Canadian PMU farms’ losses are China’s gain

PMU Farm in Xinyuan County, China (2012).

EXCLUSIVE REPORT by JANE ALLIN

Canada braces for more cuts

By now, I’m sure that most who care about the abuse of horses for human gain are aware of the shrinking need for the PMU (Pregnant Mare’s Urine) farms in Manitoba (ya, I’m late in getting this out). Urine collected from these pregnant mares is used to provide the source of estrogen hormones used in the manufacture of the Premarin family of drugs that are prescribed primarily for the symptoms of menopause.

An article last month in the Manitoba Co-operator dated May 13, 2020; “Remaining PMU producers brace for more cuts”, signals that Pfizer will be implementing further production cuts for the 2020-2021 season despite signing a three year, 18-week contract with the company’s Canadian division in 2019.

Open quote

“It follows of the heels of last year’s cuts which resulted in production of PMU to cease at five ranches; three from southwestern Manitoba, one from the Interlake region and one from southeastern Saskatchewan, as well as a production cap on some of the larger contracts. That reduction reflected a 17 per cent cut in product equalling approximately 33,000 grams of estrogen for the 2019-20 contract year.

While no ranchers will be forced out of the industry in this round of cuts, Pfizer did give producers up until March 4, 2020 to voluntarily accept a full or partial buyout package aimed at reducing the number of grams of estrogen needed by the company.”


The cuts in 2019 left 19 producers actively involved in the production of PMU in Manitoba and Saskatchewan, with the highest concentration of ranches in southwestern Manitoba. With this new announcement, one producer in south-central Manitoba opted for the full buyout and another from southwestern Manitoba, a partial buyout, leaving a total of 17 farms remaining. Of those, 4 are in southeastern Saskatchewan and the rest in Manitoba.

Open quote

“For these 17 remaining ranchers involved in the network, some will see an approximate 17 to 18 per cent reduction in total contract overall for the 2020-21 season, with some of the smaller contracts less affected. Ranchers are paid per gram of estrogen and not on the volume of urine produced.”


This doesn’t include the fact that this past season was cut 2 to 3 weeks short when ranchers were told to cease production. So, in total, over two seasons the production quantity has been reduced by a margin of up to and above 35% when the shortened production season is taken into account. 

Why such a drastic cut?

Open quote

“Pfizer routinely conducts reviews of its businesses and overall manufacturing needs and capabilities. This includes our operations in Brandon, Manitoba. Pfizer has initiated a review of its inventory management. We are able to satisfy market demand by reducing the volume of PMU that is being collected.

“As part of its normal business analysis, Pfizer continually reviews PMU collection requirements. Decisions are informed by an evaluation of the hormone therapy market, prescribing trends and related raw material and inventory requirements.

“Pfizer values its network of ranchers and the decision to reduce our PMU volume collection was not made lightly. We are committed to treating ranchers fairly and reasonably as we make these changes to our collection operations.”


This seems like an unusual strategy given the expected increase in the projected HRT market over the next few years – both globally and in the US. In fact, the NA market dominated the overall hormone replacement therapy market in terms of revenue share in 2019. Moreover, the estrogen replacement therapy segment and the treatment of menopausal symptoms is likely to showcase the fastest growth rate over the forecast period (to 2027), as well as the majority of the market share. [1]

These are the drugs Pfizer exclusively markets – the Premarin family of drugs produced from estrogen extracted from pregnant mare’s urine, which in 2019 accounted for $734 million of their revenue most of which is based in NA (94%). 

In 2019, the global hormone replacement therapy market size was valued at USD 21.8 billion and is expected to witness a compound annual growth rate (CAGR) of 7.7% until 2027. This of course includes other hormone therapies (i.e. HGH, thyroid and testosterone hormone therapies), but the majority of these products will be related to estrogen HRT. [2]

On a global basis, the top five companies involved in the production of HRT formulations collectively account for a significant revenue share (35%) of the overall hormone replacement therapy market; Novo Nordisk, Pfizer Inc., Janssen NV (a Johnson & Johnson company), Novartis AG and Bayer AG. Why would Pfizer choose to lose a share of this revenue?

