Belgian Cross by Leslie Town

Pfizer’s love affair with carcinogens continues with Aprela®

UPDATE: Aprela approved by the FDA during last federal government shutdown under the name Duavee.

Expendable Flyer re Premarin and Prempro
Expendable Flyer re Premarin and Prempro. Created by the Int'l Fund for Horses. (Click to Enlarge)

Written by JANE ALLIN

Pfizer’s recent announcement to seek U.S. regulatory approval for their combined menopausal-osteoporosis drug Aprela® is nothing short of an appalling money grab and a ruse to defer negative focus from their controversial hormone-replacement therapies – Prempro® and Premarin® – both associated with increased cancer and cardiovascular risks among countless other equally insidious maladies.

Some speculate that approval will be not be sanctioned given the delays in developmental stages and inherent risks associated with both components that comprise the new drug.

Aprela is a combination of Premarin® and bazedoxifene, a selective estrogen receptor modulator or SERM also known as Viviant® specifically developed to help prevent postmenopausal osteoporosis. Of particular note is that Viviant® has failed to receive approval from the FDA as a result of increased risks of stroke and thromboembolic events although it has been approved for use in other countries (i.e. EU and Japan) under different trade names.

Fortunately the delay in approving Viviant® has, until now, had a significant impact on the introduction of Aprela to the marketplace which was slated for 2008. Moreover, in 2010 Pfizer, announced the withdrawal of its new drug application (NDA) for Fablyn® another SERM specifically developed for the treatment of both osteoporosis and selected consequences of menopause. As with many other SERMs, Fablyn® has been shown to have significant side-effects which contraindicate widespread use. Is bazedozifene any different?

What if anything does this medication really offer other than continued abuse of pregnant mares and questionable efficacy as far as safety is concerned? Recall that conventional HRT was used for years without heed to negative and life-threatening side effects primarily as a result of the notion of menopause as a disease coupled with the idea that it is “normal” for females to succumb to breast, ovarian and endometrial cancers among other “female” issues. During those years, it seems, mitigating the discomfort of menopause prevailed over safety.

That all changed however with the eye-opening results of the WHI and the realization that conventional HRT as provided by Big Pharma, and at the mercy of the wombs of countless horses, is nothing more than a poisonous carcinogenic concoction of hormones alien to the human body. What makes anyone think that these same equine-derived biological hormones, disguised within more complex and questionable drugs with side effects of their own will safely provide a solution to a natural ageing process, common to women since the beginning of time?

But then again it is a dual acting drug that has been marketed as the panacea to the ever-ageing population; combating the woes of menopause and the risks of osteoporosis. Appealing indeed to kill two birds with one stone as the saying goes regardless of the presence of known carcinogens. Why must Pfizer continue to endorse Premarin®, present in the same quantities in this new drug with the pretty name, when there are no doubt natural or synthetic, potentially safer, alternatives? They simply continue to downplay the risks at the expense of the lives of both women and horses alike.

There is a reason why bazedoxifene has yet to be approved by the FDA and that is one of safety. And there is undeniably no question as to the harm conjugated equine estrogens (CEEs) contribute to the overall health of pre- and postmenopausal women. It is also interesting that Pfizer has opportunely eliminated the term “equine” from the description of these hormones and now refer to them as simply “conjugated estrogens”. Yet another ploy to distance the connection between the horse and the drug – Pfizer’s agenda is incredibly transparent. One need only look at their strategy of relocating the PMU farms away from North America.

In any case Pfizer claims that preliminary, and very limited, studies of Aprela® have not shown to prove deleterious to the overall health of women in terms of carcinogenic effects. In the same breath, the reservations in terms of safety continue for bazxedoxifene after longer-term studies (compared to Aprela®) continue to plague its approval by the FDA.

Moreover as is well recognized cancer typically takes years to develop. Even with lowered doses of CEEs over time, women have succumbed to death at the hands of Pfizer-Wyeth, subsidized with ghost written articles and overall cloak and dagger antics by Big Pharma in an attempt to champion unsafe drugs with the ultimate goal of reaping millions if not billions of dollars in profit.

Enough said.

Furthermore the fact that Aprela® contains the same dosage as Premarin® in a pill combined with a drug that has major side effects is disconcerting. Pfizer wants the population to believe that the two together are synergistic and negate the side effects of each other – a magic formula where two wrongs make a right. Given Pfizer’s reputation, let alone the whole of the pharmaceutical industry and its deception and greed, there is an element of trust categorically missing from the equation. Sadly the mares and foals will continue to suffer relentlessly.

