Premarin Timeline 2015

FEBRUARY 19, 2015

HIGH-QUALITY STUDIES, RATHER THAN DRUG COMPANIES, ARE FINALLY DRIVING MENOPAUSE TREATMENT — BUT THERE’S A LOT OF GROUND TO MAKE UP

The groundbreaking article, “Women have been oversold HRT for decades“, by Margaret McCartney, published by The Guardian newspaper, is always worth a read.

Excerpted here, McCartney writes:

On my desk I keep a copy of Feminine Forever, a book promoting hormone replacement therapy (HRT), published in 1966, by Robert A Wilson. On the front, it proclaims that it is “a fully documented discussion of one of medicine’s most revolutionary breakthroughs – the discovery that the menopause is a hormone deficiency disease, curable and totally preventable and that every woman, no matter what her age, can safely live a fully sexed life for her entire life”.

I keep this book to remind me of a few things. One, that it is possible to be very, dramatically wrong in medicine – especially when you are very sure of yourself. Two, that when you make big promises, you should have robust, unbiased and powerful data to support them. Three, that when medicine tries to suggest that a new large section of the population – on this occasion, that all women over menopausal age — are “diseased”, one had better look to see who is behind that claim, and why. And last, hype around new medical products are, sadly, nothing new.

As a junior doctor more than two decades ago, I attended meetings (which had sandwiches, pens and soft drinks supplied by drug companies, I am sorry to say) where HRT was promoted as not just the dream solution to all menopausal symptoms – but the way to prevent cardiovascular disease, dementia, stress incontinence, hair loss, the need for dentures, and osteoporosis. There were even claims made that it could prevent depression and supposedly restore a sex life back to ecstatic peaks. Wilson suggested that women should start hormone replacement in their mid-30s, claimed that “the myth that oestrogen is a causative factor in cancer has been proven to be entirely false” and that it would generate “youthful appearance and vigorous energy”, else poor ladies would simply “crumble in ruin”. It took until 2002 for it to emerge that Wilson was being funded by Wyeth, a major manufacturer of HRT — a fact not disclosed in the book.

HRT is still widely recommended for treatment of menopausal symptoms – particularly hot flushes and night sweats — but with the mantra of “informed choice”. Properly informed choice needs accurate information. The initial promises made that HRT could reduce future cardiovascular disease were based on observational studies. Observational studies, though, are highly prone to bias, wrong conclusions, and thus bad information. High-quality, reliable, clinical data is best generated by double-blind, randomised controlled trials that compare groups, with the only difference being the drug under test, and careful attention to monitoring benefits and harms. One such trial, the Hers study, published in 1998, found that recurrent cardiovascular disease wasn’t prevented by HRT. Then — to shock, surprise and dismay — the Women’s Health Initiative Study, published in 2002, found that the risk of cardiovascular disease was in fact increased with HRT, not decreased.

For 10,000 people-years of taking HRT, there were 15 more heart attacks or strokes, eight more pulmonary emboli — blood clots to the lungs — and eight more breast cancers. Last week, an analysis published in the Lancet found that for every 1,000 women using HRT for five years, there is one extra case of ovarian cancer — a slightly higher risk than seen in previous studies.

This week another study was also published which found that, of women who have frequent hot flushes and sweats due to the menopause, the average duration of symptoms was just over seven years. It seems that the length of time that symptoms go on for has been underestimated by doctors (but not women, if anyone had listened) — thanks to a historical lack of quality studies on such basic knowledge. And isn’t it the basics that we need to get right first, so that we can advise women properly?

Read full article »

PDF 2 pp 75 KB
Women_Oversold_HRT_for_Decades_by_Margaret_McCartney »

MAY 9, 2015

THE LANCET PUBLISHES NEW STUDY ON MENOPAUSAL HORMONE USE AND OVARIAN CANCER RISK

Menopausal hormone use and ovarian cancer risk: individual participant meta-analysis of 52 epidemiological studies

Collaborative Group on Epidemiological Studies of Ovarian Cancer, Oxford, England

— Background

Half the epidemiological studies with information about menopausal hormone therapy and ovarian cancer risk remain unpublished, and some retrospective studies could have been biased by selective participation or recall. We aimed to assess with minimal bias the effects of hormone therapy on ovarian cancer risk.

— Interpretation of Findings

The increased risk may well be largely or wholly causal; if it is, women who use hormone therapy for 5 years from around age 50 years have about one extra ovarian cancer per 1000 users and, if its prognosis is typical, about one extra ovarian cancer death per 1700 users.

