Breast Cancer Research: Expectations Versus Reality

The second morning plenary session challenged advocates to examine our expectations for scientific breakthroughs, particularly in light of recent studies that raise expectations about the efficacy and safety of promising therapies. The panel, which was moderated by Vernal Branch of the Virginia Breast Cancer Foundation, included the following panelists:
• Otis Webb Brawley, MD, American Cancer Society, Emory University
• Kay Dickersin, PhD, Johns Hopkins University
• Ezekiel Emanuel, MD, PhD, NIH Department of Bioethics at the Clinical Center
• Cindy Pearson, National Women’s Health Network

Ezekiel Emanuel started off the session by issuing a disclaimer that his comments were not the views of his employers – NIH, HHS and the White House – but that they were his own opinions – and the truth! He expressed a concern about the high cost of drugs which offer very limited benefit. He allowed that individuals should have the right to receive and pay for care they desire, but that society should not have to bear the financial burden of treatments or procedures of high cost and little or no benefit.

As we look at new drugs, Kay Dickersin suggested that the design of individual clinical trials must align with the question being asked. For example, questions of harms may not be ideally suited to randomized trials; on the other hand, sometimes those trials give evidence of harms. In the case of hormone therapy, the increased risk of breast cancer seen in the Women’s Health Initiative agreed with results of observational studies, and also showed that the expected cardiovascular benefits did not come through.

Continuing the panel’s examination of the impact of money in the research arena, Otis Brawley pointed to the role that profit plays in the development of drugs. As an example, he offered some thought-provoking figures, noting that the profits made by one drug company on an erythropoiesis stimulating agent (ESA) was about half the budget of the National Cancer Institute.

Finally, NBCC Board member and Executive Director of the Women’s Health Network, Cindy Pearson, stressed the key role that patient advocates must continue to play in insisting on the best clinical trials. She noted that research remains an iterative process. Cindy charged the advocates in attendance to maintain high expectations, plus a fearless look at reality.

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