The simple truth is, they wouldn’t choose to do so. Facts are however, that Pfizer has seen decreasing revenues from its Premarin family of drugs over the last few years. According to their 2019 annual financial report, this decline is directly in consequence of the continued competitive pressures in the U.S., which is expected to continue. [3]

This is not really surprising given the stigma and awareness associated with estrogens derived from PMU that has developed over the years, accompanied by the advances other pharmaceutical companies have made with similar drugs not sourced from PMU. 

Nonetheless, Pfizer remains committed to these products and, in particular, have been heavily marketing the Premarin cream product. This may be in response to quell fears of the side effects the oral version carries with it in favor of “less-invasive” local dermal applications, where the overall dose can be lower and circulating blood levels of the hormone aren’t raised significantly.  Or potentially, the market for these creams is very large and easier to compete in.  

Another interesting point to make is the inflated cost of Premarin compared to most other HRT products as alternatives. As shown in the chart below, for a number of years, Pfizer’s revenue from the Premarin family of drugs remained relatively stable at or around $1 billion USD annually.  

At the same time, however, the cost to purchase these products was increasing steadily, meaning that sales must have been decreasing for a number of years to maintain annual profits with little change. Nonetheless, since 2016, there has been about a 28% decrease in profits. It seems from these observations then that these products have fallen out of favor in lieu of other “safer” or “cheaper” drugs? 

So, the downsizing in NA over the years appears to make perfect sense from two aspects – decrease in demand and declining return on investment. Hence, to further minimize expenditures and maximize revenue, cost-effective changes have to be made. 

One needs only look at Pfizer’s 3 key phrases they use to justify the reason for the decreased production volume required in NA; raw materials, inventory management and collection operations, all of which are related to operating costs.

Enter the solution: China

Who needs 2 supply chains, especially one in NA that is likely more costly to run, when you can have a single supply chain to maximize the cost-reduction? Moreover, how long can they continue to inflate the costs of these products and remain competitive in the market while running NA operations? 

I don’t think there is any question that Pfizer has been sourcing the raw materials from China for a number of years, despite their continued insistence that it is in an effort to match “supply and demand”.  And while demand for HRT produced from PMU seems to have declined to some extent, it’s hard to believe that it has dwindled to the point of no return as both this and last year’s announcement would have you wondering about. In 2019 when the round of cuts was made, they said the same thing and also offered (all of) the ranchers the decision of voluntarily opting to exit the sector, in exchange for a 75 per cent total contract payout for the following year to ease the transition – all of them, not just a few, just like this year. [4]

It must be clear by now that the NA PMU farms were doubtless supplying only a small percentage of the CEEs for Pfizer’s Premarin family of drugs over the last several years. I suspect the NA operation of PMU ranchers will be obsolete within 2-4 years, if not sooner.  At that point, Pfizer can no longer conceal the fact that their HRT drugs are born and bred in China. 

And what about the horses when all of the farms are shuttered– the mares and their foals? 

There was no mention of them in this year’s announcement, but in 2019 Pfizer did state they would provide compensation for the care of the mares and foals as the producers “transitioned out of the network.” Additionally, the affected ranchers would also be eligible for equine placement assistance, but no guarantee that the mares and their foals wouldn’t end up in the slaughter pipeline if those options fell through.  

No happy endings – Pfizer doesn’t care. 

Expansion in China

Coincidentally, and quite conveniently, a couple of other articles about PMU horses surfaced about the same time as this news broke in Manitoba, announcing further expansion of PMU farming in China.

This information comes out of Northwest China’s Xinjiang Uygur Autonomous Region (XUAR). The Xinjiang Uighur Autonomous Region is home to vast grasslands, the majority of China’s ethnic Kazakh population, and is experiencing its most propitious phase of development and prosperity. 

