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New Risks: Hormone Replacement Therapy

June 25, 2003 at 12:00 AM EST
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TRANSCRIPT

SUSAN DENTZER: Mary Ganikos is just one of roughly two million women who last year quit taking a popular hormone drug. The drug treats hot flashes and other menopausal symptoms. Ganikos, who’s 54, acted after results were released from a landmark federal study, called the Women’s Health Initiative. Those results linked the drug, Prempro, a combination of estrogen and progestin, to sharply higher rates of breast cancer, heart attacks and strokes.

MARY GANIKOS: I got up one morning and turned on The Morning Show, as I usually do, and then I heard about the studies. And my ears perked up, and I thought, “gee, that’s the drug that I’m taking.” I decided right then and there that I had had my last pill.

SUSAN DENTZER: Today, the news about Prempro got even worse, as still more data was published from the same landmark study. Dr. Leslie Ford of the National Cancer Institute says the problems went beyond the fact that the drug caused higher rates of breast cancer.

DR. LESLIE FORD: There were more abnormal mammograms; they were more difficult to read. And the breast cancers that resulted in women on the active drug, on the estrogen plus progesterone, were diagnosed at a later stage, and were more likely — The tumors were larger and more likely to have positive lymph nodes, lymph nodes in the underarm

SUSAN DENTZER: Which means?

DR. LESLIE FORD: That the prognosis might be worse.

MEDICAL TECHNICIAN: I’m putting this compression paddle or your breast.

SUSAN DENTZER: Ford says the breast cancers in Prempro users were apparently being diagnosed later, because they were harder to find in the first place. The best guess is that the Prempro was making breast tissue denser, thus making it more difficult to see small tumors or lesions on a mammogram.

Hormone drugs like Prempro were long ago proven effective at relieving menopausal symptoms like hot flashes. But from the 1960s on, they were also touted as virtual wonder drugs that could practically guarantee perpetual youth and femininity. Cynthia Pearson, who heads a watchdog group on women’s health, mentions one hormone drug ad that ran in a medical journal.

CYNTHIA PEARSON: So, this ad opened with, “If your patients are asking you questions about menopause and estrogen, consider the body of evidence.” And the arrows pointed to the uterus, the breast, the brain, the skin, the bones, the teeth. And in each part of the body, there was an accompanying text that described what the connection between estrogen and healthy brains, healthy bones, healthy breasts, healthy skin. And yet, the FDA had only approved an actual claim of benefit for two of those eight body parts.

COMMERCIAL VOICE-OVER: See your doctor –.

SUSAN DENTZER: Claims that hormone drugs produced these other benefits were based on studies that had seemed to suggest the drugs could prevent conditions, like heart disease. So the Women’s Health Initiative was created to test those assumptions, through a type of study that is considered the gold standard of scientific evidence. Susan Resnick is an investigator at the National Institute on Aging. She described to us findings that emerged last month from a section of the Women’s Health Initiative called the Memory Study, referred to as WHIMS. These results contradicted the conclusions of earlier studies, which had seemed to indicate that Prempro protected women against Alzheimer’s.

SUSAN RESNICK: The results of the WHIMS study show very clearly that in women age 65 and older, estrogen is — the combined estrogen and progestin therapy — is actually doing more harm than good on the brain. It’s doubling the risk for dementia.

SUSAN DENTZER: A total of 4,500 women 65 and older participated in the whims study. Half of them got Prempro, while the other half got a placebo, or dummy pill. After five years, there were 61 cases of dementia among all the women; 21 occurred in the placebo group, and 40 in the Prempro group. Mary Ganikos told us that the link between Prempro and Alzheimer’s frightened her even more than the other WHI results.

MARY GANIKOS: My mother had Alzheimer’s, her mother had Alzheimer’s, my grandmother’s grandmother had Alzheimer’s, my mother’s brother had Alzheimer’s. If there’s any indication that there’s anything that would contribute to Alzheimer’s, I’m not going to do it.

SUSAN DENTZER: Still, another recent study coming out of WHI addressed claims that Prempro produced so-called “quality of life” benefits, such as a sense of having more energy or better mental health. Dr. Jacques Roussow is project officer with the WHI.

DR. JACQUES ROUSSOW: The women who were in this trial were given an extensive battery of tests to look at many aspects of their quality of life. There was a small improvement in sleep, about 5 percent improvement in sleep in women with symptoms. And that was significant but that was the only you know probably clinically significant finding that was present.

SUSAN DENTZER: So what might the new body of evidence picture look like if it were updated to incorporate all these results from WHI? Something like this:

Effect on the brain: In women 65 and older taking the drug, the risk of Alzheimer’s or other forms of dementia doubles. Breast cancer in women 50 and older: The risk increases 26 percent, and is accompanied by more abnormal mammograms and more invasive cancers that are diagnosed at a later stage. Heart attacks: The risk increases 29 percent. Strokes: The risks grow by 41 percent. Blood clots: The risks rise 111 percent. Overall quality of life: A small benefit of improved sleep in women with menopausal symptoms, but otherwise almost no discernible change.

To be sure, there are still some benefits. Hip fractures from osteoporosis decreased 33 percent, and the risk of colon cancer appears to decrease 37 percent. But overall, experts say, the body of evidence now clearly shows that the higher disease risks outweigh even these benefits.

Wyeth, Prempro’s manufacturer, does not dispute any of the WHI findings, and told us that they were important for women’s health. The company says sales of the drug have plummeted at least 60 percent since last July. Only about 1.2 million women in the U.S. are still taking Prempro, mostly for short-term relief of symptoms. That’s down from an estimated 3.4 million users one year ago.

One woman now on hormone therapy is Joan Norris, age 67. She told us that after being off Prempro for several months, she found the recurrent symptoms unbearable.

JOAN NORRIS: I thought I’d have a few hot flashes and maybe night sweats, and things like that, for a couple of months. But I actually counted them and wrote them down and found that I was having 20, 22 in a 24-hour period.

SUSAN DENTZER: Norris is now back on hormone therapy, and is resigned to facing the disease risks.

JOAN NORRIS: You live long enough, something is going to get you. And I think I almost just have to feel that way about it.

SUSAN DENTZER: Norris’ case underscores the fact that besides the hormone therapy drugs, there are still no other remedies proven effective for the relief of hot flashes and night sweats. And that’s why many women and researchers hope better news will emerge from a separate part of the WHI. It’s testing another hormone drug, the estrogen-only medication called Premarin. The results of that part of the WHI are expected in 2005.