Pfizer’s projected annual sales for HRT therapies – Premarin® and Aprela® – are over one billion USD by 2015 but some analysts predict it will be much lower (~$200 million) primarily as a result of the negative side effects associated with both drugs in combination with development delays and lack of FDA approval for bazedoxifene/ Viviant®. Regardless of what the actual profit margins will be this nonetheless represents a lot of urine from the PMU mares.

This becomes a dichotomy of sorts.

With the closing of many of the PMU farms beginning in the summer of 2010 with reportedly 26 ranches housing approximately 40 horses each and most recently the news of a North Dakota PMU ranch closure where many of these horses are at risk of shipping to slaughter, where will all of the pee required to manufacture these demon drugs come from? At the peak of manufacture in 2003, 400 farms were in operation churning our gallon upon gallon of pregnant mare’s urine. Pfizer wants us to believe that they have refined the process of CEE extraction from the urine such that much less is needed yet rumor has it that they have simply relocated the farms to foreign countries.

As to their rationalization Pfizer has indicated their interest in maintaining smaller farming ventures that would limit the amount of estrogen produced to 10,000 grams per contract. Some basic math taken from a 2010 iFH article will further reveal the ambiguity of this intriguing equation. See

If 25 farms each produce a total of 10,000 grams of conjugated equine estrogens (CEEs) this equates to a total harvest of 250,000 grams of CEE per annum. For the sake of simplicity, let’s assume that the average amount of CEE contained in a Premarin®-related product is 0.45 mg based on the mid-range of available dosages and presumably the most commonly prescribed measure since its introduction as a low-dose option in April 2003.

The total number of mg of CEEs produced per year under the new guidelines is given by:

Total grams CEEs/year = 250,000 grams CEEs/yr x 1,000 mg/gram
= 250,000,000 mg CEEs per year

Hence, the total number of single dosages available per year, assuming each dose is comprised of 0.45 mg can be determined as follows:

Total single dosages/year = 250,000,000 mg CEE per yr / 0.45 mg
= 555,555,555 single doses /yr

Since a typical HRT regimen is a single dose/tablet (tab) per day, the total number of prescriptions that will be available assuming the total number of farms are reduced to this level and limited to a 10,000 g contract, can be calculated as follows:

Total # prescriptions/yr = 555,555,555 tabs per yr / 365 tabs per yr [i.e. 1 tab/day]
= 1,522,070 prescriptions /yr

Interesting that only about 1.5 million prescriptions can be filled if this is the case particularly given that data from 2008 (Source: IMS Health) showed that upwards of 15 million prescriptions were filled by physicians that year, not including those available online without a doctor’s signature or other products containing the same (e.g. vaginal creams). It is unlikely that number has varied considerably since this time and sales of Aprela® no doubt, with its “safer” profile and double action efficacy, will exceed this globally.

Something is undeniably amiss.

Almost two years ago the International Fund for Horses reported on the rumors of PMU farms emerging in places consistent with general acceptance of horse slaughter such as China, Kazakhstan and Poland, as well as Pfizer’s attention to increasing sales in emerging markets outside of the US. It seems then we must resign ourselves to this sad fate for the mares and their foals; how else can Pfizer supply the current and projected global demand?

This brings us to the ever present plight of the horses.

What was and is today a brutal industry in the abysmal treatment of the pregnant mares and their foals here in North America will prove to be even more devastating for them in countries seemingly more accepting of animal abuse, horse slaughter and consumption of the meat of this heinous practice. While women can choose whether or not to engage a regimen of Premarin®-related therapy, unfortunately the mares and their foals are at the mercy of Pfizer and those who choose this unwarranted route to so-called “wellness”.

One thing is clear, as Pfizer slowly pulls the plug on the PMU industry here in North America the harsh reality is that this barbaric practice is not going away; it is simply moving house. Even with scientifically-based consensus that equine-derived estrogen therapy is almost certainly not a safe option for the relief of menopausal symptoms, Pfizer marches on at any and all costs.

Along with the announcement to seek approval for Aprela®, it seems Pfizer is ramping up new marketing strategies through the use of innovative training campaigns along with attractive new graphics and packaging in expectation that a new image will compel physicians to fill out more prescriptions. Designer drugs, just like a pair of jeans.

Disgraceful? You bet.

