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Newest Developments
(Updated 3/5/04 — Listed newest to oldest)


1860's Wyeth and Bro elixir bottle

Courtesy IGHA archives, PMU/Premarin collection

Wyeth & Bro. Pharmaceuticals (forerunner of Wyeth Inc.) elixir bottle (circa 1861), filled with one-quarter of the average PMU farm mare's pee output per day.

Statistically, 1140 of these bottles filled with PMU will result in the death of one equine in the PMU industry.



Prognosis for Premarin

HorseAid Advisory, November 9, 2003

Sales of Premarin have already plummeted 30% (2003) from their high in 1999 and will continue to do so as more and more studies link the drug to life threatening ailments and women are made more aware of these studies.

Read more...


Women Advised to End HRT at Breast Cancer Diagnosis

Press Release, November 5, 2003

A new study suggests women who develop breast cancer while on hormone therapy should stop the drugs because researchers found tumors that grow more rapidly in the presence of oestrogen become more tame when the hormone is withdrawn.

When hormone replacement therapy (HRT) is stopped, the tumors stop growing, says study leader Dr Nigel Bundred, a breast cancer expert at South Manchester University Hospital in England.


Hormone stimulates tumors

The vast majority of breast cancers in women on HRT are sensitive to oestrogen, and the hormone stimulates tumors that might otherwise remain hidden, Bundred says. Doctors can easily determine if a tumor responds to oestrogen using tissue taken at the time of biopsy to see if the cells are indeed cancerous.

By now it's well known that hormone therapy, and oestrogen in particular, slightly increases the risk of breast cancer in women who take the drugs. Less clear is what women on oestrogen should do if they develop a breast tumor


Halting oestrogen therapy common

The effect of HRT on cancer cells is similar to that of the drug tamoxifen and other so-called anti-oestrogen cancer drugs, Bundred says.

In the United States, halting oestrogen therapy is the common course for women newly diagnosed with breast cancer. But occasionally, and in certain other countries, doctors may continue HRT in these patients because suddenly stopping the drugs can lead to an uncomfortable rush of hot flashes, vaginal dryness and other symptoms of menopause for which women take oestrogen.


Practice might be harmful

The latest study, reported in the Dec. 15 issue of Cancer and available online Nov. 3, indicates that practice might be harmful. However, at least one recent study found women who continued HRT after a diagnosis of breast cancer didn't fare any worse than those who stopped taking hormones. We didn't have any adverse outcomes in terms of breast cancer, says Dr David Decker of William Beaumont Hospital in Michigan, USA, who led that work.

Decker is willing to let women on HRT continue treatment after breast cancer turns up, but admits he's in the minority in this country and that most doctors cease the hormones immediately. Still, there are some patients who just have a crummy quality of life when they stop taking oestrogen.


The research study

In the British study, Bundred's group looked at 140 women treated for breast cancer in England between 1996 and 2000. All had been taking HRT at the time of their diagnosis, but 125 immediately stopped the hormones upon learning they had cancer. The rest continued taking HRT until they had surgery to remove the cancer, a period lasting up to about a month. The researchers also studied 55 other women with breast cancer who weren't taking HRT, using them as a control group.

Of the 125 women who stopped HRT, 106 (about 85 percent) had breast tumors that were sensitive to oestrogen. Twelve of the 15 women who continued taking hormones had such cancers.


Marked reduction in growth

Cancers that grew faster in the presence of oestrogen slowed down markedly in the women who stopped taking HRT between diagnosis and surgery, judging by several molecular markers of tumor growth. Those that weren't oestrogen-sensitive didn't wind down, and for women with these cancers continuing HRT won't make a difference, Bundred says.

Breast cancer is the second most common cancer in women, behind skin cancer. This year, roughly 211,000 American women will be diagnosed with the disease, according to the American Cancer Society, and nearly 40,000 will die from it.


