Richard A. Rettig – författare

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.

Since 1972, many victims of endstage renal disease (ESRD) have received treatment under a unique Medicare entitlement. This book presents a comprehensive analysis of the federal ESRD program: who uses it, how well it functions, and what improvements are needed. The book includes recommendations on patient eligibility, reimbursement, quality assessment, medical ethics, and research needs. Kidney Failure and the Federal Government offers a wealth of information on these and other topics: * The ESRD patient population. * Dialysis and transplantation providers. * Issues of patient access and availability of treatment. * Ethical issues related to treatment initiation and termination. * Payment policies and their relationship to quality of care. This book will have a major impact on the future of the ESRD program and will be of interest to health policymakers, nephrologists and other individual providers, treatment site administrators, and researchers.

Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards.The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.