A dose of our own medicine: Alternative medicine, conventional medicine, and the standards of science

Journal of Law, Medicine and Ethics

Volumn 31, Issue 2, 2003, Pages 222-235

  Morreim, E Haavi ^a  

^a UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALTERNATIVE MEDICINE; CLINICAL MEDICINE; CLINICAL PRACTICE; CONFERENCE PAPER; ECONOMIC ASPECT; HEALTH INSURANCE; HUMAN; MEDICAL RESEARCH; PHYSICIAN ATTITUDE; STANDARD; TREATMENT PLANNING; ARTICLE; ECONOMICS; EVIDENCE BASED MEDICINE; HEALTH CARE AND PUBLIC HEALTH; METHODOLOGY; PATIENT CARE; SCIENCE;

HEALTH CARE AND PUBLIC HEALTH;

COMPLEMENTARY THERAPIES; EVIDENCE-BASED MEDICINE; HUMANS; PATIENT CARE; SCIENCE;

EID: 0642341265     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2003.tb00083.x     Document Type: Conference Paper

References (184)

1. E.W. Campion, "Why Unconventional Medicine?," N. Engl. J. Med., 328 (1993): 282-83, at 282.
2. M. Angell and J.P. Kassirer, "Alternative Medicine - The Risks of Untested and Unregulated Remedies," N. Engl. J. Med., 339 (1998): 839-41, at 841.
3. L.J. Schneiderman, "Alternative Medicine or Alternatives to Medicine? A Physician's Perspective," Cambridge Quarterly of Healthcare Ethics, 9 (2000): 83-97, at 91.
4. White House Commission on Complementary and Alternative Medicine Policy, Final Report (March 2002): at Executive Summary, available at 〈http://www.whccamp.hhs.gov/es.html〉.
5. Ibid. Id.
6. Wilk v. American Medical Ass'n, 895 F.2d 352 (7th Cir. 1990), cert. denied, 498 U.S. 982 (1990). Other conventional providers are beginning to provide some forms of CAM themselves, under the heading of "integrative medicine." See R. Snyderman and A.T. Weil, "Integrative Medicine: Bringing Medicine Back to its Roots," Archives of Internal Medicine, 162 (2002): 395-97.
7. Wilk v. American Medical Ass'n, 895 F.2d 352 (7th Cir. 1990), cert. denied, 498 U.S. 982 (1990). Other conventional providers are beginning to provide some forms of CAM themselves, under the heading of "integrative medicine." See R. Snyderman and A.T. Weil, "Integrative Medicine: Bringing Medicine Back to its Roots," Archives of Internal Medicine, 162 (2002): 395-97.
8. D.M. Marcus and A.P. Grollman, "Botanical Medicines - The Need for New Regulations," N. Engl. J. Med., 347 (2002): 2073-76; P.A.G.M. DeSmet, "Herbal Remedies," N. Engl. J. Med., 347 (2002): 2046-56; D.M. Eisenberg et al., "Credentialing Complementary and Alternative Medical Providers," Annals of Internal Medicine, 137 (2002): 965-73.
9. D.M. Marcus and A.P. Grollman, "Botanical Medicines - The Need for New Regulations," N. Engl. J. Med., 347 (2002): 2073-76; P.A.G.M. DeSmet, "Herbal Remedies," N. Engl. J. Med., 347 (2002): 2046-56; D.M. Eisenberg et al., "Credentialing Complementary and Alternative Medical Providers," Annals of Internal Medicine, 137 (2002): 965-73.
10. D.M. Marcus and A.P. Grollman, "Botanical Medicines - The Need for New Regulations," N. Engl. J. Med., 347 (2002): 2073-76; P.A.G.M. DeSmet, "Herbal Remedies," N. Engl. J. Med., 347 (2002): 2046-56; D.M. Eisenberg et al., "Credentialing Complementary and Alternative Medical Providers," Annals of Internal Medicine, 137 (2002): 965-73.
11. J.B. Hall, "Use of the Pulmonary Artery Catheter in Critically Ill Patients: Was Invention the Mother of Necessity?," JAMA, 283 (2000): 2577-78; J. Rapoport et al., "Patient Characteristics and ICU Organizational Factors that Influence Frequency of Pulmonary Artery Catheterization," JAMA, 283 (2000): 2559-67; G.R. Bernard et al., "Pulmonary Artery Catheterization and Clinical Outcomes: NHLBI and FDA Workshop Report," JAMA, 283 (2000): 2568-72; J.D. Sandham et al., "A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients," N. Engl. J. Med., 348 (2003): 5-14; P.E. Parsons, "Progress in Research on Pulmonary-Artery Catheters," N. Engl. J. Med., 348 (2003): 66-68.
12. J.B. Hall, "Use of the Pulmonary Artery Catheter in Critically Ill Patients: Was Invention the Mother of Necessity?," JAMA, 283 (2000): 2577-78; J. Rapoport et al., "Patient Characteristics and ICU Organizational Factors that Influence Frequency of Pulmonary Artery Catheterization," JAMA, 283 (2000): 2559-67; G.R. Bernard et al., "Pulmonary Artery Catheterization and Clinical Outcomes: NHLBI and FDA Workshop Report," JAMA, 283 (2000): 2568-72; J.D. Sandham et al., "A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients," N. Engl. J. Med., 348 (2003): 5-14; P.E. Parsons, "Progress in Research on Pulmonary-Artery Catheters," N. Engl. J. Med., 348 (2003): 66-68.
13. J.B. Hall, "Use of the Pulmonary Artery Catheter in Critically Ill Patients: Was Invention the Mother of Necessity?," JAMA, 283 (2000): 2577-78; J. Rapoport et al., "Patient Characteristics and ICU Organizational Factors that Influence Frequency of Pulmonary Artery Catheterization," JAMA, 283 (2000): 2559-67; G.R. Bernard et al., "Pulmonary Artery Catheterization and Clinical Outcomes: NHLBI and FDA Workshop Report," JAMA, 283 (2000): 2568-72; J.D. Sandham et al., "A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients," N. Engl. J. Med., 348 (2003): 5-14; P.E. Parsons, "Progress in Research on Pulmonary-Artery Catheters," N. Engl. J. Med., 348 (2003): 66-68.
14. J.B. Hall, "Use of the Pulmonary Artery Catheter in Critically Ill Patients: Was Invention the Mother of Necessity?," JAMA, 283 (2000): 2577-78; J. Rapoport et al., "Patient Characteristics and ICU Organizational Factors that Influence Frequency of Pulmonary Artery Catheterization," JAMA, 283 (2000): 2559-67; G.R. Bernard et al., "Pulmonary Artery Catheterization and Clinical Outcomes: NHLBI and FDA Workshop Report," JAMA, 283 (2000): 2568-72; J.D. Sandham et al., "A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients," N. Engl. J. Med., 348 (2003): 5-14; P.E. Parsons, "Progress in Research on Pulmonary-Artery Catheters," N. Engl. J. Med., 348 (2003): 66-68.
15. J.B. Hall, "Use of the Pulmonary Artery Catheter in Critically Ill Patients: Was Invention the Mother of Necessity?," JAMA, 283 (2000): 2577-78; J. Rapoport et al., "Patient Characteristics and ICU Organizational Factors that Influence Frequency of Pulmonary Artery Catheterization," JAMA, 283 (2000): 2559-67; G.R. Bernard et al., "Pulmonary Artery Catheterization and Clinical Outcomes: NHLBI and FDA Workshop Report," JAMA, 283 (2000): 2568-72; J.D. Sandham et al., "A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients," N. Engl. J. Med., 348 (2003): 5-14; P.E. Parsons, "Progress in Research on Pulmonary-Artery Catheters," N. Engl. J. Med., 348 (2003): 66-68.
16. J.E. Dalen, "'Conventional' and 'Unconventional' Medicine," Archives of Internal Medicine, 158 (1998): 2179-81, at 2180. In another example, as of 1988, a national conference on antithrombotic therapy (anticlotting treatments used to prevent stroke, pulmonary embolism, and the like) evaluated the scientific foundation for various recommendations on which physicians based treatment. The American College of Chest Physicians found that only 24 percent of those recommendations were based on appropriately scientific studies, while 55 percent were based on uncontrolled clinical observations. Ten years later, 44 percent of the recommendations were science-based, though this was largely because of Food and Drug Administration requirements for the testing of new drugs. Id. at 2179.
17. A.C. Gellins, N. Rosenberg, and A.J. Moskowitz, "Capturing the Unexpected Benefits of Medical Research," N. Engl. J. Med., 339 (1998): 693-97, at 694. See also A.R. Feinstein, "Clinical Judgment Revisited: The Distraction of Quantitative Methods," Annals of Internal Medicine, 1230 (1994): 799-805.
18. A.C. Gellins, N. Rosenberg, and A.J. Moskowitz, "Capturing the Unexpected Benefits of Medical Research," N. Engl. J. Med., 339 (1998): 693-97, at 694. See also A.R. Feinstein, "Clinical Judgment Revisited: The Distraction of Quantitative Methods," Annals of Internal Medicine, 1230 (1994): 799-805.
19. R.A. Lange and L.D. Hillis, "Use and Overuse of Angiography and Revascularization for Acute Coronary Syndromes," N. Engl. J. Med., 338 (1998): 1838-39. "Although the patients enrolled in the United States were more likely than their Canadian counterparts to undergo coronary angiography (68 percent vs. 35 percent, respectively) and subsequent revascularization (31 percent vs. 12 percent), the incidence of reinfarction and death during more than three years of follow-up was similar.... [E]xcessive use is probably related to the more widespread availability of facilities and trained personnel in the U.S." Id. at 1839. See also E.S. Fisher and H.G. Welch, "Avoiding the Unintended Consequences of Growth in Medical Care: How Might More Be Worse?," JAMA, 281 (1999): 446-53.
20. R.A. Lange and L.D. Hillis, "Use and Overuse of Angiography and Revascularization for Acute Coronary Syndromes," N. Engl. J. Med., 338 (1998): 1838-39. "Although the patients enrolled in the United States were more likely than their Canadian counterparts to undergo coronary angiography (68 percent vs. 35 percent, respectively) and subsequent revascularization (31 percent vs. 12 percent), the incidence of reinfarction and death during more than three years of follow-up was similar.... [E]xcessive use is probably related to the more widespread availability of facilities and trained personnel in the U.S." Id. at 1839. See also E.S. Fisher and H.G. Welch, "Avoiding the Unintended Consequences of Growth in Medical Care: How Might More Be Worse?," JAMA, 281 (1999): 446-53.
