The sad story of Premarin

Hey, ladies. Here’s a thought. If you wanted to end the practice of milking pregnant mares of their urine for estrogen, the horror on the highway Saturday night probably could have been prevented.

Here’s the sequence. Multinational drug empire holds the patent on a drug that replaces estrogen in menopausal women, although there is a perfectly useable vegetable based product available.

The drug – _Premarin _ is derived from horse urine. The mares are locked with shackles inside dark stalls and kept from water so their urine is more contaminated and this better for the Premarin.

The foals that eventually arrive are viewed as “trash” horses in the trade and are sent to slaughter in cramped stockyard vans.

It’s ugly.

If women arose as a unified angry political force, all this would end tomorrow because the industry could not long endure a boycott on all its optional drugs and the profit that comes from them.

Here’s a primer from an advocacy group trying to stamp out the drug:

What is Premarin(e)?

Premarin® stands for Pregnant Mares' Urine (PREgnant MARes' urINe); PMU for short (we spell it both ways, with an "e", PREgnant MARes' urINE which is the older name used in Canada, and without -- which is the more popular recent spelling, and the one that is a U.S. registered trademark).

Premarin (including Prempro, Premphase, Prempac, and Premelle) is a drug made up of conjugated estrogens obtained from the urine of pregnant mares -- put out in many forms (pills, creams, injections, patches, vaginal rings) and is used to reduce the symptoms of menopause in women or women who have had a hysterectomy. It is also prescribed to nearly eliminate the risk of osteoporosis (the brittling of bones) and reduce the chance of heart disease in women over 50.

As of November 2003, approximately nine million American women are still taking some form of Premarin (1 million women in the United States were still taking Prempro pills as of June 2003, down from the 3.4 million taking the drug before the negative Women's Health Initiative study results became known). This is a reduction of 25% from the high figure of approximately 12 million women taking PMU based medications in 1999. See also HorseAid's "Prognosis for Premarin".

About a third of the approximately fifty-five million post menopausal women in the United States are on estrogen replacement therapy (ERT), or hormone replacement therapy (HRT), and of them, about 49% currently use PMU based products (down from a high of 79% in 1999) -- while there are a number of estrogens excreted by the pregnant mare, estrone sulfate, equilin, and equilenin are the most significant.

It is the only human estrogen replacement drug that is derived from an animal (hormones beginning with the letter "e" are specific to equines, hormones beginning with the letter "h" are specific to humans).

The company that distributes and markets it world-wide, Ayerst Organics Ltd. (the world's only producer of PMU) is a subsidiary of Wyeth Inc. (Wyeth Laboratories, Inc. traces its roots to Philadelphia, Pennsylvania, U.S.A., where, in 1860, John Wyeth and his brother Frank established a drugstore). Wyeth Inc. is the world's eight largest drug maker (2003), falling from the seventh position it had held for many years.

What's in it?

Premarin tablets contain:

• estrone
• equilin
• 17 alpha-dihydroequilin

Together with smaller amounts:

• 17 alpha-estradiol
• equilenin
• 17 alpha-dihydroequilenin as salts of their sulfate esters

Premarin tablets also contain the following inactive ingredients:

• calcium phosphate tribasic
• calcium sulfate anhydrous (white tablet only)
• calcium sulfate
• carnauba wax
• cellulose
• glyceryl monooleate
• lactose
• magnesium stearate
• methylcellulose
• pharmaceutical glaze
• polyethylene glycol
• stearic acid
• sucrose
• talc
• titanium dioxide

ALL Premarin medications are non-synthetic organic, and ALL Premarin is derived from estrogens extracted from Pregnant Mares' Urine (PMU). If you ever doubt where Premarin comes from, just break open a pill and smell it!

How Long Has This Drug Been in Use?

Introduced in 1942, long before synthetic or non PMU organic alternatives existed. Premarin was one of the first drugs available when hormonal therapy for menopause was introduced. The industry thrived (mostly in Ontario, Canada) for decades until allegations of catheterized mares living in squalor and foals being mistreated could no longer be ignored.

The Ontario Government stepped in and issued regulations tied to licensing, citing, and revoking permits (PMU Farm Act, 1968-69, Regulation No. 217/70). In 1975, it became American Home Products (now Wyeth Inc.) biggest selling and most successful ever prescription drug.

