COMMENTARY

Lessons From WHI, Part 4: The Trial That Keeps on Giving

Henry R. Black, MD; Rebecca D. Jackson, MD

Disclosures

July 08, 2014

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Editor's Note: This is part 4 of Dr. Black's interview with Dr. Rebecca Jackson on the Women's Health Initiative (WHI) studies.

Part 1, on the hormone therapy findings, is available here.

Part 2, on the calcium and vitamin D supplementation and dietary modification trials, is available here.

And part 3, on the cost-effectiveness, is available here.

Henry R. Black, MD: Hi. I'm Dr. Henry Black, Adjunct Professor of Medicine at the New York University Langone School of Medicine. I am here today with my colleague, Dr. Rebecca Jackson, from the Ohio State University.

I was the principal investigator at one of the 40 sites for the WHI when I was at Rush University in Chicago, and Dr. Jackson has been there ever since -- about 20 years now.

The WHI is going to continue to give for a long time. Women between ages 50 and 79 years who are postmenopausal have contributed a great deal by participating, and those of us who were part of it are very proud to have helped get it done.

Rebecca D. Jackson, MD: The WHI has been a major influence in terms of other initiatives, from the Genetic Factors for Osteoporosis Consortium and the cardiovascular disease genetics consortium, to the Exome Sequencing Project (we found a tremendous amount of rare variants associated with that), to the question of how you use proteomics in studies. How do you do a better job of defining biomarkers for disease to be able to segment people into different trajectories and identify those who have more aggressive disease? Many cohorts and registries are analyzed after the diseases occur. Where the WHI is so valuable is that we took a swath of America that not only included women from every race and ethnic group but from the entire breadth of socioeconomic conditions.

The WHI has put the data out there in a way that was open and transparent. In the last decade, the WHI has opened up to a whole new generation of investigators. The other thing that is exciting is that all of these people are beginning to ask different questions -- for example, the ambient pollution research that Eric Whitsel[1] has done to try to understand the relationship of air pollution with heart disease.

When I think about those early years and how hard it was to recruit those women -- it's amazing that of the women who are still alive, 80%-85% continue to stay engaged in the WHI. I always say to our clinic staff (many people have worked for me for more than 20 years) that I can't go to the grocery store without people running up to me and saying, "Look at my grocery cart. I was part of the basal dietary group, and I still self-monitor 3 times a week." They are so proud. They tell everybody and put in their obituaries that they were part of WHI, and they really bought into the concept of "paying forward" -- their legacy is that they are laying a foundation of knowledge for their daughters and granddaughters.

Dr. Black: I remember how much fun we had. We always had a Christmas party with food. How do you keep the people in the intervention group away from the people in the control group? It was a challenge, but it worked.

Dr. Jackson: It did work. Out of all of the studies that I have done, it is the one that continues to warm my soul. From an osteoporosis perspective, we would have designed the study a little bit differently, if we had only been interested in osteoporosis. Where we make a mistake in most studies that are done is that we fail to broadly look at the person. The WHI, with that real commitment to risk and benefit, was a person-centered study rather than a disease-centered study. That's probably the way we should design all clinical trials because we don't do that in effectiveness trials. That's what PCORI and others are starting to ask now, that we should think about this as a person-centered and maybe as a society-centered intervention.

Dr. Black: Exactly.

Dr. Jackson: That's a good thing. We need to understand efficacy, but ultimately when you are trying to translate that to public policy and healthcare, you need to understand that.

Dr. Black: That's the translational research I'm interested in.

Dr. Jackson: The WHI was ahead of the game -- probably 20 years ahead of the game where now everybody else is starting.

Dr. Black: And this study will keep giving. Thank you.

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