The HRT Debate & Other Confusing Health Issues
"Breast cancer
is not the only risk of HRT. It also increases dementia, heart disease,
stroke, and blood clots.
So the evidence
is pretty clear that long term use to prevent the diseases of aging is
not a good idea."
Dr. Susan
Love, breast cancer expert
| Compounded
hormone therapies: unproven, untested — and popular
Compounded ‘bioidentical hormones’ trade on promise of tailored hormone therapy. As a growing population of women reaches menopause, physicians may be fielding more questions about compounded hormone therapies — or, more commonly, “bioidentical hormones.” However, the use of hormone therapies produced
by compounding pharmacies is controversial. The controversy centers around
the idea that compounded hormone therapies have not been tested and are,
therefore, questionable for use. However, the concept of individualized
or customized hormone therapy appeals to menopausal or postmenopausal women,
and these therapies have caught traction among the public.
Alan Garber, MD, PhD, chief medical editor
of Endocrine Today, said that “bioidentical hormone replacement is a clever
marketing concept devoid of scientific underpinnings, and preys upon the
patient’s desire for better hormonal replacement therapies that are both
safe and effective, properties totally unproven by the proponents of such
agents.”
Articles
do not in any way reflect the opinion of minniepauz.com
POST-MENOPAUSAL STUDY
CHICAGO — The first follow-up of a landmark study of hormone use after menopause shows heart problems linked with the pills seem to fade after women stop taking them, while surprising new cancer risks appear. That heart trouble associated with hormones may not be permanent is good news for millions of women who quit taking them after the government study was halted six years ago because of heart risks and breast cancer. But the new risks for other cancers, particularly lung tumors, in women who'd taken estrogen-progestin pills for about five years puzzled the researchers and outside experts. The analysis focused on participants' health in the first two to three years after the study's end. During that time, those who'd taken hormones but stopped were 24 percent more likely to develop any kind of cancer than women who'd taken dummy pills during the study. "There's still a lot of uncertainty about the cause of the increased cancer risk," said analysis co-author Dr. JoAnn Manson, chief of preventive medicine at Harvard's Brigham and Women's Hospital. The cancers included breast tumors, which also occurred more frequently in hormone users during the study. The researchers noted that the increased risks for all cancers amounted to only three extra cases per year for every 1,000 women on hormone pills, compared with nonusers. The initial study included 16,608 postmenopausal women The follow-up tracked 15,730 participants through March 2005. Statement From The American
Pharmacists Association Regarding FDA's Action Against Compounded Menopause
Hormone Therapy Drugs Main Category: Pharmacy / Pharmacist
Following is a statement by John A. Gans, PharmD., Executive Vice President and CEO of the American Pharmacists Association (APhA), in response to warning letters sent to seven pharmacy operations by the U.S. Food and Drug Administration (FDA). The letters state "bio-identical hormone replacement therapy," (BHRT) products, are unsupported by medical evidence and are considered by the Agency false and misleading, and that the use of estriol in these products violates the FDA's compounding compliance policy guide. "APhA does not support misleading marketing
claims of any pharmacy products. Patient safety is our utmost concern.
However, APhA believes that limiting compounded medications to those that
include bulk drug ingredients of FDA-approved drug products, greatly limits
patient access to medications that address their unique needs. While this
FDA warning focuses solely on the compounding of menopause hormone replacement
therapy drugs, APhA believes that other compounded medications may be at
risk for future FDA scrutiny.
FDA says alternative hormone
claims unsupported
WASHINGTON (Reuters) - U.S. health officials said on Wednesday they had warned seven pharmacies selling "bio-identical" hormones over the Internet that they were breaking the law with false and misleading claims about the benefits for menopausal women. The Food and Drug Administration sent letters ordering the pharmacies to stop claiming their hormones were better than approved menopause therapies and could prevent and treat serious conditions such as Alzheimer's, strokes and cancer. Full Story Audio
Report from Deborah Autor, Director, FDA Office of Compliance Center
for Drug Evaluation & Research
End Stigma of Incontinence By LAURAN NEERGAARD – December 2007 WASHINGTON (AP) — One in four U.S. adults will experience incontinence at some point, a surprisingly high toll, and the condition is so embarrassing that many suffer silently, a government panel said Wednesday. Women are most prone to incontinence, which is the inability to control urination or bowel movements. But everyone's risk rises as they get older. Being overweight and a couch potato adds to the risk. With the population rapidly graying and
fattening, scientists convened by the National Institutes of Health issued
an urgent call for research to find better ways to prevent incontinence
and to remove the stigma so more people will seek help. Read
More
For a Low-Dose Hormone,
Take Your Pick
Patches, pumps, pills, low-dose pills and super-low-dose creams and gels: Ever since the landmark Women’s Health Initiative study found that hormone therapy could be harmful, a dizzying array of new low-dose treatment options have been offered to counter the symptoms of menopause. Read more... How NIH Misread Hormone
Study in 2002
On July 9, 2002, federal government health officials announced that they had halted a major study of menopause hormones, saying the drugs increased a woman's risk of heart attack by 29%. But in the five years since, it's become
clear that some aspects of what was initially reported from the $725 million
Women's Health Initiative study were either misleading or just wrong. Although
the government initially said the findings applied to all women, regardless
of age or health status, additional data published in recent months show
that the age of a woman and the timing of hormone use dramatically changes
the risk and benefits. WHI data published in April in the Journal of the
American Medical Association showed that women in their 50s who took a
combination of estrogen and progestin or estrogen alone had a 30% lower
risk of dying than women who didn't take hormones.