But the crusade against Pfizer/Wyeth and their despicable lack of empathy for both humans and animals alike is not over; we must now direct our energies across the globe – a much more difficult task, no doubt. Continued vigilance in the fight to shut down the PMU industry is the only thing that will save the mares and their innocent foals from the greed-driven and sinister hands of Big Pharma.

Pfizer, the snake in snake oil.

Jane Allin is Chief Research Analyst for the Int’l Fund for Horses and regular contributor to Tuesday’s Horse, primarily specializing in the Premarin Horses and Horse Racing issues. Jane dedicates numerous hours working for the welfare of horses and is the proud mother of two spoiled Golden Retrievers, Alex and Abby. A native Canadian, Jane has volunteered with the Int’l Fund for Horses since 2009.

© Int’l Fund for Horses

22 thoughts on “Pfizer’s love affair with carcinogens continues with Aprela®”

  1. Big pharma is a blood (money) thirsty industry, and Pfizer is one of the biggest blood (money) suckers of all. Is it any surprise then that the pharma thugs are spinning another web of lies to try and convince naive, desperate women to grab on to yet another life perserver at the expense of their short and long term health? Until women become more educated with their own bodies, how hormones work in different phases of their lives, and begin to question what these drugs are, what natural alternatives there are (pre-menopausal and menopausal women, try Dim Plus by Natures Way; works wonders on balancing hormones), etc, there will continue to be a market for these questionable drugs that hurt and kill horses.
    I know for me currently going through menopause, I’d rather live with some hot flashes, low level mood swings, etc rather than live with what I’d be contributing to putting the poor pregnant mares and their offspring, whom are just by-products of the industry, through if I buy in (literally) to using these drugs.


      1. You’re right, they catch us coming and going with the hormone drugs AND vacs for animals. I simply do not use their vacs (I use homeopathic vaccines for protecting my horses that I get from a holistic veterinarian), and the other big player in the vac industry is Fort Dodge who have had recalls on their horse vacs.
        Both companies are very bad news IMO (which I’m still entitled to my opinion for the time being, but even those rights are under assault right now too) and big pharma is a very incestuous industry with connections with one another all over the place.


        1. I am forced to vaccinate my soon to be 21 years old Quarterhorse gelding. It is a state Law. Horses at his age do not require a rabies vaccine. In fact, it could kill him.

          They did not get Rhinovirus last year because the vaccine was ‘tainted’ and many horses, both young and old. died.

          Fort Dodge is just as bad.



          1. What?! State law to force you to vaccinate your horse? Any vet would be hard pressed to even get close enough to some of my 40 horses to just pet them, (many of them only let me touch them either because they are Mustangs and were never gentled and/or they were badly abused horses), let alone try to vaccinate them. Might be kinda fun to get a video of them tryin’ though…… :-)
            The only vaccine any of my horses get is perhaps a tentanus booster if they get a laceration or puncture, but I don’t even always do that and just keep the wound really clean. My horses live out in all types of weather, and other than a few cases of influenza that was kinda running rampant around Northern Nevada approx. 5 years ago that 3 of my horses got and recovered fine from, I don’t vaccinate them anymore and just feed good quality feed and try to keep their natural immune systems in good working order. I use West Nile Virus nosodes (since 2000) for vaccinating them that I get from a vet in Florida, and I’ve never had any cases of WNV even though it finally arrived in Nevada in 2004 in the very county where we live.
            I can understand the rabies vac if you live where there are skunks, bats, and other critters that might have it because that is a death sentence for a horse if they are bitten by a rabid animal. However, I had no idea it was a state law and the state can force you to vaccinate your horse. Thats really crazy………. :-(


            1. In NJ we have all that you have mentioned in addition to Coyotes (YES!). We need a Coggins pull every year and Rabies every year as well. New Jersey is not a horse friendly state. Mine were living with my friend for a few years and she is a natural horsekeeping believer (as am I) and she had an enormous tent like those they use for Wedding Receptions. There was a barn on the property and the only time we used it was during a blizzard with high winds. At 3am I was driving over these mountain roads and hoping my SUV would not roll! It didn’t and we found all the horses and brought them inside. I was frozen for days. So, I am forced to give my Quarterhorse the Rabies vaccine; if I don’t they have the right to take him away. If that happens he would go directly to kill. And, our state animal is….THE HORSE!!!



      2. Dear Elle,

        Big pharmaceutical companies also donate large amounts of money to both medical and veterinarian colleges. To perpetuate these donations, the med/vet students are taught the necessity for vaccines including HRT by the college instructors. “One hand washes the other”.

