Premarin (Premarine) ERT/HRT & PMU Farms Controversy: Page 1
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The
beginning of the end?
(Crush
the pill to read — Updated 11/9/03)
Courtesy
IGHA archives, PMU/Premarin collection
Wyeth & Bro. (John and Frank)
elixir bottle (circa 1861)
filled with their legacy (Pregnant Mares' Urine, circa 1991)
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.
Wyeth shares fell about 7 percent Friday (11/7/03), a
day after a Texas jury awarded $1.3 million in damages to a woman who suffered
heart
damage
after
taking the company's diet drugs, part of the banned fen-phen combination.
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.
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!
Just say NEIGH! (to Premarin)
Join HorseAid in "Op 0" (Operation Zero)
Just say NEIGH!
(to PREMARIN)
If you're
one of the 9 million women currently taking any form of Premarin, won't you
please ask your doctor to prescribe a synthetic
or non PMU based organic substitute in its place and help us realize our goal
of
ZERO
Premarin use
and production?
Become
a Part of the "Say Neigh!" Web Pill Campaign!
Place the "Neigh Pill" on your Web site and show the
world you support an end to PMU production.
"Say NEIGH! depicted within (and without)
a pill shaped representation logo, symbol or graphic,
is a copyrighted (© 1998) service mark (sm) of IGHA/HorseAid, all rights
reserved.
Use is hereby freely granted by IGHA/HorseAid under a "Conditional
Use License" for the non-commercial use and free distribution of the above "Yellow
Pill - Say Neigh!" graphic, and the term "Just Say Neigh! to PREMARIN" (collectively,
the "Say Neigh!
Campaign") to any person, persons or entity, for the items intended purposes
only (to protest PMU production). Use is conditioned solely on the agreement
that: No fee may be charged for the use of the Say Neigh! Campaign resources
in any
way; it may not be used in a parody demeaning its intended purpose; the name
of the respective graphics may not be modified; no Say Neigh! Campaign resource,
term, or associated logo may in any way be linked to, or associated with, any
Web resource, source, person, organization, or entity other than those specifically
authorized by IGHA/HorseAid (however, you are not required to provide a "hotlink" to
this page to use or display any Say Neigh! Campaign resource either, but it does
serve to explain and clarify the purpose of the campaign); and that IGHA/HorseAid
retains all world wide rights. IGHA/HorseAid claims first usage and exclusive
proprietary
rights to the terms "Just say NEIGH!
(to Premarin)", "Just say NEIGH! to Premarin", "Say NEIGH!
to Premarin", "Say NEIGH!", and "Neigh Pill", including
their phonetic
equivalents, "Op 0" (Operation Zero),
and "Say NEIGH! depicted within a pill shaped representation logo, symbol
or graphic used to denote, or be identified with, a means to protest PMU production.
Please include a link back to http://igha.org/pmu_link.html#pill to make your
visitors aware of the PMU production abuses, and the drug Premarin: The yellow
pill that kills! (it's not yellow on the outside, it's yellow on the INSIDE!),
and "The Pill that Kills" are service marks (sm) of IGHA/HorseAid.
The
petition is stronger than...
If you wish to circulate petitions against the way horses are indirectly exploited
by Wyeth-Ayerst, PLEASE do not forward
them to us any longer. Wyeth-Ayerst Laboratories no longer accepts mail bearing any of
our return addresses. You can however, send them directly to: Wyeth-Ayerst
Laboratories, PO Box 8299, Philadelphia, PA 19101 (this mailing information
is also noted on our petition).
To download a petition (petitions are in the universal Adobe Acrobat format), click on the PMU Petition graphic above. To download the Adobe Acrobat Reader (available free) required to open and print the petition for the type of computer you have, click here. The Acrobat Reader is also available as a free download on AOL (Keyword: "Adobe"). Remember to print the petition double-sided (print page one, turn the page over and print page two), for the maximum signature spaces and minimum postage per petition, and print it out on bright yellow "horse pee" colored
paper!
If you are interested in hard copy photos and more information on PMU history,
please send
$3.50
(for P&H) for our Spring/Summer`95 issue of Running Free (formally called ET-News™ — Equine
Times
News),
the
official publication of the IGHA. PMU/HorseAid, P.O. Box 6778 Eastview
Station, San Pedro, CA 90734-6778.
End All Horse  Slaughter
NOW!
IGHA/HorseAid World HQ's:
P.O. Box 6778 Eastview Station
San Pedro, CA 90734-6778
310.719.9094 (24 hour line)
The I.G.H.A. is a world-wide equine registry involved in
the registration and representation of all equines. The I.G.H.A. also involves
itself with equine welfare issues on a global basis through its equine relief
division HorseAid. HorseAid is a privately funded equine rescue/welfare group.
This Web site (© 1994 - 2004) is a part of IGHA/HorseAid's EquineRescue.NET and
is sponsored by the Generic Horse Trust (under the HorseAid name & logo)
as a public service in an effort to better educate consumers and prescribing
M.D.'s about the drug Premarin and how it is produced. Please read our disclaimer/acceptance/privacy notice before
accessing this site.
Premarin.Org
is not associated in any way with Wyeth Inc., Ayerst Organics Ltd., Wyeth-Ayerst
Inc., Wyeth Laboratories,
Inc., American Home
Products
Inc., or any of their subsidiaries. Use of any trademark (TM), service
mark (sm), or copyrighted (c) name or term is under the "fair use" provision
of U.S. & foreign copyright law, and applicable exclusions to the DMCA.
All such names and terms remain the sole property of their respective
trademark, service
mark,
or
copyright
owner(s),
and they retain all rights as granted under applicable copyright, trademark,
and service mark law, and their use here should not be construed in any
way to be an infringement of such.
[ PMU - New Developments | IGHA/HorseAid Home Page
]
Since January 1st, 1996, you are unique guest 
"The Pill that Kills" is
a service mark (sm) of IGHA/HorseAid. "Just say NEIGH! (to
Premarin)", "Just say NEIGH! to Premarin", "Say NEIGH!
to Premarin" including their
phonetic equivalents,
and "Op 0" (zero) (Operation
Zero) are copyrighted (© 1993 & 1996 respectively) service marks
(sm) of IGHA/HorseAid, all rights reserved. "Say
NEIGH! depicted within (and without) a
pill shaped representation graphic, and "Neigh Pill" is a copyrighted
(© 1998) service mark (sm) of IGHA/HorseAid, all rights reserved.
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