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Will Pfizer-Wyeth merger cure PMU horse blues?

Jeffrey B. Kindler, CEO of Pfizer (L) and Bernard Poussot, CEO of Wyeth Mario Tama/Getty Images What impact will the Pfizer-Wyeth merger have on the horses abused and killed by the PMU industry? If it goes through, probably nothing, except horse advocates will have an even larger foe to take on.

By VIVIAN GRANT

In reading about the proposed merger — or buyout — of Wyeth by Pfizer, the horse advocate immediately wonders what impact it will have, if approved, on the PMU horse situation. The only thing that seems certain is that if this business deal goes through, it will make Pfizer, the world’s largest drug company, even larger.

Analysts are scratching their heads, and wondering why Pfizer are making the move. As far back as August, 2007, Fortune writer John Simons called a merger between Pfizer and Wyeth a “marriage of weakness,” adding “Pfizer needs blockbusters to overcome looming patent expirations and Wyeth has recently been failing to deliver.” --FiercePharma.com

Catherine Arnst reports on January 4, 2009:

Acquiring Wyeth might boost Pfizer’s fortunes in the short term, but it won’t solve the long-term problems that are roiling the major pharmaceutical makers. As many observers have noted, Pfizer and the rest of the drug industry suffer from a lack of promising new products to replace older ones going off patent. What is less widely understood is that Pfizer also will face an increasingly constrained marketing environment, even if it succeeds in bulking up with Wyeth.

The fact is, it’s getting a lot harder to market the products both companies have right now. Congress is widely expected to restrict direct-to-consumer advertising by drug companies this year, and much stricter limits were put in place last year on how the industry markets to doctors. Universities and hospitals also are toughening up existing constraints on how much money their researchers can accept from companies for promotional activities. -- Business Week

Arnst tells us in a subsequent article, dated January 26, 2009:

[Pfizer CEO] Kindler told a news conference that the Wyeth merger is not about “a single product or cost-cutting,” as with past deals. Instead, “it’s about creating a broad, diversified portfolio.” -- Business Week

None of the numerous articles we read for this report mentioned hormone replacement therapy drugs as high or even on the agenda for Pfizer’s takeover of Wyeth. Yet, Wyeth forecasts Aprela sales of $2 billion a year.

Let’s take a look anyway.

— Premarin, Prempro and Premhase.

Wyeth produces the Premarin family of drugs manufactured with CEE, or conjugated equine estrogen. Equine estrogen is derived from pregnant mare’s urine. There was a significant downturn in the sale of the Premarin drug group when the Women’s Health Initiative linked them to cancer, blood clots and cancer, among others. A rash of lawsuits followed. Premarin and Prempro are still widely prescribed, and obtainable on the internet without prescription. Physician’s notes for Premarin state that it also helps with osteoporosis that occurs during menopause.

— Enter Aprela.

Wyeth has a new drug in development also made with CEE called Aprela. Aprela is currently being scrutinized by the FDA for approval this Spring. Aprela will reportedly be marketed as an osteoporosis drug to women (and men) with the added attraction that it treats menopausal symptoms of women. -- Pharmalot

— Enter Fablyn.

Pfizer has had a drug in development awaiting FDA approval called Fablyn. Fablyn is an osteoporosis drug that also treats the menopausal symptoms of women. Called Ostoria in previous go rounds for FDA approval, it is said to be in the same class as Eli Lilly’s osteoporosis drug Evista.

Jared A. Favole tell us in a report filed January 8, 2008:

A panel of medical experts on Monday said Pfizer Inc.’s (PFE) proposed osteoporosis drug has benefits for post-menopausal women, but suggested the drug be restricted to women at high-risk of fracture or those who fail other treatments.

Pfizer is seeking U.S. Food and Drug Administration approval for the drug to treat osteoporosis, which generally leads to bone fractures, in post-menopausal women. Nine panel members said the benefits of Fablyn outweigh the risks, three said it didn’t and one member abstained.

and

It’s unclear whether the FDA will approve the drug, and if it will suggest restricting it to a certain population of women. The FDA will consider the panel’s advice in its decision.