        I do not vaccinate any of my animals (horses, sheep, donkey, barn cat, house dogs) for ANY disease. I have NEVER lost an animal from a disease for which there is a vaccine.

        I have heard of horses dying from rabies vaccines.

        In Wisconsin, we are required by law, to vaccinate our dogs every 3 years – it used to be every year. Now there are rumors Wisconsin is going to extend the rabies vaccine to every 7 years. I have also been informed, by a reliable source, ONE rabies vaccine lasts a lifetime. I have yet to hear a vet suggest a titer…..

        Mari :)


  2. I saw a article last year about Pfizer moving off shore. I thought at the time that now none of us can help the mares/foals. I doubt that anyone will keep track of how many women will die from using this magic potion. From what I understand only one out of every ten drugs makes it to market in the US. This stuff may not make it either.


  3. I have an MD/gynecologist friend in Denmark who told me only a few women in her country take an HRT due to severe menopausal symptoms which render their life as miserable. Menopausal symptoms are a normal part of aging. American woman need to learn to “tough it out”. Premarin merely prolongs the eventual symptoms which will occur when stopping its ingestion.


  4. Vivian, do you think another protest is in order? I am sure that Frank could bring another PMU filly or colt. He made it into Midtown Manhattan and he had a Police Escort so he could park on 56th street. I know this is not the same as the Wyeth Protest we did and Phizer is probably on a Campus. However, I am sure we could get a permit for a peaceful protest. It would violate our First Amendment rights to not be allowed to. We need to find a great spot where people are exiting the buildings for lunch breaks. Also, warm weather is better than cold. This is something we could plan down to the last detail. Please let me know your thoughts; you know how I love demonstrations/protests on behalf of horses, or any animal. This is disgusting. They are not only outsourcing the killing but they are outsourcing ‘jobs’ that are greatly needed by Americans. We want those ‘jobs’ to end of course, but that is another negative about Phizer. Any negative light we can shine on them is all the better.



  5. I find this shocking, though I don’t know how I could be shocked, after working on this issue all these years. Wyeth, and now Pfizer, kill tens of thousands of young horses and plan to continue doing so, plus potentially put women at higher risk than ever before. And making a big marketing push to boot. This is definitely a corporation without a conscience, and the shareholders should be ashamed to take a tainted penny. What an abysmal bunch. I am beyond disgusted, and any woman who takes these drugs should be just as ashamed of keeping this corporation rolling in millions of dollars.


    1. Couldn’t agree more Vivian. It is itself malignant in nature.

      Actually when I was reviewing some stuff for this short article I came across a list of the ten best Pharma quotes of 2011…here’s the one on Pfizer.

      “[Pfizer’s] managers descended into behavior that would do Shakespeare—or Machiavelli—proud.” – Fortune writing about the last days of Jeff Kindler as CEO—“a saga of ambition, intrigue, backstabbing, and betrayal . . . exacerbated by a board that allowed the problems to fester for years.”

      So befitting. I’m sure they have recruited an equally vile successor to their throne. Pfizer is the epitomy of corrupt and also holds the honor of one of the most deadly companies in the US.




    1. Thank you Shirley, for your comment. I am glad you were spared as much as you were. And also have the good grace to spread the word, including to your daughter.


    2. Hi Shirley,

      My mother was telling us not to use it or any other form of HRT. None of us have yet hit that phase of life but she wanted us to be informed so we could pass the knowledge on. And that we do!



  7. In the US the Pharncos are NOT required to report the ADAs found in Clinical Trials in other countries. My Mother is a BSN whom worked at Ortho MacNeil prior to it being swallowed by Jannsen. She saw some of the foreign results for birth control such as Ortho Evra, and their HRT drugs as well. Her job was to explain how the drugs worked to Physicians and she was honest with them. She put her job at risk but she was so great at what she did she retired after 25 years with a nice pension.

    She told all of her daughters to never take HRT not only because of the inherent cruelty, but because they kill the women who take them. In 2005 I demonstrated against Wyeth, on behalf of the Horsefund. I had a Premarin filly named ‘Mocha’ and arranged a spot right outside the entrance of CBS Television Headquarters in Manhattan. MEN were more concerned than the women. Women were horrified about what PMU meant. CBS was running an ad with Cheryl Ladd and if I recall correctly, the ad was pulled. The Filly’s owners were there of course, and four children were handing out flyers and explaining that Mocha was saved from slaughter and that she was a by-product of the HRT industry. Shall we do it again? Phizer is in New Jersey if I recall correctly. Elle


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