A dose of Reality: Premarin Exposed

[Guest guest]

A Dose of Reality: Premarin Exposed

by Ray Kellosalmi, M.D. and Tracy Basile

 

 

Conscious Choice, November 2001

 

Of the thousands of FDA-approved prescription drugs on the market today, only

one is made from urine. As its name implies, Premarin is made from pregnant

mares' urine. Since the mid-1990s, this fact has become more widely known among

the ten million women who currently take this form of Hormone Replacement

Therapy (HRT) and among those women who have found, in its place, a wide range

of alternatives.

 

Only since the 1950s and '60s have middle-aged women flocked to their doctors

seeking relief for a host of symptoms, such as hot flashes, sleeplessness,

vaginal dryness, depression, and fatigue.

 

Since that time, Premarin's manufacturer, Philadelphia-based Wyeth-Ayerst

Laboratories, a wholly-owned subsidiary of American Home Products, has become

the key player in what has come to be known as the menopause industry. Last

year, the HRT drug -- along with its " family " of products, PremPro, PremPhase

and PremPac -- earned the company $1.9 billion.

 

Wyeth's push to get menopausal women on HRT is no secret. They have hired the

world's largest public relations firm, Burson-Marsteler, and have poured

millions of dollars into advertising.

Over the years, they have financed thousands of studies using Premarin, but as

Maryann Napoli of the Center for Medical Consumers in New York City indicates,

most of these studies, until recently, were observational, which by definition

are weak and biased. " The more sinister message, " she says, " is that as soon as

a woman hits menopause, she's on her way to getting heart disease and hip

fracture. "

 

Experts in the field say Wyeth isn't playing dirtier than any other

multinational drug corporation. They all lobby. They all try to prevent generic

competition from entering the market.

 

They all have major public relations firms under contract that create just the

right amount of spin in newly released reports or press releases. And they all

fund medical research that will perpetuate their brand. But lately, things just

haven't been going Wyeth's way.

 

For the third time this year, the pharmaceutical giant has had to recall huge

lots of Premarin pills because they fell short of federal standards that ensure

the drug is properly absorbed into the blood stream.

 

As of July 2001, after years of taking the opposite tack, the American Heart

Association has backed off of its endorsement of HRT for the sole purpose of

preventing heart attacks and strokes in women who already have heart disease and

for healthy women seeking heart disease prevention.

 

Then, in August 2001, a judge ruled to proceed with an anti-trust lawsuit

against Wyeth for allegedly perpetuating a monopoly in conjugated estrogen

products in the HMO marketplace. In September, animal welfare advocates and

horse rescue organizations stirred up another PR crisis for Wyeth by saving

hundreds of Premarin foals from slaughter. Could the cap on this prescription

bottle be ready to explode?

 

Origins

 

Sometime in the early 1930s, someone discovered that estrogen is excreted in the

urine of all mammals. The first studies using excreted estrogen used the hormone

from the urine of pregnant women. That proved to be impractical.

Stallions were enlisted next, because their estrogen levels actually exceed

those of pregnant women.

 

But the intact male horses were found to be too unmanageable for the prolonged

confinement required for urine collection. Attention then shifted to pregnant

mares. Their relatively docile nature and long eleven-month gestation period

made them good candidates for the job.

 

In order to collect the urine that goes into making Premarin today, thirty-five

to forty thousand mares are kept pregnant year after year, tied in stalls for

six months at a time in 480 barns located, for the most part, in rural areas of

the Canadian provinces of Manitoba, Saskatchewan, and Alberta, though some are

in North and South Dakota.

Winter temperatures can drop to 40 degrees below zero. These urine farms, known

as Pregnant Mares' Urine (PMU) ranches, are usually family-run operations. Visit

one in the summer and you'll see dozens of mares turned out together in lush,

large pastures, their young foals grazing beside them.

Come back one day in early September and the farmer may be busy loading most of

the one to two hundred foals born earlier that spring into trailers to make the

long drive to auction. The mares who didn't conceive during summer breeding are

likely to also make the trip.

