PMU Mares and Foals – Revenue Tools at the Mercy of Big Pharma

by JANE ALLIN

While it may seem that reports on the operations of Pfizer and their misguided, yet continued, use of conjugated equine estrogens to counteract the effects of menopause and osteoporosis has little to do with the plight of the horses at the center of this industry, this is furthest from the truth.

Each milestone that Pfizer achieves in its attempts and successes in promoting these carcinogens inflicts yet more misery on the innocent mares and their foals – now at the mercy of at least one country renowned for its cruelty and heinous acts of abuse against defenceless animals.

Two Belgian horses close up.

One cannot separate Pfizer, the creator, promoter and recipient of the obscene profits garnered from its sales, from its victims – the horses.

As much as the link between them may be lost in translation owing to the collection and manufacturing aspects that are far removed from the grandiose head offices and the slick marketing tactics, it is one and the same.

But that is their agenda.

Eliminate the word “equine” from the estrogen source and relocate the “harvesting” facilities.

One can hardly call them ranches as what remains in North America are referred to. Soon these North American ranches will disappear and with that the stigma of abuse many people associate with the PMU industry. At least that is undoubtedly Pfizer’s objective.

With this in mind the main intent of this article is to bring to light the projected sales and profits anticipated for Pfizer’s newest addition to the Premarin family – Duavee (US) or Duavive (EU).

This is in addition to the $1 Billion USD more greedily usurped every year as profit from their compendium of loathsome drugs manufactured from the urine of pregnant mares. These lucrative revenues should be a constant reminder of what life is, and what lies ahead, for the mares and their foals regardless of where they reside.

Pfizer Logo. Google image.
Pfizer Logo. Google image.

Without question Pfizer is the leading pharmaceutical company in the development of menopause drugs. However Pfizer, together with its subsidiary Wyeth Pharmaceutical, collaborated with Ligand Pharmaceutical to develop Duavee.

Despite the risks associated with Premarin, these drugs continue to perform favorably and have generated substantial revenue for Pfizer. In the past three years or so the profits have increased by some degree or margin indicating that the aggressive marketing tactics are working – bad news all around for both women and horses.

Pfizer’s most recent direct-to-consumer campaign for both Premarin and Duavee has boosted its marketing efforts and print advertisements are regularly appearing in Good Housekeeping, People, Redbook, Martha Stewart Living, and Better Homes among others.

Kim Cattrall.
Kim Cattrall.

This includes the deplorable Duavee campaign called “Tune into menopause” hosted by Kim Cattrall star of Sex and the City – what is this woman thinking?

“Duavee is a new product Pfizer launched in the U.S. about 8 months ago. Q3 prescriptions in the U.S. averaged 4,000 per month, but should increase to 7,000 per month in Q4”. [1]

7,000 prescriptions of Duavee expected per month in the 4th Quarter in the US.

Pfizer is not the only player in the game when it comes to generating revenue from Duavee. Ligand, as the biopharmaceutical company, is also focusing on gleaning compensation from the licensing agreement.

Under this agreement with Pfizer for developing Duavee, it received the milestone payment of $425,000 upon FDA approval. And if the stock market has any indication of Duavee’s potential, Ligand’s share prices jumped almost 10% on the day of Duavee’s approval.

“Ligand said it believes the drug will gross at least $10 million for Ligand on the low end and believes it could hit a range of $40 to $50 million in the high end. Duavee has a royalty rate of 0.5% to 2.5% for Ligand.” [2]

So how does a royalty rate between 0.5% and 2.5% that will generate $10 million to upwards of $50 million translate into actual sales of Duavee?

A Seeking Alpha article released on January 29, 2015; “Earning Peek: Stay with Ligand Pharmaceuticals for a Year or Three” delivers the answer. [3]

Not only does it include projected sales for Duavee but its nasty component Viviant as well, also known as bazedozifene – the SERM that when combined with conjugated equine estrogens (CEEs) make up this vile drug christened Duavee.

The potential, and otherwise expected, sales of each of these products based on Ligand’s royalty rates are shown. [4]

Duavee Royalty Rates Ligand

This is for each drug both of which belong to Pfizer. One of these (Viviant) has yet to gain approval from the FDA.

This means a potential of $2 Billion or more in revenue from drugs that carry with them life-threatening risks. And this doesn’t include the already billion dollar profits that Pfizer is soaking up on an annual basis from the sales of its Premarin products – all at the expense of the PMU mares and their foals.

The underlying strategy is not hard to understand.

“Duavee has the potential to be a blockbuster just from the sheer number of women in the U.S. with postmenopausal symptoms (expected to pass 50 million by 2020)”. [5]

And that is just the tip of the iceberg – Duavee was recently approved in the EU under the trade name Duavive.

The population of the EU is roughly 1.6 times that of the US. If my numbers are correct, this significantly increases the number of potential candidates to a total of 130 million – 50 million in the US and 80 million in the EU.

Translated, this also means a considerable increase in the number of mares required to supply the central ingredient of these ghastly concoctions.

Perhaps a solid strategy but not an ounce of ethics in its design.

But where is the science behind it? Isn’t it more a case of marketing masquerading as science?

“Most of the big drug companies have paid huge fines to settle charges of illegal activities. Last year Pfizer pleaded guilty and agreed to pay $2.3 billion to settle criminal and civil charges of marketing drugs for off-label uses—the largest criminal fine in history. The fines, while enormous, are still dwarfed by the profits generated by these activities, and are therefore not much of a deterrent.” [6]

In the case of Pfizer’s menopausal therapies it’s not hard to find glaring inconsistencies in what should and should not be considered marketable, let alone approved and sanctioned by the FDA and other governing bodies around the world.