The FDA has until sometime in October to make a decision. A rejection of Fablyn would be a setback for Pfizer as analysts estimate the drug could bring in peak sales of $1 billion. (emphasis added) -- Dow Jones Newswires

The panel voted 9 to 3 to approve Fablyn. However, the FDA has still not given the drug the go ahead.

John Carroll reports on January 20, 2009:

Pfizer has run into a roadblock at the FDA in its long-running quest to gain an approval for its experimental osteoporosis drug Fablyn. The pharma giant says the FDA has asked for more information on the drug.

Fablyn has had a long and troubled history. It was rejected as a treatment for osteoporosis almost four years ago after the agency had determined that it could cause cancer in the lining of a woman’s uterus. And it was rejected again in 2006 for vaginal atrophy. -- FierceBiotech.com

That sounds frighteningly familiar.

Will the Pfizer-Wyeth merger go through? The Greenlining Institute asked the Justice Department and Treasury Secretary Timothy Geithner to block the $64.6 billion transaction unless the companies lower consumer drug prices -- Bloomberg News

Will Fablyn or Aprela be approved?

Even if the answer to all those questions is no, thousands of foals will continue to lose their young lives, along with the mares when they can no longer become pregnant, so long as Premarin and Prempo are prescribed and sold. The approval by the FDA and sale of Aprela will simply add to the trail of blood, whatever pharma giant peddles it.

"It's a Scandal! It's an Outrage!"

NEW HORMONE REPLACEMENT THERAPY WITH A NEW NAME TO BE APPROVED BY THE FDA AFTER ONLY TWO YEARS OF TESTING!!! APRELA USES PREGNANT MARES URINE!!!

Tuesday’s Horse
A Weekly Publication of The Fund for Horses
Written by RACHEL STONE

Did y’ever see the musical Oklahoma? Remember the character Ali Hakim? It’s funny but whenever I read something about Wyeth, I think of him – a truly self-serving man who only did the right thing when lookin’ down the barrel of a gun.

I wonder what, if anything, would inspire Robert Essner to do the right thing. Bob Essner is the current CEO of Wyeth as well as the company’s President and Chairman of the Board. Bob earned over 24 million dollars for his little ol’ self in 2007, a bit less than his 2006 earnings of 32 million. Poor Bob. But I guess that’s the way it goes when you’re profiteering from sickness and suffering.

A large portion of Bob’s earnings come from Wyeth’s hormone replacement therapy (HRT) drugs – what Wyeth calls their Premarin® Family of drugs which include Premarin®, Premphase® and Prempro®. Most of you probably already know that Premarin® is short for pregnant mare’s urine. But just in case, yes siree, these drugs are made with conjugated equine estrogens (CEE) collected from the urine of pregnant horses. The circumstances the mares, foals and stallions face during their interface with the PMU farmers, and afterwards (their lives often end in slaughter for human consumption overseas) are questionable at best.

Premarin® has been around since 1942 and for decades, horse folks and animal rights activists shouted loudly about a variety of abuses the horses endured. The results were minimal. But in 2002, when a study undertaken by the Women’s Health Initiative disclosed that the use of Wyeth’s HRT drugs increased the risks of strokes, blood clots, heart attacks, heart disease and breast cancer in women, pee hit the fan. Sales plummeted 32% in 2003 and another 31% in 2004.

That was bad news for Bob but great news for horses. The reduction in sales led to a reduction in the number of mares required by Wyeth. In addition, Wyeth reworked its HRT drug formulae to enhance the safety of these drugs. The new formulae required less CEE and, as a result, reduced the number of mares under contract further. It was estimated that in 2002 there were between 40,000 and 50,000 mares peeing for Wyeth. Today, there are just 5,600.

But since 2005, sales have steadily gained. In 2007 alone, the Premarin® Family of drugs earned Wyeth $1,055,300,000. That’s a lot of money! Though still less then the $1.9 billion Wyeth earned in 2002. And with sales just over half of what they used to be, Bob’s gotta’ do something, right?

