"The Heart of the Matter"

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Transcripts: 497.1 to 497.5

Week: 497.1 Guest: Ginny Levin Topic: The Women's Health Initiative - Part One Host: Richard NEMA Producer: Ed Graham

NEMA: This is a five part series on the Women's Health Initiative, the largest study ever conducted on women's health and disease prevention. My guest is Ginny Levin from the George Washington University Medical Center in Washington, D.C.

NEMA: Ginny, what is the Women's Health Initiative and why is there even a need for a Women's Health Initiative?

LEVIN: The Women's Health Initiative is a large national NIH-sponsored study looking at ways to prevent premature death and illness in women. The reason we have to have a Women's Health Initiative is that many studies in the past have not included women. Studies that have looked at ways to prevent heart disease for instance have often included men and not allowed women to participate. Heart disease is the leading cause of death in women just as it is in men and there really have been inadequate studies that have had a chance to look at prevention for diseases in women so NIH has decided to make up for that by funding this wonderfully comprehensive large study looking just at women's health.

NEMA: How long has this study been in the planning stages and was there some resistance to putting it into effect?

LEVIN: The Women's Health Initiative has been in the planning with many experts across the country and NIH experts in the fields of disease prevention for many years. It's not a particularly controversial study. There is the hope that this will be the study that will answer some of the questions that are being asked in the study such as "Will changing the diet to a diet high in fruits and vegetables and grains and lower fat help prevent certain types of cancer?" so there has been some question about is it appropriate to only ask women at this age to change their diet but the study is looking specifically at women between the ages of 50 and 79 and these are the years that are being the focus of their study.

NEMA: Now I think that some of the criticism that has been leveled at doctors and scientists in medical research is very legitimate, that women have been neglected. Studies of drugs and different procedures have always been performed on men and really women have been very neglected in this area but in a couple of areas there is some reason that doctors initially wanted to rule out women for studies. It's not entirely without basis. Right?

LEVIN: When doctors are looking at new drugs that might help treat disease, they were careful not to give a new drug to a woman who might be able to get pregnant and that's very understandable but when we're studying whether lowering cholesterol or lowering blood pressure or changing the diet might help prevent heart disease and we're looking at a middle-aged sample primarily, there really isn't much reason that women should have been excluded from those types of studies and this is a prevention study and that's a little different than a treatment study. We're looking at ways to prevent disease.

NEMA: Is there a big difference in the way a prevention versus a treatment study is conducted?

LEVIN: Well, they're similar in structure in that the clinical trial of this study as well as other clinical trials involve a treatment group or an intervention group and a comparison group so those are same. You're testing whether something works against a similar group of people who are not having that treatment or using that prevention.

NEMA: Join me for part two on the Women's Health Initiative with Ginny Levin.


Week: 497.2 Guest: Ginny Levin Topic: The Women's Health Initiative - Part Two Host: Richard NEMA Producer: Ed Graham

NEMA: This is part two in a five part series on the Women's Health Initiative, the largest study ever conducted on women's health and disease prevention. My guest is Ginny Levin from the George Washington University Medical Center in Washington, D.C.

LEVIN: The difference in something like the Women's Health Initiative is that we're really looking for a cross-section of women all across the country who are basically healthy so we're not looking for women who have a specific disease to test a drug to treat it. We're looking for basically the average woman who may have some health conditions but who is a basically healthy woman who is willing to help us learn more about ways to keep her healthy. A research study has what are called primary end points. That's a clinical or research term but what that means is - what are the things we're looking at first of all? And the things that are first of all being looked at in the Women's Health Initiative are the prevention of heart disease, the prevention of breast cancer, colon cancer or colo-rectal cancer and osteoporosis. In addition to those, there are many other things that we are also looking such as preventing diabetes and stroke and other forms of cancer as well as some quality of life issues but we're first and foremost looking at preventing the leading causes of illness and death which are heart disease, breast cancer, colon cancer and osteoporosis. We are not studying lung cancer primarily which actually is the leading cancer death in women because we do have a pretty good understanding of how to prevent lung cancer which of course is to avoid smoking but we know very little about how to avoid breast cancer for instance and the breast cancer rates are rising as I'm sure every woman is aware so these were the end points that were selected for study.

NEMA: One thing that periodically when I talk to experts in the area of cardiology for women or breast cancer, it's always good to remind people there have been several studies that showed that women thought the number one cause of death for women was breast cancer but in fact it's by a vast majority, not that that's not an extremely frightening and serious issue because it certainly is, but also heart disease really takes more lives of women than breast cancer, does it not?

