DR. LAUREN STREICHER: Maria?
DR. LAUREN STREICHER: Hi, it's Lauren Streicher.
ELIZABETH BRACKETT: Gynecologist Lauren Streicher was in her office two hours early, trying to return the hundreds of phone calls from women asking about their hormone therapy.
The calls had poured in after the National Institute of Health announced it was stopping the largest clinical trial of hormone replacement therapy because the risks outweighed the benefits. With the permission of Dr. Streicher and her patient, we listened in, as the questions came.
PATIENT: I've been on estrogen and Provera for 16 years.
DR. LAUREN STREICHER: Right.
PATIENT: And, you know, what with the new research, I'm wondering should I get off the Provera? Should I do a different progestin; should I be taking it all?
ELIZABETH BRACKETT: About half the patients in Dr. Lauren Streicher's large practice in Chicago are menopausal women. She says she probably prescribes more hormone replacement therapy than any other practice in the city. This 57-year-old caller has osteoporosis.
DR. LAUREN STREICHER, Obstetrician/Gynecologist: My concern is that if you go off your hormone replacement all together, that your bone density may begin to decline, and you're young. I mean, you're really, really young, and what we're looking at is not so much the next few years, but where are you going to be when you're 60 or 70, in terms of your risk for fractures.
ELIZABETH BRACKETT: Dr. Streicher says each person's situation has to be individually assessed.
DR. LAUREN STREICHER: So I think my inclination with you would be, as you said, either to switch progesterone or to go down to the lower dose of estrogen. I'd hate to see you go off altogether, because I suspect you will be symptomatic.
ELIZABETH BRACKETT: Even though the Women's Health Initiative trial showed that women who took Prempro, a drug which combined estrogen and progestin, had a slightly increased chance of getting heart disease and breast cancer, many gynecologists like Streicher are not ready to give up on hormone replacement.
DR. LAUREN STREICHER: When I look at the women who we've put on hormone replacement, for some of these women we've given them their lives back. These are women who can't function, who are unable to have a sexual relationship with their partners, who can't sleep at night, who can't think clearly. And what we're looking at is, yes, maybe out of 10,000 women there have been a few additional cases of coronary artery disease that may not have happened anyway, but you have to look at the number of women that you've helped.
ELIZABETH BRACKETT: Dr. Philip Greenland, who coordinated the study for the Women's Health Initiative at Northwestern University, is convinced otherwise.
DR. PHILIP GREENLAND, Women's Health Initiative, Northwestern University: I think the only reason to take hormones, from my point of view, would be for short-term symptom relief-- maybe a year, maybe two years. Not longer. I certainly wouldn't advise a patient to take these medications longer than one or two years, maximum.
ELIZABETH BRACKETT: Greenland, a cardiologist, was particularly surprised by the news that hormones caused additional cases of heart disease.
DR. PHILIP GREENLAND: The previous information we had prior to 1993 looked so convincing that hormone replacement therapy was going to be beneficial for heart disease prevention that the consent form initially said that we expected either to see benefit or nothing. We really didn't expect to see harm for cardiovascular disease, for heart disease.
COMMERCIAL: Menopause is complicated. Talking to my doctor helped. For me, she prescribed Prempro.
ELIZABETH BRACKETT: After being sold on the benefits of hormone therapy over the last 40 years, many women are finding it difficult to stop. Wyeth-Ayerst, the drug company that supplied both the Prempro and the estrogen-only Premarin for the trial, has spent millions promoting the two drugs. Last year sales for the two drugs topped $2 billion. 13.5 million women in the U.S. now take some form of hormones. All the shocking revelations have left women confused and angry.
Sixty-year-old Hedy Ratner has been taking hormone replacement therapy for the last 16 years.
HEDY RATNER: I'm angry about it all. I'm angry because it's taken this long to do the clinical research. I'm angry because the research has been contradictory. I'm angry because we're stuck in this position. I'm angry because the hormone replacement therapy has been kind of a state of the art, and all of a sudden it's not state of the art?
ELIZABETH BRACKETT: Ratner, co- president of a non-profit center that helps develop and expand women-owned businesses, took her questions to her doctors. She and her doctors agreed to let us tape their conversation. She made her first appointment with her long-time endocrinologist, Dr. Jim Sheinin, a doctor she began seeing after a bout with thyroid cancer when she was in her 20s.
DR. JIM SHEININ, Endocrinologist: Clearly it seems that the therapy that was designed as a prevention, as opposed to a treatment for a disease, is now not apparently a prevention but tends to promote some of the diseases it was supposed to actually prevent.