21. D.T. Felson and J. Buckwalter, "Debridement and Lavage for Osteoarthritis of the Knee," N. Engl. J. Med., 347 (2002): 132-33.
22. J.B. Moseley et al., "A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee," N. Engl. J. Med., 337 (2002): 81-88.
23. Id. at 81.
24. G. Kolata and M. Petersen, "Hormone Replacement Study a Shock to the Medical System," New York Times, July 10, 2002.
25. G. Kolata, "In Public Health, Definitive Data Can Be Elusive," New York Times, April 23, 2002. See also D. Grady, "Scientists Question Hormone Therapies for Menopause Ills," New York Times, April 18, 2002; Kolata and Petersen, supra note 15; D. Grady, "A 60-Year-Old Woman Trying to Discontinue Hormone Replacement Therapy," JAMA, 287 (2002): 2130-37.
26. G. Kolata, "In Public Health, Definitive Data Can Be Elusive," New York Times, April 23, 2002. See also D. Grady, "Scientists Question Hormone Therapies for Menopause Ills," New York Times, April 18, 2002; Kolata and Petersen, supra note 15; D. Grady, "A 60-Year-Old Woman Trying to Discontinue Hormone Replacement Therapy," JAMA, 287 (2002): 2130-37.
27. G. Kolata, "In Public Health, Definitive Data Can Be Elusive," New York Times, April 23, 2002. See also D. Grady, "Scientists Question Hormone Therapies for Menopause Ills," New York Times, April 18, 2002; Kolata and Petersen, supra note 15; D. Grady, "A 60-Year-Old Woman Trying to Discontinue Hormone Replacement Therapy," JAMA, 287 (2002): 2130-37.
28. Kolata, supra note 16 (quoting Dr. Deborah Grady, a professor of medicine and epidemiology at the University of California in San Francisco).
29. See ECRI (formerly the Emergency Care Research Institute), High-Dose Chemotherapy with Bone Marrow Transplant for Metastatic Breast Cancer (1996): at Brief Summary, available at 〈http://www.ecri.org/documents/bctoc1. html#Summary〉. See also High-Dose Chemotherapy with Peripheral Stem Cell/Autologous Rescue, Treatment for Breast Cancer, in 2 Hayes Directory of New Medical Technologies' Status (updated May 1997), available through 〈http://www.westlaw.com〉, Hayes-Med Database.
30. See ECRI (formerly the Emergency Care Research Institute), High-Dose Chemotherapy with Bone Marrow Transplant for Metastatic Breast Cancer (1996): at Brief Summary, available at 〈http://www.ecri.org/documents/bctoc1. html#Summary〉. See also High-Dose Chemotherapy with Peripheral Stem Cell/Autologous Rescue, Treatment for Breast Cancer, in 2 Hayes Directory of New Medical Technologies' Status (updated May 1997), available through 〈http://www.westlaw.com〉, Hayes-Med Database.
31. M.M. Mello and T.A. Brennan, "The Controversy over High-Dose Chemotherapy with Autologous Bone Marrow Transplant for Breast Cancer," Health Affairs, 20, no. 5 (2001): 101-18, at 110.
32. W.P. Peters and M.C. Rogers, "Variation in Approval by Insurance Companies of Coverage for Autologous Bone Marrow Transplantation for Breast Cancer," N. Engl. J. Med., 330 (1994): 473-77.
33. "In 1998, Congress enacted the 'Women's Health and Cancer Rights Act of 1998,' amending ERISA. The Act requires all group health plans and health insurance issuers offering coverage for mastectomies to provide reimbursement for reconstructive surgery that is associated with a mastectomy" (citing 29 U.S.C. § 1185(b) (Supp. 1999)). S. Hoffman, "A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments," Oregon Law Review, 78, no. 1 (1999): 203-74, at 252. See also T.F. Theodos, "The Patients' Bill of Rights: Women's Rights under Managed Care and ERISA Preemption," American Journal of Law & Medicine, 26 (2000): 89-108.
34. "In 1998, Congress enacted the 'Women's Health and Cancer Rights Act of 1998,' amending ERISA. The Act requires all group health plans and health insurance issuers offering coverage for mastectomies to provide reimbursement for reconstructive surgery that is associated with a mastectomy" (citing 29 U.S.C. § 1185(b) (Supp. 1999)). S. Hoffman, "A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments," Oregon Law Review, 78, no. 1 (1999): 203-74, at 252. See also T.F. Theodos, "The Patients' Bill of Rights: Women's Rights under Managed Care and ERISA Preemption," American Journal of Law & Medicine, 26 (2000): 89-108.
35. As noted in one commentary: problems have arisen in efforts to recruit women for trials designed to assess the benefit of HDC/ABMT in the treatment of metastatic breast cancer. Because of the availability of HDC/ABMT outside of clinical trials, many women with metastatic breast cancer have not been willing to accept the chance of being randomized to a control group in a trial designed to evaluate the effectiveness of HDC/ABMT. As a result, it has taken much longer than expected to obtain an adequate number of participants in these studies to resolve the uncertainty over the value of this technology. E.P. Steinberg, S. Tunis, and D. Shapiro, "Insurance Coverage for Experimental Technologies," Health Affairs, 14, no. 4 (1995): 143-58, at 150. See also G. Kolata, "Women Rejecting Trials for Testing a Cancer Therapy," New York Times, February 15, 1995, at C8; G. Kolata and K. Eichenwald, "Hope for Sale: Business Thrives on Unproven Care, Leaving Science Behind," New York Times, October 3, 1999, at A1.
36. As noted in one commentary: problems have arisen in efforts to recruit women for trials designed to assess the benefit of HDC/ABMT in the treatment of metastatic breast cancer. Because of the availability of HDC/ABMT outside of clinical trials, many women with metastatic breast cancer have not been willing to accept the chance of being randomized to a control group in a trial designed to evaluate the effectiveness of HDC/ABMT. As a result, it has taken much longer than expected to obtain an adequate number of participants in these studies to resolve the uncertainty over the value of this technology. E.P. Steinberg, S. Tunis, and D. Shapiro, "Insurance Coverage for Experimental Technologies," Health Affairs, 14, no. 4 (1995): 143-58, at 150. See also G. Kolata, "Women Rejecting Trials for Testing a Cancer Therapy," New York Times, February 15, 1995, at C8; G. Kolata and K. Eichenwald, "Hope for Sale: Business Thrives on Unproven Care, Leaving Science Behind," New York Times, October 3, 1999, at A1.
37. As noted in one commentary: problems have arisen in efforts to recruit women for trials designed to assess the benefit of HDC/ABMT in the treatment of metastatic breast cancer. Because of the availability of HDC/ABMT outside of clinical trials, many women with metastatic breast cancer have not been willing to accept the chance of being randomized to a control group in a trial designed to evaluate the effectiveness of HDC/ABMT. As a result, it has taken much longer than expected to obtain an adequate number of participants in these studies to resolve the uncertainty over the value of this technology. E.P. Steinberg, S. Tunis, and D. Shapiro, "Insurance Coverage for Experimental Technologies," Health Affairs, 14, no. 4 (1995): 143-58, at 150. See also G. Kolata, "Women Rejecting Trials for Testing a Cancer Therapy," New York Times, February 15, 1995, at C8; G. Kolata and K. Eichenwald, "Hope for Sale: Business Thrives on Unproven Care, Leaving Science Behind," New York Times, October 3, 1999, at A1.
38. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
39. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
40. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
41. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
42. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
43. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
44. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
45. Of five studies released in 1999, four indicated that highdose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data "out of a foolish desire to make the presentation more acceptable" to the scientific meeting sponsored by the American Society of Clinical Oncology. R.B. Weiss et al., "High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study," Lancet, 355 (2000): 999-1003, at 1003. See also K.H. Antman, D.F. Heitjan, and G.N. Hortobagyi, "High-Dose Chemotherapy for Breast Cancer," JAMA, 282 (1999): 1701-03; W.J. Gradishar, "High-Dose Chemotherapy and Breast Cancer," JAMA, 282 (1999): 1378-80; P.A. Rowlings et al., "Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer," JAMA, 282 (1999): 1335-43; R. Horton, "After Bezwoda," Lancet, 355 (2000): 942-43; J. Bergh, "Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?," Lancet, 355 (2000): 944-45. Another study completed even more recently comes to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See E.A. Stadtmauer et al., "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1069-76; M.E. Lippman, "High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer," N. Engl. J. Med., 342 (2000): 1119-20. In all, some 30,000 women had received the treatment, at a cost estimated around $3 billion. Associated Press, "Breast Cancer Procedure Bogus," Memphis Commercial Appeal, March 11, 2000, A5. It might also be noted that, during the heyday of using autologous bone marrow transplant for breast cancer, many hospitals and physicians made enormous sums of money from the treatment. See Kolata and Eichenwald, supra note 22.
46. The manufacturer of a costly new drug for arthritis is hardly likely, for instance, to do a scientific comparison between its products and copper bracelets. Even a remote possibility of finding such an inexpensive remedy to be effective is enough to discourage such a study from being undertaken. And because copper is so inexpensive, the bracelet manufactures can't make enough profit to justify the expense of the research - particularly since they are not required to do any science as long as they make no health claims. Indeed, science is not merely unlikely in such scenarios. History has shown that sometimes even when high-quality scientific trials have been done, their results may not see the light of day if they are unfavorable to the study's sponsor. See D. Rennie, "Thyroid Storm," JAMA, 277 (1997): 1238-43.
47. I. Gavras, A.J. Manolis, and H. Gavras, "The Economics of Therapeutic Advances: The Paradigm of Sympathetic Suppression in Chronic Heart Failure," Archives of Internal Medicine, 159 (1999): 2634-36, at 2635. Others have likewise observed that inexpensive, effective therapies tend to be ignored. See J.S. Goodwin and J.M. Goodwin, "The Tomato Effect: Rejection of Highly Efficacious Therapies," JAMA, 251 (1984): 2387-90; J.S. Goodwin and J.M. Goodwin, "Failure to Recognize Efficacious Therapy: The History of Aspirin Treatment for Rheumatoid Arthritis," Perspectives in Biology and Medicine, 25 (1981): 78-92; F.A. Lederle, W.A. Applegate, and R.H. Grimm, Jr., "Reserpine and the Medical Marketplace," Archives of Internal Medicine, 153 (1993): 705-06.
