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

Turn your back on Premarin type drugs and seek alternatives for symptoms of menopause

October is Breast Cancer Awareness Month and as it draws to a close we urge women to please turn your backs on Premarin type drugs — tablets and cream — and seek another treatment for menopausal symptoms.

There are alternatives.

Work with your doctor to find something to help you other than drugs made from pregnant mare’s urine — for your sake as well as the innocent mares and their byproduct foals.

Crazily I have had doctors argue with me that the Premarin family of drugs are not made with conjugated equine estrogens derived from the urine of pregnant mare. The absence of the word “equine” on the packaging is proof enough for them.

Of course “equine” was removed some years ago. Yes, we heard about it and we know how and why. I assure them that the key component of the drugs taken from the estrogen rich urine of pregnant mares remains the same. End of discussion.

I share this with you in case you encounter this argument yourself whether it be with a physician trying to prescribe it to you or when trying to warn someone who is taking it.

THE ALTERNATIVES

Jane Allin put together a list of alternatives to drugs such as Premarin, Prempro, Duavee and Duavive (See also pdf version at the end of this post).

Duavee by the way is the name given to Aprela when it was approved by the FDA during the last federal government shutdown and is being peddled in Europe under the name Duavive.

We asked Jane to review her report on alternatives and give us any updates. This is what led to Jane’s recent post on Tuesday’s Horse regarding the helpful properties of rhubarb. See Breast cancer, menopause and yes, rhubarb.

This in turn launched me on a vegan rhubarb recipe hunt which you can find here. See No need to sweat menopause when you can chill with some rhubarb.

Other than that there are no notable changes.

Please keep reporting those Premarin television and magazine ads!

Thank you.

PDF
Alternatives to Drugs Made with Conjugated Equine Estrogens by Jane Allin (pdf, 7 pp)

FURTHER READING
Premstoppers Home »
Reports Regarding Premarin Horses »
Images of PMU Horses; Images from PMU Farm in China »

Pushing Premarin: Big Pharma, Big Bucks — Part 3

by JANE ALLIN

Advertising: Exploiting the public for power and profit

Despite the controversy of PMU-derived HRT, these drugs bring in profits of over a billion dollars annually to Pfizer and it seems physicians who prescribe such drugs are indifferent to the risks associated with the radical hormone imbalances induced by these equine hormones. Their central mantra being “as long as it works”.

This returns us to the slick marketing tactics employed by Big Pharma and the disturbing nature of those strategies.

Direct-to-consumer (DTC) advertisements for prescription drugs on television and in print are intended to evoke the perception that these drugs are the panacea to your medical woes. This in turn generates consumer demand through illusion – side effects are typically deemphasized while benefits are central to getting the customer hooked.

http://www.globalresearch.ca/pill-nation-are-americans-over-medicated/5367349
http://www.globalresearch.ca/pill-nation-are-americans-over-medicated/5367349

DTC pharmaceutical advertising and marketing is currently only legal in the US and New Zealand and is a practice that borders on unethical behavior by placing a higher value on profits than the health of their customers.

Most countries banned the practice of DTC advertising in the 1940’s. In fact in 2007 the WHO made a unanimous recommendation to entirely prohibit DTC advertising. [1]

Needless to say, in the US it is a lucrative proposition for Big Pharma where the return on investment is staggering.

And what could be better for Pfizer given that over 90% of their sales of Premarin and sister drugs occur in the US?

Table 1: Premarin Sales
https://tuesdayshorse.wordpress.com/2014/03/18/premarin-horses-how-many-does-it-take-to-make-a-billion-dollars-part-1/

How perfectly opportune for the largest pharmaceutical company in the world – a ticket to print money with their sleazy marketing tactics and false reassurance under the guise of safety. Although there are proponents of DTC advertising at the center of the controversy is the simple fact that DTC marketing schemes do not promote public health. Instead, they increase the cost of drugs, misinform patients, increase the number of unnecessary prescriptions as well as promote drugs for which long-term safety profiles are unknown.

There is a central rationale why certain medications are classified as prescription drugs – they may have the power to remedy symptoms and prevent illness but at the same time they carry with them risks and can cause undue harm and even death. This is the very reason why it is a physician’s decision to prescribe a particular drug based on the presumed illness, not the patient.

Unfortunately many health care professionals feel pressured by these ads to prescribe drugs that often may not be in the best interest of the patient – less effective, higher cost, and inherently more dangerous. Never underestimate the power of advertising and a populous predisposed to these misleading ads that employ emotive imagery and fail to disclose dangerous side-effects and contraindications.

