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INTRODUCTION
This is the tragic story of Wyeth’s deceptive marketing of
Hormone Replacement Therapy (“HRT”) products and the
damage it has done to thousands of women across the country.
This narrative is intended to give you a flavor for some of
the important issues in the HRT litigation. It is by no means
comprehensive. If you are unsure about the meaning of anything
you read, do not hesitate to ask. There is no such thing as a
stupid question and we are more than happy to answer your
inquiries.
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Additional Resources |
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It is important to note that, while this paper focuses on Wyeth’s
conduct, other drug manufacturers may be equally liable for
injuries caused by HRT. For instance, many women were prescribed a
drug called Provera that was often taken in combination with
Wyeth’s Premarin. Provera, which was manufactured by Pfizer,
contributed to the injuries of thousands of women.
This paper is divided into 2 main sections: The first covers a
basic understanding of hormones and menopause to give you a
perspective of why hormone therapy and this litigation came into
being. The second section provides the Wyeth liability story as we
know it so far. Again, it is general in nature and the story
continues to develop.
THE BASICS OF HORMONES AND
MENOPAUSE
How does the female reproductive hormone cycle work?
Beginning at puberty, a woman’s ovaries produce natural
hormones estrogen and progesterone. The hypothalamus and pituitary
glands send messages to the follicle (eggs encased in their sacs)
to produce hormones. It works like this: The hypothalamus tracks
the level of estrogen and progesterone in the bloodstream. The
hypothalamus releases GnRH, which instructs the pituitary gland to
generate follicle stimulating hormone (FSH). In turn, the follicle
begins producing estrogen. When estrogen rises to a certain level,
the hypothalamus gets the message and instructs the pituitary
gland to “turn off’ follicle stimulating hormone (FSH) and to
produce a surge of LH (luteinizing hormone).
When LH reaches its peak, a woman ovulates (the body releases an
egg from the follicle). Then the follicle begins to produce
progesterone in addition to estrogen for a short time. The
estrogen/progesterone combination builds up the lining of the
uterus. After that, the follicle reduces production of both
hormones. As hormone levels in the body decline, the body sloughs
off the uterine lining, which marks a woman’s period. When the
level of hormones drops low enough, the hypothalamus instructs the
pituitary gland to stimulate FSH, which starts the process all
over again.
The production of hormones slows over time. By age 35, a
woman’s hormone production has dropped considerably. Progesterone,
often called the “feel good” hormone, is the first hormone to
decline and drops 120 times more rapidly than estrogen.
Menopause is a life phase through which all women pass. It
is the body’s process of phasing out the reproductive cycle by
reducing natural estrogen. In the average woman’s reproductive
life, the menopause occurs when she is relatively young, usually
between 46 and 62. Because her average life expectancy is 80
years, the consequences of menopause are felt for years after it
begins. During menopause, a woman’s estrogen level drops sharply.
Hot flashes are a common condition of menopause. For some women,
hot flashes are just a vague feeling of warmth. For others, the
skin suddenly flushes and beads with sweat, while the pulse races.
When estrogen levels decline, so does calcium in the skeleton. As
a result, the risk of osteoporosis and spine, hip and other
fractures goes up. Menopause is a major issue in women’s lives.
What is “Hormone Therapy”?
Hormone “Replacement” Therapy or “HRT” is an umbrella term that is
used to refer to either the use of the combination of conjugated
estrogens (estrogen) and progesterone (progestin), or the
use of estrogen by itself. This is important, because Wyeth has
attempted to confuse these therapies in the media in an attempt to
downplay the risks of combination therapy. Estrogen used alone is
sometimes referred to in the following ways:
A major focus of this litigation is the combination use of
estrogen and progestin. The combination’s use became popular in
the 1980s. Progestin is synthetic progesterone. Its chemical name
is MedroxyProgesterone Acetate or MPA, The drug Prempro contains
both Premarin (estrogen derived from the urine of pregnant mares)
and MPA. Before Prempro was marketed, women were given Premarin
and MPA in separate doses at the same time. This therapy was
commonly called “P and P” for Premarine and Provera or
progesterone. Pfizer was the manufacturer of MPA until its patent
expired. Here is a breakdown of the forms of progestin that women
took in combination with Premarin.