48. I. Gavras, A.J. Manolis, and H. Gavras, "The Economics of Therapeutic Advances: The Paradigm of Sympathetic Suppression in Chronic Heart Failure," Archives of Internal Medicine, 159 (1999): 2634-36, at 2635. Others have likewise observed that inexpensive, effective therapies tend to be ignored. See J.S. Goodwin and J.M. Goodwin, "The Tomato Effect: Rejection of Highly Efficacious Therapies," JAMA, 251 (1984): 2387-90; J.S. Goodwin and J.M. Goodwin, "Failure to Recognize Efficacious Therapy: The History of Aspirin Treatment for Rheumatoid Arthritis," Perspectives in Biology and Medicine, 25 (1981): 78-92; F.A. Lederle, W.A. Applegate, and R.H. Grimm, Jr., "Reserpine and the Medical Marketplace," Archives of Internal Medicine, 153 (1993): 705-06.
49. I. Gavras, A.J. Manolis, and H. Gavras, "The Economics of Therapeutic Advances: The Paradigm of Sympathetic Suppression in Chronic Heart Failure," Archives of Internal Medicine, 159 (1999): 2634-36, at 2635. Others have likewise observed that inexpensive, effective therapies tend to be ignored. See J.S. Goodwin and J.M. Goodwin, "The Tomato Effect: Rejection of Highly Efficacious Therapies," JAMA, 251 (1984): 2387-90; J.S. Goodwin and J.M. Goodwin, "Failure to Recognize Efficacious Therapy: The History of Aspirin Treatment for Rheumatoid Arthritis," Perspectives in Biology and Medicine, 25 (1981): 78-92; F.A. Lederle, W.A. Applegate, and R.H. Grimm, Jr., "Reserpine and the Medical Marketplace," Archives of Internal Medicine, 153 (1993): 705-06.
50. I. Gavras, A.J. Manolis, and H. Gavras, "The Economics of Therapeutic Advances: The Paradigm of Sympathetic Suppression in Chronic Heart Failure," Archives of Internal Medicine, 159 (1999): 2634-36, at 2635. Others have likewise observed that inexpensive, effective therapies tend to be ignored. See J.S. Goodwin and J.M. Goodwin, "The Tomato Effect: Rejection of Highly Efficacious Therapies," JAMA, 251 (1984): 2387-90; J.S. Goodwin and J.M. Goodwin, "Failure to Recognize Efficacious Therapy: The History of Aspirin Treatment for Rheumatoid Arthritis," Perspectives in Biology and Medicine, 25 (1981): 78-92; F.A. Lederle, W.A. Applegate, and R.H. Grimm, Jr., "Reserpine and the Medical Marketplace," Archives of Internal Medicine, 153 (1993): 705-06.
51. Sepsis is a devastating blood infection in which the body's normal inflammatory response to infection goes out of control, threatening major organ systems.
52. Interestingly, although the drug is the first and only drug approved for the treatment of severe sepsis, several commentators have indicated that they "believe that there is not sufficient evidence at present for it to become the standard of care," because the performance of the drug was not consistent throughout the trial, leading to a mid-trial change in the protocol. H.S. Warren et al., "Risks and Benefits of Activated Protein C Treatment for Severe Sepsis," N. Engl. J. Med., 347 (2002): 1027-30, at 1030. See also B.J. Mannis et al., "An Economic Evaluation of Activated Protein C Treatment for Severe Sepsis," N. Engl. J. Med., 347 (2002): 993-1000; J.P. Siegel, "Assessing the Use of Activated Protein C in the Treatment of Severe Sepsis," N. Engl. J. Med., 347 (2002): 1030-34.
53. Interestingly, although the drug is the first and only drug approved for the treatment of severe sepsis, several commentators have indicated that they "believe that there is not sufficient evidence at present for it to become the standard of care," because the performance of the drug was not consistent throughout the trial, leading to a mid-trial change in the protocol. H.S. Warren et al., "Risks and Benefits of Activated Protein C Treatment for Severe Sepsis," N. Engl. J. Med., 347 (2002): 1027-30, at 1030. See also B.J. Mannis et al., "An Economic Evaluation of Activated Protein C Treatment for Severe Sepsis," N. Engl. J. Med., 347 (2002): 993-1000; J.P. Siegel, "Assessing the Use of Activated Protein C in the Treatment of Severe Sepsis," N. Engl. J. Med., 347 (2002): 1030-34.
54. Interestingly, although the drug is the first and only drug approved for the treatment of severe sepsis, several commentators have indicated that they "believe that there is not sufficient evidence at present for it to become the standard of care," because the performance of the drug was not consistent throughout the trial, leading to a mid-trial change in the protocol. H.S. Warren et al., "Risks and Benefits of Activated Protein C Treatment for Severe Sepsis," N. Engl. J. Med., 347 (2002): 1027-30, at 1030. See also B.J. Mannis et al., "An Economic Evaluation of Activated Protein C Treatment for Severe Sepsis," N. Engl. J. Med., 347 (2002): 993-1000; J.P. Siegel, "Assessing the Use of Activated Protein C in the Treatment of Severe Sepsis," N. Engl. J. Med., 347 (2002): 1030-34.
55. T.M. Burton, "Why Cheap Drugs that Appear to Halt Fatal Sepsis Go Unused," Wall Street Journal, May 17, 2002, at A1, A7, at A7.
56. For a considerably more detailed discussion of these points, see E.H. Morreim, Holding Health Care Accountable: Law and the New Medical Marketplace (New York: Oxford University Press, 2001): at Chapter 5.
57. "The HTA [health technology assessment] activities of many for-profit and not-for-profit research organizations are based almost exclusively on funding from the private sector (e.g., pharmaceutical, biotechnology, and medical device manufacturers). These assessments are commissioned generally to fulfill the needs of the funding organizations.... The most likely causes of wide variance in results are the use of evidence of inferior quality or incomplete scope, applying inadequate resources, or allowing self-interest to affect the outcome in favor of the health plan." S. Perry and M. Thamer, "Medical Innovation and the Critical Role of Health Technology Assessment," JAMA, 282 (1999): 1869-72, at 1870-71. Another type of industry-driven outcomes research is postmarketing studies of FDA-approved products. Typically, this research is undertaken to demonstrate which pharmaceuticals or other products are most cost-effective. Yet such research has no official requirements for scientific rigor, and studies sometimes are more of a marketing device than a bona fide research effort. The only requirement is that the results of such studies not be used in official marketing. A.L. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," N. Engl. J. Med., 324 (1991): 1362-65. See also A.F. Nelson, E.S. Quiter, and L.I. Solberg, "The State of Research Within Managed Care Plans: 1997 Survey," Health Affairs, 17, no. 1 (1998): 128-38; M. Friedberg et al., "Evaluation of Conflict of Interest in Economic Analysis of New Drugs Used in Oncology," JAMA, 282 (1999): 1453-57; S. Krimsky, "Conflict of Interest and Cost-Effectiveness Analysis," JAMA, 282 (1999): 1474-75.
58. "The HTA [health technology assessment] activities of many for-profit and not-for-profit research organizations are based almost exclusively on funding from the private sector (e.g., pharmaceutical, biotechnology, and medical device manufacturers). These assessments are commissioned generally to fulfill the needs of the funding organizations.... The most likely causes of wide variance in results are the use of evidence of inferior quality or incomplete scope, applying inadequate resources, or allowing self-interest to affect the outcome in favor of the health plan." S. Perry and M. Thamer, "Medical Innovation and the Critical Role of Health Technology Assessment," JAMA, 282 (1999): 1869-72, at 1870-71. Another type of industry-driven outcomes research is postmarketing studies of FDA-approved products. Typically, this research is undertaken to demonstrate which pharmaceuticals or other products are most cost-effective. Yet such research has no official requirements for scientific rigor, and studies sometimes are more of a marketing device than a bona fide research effort. The only requirement is that the results of such studies not be used in official marketing. A.L. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," N. Engl. J. Med., 324 (1991): 1362-65. See also A.F. Nelson, E.S. Quiter, and L.I. Solberg, "The State of Research Within Managed Care Plans: 1997 Survey," Health Affairs, 17, no. 1 (1998): 128-38; M. Friedberg et al., "Evaluation of Conflict of Interest in Economic Analysis of New Drugs Used in Oncology," JAMA, 282 (1999): 1453-57; S. Krimsky, "Conflict of Interest and Cost-Effectiveness Analysis," JAMA, 282 (1999): 1474-75.
59. "The HTA [health technology assessment] activities of many for-profit and not-for-profit research organizations are based almost exclusively on funding from the private sector (e.g., pharmaceutical, biotechnology, and medical device manufacturers). These assessments are commissioned generally to fulfill the needs of the funding organizations.... The most likely causes of wide variance in results are the use of evidence of inferior quality or incomplete scope, applying inadequate resources, or allowing self-interest to affect the outcome in favor of the health plan." S. Perry and M. Thamer, "Medical Innovation and the Critical Role of Health Technology Assessment," JAMA, 282 (1999): 1869-72, at 1870-71. Another type of industry-driven outcomes research is postmarketing studies of FDA-approved products. Typically, this research is undertaken to demonstrate which pharmaceuticals or other products are most cost-effective. Yet such research has no official requirements for scientific rigor, and studies sometimes are more of a marketing device than a bona fide research effort. The only requirement is that the results of such studies not be used in official marketing. A.L. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," N. Engl. J. Med., 324 (1991): 1362-65. See also A.F. Nelson, E.S. Quiter, and L.I. Solberg, "The State of Research Within Managed Care Plans: 1997 Survey," Health Affairs, 17, no. 1 (1998): 128-38; M. Friedberg et al., "Evaluation of Conflict of Interest in Economic Analysis of New Drugs Used in Oncology," JAMA, 282 (1999): 1453-57; S. Krimsky, "Conflict of Interest and Cost-Effectiveness Analysis," JAMA, 282 (1999): 1474-75.