Introduction to Xinjiang | The Xinjiang Grassland

Xinjiang, roughly half the size of India, is a historic crossroads, sharing a border with Afghanistan, Kazakhstan, Kyrgyzstan, Mongolia, Russia, and Tajikistan. The region is also home to about 10 million Uighurs—making up roughly half of China’s 22 million Muslims. In the past, resource-rich Xinjiang had become a center of sporadic violent protests, but the region’s counter-terrorism and de-radicalization efforts have laid a solid foundation of stability in the district due to the repressive policies of the Chinese government against the Turkic Muslim peoples who reside there. Not a pleasant read, but here is the reason. [5]

Xinjiang is also one of China’s major habitats for horses, with those bred in the Ili Kazakh Autonomous Prefecture standing out among the country’s sports horses. Plans are currently in place to grow its modern equine industry in 2020, with the whole industrial chain’s annual output topping 9.5 billion yuan (about 1.34 billion U.S. dollars). [6]

Now however, the proposal is to move beyond sport horses and expand its entire horse industrial chain in 2020 including large breeding bases for horse milk, meat, fat and pregnant mare urine (PMU) production. [7]

PMU farming has become a lucrative business for many of the herders in the region as well as providing a venue for a biopharmaceutical industrialization base.

Open quote

“For Erbosun Abuduhan, a herdsman in Ili’s Xinyuan County, pregnant mare urine (PMU) is a new source of income.

One kg of PMU can sell for 4.3 yuan to 7.8 yuan, and Erbosun raked in over 20,000 yuan from last December to March, the prime season for collecting PMU.

This unusual product is collected for estrogen that can be used as a hormone replacement for treating women experiencing menopause, said Xu Zhiyong, general manager of Xinjiang Nuziline Bio-pharmaceutical Co., Ltd., a local company focusing on PMU drugs.

The company collects PMU from about 400 households, with nearly half of them previously poor families. “We have strict management rules and a fixed daily collection quota to ensure that the PMU is collected in a humane way,” Xu added.

Xu’s company is also making a foray into developing horse milk and horse fat products, as they boast huge potential in the healthcare and cosmetics markets.” [8]


20,000 yuan for the 4-month PMU collection season works out to about 2,800 USD or 700 USD/month. That’s likely considerably cheaper than what the PMU ranchers in NA collect from their operations, but no doubt a king’s ransom for these rural-dwelling people.  I’m sure Pfizer didn’t need a detailed cost-benefit analysis to figure that one out. In fact, the Chinese are doing all of it for them. More on that later. 

The PMU industry in China has been recognized to exist for a number of years, so this is not new per se. The Fund for Horses first reported this in 2012 and in 2016 reported on the Chinese company, Xinjiang Xinziyuan Biological Pharmaceutical Co., Ltd.

Moreover, an abstract from a 2015 paper in the Chinese CKNI database from the journal China Rural Finance also refers to how the lucrative PMU industry has developed in the Xinjiang Autonomous Region: 

Open quote

“The pregnant horse urine industry arouses herders “money bags” Xinyuan County Rural Credit Cooperative issued a total of nearly 100 million yuan of loan from pregnant urine industry, so that the pockets of more than 1,000 herdsmen swelled up in the hinterland of Gongnais grassland in the east end of the Ili River Valley in Xinjiang……

The Fertile soil and high-quality forage grass provide unique conditions for the country to develop horse farming. Today the number of horses in Xinyuan County has reached 110,000.” [9]


This was in 2015, so no doubt there are far more PMU horses than 110,000 by now. So, this news out of China is yet another bit of information providing details of an ever-growing PMU industry in the Xinjiang Autonomous Region. 

With the establishment of the Xinjiang Xinziyuan Biological Pharmaceutical Co., Ltd. In the autonomous region in 2005, the breeding of PMU mares and sales of pregnant mare’s urine has since become the “sunrise industry” for the regional rural farm economy, providing a significant increase in income for the farmers and incentive to expand production and number of horses.

Pfizer is stated to be the reason for establishing Xinjiang Xinziyuan Biological, but the relationship described between the two companies is inconsistent – at least until now. 

Whatever the true circumstances are concerning Pfizer, the magnitude of gross cruelty to horses resulting from the creation of a domestic market in China for equine estrogen projects is in itself unthinkable.

And with this comes the news that not only are they “harvesting” the urine for the production of Premarin products but also ostensibly the milk, meat and fat of the spent mares and the foals – the now “convenient” and profitable “by-products” of the industry.

