Richard A. Rettig

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 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 analyses the failure of the technology assessments and randomised clinical trials that evaluated the procedure and the ramifications of this flawed 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.

This book is the definitive account of how private citizens, led by Mary Lasker, Sidney Farber, Laurence Rockefeller, Benno Schmidt, and Ann Landers, persuaded Congress to enact the 'War on Cancer" legislation; how Senator Edward Kennedy championed the cause in the US Senate; how Rep. Paul Rogers brokered a compromise that kept the National Cancer Institute within the National Institutes of Health; and how President Richard Nixon embraced the legislation even though he had earlier proposed to cut the cancer research budget. In the wave of technological enthusiasm from putting a man on the moon, the account documents the exaggerated claims for cancer research advanced by advocates of the legislation and the sober evaluation by the scientific community of prospects for a cure for cancer. The 1971 National Cancer Act set the stage for major expansion of federal financing of cancer research.

This text examines the US military's relationship with the US Food and Drug Administration, with regard to the need to acquire drugs and biologics, mainly vaccines, to counter the real threat of chemical and biological warfare being used in combat.

This report deals with the rule to waive informed consent for using investigational drugs in certain military contingencies. It was used in the 1991 Gulf War, when forces confronted the possibility of chemical and biological weapons.