 

PMU foal auctions are where these young horses, typically between three and four

months of age but sometimes younger, are abruptly weaned and sold by the pound

in lots or individually for $100 to $300 each, depending on their weight. The

vast majority of them are loaded into cattle carriers for the trip to meat

packers' feed lots. Some get purchased by equine rescue groups or by performance

horse buyers and a few might stay back at the farm to replenish the stock.

But the majority, before they reach their first birthday, end up as dinner on

the plates of the Japanese, Belgians, French, Italians, Germans, Dutch, and

Swiss. They are a protein source considered all the more valuable in light of

recent cullings of European livestock due to the spread of Mad Cow and

foot-and-mouth disease.

 

Meanwhile, back at the farm, from October through the end of March, mares are

kept indoors in narrow tie-stalls, fitted with rubber collection pouches

suspended on pulleys. They can take a step forward or backward, or side to side,

but they cannot turn around, scratch an itch on their rump, or roll in the dirt.

 

Sometimes, depending on the size of the mare, there is enough room to slouch

down and doze off. Equine sleep research conducted in the early 1970s revealed

that, although horses can enter slow wave sleep while standing or lying

'upright,' they must generally lie flat out for rapid-eye-movement sleep. In the

wild, members of a herd take turns -- one horse will remain on watch while

others will vary their positions from dozing standing up, sleeping lightly lying

'upright' or indulging in deep sleep lying flat out.

 

PMU mares do not have the space to lie flat out and therefore most, if not all,

are physically unable to enter a deep sleep year after year while housed in

their stalls. Exercise is unregulated and minimal. It may consist of nothing

more than being led around the aisles of the barn.

 

Some mares may exhibit edema of the lower legs as a result of inactivity. This

unnatural existence goes on all winter as the immobilized mares become heavy

with foal. In early April, the mares are turned out to give birth in fenced

pastures.

 

In a research study published by the Canadian Veterinary Journal, it was

reported that 22 percent of foals born on PMU farms in western Manitoba between

April 18 and May 31, 1994 had died due to starvation and/or exposure.

 

Figures like these are rarely calculated into official Canadian government

records and rarely publicized. In 1995, however, negative publicity from animal

welfare organizations and equine rescue groups grew. PMU farms organized tours.

Yet both the Royal Society for the Prevention of Cruelty to Animals and the

World Society for the Protection of Animals provided unfavorable reports.

 

So PMU farmers offered a second round of tours -- and declined to invite their

critics. This time, they welcomed the American Association of Equine

Practitioners and the Canadian Veterinary Medical Association, considered by

many to be little more than stake-holders in the PMU industry. It came as no

surprise when the resulting report proclaimed that all was well in " PMU land. "

 

Estrogen Explained

 

Why is estrogen so prized that people are willing to torture horses to get it?

You may remember, from basic health class, that estrogens are hormones that

control the development and function of female sexual characteristics. They also

have profound effects on other body tissue and organ systems, including bones,

skin, blood vessels, and the brain.

 

Estrogens ease hot flashes, prevent vaginal atrophy and may even decrease the

risk of Alzheimer's disease, colon cancer, and urinary incontinence. These

beneficial effects are felt to be common to estrogens in general, not specific

to any one form. And estrogen can be found in many forms. In mammals, estrogen

is primarily produced by the ovaries, but it is also available from the

following sources:

 

* plants, most commonly soybeans or Mexican yams. These are called plant-based

estrogens and are available only with a doctor's prescription.

 

* edible plants, supplements, and herbs, which contain weaker concentrations.

These are called phytoestrogens.

 

In 1942, Wyeth introduced Premarin, an effective but relatively crude and

variable mixture of horse urine-derived estrogens, degradation by-products, and

impurities.

 

There is no research to date proving that equine urine is the best source of

estrogen for human females. Dr. Uzzi Reiss, M.D. OB-GYN, author of Natural

Hormone Balance for Women, suspects that, in the absence of such research, the

development of Premarin was based on simple economics: " A mare is pregnant for a

long time. A mare has a large bladder. And hay is cheap. "

 

In the mid-fifties, plant-based estrogens began making their way into the HRT

market. They match the chemistry of the most active human estrogen, called

beta-estradiol.

This is the form that is truly natural to the human female and is available

today through many different brands, including Estrace, Ogen, Ortho-Est,

Estraderm, Vivelle, Climara, and Estring.