60. "The HTA [health technology assessment] activities of many for-profit and not-for-profit research organizations are based almost exclusively on funding from the private sector (e.g., pharmaceutical, biotechnology, and medical device manufacturers). These assessments are commissioned generally to fulfill the needs of the funding organizations.... The most likely causes of wide variance in results are the use of evidence of inferior quality or incomplete scope, applying inadequate resources, or allowing self-interest to affect the outcome in favor of the health plan." S. Perry and M. Thamer, "Medical Innovation and the Critical Role of Health Technology Assessment," JAMA, 282 (1999): 1869-72, at 1870-71. Another type of industry-driven outcomes research is postmarketing studies of FDA-approved products. Typically, this research is undertaken to demonstrate which pharmaceuticals or other products are most cost-effective. Yet such research has no official requirements for scientific rigor, and studies sometimes are more of a marketing device than a bona fide research effort. The only requirement is that the results of such studies not be used in official marketing. A.L. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," N. Engl. J. Med., 324 (1991): 1362-65. See also A.F. Nelson, E.S. Quiter, and L.I. Solberg, "The State of Research Within Managed Care Plans: 1997 Survey," Health Affairs, 17, no. 1 (1998): 128-38; M. Friedberg et al., "Evaluation of Conflict of Interest in Economic Analysis of New Drugs Used in Oncology," JAMA, 282 (1999): 1453-57; S. Krimsky, "Conflict of Interest and Cost-Effectiveness Analysis," JAMA, 282 (1999): 1474-75.
61. "The HTA [health technology assessment] activities of many for-profit and not-for-profit research organizations are based almost exclusively on funding from the private sector (e.g., pharmaceutical, biotechnology, and medical device manufacturers). These assessments are commissioned generally to fulfill the needs of the funding organizations.... The most likely causes of wide variance in results are the use of evidence of inferior quality or incomplete scope, applying inadequate resources, or allowing self-interest to affect the outcome in favor of the health plan." S. Perry and M. Thamer, "Medical Innovation and the Critical Role of Health Technology Assessment," JAMA, 282 (1999): 1869-72, at 1870-71. Another type of industry-driven outcomes research is postmarketing studies of FDA-approved products. Typically, this research is undertaken to demonstrate which pharmaceuticals or other products are most cost-effective. Yet such research has no official requirements for scientific rigor, and studies sometimes are more of a marketing device than a bona fide research effort. The only requirement is that the results of such studies not be used in official marketing. A.L. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," N. Engl. J. Med., 324 (1991): 1362-65. See also A.F. Nelson, E.S. Quiter, and L.I. Solberg, "The State of Research Within Managed Care Plans: 1997 Survey," Health Affairs, 17, no. 1 (1998): 128-38; M. Friedberg et al., "Evaluation of Conflict of Interest in Economic Analysis of New Drugs Used in Oncology," JAMA, 282 (1999): 1453-57; S. Krimsky, "Conflict of Interest and Cost-Effectiveness Analysis," JAMA, 282 (1999): 1474-75.
62. Committee on Quality of Health Care in American, Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century (Washington, D.C.: National Academy Press, 2001): at Executive Summary, at 14.
63. G. Kolata, "Research Suggests More Health Care May Not Be Better," New York Times, July 21, 2002.
64. J.E. Wennberg, E.S. Fisher, and J.S. Skinner, "Geography and the Debate Over Medicare Reform," Health Affairs, at 〈http://www. heakhaffairs.org/WebExclusives/Wennberg Web_Excl_021302.htm〉 (posted February 13, 2002).
65. "Underuse is the failure to provide a health care service when it would have produced a favorable outcome for a patient.... Overuse occurs when a health care service is provided under circumstances in which its potential for harm exceeds the possible benefit.... Misuse occurs when an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service." M..R. Chassin and R.W. Galvin, "National Roundtable on Health Care Quality. The Urgent Need to Improve Health Care Quality," JAMA, 280 (1998): 1000-05, at 1002. See also T. Bodenheimer, "The American Health Care System: The Movement for Improved Quality in Health Care," N. Engl. J. Med., 340 (1999): 488-92; M.A. Schuster, E.A. McGlynn, and R.H. Brook, "How Good Is the Quality of Health Care in the United States?," Milbank Quarterly, 76, no. 4 (1998): 517-63; M.R. Chassin, "Is Health Care Ready for Six Sigma Quality?," Milbank Quarterly, 76, no. 4 (1998): 565-91.
66. "Underuse is the failure to provide a health care service when it would have produced a favorable outcome for a patient.... Overuse occurs when a health care service is provided under circumstances in which its potential for harm exceeds the possible benefit.... Misuse occurs when an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service." M..R. Chassin and R.W. Galvin, "National Roundtable on Health Care Quality. The Urgent Need to Improve Health Care Quality," JAMA, 280 (1998): 1000-05, at 1002. See also T. Bodenheimer, "The American Health Care System: The Movement for Improved Quality in Health Care," N. Engl. J. Med., 340 (1999): 488-92; M.A. Schuster, E.A. McGlynn, and R.H. Brook, "How Good Is the Quality of Health Care in the United States?," Milbank Quarterly, 76, no. 4 (1998): 517-63; M.R. Chassin, "Is Health Care Ready for Six Sigma Quality?," Milbank Quarterly, 76, no. 4 (1998): 565-91.
67. "Underuse is the failure to provide a health care service when it would have produced a favorable outcome for a patient.... Overuse occurs when a health care service is provided under circumstances in which its potential for harm exceeds the possible benefit.... Misuse occurs when an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service." M..R. Chassin and R.W. Galvin, "National Roundtable on Health Care Quality. The Urgent Need to Improve Health Care Quality," JAMA, 280 (1998): 1000-05, at 1002. See also T. Bodenheimer, "The American Health Care System: The Movement for Improved Quality in Health Care," N. Engl. J. Med., 340 (1999): 488-92; M.A. Schuster, E.A. McGlynn, and R.H. Brook, "How Good Is the Quality of Health Care in the United States?," Milbank Quarterly, 76, no. 4 (1998): 517-63; M.R. Chassin, "Is Health Care Ready for Six Sigma Quality?," Milbank Quarterly, 76, no. 4 (1998): 565-91.
68. "Underuse is the failure to provide a health care service when it would have produced a favorable outcome for a patient.... Overuse occurs when a health care service is provided under circumstances in which its potential for harm exceeds the possible benefit.... Misuse occurs when an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service." M..R. Chassin and R.W.
69. For a broad survey with numerous references, see Morreim, supra note 29.
70. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.L. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997): 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
71. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.L. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997): 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
72. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.L. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997): 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
73. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.L. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997): 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
74. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.L. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997): 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
75. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.L. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997): 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
76. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
77. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
78. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
79. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
80. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
81. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
82. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
83. J. Avorn and D.H. Solomon, "Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics," Annals of Internal Medicine, 133 (2000): 128-35; H.S. Gold and R.C. Moellering, "Antimicrobial-Drug Resistance," N. Engl. J. Med., 335 (1996): 1445-53, at 1445-46; R. Gonzales et al., "Decreasing Antibiotic Use in Ambulatory Practice," JAMA, 281 (1999): 1512-19; N. Joshi and D. Milfred, "The Use and Misuse of New Antibiotics," Archives of Internal Medicine, 155 (1995): 569-77; D.N. McKay, "Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease," Journal of General Internal Medicine, 11 (1996): 557-62; "W.J. Hueston, "Antibiotics: Neither Cost Effective nor 'Cough' Effective," Journal of Family Practice, 44 (1997): 261-65; G.I. Fraser et al., "Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes," Archives of Internal Medicine, 157 (1997); 1689-94; A. Nyquist et al., "Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis," JAMA, 279 (1998): 875-77; B. Schwartz, A.G. Mainous, and S.M. Marcy, "Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?," JAMA, 279 (1998): 881-82; Chassin and Galvin, supra note 34; R. Gonzales, J.F. Steiner, and M.A. Sande, "Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians," JAMA, 278 (1997): 901-04; L. Culpepper and J. Sisk, "The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion," in P.M. Boyle, ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): at 77-85; S.F. Dowell et al., "Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections," Pediatrics, 101, suppl. (1998): 163-65; S.F. Dowell et al, "Otitis Media - Principles of Judicious Use of Antimicrobial Agents," Pediatrics, 101, suppl. (1998): 165-71; A.D. Fix, G.T. Strickland, and J. Grant, "Tick Bites and Lyme Disease in an Endemic Setting," JAMA, 279 (1998): 206-10.
84. B.G. Ewigman et al., "Radius Study Group. Effect of Prenatal Ultrasound Screening on Perinatal Outcome," N. Engl. J. Med., 329 (1993): 821-27; R.L Berkowitz, "Should Every Pregnant Woman Undergo Ultrasonography?," N. Engl. J. Med., 329 (1993): 874-75.
85. B.G. Ewigman et al., "Radius Study Group. Effect of Prenatal Ultrasound Screening on Perinatal Outcome," N. Engl. J. Med., 329 (1993): 821-27; R.L Berkowitz, "Should Every Pregnant Woman Undergo Ultrasonography?," N. Engl. J. Med., 329 (1993): 874-75.
86. H.M. Krumholz et al., "Thrombolytic Therapy for Eligible Elderly Patients with Acute Myocardial Infarction, "JAMA, 277 (1997): 1683-88; C.L. Pashos et al., "Trends in the Use of Drug Therapies in Patients with Acute Myocardial Infarction: 1988 to 1992," Journal of the American College of Cardiology, 23 (1994): 1023-30; D.C. Frances et al., "Outcome Following Acute Myocardial Infarction," Archives of Internal Medicine, 159 (1999): 1429-36.
87. H.M. Krumholz et al., "Thrombolytic Therapy for Eligible Elderly Patients with Acute Myocardial Infarction, "JAMA, 277 (1997): 1683-88; C.L. Pashos et al., "Trends in the Use of Drug Therapies in Patients with Acute Myocardial Infarction: 1988 to 1992," Journal of the American College of Cardiology, 23 (1994): 1023-30; D.C. Frances et al., "Outcome Following Acute Myocardial Infarction," Archives of Internal Medicine, 159 (1999): 1429-36.
88. H.M. Krumholz et al., "Thrombolytic Therapy for Eligible Elderly Patients with Acute Myocardial Infarction, "JAMA, 277 (1997): 1683-88; C.L. Pashos et al., "Trends in the Use of Drug Therapies in Patients with Acute Myocardial Infarction: 1988 to 1992," Journal of the American College of Cardiology, 23 (1994): 1023-30; D.C. Frances et al., "Outcome Following Acute Myocardial Infarction," Archives of Internal Medicine, 159 (1999): 1429-36.