Wyeth's Reduction in PMU Production Creates Surplus of PMU Horses


In the past, HorseAid has been against buying PMU foals at auction, as very little was accomplished in reforming the root of the problem, and a profitable new market was created for those with an economic interest in sending the horses and foals to auction in the first place. Besides, too many organizations were using the PMU foals as a fund raising poster child, which detracted considerably from the issue's legitimacy.

Wyeth's 10/10/03 announcement that it was reducing its number of PMU farm contracts by one-third, now makes that a moot point. HorseAid's focus is in now seeing that all the "surplus" horses that have to be dispersed by Wyeth's recent action do not end up going to slaughter.

Just keep in mind that a lot more than just the PMU horses are at risk of going to slaughter. Every day U.S. horses go north past the Canadian border on their way to slaughter. Let's all make a commitment to save as many horses as we can from BOTH sides of the border.

We know there's less cachet in saving a "backyard horse" than there is in saving a PMU one (we bet you'll never see marchers carrying a big yellow banner saying "Save the Backyard Horses!"), but to us, they are both the same — horses in need. They should be the same to you too.

Solving the PMU farms "problem" is going to take a lot more than just buying a few foals or horses. It's going to take education on the part of all rescue groups concerned with the issue for the women who use the end product. Premarin isn't the by-product of the PMU farms -- the horses are.

HorseAid estimates that for every 100 women who permanently switch from a PMU based hormone replacement therapy to another form of HRT, one horse will be saved.


Study Recommends Not Using Hormone Therapy for Bone Loss


By Denise Grady, October 1, 2003

Hormone replacement therapy should no longer be prescribed solely to prevent or treat the bone-thinning disease osteoporosis, researchers said in a study being published today, disputing the policy of the Food and Drug Administration.

Even though hormones do prevent broken bones in postmenopausal women, the researchers say the benefit is not worth the risks: increased rates of heart disease, breast cancer, strokes and blood clots in the lungs.
 
The federal agency permits the use of Prempro, the combined hormone therapy of estrogen and progestin, a form of progesterone, to prevent osteoporosis.

But agency officials will meet with researchers, including those whose work is being published today in The Journal of the American Medical Association, on Oct. 7 to evaluate the data on osteoporosis. A spokeswoman for the drug agency said it was possible that the approved uses could change.

The only other approved use of Prempro is to treat menopausal symptoms like hot flashes, night sweats and vaginal discomfort. Women are advised to take the lowest dose for the shortest time.

The medical journal report is based on a large government study, the Women's Health Initiative, which compared 8,102 women who took placebos with 8,506 who took Prempro. The study was stopped early when it became apparent that those taking hormones had a small increase in the risk of breast cancer. Its major findings were published last year.

Today's report is a further analysis of the findings on bone loss.

"Even among women at high risk of fracture, there was no added benefit," said Dr. Jane Cauley, a professor of epidemiology at the University of Pittsburgh and the leading author of the study. But, she said, some women with severe hot flashes or great worry about fractures may choose to take the hormones anyway.

Wyeth, the maker of Prempro, said in a statement that decisions about hormone use should be made by women and their doctors.


Hormones may 'boost cancer risk'


The Associated Press, October 1, 2003

OESTROGEN-progestin pills do not reduce the risk of ovarian cancer and might even increase it, according to a study that raises more red flags about a once widely accepted treatment for women going through menopause.

"It's more bad news" for hormones, said American Cancer Society epidemiologist Dr Carmen Rodriguez.

The findings came from the federally funded Women's Health Initiative study, part of which was abruptly halted in 2002 because of evidence that oestrogen-progestin pills raise the risk of breast cancer, heart attacks and strokes.

Previous findings on hormone pills and ovarian cancer have been inconsistent. Some studies, especially those involving oestrogen-only pills, showed an increased risk. But some doctors have theorized that combination pills would reduce the risk because they contain hormones similar to those in birth control pills, which have been shown to lower the odds.

The new analysis found that 32 of the 16,608 participants developed ovarian cancer during about 5 years of follow-ups. There were 20 cases in women who took hormones and 12 in those on dummy pills.

The difference is not statistically significant because the cancer was so rare, but the trend is worrisome, said lead author Garnet Anderson, of the Fred Hutchinson Cancer Research Center in Seattle. The analysis appears in the Journal of the American Medical Association.

