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Managing Editor
Scott Harris
sharris@aamc.org

Staff Writer
Elissa Fuchs
efuchs@aamc.org

Leadership Q&A: Research Should Be Safe — and Effective

Fran Visco is the first president of the National Breast Cancer Coalition, a grassroots advocacy organization of more than 600 member organizations and 70,000 individual members. A New York Times article has described Ms. Visco, herself a breast cancer survivor, as “Washington’s most powerful advocate for women with the disease…[who] has almost single-handedly persuaded lawmakers to appropriate millions for research.”

In 1993, President Clinton appointed Ms. Visco to the President’s Cancer Panel. She was also the first consumer to be elected to chair the Integration Panel of the Department of Defense Peer-Reviewed Breast Cancer Research Program. She is former co-chair of the National Action Plan on Breast Cancer, and served until recently on the National Cancer Policy Board.

Ms. Visco has contributed her considerable power and passion as patient advocate to an important AAMC effort, the Task Force on Financial Conflicts of Interest in Clinical Research, where her acuity and perspective proved most helpful to the task force’s deliberations about individual and institutional financial conflicts. She also helped shape the AAMC’s conflict of interest policy for individual researchers released last year, and soon to- be-announced groundbreaking new policy for entire institutions.

Q: What can be done about the lack of atmosphere of trust that some have cited between the patient advocacy and the research communities?

A: There are a number of steps that have to be taken to restore that atmosphere of trust. One of the most important, certainly for the National Breast Cancer Coalition, is to develop a relationship based on collaboration between the research and patient advocacy communities — a true partnership where the research process and decisions are transparent, and where the public plays a very important role. We have tested that [process] and have found it to be very successful.

Q: Can you speak to the issue of conflicts of interest in patient research?

A: We’ve been very disturbed by what we’ve seen over the past number of years where some research scientists have sort of morphed into “media stars.” There has been a great deal of money to be made certainly in the biotech arena, and the stories that hit the headlines of the deaths of individuals participating in research are only one part of the story. It really is the poorly defined clinical trials that are not designed to answer the questions and the many trials that go on that are not answering the questions and are perhaps designed to keep people busy, or getting published or promoted. A lot of that is what we see as conflict of interest.

Q: How do you see the public debate surrounding these issues?

A: There have been several stories about clinical trials or other studies that have not been designed to answer the questions that needed to be asked. There have been drug company trials where toxicity data were not disclosed and people died. There are real questions about the evidence behind screening mammography. But rather than allow public debate, there is a hue and cry from the existing infrastructure against any criticism or questions. We need to challenge long-held beliefs within the medical community when there is no or inadequate evidence behind them. All of these things have contributed in part to an erosion of trust.

Q: What should be the role of academic medical centers in clinical research?

A: Academic medical centers have to move from managing risk to protecting human participants in research. One way is to include a significant number of representatives of the patient communities in meaningful decision making. But it's important that it not just be the lawyer or the individual who makes donations to the institution. They should be individuals who represents a constituency that cares about and focuses on these issues, who are informed and educated, and bring a diverse perspective to the table. These individuals should be able to truly contribute and bring an independent patient perspective.

Q: How do you see the future research budget of the NIH, and do you think Congress will continue to support biomedical research?

A: I think Congress will continue to support biomedical research. Over the years I have heard [congressional] committee staff members say that the AIDS and breast cancer activists are the ones who have made it difficult for policy makers to turn away from biomedical research. I don’t know if they will continue doubling the NIH budget. But I think they are also — we certainly are — asking questions on how that money is being spent. We want to make certain that it’s not just about getting more money for research, and that it’s about making certain that those dollars are allocated appropriately, and that we’re prioritizing research and answering the important questions. Those are very hard-fought for taxpayer dollars and we want to make certain they are spent appropriately.

Q: You are a survivor of breast cancer yourself — what is the state of breast cancer research today compared to 16 years ago, and what hope can you offer to those who might be facing it?

A: There are incredible resources available today for breast cancer research. The National Breast Cancer Coalition alone has brought more than $1 billion to the breast cancer research community worldwide. We are helping to make certain that the research is innovative and is asking important questions. We have moved to the arena of targeted therapies in breast cancer [research], and I always say we are getting to where we know what questions to ask.

But we really don’t have the answers yet — we still don’t know how to prevent the disease, which is the most important thing, we don’t know how to cure it for every woman, we don’t know how to detect it truly early, and if we did, we wouldn’t know what to do with it. So we’re far from answers for breast cancer, but we’re moving to non-toxic therapies; we are at least beginning to ask questions about prevention, and we have certainly raised awareness about the disease.

— Michael G. Malloy, mmalloy@aamc.org