Link to source »  View PDF 8pp »

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2013

by JANE ALLIN

January
Litigation continues over the allegation that Pfizer Inc.’s Wyeth unit downplayed the risks that its Prempro menopause drug could cause breast cancer. Pfizer/Wyeth has lost the vast majority of Prempro® lawsuits it has faced since trials began in 2006 and has settled out of court on approximately 60% of the 10,000 claims filed.

March
At this time hormone replacement therapy manufactured from pregnant mare’s urine was the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes.

In mid 2012 two New Drug Applications (NDAs) were submitted to the U.S. FDA as potential replacements or alternatives for the Premarin family of drugs derived from CEEs (conjugated equine estrogens) – Sereda manufactured by Depomed Inc. and Noven Therapeutic’s LDMP (low-does mesylate salt of paroxetine).

Unfortunately on March 4, 2013, the US FDA Reproductive Health Drugs Advisory Committee voted that the overall risk/benefit profiles of both Serada and LDMP were not acceptable to support approval.

May
According to a new study conducted by the French National Institute for Health, taking estrogen pills increases a menopausal woman’s risk of needing gallbladder surgery to treat complications of gallstones. Researchers analyzed data gathered from more than 70,000 women in France between 1992 and 2008.

June
A press release from Dr. Timothy Bilash of Solana Beach CA, who specializes in women’s health issues, highlighted a 2012 study claiming that there is a reduced incidence of breast cancer while taking estrogen. This study featured online in the Lancet Oncology journal was fraught with poor sampling methods and inadequate data collection techniques. As a result its validity is questionable.

In late June, the FDA approved the first non-hormonal treatment for hot flashes associated with menopause. Brisdell contains the selective serotonin reuptake inhibitor paroxetine mesylate and is manufactured by Noven Therapeutics. This was formerly labeled as Sereda – the drug that the US FDA Reproductive Health Drugs Advisory Committee deemed unsuitable for approval in March of 2013.

September
A study performed by the Group Health Research Institute revealed that women patients who were prescribed a generic version of estradiol – a bioequivalent estrogen – experienced fewer adverse vascular events than did those prescribed conjugated equine estrogens, the drug marketed as Premarin.

In particular, estradiol was associated with less risk of developing blood clots in leg veins (deep vein thrombosis) and clots in the lungs (pulmonary emboli) than was use of conjugated equine estrogens (Premarin).


Duavee™ ad. the FDA approved the dual-acting drug DUAVEE™, formerly known as Aprela.
Duavee™ ad. the FDA approved the dual-acting drug DUAVEE™, formerly known as Aprela.

October
Amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval, on October 3, 2013 – during the federal economic shutdown – the FDA approved the dual-acting drug DUAVEE, formerly known as Aprela.

Aprela — now called Duavee — is prescribed for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy.

What is disconcerting about the approval is that neither of the drugs that make up the combination has acceptable safety profiles. Bazedoxifene has yet to gain approval in the US due to increased risk of stroke in addition to higher incidences of deep vein thrombosis and retinal thrombosis while Premarin (CEEs) have a long history of increased cancer risks and is classified as a carcinogen.

December
A BONTV video report: “Horse urine a profitable industry in China” confirms the March 2012 report by the Int’l Fund for Horses the sad reality of the relocation of the majority of the PMU farms from North America to China.

As 2013 came to a close, 95% of the Prempro/Premarin lawsuits had been settled with expectations that Pfizer will have recompensed an estimated $1.6 billion to resolve these claims when all is said and done.

Yet Pfizer continues to market and sell these deadly drugs to millions of vulnerable women.

The lawsuits have consistently and repeatedly shown that Wyeth (now a division of Pfizer) failed to adequately warn consumers about the risks of these drugs and purposely hid the risk of breast cancer and other diseases.

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2012

In February of this year Pfizer announced their intention to seek U.S. regulatory approval for the combined menopausal-osteoporosis drug Aprela®, a combination of Premarin® and bazedoxifene. Bazedoxifene is a Selective Estrogen Receptor Modulator or SERM also known as Viviant® specifically developed to help prevent postmenopausal osteoporosis.

Viviant® has failed to receive approval from the FDA as a result of increased risks of stroke and thromboembolic events although it has been approved for use in other countries (i.e. EU and Japan) under different trade names.