This can lead to strained patient-doctor relationships when patients insist on being prescribed a drug based on such deceptive advertisements and many doctors simply cave to the patient’s requests despite reservations regarding the drug and illness in question.

    Advertising to consumers puts physicians under a new kind of pressure. If they want to keep you as a patient, and if giving a prescription for a drug that you asked for keeps you happy, they might do it. Evidence backs this idea: advertising has raised the prescription rate of direct-to-consumer advertised drugs by over 30%. The prescriptions that patients ask for may be unnecessary (though harmless) and expensive, but the physician yields a bit of power to keep the patient happy.” [2]

What’s worse perhaps are the brainwashed physicians and autocratic Big Pharma who unfailingly rationalize the inherent risks of conjugated equine estrogens.

    Every treatment has its risks, they point out, but the risk of a postmenopausal woman dying of a heart attack or stroke if she doesn’t take Premarin are far greater than her risk of dying from cancer or an osteoporosis-related fracture if she does.” [3]

Nothing more than the same propaganda that DTC advertising delivers.

Moreover pharmaceutical companies strive to “medicalize and stigmatize” normal life by developing prescription solutions for natural body functions such as menopause and PMS for example. These are not diseases yet they have created drugs to treat these conditions and broaden their audience by DTC prescription drug ads while boosting profits at the same time. Ultimately this leads to unnecessary and over-medication while overlooking behavior modification and lifestyle changes to treat the condition.

analystdaypresentation11040

These are precisely the issues with all of the recent profusion of Premarin and Duavee ads.

Pfizer has the benefit of a captive US market, when it comes to DTC advertising, where the vast majority of these drugs are sold and marketed. And despite a disappointing performance the first quarter of this fiscal year, Pfizer is pinning its hope on some new drugs, including Duavee, to add to the incremental revenues toward the end of the year.

The good news is that many market analysts are predicting that Duavee may sizzle out before hitting any mega-status as far as profit margins go.

Contrary to recent analyst commentary regarding “significant revenue contribution in the near term” from sales of Duavee® and Captisol-enabled® (CE) Melphalan, Duavee® sales have been and will continue to be immaterial for the foreseeable future, while an NDA has not even been filed for CE Melphalan. [4]

First, its safety profile is questionable despite the fact that Pfizer is promoting it as a hormone therapy with fewer side-effects. Nonetheless the boxed warnings are identical to Premarin et al suggesting that even Pfizer is skeptical.

Secondly there was a non-hormonal alternative that received FDA approval this year – Brisdelle, a low dose version of Paroxitene with far fewer side-effects such as cancer and other dire health risks.

Duavee Booth at ICE/ENDO in Chicago 2014.  Image: Ligand's Twitter feed.
Duavee Booth at ICE/ENDO in Chicago 2014. Image: Ligand’s Twitter feed.

Moreover Duavee is in competition with its parent drug Premarin as well as Eli Lilly’s Evista for prevention of postmenopausal osteoporosis which is also at blockbuster status and carries with it no stigma of conventional equine derived estrogen therapies.

In the end, despite all the negativity surrounding the combination drug Duavee, a drug containing a known carcinogen and a selective estrogen receptor modulator (SERM) not yet approved by the FDA, Pfizer persevered and launched it amidst much speculation – presumably out of desperation given that Duavee is patent protected and will generate profits due to the ability to retain the high price mark-ups compared to generic products.

Even Pfizer contractors and others who work in the pharmaceutical industry don’t have anything positive to say about Duavee.

A few interesting comments at CafePharma online boards convey the general consensus. [5]

    • Another me-too product late in class for an age-old problem with many generic alternatives of similar efficacy. This is the problem with Pfizer these days – no novel innovation.

    • Duavee sounds like a guy at the local bar. As in Duavee Crockett.

    • Instead of a SERM, plus estrogen how about promoting sperm, plus estrogen?

    • Everyone will sell DuaDog….it’s the future of the company!!!

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

    • Duavee may cause Prolapsed uterus. But what the heck do you need a post-menopausal uterus for anyways?

    • Leave PETA out of this….the beagle didn’t drop a uterus…but you will…good luck…this drug is bogus, bogus, bogus.

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

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

    • DUAVEE: Dropped Uterus And Vaginal Equine Estrogen.

In the end, if Duavee isn’t a success the old Premarin family of drugs regardless of patent loss, continue to generate over a billion USD annually. Recall that there is no bona fide generic Premarin made from horse pee and doctors still believe it is the universal remedy to a menopausal woman’s health.