Y’ever heard of Aprela? Aprela, is a new drug under development at Wyeth that targets both menopause symptoms and osteoporosis. The drug is now in phase 3 clinical trials and expected to be submitted for FDA approval during the first half of 2009. Aprela’s success could be a real boon for Bob. According to International Marketing Services (IMS), the osteoporosis market is much larger than the menopause market - generating international sales of $8.9 billion in 2007. And guess what. Aprela contains the same CEE found in Wyeth’s Premarin® Family of drugs. Talk about smart marketing! Not only did Bob rename the drug, he’s mixed it with a new batch of ingredients, targeted a larger market and targeted a market that’s expected to increase as baby-boomers age!

How might this affect the horses? Well, if decreased sales reduced the need for horse pee, wouldn’t increased sales reverse that trend? As it stands, there are at least 5600 reasons why these drugs should no longer be made in my opinion. Will Wyeth once again “hire” tens of thousands of mares in order to collect their excrement? How many more unwanted horse babies will be born each year? How many more horse moms will have to stand in a 3 1/2’ X 8’ stall for a solid six months out of every year? Since I couldn’t get anyone from Wyeth on the phone or via email, the questions linger.

I haven’t experienced menopause yet so I can’t say from experience that Wyeth’s HRT drugs are or aren’t the be all and end all. But I do know there are plenty of tested, effective plant and synthetic alternatives on the market these days. And I do know women transitioned through menopause drug-free for millennia (and still do). And I know one more thing - I’m jist a girl who cain say no to Bob and his golden circle of cronies. Where’s Ado-Annie’s pa got to anyway?

© Tuesday’s Horse

The hormone replacement therapy PREMARIN (PREgnant MARes urINe) and other products such as PremPro and PremPhase are taken by millions of women every day. With recent news that these drugs have been medically proven to cause cancer, blood clots, and other harmful medical conditions in women, Wyeth Pharmaceuticals has cut production of Premarin by 50%. Although in the long run this is good news, currently there are 20,000 stallions, mares and foals without homes. Some are being rescued by individuals, some by non-profit groups, but the majority are sent to slaughter for human consumption. For those pregnant PMU mares who still have their jobs, their days of suffering are far from over. They live each day in cramped stalls too small to even lie down, they are denied free access to water, standing for up to six months in a “pee-line” with rubber collection cups hooked tightly around their urethras. Once they have their foals, they are immediately impregnated and brought back to the “pee-line”. The foals are sent to auction, ultimately to slaughter, since they are a “by-product” of the industry. When the mares are too old to bear any more foals, they are then sent to auction, and like the foals, sent to the slaughter house.

Mare in a "Pee Line"

 

The Effect the HRT drug Premarin has on women

Over nine million women take Premarin, or some form of Premarin every day. For over 50 years, Wyeth Pharmaceuticals has been marketing Premarin which was FDA approved in 1942. This “miracle drug” Premarin, produced by Wyeth Pharmaceuticals, earns over $1 billion dollars every year, all at the expense of thousands of mares, foals and women.

The women’s health initiative (www.whi.org) conducted a 5 year government funded study on the effects HRT has on women and the findings were astounding. The HRT drug, Premarin, has been tested and proven to cause serious health problems in women. Blood clots, diabetes, ovarian cancer, dementia and alzheimers are only some of the problems women who have taken Premarin are facing today.

Our goal at Equine Voices Rescue & Sanctuary™ is to be a voice for the horses that need us, and also a voice for women who are faced with the difficult decision of whether to take Premarin or an equivalent HRT drug. I ask you to please take a serious look at the effects the Premarin industry has on women and look deeper into the issues surrounding the production of Premarin and comparable drugs. I hope you will take this information and consult with your doctor about cruelty free, plant based or synthetic alternatives to Premarin. 
 