 

More complex plant-based estrogens -- the main ingredients of which are similar

to those in Premarin, which contain no hormones from equine sources -- are also

available. These include Estratab and Menest. The newest plant-derived estrogen

in the United States is Cenestin. Made from soybeans and yams, its nine

estrogens closely mimic the formulation of Premarin, minus the host of unknown

ingredients and impurities that plague the horse urine product.

 

Strong Bones

 

Medically, there is widespread support for using HRT where there is a history of

osteoporosis. In the United States, the Food and Drug Administration has

accepted studies supporting this benefit for Estrace, Ogen, Estraderm, and

Premarin. The dose of estrogen needed to keep bones strong is less if calcium is

taken.

Studies have also suggested that bone protection can be enhanced by eating a

diet high in non gmo soy, exercising, and refraining from alcohol, caffeine, and

smoking.

 

The use of progesterone without estrogen has attracted some medical interest and

studies have shown sizable benefits against osteoporosis through its ability to

increase bone density.

 

Available progesterones are derived from plant sources or are totally

synthesized. Cream forms, long used for local vaginal effects, also have been

recently advocated for hot flashes.

 

Buyer Beware

 

In 1975, research confirmed that estrogen replacement therapy sharply increased

a woman's chances of endometrial cancer. To prevent this risk, progestin, a

synthetic formulation of the natural hormone progesterone, was added to the

therapy.

 

A growing number of studies have also shown that standard prescription estrogens

(in other words, Premarin, plant-based, and synthetic estrogens) can begin to

significantly raise breast cancer risk after five years of use. Based on their

similar formulation and mode of action, all standard prescription estrogens

could be expected to contain this serious downside.

 

Since it appears that estrogen replacement therapy increases the ratio of " good "

to " bad " cholesterol, it was commonly thought that it should lower the incidence

of heart problems.

 

However, the well-known Heart and Estrogen/Progestin Replacement Study (HERS),

published in August 1998 which used only Premarin and was funded by Wyeth,

failed to show any significant benefit. The study followed women with prior

heart disease for four years.

 

In a report issued in July 2001, the American Heart Association (AHA) says that

the evidence that estrogen replacement therapy is beneficial to cardiovascular

disease is just not there.

 

The organization has gone on record as advising physicians against prescribing

HRT for the sole purpose of preventing heart attacks and strokes in women who

already have heart disease.

 

According to Lori Mosca, M.D. Ph.D. , lead author of the AHA's Science Advisory

and director of preventative cardiology at New York Presbyterian Hospital of

Columbia and Cornell Universities, " the established benefits of HRT for the

treatment of menopausal symptoms, such as hot flashes, and prevention of

osteoporosis, must be weighed against risks for blood clots,

gallbladder disease and a possible increased risk of breast cancer. "

 

Even as clear dangers become more apparent, however, misinformation abounds. Web

sites, where the majority of women today go to get the latest health

information, are not always updated or reliable.

 

For example, in a section called " Frequently Asked Questions, " at a Web site

called " Vitality: Health and Wellness for Midlife and Beyond, " you can find this

advice:

" Don't panic when new information is given. You don't make an investment and

then pull out because of one scary headline.

When we're talking about investments in our health, we shouldn't just stop

taking our medication that we've come to know and trust just because of a scary

headline. "

 

At the bottom of the site's home page, in very tiny letters, this statement

appears: " Vitality: Health and Wellness for Midlife and Beyond is sponsored by

an educational grant from Wyeth-Ayerst Laboratories. "

 

Nowhere does it mention Wyeth's commercial interests in selling the top HRT

drug, Premarin.

 

Nutrition, Herbs, and Exercise

 

Although strictly speaking, only prescription estrogens are used in Hormone

Replacement Therapy, phytoestrogens have also been shown to be beneficial to

menopausal and post-menopausal women. They are effective for treating hot

flashes and do not increase breast cancer risk.

 

Phytoestrogens are present in most plant foods, but the highest concentrations

are in kudzu, non-gmo soy, and flaxseed, with significant amounts in lentils,

chickpeas, and beans.

 

Minor amounts exist in fruits, grains, vegetables, seeds, and many cereals.