And don’t forget about the unexploited market in Asia and other parts of the world, millions and millions of women to hoodwink. There is an abundant presence of future growth opportunities in the Asia Pacific region (especially China) in terms of untapped markets and growing customer awareness levels.

Pfizer will be laughing all the way to the bank.

And as usual the FDA is in bed with Big Pharma when it comes to DTC advertising. No surprise there. In 1997, the FDA relaxed its rules for pharmaceutical companies so that rather than providing a full disclosure, companies only needed to meet an “adequate standard” when it came to describing risks to consumers.” [6]

In response to this amendment pharmaceutical companies began meting out millions of dollars into DTC advertising. Today Big Pharma spends billions each year in an attempt to persuade the consumer to adopt prescription drugs and keep taking them regardless of whether they are necessary, all the while breaking the rules pertaining to those “adequate standards” imposed by the FDA.

What has the FDA done in response to these deceptive and unethical marketing strategies?

    FDA officials say they intend to conduct studies on misleading pharmaceutical advertising, but the government agency has done little to curtail the rampant ads. In fact, a 2007 study published by the New England Journal of Medicine reveals that the FDA has drastically decreased the citations issued to drug companies.” [7]

And now, 17 years later pursuant to the FDA’s revisions, and no doubt to help boost Big Pharma profits at any and all costs to the consumer, the FDA seems to have relaxed those rules even further.

On Feb. 12, 2014 the FDA issued a comment request for the public to consider having fewer risks mentioned in DTC broadcast ads. The FDA is concerned that the ‘major statement’ (the long disclosure of risks) is “often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.”

“They have proposed limiting the “major statement” to risks “that are serious and actionable” and having the ad “include a disclosure to alert consumer that there are other product risks not included in the ad.” [8]

Eternally the exploited consumer, forever at the mercy of unethical Big Pharma.

Ultimately, under the not-so-watchful eye of the FDA, Pfizer will continue to spiel the same old lies about the same old HRT drugs, drugs with a history reminiscent of death, deceit and denial. Drugs that are routinely prescribed for anything remotely related to menopause – physical and mental alike – all because they can.

And while they continue to downplay the side-effects and risks of conventional HRT manufactured from CEEs, they’ll be promoting the same old clichéd imagery of HRT as the redeemer of women from the clutches of old age and wrinkled skin. These innuendos alluding to the decline of the female body after menopause are perpetuated in the media every day, gracing the glossy pages of magazines with their promise that these vile drugs will make life blissful. Indeed those millions in marketing and advertising dollars are well-spent – no waste for Big Pharma and their callous tactics.

    The ritualization of the stages of life is nothing new. What is new is their intense medicalization … Lifelong medical supervision … turns life into a series of periods of risk.” [9]

Sadly, the “menopause industry” refuses to go away. There is far too much money involved and the likes of Pfizer and the rest of Big Pharma are unlikely to relinquish the target audience of the roughly 40 million female baby boomers that currently reside in the US alone. [10] Not at all – they will maintain the mythical status quo that menopause requires significant medical intervention.

No one is willing to take responsibility for allowing unscrupulous science and marketing strategies to rise above irrefutable medical research. It isn’t like there haven’t been enough warnings about the risks of conventional HRT yet these carcinogenic potions remain on the market and advertized as safe because corruption of Big Pharma and the FDA runs deep.

You are central to your decisions in your health care. Say NO to the Premarin family of drugs.

Pray for the horses for they are at the mercy of this insanity.
__________
[1] http://prescriptiondrugs.procon.org/
[2] http://io9.com/5853356/sick-of-pharmaceutical-ads-heres-why-they-wont-go-away
[3] http://www.smart-publications.com/articles/dont-let-your-doctor-give-you-horse-urine-for-menopause
[4] http://www.valuewalk.com/2014/07/lemeson-ups-ligand-pharmaceuticals-inc-lgnd-short/
[5] http://www.cafepharma.com/boards/showthread.php?t=541600
[6] http://articles.mercola.com/sites/articles/archive/2012/07/16/drug-companies-ads-dangers.aspx
[7] http://www.drugwatch.com/2012/01/18/direct-to-consumer-marketing/
[8] http://prescriptiondrugs.procon.org/
[9] Medical Nemesis p 78 http://www.healthyhormones.com/news/news10-16-06_5.html
[10] http://www.prb.org/Publications/Articles/2002/JustHowManyBabyBoomersAreThere.aspx

THE END

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ATTENTION! If you see an ad for any Premarin product including Duavee, please contact us and tell us what network, the channel you saw it on, the city and what it was for. Thanks.