89. T.J. Wang and R.S. Stafford, "National Patterns and Predictors of β-Blocker Use in Patients with Coronary Artery Disease," Archives of Internal Medicine, 158 (1998): 1901-06. See also L.N. Newcomer, "Physician, Measure Thyself," Health Affairs, 17, no. 4 (1998): 32-35; T.M. Burton, "An HMO Checks Up on Its Doctors' Care and Is Disturbed Itself," Wall Street Journal, July 8, 1998, at A1, A8; R. Winslow, "Studies Show Doctors Underprescribe Beta Blockers for Heart Attack Patients," Wall Street Journal, August 19, 1998, at B5; Frances et al., supra note 38; R.M. Califf and C.M. O'Connor, "β-blocker Therapy for Heart Failure: The Evidence Is in, Now the Work Begins," JAMA, 283 (2000): 1335-37, at 1336. In another study, "less than 50% of cardiologists' patients were taking β-blockers." M.T. Donohoe, "Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses," Archives of Internal Medicine, 158 (1998): 1596-608, at 1597. Likewise, it is well-known that patients with congestive heart failure can benefit greatly from angiotensin-converting enzyme (ACE) inhibitor drugs. Yet in one study of patients with congestive heart failure, "only three quarters of eligible patients were taking an [ACE] inhibitor, and only 60% of those were at doses known to be efficacious." Id.
90. T.J. Wang and R.S. Stafford, "National Patterns and Predictors of β-Blocker Use in Patients with Coronary Artery Disease," Archives of Internal Medicine, 158 (1998): 1901-06. See also L.N. Newcomer, "Physician, Measure Thyself," Health Affairs, 17, no. 4 (1998): 32-35; T.M. Burton, "An HMO Checks Up on Its Doctors' Care and Is Disturbed Itself," Wall Street Journal, July 8, 1998, at A1, A8; R. Winslow, "Studies Show Doctors Underprescribe Beta Blockers for Heart Attack Patients," Wall Street Journal, August 19, 1998, at B5; Frances et al., supra note 38; R.M. Califf and C.M. O'Connor, "β-blocker Therapy for Heart Failure: The Evidence Is in, Now the Work Begins," JAMA, 283 (2000): 1335-37, at 1336. In another study, "less than 50% of cardiologists' patients were taking β-blockers." M.T. Donohoe, "Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses," Archives of Internal Medicine, 158 (1998): 1596-608, at 1597. Likewise, it is well-known that patients with congestive heart failure can benefit greatly from angiotensin-converting enzyme (ACE) inhibitor drugs. Yet in one study of patients with congestive heart failure, "only three quarters of eligible patients were taking an [ACE] inhibitor, and only 60% of those were at doses known to be efficacious." Id.
91. T.J. Wang and R.S. Stafford, "National Patterns and Predictors of β-Blocker Use in Patients with Coronary Artery Disease," Archives of Internal Medicine, 158 (1998): 1901-06. See also L.N. Newcomer, "Physician, Measure Thyself," Health Affairs, 17, no. 4 (1998): 32-35; T.M. Burton, "An HMO Checks Up on Its Doctors' Care and Is Disturbed Itself," Wall Street Journal, July 8, 1998, at A1, A8; R. Winslow, "Studies Show Doctors Underprescribe Beta Blockers for Heart Attack Patients," Wall Street Journal, August 19, 1998, at B5; Frances et al., supra note 38; R.M. Califf and C.M. O'Connor, "β-blocker Therapy for Heart Failure: The Evidence Is in, Now the Work Begins," JAMA, 283 (2000): 1335-37, at 1336. In another study, "less than 50% of cardiologists' patients were taking β-blockers." M.T. Donohoe, "Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses," Archives of Internal Medicine, 158 (1998): 1596-608, at 1597. Likewise, it is well-known that patients with congestive heart failure can benefit greatly from angiotensin-converting enzyme (ACE) inhibitor drugs. Yet in one study of patients with congestive heart failure, "only three quarters of eligible patients were taking an [ACE] inhibitor, and only 60% of those were at doses known to be efficacious." Id.
92. T.J. Wang and R.S. Stafford, "National Patterns and Predictors of β-Blocker Use in Patients with Coronary Artery Disease," Archives of Internal Medicine, 158 (1998): 1901-06. See also L.N. Newcomer, "Physician, Measure Thyself," Health Affairs, 17, no. 4 (1998): 32-35; T.M. Burton, "An HMO Checks Up on Its Doctors' Care and Is Disturbed Itself," Wall Street Journal, July 8, 1998, at A1, A8; R. Winslow, "Studies Show Doctors Underprescribe Beta Blockers for Heart Attack Patients," Wall Street Journal, August 19, 1998, at B5; Frances et al., supra note 38; R.M. Califf and C.M. O'Connor, "β-blocker Therapy for Heart Failure: The Evidence Is in, Now the Work Begins," JAMA, 283 (2000): 1335-37, at 1336. In another study, "less than 50% of cardiologists' patients were taking β-blockers." M.T. Donohoe, "Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses," Archives of Internal Medicine, 158 (1998): 1596-608, at 1597. Likewise, it is well-known that patients with congestive heart failure can benefit greatly from angiotensin-converting enzyme (ACE) inhibitor drugs. Yet in one study of patients with congestive heart failure, "only three quarters of eligible patients were taking an [ACE] inhibitor, and only 60% of those were at doses known to be efficacious." Id.
93. T.J. Wang and R.S. Stafford, "National Patterns and Predictors of β-Blocker Use in Patients with Coronary Artery Disease," Archives of Internal Medicine, 158 (1998): 1901-06. See also L.N. Newcomer, "Physician, Measure Thyself," Health Affairs, 17, no. 4 (1998): 32-35; T.M. Burton, "An HMO Checks Up on Its Doctors' Care and Is Disturbed Itself," Wall Street Journal, July 8, 1998, at A1, A8; R. Winslow, "Studies Show Doctors Underprescribe Beta Blockers for Heart Attack Patients," Wall Street Journal, August 19, 1998, at B5; Frances et al., supra note 38; R.M. Califf and C.M. O'Connor, "β-blocker Therapy for Heart Failure: The Evidence Is in, Now the Work Begins," JAMA, 283 (2000): 1335-37, at 1336. In another study, "less than 50% of cardiologists' patients were taking β-blockers." M.T. Donohoe, "Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses," Archives of Internal Medicine, 158 (1998): 1596-608, at 1597. Likewise, it is well-known that patients with congestive heart failure can benefit greatly from angiotensin-converting enzyme (ACE) inhibitor drugs. Yet in one study of patients with congestive heart failure, "only three quarters of eligible patients were taking an [ACE] inhibitor, and only 60% of those were at doses known to be efficacious." Id.
94. T.J. Wang and R.S. Stafford, "National Patterns and Predictors of β-Blocker Use in Patients with Coronary Artery Disease," Archives of Internal Medicine, 158 (1998): 1901-06. See also L.N. Newcomer, "Physician, Measure Thyself," Health Affairs, 17, no. 4 (1998): 32-35; T.M. Burton, "An HMO Checks Up on Its Doctors' Care and Is Disturbed Itself," Wall Street Journal, July 8, 1998, at A1, A8; R. Winslow, "Studies Show Doctors Underprescribe Beta Blockers for Heart Attack Patients," Wall Street Journal, August 19, 1998, at B5; Frances et al., supra note 38; R.M. Califf and C.M. O'Connor, "β-blocker Therapy for Heart Failure: The Evidence Is in, Now the Work Begins," JAMA, 283 (2000): 1335-37, at 1336. In another study, "less than 50% of cardiologists' patients were taking β-blockers." M.T. Donohoe, "Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses," Archives of Internal Medicine, 158 (1998): 1596-608, at 1597. Likewise, it is well-known that patients with congestive heart failure can benefit greatly from angiotensin-converting enzyme (ACE) inhibitor drugs. Yet in one study of patients with congestive heart failure, "only three quarters of eligible patients were taking an [ACE] inhibitor, and only 60% of those were at doses known to be efficacious." Id.
95. A.P. Legorreta et al., "Compliance with National Asthma Management Guidelines and Specialty Care," Archives of Internal Medicine, 158 (1998): 457-64; T.V. Hartert et al., "Inadequate Outpatient Medical Therapy for Patient with Asthma Admitted to Two Urban Hospitals," American Journal of Medicine, 100 (1996): 386-94; D.P. Havranek et al., "Process and Outcome of Output Management of Heart Failure: A Comparison of Cardiologists and Primary Care Providers," American Journal of Managed Care, 2, suppl. (1996): S6-S12, at S10. See also Donohoe, supra note 39, at 1599.
96. A.P. Legorreta et al., "Compliance with National Asthma Management Guidelines and Specialty Care," Archives of Internal Medicine, 158 (1998): 457-64; T.V. Hartert et al., "Inadequate Outpatient Medical Therapy for Patient with Asthma Admitted to Two Urban Hospitals," American Journal of Medicine, 100 (1996): 386-94; D.P. Havranek et al., "Process and Outcome of Output Management of Heart Failure: A Comparison of Cardiologists and Primary Care Providers," American Journal of Managed Care, 2, suppl. (1996): S6-S12, at S10. See also Donohoe, supra note 39, at 1599.
97. A.P. Legorreta et al., "Compliance with National Asthma Management Guidelines and Specialty Care," Archives of Internal Medicine, 158 (1998): 457-64; T.V. Hartert et al., "Inadequate Outpatient Medical Therapy for Patient with Asthma Admitted to Two Urban Hospitals," American Journal of Medicine, 100 (1996): 386-94; D.P. Havranek et al., "Process and Outcome of Output Management of Heart Failure: A Comparison of Cardiologists and Primary Care Providers," American Journal of Managed Care, 2, suppl. (1996): S6-S12, at S10. See also Donohoe, supra note 39, at 1599.
98. J.P. Weiner et al., "Variation in Office-Based Quality: A Claims-Based Profile of Care Provided to Medicare Patients with Diabetes," JAMA, 273 (1995): 1503-08; L.L. Leape, "Translating Medical Science into Medical Practice: Do We Need a National Medical Standards Board?," JAMA, 273 (1995): 1534-37; H.M. Harris, "Disease Management: New Wine in New Bottles?," Annals of Internal Medicine, 124 (1996): 838-42; Newcomer, supra note 39; R.S. Epstein and L.M. Sherwood, "From Outcomes Research to Disease Management: A Guide for the Perplexed," Annals of Internal Medicine, 124 (1996): 832-37; Donohoe, supra note 39, at 1600; Burton, supra note 39.
