Written by JANE ALLIN
Research Analyst, Int’l Fund for Horses
(August 3, 2010) — The introduction of Aprela® looms ever closer in the EU and Japan. Viviant® (i.e. bazedoxifene), a SERM (selective estrogen receptive modulator) which is the post-menopausal osteoporosis component of Aprela® was approved by the European Commission under the name Conbriza in April of 2009 and just this past week Japan has followed suit.
It is only a matter of time before Aprela® will be available in these regions of the world.
Meanwhile, to Pfizer/Wyeth’s dismay, in North America the endorsement of Viviant® by the FDA has been postponed repeatedly due to complications of stroke and venous thrombotic events. Accordingly the delay to approval for Viviant® has had a significant unexpected effect for Aprela®, since it is a combination of bazedoxifene and conjugated equine estrogens (CEEs). Initially, the NDA (New Drug Application) filing timeline for Aprela® was the second half of 2008; currently this has been pushed out to 2010 however even this agenda is questionable given the issues associated with Viviant®.
Moreover, with the US FDA withdrawal of the NDA for Fablyn®, a SERM for the treatment of both osteoporosis and selected consequences of menopause, things are not looking favorable for the giant drug manufacturer in the North American market. In contrast, Fablyn® received approval from the European Commission in February 2009.
Coincidentally, the slaughter of horses and consumption of the tainted meat is commonplace in both the EU and Japan where it is considered a delicacy. Is the fact that there is much controversy over these topics and the current ban on horse slaughter in the US integral to these delays or is it simply wishful thinking.
Additionally, recall the recent announcement of the large reductions in PMU facilities in NA and rumors of PMU farms emerging in places consistent with general acceptance of horse slaughter such as China, Kazakistan and Poland. Today, August 3, Pfizer will discuss drug development, sales in developing markets and ongoing integration from its mega-acquisition of Wyeth when it reports second-quarter results before the stock market opens. Of particular note in relation to the PMU industry is their attention to increasing sales in emerging markets outside of the US.
“Pfizer, a Dow component, likely will discuss its progress in increasing sales in emerging markets. Major drugmakers are counting on countries including Brazil, Russia, India and China bringing them much higher growth rates than the U.S. and Europe in the future……… Getting new drugs approved and boosting revenue outside core Western markets is crucial for Pfizer….. Over the past 18 months several promising experimental drugs, after years and tens of millions of dollars worth of testing, have failed just shy of the finish line due to limited effectiveness or safety problems.”
See http://www.sfexaminer.com/economy/99641144.html
Does this imply that Pfizer will progressively move the location of their PMU “factories” from NA to other parts of the world more accepting of the atrocities associated with the industry? Probably, given that the acquisition of Wyeth was motivated by their blockbuster Premarin® family of drugs together with the fact that Aprela® is expected to amass even more profits due to its osteoporosis claim to fame – a designer drug for the ageing population no less.
Equally disturbing is the quest to seek approval in these countries for drugs deemed risky or ineffective here in NA. Have they no respect whatsoever for human and animal life or are we all simply sacrificial lambs? In reality, there is nothing surprising when it comes to the devious ways of pharmaceutical companies and it seems that Pfizer is no better than Wyeth in terms of ethics and moral values – perversely diabolical.
“In fact, to say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia.”
See http://pharmagossip.blogspot.com/2010/07/opednews-article-is-pfizer-bp-of-drug.html
That said, I doubt that there is any greater hope of influencing their agenda than it was for Wyeth when it comes to the use of CEEs in HRT; more insidiously they endeavor to hide it from our sight rather than ethically address the issues. Money at all costs – both cowardice and gluttony prevail.
PMU issues now transcend North America and we must act globally to eradicate this abhorrent industry to protect both horses and women alike. The movement of PMU farms away from NA and the expanded marketing of CEE-based HRT in emerging economies present a more formidable task for horse advocates than when concentrated in a central NA location where horse slaughter is condemned as barbaric. Cultural, political and legal disparities in these developing countries compared to our own will no doubt impede the efforts and milestones achieved to date.
Bio-identical Hormones Take Center Stage
On a more positive note, there seem to be bio-identical hormone clinics and specialty physicians cropping up all over the place. Dr. Tutera’ s practice is just one of several in the news.
