HRT Warning
HRT Warning Signs Overlooked?
Until the beginning of July 2002, medical groups
were recommending as soon as a woman turns 50 she should discuss
HRT (hormone replacement therapy) with her doctor and the
doctor should encourage taking the estrogen and progestin
combination. HRT had become common over the last
decades it was available, and 6 million American women were
taking HRT drugs. HRT had grown in popularity over the years,
but some groups and medical experts never bought into the
idea being described as having "claims too good to be
true" and began issuing HRT warnings.
The executive director of the National Women's Health Network,
Cynthia Pearson, was offended by the message HRT gave women.
She felt HRT was both sexist and ageist and delivered the
message to "Stay young. Stay healthy. Stay sexually vital.
Be less of a pain to your husband." Wyeth, the drug company
that makes the top-selling HRT drugs, asked the FDA in 1990
requesting a label change on their drug saying their HRT protects
against heart disease.
Pearson was appalled at Wyeth's request that failed to have
any real data supporting this claim. The FDA advisory committee
did recommend to the FDA that Wyeth be able to market their
HRT drugs as protective against heart disease, but the FDA
overruled their recommendation stating better data was necessary
to make this claim. Wyeth did begin a randomized controlled
HRT study that most assumed would show the beneficial effects
on the heart, but the HRT study involved women that already
had heart disease. Women already suffering from heart disease
were the group that would show HRT side effects the easiest.
As Wyeth's HRT study began, Congress had set aside money
for new research at the National Institute of Health in response
to the public criticism of the lack of attention given to
women's health. The Wyeth HRT study did not, in fact, show
that HRT protected women against heart attacks, but instead
found it increased
risk in the first few years of taking the HRT drugs. The
data from the Women's Health Initiative that emerged caused
the HRT study to be halted after finding risk of breast cancer,
heart attacks, strokes, and blood clots when women took HRT
involving both estrogen and progestin. The other part of the
HRT study has continued with women who have had hysterectomies
and who are taking just estrogen as the data has not yet shown
any significant risk or significant benefit from the hormone.
The results of the HRT study were shocking to most doctors
and medical experts, and the results of the HRT study were
thought to have such urgency considering the number of women
with potentially very
serious risks that the results of the trial were released
early. Many are wondering why it took so long for these HRT
results to emerge when so many medical experts and doctors
were encouraging so many women to take HRT. The trial was
the first and only large study comparing the side effects
of HRT with placebos in healthy women.
Intended to continue until 2005, immediately after the HRT
study was halted, the Women's Health Initiative sent letters
to the study's 16,000 participants telling them to stop taking
their HRT medications that were to be received July 9, 2002.
Data indicates if 10,000 women take HRT drugs, estrogen and
progestin, for a year, 9 more will develop invasive breast
cancer, compared with 10,000 who were not taking HRT. In addition,
7 will have a heart attack, 8 will have a stroke, and 18 will
have blood clots.
The future of HRT is still carrying many questions. The other
part of the Women's Health Initiative study is still underway,
and people are awaiting the results of taking estrogen alone.
Dr. Utian of the Menopause Society finds the debate on HRT
expected saying, "there are an awful lot of interests
at stake here beyond women's health. There are investigators
with research grants, N.I.H. grants and grants from the pharmaceutical
industry. There are academics with careers to build. It's
not just a matter of what the data says. Truth is opinion,"
(New York Times, 7/10/02).
For more information on HRT warnings, side effects and your
legal rights, please
contact a HRT lawyer.
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