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

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.

Update! Alternative to Drugs Made with Pregnant Mare’s Urine

Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell

INTRODUCTION

We are thrilled to release to you here Jane Allin’s update to our popular Alternative to Drugs Made with Pregnant Mare’s Urine. Premarin® started it all in this 50s, and tragically is still being prescribed. But there are alternatives. Many alternatives — more than ever before.

Jane Allin walks you through many of them. However, this is not an exhaustive list.


Alternatives to drugs made with pregnant mare’s urine

Updated on March, 2018 Jane Allin

BY JANE ALLIN

As part of The Horse Fund’s continuing campaign against the manufacture and use of the Premarin® family of drugs – Premarin®, Prempro® and Duavee® – we have compiled a list of alternatives to drugs made with pregnant mare’s urine (conjugated equine estrogens).

We encourage you to go online to further acquaint yourself with the effectiveness and safety of these compounds. There is a wealth of information out there, but beware of false claims and err on the side of caution.

And, as always, please consult with your doctor before you use these or any other alternatives for the relief of menopausal symptoms.

LIFESTYLE CHANGES

Probably the simplest and most natural approach to the treatment of menopause is to adopt a healthy lifestyle in regard to diet, exercise and stress management. Not only will this help alleviate symptoms but the benefits will ensure that you remain healthy now and in the future.

Nutrition: It should go without saying, avoid refined and processed foods, choose more whole foods, fresh fruit, vegetables and complex carbohydrates. Avoid high fat dairy products and meats and supplement these items with healthy fats such as olive oil, nuts, seeds and lean cuts of meat or fish. Additionally, practice portion control and avoid empty calorie foods.

Exercise: Exercise is vital to keeping symptoms in check. Exercise directly affects hormonal activities in the body by raising the level of endorphins, for example, to maintain emotional stability and suppress anxiety. Moreover, the benefits are unsurpassed: maintenance of muscle and joint strength, increased metabolism, reduced weight, improved cardiovascular health, increased cognitive function, maintenance of bone integrity, and the list goes on.

Stress Management: It is a well-known fact that stress induces more severe hot flashes. There are many stress-reduction techniques available to manage the burden of everyday anxiety – rest, relaxation, varied leisure activities, and most importantly self-affirming thoughts to maintain self-image and confidence.

Lifestyle Solutions: Common sense solutions that include dressing in layers, lowering room temperatures, consuming cool drinks, and cutting down on alcohol, caffeine and spicy foods. For those women who are overweight, weight loss can also help.

Give Up Smoking: If you smoke, giving up will help reduce hot flushes and your risk of developing serious health conditions, such as heart disease, stroke and cancer.

NON-HORMONAL THERAPIES FOR SYMPTOMS OF MENOPAUSE

Many women find the risks associated with hormone therapy to be unacceptable and are requesting non-hormonal therapies to manage their hot flash symptoms. There have been numerous reports in the medical literature and general media as to the effectiveness of various over-the-counter agents and prescription drugs in reducing menopausal hot flash symptoms.

A potential confounder in most hot flash trials is the placebo response rate, which in many studies has been reported as between 18 and 40 percent. This is similar to rates found in studies of hormonal agents, but makes it more difficult to ascertain the true effects of therapy on hot flashes.

NON-PRESCRIPTION (NON-HORMONAL) THERAPIES

The exact mechanism of action for many of the non-prescription alternatives is unknown, however several theories have suggested they act as antagonists on estrogen receptors, or alternatively as selective estrogen receptor modifiers (SERMs). Others are thought to relieve stress and anxiety to help with menopausal mood swings, or have mild anti-inflammatory action.

Dietary Phytoestrogens

Phytoestrogens are naturally occurring substances found in fruits, vegetables, and whole grains such as soybeans, alfalfa sprouts, and oilseeds (such as flaxseed).

Epidemiological data suggest that women ingesting high amounts of phytoestrogens and plant-derived diphenolic compounds, which are functionally similar to estradiol (i.e. allow estrogen receptor binding), have less CAD (coronary artery disease) and breast and uterine cancer and fewer vasomotor symptoms compared with those who consume Western diets.