July 2007--Wyeth's First Non-Hormone Menopause Pill May Be Safer (Update3) By Lisa Rapaport Wyeth's menopause treatment Prempro July 23 (Bloomberg) -- Wyeth may win U.S. approval for Pristiq, the first non-hormone menopause pill, based on studies suggesting the medicine is safer than the drugmaker's current therapies. Sales slowed for Wyeth's hormone-based menopausal treatments, Premarin and Prempro, after U.S. research in 2002 linked them to breast cancer and heart attacks. Pristiq, derived from Wyeth's best-seller, the antidepressant Effexor, curbs hot flashes by acting on brain chemicals. Read more..... April 19, 2007 - FDA Decision
on New Wyeth Drug Postponed
WASHINGTON — Pharmaceutical maker Wyeth said Thursday regulatory approval of a new drug to treat menopause symptoms won't happen until at least July, several months later than expected. The Food and Drug Administration was scheduled to make a decision next week on Pristiq, the first non-hormonal drug to treat hot flashes and other menopausal symptoms. During an earnings teleconference Thursday,
Wyeth told investors and analysts the decision had been postponed until
the FDA can review additional data Wyeth submitted.
April 2007 -- Hormones
not always risky, new study says
The finding suggests guidelines need to be sharpened so that hormones are used shortly after menopause only, researchers say. Read full article December 2006 -- Breast
cancer drop may be due to women quitting menopause hormones, doctors say
By
MARILYNN MARCHIONE
SAN ANTONIO -- U.S. breast cancer rates plunged an unprecedented 7 percent in 2003, the year after millions of women stopped taking menopause hormones when a study showed the pills raise the risk of tumors. The startling new analysis, reported Thursday
at the San Antonio Breast Cancer Symposium, does not prove a link between
hormone therapy and breast cancer, but strongly suggests it, many experts
said. Read
full article
July 2006 -- Study: Estratest
doubles breast cancer risk By CARLA K. JOHNSON
Associated Press Writer
"This type of hormone therapy may help
with mood, libido and bone mineral density, but the possible risk of breast
cancer may outweigh these benefits," said study co-author Rulla Tamimi
of Harvard Medical School. Read
full article
May 8, 2006 --Menopause: Anatomy of a Hot Flash Hot flashes are no joke when they leave you soaked in sweat and feeling dazed. Technically, hot flashes exaggerate how the body normally cools down: blood vessels dilate, letting more blood reach the skin to release heat. They tend to come on rapidly and last from one to five minutes. They range in severity from a fleeting sense of warmth to a feeling of being on fire. Some women have just a few during a week; others get them day and night. Read more Feb. 28, 2006- NEW YORK - Herbal combo may ease menopause symptoms Study: Women felt relief after taking St. John's wort, black cohosh. Pairing up two commonly used herbal medicines is “very effective” for easing physical and psychological symptoms of menopause, German researchers report. St. John’s wort is widely used to treat
mild to moderate depression, while women have traditionally taken black
cohosh for menopausal complaints, Dr. Joerg Gruenwald of Analyze &
Realize, a Berlin-based botanical consulting company, and colleagues write
in the February issue of Obstetrics & Gynecology.
Feb. 14, 2006 - Is Estrogen Therapy Helpful After All? (WebMD) In recent years many women stopped taking hormones for menopause after a report linked them to heart disease. Now researchers have found that estrogen might not be as bad as we thought — especially for younger women. The new findings suggest a possible estrogen benefit for women in their 50s, but experts say it's too early to recommend hormones to help the heart. The study also confirmed previous findings that estrogen treatment does not protect older, postmenopausal women against heart disease.
Feb. 10, 2006 - Evidence for health advice confusion Hormone replacement therapy, recently a huge no-no, got the green light this week from Canadian gynecologists. The same day, a low-fat diet, promoted
by everybody from Loblaws to your family doctor, was trumpeted as being
little or no help to women's health, according to results of a large-scale
study by the U.S. National Institutes of Health.
Jan 26, 2006 - Hormone Replacement Therapy May Increase Lung Cancer Risk NEW YORK JAN 26, 2006 (Reuters Health)
- A history of hormone replacement therapy (HRT) appears to decrease survival
rates among women diagnosed with lung ...
December 30, 2005....
Hormone prescription dropped to 6 million
from 12.6 in 2001 due to fears about breast cancer, strokes and heart disease.