How Long Has HorseAid Been Involved in The PMU/Premarin Controversy?

Since 1986. HorseAid was the first equine welfare organization to do an in depth "hands-on" (and on-site) investigation into the operation of the PMU farms and the suspected health risks to women taking PMU based medications. Up until that time, no animal rights/welfare organization had ever reported on the horse abuses that were occurring on the majority of the PMU farms or the linked risks in taking HRT medications.

This was before the advent of the public Internet or Web, so our information had to gathered the "old fashioned way", by on-site visits and following the paper and money trails of the various aspects of the PMU/Premarin industry. We published the results of that initial 1986/87 investigation (with photographs) in our 1988 Fall/Winter issue of Equine Times News (ET-News, forerunner of our current Running Free publication) under the heading, "The Pill that Kills".

In 1993, Animal People Magazine published an extensive article on the PMU farm abuses, also noting the suspected health risks to women taking PMU based medications. HorseAid collaborated with APM on some of the statistics for that article. APM was the first wide circulation magazine to do such a report. Both of these articles appeared long before PMU farms abuses and Premarin based medications became a favorite fundraising issue for some of the organizations that later became involved in the controversy.

HorseAid was also first to publish the PMU/Premarin controversy on the Internet — in 1994, under the page heading "PREgnant MARes' urINe, Curse or Cure?". Second only to the HorseAid equine rescue and adoption programs, our PMU/Premarin research has been HorseAid's greatest expenditure in both funds and volunteer resources.

Why Are There Still PMU ("pee") Farms in Existence?

Good question. HRT drugs containing PMU, like the hormone replacement insulin before it, can now be 100% synthesized or organically compounded PMU free.In 1982, the U.S. Food and Drug Administration approved the use of insulin derived from recombinant-DNA techniques (using bacteria cultures) for diabetic patients who, heretofore, relied solely on insulin derived from the pancreases of pigs to control their disease ("pig"* sincerely thanks you, FDA!). So, like we no longer use pigs for human hormone replacement sources, we shouldn't (and don't have to) use horses either.

(*"the pig" content courtesy of Universal City Studios, Inc. © 1996, All Rights Reserved)

However, the FDA ruled in 1997, that because of the delta 8,9 DHES factor that the synthetics and non PMU organics lack, "generic" forms of the drug do not meet the "identical active ingredients/efficacy" test that is required under the federal Waxman-Hatch Act of 1984 of a "generic substitute".

Formerly, the FDA classified delta 8,9-dehydroestrone sulfate (named after the new molecule's shape) as an "impurity", now it's a "concomitant" (concomitants are defined by what they are not. They are not active ingredients and they are not impurities -- both the USPC and the FDA had declined in the past to re categorize delta 8,9 as an active ingredient).

Since the FDA readily admits it has no conclusive clinical proof what role, if any, delta 8,9 DHES plays in Premarin ERT/HRT (the FDA's Office of Clinical Pharmacology and Biopharmaceuticals found that "none of the pharmokinetic data presented by the firm [Wyeth] can be interpreted as demonstrating that delta 8,9 or its metabolite 17-B is essential to the estrogenic activity of Premarin." — also adding that "the data submitted by Wyeth was either incomplete or conflicting."), and since Wyeth has advanced no valid clinical claims for delta 8,9 DHES -- instead asking for the new "concomitant" category so it could use its patent on delta 8,9 to block its competitors from adding delta 8,9-dehydroestrone sulfate to any new synthetic or organic generic.

HorseAid wonders what led to this "sudden" about-face by the FDA? We are sure we will get an honest answer to that question when "pig"* (who as you know, loves horses) also learns to sing a different tune.

While Wyeth-Ayerst and the FDA would like women to believe that the above decision was based on good health management practices, in reality -- it was the lobbyists that steered the FDA toward this decision (which seems to be entirely politically motivated), is full of unresolved conflict of interest issues, and characterized by some very questionable political maneuvering.

On March 24th, 1999, the FDA approved the New Drug Application (NDA) of Duramed Pharmaceuticals' "Cenestin" brand of plant based conjugated estrogens. It is important to note that Duramed Pharmaceuticals filed a NDA for Cenestin instead of the previous Abbreviated New Drug Application (ANDA) used when requesting a drug be classed as a generic to an already existing branded drug, thus not requesting the FDA classify Cenestin as a direct replacement generic form of Premarin (the previous ANDA, which the FDA denied, was to class Cenestin as a generic form of Wyeth-Ayerst's drug Premarin). Duramed Pharmaceuticals however, was unsuccessful in marketing the drug as an "alternative" to Premarin.

