Menopause: Women weigh risks of relief.
The hot flashes came without warning. "I would be on the airplane," said Earlene Bennett, 61, a Northwest Airlines flight attendant. "My face would get real flushed. Here I am with a beverage cart, and I'm sweating to death."
Synthetic hormones helped curb her symptoms, but then they returned. She also worried about reports linking the hormones to breast cancer. So she turned to "bioidenticals," hormones derived from plants, which have the same chemical makeup as a woman's natural hormones.
Now she feels healthier, if not completely at ease. "I don't know if it's safer," she said, "but I'm more comfortable with it."
Bennett's uncertain choice illustrates an important new crossroads in women's health care.
As 40 million women enter menopause, they are stepping into growing disputes among doctors and pharmaceutical companies over how to manage its symptoms -- and hearing more debate over whether menopause should be treated as an illness or a life passage.
The marketplace of medicines for menopausal women is exploding into a nearly $4 billion industry, providing women an array of options. But even as they seek something more than one-size-fits-all treatments, they are getting no clear answers on the safest and most effective forms of relief.
Last month Wyeth, the biggest seller of prescription hormones, called on the Food and Drug Administration to investigate pharmacies that sell and market "custom-mixed" or "custom-compounded" bioidenticals.
Wyeth says it does not object to the many FDA-approved bioidenticals, which undergo stringent scrutiny. It is charging, however, that there is no way to guarantee the safety or efficacy of blends, which use varying amounts of three naturally occurring estrogens, as well as progesterone. The pharmaceutical giant is demanding that pharmacies be required to play by the same rules as other drugmakers.
But pharmacists dismiss such concerns as turf protection by drug companies, some of which sell bioidentical hormones. A lawsuit filed by a group of pharmacies that does custom-compounding seeks protection against FDA actions and probably will be heard next year.
"There is no reason to believe that a custom-compounded product is safer," said Pamela Boggs, director of education of the North American Menopause Society. "It may be more dangerous, because it has never been tested. They are experimental drugs." Others say prescriptions typically are created based on a saliva test, whose accuracy many doctors find suspect.
Supporters of custom-compounding say it results in fewer side effects, may have fewer long-term health risks, and can be tailored to the individual.
"You're putting back in your body something biochemically identical to us," said Sandy Greenquist, a certified nurse midwife and menopause clinician who founded the Menopause Center of United Hospital in St. Paul three years ago. "From a logical perspective, that seems safer to me."
Bennett, who went through menopause at 50, is one of many women finding relief through custom-compounding. She uses a cream that's a mix of estriol, estradiol -- two of the three estrogens -- and progesterone. While not all insurers pay for such prescriptions (up to $50 a month), Bennett's does.
Julie Andersen, 50, of New Hope also uses custom hormones. After a hysterectomy in January, "it was like someone flipped a switch." She suddenly had hot flashes, forgetfulness and other symptoms. Many have disappeared in the months since the Jazzercise franchise owner began taking bioidentical hormones. "I feel like it's given a lot of my younger life back," she said.
A huge and growing market
The market for hormone replacement took an $800 million hit after the Women's Health Initiative's 2002 study linked artificial hormones to increased risks of heart disease, stroke, breast cancer and blood clots. But as waves of baby-boom women enter menopause, the market is expected to hit $4.8 billion by 2010, according to a marketing research company Frost & Sullivan.
A woman officially enters menopause when she has not menstruated for 12 consecutive months. In the United States, the average age of menopause is 51. But symptoms such as hot flashes, mood swings, depression, irregular periods and low libido may begin years before, even in a woman's 30s, in a phase called "perimenopause." Perimenopause can last a decade; on the other end, some women experience post-menopausal symptoms into their 80s.
Until the 20th century, when lifespans increased, menopause was part of the final stage of life. But in the mid-20th century, synthetic estrogens and progesterones were developed to help treat discomfort and have been used by most doctors since. The most common are still Premarin and Provera.
Interest in alternatives has increased since the 2002 study, which prompted the FDA to mandate warning labels on all estrogen products advising women to use the least amount of hormone necessary for the shortest time possible. Still, millions quit hormone therapy even though, for many, it is still safe and effective. Some are returning to traditional therapy as symptoms resurface.
Options are plentiful
There are many ways to take hormone therapy, including pills, skin patches and gels, which allow estrogen to circulate throughout the body. Creams, vaginal rings and suppositories release a small amount of circulating estrogen. These products are used to treat everything from hot flashes and night sweats to vaginal dryness. But the FDA's versions are largely one-size-fits-all; only custom-compounding offers women a unique mix tailored to specific needs. Andersen's doctor, for example, added testosterone to her original estrogen-progesterone mix to pump up her libido.
Greenquist, who treats about 400 patients ranging in age from 33 to 81, said she sees patients who were put on hormones by their physicians without much explanation. "I knew there had to be a better alternative," she said.
Custom-compounding has been widespread in Europe for years, as well as in parts of the United States. In 2004, after publication of actress Suzanne Somers' "The Sexy Years," a primer on bioidentical hormones that promotes custom-compounding, interest soared.
In July, the Mayo Clinic in Rochester opened the Women's Health Clinic, offering comprehensive care and a variety of approaches to menopause -- including herbal remedies, relaxation techniques, nutritional advice and FDA-approved bioidenticals.
Is doing nothing best?
Some women find this whole discussion perplexing. They view menopause as a normal life passage, not an illness.
Carolyn Bordeaux, 53, a Sicangu Lakota Indian, sought natural remedies when she began experiencing menopausal shifts a decade ago. She gets acupuncture treatments for skin problems, takes black cohosh, herbal remedies used to balance hormones, and herbal teas. She also sees two medicine men for healing.
"Western medicine often treats natural occurrences as disease," Bordeaux said. "Women have gone through this for thousands of years. It is a time to honor your body and realize the full potential and wisdom that women gain through this process."
Like Bordeaux, Dr. Zhuoling Ren, a practitioner of traditional Chinese medicine in St. Paul and Minneapolis, believes the difference is cultural. "For a lot of Asian females, we treat menopause as a stage of life. We try to seek ways to ease symptoms without being manipulated by them," she said. "We need to help women get through this, but also remind them that eventually it will be fine."
And some women sail through menopause with little discomfort. Dr. June LaValleur, an associate professor in the department of obstetrics, gynecology and women's health at the University of Minnesota, said 20 to 30 percent of women experience no symptoms at all.
"I never had hot flashes, sweats, obesity, turning mean and nasty or going crazy from menopause," said Daria Jmill, 58, of St. Paul, who is three years post-menopausal and putting her energy into creating and patenting a wheelchair-tire cleaning device. "They want you to make an illness out of it and to buy stuff that your body doesn't need."
"We're really caught in a place where it's hard to make a judgment," said Dr. Noël Radcliffe, an Edina family practice physician who prescribes bioidentical hormones among many options for her patients. "We don't know all the answers. We have to evaluate every year."
Leyla Kokmen is a Minneapolis health writer and lecturer at the University of Minnesota School of Journalism.
Leyla Kokmen, Special To The Star Tribune
November 13, 2005
Staff writer Gail Rosenblum and Wall Street Journal reporter Tara Parker-Pope contributed to this report.