"If women have no menopausal symptoms, they should not be taking" hormone pills, Anderson said.

The analysis is "probably the best we have so far," said Rodriguez, though questions remain because so few women developed the rare cancer.

Wyeth Pharmaceuticals, which makes the Prempro pills used in the study, downplayed the results. "It does not prove that there's any kind of causal relationship," Wyeth's Dr Victoria Kusiak said.

Women's Health Initiative data also have linked hormones with an increased risk of dementia, adding to confounding evidence that the pills might contribute to the very ailments they once were thought to prevent.

Hormone pills are approved for relieving hot flushes, night sweats and other temporary problems of menopause, as well as for preventing bone-thinning osteoporosis.

Wyeth has been saying since the first Women's Health Initiative results were published in 2002 that hormones remain an effective treatment for menopausal symptoms, and Kusiak reiterated that women seeking relief should take the lowest possible dose for the shortest possible duration.

The company estimates that 1 million women in the United States were still taking Prempro pills as of June, down from 3.4 million before the study was halted.

An arm of the government study involving oestrogen-only pills is continuing.


New U.S. PMU Production Slated for 2004 Halted by Court

Natural Biologics, Inc., was planning on establishing a large number of PMU farms in the U.S. by 2004, taking a franchise approach to PMU production.

The company had issued several promotional brochures over the past few years listing the following "positive" aspects in becoming a U.S. "Urine Producer": "Urine production is designed to be very profitable", and "The facilities and equipment consist of modified dairy or beef cattle structures".  The brochures went on to state that each farm "will house 50 to 300 hundred mares, and a "premium will be paid for urine quality" ("quality" is usually obtained by restricting the water intake of the horses).

However, on September 15, 2003, U.S. District Judge Joan Ericksen, ruled that Albert Lea-based Natural Biologics misappropriated valuable and confidential trade secrets from Wyeth Pharmaceuticals for the manufacture of its generic version of the widely used Premarin estrogen replacement therapy.

In a sweeping decision handed down on that day, Judge Ericksen also barred Natural Biologics from using a proprietary estrogen-extraction process and formula as well as ordering the company to retrieve and destroy all of the estrogen it has produced to date.

Natural Biologics was also banned from doing any further research on the therapy, must destroy all documents related to the drug, and identify anyone who may have had access to the extraction technology.

The privately held Natural Biologics is the brainchild of brothers David and Steve Saveraid. The pair went commercial in 1997 with the early financial backing of John Albers, a Minnesota native and retired chief executive of the Dr. Pepper and Seven-Up Companies Inc. The company built a 30,000-square-foot $9 million plant in Albert Lea, MN five years ago.

Natural Biologics did not respond to HorseAid's requests for their comment on the Ericksen decision, which has a considerable impact on its future, since the estrogen replacement drug is its only product.

Wyeth filed a lawsuit in 1998 accusing Natural Biologics of trade secret theft. The dispute went to trial before Ericksen in November 2002 and the court proceedings lasted two weeks.

The original complaint against Natural Biologics suggested a Wyeth insider provided information to Natural Biologics about the hormone extraction process and that Natural Biologics "knew or had reason to know that the means of acquisition were improper."

The judge's order also threatens a multimillion-dollar agreement between Natural Biologics and New Jersey-based Barr Laboratories Inc. to develop, manufacture, and market a generic version of Premarin.

The order prohibits Natural Biologics from "providing services, information, materials or other assistance" to "any other person or entity" involved in the development of the estrogen product.

Barr announced its partnership with Natural Biologics in March 2002, offering the Minnesota company up to $35 million in financing over three years. Barr filed a new-drug application with the U.S. Food and Drug Administration in July.

Barr said the court ruling, if allowed to stand, would ban it from using raw material from Natural Biologics to make a generic version of Premarin. A later statement by Barr said it had been informed that Natural Biologics intends to ask for a rehearing or file an appeal. Barr also revealed it has $16 million in outstanding loans to Natural Biologics and that the ruling creates uncertainty over the Minnesota company's ability to repay those loans.

