HORMONES BY DESIGN
January 12, 1998
The number one selling prescription drug in the United States might surprise you: estrogen. Menopausal women use this hormone to relieve their symptoms, but studies show estrogen may provide some defense against other health problems, including heart disease and possibly Alzheimer's. The FDA approved a so-called "designer" estrogen for the prevention of osteoporosis this week, but some women remain skeptical. Elizabeth Brackett reports.
ELIZABETH BRACKETT: Pills containing the hormone estrogen are the number one selling prescription in America. An estimated 6 million women use the pills or patches to replace the estrogen their bodies stop producing when they reach menopause. Some studies show that estrogen protects not only against hot flashes but against heart disease and maybe even Alzheimer's. But there are side effects.
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JOY DORDCIK: And I got scared, so I called my doctor--
ELIZABETH BRACKETT: When a group of women who have reached menopause get together, questions about estrogen replacement are a hot topic.
JOY DORDCIK: The frightening thing for me is heart. There's a lot of heart disease in my family. And I'm scared of giving myself cancer from taking all of this stuff for so long.
BOBBIE ROTHENBAUM: My background is pretty similar to yours in that I've been taking it for--taking estrogen since, well, I guess for the last 23 years. So--and I'm not thrilled about the symptoms that I've gotten because I've gotten periodic headaches, and my breasts have enlarged tremendously since then. I'm not happy about those side effects. I'm open to a new product, but I don't want to be a guinea pig.
The Raloxifene controversy.
ELIZABETH BRACKETT: There is a new product just hitting pharmacy shelves this week. The FDA approved Raloxifene for the prevention of osteoporosis. Osteoporosis affects more than 28 million Americans, most of them women. Raloxifene, manufactured by Eli Lilly under the trade name Evista, and labeled a designer estrogen by some, provides some of the same benefits as estrogen. But unlike estrogen, it will not increase the risk of breast cancer. Dr. Douglas Muchmore oversaw the research material Eli Lilly submitted to the FDA.
DR. DOUGLAS MUCHMORE, Eli Lilly & Company: Evista will be--is marketed, and it is appropriate for women who have concerns about the health risks associated with the menopause, specifically osteoporosis, because it's approved for the prevention of osteoporosis. It has a broad profile of pharmacological activity, including beneficial effects on the lipids or cholesterol profile, and that is a consideration that can be brought into play in the decision to take Evista.
DR. LAUREN STREICHER, Obstetrician/Gynecologist: How have you been feeling?
LINDA SORKIN-EISENBERG: I've been feeling pretty good. I'm really concerned about not taking estrogen, so--
DR. LAUREN STREICHER: Well, I know osteoporosis has been an issue for you for a long time.
ELIZABETH BRACKETT: Fifty-six-year-old Linda Sorkin-Eisenberg was anxious to hear what her gynecologist had to say about Raloxifene. Fibroid tumors in her uterus have made her reluctant to take estrogen. But she has already experienced bone loss from osteoporosis.
DR. LAUREN STREICHER: The studies do show that it prevents bone loss probably as well as estrogen and will also decrease your cholesterol and may give you some cardiovascular benefit as well.
LINDA SORKIN-EISENBERG: It sounds like something that's very exciting.
ELIZABETH BRACKETT: Dr. Lauren Streicher sees a lot of menopausal women in her Chicago practice. She does stress that Raloxifene is not for everyone.
DR. LAUREN STREICHER: The confusion with Raloxifene, of course, is that everyone thinks this is it, this is an estrogen substitute. It is not meant to be an estrogen substitute, and it's not being marketed as such. It is being marketed as an alternative to women who cannot take estrogen, who would like to prevent osteoporosis. It's not going to help hot flashes, in fact, may increase hot flashes, and it may not--no one has really looked to see other tissues, in terms of is this going to benefit the bladder, is this going to help with Alzheimer's, which we know that estrogen can.
Is estrogen dangerous?