Name of
Drug Type of Drug Manufacturer
Premarin
Estrogen Wyeth
Provera
Progestin Pfizer
Cycrin
Progestin Wyeth
Prempro
Estrogen +
Progestin Wyeth (Introduced in 1996)
Premphase
Estrogen +
Progestin Wyeth
Generic MPA
Progestin Barr Laboratories
Generic MPA
Progestin Greenstone Ltd (sub of
Pfizer)
Women who are treated with Hormone Therapy
Women who underwent surgical menopause (i.e., had a hysterectomy)
are treated with estrogen. Women with natural menopause have been
treated with both estrogen and estrogen
+
progestin for symptomatic relief of hot flashes, night sweats,
mood swings, etc.
THE WYETH STORY: A VERY
GENERAL NARRATIVE
How
Wyeth created a demand for its hormone therapy
products
Menopause was first described in the published medical
literature in the late 1800’s. The dawn of the
20th
century saw a growing quest for treatment to maintain
the youthfulness, sexual health and vitality of women.
As awareness of the effects of menopause increased, so
did the desire for a magic “cure”. Wyeth
saw the opportunity to capitalize on this trend by developing
a blockbuster drug. In 1942, Wyeth’s predecessor Ayerst received
approval for the patent of Premarin, a mix of estrogens extracted
from the urine of pregnant mares. Ayerst received FDA approval to
market Premarin the same year.
Premarin was approved initially as a “replacement”
therapy, to “replace” the estrogens that began to disappear from a
woman’s body. In other words, the FDA approved Premarin only to
relieve menopausal symptoms like hot flashes, vaginal atrophy and
osteoporosis. Nevertheless, Wyeth boasted additional benefits for
Premarin (and later Prempro) beyond FDA-approved uses. It is a
violation of FDA regulations for drug companies to promote their
products for off-label uses. As described below, in its zeal to
monopolize the enormous menopause market, Wyeth shamelessly broke
the law.
Wyeth created a demand for Premarin by overpromoting it through
the popular press.
In 1962, Dr. Robert Wilson, a New York gynecologist, wrote
an article published in the Journal of the American Medical
Association (JAMA),
which claimed that taking estrogen during menopause
reduces breast and genital cancers. Later, in 1966, Dr.
Wilson authored a bestseller entitled Feminine Forever.
Wilson denied that menopause is a phase of life. Instead, he
characterized it as a disease. Wilson claimed that estrogen was
the cure for “the tragedy of women.” Menopause, he declared,
caused women to lose their youthful appearance and lose their
sexuality as if they were castrated. Not only was menopause
curable, but it was “completely preventable” if women would take
estrogen before entering menopause and continuing for the rest of
their lives. The following quotes illustrate how Wilson’s book
sold the estrogen concept to naïve physicians and a susceptible
generation of women:
Dr. Wilson did not divulge in his book that Wyeth paid him to
write Feminine Forever. Wyeth also paid Wilson to lecture
to women’s groups about his book and poured thousands of dollars
into his research. Wyeth purchased thousands of copies of the book
— so
many copies that Feminine Forever made it onto the
Bestseller List. Wyeth’s sales force then distributed copies to
physicians throughout the country. As a result, Wyeth’s sales of
Premarin quadrupled.
Wyeth saw enormous profit in the notion that it could convince
doctors to prescribe Premarin to every middle-aged woman in
civilized society for the rest of their lives. Wyeth ran ads in
medical journals urging physicians, “Treat her with Premarin. Keep
her on Premarin.”
In 1975, Wyeth ran an advertisement in JAMA,
claiming that Premarin would relieve “tension, irritability,
headaches, undue fatigue, depression and insomnia” caused by
declining hormone levels. In bold large, letters, Wyeth advised
doctors, “Almost any tranquilizer will calm her down
... but
at her age, estrogen may be what she really needs.”
Wyeth also targeted popular women’s magazines by placing objective
looking “articles” about menopause. For instance, a piece
published in Harper’s Bazaar claimed, “There doesn’t seem
to be a sexy thing estrogen can’t and won’t do to keep you
flirtatiously feminine for the rest of your days
... a
real package deal that spruces up your vagina Prevalent medical
opinion is that the safety and benefits of ERT have been
convincingly demonstrated.”
Wyeth’s plan worked. By the mid-1970s, doctors wrote more than 30
million prescriptions for Premarin every year. Over time, Premarin
became the fifth most frequently prescribed drug in the United
States.
Despite cancer side effects, Wyeth found new ways to keep
promoting Premarin.