There is some evidence that they have a weak estrogen-like effect that may reduce the intensity and frequency of hot flashes, however much less potent than that of estrogen. Phytoestrogens consist of three main groups: isoflavones, lignans, and coumestans.

Isoflavones (Soy)

Isoflavones, the soy protein-based group, are most potent of the phytoestrogens and have received the most attention. In several randomized controlled trials using soy and placebo, less than half of these trials (45%) showed a significant improvement in symptoms compared to placebo. Where positive effects were shown, the soy reduced hot flashes by 9 to 40 percent in some trials, but others showed no difference compared with placebo.

Breast density does not appear to be affected by soy preparations after 2 years however, women with breast cancer or with a family history of breast cancer should use concentrated isoflavones with caution. Moreover, long term treatment with soy has shown a small risk of endometrial hyperplasia (growth of abnormal cells/precancerous neoplasms) that can lead to endometrial cancer in a small percentage of women.

Genistein, an isoflavone found in low concentrations in soybeans and elevated amounts in certain soy-derived food has attracted scientific interest for its possible benefits in cancer and heart disease prevention as well as reducing menopausal symptoms.

Data suggest that genistein might have a potential preventative role in reducing coronary artery disease. Acting as a natural selective estrogen receptor (ER) modulator, it may also positively affect the cardiovascular system without the harmful estrogenic side effects in breast and uterine tissue. Genistein is available as non-prescription OTC supplements from a variety of manufacturers.

Lignans (Flaxseed)

An example of the lignand group of phytoestrogens is flaxseed. Flaxseed also contains omega-3 and omega-6 fatty acids. Some clinical studies suggest that replacing dietary fats with flaxseed might be effective for patients with milder symptoms. Others say flaxseed does not significantly affect menopause-specific quality of life or hot flash symptoms.

Coumestins (Red Clover)

Red clover belongs to the coumestin group. Several placebo-controlled studies that evaluated the effectiveness of red clover in reducing hot flashes showed a modest reduction in frequency in women administered various amounts of red clover compared to those receiving placebo. There were no adverse effects or safety concerns with short term administration although long-term randomized studies are lacking.

Black Cohosh

Black Cohosh is probably the most studied and most popular herb for treatment of hot flashes. Black cohosh seems to work by supporting and maintaining hormonal levels, which may lessen the severity of hot flashes. Many women report that the herb works well but it isn’t effective for everyone. It has been reported to be well-tolerated with no serious side effects linked to its use, however, its actual efficacy in clinical studies has been inconsistent.

St. John’s Wort

St. John’s wort has been used as a medicinal herb for its antidepressant and anti-inflammatory properties for over 2,000 years. Many studies show that St. John’s wort may help fight mild to moderate depression and anxiety and has fewer side effects than most other prescription antidepressants, such as loss of sex drive.

Because of its positive effects on mood, St. John’s wort has been used to alleviate and naturally remedy PMS symptoms, such as depression, chronic fatigue and hormonal imbalance. Researchers reported that daily treatment with St. John’s wort was more effective than placebo treatment for the most common physical and behavioral symptoms associated with PMS.

Ginko Biloba

Ginko Biloba is typically associated with decreasing the risk of dementia onset, however limited trials have shown no significant difference compared with placebo.

Kava – WARNING

Some studies claim that kava may be an effective option for treating anxiety, stress, and restlessness, for menopausal mood swings as well as sleeping problems but the data is conflicting. There are, however, safety concerns which should preclude its use.

Kava is possibly unsafe when taken orally. Serious illness, including liver damage, has occurred even with short-term use of normal doses. The use of kava for as little as one to three months has resulted in the need for liver transplants, and even death. This was included to warn the reader of the dangers associated with this particular natural alternative.

Dong Quai

Dong quai finds its roots in traditional Chinese medicine. It is thought to reduce hot flashes. Increasing research shows that there may be scientific connections between dong quai’s uses and its claims, but in limited trials there is nothing to attest to its effectiveness to support its use for vasomotor symptoms. Moreover, because it contains coumarins, interactions with warfarin and photosensitization have been reported.

