The cruelty about Premarin

Premarin is produced at Ayerst Organics in Brandon, Manitoba, Canada. Brandon is known as the "PMU capital of the world." Urine extracted from the mares on about 700 PMU "farms" in Canada and the United States is shipped to the processing plant in Brandon. The company sets the quotas, sets the price, and picks the PMU producers, as farmers compete to obtain contracts with "Wyeth" to set up PMU farms. The company also runs a "research" facility in Carberry, Manitoba (near Brandon) which is operated like a working PMU farm. Security there is tight as the "work" and experiments are kept strictly confidential.

For six to seven months of their eleven-month pregnancies, an estimated 80,000 mares are confined to tiny stalls where, contrary to Wyeth-Ayerst's explicit statement, they cannot turn around, groom themselves, or lie down comfortably. They are harnessed in with urine collection pouches fitted over their urethras designed to collect the precious urine. The urine then travels through hoses that lead to plastic containers on the ground in front of each stall where PMU farmers empty them when full for collection and shipment to Ayerst Organics.

The urine pouches and the manner by which they are attached to the mares' bodies often cause infections of their vulvas and chafing of their legs, and make it practically impossible for them to lie down. They are also tied by their necks to prevent them from turning around. These mares get little or no exercise, with some of them actually standing in that position for the entire six to seven months. Due to the nature of their confinement on the "pee lines", the mares are denied the opportunity to assume all of their natural postures. When sleeping, the mares are unable to enjoy the fully relaxed position of lateral recumbence (lying stretched out on their sides). Instead, they must sleep standing up or lying down in the more cramped position of sternal recumbence (lying on their chest with legs tucked up). There is no official government regulation for the treatment of PMU mares, only a "Code of Practice" written by Wyeth-Ayerst for the PMU farmers to follow.

The mares are commonly fed and watered on a time-release basis. They are deliberately deprived of water so that the estrogen is as concentrated as possible. Mares are given minimal amounts of water 17 or 18 times a day. They can be seen trying to drink out of empty water bowls and are in such anticipation of each allotment that they continue to try to drink long after the water is gone. They also exhibit stressful and anxious behavior when they know the water is coming. Liver and kidney disease are common in these mares, as is swelling of the legs.

Life for a PMU

In general, most horses live well into their twenties and thirties, but not PMU mares. The ones who are considered to be "good producers" can stand on the "pee lines" for as long as twelve to fourteen years before being scrapped at the slaughter auctions for meat. The same fate is a common occurrence for most of the mares who don't become impregnated. In the spring, when they give birth and their estrogen levels are down, the mares are allowed out in the fields again...but not for long. They are soon impregnated again and placed back on the "pee lines."

Life for the mares on the PMU farms is so hard that one-fourth of them are replaced each year, even though typical life expectancy for the draft breeds used on most of these farms is twenty years or more.

What happens to the baby horses?

A majority of the mares on Canadian PMU farms give birth on "community pastures," which are on public land. Many of the foals born to the 52,000-plus mares in Canada die soon after birth, unable to survive the harsh conditions of the prairies. The surviving colts are considered to be byproducts and the majority of them are sold for slaughter. Most of the fillies are either slaughtered or kept to replace the worn-out mares on the PMU lines.

Most of the foals are sold at auctions in the fall, at which time they are between two and three months old. They can regularly be observed trying to nurse off each other. The colts are sold by lot where almost all are bought by "killer buyers" (middlemen for the slaughterhouses) and feedlot operators who fatten them up before shipping them to slaughter plants in Canada and the United States. There they are butchered and their meat is then exported to Europe and Japan as a delicacy (with certain cuts selling for $25 per pound) for human consumption.

The fright and terror in these babies is apparent as they are herded through the sales arenas and then on to cramped trailers with canes and electric cattle prods. Some of them are loaded on to the backs of pickup trucks. Injuries are common, but veterinary care is virtually non-existent at these auctions. Young, frail horses are often loaded together with large, heavy horses with no one present to stop the cruel and inhumane treatment during the loading process.

How does Premarin effect woman?

