeast.com/big-pharma-is-americas-new-mafia

[9] https://www.acsh.org/news/2015/05/19/science-publication-is-hopelessly-compromised-say-journal-editors

[11] http://nautil.us/issue/4/the-unlikely/sciences-significant-stats-problem

[12] http://www.who.int/bulletin/volumes/87/8/09-040809/en/

[13] https://tuesdayshorse.wordpress.com/2014/07/23/pushing-premarin-big-pharma-big-bucks-part-1/

[14] http://www.collective-evolution.com/2016/05/14/pfizer-vp-comes-clean-tells-the-truth-about-pharmaceutical-companies-video/

© The Horse Fund

WHI — Women’s Health Initiative

The Women’s Health Initiative (WHI) was initiated by the U.S. National Institutes of Health (NIH) in 1991. The Women’s Health Initiative, which consisted of three clinical trials (CT) and an observational study (OS), was conducted to address major health issues causing morbidity and mortality in postmenopausal women.

Related Reading

Further reading on the use of “P values” and other sources of statistical error:

“Why Most Published Research Findings are False” http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124

“A Dirty Dozen: Twelve P-Value Misinterpretations” http://exp-platform.com/Documents/2017-08%20KDDMetricInterpretationPitfalls.pdf

“Science’s Significant Stats Problem” http://nautil.us/issue/4/the-unlikely/sciences-significant-stats-problem

Don't sweat the latest report damning WHI report on Premarin. Take an alternative.
Don’t sweat the latest report damning WHI report on Premarin. Take an alternative.

Women — Don’t Sweat It

Don’t sweat it concerning these drugs and the confusion surrounding them. Work with a health care professional to find the right alternative for you. Here are some good alternative avenues for you to explore.

More at Tuesday’s Horse

• Horse pee reduces breast cancer. Say what? by Jane Allin
https://tuesdayshorse.wordpress.com/2013/06/13/horse-pee-reduces-breast-cancer-risk-say-what/

Premarin Horses

March for Premarin Horses featured image.
Pfizer’s Premarin family of HRT drugs is made from the urine of pregnant mares.

The Premarin family of drugs is made from the estrogen rich urine of pregnant mares. Hence the name Pregnant Mare’s Urine.

The conjugated equine estrogens produced from the urine of pregnant mares to make these drugs have been declared known carcinogens by the World Health Organization.

See all posts on Premarin Horses »

Learn how more about how these horses are used and what happens to cast off mares and byproduct foals at Premstoppers at http://horsefund.org/premstoppers-home.php.

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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.