If and when approved, Aprela® will be offered as an alternative to Pfizer’s controversial hormone-replacement therapies – Prempro® and Premarin® – both associated with increased cancer and cardiovascular risks among countless other maladies. Aprela® is predicted to restore the HRT market with peak sales of approximately $1 billion if approved in 2013. Some speculate that approval in North America will be not be sanctioned given the delays in developmental stages and inherent risks associated with both components that comprise the new drug.

On February 17, 2012, just shortly before the Premarin® patent expired, Pfizer and Zhejiang Hisun Pharmaceutical, a leading pharmaceutical company in China, signed a framework agreement pursuant to an earlier announcement which would establish a joint venture to develop, manufacture and commercialize off-patent pharmaceuticals in China and global markets.

Ostensibly this was a direct consequence of Premarin’s patent expiration with the potential to drive brand sales over the long term and substantially boost overall sales give China’s large population.

Nearing the end of March the Int’l Fund for Horses revealed, via information procured from an inside source at a bulk powder conjugated estrogen manufacturing company in China, that PMU farms have been in operation in Northern China for the last 8 years with the company’s manufacturing site also in the same location.

This more or less coincides with the release of the WHI study citing the horrors associated with CEE-derived HRT. Well aware of the risks involved, Wyeth had probably begun to move their PMU facilities prior to or just after the damning results of the WHI were released to the public.

On April 1, 2012 a large study was presented at a cancer conference in Chicago. The research involved roughly 60,000 nurses who participated in The Nurses’ Health Study. Data was analyzed from 1980 through 2008. Women who took both estrogen and progesterone (Prempro for example) had an 88 percent higher risk of breast cancer after 10 years on the treatment.

Those who took estrogen alone for at least a decade had a 22 percent increased risk of developing breast cancer. Those women who were exposed to just estrogen for more than 15 years had a 43 percent greater chance of being diagnosed with breast cancer.

Despite the continuing efforts of the medical profession and Big Pharma to reassure women that taking estrogen by itself, short term, to relieve symptoms will decrease the risk of breast cancer, the data continues to roll in against this reasoning. There’s a continued increase in risk with longer durations of use and there does not appear to be a plateau.

In May results of a study conducted at Massachusetts General Hospital in Boston revealed that hormone replacement therapy taken by some women after menopause is linked with ulcerative colitis. It is a disease of the colon (large intestine) or rectum causing diarrhea, abdominal cramping and rectal bleeding. Data from nearly 109,000 women past menopause enrolled in the Nurses’ Health Study that began in 1976 indicate that those on hormone therapy had a 1.7 times higher risk of ulcerative colitis, compared to never-users.

Also in May Pfizer announced a restructuring of its estrogen extraction plant at Brandon, Manitoba calling for about 40 per cent fewer employees by the end of next year. Pfizer stated that it plans to cut about 50 of 130 positions at the plant “gradually through to the end of 2013. Apparently this layoff will not affect the PMU ranchers “for now”. Time will tell.

On the heels of the announcement that Pfizer would be downsizing their Brandon Manitoba estrogen extraction plant, in June the Int’l Fund for Horses learned, through direct correspondence, that certain companies seeking to get into the generic Premarin® market are looking to enter into contracts with PMU ranchers for the collection of pregnant mare’s urine ostensibly as Pfizer vacates them.

As much as the patent stifled the competition for such a long time, there is no doubt that during these years the technology for manufacture has been developed by other pharmaceutical companies awaiting the loss of patent protection.

Premarin and Prempro.
Premarin and Prempro.

Of course the lawsuits continue. Also in June the price tag Pfizer’s Prempro® settlements was estimated.

The drugmaker has paid $896 million to wrap up about 60% of the patient lawsuits representing about 6,000 cases Pfizer has also set aside more money–$330 million–to cover the rest of its Prempro® liability for about 4,000 suits still outstanding. Total: $1.226 billion for 10,000 cases. The company also noted that the extra $330 million is just an estimate and may not cover all of the remaining 4,000 claims.

In July more deception by the medical profession surfaced. A coalition of leading medical groups has concluded that hormone-replacement therapy can be useful and safe for many women suffering from the symptoms of menopause.

The coalition includes 15 medical groups, including the North American Menopause Society, the American Society for Reproductive Medicine, the Endocrine Society and the American Academy of Family Physicians. The goal of the statement, released Monday, is to reassure women and doctors that hormone-replacement therapy (HRT) is acceptable and relatively safe for healthy, symptomatic, recently postmenopausal women.