Barr Labs acquired Duramed Pharmaceuticals in 2002. Duramed Pharmaceuticals was unsuccessful in getting its Cenestin brand of HRT medication classified as a generic form of Premarin, and was not able to successfully market the product as an alternative.

(Some of the above information is quoted from David Phelps, Star Tribune article)


Risks Cited in Halting the Woman’s Health Initiative Study

C-MRI Scan
C-MRI Scan showing a tumor in the left breast

A study by the National Institute of Health Woman’s Health Initiative, which was supposed to last eight years, was cancelled prematurely in October 2002. The study concluded PMU hormone replacement therapy increased the risk of stroke by 41 percent, heart attack by 29 percent and breast cancer by 26 percent. Researchers concluded the study was too risky to complete.

Some of the more significant results of the study revealed that HRT users had more than twice the risk of stroke compared with those who never used HRT. The risk went up to three times for those hypertensive women who were using a combination therapy.

JAMA extract of the full report



Cruelty-Free Substitute Challenges Premarin in British Columbia

The means that B.C. pharmacists fill prescriptions for estrogen-replacement treatments could affect the lives, and deaths, of thousands of horses in Alberta, Manitoba and Saskatchewan. That's because in a 1999 issue of "The Bulletin", the official journal of the College of Pharmacists of British Columbia, the college has declared the organic drugs CES and Premarin to be interchangeable.

Both CES and Premarin can be prescribed to women suffering the symptoms of menopause. They are also said to help prevent heart disease and osteoporosis. But while CES is made from soy beans and yams, Premarin is derived from the urine of pregnant mares.

What the College of Pharmacists' decision means is that when a patient who has been prescribed Premarin goes to a druggist to fill that prescription, the druggist may suggest to her that she take CES instead. CES is about 25-per-cent less expensive than Premarin and because it's plant-derived, there are no ethical concerns with its production.

Previously, if a woman wished to substitute Premarin with CES, the pharmacist would be obliged to phone the woman's doctor to ask permission.

Officials at Wyeth-Ayerst refused to comment on either the college's decision or any criticism of Premarin's production. However, a company representative has sent a letter to both the college as well as physicians throughout the province advising them that it is "extremely concerned" about the decision and the way it was taken.

College registrar Linda Lytle said she isn't surprised by the letter since the college's decision could mean a loss of sales for Wyeth-Ayerst in B.C. However, she said Ontario declared CES to be interchangeable with Premarin in 1980 and there has been no consideration to reversing that decision. Quebec and Alberta pharmacists are also considering following B.C.'s lead, she said.

In May 1996, the FDA received data comparing Premarin with CES which revealed that both drugs provided the same amount of estrogen needed to protect women against post-menopausal symptoms and osteoporosis. CES does not contain delta 8,9.


Program Seeks to Generate Non-Slaughter Source Demand for PMU Foals

Those rancher / businessmen involved in the collection of pregnant mares' urine used in the production of controversial estrogen replacement products now have the opportunity to participate in an effort designed to introduce Thoroughbred stallions into their breeding programs.

The result of this effort will be hopefully be perceived as an improvement to the pedigree and value of foals produced in the PMU program, according to the North American Equine Ranching Information Council (NAERIC), the non-profit association representing over 400 PMU farms in Canada and North Dakota.

Ranchers who participate will have their mares evaluated using a scoring criteria adapted from the Alberta (Canada) Horse Improvement Program. A certificate will be issued by NAERIC confirming the physical attributes of the mare, with descriptive data entered into a master database.

Mares that meet the criteria will be paired with loaned or leased Thoroughbred stallions. The stallions will be housed with the participating rancher, or stand at stud in cooperative fashion to groups of PMU ranchers.

Since the resulting foals will be at least half Thoroughbred, they will be eligible for registration in The Jockey Club's Performance Horse Registry (PHR), which was formed to record the Thoroughbred's influence in non-racing equine activities. Thoroughbred / Draft crosses are becoming quite popular in the jumping and dressage arenas, but so far, these particular foals have not been purchased in large numbers by trainers and riders as prospects.