Horse milk, meat and fat have long been staples in Asia, and since then these ancient traditional remedies have been extended to many European countries in particular, and even in NA. Pregnant mare’s milk is touted for its ability to combat inflammatory diseases, diabetes, tuberculosis, blood pressure, and even certain types of cancer (ya right – eye roll). 

Horse fats? Turned into oils for its inflammatory properties and used in topical ointments for mild skin complaints (e.g. burns, cuts, eczema), due to its higher linoleic acid (fatty acid) content, than found in cows and sheep.

Horse meat is self-explanatory. 

But it’s all “humane” so they claim. 


“We have strict management rules and a fixed daily collection quota to ensure that the PMU is collected in a humane way”.


No, it’s horrific and oppressive. 

It’s a “horse mecca”. Let’s not waste a thing, let’s exploit them for every last bit of flesh and fluids in their bodies. When the mares are beyond their productive years, and when the by-product foals have no economic use, they can be turned into meat and their milk and fat used in “health care” products and cosmetics.

Vile. 

The main players — N. America and China

Pfizer’s international market for Premarin has been open game for competitors without the U. S. Food & Drug Administration’s protection of the company’s monopoly trade secret and the Chinese industry has grown considerably as a result of it over the years. In fact, it has evolved to be the largest in the world for conjugated equine estrogen collection and derived HRT products (Premarin). 

The number of middle-age women in China presently within the target demography for estrogen products exceeds the total population of the rest of world. Furthermore, the corresponding number of horses required to meet China’s domestic demand annually is greater than the total number of horses used for Premarin production during the 75 years since FDA approval in 1942.

Just as the collective HRT market is expected to grow over the next few years, the Premarin-API (active pharmaceutical ingredient) market is also expected to witness growth acceleration during the five-year period from 2020-2025.  

An active pharmaceutical ingredient is defined as “any substance or mixture of substances (usually in powder form) intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product – this would be the CEE’s extracted from the pregnant mare’s urine in the case of Premarin. 

According to a Premarin-API Market 2020 report, the key companies operating in the global Premarin industry include:

  • Pfizer 
  • Xinjiang Tefeng (Henan Huaxing)
  • Anhui Tiger
  • Zhejiang Garden Biochemical High-tech

Taizhou Hisound Pharmaceutical.  [10, 11]

The “vendor base” is made up of Pfizer and Xinjiang Tefeng who manufacture and sell the finished products while the remaining three produce the key ingredient (CEEs) in bulk, typically in powder form, for the production of the “Premarin” in its various formulas (tablet and cream). 

Currently however, some companies that produce the bulk CEEs for the industry are looking to expand their portfolios to finished products to capture some of the market share with the predicted growth over time. 

Both Xinjiang Xinziyuan Biological Pharmaceutical and Xinjiang Nuziline Bio-pharmaceutical mentioned above, appear to be part of the Xinjiang Tefeng pharmaceutical company, or subsidiaries, as both of their websites are linked directly to the “parent” company (http://www.tefeng.com). If not, they are working in close affiliation to supply the bulk CEEs for the different versions of “Premarin” products manufactured by Xinjiang Tefeng.

Open quote

“Tefeng Pharmaceutical has formed a complete pharmaceutical quality management and security system. It has three production bases that have passed the national GMP standard certification and has a variety of dosage forms such as tablets, hard capsules, soft capsules, ointments, dripping pills, oral liquid, granules, etc. The production capacity of estrogen raw materials combined with pregnant horses.” [12]


In 2011, Tefeng announced the construction of a modern biomedical park in the high-tech development zone of Urumqi. The project was developed to contain a Premarin production base, a Xinjiang local biological drugs extracting base, a post-doctoral workstation and pharmaceutical technological center, a comprehensive preparations production base and a health food (horse milk?) production base. 

Its purpose was to take advantage of the agriculture and animal husbandry industry in Xinjiang, stimulate the economy of the pastoral area, help farmers reduce deficiencies and promote the industrialization of Xinjiang. 