Despite synthetic and non PMU based organic FDA-approved alternatives (Ogen, Estrace, Estradiol Transdermal System, Estradiol tablets, Estropipate, Estrone, Meneste, and Cenestin, to name a few), production of the PMU based organic material is good for the Canadian agricultural industry. As in America, there aren't many ways for farmers to make a living anymore.

Most of the Canadian PMU farms have re-emerged in Manitoba, Alberta, and Saskatchewan, where there are relatively few laws governing the industry as there are in Ontario.

On October 10, 2003, Wyeth Organics (Wyeth Inc.) started its first round of cuts in their PMU production contracts by notifying PMU farmers in Alberta, Saskatchewan and Manitoba that they'll be reducing the number of ranchers who produce the urine by one-third.

The continued production of Premarin based medications produces revenues of 1.2 billion dollars annually for Wyeth-Ayerst Laboratories, the only pharmaceutical company which manufactures this product (of Wyeth Inc.'s 2002 net sales of 12 billion dollars world-wide, sales of Wyeth's Premarin branded drugs accounted for 13.35%).

As Premarin sales continue to plummet in the U.S. and Canada,
Wyeth, Inc. seeks to increase sales in foreign markets to compensate
Premarin, once the most prescribed drug in America (1975 to 1999), is now (2002) the fourth most prescribed drug in both the U.S. and Canada, holds 75% of the estrogen supplement market worldwide, and is Canada's most lucrative pharmaceutical export to date. Premarin is also expensive -- a typical regimen usually costs more than $400 per year to maintain, including physicians fees (1998). It ranks at number ten in Medicaid subsidized prescription drugs (subsidized by U.S. taxpayer dollars).

Premarin is produced at Ayerst Organics Ltd. in Brandon, Manitoba, Canada (which we call the Canadian "pee provinces"). Urine extracted from the mares on the PMU farms (both in Canada and the United States) is shipped to the processing plant in Brandon.

The demand for Premarin based meds was once rising so fast among the maturing "Baby Boomers" that Ayerst Organics, Ltd. built a new factory there to handle the increase. Wyeth-Ayerst sets the PMU farm quotas, the price, and picks the producers. Their control of the entire Premarin industry is both complete and absolute.
Wyeth-Ayerst Laboratories was also the manufacturer of fen-phen, the diet drug withdrawn under FDA pressure in September, 1997 for causing heart-valve leakage in people using these medications (and the cause of several tort lawsuits against Wyeth settled in favor of the plaintiffs).

Until they were withdrawn, Wyeth-Ayerst continued to actively and aggressively promote this drug combo that was found to be dangerous and life threatening to those using them, even though there were reports of the negative side effects of these medications long before Wyeth withdrew them.

The fen in fen-phen refers to Pondimin (fenfluramine) and Redux (dexfenfluramine), both sold by Wyeth. Phentermine, the other half of the combo, is not made by Wyeth and is still available.

A 1999 lawsuit claimed that Wyeth-Ayerst Laboratories hired ghostwriters for articles promoting obesity treatment and then used prominent researchers to publish the works under their names. It again seems by these revelations that Wyeth Inc. (the parent company of Wyeth-Ayerst Laboratories), is more interested in promoting consumer sales than consumer health.

Deborah Hayes, 46, is one of about 70,000 people who have opted out of the company's $3.75 billion trust fund for injured fen-phen patients, so the large settlement does not bode well for Wyeth.

A jury in Beaumont, Texas, awarded Hayes $810,000 for future medical expenses and $500,000 for future mental anguish. She had sued Wyeth's pharmaceutical arm, Wyeth-Ayerst Laboratories, claiming a valve in her heart was damaged after she took fen-phen for 90 days over a six-month period in 1999.

Madison-based Wyeth, has set aside $16.6 billion to cover fen-phen settlements, including $2 billion reserved in the last quarter. It has paid more than $13 billion in claims, including part of the $3.75 billion trust fund resulting from a huge national class-action settlement.