As a representative of its PMU farmer members, NAERIC has a clear interest in countering any criticism of the PMU industry as a whole, and the slaughtering of foals in particular. In looking at the 1999 figures NAERIC posted on their Web site, we noted several inconsistencies. If 24% of all PMU foals are retained for "replacement stock", and a PMU mare is "on-line" for an average of 12 years (NAERIC's figure), that would add up to a 15% animal surplus per year. So where are all the surplus horses being kept?

NAERIC stated (on their FAQ Page, as of 5/22/99, now taken off line), "More than two-thirds of the offspring are either sold to new owners for recreation, ranching and show purposes, other equine activities, or remain on PMU ranches. Approximately 9 percent are sold as show horses, 20 percent for recreational purposes, 15 percent for ranch and rodeo work, and 24 percent as replacement stock. Some foals may eventually be sold to agents who sell them to the international meat market when they are mature. The international market is independent of PMU ranching and would exist regardless of the small number of horses coming from PMU farms."

Unless NAERIC is using some sort of "word semantics" to provide this information to the horse community, we see this statement as plainly saying that two-thirds of ALL PMU foals (approximately 39,690 foals using 1998 stats) are "either sold to new owners for recreation, ranching and show purposes, other equine activities, or remain on PMU ranches", and do not go to, or are ever sold for, slaughter. If that is the way their statement was meant to be interpreted, then HorseAid challenges this statement by NAERIC as being inaccurate.

Please bear in mind, that one of the most ancient of ploys in getting someone to think in the same manner as you, is to give them a vested interest in the issue (money not only buys hay, it buys silence and support as well). The end result of this so-called "Breeding Enhancement Program" may actually be the development of a "MONEY Enhancement Program" for its supporters, and even more unwanted foals on the ground.

NAERIC seemingly places all its trust in the Wyeth-Ayerst dictated "Recommended Code of Practice" (the key word being "Recommended") as a means of insuring against PMU farm abuses, while we place our faith in the lure of greater profits insuring that it doesn't.

In an attempt to "prove" how well the PMU mares are taken care of, NAERIC offers us this bit of soothing news: "During the collection season, mares are housed in temperature-controlled barns, which are approximately 40 degrees Fahrenheit, as compared to the outside temperature which may average minus 40 degrees through the winter. Each horse is stabled in its own stall, the size of which varies depending on the size of the horse. The urine collection system consists of a light-weight, flexible pouch that is suspended from the ceiling by rubber suspension lines. The mares adapt very well to this system, which provides a full range of motion and allows the horses to lie down comfortably. Each horse is provided with adequate bedding, according to the Code of Practice. Ranchers provide food and water for the horses in accordance with the nutritional standards provided by the National Research Council's Nutrient Requirements of Horses. In most barns, hay is available continuously, while water is delivered multiple times per day by automated watering systems, which are designed to keep stables dry. In barns that do not have automated watering systems, the mares are given water at least five times per day and allowed as much water as they want each time."

We challenge just about everything in that paragraph (taken under "fair use" from their Web site).

On October 10, 2003, Wyeth Organics (Wyeth Inc.) announced a reduction of their PMU production contracts by one-third. This reduction is estimated to decrease Wyeth's required number of PMU producing mares by 50%.

Wyeth is currently working with the North American Equine Ranching Information Council (NAERIC) to develop and implement programs to help producers market their mares. In an effort to protect the mares from slaughter, the council is considering a transportation subsidy to move the mares out of the pee provinces and into "legitimate" horse sales in Eastern Canada and the U.S.

NAERIC's position is still unclear at this time as to how diligently it will monitor the dispersal and sale of these horses (under Wyeth's no known slaughter sales mandate).


American Association of Equine Practitioners

The AAEP , under the recommendations of Dr. Nat Messer, who chairs the Equine Welfare Committee, has "officially" sanctioned the PMU industry as it exists today (this recommendation was based on a few "managed" visits by members of the committee to Wyeth "pre-selected PMU farms").