LEVIN: Not only are you correct in saying that - heart disease kills more women each year that all cancers combined so that includes lung cancer as well as breast cancer and colon cancer so you're right. Many women think if you just would have asked them what is the biggest threat to a woman's health, they would say breast cancer when in fact it is heart disease. In fact, I've even heard some lectures given by people in the medical field that have not made that clear enough so it's important that women realize that when we think of women's health, we don't want to just focus on our reproductive organs, that it's important to understand that our cardiovascular systems are just as important to women as they are to men.

NEMA: How many women do you hope to ultimately have in number from around the country in this study?

LEVIN: The total, what we call sample size which is the number of participants we hope to enroll, is 164,000 and that's to be divided among the 40 clinic sites. Of the 164,000 women, we hope that about 64,000 of them will go in the part of the study called the clinical trial and that will leave 100,000 women that we are looking for to join the observational study. These are two different types of study designs and they will affect a woman's choice of which part she might be interested in.

NEMA: Join me for part three on the Women's Health Initiative with Ginny Levin.


Week: 497.3 Guest: Ginny Levin Topic: The Women's Health Initiative - Part Three Host: Richard NEMA Producer: Ed Graham

NEMA: If you are a woman between the ages of 50 and 79 you could participate in the largest study of women's health ever conducted, the Women's Health Initiative. This is part three in a five part series on the Women's Health Initiative with Ginny Levin from the George Washington University Medical Center in Washington, D.C.

LEVIN: It is the largest clinical trial that has ever been undertaken in this country as well as the largest study of any kind looking at women's health so we are really excited about this huge study.

NEMA: And the length in years is expected to be how long?

LEVIN: The study is going to follow women for an average of eight to twelve years with an average of about nine to ten and that depends on when women join the study. Their period of follow-up will be until the year 2005 so that means that women that are joining the study this year in 1995 will be followed for about nine years or so, nine or ten years. Women who don't join until next year will have one less year of follow-up so we say that the average period of follow-up is about nine or ten years. So it's important that the study be that long if you're going to actually look at differences in disease rates. These are other types of studies which don't have to be that long. If you're looking at, for instance, whether there's a new drug for cholesterol that might do a better job than an older drug, you can test that drug in a group of women and men for instance for about a year and have a pretty good sense of how well it works and whether there's any safety problems to be concerned with but in the Women's Health Initiative we're actually following women long enough to get an idea of who develops breast cancer compared to who doesn't, who develops an osteoporotic hip fracture compared to who doesn't, who has a heart attack versus who doesn't. So that's why the study has to be so big and so long.

NEMA: I can't imagine a study that was basically structured to sort of redress a problem of the past, namely discrimination against women in research wouldn't be very sensitive to that subject, but is this a study that's very racially and ethnically diverse?

LEVIN: As NIH several years ago made a special effort to change the imbalance in who has been in past studies, they'd look not only at women being excluded but also different parts of the population, different racial and ethnic minorities also being underrepresented so there are actually some explicit aspects to the Women's Health Initiative to help redress that. For instance, there are several sites across the country of the 40 clinical sites who have a specific contractual or by contract arrangement with NIH to recruit 60%, in other words more than half from a particular group of the population, so there are several sites which are looking to recruit more than half from the African-American population, some sites looking for more than half from the Hispanic or Latino population. There's even a site that's looking for a 60% sample of Native-American women. All of the sites, regardless of whether they're a minority site or not, when we say minority that means aiming to recruit this particular group, all of us are trying to recruit a sample that reflects the diversity within our own areas. The staff at clinics are supposed to reflect the diversity that we're looking for in the sample sites so we really are looking for a cross-section of women in the country.

NEMA: Join me for part four on the Women's Health Initiative with Ginny Levin.


Week: 497.4 Guest: Ginny Levin Topic: The Women's Health Initiative - Part Four Host: Richard NEMA Producer: Ed Graham

NEMA: This is part four in a five part series on the Women's Health Initiative. My guest is Ginny Levin from the George Washington University Medical Center in Washington, D.C. I asked Ms. Levin about the racial and cultural diversity among the study participants.

LEVIN: It would be a shame to have such a large study and such an expensive study not be representative because we want to be able at the end of the study after we look at the initial analysis to be able to go into the data and then analyze it by specific groups so we could see if those disease prevention strategies work very well for white women, will it work just as well for African-American women? Might it work better for African-American women? It will really be large enough we hope to be able to answer those questions.

NEMA: What type of evaluation will you be doing of the participants in the study as the study is ongoing? Is there something that will take place on some sort of an monthly incremental basis?