Wyeth shares closed down $2.98 at $39.72 in trading on the New York Stock Exchange Friday. The shares are down from about $50 in July 2002.

What Are the Living Conditions of the Mares?

Since there are approximately 431 current Canadian and U.S. PMU farms (but only 308 producing farms as of 11/1/03), and not having visited each one, HorseAid can only generalize based on the ones we have visited (our last visit was to Canada by our HorseAid founders and volunteers in May and June of 1999, that included a side visit to Minnesota).

Pro-PMU people focus on the fact that the mares live out in 1,000+ acre pastures with their foals for up to six months of the year (on most PMU farms, mares are 175 - 185 days pregnant when the collection period begins. Estrogen production starts to peak between day 200 - 275 of pregnancy, then decreases to parturition. Mares are collected for a period of 160 - 180 days with the collection period usually being from October to April).
Anti-PMU people focus on the fact that the pregnant mares are kept tied up indoors for at least six months out of the year.

PMU farmers work to maintain a constant urine volume to meet both their quota requirements and the urine grade. Mares usually produce 90 - 100 gallons of urine throughout the collection season. On a daily basis, a pleasure horse type mare will produce about 0.5 - 0.6 gallon per day while a draft type mare will produce up to 0.75 gallon per day.

To produce Premarin, these mares are impregnated, fitted with a UCD and normally kept throughout their last six months of pregnancy in stalls just 8 feet long, by 3 1/2 feet wide, by 5 feet high! Just before foaling they are taken "off line" and allowed to foal in outside paddocks (90% of the mares will carry a foal full term). In most cases they are impregnated by natural cover (artificial insemination has been tried in the past to "streamline" the operation, but was discarded as too expensive).

Within six months of a successful breeding, they are returned to the PMU production line again (mares that do not become pregnant within a very short time, cannot be returned to the collection barns and will most likely be sent to auction or straight to the slaughterhouse).

Foals removed from the mare are sometimes fattened on feedlots and then sold for slaughter ("The Foals of August"). The ones not sent to feedlots go straight to the meat auctions, or are sold to resale agents. A small number are sold by foal rescue operations to mostly U.S. rescue organizations.

A filly foal has a less than one in 10 chance of not going to slaughter, a colt foal, less than one in 50!

As far as the use of catheters are concerned, PMU supporters say that they are no more (and in fact our research shows they were never used industry wide, if used at all) -- now "urine collection devices" (UCD's) are used. The UCD's are not very hygienic for the mares, since they allow the urine to soak the skin of the vulva, sometimes causing severe infections and painful lesions.

As for the actual living space they have, current PMU farm guidelines (strictly "voluntary" guidelines that have no consequences, and are not enforceable in any way) state that for horses weighing under 900 lbs. the width of the stalls should be no less than 3.5 feet in width; for horses over that weight, the width is increased to 5 feet.

This may well be large enough for the horses to lie down -- but so is a coffin for a person. Would you like to sleep in one? While pro-PMU people, PMU farm vets included, say that it's enough room to lie down and sleep, some have contradicted themselves in print by saying that "horses can sleep standing up anyway."

Horses can lock their legs and doze, but they must lie down for their essential 'deep sleep' period (in the wild and in pasture, horses lie down approximately three hours for every twenty-four). As for exercise, the guidelines leave that up to the discretion of the farm manager or farm employees.
HorseAid has carefully reviewed the guidelines with leading animal husbandry veterinarians and found them insufficient to protect either the wellness of the mares or the thousands of foals they produce. Our latest investigations reveal that even these inadequate guidelines are not being followed.

Pro-PMU people say, "It's 20 below zero out there in the winter, which is when the mares are confined. It's more humane to keep them inside." However, no indoor arenas or turn-out pens were observed in any of the farms we visited. There are an estimated 125 producing mares on each farm (averaged across all farms - 150, if you include reserves, "hires" and foaling/nursing mares), and to hire employees to hand-walk each one even once a day would not be cost-effective (and so, usually not done).

As a result, the already too-fat mares have problems with stocking up, soreness and hoof/wall separation. At almost EVERY farm we visited, there was some form of respiratory distress evident in the mares "on-line".
In addition to the physical stresses, mentally -- horses cannot be compared to other constantly penned, tethered livestock (such as dairy cattle).