Just as Wyeth’s Premarin profits peaked, new studies showed a link
between menopausal use of estrogen and endometrial (uterine)
cancer. The first study appeared in the New England Journal of
Medicine in 1976. As a result, physicians stopped prescribing
Premarin for women, except those who had hysterectomies and
therefore were not at risk for endometrial cancer. Estrogen sales
plummeted. By 1979, the only FDA approved use of estrogen was for
treatment of hot flashes and vaginal dryness.
Wyeth needed a new justification for women to keep taking Premarin.
In 1980, Wyeth found it: An article by Dr. Don Gambrell published
in Obstetrics and Gynecology reported that adding progestin
to estrogen led to a decline in endometrial cancer. Thus,
Wyeth, through its sales representatives, convinced doctors that
adding progestin (MPA) to estrogen hormone therapy would protect
the uterus from cancer.
In 1985, Wyeth developed another marketing spin to promote hormone
therapy drugs:
HRT could prevent osteoporosis, or bone loss. But, in order to
generate sales, Wyeth had to recast osteoporosis into a
terrible, debilitating disease that targeted and struck down
menopausal women. Accordingly, Wyeth hired a public relations firm
to create public awareness of osteoporosis. In the process, Wyeth
learned that 77% of women had never even heard of osteoporosis.
Wyeth jumped at the chance to turn ignorance into profits. Wyeth
embarked on a major PR campaign, including funding a National
Osteoporosis Week, and later, the National Osteoporosis
Foundation. Wyeth cleverly used these organizations to promote
Premarin as a cure for bone loss in older women.
At around the same time, Wyeth also wanted to claim that HRT
prevented cardiovascular disease. Wyeth knew that if it could make
the claim that its drugs protected against the biggest killer of
all, it could promote Premarin as a recommended treatment for
all women. In 1985, the Nurses Health Study (NHS) was
published. The NHS was a huge study of nearly 122,000 women
nurses. The study suggested that women using HI were at a lower
risk of developing coronary heart disease. Wyeth asserted that the
results proved Wyeth’s claim that HRT prevented cardiovascular
disease. Wyeth used the NHS as another promotion gimmick to boost
sales of Premarin and MPA. Wyeth overstated the study’s findings.
Wyeth ignored the study’s numerous limitations. For instance, the
study was not randomized. Moreover, the nurses in the study were
more educated and compliant as patients than the population at
large. However, those obvious shortcomings did not prevent Wyeth
from exploiting the NHS for its own gain.
Wyeth
made wild claims about benefits of its HRT drugs without
scientific support
By the late 1 990s, Wyeth touted Prempro as effective treatment
for myriad diseases, including Alzheimer’s, vision problems, tooth
loss, heart disease and colon cancer. Yet the FDA had not approved
Prempro for treatment of any ofthese conditions. Wyeth’s
promotional tactics in making these dazzling but unwarranted
claims included scaring women about menopause. For example, in
1999, Wyeth distributed a brochure to women through the waiting
rooms of doctors’ offices, which read ‘Menopause isn’t gone in a
flash —
its debilitating consequences can affect the rest of your life.”
Wyeth hired model Lauren Hutton to boast estrogen’s cosmetic
effects, claiming the drug was her Number 1 secret: “It’s good for
your moods, it’s good for your skin. If I had to choose between
all my creams and makeup for feeling and looking good, I’d take
the estrogen.”
Wyeth
promoted long-term use but understated the side effects
Wyeth also pushed HRT for long-term use to prevent an
ever-increasing assortment of diseases with little or no
scientific justification. In its advertisements and promotional
materials, Wyeth emphasized HRT’ s “long-term health protection”
and urged physicians to prescribe it indefinitely, even after
short-term menopause symptoms, such as hot flashes, had subsided.
Meanwhile, in its advertisements, Wyeth glossed over the risks
associated with HRT. Most disturbing were “seminar” programs Wyeth
created for consumers in the early 1990s. These videos used a
doctor-spokesperson to emphasize long-term benefits of HRT and to
advise patients that the benefits far outweighed cancer risks.
Wyeth
needed a new HRT drug to make up for the loss of
Premarin’s patent
Premarin’s patent protection would end in 1995. Faced with the
threat of a shrinking market, Wyeth developed a single combination
therapy pill that would combine Premarin with progestin (MPA).
Before then, Wyeth had little success marketing Cycrin, its own
brand of MPA compared with its better-known competitor Provera,
manufactured by Pfizer. By combining both Premarin and MPA into a
single pill offered convenience and guaranteed a new long patent
life for Wyeth’s HI product line.