"Women are not horses," said one of numerous medical practitioners interviewed regarding the health issues associated with Premarin, all of whom conclude that the risks may outweigh the benefits of taking this questionable drug.

Here's more of what some of them had to say:

R. M. Kellosalmi, B.Sc., M.D., L.M.C.C., physician and surgeon, Peachtree Medical Centre:
"I prefer to know exactly what I am prescribing," said Dr. Kellosalmi. "Premarin contains a host of unknown ingredients that have not been identified. Any possible effects that could be caused by such ingredients are thus also unknown. The question has been raised as to whether Premarin would even pass if it were applying for FDA approval today, rather than some 56 years ago. In those days, the regulations were far less stringent.

"Estrogen replacement drugs derived from plant-based natural sources are also purer and simpler drugs. Premarin is a complex blend of known and unknown estrogens, most of which are natural for the horse, but not for the human. Some of the plant-based estrogen products contain only the most active human type of estrogen. This is Estradiol, and these simple single entity estrogens have been passed with flying colors by the FDA for the treatment of menopausal symptoms, including hot flashes and osteoporosis. They are fully effective drugs, and certainly do not need to take a back seat to horse urine products.

"'Formulating' or 'Compounding' pharmacies can also produce natural Estriol or Estriol-Estradiol combinations which have been suggested as minimizing the risks of cancers attributed to other estrogens. I feel very strongly that patients have a right to an informed choice, and that includes information which involves ethics, as in the PMU situation."

Allan Warshowsky, M.D., F.A.C.O.G., board-certified obstetrician and gynecologist:
"For many years, Premarin has been the major estrogen for hormone replacement therapy (HRT) in menopause. Most (but not all) of the studies [of HRT] have been based on Premarin. In my view and in the view of many other physicians, Premarin is responsible for a host of women's health problems including such frightening entities as breast and uterine cancer. Premarin has been given with another drug which many consider to be dangerous, medroxyprogesterone (as opposed to natural progesterone), which can add to the adverse health problems.

"There are many natural hormone alternatives made from soy or yam products which can be used instead of Premarin with equally beneficial results, but eliminating the negative effects. I choose to go with the natural hormones whenever possible."

Don Sloan, M.D., F.A.C.O.G., board certified gynecologist

(excerpted from a 1997 letter to fellow gynecologists)
"As a colleague and practitioner in our specialty over the past many years, I urge you to consider the use of medication other than Premarin for your patients in need of hormone/estrogen replacement therapy (HRT/ERT). It is well established and documented in the medical literature that the many synthetic estrogens readily available at the pharmacy will provide them with adequate coverage...Our patients are becoming more and more aware of Premarin's use of equine urine in its production.“

“The validity of using another species' excretion for human use is being seriously questioned...Many reports from reliable sources both in Canada and the United States have described the deplorable living conditions these horses endure, all designed to create maximum urinary output...Such practices should disturb us as sensitive human beings in a profession devoted to the care and well-being of others."

Virginia Reath, registered Physicians' Assistant in Gynecology:
"I like to prescribe naturally-occurring estrogens, such as Estradiol and Tri-Est, a combination of Estriol, Estradiol, and Estrone derived from natural sources [which can be produced at a formulating or compounding pharmacy]. I tend not to prescribe Premarin to my patients. There are options to Premarin and patients have the right to know what they are. Medical practitioners should be informed and able to offer different options to women. I don't think we compromise anything by not prescribing Premarin."

Premarin and politics

The approval by the Food and Drug Administration (FDA) of a synthetic/generic form of conjugated estrogens would virtually end the cruelty and save money for millions of women. Both Barr Labs of Pomona, New York and Duramed Pharmaceuticals of Cincinnati, Ohio have produced synthetic/generic forms of Premarin, but the FDA has not approved either. According to the Boston Globe, "It is impossible to predict when a generic, vegetable-synthetic copy of Premarin will be approved by the FDA. Wyeth-Ayerst, grossing a billion dollars a year from Premarin, has the financial incentive to block a generic substitute and has the scientific and legal consultants to do the job."