With concerns about risks associated with conventional hormone replacement therapy manufactured from the urine of pregnant mares (i.e. Premarin®, Prempro®) Depomed Inc., a specialty pharmaceutical company headquartered in Newark, CA submitted a New Drug Application (NDA) to the U.S. FDA on July 31, 2012 for Serada™ – an extended time release formulation designed to provide women with prolonged relief of menopausal “hot flashes” with potential for reduced side effects.

Approximately one month later on August 29, 2012, Noven Pharmaceuticals announced that it had submitted a NDA for low-dose mesylate salt of paroxetine (LDMP) to the FDA also seeking approval for the treatment of vasomotor symptoms associated with menopause. LDMP is an investigational oral non-hormonal therapy specifically developed for the treatment of vasomotor symptoms due to menopause.

The FDA formally accepted the application for Serada™ on October 15, 2012 and established a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. Similarly, the application for LDMP was also accepted with an assigned PDUFA action date of June 28, 2013. These dates represent the goal date for the completion of the FDA NDA review.

Hormone replacement therapy (HRT) manufactured from pregnant mare’s urine is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes. Such non-hormonal drugs as these would be a welcome reprieve for women and horses alike.

In October Martha Rosenberg long-time writer about the issues surrounding the Premarin® family of drugs penned another excellent article: “Will Women Have Short Memories About Hormone Replacement Therapy?

The question arises as to whether a new generation of women approaching menopause will lose sight of the HRT lessons of the 1970’s and 2000’s. No doubt Big Pharma’s slick marketing tactics will try to sway this generation in favor of these carcinogenic drugs despite the risk. It has never stopped them before and the FDA still condones their sales.

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2011

Pfizer/Wyeth continues to promote the use of their controversial Premarin® family of drugs.

According to the new theory developed as a result of Wyeth-linked research, women shouldn’t take less hormones but rather more and start taking them at an earlier age. Unfortunately for Pfizer past research found that women with the greatest risk of breast cancer from hormones are those who took them the earliest — before or soon after menopause. In other words, women who observed the timing theory. Oops.

Pfizer Pharmaceuticals sponsors a teleconference on solutions to the “unwanted horse” problem featuring Tom Lenz following the release of the GAO slaughter report. Lenz is the Senior Director, Equine Veterinary Services, at Pfizer Animal Health and acknowledged pro-horse slaughter advocate.

Pfizer’s affiliation with the most powerful equine organizations in North America leverages their position in terms of horse slaughter and the “unwanted horse’ – a “humane” alternative by their standards.

Pfizer logo against blue sky.
Pfizer logo.

Pfizer continues to be at the center of the slaughter debate through its on-going sponsorship of pro-slaughter organizations such as the AQHA, AAEP, AVMA, UHC, UOH, NAERIC and AHC to name a few.

An extended WHI study carried out at the University of Buffalo shows that conjugated equine estrogen based HRT interferes with the detection of breast cancer leading to cancers being diagnosed at a more advanced stage and tended to have more involvement with the lymph nodes which generally indicates a poorer prognosis. Not only were the women taking the combination of estrogen and progestin more likely to die from breast cancer, but they were also more likely to die from other causes than women who did not take the hormones.

The Buffalo study also found that estrogen therapy is associated with a significant increase in risk of kidney stones regardless of age, ethnicity, body mass index, prior hormone therapy use, or use of coffee or thiazide diuretics.

As of December 31, 2011, Pfizer and its affiliated companies had settled, or entered into definitive agreements or agreements−in−principle to settle, approximately 52% of the hormone−replacement therapy actions pending against them and affiliated companies.

Recorded aggregate charges with respect to these actions were $336 million in 2011 and $300 million in prior years. In addition, Pfizer recorded a charge of $359 million in 2011 that provides for the minimum expected costs to resolve all remaining hormone−replacement therapy actions.

January: A Puerto Rican jury has awarded $1.5 million in compensation to a woman who claimed that she developed breast cancer from Prempro® HRT.

February: A Pennsylvania appeals court has upheld a jury award of more than $10 million in a Prempro® breast cancer lawsuit, reversing a lower court’s ruling that overturned the award of compensatory and punitive damages in the case.

June: Pfizer will have to pay $58 million to three women who previously won a Prempro® breast cancer lawsuit against the company’s Wyeth unit, after the U.S. Supreme Court refused to entertain an appeal by the company.