HEDY RATNER: So you're saying it doesn't prevent heart disease? It doesn't prevent...
DR. JIM SHEININ: Alzheimer's.
HEDY RATNER: Alzheimer's? It doesn't prevent stroke?
DR. JIM SHEININ: Right. It does help maintain the bone density, but there are lots of other non-hormonal therapies that are available to do that.
HEDY RATNER: What about hot flashes? What do you do about hot flashes?
DR. JIM SHEININ: If the hot flashes become a severe problem, there are several approaches. They're not as good as hormone replacement therapy. For your situation, because of the difficulties you've had when you've gone off, my prejudice would be for you to do it at four-week intervals so that your body can gradually adjust to the lower dose.
HEDY RATNER: Is there any possibility that, say, at the end of the six-month period that all menopausal symptoms will have disappeared and I won't have to worry about it?
DR. JIM SHEININ: Yes, absolutely.
HEDY RATNER: What are the chances of that happening?
DR. JIM SHEININ: It's hard to say, but generally the longer you are past menopause, the less likely the symptoms are to be as severe as they were in the period soon after menopause.
ELIZABETH BRACKETT: Armed with the advice from her endocrinologist that she should taper off her hormones with the goal of quitting altogether, Ratner went to see her gynecologist, Dr. Alan Charles, also a doctor who had been treating her for the last 25 years.
HEDY RATNER: I'm pissed. This whole story, all the research that's been done in the world health initiative says that all of the wonderful value and benefits of hormone replacement therapy aren't... aren't benefits and are damaging, and here I am, stuck 16 years later.
DR. ALAN CHARLES, Obstetrician/Gynecologist: The fact is, the only thing they said doesn't bear out, has to do with the prevention of coronary artery disease. Almost all the other benefits are still available: Prevention of osteoporosis; reduction in the incidence of colon cancer; maintaining the integrity of vaginal tissues. So there are many, many advantages which aren't spoken about, including there's a lot of inferential evidence that estrogens protect the brain, and I think that may, in the long term, be the more important thing.
HEDY RATNER: But I went off cold turkey and the symptoms were enormous: Monster hot flashes, incontinence all the time.
DR. ALAN CHARLES: Okay. We do know that women who develop hot flashes, that is a malfunction in the brain. The thermostat of the body is in the hypothalamus-- that's a part of the brain-- and if you're having hot flashes and sleep disturbances, this may mean that something's going wrong with the wiring in your brain, which is responsive to estrogen. So that might be a very good reason for you to stay on it.
HEDY RATNER: I'm 60 years old-- perhaps if I went off very gradually, the menopausal symptoms would... I mean, I'm asking you.
DR. ALAN CHARLES: It's the same as if you hadn't gone through the menopause. Whenever you stop, the estrogen deprivation will be there. Since you are 60, even though you don't look it-- probably because you are taking Premarin-- but the point is, the fact that you were talking about such severe menopausal symptoms whenever you tried to withdraw would give you a good reason to be on it, because, as I said, I think your intellectual capacity is very high, and, you know, I can't prove it-- there's no way to prove it-- but there does seem to have a beneficial effect on brain function.
HEDY RATNER: Forever? Do I keep taking it forever?
DR. ALAN CHARLES: I think so.
HEDY RATNER: Forever until I die?
DR. ALAN CHARLES: Yeah, well, I have to tell you my wife is a little older than you and she's still on it, and I have no intention of taking her off.
ELIZABETH BRACKETT: The two appointments had not made Ratner's decision much easier.
HEDY RATNER: I'm pretty conflicted here. The two... my two doctors, who I have been seeing for 25 years and who I trust-- and I don't usually trust most doctors, but I trust these two-- give me two conflicting answers.
ELIZABETH BRACKETT: So what are you going to do?
HEDY RATNER: I still think I'm going to try to gradually wean myself, at least to a lower dosage, but I do want to know more about brain function. That really is critical to my life.
ELIZABETH BRACKETT: Because of the concern over brain function, two additional components were added to the Women's Health Initiative. One study looks at whether or not hormone replacement can delay the onset of Alzheimer's and dementia. The other looks at the impact of hormones on cognitive function. Even with the abrupt cancellation of the Prempro study, researchers still hope to look at whether estrogen alone impacts women's brains. But those results may not be available until 2005, the year trial was scheduled to end.
Some women are not waiting that long to vent their anger; a class action suit has been filed against Wyeth-Ayerst asking that Prempro be taken off the market. The suit asks for compensation, for harm allegedly associated with Prempro. The company says there's no factual basis for the complaint.