Open quote

“It will strive to pass international authentication of the production bases and push the Premarin products and Xinjiang biomedical resources to European and American markets.” [13]


The other three companies have no clear information pertaining to conjugated equine estrogens, at least from what is available on their websites; all three appear to be largely associated with lipid (fat) technology and the manufacture of various vitamins (e.g. Vit D3, Biotin), cholesterol and lanolin products. Nevertheless, they also supply “other” pharmaceuticals, presumably the API (conjugated equine estrogens) for the manufacture of Premarin.


Are the “fats” of the mares and foals considered as “by-products” used in their “lipid technology” applications?


Seemingly, they are involved in the collection of pregnant mare’s urine from farms and/or constitute a large source for extraction and production for the bulk conjugated equine estrogens. How this ties into their main products derived from lipids is unknown, if in fact it does. Are the “fats” of the mares and foals considered as “by-products” used in their “lipid technology” applications?

  • Anhui Tiger Biotech Co, Ltd., a holding subsidiary of China BBCA Group Corporation (see bbcagroup.com )
  • Taizhou Hisound Pharmaceutical Co. Ltd., founded in 2000, a subsidiary company of Xianju Pharmaceutical Co. (see hisoundpharma.com)
  • Zhejiang Garden Biochemical High-tech Co. Ltd., together with the subsidiary companies of Hangzhou XIASHA Biotech Co., Ltd and Hangzhou ROSSEN Lipids Technology Co., Ltd. is the world’s famous manufacture of Vitamin D3, Cholesterol and lanolin products (see http://en.hybiotech.com/)

Growth of the PMU industry in China

All of these developments have occurred over the last several years, so chances are that Pfizer is, and has been, sourcing a portion of its bulk CEEs from China if not some of the finished products from this organization, effectively allowing them to reduce the PMU footprint in North America. Eventually, China will be the primary, if not the single, source of all Premarin products. 

And for good reason. Over the last several years, there has been a wealth of research that has been conducted in China with respect to PMU and CEEs.

Cost-benefit analyses have taken place to determined the optimum breeding protocols to produce the maximum estrogen quantities based on cost and production optimization.

A US patent has been filed that solves the problems of low adsorptive capacity and high cost existed in the conventional methods, and is suitable for large-scale production. (Method for obtaining conjugated estrogen mixtures from pregnant mare’s urine and use of a macroporous resin in the method). [14]

Scientific studies on factors affecting the estrogen content in pregnant horses and the pharmacological effect of combinations of various components within the PMU (e.g. estrogens, progestogens, acids and their salts, androgens) have been carried out to determine the most effective formulations to maximize their effect on menopausal symptoms. Different and more efficient quantitative measurement (QAMS) of estrogenic components in PMU based on mass spectrometry have been developed, and so on. 

What Pfizer couldn’t be bothered to invest their money in the Chinese have.

So, in effect, Pfizer has let the Chinese do all of the work and are reaping the benefits from their technology at no cost to them apart from the purchase of their product, while maintaining their position as the leading supplier outside of China. A definite win for them. But for how long?

Will the Chinese products, as Tefeng claims, “push the Premarin products and Xinjiang biomedical resources to European and American markets”? No doubt it will. 

The biggest pharmaceutical companies in the world, known as “Big Pharma”, are American and European, but rely on global supply chains. And China and India play key roles in the supply of both ingredients and finished drugs.

And so, just as Wyeth/Pfizer cornered the market on CEEs for almost 80 years, so it seems the torch will be handed over to China. 

Do we need these drugs? The resounding answer is no.

But the exploitation will continue, now at the hands of a country with a sordid history of extreme animal abuse. That is not to say that animal abuse does not occur throughout the world — it most certainly does. NA and other democratic nations are guilty as well.

We cannot give up hope

But we cannot give up hope. There has been a movement in China over the last several years; the rise of the voice for the voiceless, the tireless, equally compassionate, advocates and activists in China who should be lauded for their efforts against an unforgiving regime. We can hope that things will change over time, but the Chinese animal protection movement faces many challenges. 

Yet, China is at a historical crossroads, and these people are charting a new roadmap for China’s future.

