BB&T Executive Editor.

Phyllis Greenberger, MSW, is president/CEO of the Society for Women's Health Research (Washington), which bills itself as the nation's only non-profit organization with the mission of improving the women's health through research, education and advocacy. Greenberger was a leader in establishing the society in 1990 and has headed it since 1993.

Under her leadership, the organization can claim that it successfully fought to bring the inclusion of women in medical research, as a critical issue, to national attention.

She is a co-editor of "The Savvy Woman Patient: How and Why Sex Differences Affect Your Health" (Capital Books, 2006), and a frequent presenter on women's health.

Nationally, her presentations include an address to the World Health Care Congress on healthcare benefit plan design and to the Biotechnology Industry Organization (Washington) on health disparities and drug development for women and minorities. She frequently testifies before Congress, advocating for research and funding for women's health.

Internationally, Greenberger has spoken before the American Jewish Congress Commission for Women's Empowerment conference in Israel, as well as the International Pharmaceutical Federation and the International Council of Nurses. Greenberger serves in an advisory role to PBS' To the Contrary, the only national all-women's news analysis program, Shape magazine, and Style & Sense magazine.

Greenberger serves on numerous health, media and women's issues advisory boards, promoting the need for appropriate recognition and suppport of women's health needs and women's health research. She is advisory board co-chair for WomenHeart, the national coalition for women with heart disease, a board member of the Interstitial Cystitis Association and the Medical Technology Leadership Forum, and an advisory board member for the Association of Black Cardiologists' Center for Women's Health.

For her work, Greenberger has received many honors. The Medical Herald selected her as one of the 20 most influential women in medicine today. She received the 2007 Clinical Research Forum's Public Service Advocacy Award for bringing the issues of women's health and sex differences to the forefront of basic and clinical research. Greenberger was named one of Washingtonian's 100 Most Powerful Women by Washingtonian Magazine in June 2006, and Women's Day awarded her a 2006 Red Dress Award for her work in the fight against heart disease in women.

The Women's Health Research Society was the driving force behind the 2001 Institute of Medicine IOM report, "Exploring the Biological Contributions to Human Health: Does Sex Matter?," which called on researchers to understand the implications of basic biological sex differences for the betterment of human health. The IOM report is part of the society's and Greenberger's broad and successful work to encourage the public and private sectors to devote more attention, more resources and better analysis to women's health.

Q. How did you come to focus on women's health and the establishment of the Society for Women's Health Research?

A. I started a second career at the American Psychiatric Association [in 1981]. When I got to the APA, I was drawn to some of the mental health issues for women. I never considered myself a feminist but I found myself gravitating [to those issues]. I was close to women psychiatrists and their concerns about tenure, not being published, how women were disproportionately affected [by mental health issues], the lack of women included in clinical trials. I convinced my boss at that time that women's issues needed to be focused on. I found myself as the point person on women's issues, however they appeared — parental leave, the Equal Rights Amendment, whatever … .

I found myself as the point person for women's mental health issues and then I became very involved in the political arena, and the APA developed a political action committee. I ended up running this PACS, and I decided that I was going to fund women, and help women. There were very few women in the Senate and women couldn't win because they couldn't raise money. I started funding, not exclusively, but disproportionately, women. Luckily for me, they won. [Among several Greenberger mentions is Nanci Pelosi].

[Greenberger next joined the board of a new organization, the Society for the Advancement of Women's Health Research in 1990, the name later changed to the Society for Women's Health Research.]

The other people on the board were doctors or researchers. They were brilliant and knew the issues but didn't know Washington, so I'd take them to the Hill to get media attention…. We ended up going to the Hill and saying the NIH was not focusing on women's health research — they were not included in clinical trials - certainly not in significant numbers. Women were 52% of the taxpayers in this country, but the research was not related to them.

[Greenberger recounted various steps from here, among them a 1986 report by the National Institutes of Health saying that women's health was not getting adequate funding; the leverage of funding for breast cancer research; development of a bill - initially vetoed - to establish an office of women's health research; her involvement with the presidential campaign of Bill Clinton and then inclusion in the NIH revitalization act of 1993 to establish an office of women's health research; and five years of work to raise $650,000 to support the development of research at the Institute of Medicine (Washington) supporting the need to look at sex differences.]

Q. What was the result of these efforts?

A. I would like to say, 15 years later, that that was the beginning of people taking women's health seriously and everything's fine. It's not fine. But we've made progress. Women's health became much more focused and a national issue, instead of an inside-the-Beltway issue.

Before this all the research was focused on young, healthy white men and that was it. You took that research and went with it. We found that at the NIH the average number of proposals specifically looking at sex difference research was 3%. There was nothing at all at the American Heart Association. It wasn't until we made a lot of noises that people started looking for other differences.

[When sex differences were found before, it was a combination] of intuitiveness and serendipity. Researchers were not looking for sex differences and they found it and didn't expect it.

Q. Are these differences of real significance?

A. Does sex matter? Unequivocally, yes, it has to be taken as a clinical hypothesis in all of research, from basic science to provision of care. Every cell has a sex, and it needs to be taken into consideration from womb to tomb — those are direct quotes from the IOM report.

Ten years ago, I was on the Medical Technology Leadership Forum board and I was the only woman, the rest of the board was made up of people in very high positions at medical device companies: Cook, Medtronic, St. Jude, Zimmer, [and] Boston Scientific was involved for awhile. I was the only woman, the only advocate, I gave them all the information about sex differences, I kept saying "don't forget the women, look at the women, be supportive of the society financially."