According to the Washington Post, "Wyeth-Ayerst has played Washington hardball, lining up support from women in Congress and women's organizations. The pitch to the FDA has been that the generics don't contain delta 8,9 dehydroestrone sulfate, an ingredient of Premarin that the FDA has repeatedly found to be an impurity and not a required component of any generic... Nevertheless, Wyeth-Ayerst, which holds the patent on delta 8,9, has been saying both in a citizens petition filed with the FDA and in its public relations campaign that it may be a key ingredient and that the FDA should require it to be included in any generic version."

This is only one of Wyeth-Ayerst's attempts to spin up a wall of pseudo-technology to block generics. In 1991, they persuaded the FDA to withdraw its approval of generics because they were absorbed into the blood faster than Premarin and, according to Wyeth-Ayerst, this faster absorption could increase cancer incidence. FDA took this step and called for lengthy studies of the issue even though Wyeth-Ayerst was selling a fast-absorption version of Premarin in Canada.

Meanwhile, Duramed and Barr went ahead and addressed the absorption issue and were, in 1995, given reason by the FDA to expect approval, but pressure on the FDA from members of Congress and several women's organizations, all of which have received significant amounts of money from Wyeth-Ayerst, led to the delta 8,9 debacle. An internal FDA document from May 1997 is the latest to cite this substance as an impurity and names at least 25 more impurities of unknown medical properties found in Premarin.

Something other than science or medicine appears to be keeping the FDA from approving generic alternatives to Premarin.

What is the good news?

There are numerous alternatives to Premarin, including synthetic estrogens and changes in diet and lifestyle which can be at least equally effective in treating menopausal symptoms without involving cruelty.

* ALTERNATIVE ESTROGENS: Vegetable-derived Estrace is the second most prescribed estrogen therapy drug. There are others including Orthoest, Ogen, Estradiol, Estriol, Estrone, Estrovis, Estropipate, and the Estraderm and Climara patches, and others, all of which are considered to be effective for hormone replacement therapy. Ask your doctor to go over the choices with you.

* OTHER HORMONES: Estrogen is not the only hormone produced by pre-menopausal women's bodies, and therapies including progesterone and other naturally occurring hormones in addition to estrogens appear, in some cases, to offer better mitigation of symptoms with less risk than estrogen-only therapy.

* RALOXIFENE: Produced by Eli Lilly, this new drug increases bone density and, unlike Premarin, involves no risk of breast cancer or cancer of the womb (uterine cancer). It also appears to protect the heart.

* DIET: "There is no Japanese word for hot flashes," writes physician and author Dr. Neal Barnard. In his book Eat Right, Live Longer, he says, "Diet is a great contributor [to hot flashes]. It has long been known that menopause is much easier for Asian women than for most Westerners," referring to the low-fat, tofu and rice-based diets of many Asian women.

* PHYTOESTROGENS: Foods including flaxseed, soy milk, and tofu contain naturally occurring estrogens known as "phytoestrogens." Books like Estrogen: The Natural Way by Nina Shandler and Dr. Susan Love's Hormone Book, encourage diets high in phytoestrogens. Shandler's book also includes recipes for adding foods with phytoestrogens to meals.

You can purchase a copy of “Better Than the Blue Pill” by Dr. Julian Whitaker about HRT (Hormone Replacement Therapy) (800/539/8219), where you can read about alternative estrogen therapy drugs.
 
All questions of a medical nature should be taken up with your doctor.

WHAT YOU CAN DO

*Support The Gentle Barn’s new Premarin babies and give directly to an organization that is spreading the word on a daily basis and needs support for their horses.

* Call Wyeth-Ayerst in the United States (800) 666-7248 to protest how Premarin is produced. (For Canada, call 215 971-5823). Write to Robert Essner, President of Wyeth-Ayerst, at P.O. Box 8299, Philadelphia, PA 19101 and let him know how you feel.

* Write to Dr. Janet Woodcock at the FDA and express your demand for that agency's prompt approval of one or more synthetic/generic forms of Premarin to make them available to those who wish to use them. Write to her at: FDA, 5600 Fisher's Lane, Rockville, Maryland 20857.

(PLEASE act immediately on this last suggestion as the approval of a synthetic/generic form of Premarin would virtually stop the cruelty and use of horses in the PMU industry.)

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