99. J.P. Weiner et al., "Variation in Office-Based Quality: A Claims-Based Profile of Care Provided to Medicare Patients with Diabetes," JAMA, 273 (1995): 1503-08; L.L. Leape, "Translating Medical Science into Medical Practice: Do We Need a National Medical Standards Board?," JAMA, 273 (1995): 1534-37; H.M. Harris, "Disease Management: New Wine in New Bottles?," Annals of Internal Medicine, 124 (1996): 838-42; Newcomer, supra note 39; R.S. Epstein and L.M. Sherwood, "From Outcomes Research to Disease Management: A Guide for the Perplexed," Annals of Internal Medicine, 124 (1996): 832-37; Donohoe, supra note 39, at 1600; Burton, supra note 39.
100. J.P. Weiner et al., "Variation in Office-Based Quality: A Claims-Based Profile of Care Provided to Medicare Patients with Diabetes," JAMA, 273 (1995): 1503-08; L.L. Leape, "Translating Medical Science into Medical Practice: Do We Need a National Medical Standards Board?," JAMA, 273 (1995): 1534-37; H.M. Harris, "Disease Management: New Wine in New Bottles?," Annals of Internal Medicine, 124 (1996): 838-42; Newcomer, supra note 39; R.S. Epstein and L.M. Sherwood, "From Outcomes Research to Disease Management: A Guide for the Perplexed," Annals of Internal Medicine, 124 (1996): 832-37; Donohoe, supra note 39, at 1600; Burton, supra note 39.
101. J.P. Weiner et al., "Variation in Office-Based Quality: A Claims-Based Profile of Care Provided to Medicare Patients with Diabetes," JAMA, 273 (1995): 1503-08; L.L. Leape, "Translating Medical Science into Medical Practice: Do We Need a National Medical Standards Board?," JAMA, 273 (1995): 1534-37; H.M. Harris, "Disease Management: New Wine in New Bottles?," Annals of Internal Medicine, 124 (1996): 838-42; Newcomer, supra note 39; R.S. Epstein and L.M. Sherwood, "From Outcomes Research to Disease Management: A Guide for the Perplexed," Annals of Internal Medicine, 124 (1996): 832-37; Donohoe, supra note 39, at 1600; Burton, supra note 39.
102. Donohoe, supra note 39.
103. At the beginning of the study, "handwashing compliance before and after defined events was 9% and 22% for health care workers in the medical ICU and 3% and 13% for health care workers in the cardiac surgery ICU, respectively. After the education/feedback intervention program, handwashing compliance changed little...." Of note, after an alcohol-based waterless handwashing antiseptic was made easily available by each bed, handwashing compliance improved to 48 percent. Still, that is less than half the desirable level. W.E. Bischoff et al., "Handwashing Compliance by Health Care Workers: The Impact of Introducing an Accessible, Alcohol-Based Hand Antiseptic," Archives of Internal Medicine, 160 (2000): 1017-21, at 1017.
104. L.N. Newcomer, "Medicare Pharmacy Coverage: Ensuring Safety Before Funding," Health Affairs, 19, no. 2 (2000): 59-62, at 60 (citations omitted).
105. E.A. McGlynn and R.H. Brook, "Keeping Quality on the Policy Agenda," Health Affairs, 20, no. 3 (2001): 82-90, at 83.
106. E.C. Burton, D.A. Troxclair, and W.P. Newman, "Autopsy Diagnoses of Malignant Neoplasms: How Often Are Clinical Diagnoses Incorrect?," JAMA, 280 (1998): 1245-18 (finding a 44% discordance between clinical and autopsy diagnoses of malignant neoplasms). See also G.D. Lundberg, "Low-Tech Autopsies in the Era of High-Tech Medicine," JAMA, 280 (1998): 1273-74. Another study comparing autopsy findings to premortem diagnoses found that in a third of the cases, the autopsy detected an unexpected pathological diagnosis directly contributing to the patient's death. Additional unexpected diagnoses were found in nearly 80 percent of the cases. S. Durning and L. Cation, "The Educational Value of Autopsy in a Residency Training Program," Archives of Internal Medicine, 160 (2000): 997-99. See also T.C. Mort and N.S. Yeston, "The Relationship of Pre Mortem Diagnoses and Post Mortem Findings in a Surgical Intensive Care Unit," Critical Care Medicine, 27 (1999): 299-303 (finding a 41 percent rate of discrepancies between pre- and post-mortem diagnoses in a surgical intensive care unit; of these errors, 85 percent were undiagnosed infectious processes).
107. E.C. Burton, D.A. Troxclair, and W.P. Newman, "Autopsy Diagnoses of Malignant Neoplasms: How Often Are Clinical Diagnoses Incorrect?," JAMA, 280 (1998): 1245-18 (finding a 44% discordance between clinical and autopsy diagnoses of malignant neoplasms). See also G.D. Lundberg, "Low-Tech Autopsies in the Era of High-Tech Medicine," JAMA, 280 (1998): 1273-74. Another study comparing autopsy findings to premortem diagnoses found that in a third of the cases, the autopsy detected an unexpected pathological diagnosis directly contributing to the patient's death. Additional unexpected diagnoses were found in nearly 80 percent of the cases. S. Durning and L. Cation, "The Educational Value of Autopsy in a Residency Training Program," Archives of Internal Medicine, 160 (2000): 997-99. See also T.C. Mort and N.S. Yeston, "The Relationship of Pre Mortem Diagnoses and Post Mortem Findings in a Surgical Intensive Care Unit," Critical Care Medicine, 27 (1999): 299-303 (finding a 41 percent rate of discrepancies between pre- and post-mortem diagnoses in a surgical intensive care unit; of these errors, 85 percent were undiagnosed infectious processes).
108. E.C. Burton, D.A. Troxclair, and W.P. Newman, "Autopsy Diagnoses of Malignant Neoplasms: How Often Are Clinical Diagnoses Incorrect?," JAMA, 280 (1998): 1245-18 (finding a 44% discordance between clinical and autopsy diagnoses of malignant neoplasms). See also G.D. Lundberg, "Low-Tech Autopsies in the Era of High-Tech Medicine," JAMA, 280 (1998): 1273-74. Another study comparing autopsy findings to premortem diagnoses found that in a third of the cases, the autopsy detected an unexpected pathological diagnosis directly contributing to the patient's death. Additional unexpected diagnoses were found in nearly 80 percent of the cases. S. Durning and L. Cation, "The Educational Value of Autopsy in a Residency Training Program," Archives of Internal Medicine, 160 (2000): 997-99. See also T.C. Mort and N.S. Yeston, "The Relationship of Pre Mortem Diagnoses and Post Mortem Findings in a Surgical Intensive Care Unit," Critical Care Medicine, 27 (1999): 299-303 (finding a 41 percent rate of discrepancies between pre- and post-mortem diagnoses in a surgical intensive care unit; of these errors, 85 percent were undiagnosed infectious processes).
109. E.C. Burton, D.A. Troxclair, and W.P. Newman, "Autopsy Diagnoses of Malignant Neoplasms: How Often Are Clinical Diagnoses Incorrect?," JAMA, 280 (1998): 1245-18 (finding a 44% discordance between clinical and autopsy diagnoses of malignant neoplasms). See also G.D. Lundberg, "Low-Tech Autopsies in the Era of High-Tech Medicine," JAMA, 280 (1998): 1273-74. Another study comparing autopsy findings to premortem diagnoses found that in a third of the cases, the autopsy detected an unexpected pathological diagnosis directly contributing to the patient's death. Additional unexpected diagnoses were found in nearly 80 percent of the cases. S. Durning and L. Cation, "The Educational Value of Autopsy in a Residency Training Program," Archives of Internal Medicine, 160 (2000): 997-99. See also T.C. Mort and N.S. Yeston, "The Relationship of Pre Mortem Diagnoses and Post Mortem Findings in a Surgical Intensive Care Unit," Critical Care Medicine, 27 (1999): 299-303 (finding a 41 percent rate of discrepancies between pre- and post-mortem diagnoses in a surgical intensive care unit; of these errors, 85 percent were undiagnosed infectious processes).
110. "[A]ll residents we tested had great difficulty in identifying 12 commonly encountered and important events. Residents were incorrect 4 of 5 times, improved little with year of training, and were not more accurate than a group of medical students. Indeed, trainees in both residencies were less accurate than students [for certain kinds of heart sounds].... [W]e found minimal gains, if any, as a result of residency training. Deficiencies of this type will probably persist even after residents enter practice. Indeed, increasing evidence in the literature seems to suggest that errors in physical diagnosis are commonly encountered among generalists. These errors may even lead to greater utilization of resources and a higher cost of care." S. Mangione and L.Z. Nieman, "Cardiac Auscultatory Skills of Internal Medicine and Family Practice Trainees: A Comparison of Diagnostic Proficiency," JAMA, 278 (1997): 717-22, at 721.
111. The chief brand names are Celebrex and Vioxx.
112. Newcomer, supra note 44, at 60. "A month's prescription of either Celebrex or Vioxx costs about $80, many times the cost of generic pain relievers." M. Peterson, "Study Finding Celebrex Safer Was Flawed, Journal Says," New York Times, June 1, 2002.
113. P. Juni, A.W.S. Rutjes, and P.A. Dieppe, "Are Selective COX 2 Inhibitors Superior to Traditional Non-Steroidal Anti-Inflammatory Drugs?," BMJ, 324 (2002): 1287-88; K.L. Francis et al., "Celecoxib versus Diclofenac and Omeprazole in Reducing the Risk of Recurrent Ulcer Bleeding in Patients with Arthritis," N. Engl. J. Med., 347 (2002): 2104-10; D.Y. Graham, "NSAIDs, Helicobacter pylori, and Pandora's Box," N. Engl. J. Med., 347 (2002): 2162-64.
114. P. Juni, A.W.S. Rutjes, and P.A. Dieppe, "Are Selective COX 2 Inhibitors Superior to Traditional Non-Steroidal Anti-Inflammatory Drugs?," BMJ, 324 (2002): 1287-88; K.L. Francis et al., "Celecoxib versus Diclofenac and Omeprazole in Reducing the Risk of Recurrent Ulcer Bleeding in Patients with Arthritis," N. Engl. J. Med., 347 (2002): 2104-10; D.Y. Graham, "NSAIDs, Helicobacter pylori, and Pandora's Box," N. Engl. J. Med., 347 (2002): 2162-64.
115. P. Juni, A.W.S. Rutjes, and P.A. Dieppe, "Are Selective COX 2 Inhibitors Superior to Traditional Non-Steroidal Anti-Inflammatory Drugs?," BMJ, 324 (2002): 1287-88; K.L. Francis et al., "Celecoxib versus Diclofenac and Omeprazole in Reducing the Risk of Recurrent Ulcer Bleeding in Patients with Arthritis," N. Engl. J. Med., 347 (2002): 2104-10; D.Y. Graham, "NSAIDs, Helicobacter pylori, and Pandora's Box," N. Engl. J. Med., 347 (2002): 2162-64.