Evening Primrose Oil

EPO contains high levels of gamma-linolenic acid (GLA) and linolenic acid, which are both omega-6 fatty acids, known to reduce inflammation. It is believed to help influence prostaglandin synthesis and help moderate menopausal symptoms. However, it is important to take the correct dosage – if too high, there may be adverse side effects (e.g. abdominal pain, headaches, upset stomach, and nausea).

Ginseng

Ginseng’s primary menopausal benefit is its ability to support vitality and ease stress. Sleep is often interrupted as a result of menopause, especially due to hot flashes. Ginseng may come to the rescue on this front, possibly supporting healthy sleep cycles by aiding relaxation.

Vitamin E

A daily dose of 400 IUs of natural vitamin E (as mixed tocopherols and tocotrienols) can help alleviate symptoms of hot flashes in some menopausal women.

Melatonin

As a woman approaches menopause the levels of estrogen sharply decrease. Melatonin serum levels also decrease. Vasomotor symptoms (i.e. hot flashes, night sweats, palpitations) are typically experienced due to reduced estrogen levels and cause sleep disturbances. It has been found that melatonin and some of its analogs promote sleep. However, there is inconsistency and discrepancy among the large number of reports regarding the degree of efficacy and the clinical significance of these effects.

Amberen

In 2010 a non-hormonal supplement called Amberen, manufactured by Lunada Biomedical, was touted as the next cure-all for relief of menopausal symptoms. Claiming to have a double-blind, placebo-controlled clinical study to back its effectiveness, it contains 100% natural ingredients, all on the FDA’s approved Generally Recognized As Safe (GRAS) list. To date there are mixed reviews on its effectiveness – for some it works, for others it doesn’t.

Using OTC products or eating natural foods that contain these compounds (e.g. phytoestrogens, Vitamin E) are thought to be relatively safe for the most part, but be aware that no substantiated medical studies are available for many of these therapies and most do not have to comply with the stringent safety, quality and manufacturing regulations that govern conventional medicines.

Acupuncture

Several clinical studies have shown that acupuncture can reduce symptoms of menopause. The premise is that serotonin levels rise which can alter the temperature set point in the hypothalamus.

One such trial compared the effectiveness of; (1) shallow acupuncture; (2) electro-acupuncture and; (3) oral estrogen. A significant reduction in hot flushes was found for all three groups of participants although the degree of symptom reduction was largest in the estrogen cohort.

As a word of caution, in some individuals adverse effects can occur with acupuncture. For example; cardiac tamponade (fluid buildup in the pericardium that compresses the heart); pneumothorax (collapsed lung) and; hepatitis.

Reflexology

Reflexology is the application of pressure to areas on the feet, hands and ears. Reflexology is generally relaxing and may be an effective way to alleviate stress.

The theory behind reflexology is that these areas correspond to organs and systems of the body. Proponents believe that pressure applied to these areas affects the organs and benefits the person’s health.

A small randomized study of women aged 45-60 experiencing vasomotor symptoms who were administered either reflexology or non-specific foot massage showed there was a reduction in both groups but no significance between the two groups.

PRESCRIPTION (NON-HORMONAL) THERAPIES

There is also convincing evidence that some prescription drugs which are not licensed for treating menopausal symptoms do in fact alleviate hot flashes and night sweats. These are powerful drugs yet in severe cases some doctors may be willing to prescribe one of these treatments with the patient’s consent.

SSRIs and SNRIs

SSRIs (selective serotonin reuptakes inhibitors) are a group of anti-depressants and anti-obsessive-compulsives. Although their exact mechanism is unknown, SSRIs are believed to ease depression by increasing levels of serotonin in the brain.

Serotonin is one of the chemical messengers (neurotransmitters) that carry signals between brain cells. SSRIs block the reabsorption (reuptake) of serotonin in the brain, making more serotonin available. SSRIs are called selective because they seem to primarily affect serotonin, not other neurotransmitters.

In a similar fashion to SSRIs, SNRIs (serotonin and noepinephrine reuptake inhibitors) block the reabsorption (reuptake) of the neurotransmitters serotonin and norepinephrine in the brain.

