In the late 1980s, based on limited studies, high-dose chemotherapy with autologous bone marrow transplantation (HDCT/ABMT) emerged as a prominent procedure in the treatment of metastatic and early-stage breast cancer. Subsequent randomized clinical trials showed that HDCT/ABMT had no benefit, compared with standard chemotherapy; however, in the interim, some 30,000 women had undergone unnecessary treatment.
Cancer Care & Economics (CC&E) recently spoke with Richard A. Rettig, PhD, one of four prominent researchers who examined the reasons for this lapse in clinical judgment. The findings were published in the book False Hope: Bone Marrow Transplantation for Breast Cancer (Oxford University Press, 2007). Dr. Rettig is an adjunct senior social scientist for the RAND Corporation, Arlington, Virginia. His three coauthors are Peter Jacobson, JD, MPH; Cynthia M. Farquhar, MD, MPH; and Wade Aubry, MD.
CC&E: What factors propelled the acceptance of high-dose chemotherapy/autologous bone marrow transplantation (HDCT/ABMT) as treatment for metastatic breast cancer?
DR. RETTIG: Widespread clinical utilization of HDCT/ABMT was driven by several factors. First off, the women typically were in their middle years, married with children, and their personal stories evoked great sympathy.
Health insurers initially denied coverage because the procedure was deemed experimental, without solid evidence of effectiveness. But when the mainstream press reported stories of desperate women with cancer being deprived of life-saving, cutting edge technology for financial reasons, there was a surge of public demand. This resulted in litigation, commercial exploitation, and government mandates of insurance coverage.
It's important to note that the oncology community legitimized this treatment long before thorough examination was complete. We found that decisions reached at the front-end of the diffusion process drove subsequent developments for a long period of time.
CC&E: What role did clinical trials play in ending the use of this treatment?