In the late 1980s, a promising new treatment for breast cancer emerged: high-dose chemotherapy with autologous bone marrow transplantation or HDC/ABMT. By the 1990s, it had burst upon the oncology scene and disseminated rapidly before having been carefully evaluated. By the time published studies showed that the procedure was ineffective, more than 30,000 women had received the treatment, shortening their lives and adding to their suffering. This book tells of the rise and demise of HDC/ABMT for metastatic and early stage breast cancer, and fully explores the story's implications, which go well beyond the immediate procedure, and beyond breast cancer, to how we in the United States evaluate other medical procedures, especially life-saving ones. It details how the factors that drove clinical use--patient demand, physician enthusiasm, media reporting, litigation, economic exploitation, and legislative and administrative mandates--converged to propel the procedure forward despite a lack of proven clinical effectiveness. It also analyzes the limited effect of technology assessments before randomized clinical trials evaluated decisively the procedure and the ramifications of this system on healthcare today. Sections of the book consider the initial conditions surrounding the emergence of the new breast cancer treatment, the drivers of clinical use, and the struggle for evidence-based medicine. A concluding section considers the significance of the story for our healthcare system.
Author(s): Richard A. Rettig, Peter D. Jacobson, Cynthia M. Farquhar M.D., Wade M. Aubry M.D.
Edition: 1
Publisher: Oxford University Press, USA
Year: 2007
Language: English
Commentary: 40282
Pages: 368
Contents......Page 12
Introduction......Page 16
Part I: Initial Conditions......Page 22
1. Breast Cancer Patients and the Emergence of a Treatment......Page 24
2. Jumping the Gun......Page 48
Part II: Drivers of Clinical Use......Page 84
3. Court Trials......Page 86
4. Litigation Strategies......Page 116
5. Entrepreneurial Oncology......Page 142
6. Government Mandates......Page 165
Part III: The Struggle for Evidence-Based Medicine......Page 192
7. Technology Assessments......Page 194
8. Clinical Trials......Page 219
9. Dénouement......Page 252
Part IV: The Significance of the Story......Page 270
10. Values in Conflict......Page 272
Appendix: Evidence-Based Reviews of Clinical Trials......Page 300
Notes......Page 314
References......Page 328
B......Page 356
C......Page 357
D......Page 358
F......Page 359
H......Page 360
I......Page 361
M......Page 362
N......Page 363
P......Page 364
R......Page 365
S......Page 366
U......Page 367
Z......Page 368