|
|
|
|
|
|
||
|
|
||||
|
|
||||
|
||||
RAND
University of California at San Francisco
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.
Ader, M. 1996. Access to Investigational Treatments. Health Matrix 6: 187-199.[Medline]
Antman, K., L. E. Schnipper, and E. Frei III. 1988. The Crisis in Clinical Cancer Research: Third-Party Insurance and Investigational Therapy. New England Journal of Medicine 319: 46-48.[ISI][Medline]
Black, H. L. 1991. Black's Law Dictionary. Abridged 6th ed. St. Paul, MN: West.
Eddy, D. M. 1992. High-Dose Chemotherapy with Autologous Bone Marrow Transplantation for the Treatment of Metastatic Breast Cancer. Journal of Clinical Oncology 10: 657-670.
Glasziou, P., I. Chalmers, M. Rawlins, and P. McCulloch. 2007. When are Randomised Trials Unnecessary? Picking Signal from Noise. BMJ 334: 349-351.
Hall, M. A., and G. F. Anderson. 1992. Health Insurers' Assessment of Medical Necessity. University of Pennsylvania Law Review 140: 1637-1712.
Jacobson, P. D., and S. A. Doebler. 2006. "We Were All Sold a Bill of Goods": Litigating the Science of Breast Cancer. Wayne Law Review 52: 43-112.
Jacobson, P. D., and W. E. Parmet. 2007. A New Era of Unapproved Drugs: The Case of Abigail Alliance v. von Eschenbach. Journal of the American Medical Association 297: 205-208.
Jacobson, P. D., and E. Selvin. 2005. Health, Inequality, and the Courts. In Healthy, Wealthy, and Fair: Health Care and the Good Society, ed. J. A. Morone and L. R. Jacobs, 235-264. New York: Oxford University Press.
Jacobson, P. D., E. Selvin, and S. D. Pomfret. 2001. The Role of the Courts in Shaping Health Policy: An Empirical Analysis. Journal of Law, Medicine, and Ethics 29: 278-289.
Jacobson, P. D., and M. E. Tunick. Forthcoming. Consumer-Directed Health Care and the Courts: Let the Seller (and Buyer) Beware. Health Affairs.
Jacobson, P. D., and K. E. Warner. 1999. Litigation and Public Health Policy: The Case of Tobacco Control, Journal of Health Politics, Policy and Law 24: 769-804.[ISI][Medline]
Kuszler, P. 2000. Financing Clinical Research and Experimental Therapies: Payment Due, but from Whom? DePaul Journal of Health Care Law 3: 441-493.
Maugh, T. H. II. 2000. Studies Refute Marrow Procedure for Breast Cancer. Los Angeles Times, March 11.
Mello, M. M., and T. A. Brennan. 2001. The Controversy over High-Dose Chemotherapy with Autologous Bone Marrow Transplant for Breast Cancer. Health Affairs 20 (5): 101-117.
Morreim, E. H. 2001. From the Clinics to the Courts: The Role Evidence Should Play in Litigating Medical Care. Journal of Health Politics, Policy and Law 26: 409-427.[CrossRef][ISI][Medline]
Newcomer, L. N. 1990. Defining Experimental Therapy—A Third-Party Payer's Dilemma. New England Journal of Medicine 323: 1702-1704.[ISI][Medline]
Peters, W. P., G. Rosner, J. J. Vredenburgh, E. Shpall, M. Crump, P. Richardson, L. Marks, et al. 1999. A Prospective, Randomized Comparison of Two Doses of Combination Alkylating Agents (AA) as Consolidation after CAF in High-Risk Primary Breast Cancer Involving Ten or More Axillary Lymph Nodes (LN): Preliminary Results of CALGB 9082/SWOG9114/NCIC MA-13. American Society of Clinical Oncology, 1999 Annual Meeting, May 15-18, Atlanta, GA, Abstract No. 2. www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=17&abstractID=14259#.
Peters, W. P., M. Ross, J. J. Vredenburgh, B. Meisenberg, L. B. Marks, E. Winer, J. Kurtzberg, R. C. Bast Jr., R. Jones, and E. Shpall. 1993. High-Dose Chemotherapy and Autologous Bone Marrow Support as Consolidation after Standard-Dose Adjuvant Therapy for High-Risk Primary Breast Cancer. Journal of Clinical Oncology 11: 1132-1143.
Rettig, R. A., P. D. Jacobson, C. M. Farquhar, and W. M. Aubry. 2007. False Hope: Bone Marrow Transplantation for Breast Cancer. New York: Oxford University Press.
Rose, L. 2001. Autologous Bone Marrow Transplants. Health Affairs 21 (2): 308.
Rosenberg, G. N. 1991. The Hollow Hope: Can Courts Bring About Social Change? Chicago: University of Chicago Press.
Stadtmauer, E. A., A. O'Neill, L. J. Goldstein, P. A. Crilley, K. F. Mangan, J. N. Ingle, I. Brodsky, et al. 2000. Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer. New England Journal of Medicine 342: 1069-1076.
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