Horses are not cows!

Horses are by nature wanderers, and although it is also not right for the privately owned horse to be cooped up in a box stall day after day, this is a completely separate issue: These mares are actually tied up in front and strapped in behind. They absolutely cannot turn around or take more than two or three steps forward or backward.

As for feeding, the horses are more than adequately fed -- most farms feed hay, grain and oats, which is in excess of what the sedentary mare requires. PMU detractors say that this is to keep them in profitable slaughter-weight for when they break down.

Guidelines state that horses should be offered water no less than twice per day (now amended, because of adverse publicity, to twice that). Still, although the urine volume is less, PMU farmers supposedly prefer to water as little as possible, thereby increasing the concentration of estrogen in the urine -- which is what it's all about (the farmers are under contract to Ayerst for a certain volume of urine per collection season. They are paid based on the concentration of estrogen in the urine shipped). Contracts vary with each farm, but generally, the gross revenue from pregnant mare urine ranges from around $2,000 to $2,500 per mare per year.
Farmers, the low-men on the economic totem-pole in this business, are paid up to $11.00 U.S. dollars per one gallon of PMU (about $0.00275 per gram of estrogen collected). 43 million U.S. dollars was generated off of urine sales in 2002.

Typical PMU producing farm "collection" area

Are the Foals Really Sent to Slaughter?

Some of the farms observed, do breed quality draft and Quarter horses (and obviously care about the welfare of the horses they breed), while others use combinations (Appaloosas, Belgians, "Generics", Percherons, and Thoroughbreds) of both registered and unregistered horses purchased at local auction (the most common breed being the Quarter horse, which is coincidentally, the most desirable horse breed slaughtered for human consumption).
The offspring from the former are sometimes sold for show purposes and sometimes fillies are raised to go 'on line' as soon as they're able to conceive (usually at the age of 20 - 24 months), but mostly they go to slaughter.
As for the latter, their future is almost 100% death. "This also true of pleasure horses' unregistered foals sold at auction," pro-PMU people say. HorseAid doesn't dispute that, but we're not discussing privately owned pleasure horses here -- we're talking about PMU foals.
Pro-PMU people argue that there is no slaughter market for foals that young. There is certainly no market for them as pleasure horses to be used in the private sector that young either -- but meat is meat (tender foal meat is particularly in demand in Japan).