October: About 150 HRT lawsuits pending in New Jersey state court may be in jeopardy after an appeals court upheld the dismissal of claims that the manufacturers of Prempro®, Provera® and Premarin® failed to adequately warn consumers about the risk of breast cancer and misled federal regulators

December: A Philadelphia jury hit Pfizer with a $72.6 million verdict in a Prempro® lawsuit brought by three women who alleged that they developed breast cancer after taking hormone replacement therapy (HRT) drugs. In addition to the compensatory damages award, Pfizer could face punitive damages of many times that amount depending on the further deliberations of the jury.

The FDA has yet to approve Aprela® or Viviant® (i.e. bazedoxifene) although the approval and sales of bazedoxifene under different trade names is advancing rapidly in other parts of the world.

There is still speculation as to the downsizing of the PMU farms in North America and Pfizer/Wyeth’s ability to produce adequate quantities of pregnant mare’s urine necessary for current and projected sales of the Premarin® family of drugs. Relocation of these facilities to other parts of the world such as China for example seems a plausible and valid assumption.

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2010

by JANE ALLIN

Further studies indicate higher risks of asthma, lung cancer, malignant melanoma, and reduced insulin resistance associated with HRT.

Since 1976, Wyeth (now a Division of Pfizer) have been fighting on-going lawsuits related to the use of their Premarin® family of drugs. This number is estimated to be as many as 5000 cases primarily related to the incidence of breast cancer.



Pfizer’s/Wyeth’s estimated sales figures suggest that Aprela will be available on the market in 2011.

Pfizer Q4 2009 earnings from Biopharmaceutical were $14.6 billion, an increase of 30% compared with $11.2 billion in the year-ago quarter.

Operationally, revenues increased $2.9 billion, or 26%, of which $2.5 billion, or 22%, was attributable to legacy Wyeth products, primarily Premarin® in the Primary Care unit.

Pfizer/Wyeth’s projected sales for their HRT therapies (Premarin®, Aprela®) to exceed one billion USD by 2015.

Pfizer Inc. re-affirms confidence in its (Wyeth) hormone therapy medicines (Premarin®) as important treatment options for symptoms of menopause and osteoporosis.

Hormone replacement therapy makes a comeback in New York Times magazine article called “The Estrogen Dilemma”. One of the authors, Cynthia Gorney, spins a poignant tale about a psycho-socio-hormonal-spiritual breakdown that led her to hormone discipleship in midlife. Turns out that Gorney’s “sources” are (1) the Wyeth funded Roberta Diaz Brinton, (2) Thomas Clarkson-who worked with the Wyeth ghostwriting firm, DesignWrite-and Louann Brizendine and (3) Claudio N. Soares, who have served as actual paid Wyeth speakers.

Pfizer Inc. announces closure of eight manufacturing plants, decreased production at six others and 6,000 job cuts since acquiring rival drug maker Wyeth.

Plans are to cease operations at several plants in Ireland, Puerto Rico, Germany, Britain and the United States by late 2015.

Pfizer manufactures three former Wyeth hormone-based medications in Rouses Point: Premarin®, Premarin® Vaginal Cream and Prempro® which will close in 2011. Manufacturing responsibility for these products is expected to be mostly shifted to other Pfizer sites once the company permanently pulls out.

Due to increased risks of stroke and thromboembolic events, the FDA delays the approval of Bazedoxifene (Viviant®), the osteoporosis component of Aprela®. Once slated for release in 2011, Aprela is now subject to delay as well (possibly 2012 or later).

Giant drug manufacturer Wyeth, a division of Pfizer, announces their intention to downsize the PMU industry through the cancellation of ranch contracts that will see their numbers dwindle from the current 64 to as few as 25. Herein lies a conundrum based on their projected sales for Premarin® and Aprela® of more than 1 billion USD by 2015.

Pfizer, the world’s largest drug maker, announces the withdrawal of its new drug application (NDA) for Fablyn® a selective estrogen receptor modulator (“SERM”) for the treatment of both osteoporosis and selected consequences of menopause. As with other SERMs, Fablyn® has been shown to have significant side-effects which contraindicate widespread use. Of note is that Viviant®, the osteoporosis component of Aprela® , is also a SERM.

The apparent ambiguity of the relationship of the decrease in North American PMU industry and projected sales of Premarin® and Aprela® is solved.