Hope.


Fund for Horses Logo

Purchasers of Premarin, Prempro, or Premphase in California between Jan 1995 and Jan 2003 could get money from class action settlement

Mutli image Premarin artwork for Tuesday's Horse.

SAN DIEGO, May 11, 2020 /PRNewswire/ — The following is being released in the matter of Krueger v. Wyeth, Inc. et al, by Wyeth and Wyeth Pharmaceuticals Inc. and the law firms of Rushall & McGeever, Beasley Allen, P.C., and Gary Holt & Associates, P.A. (Counsel for the Plaintiff-Class).

Counsel for the Plaintiff-Class has reached a class action Settlement in the amount of $200 million with the pharmaceutical company Wyeth and Wyeth Pharmaceuticals Inc. (“Wyeth”) regarding the prescription hormone replacement therapy medications Premarin, Prempro, and Premphase.

What is this case about? The lawsuit claims that Wyeth violated California laws by misstating the benefits and/or failing to disclose the risks of Premarin, Prempro, and Premphase purchased in California between January 1995 and January 2003.  Wyeth denies it did anything wrong. 

Who is included? An individual is included in this Settlement as a Class Member if they:

  • Lived in California between January 1995 and January 2003;
  • Bought Premarin, Prempro, and/or Premphase in California between January 1995 and January 2003; and,
  • Are not claiming any personal injury from the use of Prempro, Premarin, and/or Premphase.

What Can a Class Member Get from the Settlement? There are two options to get money from the Settlement. Read on »


Fund for Horses Logo

Premarin 2019 Year in Review

Mutli image Premarin artwork for Tuesday's Horse.

JANUARY 2019

FDA denies Pfizer Petition asking for new method of assessing Premarin generics

The FDA has denied a citizen petition from Pfizer calling on the agency to use the company’s method for assessing sameness in generics for its estrogen drug Premarin (conjugated “equine” estrogens).

Pfizer had appealed to the FDA to force sponsors of generics for Premarin to use the “Pfizer method” for assessing sameness rather than the method recommended in FDA draft guidance.

Pfizer claimed that the FDA’s December 2014 draft guidance for establishing sameness is “fundamentally flawed”. Additionally claiming that not only does it lack a critical level of sensitivity on API (Active Pharmaceutical Ingredient) steroidal composition, but also it does not account for all classes of components in the API or the non-steroidal components.

They maintained that guidance should instead use the “Pfizer Method” that the company developed at the FDA’s request and with their input, which permits a determination of sameness between a proposed generic for the company’s drug Premarin and the reference drug based upon the mixture as a whole, while allowing a comparison across all categories of components making up the API.

APRIL 2019

Bijuva launched for moderate to severe hot flashes in menopause

TherapeuticsMD announced the launch of Bijuva (estradiol and progesterone) capsules for use in women with a uterus for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause. It initially received approval from the Food and Drug Administration (FDA) in October 2018.

Bijuva is the first bio-identical hormone therapy that combines estradiol and progesterone in a single capsule. Compared with synthetic hormone products, the estradiol and progesterone found in Bijuva are structurally identical to the hormones naturally circulating in the woman’s body.

Bijvua carries a Boxed Warning regarding cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia. Breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain were the most common adverse reactions associated with Bijuva.

JUNE 2019

PMU Ranchers feel pinch as cuts announced

Pfizer Canada’s cuts to pregnant mares’ urine production will force four Manitoba ranches and one Saskatchewan ranch out of the industry.

The reduction affects three ranches in southwestern Manitoba, one in the Interlake region of Manitoba, and one in Saskatchewan. Of those five, three producers raised registered Quarter horses, one bred purebred Percherons, and one raised sport horses.

Pfizer has initiated a review of its inventory management and determined they are able to satisfy market demand by working with fewer ranchers.

The latest reduction leaves 19 producers still involved in PMU production in Manitoba and Saskatchewan, with most ranches located in southwestern Manitoba, four each in south-central Manitoba and southeastern Saskatchewan and one in the Interlake.

