Chronic kidney disease in the United States: a public policy imperative.

BACKGROUND AND OBJECTIVES: In the past decade, a crisis in nephrology has slowly emerged in the areas of both clinical care and public policy. In 2003, the Council of American Kidney Societies (CAKS) identified 19 barriers to improved patient outcomes in chronic kidney disease (CKD). DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Site visits and in-depth telephone interviews were conducted with 15 nephrologists focusing on current issues with identifying and treating patients with CKD. The qualitative analyses were considered in the context of CAKS-identified barriers to assess the present state of nephrology care and provide a foundation for a more detailed quantitative CKD project potential implications for advancing nephrology-related health policy. RESULTS: Despite new evidence-based therapies to slow, stop, or reverse the progression of CKD to ESRD as well as premature cardiovascular disease, major systemic barriers continue to limit the implementation of this body of evidence at the level of the nephrology practice. Key factors include under- or uninsurance, unstructured medical care systems, and lack of enabling public policies. CONCLUSIONS: The crisis of nephrology is embedded within the unresolved duress of the ability to provide quality early intervention juxtaposed upon inadequate reimbursement for clinical care and procedures, unfunded mandates for information technology systems, and organizational inconsistencies between nephrology and other specialties. We believe now is the time for the renal community and related stakeholders to unite in an effort to address the clinical, financial, and public policy issues that will enable the delivery of appropriate CKD care to this vulnerable patient population.

Litigating the science of breast cancer treatment.

Beginning in the late 1980s, many health insurers refused to cover high-dose chemotherapy with autologous bone marrow transplant (HDC/ABMT) for high-risk and metastatic breast cancer patients. Insurers denied coverage because there was no persuasive evidence of clinical effectiveness. In response, many women sued to compel coverage. After years of litigation and the expenditure of approximately $3 billion, randomized clinical trials (RCTs) showed that the procedure was no more effective and possibly more harmful than conventional therapy. To understand whether and how litigation contributed to the diffusion of the procedure, we conducted a series of case studies that examine the litigation tactics and strategies used by defense and plaintiffs' counsel. Despite the fact that HDC/ABMT lacked proven scientific effectiveness, insurance defense attorneys were unable to stop the procedure's diffusion. Plaintiffs' attorneys had a much easier and more sympathetic story to tell and were able to exploit vulnerabilities facing the defense.

Why is revitalizing clinical research so important, yet so difficult?

We believe that support for academic clinical research has greatly declined in recent decades. Here we discuss our views on why this has happened. We define clinical or patient-oriented research as limited to the study of human beings or populations of individuals, and argue that its eclipse in favor of basic and "translational" research is the result of inappropriate conceptual paradigms or "models" for medical advances. We believe that medical history shows that the "bench-to-bedside" model is inadequate to explain most recent progress and that clinical advances themselves often lead to new basic research. Discussion of alternate conceptual frameworks for biomedical research should help lead to changes in funding and organizational structures that might finally revitalize clinical research.