Prempro’s big clinical study goes South on Wyeth
Soon after introducing Prempro, Wyeth began funding a 4-year heart
disease prevention trial known as HERS (Heart and
Estrogen/Progestin Replacement Study). Wyeth had high hopes that
HERS would show that HRT prevents heart disease in high-risk
women. If so, Wyeth could then receive FDA approval to market
Preinpro for heart disease. In 1998, Wyeth’s hopes were dashed.
That year, the HERS investigators reported that HRT did not
reduce the rate of coronary adverse events in women with
pre-existing heart disease. The fate of Prempro for treatment of
heart disease lay in another study already underway, known as WHI
(Women’s Health Initiative Study).
While Wyeth waited for the WHI study researchers to collect their
data and reach their conclusions, the company continued to exploit
the menopause market through overzealous HRT promotion. In its
brochures, Wyeth assured consumers with testimonials that Prempro
was “time tested” and had a successful safety track records.
However, buried in fine print were warnings about numerous serious
side effects.
WHI
study revealed that estrogen therapy causes
disease instead of preventing it
The Women’s Health Initiative is a group focused on defining the
risks and benefits of potential treatments to reduce the incidence
of heart disease, breast and colorectal cancer and fractures in
post-menopausal women. Between 1993 and 1998, the WHI enrolled
161,809 post-menopausal women from 50 to 79 years old in a set of
clinical trials and an observational study at 40 clinical centers
in the United States. One arm of the study was done by the
National Heart, Lung and Blood Institute (NHLBI), which was a
sub-organization of the prestigious National Institutes of Health
(NIH).
The NHLBI arm of the Will study consisted of 16,608 women ages 50
to 79 with a uterus. They were randomly assigned to a dose of
either placebo or the combination of estrogen plus progestin (i.e.,
combination HRT) in the form of Wyeth’s drug Prempro. The study’s
objective was to look at the effect of HRT on the prevention of
heart disease and hip fractures, as well as any change in risk for
breast and colon cancer over the 5-year study period.
On May 31, 2002, the study’s Data Safety and Monitoring Board
— which
met regularly to review results and patient safety
—
determined that the number of cases of invasive breast cancer in
the Prempro group had risen to the point of’ showing an increased
risk. The DSMB recommended stopping the trial based on the finding
a heightened breast cancer risk, supported by the evidence that
overall health risks exceeded any benefits. In July, patients were
notified of the results and told to discontinue the medications.
The results of the WHI study were published in JAMA in
July, 2002. The results showed not only an increased risk of
breast cancer, but an elevated risk of cardiovascular disease and
heart attacks, the very conditions Wyeth claimed its HF drugs
would prevent. Compared to placebo, HRT was associated with the
following:
-
41%
increase in strokes.
-
29%
increase in heart attacks
-
100%
increase --
a doubling of risk
-- of
venous thromboembolism (blood clots)
-
22%
increase in total cardiovascular disease
-
26%
increase in breast cancer
-
37%
reduction in cases of colorectal cancer
-
*33%
reduction in hip fractures
The study concluded that over the long-term, combination HRT
should not be used or continued for the primary prevention of
coronary heart disease. The authors stated that the risk was too
high a price to pay for any benefits such as reduction of the risk
of hip fractures. Dr. Roussow, the lead author, pointed out that
“even small individual risks over time, and on a population-side
basis, add up to tens of thousands of these serious adverse health
events.”
A
study by the NCI found that Estrogen-only theraov auses
ovarian cancer
In July 2002, just days after the WI-H results were
reported, JAMA
published the results of a study by the National Cancer Institute,
which found that women who took estrogen therapy were more likely
to develop deadly ovarian cancer than those who didn’t. The NCI
study followed 44,241 women for 19 years who took estrogen only
and found that they had a 60% higher risk of ovarian cancer. The
risk increased proportionately the longer women took estrogen.
Women on estrogen for 10-19 years had an 80% higher risk, and
those on the drug for 20 years or more were more than 3 times as
likely to develop ovarian cancer.
Dr. James Lacey, the lead author, expressed concerns about the
public health impact of estrogen therapy. His findings translated
into one or two additional ovarian cancers each year per 10,000
women taking estrogen alone. Indeed, in 2000, some 8 million women
took Premarin. Based on the Lacey study, Premarin is responsible
for up to 1,600 additional ovarian cancers in 2000 alone.
A year later, the Will Prempro study group published more
findings, which echoed the findings of Dr. Lacey’s NCI study.
JAMA reported in October 2003 that the combination of estrogen
and progesterone was associated with a 58% increase in ovarian
cancers.