On a more positive note, there seem to be bio-identical hormone clinics and specialty physicians cropping up all over the place. Dr. Tutera’ s practice is just one of several in the news.
“Dr. Gino Tutera recently opened a medical practice dedicated to the treatment of hormonal imbalance and well-being for the people of Nashville. Dr. Tutera saw an opportunity to give Nashvillians the same quality of care that he offers to his patients in his other locations around the US. His medical company, SottoPelle, offers a unique process that ensures all patients are treated as individuals and can regain their desired quality of life.”
[http://www.examiner.com/x-57653-Nashville-Longevity-Examiner~y2010m7d29-Nashville-Embraces-Pioneer-of-Hormone-Replacement-Therapy]
And for those who want up-to-date information, “Medical Mondays”, a video series conducted by bio-identical hormone experts is also available to both women and men who have specific questions related to BHRT.
Bioidentical Hormone Experts Blog Kicks-Off ‘Medical Mondays’ Video Series
Weekly Video Blog Postings Answers Questions on Bioidentical Hormones
BOCA RATON, Fla.–(EON: Enhanced Online News)–When it comes to your health, it’s important to use a resource that you can trust. In a continued effort to provide information that is timely, relevant and accurate, the highly trained physicians at BioidenticalHormoneExperts.com (BHE) are kicking off a new video-based blog campaign, called “Medical Mondays.” The weekly blogging series, starting August 2, 2010, will offer women and men the opportunity to ask health related questions and have them answered in video format, recorded live by one of the bioidentical hormone expert physicians.
Tuesday's Horse 
thanks for this useful information
hopefully benefit us all and success for your
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Part of the issue too, is that we have to convince women that there are workable alternatives to premarin …to horse based estrogen products…one of the things that works to kill a project or a product is to take away it’s market..don’t buy it..they won’t make it. I still know women who don’t care where it comes from, as long as it works.
Jane is quite right when she says there are good people in all countries who are working to protect animals and stop horsemeat, horse products, the slaughter of dogs and cats for meat and fur…but it is going to be so much harder in countries that have very few, if any, animal welfare laws. We in Canada tend not to eat horse…but we have slaughter-houses for them for other people…we also have PMU farms…and we do have laws…just not very good ones. I do not want to see production moved to some of these countries because it will make it so much harder to stop…and money seems always to be a more motivating factor than morals or ethics.
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I agree Nancy.
By moving the PMU farms, the horses undoubtedly will suffer more as a direct result of the lack of animal welfare laws. And yes, there is definitely a need to campaign about alternatives. Unfortunately, believe it or not, there are even doctors who are unaware that Premarin etc. is manufactured from horse urine. Raising awareness is therefore very important to dismantling this industry.
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You are right Elizabeth. How can we stop this? It is definitely a monumental task and simply ridding NA of the PMU industry does nothing for the rest of the world. And I agree, education is the answer but how do we do it? Foreign countries who slaughter and eat horses have a different philosophy than ours, overall. We need to infiltrate these cultures and find those within them that are in line with our beliefs. They do exist. Just look at Asian countries such as China and Korea who slaughter and skin animals alive whether it be for food or fur or whatever. They too have animal advocates that abhor these practices and are working to abolish animal cruelty and inhumane practices. The world is not simply black and white. There are many good people on it regardless of their ancestry or political and cultural beliefs.
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Apparently these have no respect for Animals or Humans. It is all the bottom dollar. They have no community responsibilty, morals or ethics. The have no consience when they continue to torture the pregnant mares to get thier urine and then throw the babies away when they are born never allowing the mares to raise thier babies. It is truly heartbreaking and hope that it will continue to decrease not only in the US but Worldwide.
This is all good info, but what can we do to stop them outside the US. If we drive them out of the US that is just that many more jobs the US is sending to foreign countries. So where do we go from here? Maybe we have to educate the foreign public so that they will stop allowing their doctors to perscribe these types of birth control or osteoporosis medications or any medication obtained or manufactured using equine by products (pregnant mare (horse) urine – hence the name pre marin for those who don’t already know.
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