LEVIN: That's a very good question because when women are thinking about joining a study, they're often thinking right away of how much time is it going to take? What are they going to ask me to do? And how much time depends on which part of the study is chosen. The part of the study that requires the least amount of participant time and the least follow-up is the observational study.

NEMA: Would you explain what that term means to distinguish that?

LEVIN: Right. I'm sorry. An observational study is the type of study where we are just looking at the health status of the participant without in any way trying to treat them or change them, offer them counseling so in an observational study we see people at the beginning of their study and collect information from them and in this study we also collect a fasting blood sample and some other simple measurements. We do that again in three years but for the rest of the period of follow-up which is the same as in the rest of the study, we are collecting questionnaires by mail so in the observational study, most women will come to their clinic two times in ten years. There's actually a 1% sample that's being asked to come back an additional one time.

NEMA: Essentially then, this is a control group that you're not going to make lifestyle alterations in and therefore there'll be a basis for comparison of the people who did make changes versus those who didn't, right?

LEVIN: That's close but it's not exactly right. You're right in saying that they're not asked to make any changes but they don't exactly form the control group for the part of the study that do. For instance, in the hormone replacement portion of the study where we're testing whether women who start taking hormone replacement therapy compared to women who don't have a lower rate of developing heart disease or hip fractures, that will look at women who are not on hormone therapy and it will assign by computer half of the group to take hormone therapy and half that won't and that's the group that's being compared. Now in the observational study, women are eligible to come in to the observational study if they're on hormones or not on hormones and there's no attempt to change that but you can't exactly compare that group with the clinical trial group because it may be that the women who are already choosing to take hormone therapy on their own may in other ways be different. For instance, they may get better health care. They may have more frequent exams. They may be healthier to begin with so you're right in saying that we are using it for comparison purposes but not exactly to test whether a specific treatment works.

NEMA: Join me for part five on the Women's Health Initiative with Ginny Levin.


Week: 497.5 Guest: Ginny Levin Topic: The Women's Health Initiative - Part Five Host: Richard NEMA Producer: Ed Graham

NEMA: This is part five in a five part series on the Women's Health Initiative, a 164,000 participant study of women's health and disease prevention. My guest is Ginny Levin from George Washington University Medical Center in Washington, D.C.

LEVIN: The study is focusing on what are the leading causes of illness and death in women and we will be looking specifically at ways to prevent them and these include the leading cause of death in women which is heart disease, coronary heart disease. We'll also be studying how to prevent breast cancer and colon cancer and how to prevent the fractures that accompany osteoporosis which is not a leading cause of death but is a leading cause of disability in women so those are the areas that we're focusing on first of all. We'll also be looking in addition at other health issues that are common to women including diabetes, some other forms of cancer, stroke and really there's an unlimited potential to learn about disease prevention but the primary focus is on heart disease, certain cancers and osteoporosis.

NEMA: Now for women who would be interested in participating in the study, how do they go about doing that and for the people that would be in some of the most intensive parts of the study, how much of an investment in time would be required from them?

LEVIN: Okay. First of all there are 40 clinic sites across the country so if a woman is interested in finding out more about the study and if there's a clinic site near her, there is an 800 toll free number that women can call and that is 1-800-54-WOMEN. And when they dial that number, they can be directed to the clinic site that's closest to them if there is one close to them. Unfortunately not every woman who's interested will find that she lives close enough to a clinic site but for those women who do, then when she calls the clinic she can get some initial information on the telephone, she'll learn about the different parts of the study. She will learn for instance that the dietary change portion of the study which is looking at the prevention of cancers and heart disease by changing to an eating pattern high in fruits, vegetables and grains and low in fat, that that could require her to come to the clinic as often as 18 to 20 times the first year and six times a year after that. So if she's interested in that part of the study, the clinic would explore with her if that seems manageable for her. I do want to add that we are particularly looking for women in their 70s to join the study. The study is open to women between the ages of 50 and 79 and we need to have actually 25%. A whole quarter of this group is targeted to be for women in their 70s. The participants who are in this study are having a very good time. To be honest with you, most women find that coming into a research study is a really positive experience. We care very much about our participants. We know them. They know us and it really is a sense of belonging and that's something that we're actually trying to instill because if a woman is thinking about joining a study that's going to last so long, it's important that she feels comfortable and that she feels that what's she's doing is important and that we value her participation so I think that's what women will find when they call the different clinic sites. . . that we are all very eager to meet them, answer their questions and hopefully enroll them in the part of the study that they feel comfortable in joining.


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