SSRIs such as Prozac (fluoxetine) and Paxil (paroxetine) and SNRIs such as Effexor (venlafaxine), Pristiq (desvenlafaxine) and Desryl (trazodone) have shown a risk reduction in hot flashes of 19 to 60 percent compared to placebo depending on the type of SSRI or SNRI, its potency and dosage. Additionally, significant improvements were seen in general, emotional and mental fatigue as well as the occurrence of clinical depression (as expected). The most common side effects include; headache, nausea, insomnia, dry-mouth, dizziness and decreased appetite.

Of note is that Paroxetine/Paxil is sold under the trade name of Brisdelle for the treatment of menopausal hot flashes – the first non-hormonal treatment to be approved by the FDA for hot flashes associated with menopause. The dosage and duration of these medications most appropriate in alleviating hot flashes is unknown; however, regimens using low to moderate dosages seem to be as effective as those using high dosages and have significantly fewer reported adverse effects.

When using an SSRI or SNRI to treat hot flashes and mood, it is prudent to start the medication at a low dosage and increase to effect. Other SSRIs that have undergone clinical testing include; Citalopram (Celexa) and Sertraline (Zoloft).

Gabapentin

Gabapentin is a drug used to control epileptic seizures, shingles and restless leg syndrome that in some studies has shown to be as effective as estrogen in treating symptoms of menopause.

In one trial that compared gabapentin and estrogen head-to-head against a placebo, the women taking gabapentin and estrogen experienced a 71 percent to 72 percent decline in symptoms versus the placebo effect of 54% reduction in hot flashes. The most common side effects of gabapentin are drowsiness, dizziness, and a “spacey” feeling. These effects tend to subside after a month of treatment.

Clonadine (Catapres)

Clonadine acts in the brain to decrease blood pressure. It has a long history of being used for blood pressure control, but it has potentially annoying side effects, such as dry mouth, constipation, drowsiness, or difficulty sleeping. Clonidine, available in pill or patch form, effectively relieves hot flashes in some women but is completely ineffective in others.

Osphena

Touted as the new female Viagra, Osphena was FDA approved in 2013 for the treatment of painful sex due to vaginal atrophy associated with menopause. Osphena is a SERM (selective estrogen receptor modulator) that acts as an estrogen agonist/antagonist – the same class of drugs as bazedoxifene. Osphena carries with it risky side effects; stimulation of the lining of the uterus that can lead to uterine cancer, increased risk of blood clots, hot flashes and drug interactions.

BUYER BEWARE!

Bio-identical Hormones

The term Bioidentical Hormone Replacement Therapy (BHRT) or “natural hormone therapy” is poorly defined and without a precise medical definition.

Bio-identical hormones are synthesized in the lab from plant sources and as the term implies are pharmaceuticals that closely mimic natural hormones produced in the body since they possess the same molecular structure as endogenous hormones.

There are two classifications of bioidentical hormones; (1) FDA-approved and; (2) compounded in pharmacies based on hormone levels measured in saliva and blood tests (not FDA approved).

The terminology is confusing and the FDA considers “BHRT” to be a marketing term. The lack of distinction between FDA-approved bioidentical hormones (often referred to as synthetics) and compounded bioidentical hormones has resulted in considerable misunderstanding regarding exactly what BHRT is.

The vast majority of advocates of BHRT are referring to the compounded versions where hormones are custom-mixed by a pharmacist – unapproved drugs.

In addition to estrogen and progesterone, these compounded drugs may contain other hormones such as testosterone, DHEA and adrenal hormones extracted from animal glands.  See http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

Often promoted as being safer than conventional HRT derived from pregnant mare’s urine, are these claims of a safer alternative justified?

This includes both FDA-approved and compounded hormones. A Harvard Women’s Health Watch article illustrates that there is much evidence to suggest they are not. Other medical articles call attention to the same warnings. See http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

In contrast to mainstream thought, compounded BHRT hormones are drugs – just not approved.

As much as it may seem that these hormones are safer than the Premarin® family of drugs, there is no solid evidence to prove this.