116. J. Avorn, M. Chen, and R. Hartley, "Scientific versus Commercial Sources of Influence on the Prescribing Behavior of Physicians," American Journal of Medicine, 73 (1982): 4-8; R.K. Schwartz, S.B. Soumerai, and J. Avorn, "Physician Motivations for Nonscientific Drug Prescribing," Social Science and Medicine, 28, no. 6 (1989): 577-82.
117. J. Avorn, M. Chen, and R. Hartley, "Scientific versus Commercial Sources of Influence on the Prescribing Behavior of Physicians," American Journal of Medicine, 73 (1982): 4-8; R.K. Schwartz, S.B. Soumerai, and J. Avorn, "Physician Motivations for Nonscientific Drug Prescribing," Social Science and Medicine, 28, no. 6 (1989): 577-82.
118. J.P. Orlowski and L. Wateska, "The Effect of Pharmaceutical Firm Enticements on Physician Prescribing Patterns," Chest, 102, no. 1 (1992): 270-73.
119. A.R. Feinstein, "System, Supervision, Standards, and the 'Epidemic' of Negligent Medical Errors," Archives of Internal Medicine, 157 (1997): 1285-89, at 1286. Feinstein goes on to note: "The combination of shortened durations of time for both the patient in [the] hospital and the house officer on a service has reduced the house officer's sense of continuity of care within the hospital... and has increased the difficulties of maintaining rigorous patterns of supervision and discussion." Id. at 1287.
120. J.D. Lantos and J. Frader, "Extracorporeal Membrane Oxygenation and the Ethics of Clinical Research in Pediatrics," N. Engl. J. Med., 323 (1990): 409-13.
121. In scientific research, evaluation of diseases and treatments "generally requires a priori hypotheses, randomization (to eliminate selection bias and confounding), homogeneous patients at high risk for the outcome, experienced investigators who follow a protocol, a comparative measure such as a placebo (if ethical), and intensive follow-up to ensure compliance. Under these circumstances, if a treatment proves to be better than a placebo (or a comparative measure), one can be reassured that the treatment can work. However, questions may remain about the ability of the treatment to work adequately in a broader range of patients and in usual practice settings in which both patients and providers face natural barriers to care." Epstein and Sherwood, supra note 41, at 833. See also A.R. Feinstein and R.I. Horwitz, "Problems in the 'Evidence' of 'Evidence-Based Medicine,'" American Journal of Medicine, 103 (1997): 529-35; K.B. Wells and R. Sturm, "Care for Depression in a Changing Environment," Health Affairs, 14, no. 3 (1995): 78-89, at 80. "Clinical trials are not real life. To assess efficacy in as unconfounded a manner as possible, trials sometimes exclude certain patients (e.g., the elderly, the very young, those too sick, or those taking certain other medications). Any special vulnerability to adverse events in those groups will be missed." M.A. Friedman et al., "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?," JAMA, 281 (1999): 1728-34, at 1733.
122. In scientific research, evaluation of diseases and treatments "generally requires a priori hypotheses, randomization (to eliminate selection bias and confounding), homogeneous patients at high risk for the outcome, experienced investigators who follow a protocol, a comparative measure such as a placebo (if ethical), and intensive follow-up to ensure compliance. Under these circumstances, if a treatment proves to be better than a placebo (or a comparative measure), one can be reassured that the treatment can work. However, questions may remain about the ability of the treatment to work adequately in a broader range of patients and in usual practice settings in which both patients and providers face natural barriers to care." Epstein and Sherwood, supra note 41, at 833. See also A.R. Feinstein and R.I. Horwitz, "Problems in the 'Evidence' of 'Evidence-Based Medicine,'" American Journal of Medicine, 103 (1997): 529-35; K.B. Wells and R. Sturm, "Care for Depression in a Changing Environment," Health Affairs, 14, no. 3 (1995): 78-89, at 80. "Clinical trials are not real life. To assess efficacy in as unconfounded a manner as possible, trials sometimes exclude certain patients (e.g., the elderly, the very young, those too sick, or those taking certain other medications). Any special vulnerability to adverse events in those groups will be missed." M.A. Friedman et al., "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?," JAMA, 281 (1999): 1728-34, at 1733.
123. In scientific research, evaluation of diseases and treatments "generally requires a priori hypotheses, randomization (to eliminate selection bias and confounding), homogeneous patients at high risk for the outcome, experienced investigators who follow a protocol, a comparative measure such as a placebo (if ethical), and intensive follow-up to ensure compliance. Under these circumstances, if a treatment proves to be better than a placebo (or a comparative measure), one can be reassured that the treatment can work. However, questions may remain about the ability of the treatment to work adequately in a broader range of patients and in usual practice settings in which both patients and providers face natural barriers to care." Epstein and Sherwood, supra note 41, at 833. See also A.R. Feinstein and R.I. Horwitz, "Problems in the 'Evidence' of 'Evidence-Based Medicine,'" American Journal of Medicine, 103 (1997): 529-35; K.B. Wells and R. Sturm, "Care for Depression in a Changing Environment," Health Affairs, 14, no. 3 (1995): 78-89, at 80. "Clinical trials are not real life. To assess efficacy in as unconfounded a manner as possible, trials sometimes exclude certain patients (e.g., the elderly, the very young, those too sick, or those taking certain other medications). Any special vulnerability to adverse events in those groups will be missed." M.A. Friedman et al., "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?," JAMA, 281 (1999): 1728-34, at 1733.
124. Epstein and Sherwood, supra note 41. "The failure to account for the effects of comorbid and associated conditions on the clinical outcome of chronic diseases is reflected in the common disjunction that occurs between the efficacy of an intervention, such as a drug used in a clinical trial, and the lack of effectiveness of the same drug used in clinical practice." R.B. DeBusk et al., "Chronic Disease Management," Archives of Internal Medicine, 159 (1999): 2739-42, at 2740. Regarding coronary bypass surgery, Gellins and colleagues observed that "only 4 to 13 percent of the patients who now undergo this operation would meet the eligibility criteria for the randomized controlled trials that established its efficacy." Gellins, Rosenberg, and Moskowitz, supra note 10, at 694. See also Feinstein, supra note 10.
125. DeBusk et al, supra note 56, at 2740.
126. P. Jong et al., "Prognosis and Determinants of Survival in Patients Newly Hospitalized for Heart Failure," Archives of Internal Medicine, 162 (2002): 1689-94, at 1692. Mainly these research subjects were white male populations with a mean age of about 60 and few comorbidities.
127. Id. at 1692.
128. Leape, supra note 41; S.H. Woolf, "Practice Guidelines: A New Reality in Medicine. III. Impact on Patient Care," Archives of Internal Medicine, 153 (1993): 2646-55, at 2646; E.J. Power, "Identifying Health Technologies That Work," JAMA, 274 (1995): 205; Feinstein, supra note 10.
129. Leape, supra note 41; S.H. Woolf, "Practice Guidelines: A New Reality in Medicine. III. Impact on Patient Care," Archives of Internal Medicine, 153 (1993): 2646-55, at 2646; E.J. Power, "Identifying Health Technologies That Work," JAMA, 274 (1995): 205; Feinstein, supra note 10.
130. Friedman et al., supra note 55, at 1729.
131. T.L. Delbanco, "Bitter Herbs: Mainstream, Magic, and Menace," Annals of Internal Medicine, 121 (1994): 803-04; D.W. Gordon et al., "Chaparral Ingestion: The Broadening Spectrum of Liver Injury Caused by Herbal Medications," JAMA, 273 (1995): 489-90; R.S. Koff, "Herbal Hepatotoxicity: Revisiting a Dangerous Alternative," JAMA, 273 (1995): 502.
132. T.L. Delbanco, "Bitter Herbs: Mainstream, Magic, and Menace," Annals of Internal Medicine, 121 (1994): 803-04; D.W. Gordon et al., "Chaparral Ingestion: The Broadening Spectrum of Liver Injury Caused by Herbal Medications," JAMA, 273 (1995): 489-90; R.S. Koff, "Herbal Hepatotoxicity: Revisiting a Dangerous Alternative," JAMA, 273 (1995): 502.
133. T.L. Delbanco, "Bitter Herbs: Mainstream, Magic, and Menace," Annals of Internal Medicine, 121 (1994): 803-04; D.W. Gordon et al., "Chaparral Ingestion: The Broadening Spectrum of Liver Injury Caused by Herbal Medications," JAMA, 273 (1995): 489-90; R.S. Koff, "Herbal Hepatotoxicity: Revisiting a Dangerous Alternative," JAMA, 273 (1995): 502.
134. W.C. Meeker and S. Haldeman, "Chiropractic: A Profession at the Crossroads of Mainstream and Alternative Medicine," Annals of Internal Medicine, 136 (2002): 216-27, at 222. But see W.S. Smith et al., "Spinal Manipulative Therapy Is an Independent Risk Factor for Vertebral Artery Dissection," Neurology, 60 (2003): 1424-28.
135. W.C. Meeker and S. Haldeman, "Chiropractic: A Profession at the Crossroads of Mainstream and Alternative Medicine," Annals of Internal Medicine, 136 (2002): 216-27, at 222. But see W.S. Smith et al., "Spinal Manipulative Therapy Is an Independent Risk Factor for Vertebral Artery Dissection," Neurology, 60 (2003): 1424-28.
136. L. Kohn, J. Corrigan, and M. Donaldson, eds., Committee on Quality of Health Care in America, Institute of Medicine, To Err Is Human: Building a Safer Health System (Washington, D.C.: National Academy Press, 1999): at 1, 26.
137. Quality Interagency Coordination Task Force, Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, Report to the President (February 2000): at 29 (citing L. Kohn, J. Corrigan, and M. Donaldson, eds., supra note 64). See also L.L. Leape, "Foreword: Preventing Medical Accidents: Is 'Systems Analysis' the Answer?," American Journal of Law & Medicine, 27, nos. 2 and 3 (2001): 145-48; T.J. Krizek, "Surgical Error: Ethical Issues of Adverse Events," Archives of Surgery, 135 (2000): 1359-66.