Read
More
Opposing reports? Despite the risks, still on estrogen
As president and chief executive of the Society for Women's Health Research, Phyllis Greenberger knows all about the studies showing that women who take hormones after menopause have a greater risk of breast cancer, stroke, heart attack, incontinence and dementia. She is aware that federal health officials recommend that the drugs be taken at the lowest dose for the shortest time possible to treat severe symptoms of menopause such as hot flashes. Read more...... Estrogen Not Effective After Menopause
CHICAGO -- Estrogen pills have little effect on older women's quality of life, fresh evidence from a landmark study shows in yet another blow to the myth that most women need the hormones to feel better after menopause. More than 10,000 women with an average age of 63 were asked about their general health, mental, physical and social functioning, energy level and emotional health before and a year after they started taking either estrogen or dummy pills. Read more
Special Report -- In January, 2002, the Jim Leher NewsHour on PBS aired a segment focusing on the National Institute of Health's announcement it was stopping the largest clinical trial of hormone replacement therapy because the risks outweighed the benefits. Video and a transcript are available on PBS.org. A follow-up to this story aired in June, 2003 Ordinarily I wouldn't bring something from two years ago to the forefront, but there are STILL so many women who are confused about whether they should take hormone therapy or not that I thought you would still benefit from hearing what some women went through back in 2002. We're STILL getting mixed messages from our healthcare professionals and still having to rely on each other and anecdotal evidence of what works and what doesn't. I keep trying to find one central source of information that will benefit the most women, but at this point in time, there isn't one. I'm very proud to see that minniepauz.com is listed as a menopause resource on PBS! July 2005 - Hormone
replacement therapy safe for women with menopause & cancer survivors
June 2005 - OHSU
Researchers Uncover Cause, Possible Treatment For Abdominal Fat In Postmenopausal
Women
May 2005 - New HRT patch available to Aussie women May 2005 - Menopause and African-American Women March 2005 - HRT:
Still a Useful Therapeutic Tool
February 2005 - Hormone
supplements raise another red flag for women -- BY
LINDSEY TANNER - THE ASSOCIATED PRESS
January 2005 - Women who use postmenopausal hormone therapy containing estrogen shortly after menopause are less likely to experience cognitive impairment as they age, according to research published in the January/February 2005 issue of Menopause, the official journal of The North American Menopause Society (NAMS). Read full article.... December 2004 - Drug
limits return of breast cancer
October 2004 - Women
Returning to HT
August 2004 - Pros
& Cons of short term HT
June 2004 -
Study
Finds Menopause Can Be Predicted
Researchers now say they may be able to predict when that clock will wind down. May 2004 - Perimenopause
could cause serious first-time depression By
Marilyn Elias, USA TODAY
Apr 2004 - Study
Plans to Retest Use of Hormones
Mar 2004 - Possible
Peril Found in Menopause Cream
Pro-Gest, one of more than two dozen creams containing natural progesterone, is a widely used alternative to synthetic hormone therapies that have been linked to a higher risk of breast cancer and heart disease. Millions of tubes of progesterone cream are sold annually. Mar 2004 - The
Menopause Market -- Salon -- by
Pamela Paul
Mar 2004- National Hormone Therapy Study Halted -- Nearly 11,000 American women received a letter from the National Institutes of Health (NIH) this past Monday explaining that the estrogen hormone therapy clinical trial they had been involved in was being stopped a year earlier than planned due to the unacceptable health risks associated with the treatment. Feb 2004 - SWEDEN -- Scandinavian scientists announced Tuesday that they have called off a study of the effects of hormone-replacement therapy for women with a history of breast cancer because early results showed an "unacceptably high" risk of recurrence. Their findings add to earlier reports that using hormone replacement to control menopausal symptoms carries significant health risks. Eighteen months ago, U.S. scientists abruptly ended the nation's biggest study of hormone-replacement therapy using the combined hormones estrogen and progestin, saying long-term use significantly increases the risk of breast cancer, strokes and heart attacks. In the Scandinavian study, half the women were on replacement therapy and the other half on a non-hormonal treatment. In the HRT group, 26 women had a recurrence or a new case of breast cancer compared with seven women among those who took the other treatment. Jan 2004 The North American Menopause Society Releases Position Statement on the Treatment of Menopause-Related Hot Flashes Treatment of hot flashes, especially those moderate to severe in intensity, has focused primarily on estrogen therapy. However, recent studies questioning the benefit-risk ratio of long-term estrogen use have increased the search for alternative treatments. Read more....
START HERE The Women's Health Initiative Interview on PBS The JAMA The American College of Obstetricians and Gynecologists Archives from 2002
The North American Menopause Society |
Quotes from various Doctors:
Dr. David Elmer, a Hyannis gynecologist ******************* From Dr. Susan Love's website..."Although HRT may be right for some women, the research to date shows little evidence that HRT is playing a key role in disease prevention, while risks associated with its use remain." http://video.nbc11.com/player/?id=169195 *************************** Dear Dee, I appreciate your common sense approach to the HRT issue. And I agree that Humor Replacement is in order. ........ Paul D. Burstein, M.D. FACOG Clinical Professor Obstetrics-Gynecology University of Wisconsin
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