Some of these drugs have been approved by the FDA because data collected from trials has proven their effectiveness in relieving menopausal symptoms and reducing the risk of osteoporosis. However there have been no long-term studies like the WHI performed to assess their safety profile.

FDA-approved bioidenticals come with black box warnings analogous to those for conventional HRT. Because compounding pharmacies are not required to detail the risks of their bioidenticals (i.e. they are not approved) they may therefore create the illusion of being safer than commercially marketed drugs.

Overall, FDA-approved and compounded bioidenticals contain the same hormones. The difference between the two is the accuracy of preparation. Where FDA-approved versions are measured precisely under rigid control, compounded bioidenticals lack these specifications. Random testing has shown that the indicated potency of compounded hormones varies substantially.

Blood and saliva tests to measure a woman’s hormones is only a snapshot in time and are not reflective of serum (blood) hormone levels which can fluctuate from hour to hour. In menopausal women hormones levels are particularly unstable without a “normal” concentration. Accordingly dosage may be inappropriate for treating symptoms. Don’t waste your money.

There have been cases of endometrial (uterine) cancer noted among some users of bioidenticals. This underscores the risks associated with using unregulated medications.

Many health insurance companies don’t cover the cost of these compounded hormone therapies.

Although many women believe that these compounded bioidentical therapies are more natural and safer, since they are not FDA approved, they are not tracked or monitored the same way. Some types of bioidenticals have been falsely advertised to prevent breast cancer and heart disease, achieve weight loss and slow the aging process without any studies to back these claims.

There are tens of millions of compounded hormone therapy prescriptions a year filled at community and compounding pharmacies for at least 2 billion dollars – definitely a money-making business.

One might ask how these unregulated products can be sold. In 2001, the US Supreme Court ruled that pharmacies could indeed market compounded products that were unregulated by the FDA. Why? Your guess is as good as mine.

FDA-Approved Hormone Therapy

Contrary to popular belief, the FDA has yet to approve any “true” generic as a substitute for Premarin® and its daughter products (i.e. Prempro®, Premphase®). In other words no prescription drugs used to treat menopausal symptoms, other than the Premarin® family, contain pregnant mare’s urine (this does not include China or other locations outside of the FDA’s jurisdiction).

Currently the vast majority of FDA-approved HRT prescription drugs are synthetic bioidenticals often referred to as “Synthetics” (i.e. hormones identical on a molecular level to endogenous hormones that are synthesized in the lab from natural plant sources) – these are not the versions produced at a compounding pharmacy which are not FDA approved.

What’s important however is that these drugs carry with them the same risks and warnings associated with drugs derived from conjugate estrogen estrogens, whether that be estrogen alone or combined with progestin.

In pre- and postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs.

Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.

There are basically four categories of FDA- approved synthetic bioidentical HRT products on the market that do not contain CEEs as shown in the table below, along with their common brand names. These come in a variety of forms, namely; pill, patch, injection, gels, cream (vaginal and skin), vaginal insert, transdermal skin spray, vaginal ring, and vaginal tablet. Some examples that fall into each of these categories are listed. Check with your doctor to determine what product would be more appropriate given your current health and risk factors.

PRODUCT BRAND NAME
Estradiol/Norethindrone
(Estrogen/Progestin Combinations)
Activella, Angeliq, Climara Pro, Combipatch, Femhrt, Jevantique, Prefest
Synthetic Conjugated Estrogen, Estradiol, Esterified Estrogens Alora, Climara, Delestrogen, Dinigel, Divigel, DotCenestin, Elestrin, Enjuvia, Esclim, Estrace, Estraderm, Estrasorb, Estring, Estrogel, Evamist, Femring, Femtrace, , Menest, Menostar, Minivelle, Ogen, Ortho-Est, Vagifem, Vivelle, Vivelle-Dot
Esterified Estrogens/Methyltestosterone
(Estrogen/Androgen Combinations)
Covaryx, Essian, Estratest, Menogen, Syntest D.S., Syntest H.S.
Progestin-Only Medicines Prometrium, Provera

Types of FDA-approved Estrogen Therapy – Pros and Cons

If you elect to take any of the FDA-approved hormone replacement therapies (HRT) the optimum form will depend on your health, your symptoms, personal preference, and what you need to get out of treatment. Below is an overview of the common types available.