 

A new supplement in pill form, called Promensil, is available at health food

stores; it reportedly utilizes multiple phytoestrogens from red clover to arrive

at the highest concentration presently available.

 

Many other herbal products have enjoyed considerable sales success for patients

suffering from menopause.

 

Remifemin, an extract from the herb black cohosh, has proven to be beneficial in

relieving hot flashes.

 

Dong quai is also used but one study suggested the presence of cancer-causing

ingredients. More quality-controlled studies on herbal remedies are needed, but

funding is minimal because there is little money to be made from products that

cannot be patented.

 

But there's more to this story than estrogen. There's the growing appreciation

that lifestyle changes, rather than drugs, may be what menopausal women require.

 

In some cultures, including Asian ones, hot flashes and brittle bones usually

are not bothersome enough to interest women in HRT.

 

So what do these women do differently?

 

Eat a diet low in animal protein and high in vegetables, fruits, fiber, legumes,

and grains, which contain phytoestrogens. They do not ingest much salt,

caffeine, alcohol, or tobacco. They tend to be active. Studies have shown that

increasing physical activity and avoiding obesity results in fewer hot flashes

and stronger bones.

 

In fact, aerobic and deep-breathing exercises have been shown to decrease hot

flashes by up to 40 to 50 percent.

 

Profits and Politics

 

" The medical necessity for a drug does not necessarily have anything to do with

the economics of the drug industry, " explains Marc Speert, a registered

pharmacist in New York for twenty-eight years and the editor of the electronic

edition of Prescribing Reference Inc. in New York City.

 

" Trillions of dollars are involved, " he says and then pauses, " Not billions,

trillions. "

 

In 1997, after a two-year battle, Wyeth succeeded in preventing the approval of

a competitor's rival generic substitute for Premarin. In a game of classic

Washington hardball, Wyeth lined up support from women in Congress and women's

organizations and used the absence of impurities as legal grounds to block the

generic's approval.

 

If approved, it was estimated that the generic version -- made from yams, not

horse urine -- would have saved U.S. female consumers $300 million a year and

that the lower cost would have made HRT affordable to tens of thousands of women

who can't afford it now. Wyeth's opponent, Cincinnati-based Duramed

Pharmaceuticals may have lost the battle, but they haven't given up the fight.

In 1999, the company launched their drug without generic status under the name

Cenestin.

 

The newest chapter in the Premarin saga reveals that Wyeth is quietly gaining

the lion's share of HMO business by offering low discount prices. With Wyeth's

cost at just pennies per pill, undercutting all the competition in the HMO

marketplace is relatively easy.

In August 2001, a judge ruled that Duramed can proceed with an anti-trust

lawsuit against Wyeth in September 2000 for allegedly perpetuating a monopoly in

conjugated estrogen products, but " every year that Wyeth is successful in

dragging out the lawsuit, they make a fortune, " says Speert.

 

Last year, according to IMS Health, U.S. doctors wrote 23,454,000 prescriptions

for Premarin. Today it is patented under more than thirty brand names and

marketed in approximately sixty countries worldwide. Yet the need for HRT may

largely be of our own making.

" At what point does the need for a drug create the profit, " muses Speert, " and

at what point does profit create the need? " Wyeth keeps reminding women that

they have trusted Premarin for fifty-eight years, but when will women begin to

trust themselves?

 

It's important to realize that diet, exercise, and eating habits can either

exacerbate or minimize the discomforts people associate with menopause.

 

Sensible eating habits, with lots of phytoestrogens, but little or no caffeine,

alcohol, sugar, tobacco, and meat, can make a big difference.

 

So can regular exercise and adequate calcium intake. Of course, the decision

whether or not to use HRT is a decision as individual as each woman's genetic

history, lifestyle, and symptoms.

 

But in order to reach that decision, every woman deserves to know her full

spectrum of choices. Commercially prepared mare's urine is not your only choice,

nor perhaps even your best.

 

Dr. Kellosalmi is a practicing family physician and surgeon in Peachland, BC,

Canada. He has written articles on Hormone Replacement Therapy for Family

Practice, The Journal of Clinical Diagnosis, and other publications.

 

Freelance writer Tracy Basile, is the former features editor of Animal Watch

magazine of the ASPCA, and writes often on animals and the environment.

 

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