JULY 2019

Pfizer’s Wyeth loses bid to duck hormone-therapy lawsuit

Pfizer Inc’s Wyeth unit must face a class action alleging that the drugmaker misled California women by downplaying risks including breast cancer associated with its hormone-replacement therapy products, a federal judge has ruled.

U.S. District Judge John Houston in San Diego on Monday ruled the plaintiffs presented sufficient evidence for a jury to decide whether Wyeth’s alleged misrepresentations caused women to buy Prempro, Premarin and Premphase.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2FOpbRU »

New Book — Flash Count Diary: Menopause and the Vindication of Natural Life, by Darcy Steinke

“What orcas can teach humans about menopause and matriarchs” — A new book argues for a sea change in the way our culture views older women

Her research unearthed a long history of dubious “cures,” from transfusions of dog’s blood to vinegar sponge baths to putting a magnet in your underpants. All of which, she says, seem a little less strange once you realize that the most popular hormone replacement treatment, Premarin, is made from the urine of pregnant horses. Source: Crosscut »

AUGUST 2019

Hormone therapy during menopause raises breast cancer risk for years, study finds

New analysis adds to the evidence that many women who take hormone therapy during menopause are more likely to develop breast cancer — and remain at higher risk of cancer for more than a decade after they stop taking the drugs. 

The study, in the Lancet, looked at data from dozens of studies, including long-term data on more than 100,000 women who developed breast cancer after menopause. The longer women took the medicine, the more likely they were to develop breast cancer. Experts say the findings could shape how women and their health care providers decide how to manage symptoms of menopause.

For years, research has suggested a potential link between MHT (Menopausal Hormone Therapy) and an increased risk of breast cancer.  But there wasn’t much information on whether that risk persisted, or how it differed based on the type of MHT a woman took. So, an international group of researchers pulled together data from dozens of studies — published and unpublished — to examine the issue more closely. 

The researchers found that compared with women who never used MHT, women who did had a significantly higher risk of developing invasive breast cancer. Also, the longer women used MHT, the greater their risk of breast cancer. 

OCTOBER 2019

Premarin sales figures continue to deline

The Premarin family of hormone replacement products was the 11th best seller in 2018 at $832 million, a decline of 14.8 percent. Sales in the first six months of 2019 were $361 million, 10 percent less than in same period of 2018.

Third quarter sales of Premarin (conjugated estrogens tablets, USP) family — $182 million, down 11%.

Data as of 12.27.19


About Horses and Premarin

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 are in the dairy industry).

THE DRUGS

Premarin is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women. Premarin is also used to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body.

There are many 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.

by JANE ALLIN

Premarin® Horses 2019 Year in Review

Belgian Foal

JANUARY 2019

FDA denies Pfizer Petition asking for new method of assessing Premarin generics

The FDA has denied a citizen petition from Pfizer calling on the agency to use the company’s method for assessing sameness in generics for its estrogen drug Premarin (conjugated “equine” estrogens).

Pfizer had appealed to the FDA to force sponsors of generics for Premarin to use the “Pfizer method” for assessing sameness rather than the method recommended in FDA draft guidance.

Pfizer logo (uncredited image)
Pfizer logo (uncredited image)

Pfizer claimed that the FDA’s December 2014 draft guidance for establishing sameness is “fundamentally flawed”. Additionally claiming that not only does it lack a critical level of sensitivity on API (Active Pharmaceutical Ingredient) steroidal composition, but also it does not account for all classes of components in the API or the non-steroidal components.

They maintained that guidance should instead use the “Pfizer Method” that the company developed at the FDA’s request and with their input, which permits a determination of sameness between a proposed generic for the company’s drug Premarin and the reference drug based upon the mixture as a whole, while allowing a comparison across all categories of components making up the API.

APRIL 2019

Bijuva launched for moderate to severe hot flashes in menopause

TherapeuticsMD announced the launch of Bijuva (estradiol and progesterone) capsules for use in women with a uterus for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause. It initially received approval from the Food and Drug Administration (FDA) in October 2018.

Bijuva is the first bio-identical hormone therapy that combines estradiol and progesterone in a single capsule. Compared with synthetic hormone products, the estradiol and progesterone found in Bijuva are structurally identical to the hormones naturally circulating in the woman’s body.