Pills

Examples: Estrace, Cenestin, Enjuvia, Femtrace

Pros: Ease of administration, best-studied

Cons: Risks have been well-publicized; increased risk of stroke, blood clot. When in combination with progestin; breast cancer, heart attack. Also cause uncomfortable side effects; painful swollen breasts, vaginal discharge, headache and nausea. Oral estrogens are hard on the liver so people with liver problems should seek alternate forms that do not pass through the liver.

Skin Patches

Examples: Alora, Climara, Estraderrm, Vivelle

Pros: Convenient. Unlike oral forms, estrogen by-passes the liver and goes directly into the bloodstream so they are safer for individuals with liver problems. One study showed that the path doesn’t pose risk of blood clots like oral estrogen however more studies are needed to confirm this. At the moment all estrogen therapies carry the same black-box warning with respect to clot formation.

Cons: Some believe patches are safer than pills however it is too early to know. Therefore, for the time being, assume that they carry the same risks are oral medications. Heat can cause the patch to release the estrogen too quickly so it is important not to expose them to high heat or direct sunlight (e.g. tanning beds, saunas). Similar, yet perhaps milder, side effects as oral dosages.

Topical creams, gels and sprays

Examples: Divigel (gel), Evavist (spray), Estrace and Estrasorb (vaginal and transdermal creams respectively)

Pros: As with skin patches, safer for people with liver problems as they are directly absorbed through the skin into the bloodstream.

Cons: Not well-studied so assume they poses the same risks as other forms (e.g. cancer and stroke). Gels, sprays and creams can rub off before it’s been fully absorbed so it is necessary to allow them to dry prior to getting dressed. Since these forms are absorbed through the skin directly into the bloodstream, it’s important to prevent people from touching any of these as they will inadvertently get a dose of estrogen as well.

Vaginal suppositories, rings, creams and tablets specific to vaginal dryness

Examples: Vagifem (tablet), Estrzce (cream), Estring and Femring (insertable rings)

Pros: Convenient in some cases. These are designed specifically for women who suffer from vaginal dryness, itchiness and burning or pain during intercourse and are more effective than other forms of estrogen for these symptoms. Most are low dose and only affect the immediate are meaning that they can reduce symptoms without exposing the entire body to the effects of estrogen therapy.

Cons: Although these low dose rings and suppositories help with vaginal symptoms, they don’t help with things like hot flashes and mood swings. At higher doses they might help however, may expose you to the same risks as other types.

WORK WITH YOUR DOCTOR

As always, it is important to work with your physician to make an educated decision on what type of HRT would best suit your needs while limiting your risks. Currently, the full risks of HRT are uncertain. For this reason, experts typically recommend the lowest dosage possible for the shortest time possible.

WHAT ABOUT ALL THOSE PREMARIN® CREAM ADS?

As you may have noticed, the Horse Fund has an on-going campaign to help put a stop to Premarin® ads by reporting them to the Horse Fund and by encouraging you to share this personally and publicly, far and wide https://tuesdayshorse.wordpress.com/2017/05/30/report-premarin-ads-on-behalf-of-women-and-horses/ .

Putting a stop to Premarin® ads is one way we can act on behalf of women and horses.

There are more reasons not to use Premarin®, than to use it. And yes, there are many alternatives for vaginal issues related to menopause that do not contain CEEs (conjugated equine estrogens).

Apart from the oral non-hormonal and hormonal alternatives, both the FDA-approved vaginal creams, inserts, rings, suppository and tablets (previously discussed) as well as non-prescription over-the-counter (OTC) products will help to relieve vaginal symptoms of menopause.

Products designed specifically for vaginal dryness and irritation are low dose and only affect the immediate area meaning that they can reduce symptoms without exposing the entire body to the effects of estrogen therapy, unlike oral types, skin patches and sprays for example.

Because these products prevent large amounts of estrogen from passing through the rest of the body, as a rule they are considered safer than other forms of HRT and just as importantly do not contain CEEs like Premarin® cream does.