According to an article in The Western Producer; “Wyeth plans to ramp up production of PMU facilities in China, Kazakhstan and Poland, out of the scrutiny of North American values. The byproduct of meat foals has a lucrative market, while Wyeth can continue to make statements relating to supply and demand to justify price of HRT”.

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2001—2009

by JANE ALLIN

2001: First results of the WHI study are released spreading bad news to not only doctor’s offices but also Wall Street. Although physicians remained ambiguous about the results of increased cancer risk and heart attacks, shares of Wyeth fell 19%. The company responded by emphasizing it was the combination therapy of estrogen-progestin Prempro® and not Premarin® that was at fault.

2002: Barr Laboratories suffers at the hands of Wyeth. A Minnesota Federal judge finds that Barr misappropriated trade secrets thereby protecting Wyeth’s lucrative monopoly of Premarin®.

Government scientists abruptly end the WHI HRT study – the nation’s largest – which states that long-term use of estrogen and progestin significantly increases women’s risk of breast cancer, strokes and heart attacks.

After the government’s announcement, millions of women discontinue the use of HRT – down from about 6 million users for Prempro® to 3.3 million.

FDA announces it will more thoroughly evaluate HRT use – the first official response from the government.

Prempro®’s sales plummet 32% for 2002.

2003: Further studies indicate there were increased incidences of cardiovascular events, and breast cancer in women taking the combination therapy drug Prempro®.

FDA orders that both medications – Premarin® and Prempro® – carry warning labels advising users of the increased risk of heart disease, stroke, breast cancer, pulmonary embolisms and blood clots.

Additional results from the NIH study indicate that HRT contributes to dementia.

Media reports escalate the public awareness of the sequestered pregnant mares and slaughtered foals – the “byproducts” of the PMU industry.

Premarin foals. By Vivian Grant Farrell..
Premarin foals. By Vivian Grant Farrell.

2004: As a result of falling sales of Premarin® and Prempro®, Wyeth introduces a lower dosage estrogen-progestin drug claiming it is safe.

The estrogen-only (Premarin®) division of the WHI study continues to 2004 but it also is terminated prematurely due to indications of increased risk of stroke, deep vein thrombosis and without benefit in terms of coronary heart disease.

Sales of Premarin® and Prempro® freefall from $1.3 billion in 2002 to $880 million in 2004.

2005: Wyeth closes a manufacturing plant and eliminates 15% of its sales force as sales of Prempro® falls 76% and Premarin® 47%.

Wyeth asks the FDA to investigate independent pharmacies producing bio-identical hormone replacement therapy (BHRT) claiming there are potential risks to women’s health and possible violations of manufacturing practices. In October of 2005, Wyeth files a “Citizen’s Petition” demanding the ban of bio-identical hormones which coincidentally compete with their synthetic hormones.

2007: Numerous cancellations of contracts for the Premarin® family of drugs results in herd reductions on PMU farms.

A report in The Lancet found that HRT increases the risk of ovarian cancer by 20%.

FDA declines to approve Pristiq – a non-hormonal drug for menopausal symptoms produced by Wyeth – without further testing due to some indications that the drug causes serous heart and liver complications.

After years of research, analysis, and debate, the International Agency for Research on Cancer, the U.N.’s cancer research agency, has reclassified HRT from “possibly carcinogenic” to “carcinogenic.”

2008: Wyeth announces that it plans to meet with the FDA in February to discuss product formulation, bioequivalence and clinical study efforts to support the planned NDA filing of Aprela – a new drug containing CEEs for menopausal symptoms and a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis.

2009: Another report is published by WHI investigators regarding the “timing hypothesis” of HRT. Advocates suggest that if HRT is started within six years of the menopause transition, the favorable estrogen environment of pre-menopause can be sustained and may improve cardiovascular status. The results of the study and the WHI data clearly refute this hypothesis.

Pfizer acquires Wyeth to become the largest pharmaceutical company in the world.

Court documents reveal that Wyeth paid ghostwriters to produce 26 papers backing the use and safety of HRT suggesting that the hidden agenda of Big Pharma and its manipulation of medical literature and promotion of questionable medications are more wide-spread than once believed.

Despite the controversy and factual evidence of the risks of HRT, Pfizer affirms confidence in its HRT drugs and maintains the coverage of these drugs is misleading and heavily weighted in favor of selective literature that condemns their use.

The Horses or PMU’s.

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.