The
WHI and NCI studies generated unprecedented media attention and
research
Never before had hormone therapy created so much attention until
the results of the WHI and NCI became public. The two studies
received enormous media coverage. Front-page newspaper headlines,
magazine covers and broadcast news programs urgently reported the
alarming findings.
For the first time, physicians and researchers were forced to
confront the risks versus benefits of hormone therapy for
patients. The following two comments are illustrative:
“The reduction in colorectal cancer risk in the Will is
intriguing, but the balance of harm versus benefit does not
justify any woman beginning or continuing to take estrogen plus
progestin for this purpose.” Dr. Leslie Ford, Associate Director
for Clinical Research, Division of Cancer Prevention, NCI.
“Quality of life is very, very important
...
From a heart and breast cancer point of view, the drug should be
outlawed. But for hot flashes, there’s nothing better.” Dr.
Isaac Schiff, Massachusetts General Hospital.
The publicity that the WHI and NCI studies received also generated
new research on the risks and benefits of hormone therapy. As the
next section explains, later studies confirmed the findings of WHI
and NCI.
Study
after study shows that the risks of HRT outweigh its
benefits
Beginning in
2002, additional research yielded more evidence that
long-term hormone therapy has dangerous side effects and no
meaningful upside. Specifically, these studies found that Hi’
increases the risk of breast cancer, heart attacks, bone loss and
other conditions. And more studies are currently underway. Below
is a summary of the key research:
*
WISDOM. The United Kingdom’s Medical Research
Council began a prospective study entitled Women’s International
Study of Long Duration Oestrogen after Menopause (WISDOM). The
study was to follow 22,000 women. Following the WHI study, the
Council canceled WISDOM on October 22. 2002, concluding that
“[t]here is strong evidence that taking hormone therapy long term
increases the risks of some diseases such as breast cancer and
decreases the risks of others such as osteoporosis.”
*
Li Study (University of Washington). January
2003. J. Clini. Oncol. Dr. Li and colleagues conducted a
case/control study of a nationwide comprehensive breast cancer
registry from 1992 to 1998. The data from the registry have long
been available to the public. They found that among older women,
hormone receptor negative breast cancers did not increase. But the
rate of hormone receptor positive breast tumors did
increase in older women. The study concluded that HRT is probably
responsible for all of the increase in breast cancer in the U.S.
since at least 1992.
*
Quality of Life Study:
NEJM, March 17, 2003.
This was the same study pool of 16,000 women as the 2002 WHI
study. In its follow-up, researchers found that HRT drugs fail to
do the very thing women took them for in the first place: to make
them feel happier and healthier after menopause. In other words,
HRT did not improve the quality of life for menopausal women. In
addition, the authors concluded that HRT plays no meaningful role
for HRT in treating women without menopausal symptoms. If women do
continue with HRT, they should take the losest possible dose
for the shortest possible time.
*
Bone Loss Study:
JAMA, May 21, 2003. This study examined the efficacy of
estrogen +
progestin therapy (e.g., Prempro) for prevention of bone
loss in elderly women, It included 373 women ages 65 to 90
who had either thinning bones or full-blown osteoporosis. The
study compared the effectiveness of HRT to Fosamax (alendronate, a
bone-building drug), the combination of Fosamax and HRT, and
placebo. The authors concluded that Fosamax alone was more
effective than both Fosamax/HRT and placebo.
*
Alzheimer’s and Dementia:
JAMA, May 28, 2003.
This was a 4-year trial of 4,532 women. Half took Prempro, half
took placebo. The study found that estrogen
+
progestin doubled the risk of dementia for women who started HRT
at age 65 or older.
*
Mammography Study: JAMA, June 25, 2003. This
study analyzed additional data from the Will. It found that
besides stimulating the growth of breast cancer combination
estrogen-progestin therapy makes breast tumoi~s harder to detect,
leading to dangerous delays in diagnosis. The report found that
breasi abnormalities can develop even after short-term use.
In the same issue, JAIvL4
published an editorial by Dr. Peter Gann, a cancer
epidemiologist, who stated that the study represents “further
compelling evidence against the use of combination estrogen plus
progestin hormone therapy.”
*
Million Women Stucty: Lancet, August 9, 2003.
This is an ongoing study of over 1 million women between ages 50
and 64, which will continue to yield valuable research over time.