Dr. Messer has been at the forefront of advising Wyeth-Ayerst, manufacturer of Premarin, on how to "better manage" horses on PMU farms.

In a March 1997 article published by the AAEP, Messer is quoted as saying, "It is my opinion that mares being utilized for collection of pregnant mare urine are not being abused, neglected or treated inhumanely...I feel this industry does represent a responsible use of horses and that using horses to produce a commodity for the benefit of mankind is appropriate, as long as the horses receive the type of humane care they do on these farms."

HorseAid would like Dr. Messer to explain how he (and the AAEP) can endorse an "industry" that he says "represents the responsible use of horses" yet claims the lives of thousands of foals and exhausted mares each year, most of whom are then sold to slaughter.

Their slogan says:

"To improve the health and welfare of the horse, to further the professional development of its members, and to provide resources and leadership for the benefit of the equine industry."

But we think that by their current actions, the AAEP leadership is less concerned these days with the "health and welfare" section of that slogan and more focused on the"further the professional development of its members", and "provide resources and leadership for the benefit of the equine industry" sections of it.

AVMA Position on Animal Welfare and Animal Rights:

Written in 1990, the AVMA "position" on animal welfare and animal rights is sorely out of date and out of step with today's views on the subject.

AVMA Joins AAEP in Support of PMU Farm Management:

Arrived at without any primary research into PMU farm conditions on the American Veterinary Medical Association's part. This amounts to little more than "me too" rubber stamp support.

AAEP Equine Welfare Award Finalists Named:

Interesting to note that the finalists listed for the "Equine Welfare Award" are all commercial entities, none of them known for any type of "equine welfare" work that doesn't benefit them (or their members) directly (and mostly financially). Even more interesting -- is that the AAEP's "Links" Web page, lists not one single organization active in animal welfare issues. This is probably their strongest statement on the entire "Animal Welfare" issue. Of course, after we published this information, the AAEP quickly removed the links page in question. Hardly a positive statement on their forthcoming of their real policies and agendas.


Get Involved!

PMU Demonstration - HorseAid / PeTA

PeTA joins HorseAid in the nation-wide "National Two Hours
of Shame" demonstration against the way
Premarin is produced.


FDA Rules Against the Horses
(more politics of Premarin)

On 5/5/97, the FDA rejected generic versions of Premarin - currently the nation's second most prescribed medicine -- saying they fail to exactly replicate the organic brand product. "For something to be generic, it has to be absolutely identical and deliver the same active ingredients as the original product," Don McLearn, a Food and Drug Administration spokesman, said. "They (the generics) haven't been able to do that."

"We're certainly gratified that the FDA has recognized that the science here is extremely important," said Marc Deitch, senior vice president and medical director at Wyeth-Ayerst.

However, the generic companies contended Monday that a heavy lobbying effort by women's groups and scientists on behalf of Wyeth-Ayerst had influenced the FDA's decision. "I think this is a case of politics over science," said Bruce Downey, president of Pomona, N.Y. based Barr Laboratories. Barr and Cincinnati-based Duramed Pharmaceuticals (combined in 2002) are two companies vying to have their generic forms of Premarin approved.

One woman's health organization said saving money isn't worth a potential medical risk. "To take a drug that is so critical to post-menopausal woman and... to have a generic drug that is not exactly the same would be a disservice to women," said Debora R. Judelson, president of the American Medical Women's Association, one of several groups that lobbied against generic forms of Premarin (the American Medical Women's Association, along with Business and Professional Women/USA, Association of Women's Health, Obstetric and Neonatal Nurses and others, have admitted to having received financial support from Wyeth-Ayerst in the past).

All the various protests HorseAid has read against the approval of a generic synthetic alternative to Premarin share one statement in common, and one that is scientifically misleading: That the proposed generic versions of Premarin lack the "same" active ingredients as Premarin.