"Unknown" filly foal being rendered while still alive
(slaughter is the unlisted primary ingredient of all PMU based drugs)
Tom Hughes (Canadian Farm Animal Care Trust) has publicly stated "Most of the foals from the average PMU farm will be sold purely for meat."
Ollie Bracken, a retired Manitoba, Canada PMU farmer, stated in a 1995 interview that he retired from PMU farming because, "When you have to see a colt being born and then have to destroy it, it's rough because they're just babies. I just didn't think it was right to continue what I was doing." He is only one of many in recent years that have abandoned PMU farming for other Ag pursuits.
Most of the PMU foals going to auction (the largest auctions are held in Virden and Winnipeg, Manitoba), will eventually go to slaughter (the Canadian killing plants are located in Lethbridge and Fort Macleod, Alberta; Laval, Massueville and Yamachiche, Quebec; and Owen Sound, Ontario.
In 2002, the number of foals sold directly to slaughter sources by PMU producers and independent agents dealing in PMU foals, was approximately 15,000 in number (from all venues - our figures, obtained from various official sources, show that between 13,000 and 17,000 foals went to slaughter sources in 2002). This includes foals sold to co-op "feed lots" (where they are fattened up to fetch a better price).
Figure approximately $250 to $350 a head for unfattened "real" PMU weanlings, and $450 to $650 for fattened ones (usually sold at Trois Rivieres), and there is some real money to be made from the selling of these foals.
Note that the above 2002 foal slaughter figure does not directly include neo-natal deaths, but these deaths may have contributed indirectly to the above total as it is customary to sell these dead foals for "by-product" rendering.
Let's not forget that more than just the PMU foals are affected by the Premarin "pee farms"; the total number of mares, replacement mares, stallions, and PMU foals adversely impacted by PMU production is currently estimated by HorseAid to be at over 75,000 per year.
Our figures (cross-checked against various sources, official and unofficial) obtained on our October 2003 Canadian and U.S. inquiries, list somewhere between 40,000 to 50,000 mares on the PMU "pee lines" (U.S. and Canada) in 2002. Because of the PMU farms contract cuts, about 50% of the pee line mares will be taken off line by the end of 2003.
Foals are also sent to "open" and "specialty" feedlots to be fattened and eventually slaughtered. The meat is then exported to affluent European and Asian markets for human consumption. Some of the feedlot-raised foals are even shipped live to Japan at great expense (thereby violating the USDA "no live export for slaughter" regulations).
Several years ago, HorseAid was able to track over a hundred PMU foals shipped from feedlots in Canada (classified as "feeder horses" by the USDA) to an export quarantine station near Seattle, WA (U.S.). From there, they were shipped live to Japan. One of our HorseAid founders (Staci Wilson, pictured left, giving a TV interview in Tokyo about the fate of these foals) traveled to Japan (on her personal funds) to confirm that the horses were indeed going to specialty meat markets there. So we know first-hand that these foals were not destined for someone's stable, they were destined for someone's table!
In our May/June, 1999 investigations into PMU production practices, we again uncovered that foals, yearlings (and sometimes even older horses) were being shipped live from Seattle's SeaTac airport via a foreign air carrier destined for the Asian market (and most likely human consumption).
One fact that is often overlooked is the neonatal mortality rate on PMU farms. The Canadian magazine "Canadian Veterinarian" in its February 1996 issue (Volume 37) ran a study under the title of "Risk factors associated with the incidence of foal mortality in an extensively managed mare herd" (by Shawn D. Hass, Frank Bristol, and Claire E. Card), in which they state that in a study of 415 PMU farm mares, a 67% foal mortality rate was observed in the first week following foaling, followed by a 45% foal mortality rate during the following week.
This very intensive statistical study goes on to suggest that the mortality rate observed in the 415 mare control group may be typical for all PMU "managed herd" farm operations. The principal cause of death noted for the foals was exposure and starvation (the mares are usually turned out in large unsheltered open paddocks, very often in sub-zero temperatures, to deliver their foals).

How Are These Horses Monitored?

There is a set of guidelines ('Recommended Code of Practice'), which suggest that the horses be "exercised as is necessary for their welfare"; that bedding of some kind "should" be provided on the non-skid (brushed cement) floors; that horses "should be offered water no less than twice per day" (amended, because of adverse publicity, to twice that), and so on.
But remember that the 'guidelines' (which are quoted over and over by pro-PMU people as being "written in stone" and the absolute safeguard against abusive practices) are strictly voluntary, not enforceable, and a failure to comply carries no adverse consequences (hardly "written in stone" nor any kind of a realistic safeguard). The Ayerst Company employs the PMU farm inspectors -- doesn't that seem a little bit like the wolf guarding the hen house?
There is no doubt that things have certainly improved since the 50's, 60's and early 70's. People are more aware now, and no company or entity likes negative publicity. However -- there are now many synthetic and non PMU organic alternatives! Why not use them instead and spare the horses this half-life they must endure without reason?
Detractors of animal welfare supporters say that if the PMU farms are suddenly shut down, "Where will all the mares go?" "Over 40,000 mares would go to slaughter!", they say -- but 15,000 foals are already going to slaughter right now, so what's their point?

What Can I Do?