 
Alternatives to Hormone Replacement Therapy

by Cheryl Hoard

I am frequently asked questions about alternatives to Hormone Replacement Therapy. The use of herbs, essential oils and hydrosols gives more options to adapt to changes during menopause. Herbalism is most effective when used in a holistic approach, which is integration of the body, mind and spirit. Changes during menopause happen not only to the body, but to the mind and spirit as well. Herbs and essential oils can have a positive impact on all these parts of a woman’s life. These same herbs are successfully used to ease discomforts of the female cycle, PMS, menarche and other times when hormonal balancing is desired.

 It is unclear as to exactly how these herbs work to balance the hormones. Some books say that they contain estrogenic properties or activities. Other authors state that true female sex hormones are not found in higher plants, but some herbs apparently contain compounds that influence the production of hormones by the body. It is explained by some that certain herbs are considered precursors to estrogen or progesterone and the action of these herbs are just generally balancing on the endocrine system to help it normalize itself to the point of reduction of uncomfortable symptoms. Sometimes one herb influences more than one gland. For example it has been reported that Ginseng effects the pituitary, hypothalamus & adrenal glands. It so happens that this set of interacting glands has been recognized for centuries by the Chinese as a functional unit influencing stress, aging, sexual function & overall vitality.

This information is not intended to replace necessary care by a qualified physician. It is important to work with your doctor to achieve your health goals in the safest and most efficient manner. Past history or current appearance of cancer is extremely important when considering use of agents that effect levels of the female hormone, estrogen. Just because something is natural doesn’t mean it is safe in every situation.

Because the effort here involves cycles, time is needed to give all therapies a chance to become as fully effective as possible. The point being, this is not the same as treating a cold or flu in which you probably could evaluate the success of the remedy in a week or two. Sometime the time span of several cycles is needed before any conclusions are made.

Regarding questions about using these natural remedies alongside Hormone Replacement Therapy, I can only speak for myself to say that I would integrate the two therapies. I would only do this by working together with my physician to make sure proper levels were maintained. Proper levels of hormones is an individual issue and your doctor will be your best resource. If it were me I would hope to be able to use natural agents to the point of not needing conventional medical treatment. To achieve this goal I would imagine you would have to be tested periodically to know how your levels are changing or maintaining.

One of the most effective tools for maintaining comfort during menopause is diet. Nutritional needs vary greatly for each individual so I’m not going to attempt to make any broad or specific statements about diet. You will know first hand which foods contribute to your well-being and which foods cause you more discomfort. Professional dietary advice is easily available as well. For myself, I am more comfortable with other means besides synthetic hormones to maintain healthy bones. I would rather make enough effort with diet and exercise to avoid osteoporosis. I understand this could be considerable effort needed on my part but that is my choice.

The best advice I have ever seen is a book by Christiane Northrup called Women’s Bodies Women’s Wisdom New York: Bantam Books. 1998. Northrup covers nearly all women’s unique health problems with an all encompassing holistic health perspective. Very few books bring the inclusion of the whole person, (mind, body and soul) into each and every aspect of a condition’s various symptoms as Northrup does. Because she is a practicing MD drawing from her experiences and case histories, makes the profoundness of her findings so outstanding. This book has changed the lives of many. Should be required reading for men, women and doctors. She has recently published a new book specifically about menopause.

Menopause is a time of life highly respected in many cultures where women of this age are given roles or positions of honor and dignity. This is not always the case in our society but I think women need to remember that change can be made into opportunity. Menopause presents an opportunity to consider again your purpose in life which can lead to liberation and new fulfillment. Change can be good! Change can be positive! I firmly believe our thoughts and attitudes greatly influence our physical body so if women approach this time of life without fear of discomfort or fear of unhappiness they are more likely to breeze right through this time with minimal discomfort.

Examples of natural products I would use myself:

WILD YAM BLEND
Contains: Lavender and Geranium Essential Oils in extract of Wild Yam Root and Aloe Gel. Applied externally.