No one sought to point out that the FDA had decided twice before that Premarin had only two active ingredients, both of which were contained in Duramed's and Barr's generic synthetic version of Premarin. In a 1992 study (often referred to as the "Estratab Study"), it was demonstrated that administering varying doses of estratab, a drug which contained only the two active ingredients, equilin and estrone contained in organic Premarin, delivered the requisite estrogens levels needed to treat post-menopausal symptoms and osteoporosis.

Wyeth-Ayerst's own research has shown that in a significant number of women taking Premarin, delta 8,9 doesn't even appear in the bloodstream in any measurable amount. Yet, these women had the same levels of equilin and estrone and showed the same effect on bone density as those women having a measurable amount of delta 8,9 in their blood workup. No definitive tests comparing conjugated estrogens containing delta 8,9 with conjugated estrogens without delta 8,9 have ever been conducted.

Too bad the FDA decided against the synthetic generics. The benefit to horses from an available generic would be profound. HorseAid estimates that as much as 80% of Premarin prescriptions in the U.S. would soon be replaced by the generic (Medicare and HMO's normally require the use of generics, whenever possible, to reduce medical expenditures -- a generic would cost one-half to one-third the price of organic Premarin, saving female consumers over $300 million a year. Such an enormous dip in the market share for Premarin would result in many thousands of horses being taken out of the PMU "collection" barns).

A new synthetic generic would also most likely be the drug of choice for physicians to prescribe, and so hopefully finally bring an end to the inhumane form of Premarin production now in effect. We can only hope the FDA will reconsider its decision -- and soon.

Although the FDA denied their application, Duramed Pharmaceuticals, 5040 Durame Drive, Cincinnati, Ohio 45213, 513.731.9900, is still trying to get approval on their synthetic version of Premarin (called "Cenestin"). Since this synthetic will NOT involve the use of horses to produce, they are setting an economic example for alternative ways of increasing company profits while decreasing equine suffering.

Wyeth-Ayerst, whose patent on Premarin has expired, is currently strongly contesting the approval of any synthetic on the grounds that it lacks Wyeth's patented estrogen "delta 8,9 DHES". Premarin is composed of 6 different estrogen in combination. The Duramed "generic" lacks one of these estrogen, called 8,9 DHES, that is present only in Premarin and cannot (at this time) be artificially synthesized cheaply.

Wyeth-Ayerst is also trying to use the differing absorption rate factors to block the approval of the generic synthetics (something that Wyeth-Ayerst themselves did not adhere to in the Canadian branded compound).

On June 5, 1997, Duramed Pharmaceuticals announced that it would appeal the FDA's decision, and on July 29, 1997, the company filed a citizen's petition (which is essentially an injunction).

Duramed's petition asks the FDA to declare Premarin's labeling "deficient", and to withhold any new indications for Premarin (Wyeth-Ayerst is currently seeking a new heart disease indication for the drug) until all its active ingredients are fully identified.

Duramed Chairman and CEO Thomas Arington states that "the double standard demonstrated by the FDA in this case is unacceptable."

No matter what the outcome of Duramed's citizen's petition against the FDA is, a dangerous precedent has already been set. Wyeth-Ayerst has been able to delay a decision for six years on approving a generic, that by all accounts and scientific data should have been a "shoo-in", and by so doing, extended its monopoly on the ERT/HRT market at a fraction of the cost of developing a new drug. The horses however, have not been so lucky...

HorseAid believes that nothing short of Congressional hearings into the events surrounding all the reclassifications by the FDA concerning Premarin and the rejection of the generic synthetics are now warranted.

The FDA's own internal documents reveal deep divisions within the agency, and document how scientific data supporting approval of a generic alternative to Premarin was systematically ignored.

There is also ample evidence of inappropriate political pressure being brought to bear on the FDA, as well as many conflict of interest issues. By its action in this matter, the FDA has sent a clear signal that for the right amount of money, channeled into the right pockets, the public health can be bought and sold just as easily as a PMU foal.



FDA Approves Duramed Pharmaceuticals' "Cenestin™"

On March 24th, 1999, the FDA approved the New Drug Application (NDA) of Duramed Pharmaceuticals' "Cenestin" brand of conjugated estrogens (currently available only in USP tablets).