Look no further than bazedoxifene (Viviant).

What has always been disturbing about bazedoxifene’s role in Duavee’s alleged effectiveness is that the FDA has failed to approve this as a stand-alone drug due to the risk of deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis.

These risks have been carried over to the package insert for Duavee as well, along with the extensive list that accompany Premarin products.

These package inserts are not scientific documents but rather, first and foremost, legal documents. In this case double indemnity, so to say this buffers Pfizer from future litigation.

Premarin foals.
Premarin foals.

Apparently no one, including the manufacturers or the FDA, has a clue exactly what potential harm these drugs may pose.

And of course there are the irrefutable and ever-present risks associated with CEEs that are the abhorrent makeup of the prehistoric Premarin products. What’s more it’s not just the stigma of using horse hormones and the fallout of the lethal effects these drugs have on women who choose to take them.

The unequivocal reason is that these are horse hormones and should clearly not be administered to humans.

In fact, a major gene study performed at the Karolinska Institute in Sweden has shown that there is a genetic component that plays a major part in the development of breast cancer in those exposed to the ravages of CEEs.

“Researchers have measured activity of genes associated with breast cancer in women before and while, they took different types of HRT. They found that an HRT used in the WHI trial had a greater activating effect on these genes than a “natural” formulation applied via an estrogen gel applied to the skin in combination with oral progesterone. This shows that varying the HRT and the way it is taken can have very significant effects on the genes associated with breast cancer.” [7]

Simply put, there is an inherent risk of ingesting horse hormones that significantly augment the risk of breast cancer – mostly likely a number of cancers – as well as the vast array of other life-threatening conditions attributed to the use of CEEs.

Surprised?

Not really, after all there are numerous studies that have shown that CEEs are extremely complex with over 200 individual components identified including not only estrogens but also androgens and progestins, all of which produce various effects in different tissues.

Moreover it has been shown that specific equine estrogens, notably equilin and equilenin, are metabolized to highly cytotoxic compounds causing oxidative stress, a precursor to the development of cancer. [8]

Indeed, cancer initiation and progression has been linked to oxidative stress by increasing DNA mutations or inducing DNA damage, genome instability, and cell proliferation.

The bottom line is that CEEs are mostly foreign substances within a human and are activating genes within the cells that give rise to cancers and other serious side effects. PERIOD. What doesn’t the FDA understand?

And what about the horses?

Women around the world must strive to educate those who are unaware of the perils of drugs containing conjugated equine estrogens – both women and men alike.

Safer alternatives, including estrogens not manufactured from horse hormones, are available. [9]

Word of Mouth Marketing artwork.
Word of Mouth Marketing. If they can use it to sell Premarin drugs, we can use it to warn people against it.

Think of it as a marketing tool to save the horses. There will always be the conformists, nevertheless do not underestimate the power of word of mouth marketing (WOMM).

“According to Nielsen, 92% of consumers believe recommendations from friends and family over all forms of advertising. WOMMA and the American Marketing Association (AMA) decided to find out exactly what brands were doing about that fact. In a recent study, 64% of marketing executives indicated that they believe word of mouth is the most effective form of marketing.” [9]

Despite this seemingly monumental task, even incremental movements to walk away from equine derived hormone replacement therapy will gradually erode the market that Pfizer/Wyeth have so deviously built upon the backs of the pregnant mares and their foals.

Engage. Equip. Empower.
—-
[1] http://seekingalpha.com/article/2865526-earnings-peek-stay-with-ligand-pharmaceuticals-for-a-year-or-three
[2] Same as at 1.
[3] Same as at 1.
[4] Same as at 1.
[5] Same as at 1.
[6] http://www.bostonreview.net/angell-big-pharma-bad-medicine
[7] http://www.sciencedaily.com/releases/2014/05/140502172035.htm
[8] http://www.ncbi.nlm.nih.gov/pubmed/10027800
[9] http://www.horsefund.org/pmu-alternatives-to-cee-drugs.php
[10] http://www.forbes.com/sites/kimberlywhitler/2014/07/17/why-word-of-mouth-marketing-is-the-most-important-social-media/

END

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4 thoughts on “PMU Mares and Foals – Revenue Tools at the Mercy of Big Pharma”

  1. After having penned this I just happened upon an update regarding the sales of Duavee. Pfizer’s 4th quarter results show sales greater than predicted ~sigh~

    “Now, a comment about DUAVEE, a product launched in the U.S. one year ago by Pfizer. It is a product for the prevention of osteoporosis and hot flash symptoms. U.S. monthly prescriptions have doubled in the last several months and now are on track to exceed 10,000 per month. The product was approved in Europe in December and now Pfizer is working through pricing. There is a goal to contest the regulatory bodies to approve premium pricing not parity pricing. We are encouraged by that as it indicates Pfizer’s conviction for the product.

    On its Q4 earnings call last week, Pfizer called out DUAVEE in a list of products as one of its growth brands for 2015. Now it is early days for this product but the women’s health category is changing and we believe DUAVEE has the potential to be an important drug in the new medical treatment paradigm.”

    http://seekingalpha.com/article/2899216-ligand-pharmaceuticals-lgnd-ceo-john-higgins-on-q4-2014-results-earnings-call-transcript?page=2

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