FOR HER EXTRACT COMBINATION CAPSULES
Contains: Dong Quai Root, Black Cohosh Root, Licorice Root, False Unicorn Root, Raspberry Leaf, Saw Palmetto Berry, Squaw Vine Herb, Sarsaparilla Root, Blessed Thistle Herb, Damiana Leaf

FOR HER LIQUID EXTRACT COMBINATION
Same as above but in liquid form.

EVENING PRIMROSE OIL CAPSULES

ROSE GERANIUM HYDROSOL
I know many ladies who like to spray this refreshing hydrosol on their skin to ease hot flashes. A gentle mist on the face, neck and arms can be refreshing and cooling in almost any situation. Contains: Rose Geranium Hydrosol Pelargonium graveolens

HERB BOTANICAL & SAFETY INFORMATION:

Black Cohosh Root Cimicifuga racemosa
Avoid when pregnant or nursing, limit use to 6 months.

Blessed Thistle Herb Cnicus benedictus
Avoid during pregnancy. High doses (more then 5.0 grams per cup of tea) may irritate the stomach and cause vomiting. Allergic reactions to this and other composites are possible.

Damiana Leaf Turnera aphrodisiaca
Safe to consume when used appropriately.

Dong Quai Root Angelica sinensis
Avoid during pregnancy.

False Unicorn Root Chamaelirium luteum
Avoid during pregnancy. Sparing use is recommended for individuals with history of digestive system sensitivity.

Licorice Root Glycyrrhiza glabra
Avoid during pregnancy, nursing, diabetes, hypertension, liver disorders, severe kidney insufficiency, and hypokalemia. Not for prolonged use (over 4 - 6 weeks) or in high doses except under supervision of a qualified health practitioner. May potentiate potassium depletion of thiazide diuretics and stimulant laxatives, as well as the action of cardiac glycosides and cortisol. May cause reversible potassium depletion and sodium retention, resulting in such symptoms as hypertension, edema, headache, and vertigo when consumed in therapeutic dosages over a prolonged period.

Raspberry Leaf Rubus idaeus
Safe to consume when used appropriately.

Sarsaparilla Root Smilax medica
Safe to consume when used appropriately. Some authorities warn it leads to gastric irritation and temporary kidney impairment and advise of potential drug interactions with hypnotics, digitalis glycosides, and bismuth.

Saw Palmetto Berry Serenoa repens
Safe to consume when used appropriately. Regular consultation with a physician is advised when using this herb for treatment of enlarged prostate.

Squaw Vine Herb Mitchella repens
Safe to consume when used appropriately.

Wild Yam Root Dioscorea villosa
Safe to consume when used appropriately. Large doses of the tincture can produce vomiting.

ESSENTIAL OIL BOTANICAL & SAFETY INFORMATION:

Lavender Lavandula angustifolia
Tested non-toxic at low levels.

Geranium Pelargonium roseum
Tested non-toxic at low levels. Avoid in early pregnancy.

REFERENCES:

Blumenthal, Mark., et al Ed. The Complete German Commission E Monographs. Austin: American Botanical Council. 1998.

Duke, James A. The Green Pharmacy. New York: St. Martin’s Paperbacks. 1998.

Gladstar, Rosemary. Herbal Healing for Women. New York: Fireside. 1993.

Hoffmann, David. The Complete Illustrated Holistic Herbal. Shaftsbury, Dorsett: Element Books. 1996.

McGuffin, Michael, et al Ed. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton: CRC Press. 1997.

Mowrey, Daniel B. Herbal Tonic Therapies. New Canaan: Keats Publishing Co. 1993.

Mowrey, Daniel B. The Scientific Validation of Herbal Medicine. New Canaan, CT: Keats Publishing, Inc. 1986.

Northrup, Christiane. Women’s Bodies Women’s Wisdom. New York: Bantam Books. 1998.

Weiner, Michael A. and Janet A. Weiner. Herbs That Heal. Mill Valley: Quantum Books. 1994.

White, Linda B., Foster, Steven and the staff of Herbs for Health. The Herbal Drugstore. Emmaus, Pennsylvania: Rodale Press. 2000