This particular report looked at the data between 1996 and 2001,
following women to look for cancer incidence and death. It is the
largest study of women to date. Results showed that
post-menopausal women using combination estrogen/progestin therapy
were twice as likely to develop breast cancer as non-users
— a 100%
increased risk. The risk went up with the duration of use. The
study confirms the findings of Will.
*
Swiss Breast Cancer Study:
Int. J. Cancer, May 10. 2003. Researchers analyzed the
histology of 6,647 breast cancers in the Geneva breast cancer
registry to see if there was an increasing trend of breast
cancers. The study found a significant 7-fold increase in lobular
breast cancers, but only in post-menopausal women. The increase
could not be explained by more widespread use of mammography. The
authors attributed the rising rate of lobular cancers to hormone
therapy and found that the trend was similar to Dr. Li’s findings
in the University of Washington study.
HRT
also causes other diseases, including autoimmune diseases
Still more studies suggest that hormone therapy can lead to
gallbladder cancer, arthritis, asthma, hearing loss, and
autoimmune disease, including lupus. Wyeth had never warned of
these diseases in its labeling.
*
Lupus: Ann. Internal Med, March 1995. This
prospective study of 69,435 women found a 2.7 -fold increased risk
of systemic lupus erythematosus with estrogen therapy after 5 to
10 years. The risk rose to a 3.5-fold increased risk after 11 or
more years.
*
Arthritis: Health Records, Autumn 1999. The
study found a two-fold increased risk of incident arthritis in
women over 38 who had used UT for five years or longer.
*
Asthma: Arch. Intern Med., 2004. Current
users of estrogen/progestin therapy were more than twice as likely
as non-users to develop asthma.
*
Gallbladder: Int. J. Cancer, 2003. Women over
45 years on HRT were over 3 times as likely to develop gallbladder
cancer than non-users. The risk appears to increase with duration
of use. (note —
it is not clear whether HI use consisted of El or
combination use).
Wyeth
changed its HRT label and reversed its “long-tern use” marketing
strategy
After the WHI, NCI and other studies became public, it was
clear that the labeling information Wyeth provided to consumers
was inaccurate and misleading. Wyeth changed its warning label on
Premarin and Prempro during the last week of August, 2002 to
reflect the results of the July, 2002 Will and NCI studies.
Before the August 2002 label change, Premarin contained no warning
or mention whatsoever of ovarian cancer.
There were never any warnings in the Premarin or Prempro
labels for autoimmune disease, arthritis, dementia, hearing loss
or gall bladder cancer.
Before August 2002, the Prempro warning labels were also
inadequate and misleading. For example, the label stated a risk of
breast cancer with conjugated estrogens (i.e., the Premarin
component of Prempro), but then indicated that combining the
progestin component did not raise the risk of breast cancer: “The
overall incidence of breast cancer does not exceed that expected
in the general population.” The WHI study plainly reveals that
this warning is false and was known or should have been known by
Wyeth for decades.
The Prempro warnings also understated the risk of two
thromboembolic disorders: pulmonary embolisms and blood clots.
Wyeth also downplayed the risks of cardiovascular disease and
strokes. The “precautions” sections stated, “The effects of
estrogen replacement therapy on the risk of cardiovascular disease
have not been adequately studied.” Nevertheless, Wyeth has long
promoted the supposed benefits of long-term hormone therapy for
cardiovascular disease.
On January 6, 2003, Wyeth finally abandoned its long-standing
marketing strategy of promoting long-term use of Premarin and
Prempro. Wyeth issued a “Dear Doctor” letter to healthcare
professionals, explaining that it would adopt new labeling for its
HI drugs as a result of the Will findings. According to the
letter, Wyeth’s new HRT labels would contain a “black box”
warning:
“...[E]strogens and estrogens plus progestin therapies should
not be used for prevention of cardiovascular disease
...
The boxed warning also includes information [stating that
because of the WHI study]
...
estrogens and estrogens plus progestin should be prescribed
for the shortest duration consistent with treatment goals.”
In early June, 2003, Wyeth launched its new marketing and public
relations campaign with full-page advertisements placed in
newspapers worldwide, titled “A message from Wyeth.” The
advertisement stated hormone therapy should be takenfor the
shortest duration at the lowest effective dose. By then, Wyeth
was marketing a low dose form of Premarin and Prempro pursuant to
FDA’s request to do so.
Courtesy of The Gast Law Firm
A
Primerus Law Firm
NOTE: While we have made
every effort to ensure the information on this Web site is
accurate and current, William E. Gast, PC, LLO shall not be responsible or held liable
for errors or omissions. This Web site is subject to change
without notice.
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