If you are currently taking estrogen-replacement drugs, find out from your doctor or pharmacist if they are PMU based, synthetic, or non PMU organic. If the former, you can demand that your medication be switched to a synthetic or non PMU based organic form of HRT (which reportedly have less side-effects than PMU-based ones anyhow).
Many women have also been successful in using "natural" estrogen replacement approaches to hormonal shifts, and the new SOY protein studies are proving very promising (ALWAYS check with your medical doctor or health practitioner before starting or changing any estrogen replacement therapy!).
Lastly, help spread the word and let other horse lovers know about this billion dollar industry based entirely on the suffering of horses.
What is The Prognosis For Premarin?
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.
On October 10, 2003, Wyeth Inc. effectively cut its Premarin family of drugs production by a third when it announced that it was reducing its PMU producing contracts by a like amount. HorseAid predicts that this is only the first round of cuts in PMU producing contracts that Wyeth will announce.
Wyeth is already downplaying the use (as well as the length of use) of its Premarin family of drugs, a complete turn-around to the stance they followed for many years. While HorseAid hopes that Wyeth's new use guidelines are based upon Wyeth's concern about the risk issues linked to taking the drug, we think that it's in part motivated over the concern of future tort litigation. To their credit, in January of 2003, they issued a safety alert detailing new FDA recommend doses and uses, as well as new labeling for their Premarin family of medications.
Wyeth has already learned in the fen-phen mass tort and subsequent settlement, that successful tort litigation can affect a corporation's bottom line quicker than plummeting sales. While there are several ongoing tort actions against Wyeth dealing with the associated health risks in taking Premarin, these actions have yet to reach a mass or class tort status. You can bet that there are some very large law firms specializing in mass torts that are circling the Premarin risks issues like hungry sharks. We know it, and Wyeth knows it as well.
In July of 2003, federal regulators approved a lower-dose version of Premarin based HRT, and it is this lower dose that Wyeth is now recommending (specifically Prempro 0.45 mg/1.5 mg doses). Prempro 0.45 mg/1.5 mg contains 28% less estrogen and 40% less progestin than the current standard dose (Prempro 0.625 mg/2.5 mg). This new focus by Wyeth is cited as one reason for its recent cut in PMU producing contracts.
Since the lower doses of Premarin based medications that Wyeth is now recommending are too new to have a research history, it is not known if they will significantly lower the associated health risks in taking the medications or not. Our own medical consultants are predicting that the lower doses will not significantly lower the overall risks to the women taking them.
In the event that our predictions are accurate, we further predict that Wyeth will ask for approval of even lower doses in the future, until only traces of Premarin are present in the marketed drug. At which point, Premarin based HRT medications will be nothing more than an expensive placebo, albeit one almost entirely devoid of health risks.
As long as Wyeth vigorously defends its patent protection on delta 8,9 DHES — HorseAid believes the FDA will never approve a generic replacement for Premarin. While most medical doctors will prescribe a generic equivalent of a drug, most will not prescribe a non-generic replacement. This is probably the main reason several HRT medications touted as direct non generic replacements to Premarin have failed to catch on.
In September, HorseAid filed a petition with the FDA Advisory Committee asking for a clarification on why the FDA had not removed their approval of PMU based medications from the U.S. marketplace in light of the many studies (many FDA funded) showing a link between the Premarin family of medications and several severe health risks associated with their use.
In early to mid 2004, HorseAid will file a citizens petition with the FDA to show cause why Premarin based HRT medications should not be pulled from the U.S. market as unsafe and a health risk to consumers. This petition will include over a thousand supporting documents, including the FDA's own study group and the comprehensive 2002 National Institute of Health Women's Health Initiative HRT study.
HorseAid's prognosis of Premarin's future: While no one action or study in itself will kill the current market for Premarin based medications, HorseAid believes that the overwhelming sum of all the above actions will in the near future so reduce the market for them, that it will become unprofitable for Wyeth to continue to market the drug.
We predict that within the next five years, Premarin based medications (and the PMU farms required to supply the raw product) will become a thing of the past. If the FDA acts favorably on HorseAid's citizen petition, we may see the end of all PMU based medications in as little as two years.
We also predict that Wyeth Inc. will not vigorously combat the trend of falling Premarin based product sales overall. It's a big corporation with lots of other profitable products to sell and many stockholders to answer to. Trying to shore up a division that will soon become unprofitable and open to product liability lawsuits will not sit well with Wyeth's stockholders in the current soft economic market.
Wyeth is already bleeding copious amount of money as its stock prices continue to fall due to jury awards in fen-phen litigation and the soft market in Premarin based medications. The last thing stockholders want to see is the potential risk the company faces in any future Premarin litigation. HorseAid's consulting financial analysts do not believe Wyeth has enough current reserves to keep the company solvent and raider free if it has to defend itself against the increasingly rising Premarin damage torts as well as the current fen-phen litigations.
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The solution is really quite simple...
There are approximately 9 million women still taking some form of Premarin. Educating those 9 million women (and their doctors) as to how Premarin is actually produced, as well as the linked health risks involved in taking the drug, and having them use one of the many synthetics or non PMU organics now available as a substitute, will eventually dry up all the profits and sales from PMU and Premarin production.
ZERO women taking Premarin equals ZERO Premarin produced!