Bijvua carries a Boxed Warning regarding cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia. Breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain were the most common adverse reactions associated with Bijuva.

JUNE 2019

PMU Ranchers feel pinch as cuts announced

Pfizer Canada’s cuts to pregnant mares’ urine production will force four Manitoba ranches and one Saskatchewan ranch out of the industry.

Belgian draft weanling. Unaccredited image.
Belgian draft weanling. (uncredited image)

The reduction affects three ranches in southwestern Manitoba, one in the Interlake region of Manitoba, and one in Saskatchewan. Of those five, three producers raised registered Quarter horses, one bred purebred Percherons, and one raised sport horses.

Pfizer has initiated a review of its inventory management and determined they are able to satisfy market demand by working with fewer ranchers.

The latest reduction leaves 19 producers still involved in PMU production in Manitoba and Saskatchewan, with most ranches located in southwestern Manitoba, four each in south-central Manitoba and southeastern Saskatchewan and one in the Interlake.

JULY 2019

Pfizer’s Wyeth loses bid to duck hormone-therapy lawsuit

Pfizer Inc’s Wyeth unit must face a class action alleging that the drugmaker misled California women by downplaying risks including breast cancer associated with its hormone-replacement therapy products, a federal judge has ruled.

U.S. District Judge John Houston in San Diego on Monday ruled the plaintiffs presented sufficient evidence for a jury to decide whether Wyeth’s alleged misrepresentations caused women to buy Prempro, Premarin and Premphase.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2FOpbRU »

New Book — Flash Count Diary: Menopause and the Vindication of Natural Life, by Darcy Steinke

“What orcas can teach humans about menopause and matriarchs” — A new book argues for a sea change in the way our culture views older women.

Her research unearthed a long history of dubious “cures,” from transfusions of dog’s blood to vinegar sponge baths to putting a magnet in your underpants. All of which, she says, seem a little less strange once you realize that the most popular hormone replacement treatment, Premarin, is made from the urine of pregnant horses. Source: Crosscut »

Don't sweat it. Take an alternative.
Don’t sweat it. Take an alternative.

AUGUST 2019

Hormone therapy during menopause raises breast cancer risk for years, study finds

New analysis adds to the evidence that many women who take hormone therapy during menopause are more likely to develop breast cancer — and remain at higher risk of cancer for more than a decade after they stop taking the drugs.

The study, in the Lancet, looked at data from dozens of studies, including long-term data on more than 100,000 women who developed breast cancer after menopause. The longer women took the medicine, the more likely they were to develop breast cancer. Experts say the findings could shape how women and their health care providers decide how to manage symptoms of menopause.

For years, research has suggested a potential link between MHT and an increased risk of breast cancer. But there wasn’t much information on whether that risk persisted, or how it differed based on the type of MHT a woman took. So, an international group of researchers pulled together data from dozens of studies — published and unpublished — to examine the issue more closely.

The researchers found that compared with women who never used MHT, women who did had a significantly higher risk of developing invasive breast cancer. Also, the longer women used MHT, the greater their risk of breast cancer.

OCTOBER 2019

Premarin sales figures continue to decline

The Premarin family of hormone replacement products was the 11th best seller in 2018 at $832 million, a decline of 14.8 percent. Sales in the first six months of 2019 were $361 million, 10 percent less than in same period of 2018.

Third quarter sales of Premarin (conjugated estrogens tablets, USP) family — $182 million, down 11%.

Data as of 12.31.19


LEARN MORE

About Premarin 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. Most, however, who can not be ‘repurposed’ in some way are sent to slaughter — seen as a byproduct of the industry much like male calves are in the dairy industry.

Alternatives to PMU Drugs

There are many alternatives to drugs made from the urine of pregnant mares.

Visit The Fund for Horses website for alternatives to Premarin type drugs.
Visit the Fund for Horses website for alternatives to Premarin type drugs.

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.

See also our Alternatives to Drugs Made with Pregnant Mare’s Urine page. Please share this with the women and horse lovers in your life.

Thank you.