After a number of years, all those companies are looking at women's health or have women's health divisions, one by one — and they're all very proud of themselves ….

We're encouraged about it and people are paying attention. They're talking about [sex differences] and they weren't talking about it 15 years ago. They are asking questions that never were asked before.

Q. What do you think were the reasons for the absence of women from clinical research?

A. I think historically the reasons were several. Most of the [early] research was done in penal institutions, military schools, medical schools, all predominantly male. And then people thought men and women were essentially the same, except for their reproductive organs, and there was no reason to think that wasn't the case. Another reason was a protectionist attitude — women have menstrual cycles and they get pregnant, so it was more complicated.

I don't want to give the impression that nobody cared or there was some sort of collusion, but it was just felt you had a population of [white males] and there wasn't any reason to the contrary…. it was safer [not to do women's research], based on the science at the time.

It was not until we started investigating and finding differences pop up that anybody took it seriously …. The research [focused on women] was always along the lines of reproductive issues, and it was believed that only hormones effected women differently; there was no understanding of estrogen, the receptors to estrogen, and the role of hormones.

Q. It's commonly thought that because of their responsibilities, such as pregnancy, that it's harder to get women into clinical trials and to retain them in trials. Do you find this true?

A. We have done market research and that's clearly not true…. It's not rocket science that women and minorities are different than men. It's the same with all clinical trials. Your method of approach needs to be tailored to the people you want to get the message to.

Women don't have 9-to-5 hours. You have to be more flexible, maybe offer child care facilities, some transportation. You have to have recruiters that people can identify with, use recruiters that reach out to these women. Just putting an ad in the newspaper isn't going to do it.

We did focus groups and found that women wanted to be included in clinical trials. Their overriding reason was for posterity, for their families — particularly in the breast cancer population. They were willing to be included to help to prevent this disease.

Men and women go into trials for different reasons but they have to be approached differently and minorities differently still.

Q. What are the continuing barriers to research for women's health?

A. AHA did a survey and one of the questions was to primary care physicians and cardiologists, and one of the questions was, Do you know how many women die of heart disease? Only 8% of primary care physicians knew that more women die of heart disease than men; 17% of cardiologists knew that more women die of heart disease — 55% of women knew that more women than men die of heart disease.

In certain circles, there are still more questions than answer in every area of women's health —autoimmunity, we haven't had any answers about that, musculoskeletal differences, depression in men and women, how drugs work differently.

And then clinical trials have gotten a lot more complicated, and there are a lot more of them. There is no question this makes it more complicated and more lengthy if you want to do subpopulations. Part of the problem is that the FDA is not really set up to get the information or extracting information on sex differences ….We had actually gotten money from Congress appropriated from Office of Women's Health to set up demographics to look at age, ethnicity and sex, but it can't interact with the current FDA technology.

Until the FDA upgrades and all these computers speak to each other, we're not getting all this information…. [T]here's this voluminous amount of information coming in from drug companies, but [women's research] is not at the top of their list of priorities. We don't know how many are doing the analysis, and if they are doing it, does it get to the FDA or getting the information to educate or put on the labeling….

It's taking time. Cardiovascular is pretty much where we know the most and even there we still have a lot of questions…. You open up the scientific journals and you get the participation of patients without describing who those patients were. Medical textbooks have to be upgraded in terms of information about the difference between men and women.

There's this whole train, from the lab to research to clinical trials to journals to what's taught in medical schools.

Q. Where do you see the most progress — on the device/med-tech side or on the pharmaceutical side?

A. We started working with the pharmaceutical companies way before the technology companies, but I think that med-tech has been doing better.

You can see if a knee implant is going to fit better, and there are more trials divided up according to ethnicity and gender. The [med-tech] trials are shorter; pharma trials are many years longer. I do get the sense that the tech companies seem to have responded more quickly. [There is less progress] in pharma research, that's the major need. We still don't know how and if pharmaceuticals work differently in women.

The whole idea of personalized medicine is going to be able to determine initially how your body metabolizes and absorbs therapies, adverse reactions or whatever, narrow it down to certain classes of people, not just gender. I see more in that direction. But sex is going to have to be considered as a variable. That will be important for how new medications developed.

In terms of diagnostics, women unfortunately suffer disproportionately from different kinds of cancers. In breast cancer diagnostics there are a lot of false positives and false negative. We know that some of the stress tests for women aren't as accurate [as in men], EKGs are sometimes not as accurate.

Our concern is Congress's threat to cut reimbursement for a lot of diagnostic and imaging technologies. That will be a terrible blow for women &helllip;. There aren't going to be motivating factors for companies to continue to develop more and better screening tech if they're not going to be reimbursed for them.

Another area is immunology, autoimmune diseases. There are not very many treatments — there are more for symptoms than cures — and all these other issues that disproportionately effect women, chronic fatigue, irritable bowel syndrome.

In reproductive health, what's happened, ironically, is that with all the focus on these other conditions there seems to be a lot of gynecological areas, or related to reproductive issues, where there still is a great need for research [such as] fibroids, premature babies, prenatal delivery.

A lot of work still needs to be done.

Q. What's next for the organization?

A. We're planning a conference in 2008, looking at some of the new research and where we need to go.

We'll have an industry panel and we'll have industries that are doing the right thing, to speak to the audience, different pharma companies. But we don't want just industry. We'll also have academic people speaking.

I want industries that are doing the right thing to speak to people in the audience.

[Note: BB&T will provide additional information about this conference in a future issue.]