ELIZABETH BRACKETT: But Dr. Samuel Epstein, author of the "Breast Cancer Prevention Program," has major concerns about Raloxifene. His concern is not about breast cancer with Raloxifene but ovarian cancer. He points to the research submitted by Eli Lilly to the FDA, which shows an increase in ovarian tumors in mice and rats.
DR. SAMUEL EPSTEIN, University of Illinois, Chicago: The alarming information is that in studies on mice and rats Raloxifene produces a high incidence of ovarian cancers. The end of the section dealing with these studies says the clinical relevance of this is not known. However, when you turn to the warning section on Raloxifene in which women are told about their dangers, there's not a single mention about ovarian cancer.
ELIZABETH BRACKETT: Do you think Raloxifene to be allowed on the market?
DR. SAMUEL EPSTEIN: Under no circumstances.
ELIZABETH BRACKETT: But Eli Lilly says the mice and rats in the study were pre-menopausal when ovarian cancer is common. The company says ovarian cancer was not found in humans.
DR. SAMUEL EPSTEIN: Our extensive testing of these thousands of women over the years, has shown no evidence whatsoever of ovarian tumors in women at a rate that's any different from that seen in the placebo-treated control groups.
The case for replacement therapy.
ELIZABETH BRACKETT: But since one in eight American women get breast cancer, it is the fear of that form of cancer that has many women shying away from estrogen replacement. And a study published last June in the New England Journal of Medicine did little to calm those fears. The study found that women who take hormone replacement therapy for 10 years reduce their risk of dying from all causes by 37 percent. The risk of dying from heart disease is cut by 57 percent, from breast cancer by 24 percent. But if a woman continues with hormone replacement therapy more than 10 years, the risk of death from breast cancer jumps to 43 percent. Still, most gynecologists, including Streicher, think the benefits outweigh the risks with estrogen replacement.
DR. LAUREN STREICHER: Most women die of heart disease. Estrogen protects against heart disease. And if, in fact, we find that estrogen does somewhat increase the risk of breast cancer in a small population of women, I think that the studies really have shown that the protection against heart disease outweighs that.
DR. SAMUEL EPSTEIN: My view is very clearly that it's not worth the risk of breast cancer, and my particular reason for saying that is there are many safe alternatives for preventing heart disease and osteoporosis. What you have--there are no other effective methods of preventing breast cancer, so if you increase your risks of breast cancer, this is something which is preventable.
ELIZABETH BRACKETT: Since there are questions about estrogen, why not just take a lower dose? There are products on the market, sometimes referred to as estrogen-light, that contain half as much estrogen as the standard dose. Estrotab, an estrogen synthesized from soy and yam sources, has been prescribed in doses of .3 milligrams, as opposed to the usual dose of .625 milligrams. A recent study published in the archives of Internal Medicine found that the low dose of Estrotab protected against bone loss as well as the higher dose. That sounded good to the woman's group.
WOMAN: The idea of going on something light was very, very appealing to me because I'm scared, like all of us are scared.
ELIZABETH BRACKETT: But Streicher says half as much estrogen does not necessarily mean half as much risk for breast cancer.
DR. LAUREN STREICHER: Because we don't know, first of all, absolutely that estrogen increases the risk of breast cancer, it appears that in certain populations it might, and we certainly don't know whether it's dose-related or not. Many people say, well, it stands to reason if one dose causes it, then a lower dose won't cause it. But that's really not evidence-based. You really have to look and see if something is dose-related or substance-related.
ELIZABETH BRACKETT: But Epstein doesn't like anything that adds to the estrogen levels in women's bodies.
DR. SAMUEL EPSTEIN: We have the clear evidence from the fact that women are being exposed to more estrogens than ever before from sources including hormone replacement therapy, the pill, from some pesticides that have weak estrogenic effects, and also, very, very importantly but unrecognized by the American public at large from meat, because meat contains very significant levels of sex hormones, particularly estrogens. So from birth till death women are exposed to estrogens in a wide range of different forms.
ELIZABETH BRACKETT: So despite new studies and new drugs, women still have no clear-cut answers. Instead, they are advised to look at their own health history, weigh the risks and benefits, then decide for themselves.