It is important to note that Duramed Pharmaceuticals filed a NDA for Cenestin seeking approval for Cenestin only as an alternative to Premarin instead of the Abbreviated New Drug Application (ANDA -- used when requesting a drug be classed as a generic to an already existing branded drug), they had filed previously -- requesting Cenestin be classed as a generic form of (or direct replacement to) Wyeth-Ayerst's Premarin.

To most doctors (and more importantly, Medicare and the various HMO's) there is a huge difference between an alternative to a FDA classified drug, and a generic version of the same drug.

Cenestin is classed by the FDA as an alternative to, not a generic replacement of, Premarin, and is not currently approved for long term use. Cenestin is entirely plant based.

Cenestin has long been touted as the direct generic replacement to Premarin, but was approved (as stated above) by the FDA only as an alternative to Premarin, not its generic equivalent. Duramed Pharmaceuticals' previous attempts for FDA approval of Cenestin as a generic replacement for Wyeth-Ayerst's Premarin were thwarted because Duramed's composition lacked delta 8,9 -- thus failing to exactly replicate the organic brand product.

Duramed Pharmaceuticals (purchased by Barr Labs in 2002) has so far been unsuccessful in marketing Cenestin as a Premarin alternative for HRT.


Past Reports, News Items, and Medical Studies

Estrogel Available In Canada For ERT

JAMA Reports Estrogen Therapy Quandary

Breast Cancer and Hormone Replacement Therapy

U.S. Study May Help Explain how Estrogens Cause Cancer

American Home Products Study Spurs Mixed Ratings Changes

Heart Attack Risks Associated with Hormone Replacement Therapy


MILLENNIUM

The discontinued television series MILLENNIUM produced by Fox Broadcasting which used to air on Friday nights at 8:00 Central and 9:00 Eastern time had an episode on May 2, 1997 (episode 119) called "Broken World" (with very stark and effective film noir cinematography by Robert McLachlan) regarding Premarin production.

The plot dealt with a serial killer who killed women and their horses because he was jealous of the attention and caring the horses got instead of him. Frank (Lance Henriksen) and friendWhile discussing the case with Claudia Vaughan (Jo Anderson), a local veterinarian, Frank (Lance Henriksen) is shocked when he sees foals being led to slaughter. Claudia explains that P.M.U., or Pregnant Mares' Urine, is the main element in Hormone Replacement Therapy which is the most profitable pharmaceutical in the United States. Mares are deliberately kept pregnant for their urine, and when the animal gives birth, the foal is killed and the meat is shipped overseas. Frank concludes that the killer was raised on a P.M.U. farm.

The exciting climax takes place in a horse slaughterhouse where several of the show's characters come face to face with a "stun-gun" (pneumatic bolt gun used to slaughter horses). This extremely well written (Robert Moresco and Patrick Harbinson), and directed (Winrich Kolbe) episode proves that social issues can be raised and told in an interesting and entertaining way. You can download the trailer from this episode here (Quick Time Movie Format- 1.6 MB).

It was reported to us by a Fox Broadcasting executive that Chris Carter, the Creator of "Millennium", who is also one of the Executive Producers, a sometimes writer, and always the driving force behind this excellent series, used the IGHA/HorseAid Premarin Web Site as the main reference for this episode.

"Millennium" Logo, Production Still, and Episode 119 Trailer Courtesy of FOX Broadcasting Company, Inc. Trademark and Copyright, 1997, All Rights Reserved.


Note that Wyeth-Ayerst has in the past employed the large U.S. public relations firm of Burston - Marstellar, the $200 billion-a-year multi-national public relations empire that put together the 36-company consortium responsible for founding the "Wise Use" movement in 1988, and represents five of the top eight firms responsible for animal use in consumer product testing, as well as National Livestock Inc., to respond to negative publicity generated by "pressure campaigns" like the HorseAid "Op 0", "Just say NO! to Premarin", and "Just say NEIGH! to Premarin" anti-Premarin campaigns.

Remove the profit, and you remove the problem!


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