FDA-approved estrogen products for vaginal dryness

As discussed, there are several FDA-approved vaginal products that will relieve the symptoms associated with dryness, irritation and painful intercourse. All of these are plant-derived estrogens and/or hormones. A list of some of the prescription alternatives to Premarin® cream in their various forms is shown below.

FORM TRADE NAMES / ACTIVE INGREDIENT(S)
Cream Ovestrin (estriol), Estrace (estradiol), Ogen (estropipate), Neo-estrone (estradiol), Estragyn (estrone)
Gel Divigel (estradiol), Elestrin (estradiol), Estrogel (estradiol)
Ring Estring (estradiol), Femring (estradiol acetate)
Tablet Vagifem (insertable tablet containing estradiol)
Suppository Intrarosa (DHEA – dihydroepiandrosterone)

Please consult your doctor for more information on these FDA-approved prescription alternatives to Premarin® vaginal cream.

Non-prescription products for vaginal dryness

There are plentiful other non-prescription products available that women with vaginal dryness may find soothing.

Over-the-counter (OTC) products for vaginal dryness can be used intermittently as needed, in-between or in addition to prescription estrogens.

There is a wide selection of both hormonal and non-hormonal products on the market today to treat vaginal dryness, irritation and painful intercourse.

Over-the-counter estrogen and progesterone creams typically contain bio-identical, or plant- or herbal-based hormones. As with prescription creams, they are intended to relieve common vaginal symptoms of menopause.

The American College of Obstetricians and Gynecologists cautions that there has been insufficient research on the effectiveness and safety of these over-the-counter products, and they are not regulated by the FDA.

There are numerous variants of these OTC commercial offerings available. Please discuss using OTC hormone products with your medical provider prior to use.

As with the OTC hormonal creams there is an extensive selection of natural lubricants available on the market. These are water- or oil-based moisturizers or lubricants that may contain chemicals in some cases. Be sure to read the ingredient labels prior to use.

A few examples of the different kinds of OTC (over the counter) alternatives follow.

PRODUCT WEBSITE
Replens http://www.replens.com/
Julva https://store.cabecahealth.com/products/julva-dr-annas-cream-for-delicate-feminine-parts?variant=29958880899
Vagisil http://vagisil.com/
K-Y Liquibeads https://www.k-y.com/product/k-y-liquibeads-vaginal-moisturizer-6-ea-067981160468
Progesto-Life http://femininehealthreviews.com/smoky-mountain-naturals-progesto-life-full-review-does-it-work/
Estro-Life https://smokymountainnaturals.com/products/paraben-free-estro-life-cream
Sylk https://sylkusa.com/?v=7516fd43adaa
NewEve Silk https://www.neueve.com/silk
Nutrablast http://boricplan.com/nutrablast-boric-life-full-review-does-it-work/
VMagic https://vmagicnow.com/products/vmagic-intimate-skin-cream?variant=16308526343
FabuVag https://www.naturalvaginalsolutions.com/

These are just a handful of examples of probably hundreds out there on the market.

A simple search for vaginal dryness on Amazon.com will give you an idea of just how many and what kinds of OTC products are available.

See https://www.amazon.com/s/ref=nb_sb_noss?url=search-alias%3Daps&field-keywords=vaginal+dryness&rh=i%3Aaps%2Ck%3Avaginal+dryness

Please browse the websites to learn more about these products and consult your doctor to determine whether any would be beneficial in treating your symptoms.

CONSULT YOUR DOCTOR

No matter what, it is important to separate fact from fiction and be astutely aware of the consequences of clinically unproven medications. Apart from the unmistakable benefits of lifestyle changes, before considering any of the alternatives listed please consult your doctor.

What About the Horses Used?

What about the horses used to make pregnant mare’s urine based drugs? It is a life full of abuse tossed or aside or killed when they are of no longer of use.

Why do pharmaceutical giant Pfizer persist with the Premarin line of drugs?  Introduced in the 50s, these drugs are still making millions and millions of dollars.

We are working to stop the heinous abuse of these poor pregnant mares and their vulnerable offspring. To learn more see our Premstoppers campaign on our website.

©The Horse Fund