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. 
  
Even the term “bioidentical hormones” has taken on a different meaning. The FDA has approved hormones that are bioidentical, or having the exact structure as those produced in the body. However, marketing of compounded hormone therapies as “bioidentical hormones” may lead to confusion over what the term refers to. 

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.” 
Read complete article here: http://www.endocrinetoday.com/view.aspx?rid=27231

Articles do not in any way reflect the opinion of minniepauz.com
 

POST-MENOPAUSAL STUDY
New cancer risks appear after hormone use ends
By LINDSEY TANNER 
THE ASSOCIATED PRESS 

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
Article Date: 15 Jan 2008 - 2:00 PST

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
Wed Jan 9, 2008 6:31pm EST

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

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 
By RONI CARYN RABIN Published: August 28, 2007

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
By TARA PARKER-POPE  July 9, 2007

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.
more.....

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
By MATTHEW PERRONE AP Business Writer 
© 2007 The Associated Press 

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.
More......
 

April 2007 -- Hormones not always risky, new study says
Timed to menopause Sharon Kirkey, CanWest News Service
A new look at a massive trial that led women to give up hormone therapy in droves has found no increased risk of heart disease in women who start hormones soon after menopause.

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
AP medical writer Sunday, December 17, 2006

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
 CHICAGO — Older women who take hormone pills that combine estrogen and testosterone more than double their risk of breast cancer, according to a study of more than 70,000 nurses. 

"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

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. 

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. 

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. 

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....
NANCY J. WHITE
TORONTO STAR

Hormone prescription dropped to 6 million from 12.6 in 2001 due to fears about breast cancer, strokes and heart disease. Read More

Despite the risks, still on estrogen
THE WASHINGTON POST
September 27, 2005

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
By LINDSEY TANNER  AP Medical Writer
September 26, 2005, 7:57 PM EDT

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

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
Research shows that short-term hormone replacement therapy (HRT) is appropriate for peri- and postmenopausal women. These and other results from the Women's Health Initiative (WHI), the largest, most statistically valid and well analyzed research evaluating the use of HRT, are reviewed in the International Journal of Gynecological Cancer. 

June 2005 - OHSU Researchers Uncover Cause, Possible Treatment For Abdominal Fat In Postmenopausal Women
SAN DIEGO, Calif. -- Oregon Health & Science University researchers will unveil research results that help explain why middle-aged women develop central body fat. The announcement will take place during the 2005 Society for Endocrinology annual meeting today in San Diego. The OHSU research team has also conducted initial testing of estrogen replacement therapy as a possible method for counteracting the problem. Read more....

June 2005 - New Studies Point to Enhancing Women's Quality of Life in Areas From Post Menopause to Fertility to Breast Cancer Reduction

May 2005 - New HRT patch available to Aussie women

May 2005 - Menopause and African-American Women

March 2005 - HRT: Still a Useful Therapeutic Tool
By Mark Bloom, HealthDay Reporter

February 2005 - Hormone supplements raise another red flag for women -- BY LINDSEY TANNER - THE ASSOCIATED PRESS
Researchers led by a Wayne State University doctor have found another problem that hormone pills taken at menopause seem to make worse: incontinence.

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
New treatment much more effective for women after menopause, doctors say By Marilynn Marchione / AP Medical Writer
SAN ANTONIO -- A newer drug clearly outperforms tamoxifen at preventing breast cancer from returning and should become the first-choice treatment for most women who have had the disease, doctors are reporting.

October 2004 - Women Returning to HT
WASHINGTON (Reuters) - About a quarter of U.S. women who stopped taking hormone replacement therapy after it was found to raise the risk of heart disease and some cancers have gone back on it, the American College of Obstetricians and Gynecologists (ACOG) said on Friday. 

August 2004 - Pros & Cons of short term HT
A computer-based simulation model suggests that short-term hormone therapy (HT) is associated with increases in quality of life for women with menopausal symptoms, but may shorten life expectancy, according to an article in the August 9/23 issue of The Archives of Internal Medicine, one of the JAMA/Archives journals. 

June 2004 - Study Finds Menopause Can Be Predicted
By Amanda Gardner; HealthDay Reporter 
The number of eggs left in a woman's ovaries are like the grains of sand in an hourglass, ticking away the hours on her biological clock. 

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
A woman's odds of developing depression for the first time increase greatly during perimenopause, a time of irregular periods and hormonal shifts before menopause, a landmark study reported Wednesday.

Apr 2004 - Study Plans to Retest Use of Hormones
Despite studies in recent years finding that hormone therapy after menopause did women more harm than good, researchers at a group of major medical centers have decided to test the treatment again because they still suspect it may have benefits, particularly for younger women. The researchers hope to find out whether hormones can protect against artery disease if women start treatment early in menopause.

Mar 2004 - Possible Peril Found in Menopause Cream
A popular cream that eases the symptoms of menopause exposes women to higher levels of the hormone progesterone than has been commonly thought, researchers have found.

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
"There's been a tremendous increase in new product development and marketing since the WHI study," says Wulf Utian, executive director of the North American Menopause Society. "All sorts of stuff is being pitched to 'the menopause market.' For many of these companies, whether their products work or not is irrelevant. In fact, most of the stuff in the health-food store are just expensive placebos that women think are safe because they've got 'natural' on the label." According to Utian, "They're preying on a vulnerable and gullible population."

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....

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Quotes from various Doctors:
 "Women should not conclude they will get breast cancer or have a heart attack if they've taken these drugs.On the other hand, women should not start or continue to use the therapy to prevent heart disease. Diet and exercise, hypertension drugs, a low dose of aspirin and cholesterol-lowering drugs are alternatives."
Dr. Jacques Rossouw, acting director of the Women's Health Initiative