138. Quality Interagency Coordination Task Force, Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, Report to the President (February 2000): at 29 (citing L. Kohn, J. Corrigan, and M. Donaldson, eds., supra note 64). See also L.L. Leape, "Foreword: Preventing Medical Accidents: Is 'Systems Analysis' the Answer?," American Journal of Law & Medicine, 27, nos. 2 and 3 (2001): 145-48; T.J. Krizek, "Surgical Error: Ethical Issues of Adverse Events," Archives of Surgery, 135 (2000): 1359-66.
139. Quality Interagency Coordination Task Force, Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, Report to the President (February 2000): at 29 (citing L. Kohn, J. Corrigan, and M. Donaldson, eds., supra note 64). See also L.L. Leape, "Foreword: Preventing Medical Accidents: Is 'Systems Analysis' the Answer?," American Journal of Law & Medicine, 27, nos. 2 and 3 (2001): 145-48; T.J. Krizek, "Surgical Error: Ethical Issues of Adverse Events," Archives of Surgery, 135 (2000): 1359-66.
140. J. Lazarou, B.H. Pomeranz, and P.N. Corey, "Incidence of Adverse Drug Reactions in Hospitalized Patients. A Meta-Analysis of Prospective Studies," JAMA, 279 (1998): 1200-05, at 1203.
141. L. Landro, "The Informed Patient: Deadly Errors Dog Procedures at Doctors' Offices and Clinics," Wall Street Journal, August 29, 2002.
142. "[P]atients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful." Schneiderman, supra note 3, at 91.
143. D.M. Eisenberg et al., "Unconventional Medicine in the United States," N. Engl. J. Med., 328 (1993): 246-52, at 250.
144. Id. at 248-49.
145. Modalities showing the greatest increase in use were herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing, and homeopathy. D.M. Eisenberg et al., "Trends in Alternative Medicine Use in the United States, 1990-1997," JAMA, 280 (1998): 1569-75.
146. Moseley et al., supra note 13, at 81.
147. Id. at 87. See also Felson and Buckwalter, supra note 12; S. Horng and F.G. Miller, "Is Placebo Surgery Unethical?," N. Engl. J. Med., 347 (2002): 137-39.
148. McGlynn and Brook, supra note 45, at 83.
149. Mello and Brennan, supra note 19, at 110. "Although the cost has decreased somewhat in the past several years, it remains in the neighborhood of $80,000." Id. See also Kolata and Eichenwald, supra note 22.
150. Peters and Rogers, supra note 20. See also J.H. Ferguson, M. Dubinsky, and P.J. Kirsch, "Court-Ordered Reimbursement for Unproven Medical Technology: Circumventing Technology Assessment," JAMA, 269 (1993): 2116-21.
151. Hoffman, supra note 21.
152. Another example is cerebral revascularization featuring superficial anastomosis of temporal to middle cerebral artery. See P.J. Cohen, "The Placebo Is Not Dead: Three Historical Vignettes," IRB, 20, nos. 2-3 (1998): 6-8.
153. F.A. Tausk, "Alternative Medicine: Is It All in Your Mind?," Archives of Dermatology, 134 (1998): 1422-25, at 1423 (citing A.H. Roberts et al., "The Power of Nonspecific Effects in Healing: Implications for Psychosocial and Biological Treatments," Clinical Psychology Review, 13 (1993): 375-91).
154. F.A. Tausk, "Alternative Medicine: Is It All in Your Mind?," Archives of Dermatology, 134 (1998): 1422-25, at 1423 (citing A.H. Roberts et al., "The Power of Nonspecific Effects in Healing: Implications for Psychosocial and Biological Treatments," Clinical Psychology Review, 13 (1993): 375-91).
155. J.E. Wennberg, ed., The Dartmouth Atlas of Health Care in the United States (Chicago: American Hospital Publishing, 1996); J.E. Wennberg, "Understanding Geographic Variations in Health Care Delivery," N. Engl. J. Med., 340 (1999): 52-53.
156. J.E. Wennberg, ed., The Dartmouth Atlas of Health Care in the United States (Chicago: American Hospital Publishing, 1996); J.E. Wennberg, "Understanding Geographic Variations in Health Care Delivery," N. Engl. J. Med., 340 (1999): 52-53.
157. J.E. Wennberg, "Which Rate Is Right?," N. Engl. J. Med., 314 (1986): 310-11, at 310.
158. Wennberg, Fisher, and Skinner, supra note 33.
159. E.H. Morreim, "Defined Contribution: From Managed Care to Patient-Managed Care," Cato Journal, 22, no. 1 (2002): 103-20.
160. Portions of this discussion rely on an earlier publication. See id.
161. J. Gabel et al., "Job-Based Health Benefits in 2002: Some Important Trends," Health Affairs, 21, no. 5 (2002): 143-51.
162. R. Winslow and E. McGinley, "Back on the Front Burner," Wall Street Journal, February 21, 2001, at R3; M. Parrish, "A New Day Dawns ... When Patients Buy Their Own Health Care," Medical Economics, 78, no. 5 (2001): 95-111; D. Blumenthal, "Controlling Health Care Expenditures," N. Engl. J. Med., 344 (2001): 766-69; J.V. Jacobi and N. Huberfeld, "Quality Control, Enterprise Liability, and Disintermediation in Managed Care," Journal of Law, Medicine & Ethics, 29, nos. 3 and 4 (2001): 305-22, at 309-12; R. Galvin and A. Milstein, "Large Employers' New Strategies in Health Care," N. Engl J. Med., 347 (2002): 939-12.
163. R. Winslow and E. McGinley, "Back on the Front Burner," Wall Street Journal, February 21, 2001, at R3; M. Parrish, "A New Day Dawns ... When Patients Buy Their Own Health Care," Medical Economics, 78, no. 5 (2001): 95-111; D. Blumenthal, "Controlling Health Care Expenditures," N. Engl. J. Med., 344 (2001): 766-69; J.V. Jacobi and N. Huberfeld, "Quality Control, Enterprise Liability, and Disintermediation in Managed Care," Journal of Law, Medicine & Ethics, 29, nos. 3 and 4 (2001): 305-22, at 309-12; R. Galvin and A. Milstein, "Large Employers' New Strategies in Health Care," N. Engl J. Med., 347 (2002): 939-12.
164. R. Winslow and E. McGinley, "Back on the Front Burner," Wall Street Journal, February 21, 2001, at R3; M. Parrish, "A New Day Dawns ... When Patients Buy Their Own Health Care," Medical Economics, 78, no. 5 (2001): 95-111; D. Blumenthal, "Controlling Health Care Expenditures," N. Engl. J. Med., 344 (2001): 766-69; J.V. Jacobi and N. Huberfeld, "Quality Control, Enterprise Liability, and Disintermediation in Managed Care," Journal of Law, Medicine & Ethics, 29, nos. 3 and 4 (2001): 305-22, at 309-12; R. Galvin and A. Milstein, "Large Employers' New Strategies in Health Care," N. Engl J. Med., 347 (2002): 939-12.
165. R. Winslow and E. McGinley, "Back on the Front Burner," Wall Street Journal, February 21, 2001, at R3; M. Parrish, "A New Day Dawns ... When Patients Buy Their Own Health Care," Medical Economics, 78, no. 5 (2001): 95-111; D. Blumenthal, "Controlling Health Care Expenditures," N. Engl. J. Med., 344 (2001): 766-69; J.V. Jacobi and N. Huberfeld, "Quality Control, Enterprise Liability, and Disintermediation in Managed Care," Journal of Law, Medicine & Ethics, 29, nos. 3 and 4 (2001): 305-22, at 309-12; R. Galvin and A. Milstein, "Large Employers' New Strategies in Health Care," N. Engl J. Med., 347 (2002): 939-12.
166. R. Winslow and E. McGinley, "Back on the Front Burner," Wall Street Journal, February 21, 2001, at R3; M. Parrish, "A New Day Dawns ... When Patients Buy Their Own Health Care," Medical Economics, 78, no. 5 (2001): 95-111; D. Blumenthal, "Controlling Health Care Expenditures," N. Engl. J. Med., 344 (2001): 766-69; J.V. Jacobi and N. Huberfeld, "Quality Control, Enterprise Liability, and Disintermediation in Managed Care," Journal of Law, Medicine & Ethics, 29, nos. 3 and 4 (2001): 305-22, at 309-12; R. Galvin and A. Milstein, "Large Employers' New Strategies in Health Care," N. Engl J. Med., 347 (2002): 939-12.
167. See Wye River Group on Healthcare et al., An Employer's Guide to Consumer-Directed Healthcare Benefits (2001), available at 〈http://www. ncpa.org/extra/health/wye_full.pdf〉. See also K.E. Martin, Shifting Responsibilities: Models of Defined Contribution (Washington, D.C.: Academy for Health Services Research and Health Policy, 2002), available at 〈http://hcfo.net/pdf/definedcontribution.pdf〉; J. Robinson, "The End of Managed Care," JAMA, 285 (2001): 2622-28; M. Freudenheim, "H.M.O. Costs Spur Employers to Shift Plans," New York Times, September 6, 2000; Parrish, supra note 86; R. Winslow and C. Gentry, "Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan," Wall Street Journal, February 8, 2000, at A1, A12; G. Shaw, "The Defined Contribution Solution," Managed Healthcare News, February 2001, at 1.
168. See Wye River Group on Healthcare et al., An Employer's Guide to Consumer-Directed Healthcare Benefits (2001), available at 〈http://www. ncpa.org/extra/health/wye_full.pdf〉. See also K.E. Martin, Shifting Responsibilities: Models of Defined Contribution (Washington, D.C.: Academy for Health Services Research and Health Policy, 2002), available at 〈http://hcfo.net/pdf/definedcontribution.pdf〉; J. Robinson, "The End of Managed Care," JAMA, 285 (2001): 2622-28; M. Freudenheim, "H.M.O. Costs Spur Employers to Shift Plans," New York Times, September 6, 2000; Parrish, supra note 86; R. Winslow and C. Gentry, "Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan," Wall Street Journal, February 8, 2000, at A1, A12; G. Shaw, "The Defined Contribution Solution," Managed Healthcare News, February 2001, at 1.
169. See Wye River Group on Healthcare et al., An Employer's Guide to Consumer-Directed Healthcare Benefits (2001), available at 〈http://www. ncpa.org/extra/health/wye_full.pdf〉. See also K.E. Martin, Shifting Responsibilities: Models of Defined Contribution (Washington, D.C.: Academy for Health Services Research and Health Policy, 2002), available at 〈http://hcfo.net/pdf/definedcontribution.pdf〉; J. Robinson, "The End of Managed Care," JAMA, 285 (2001): 2622-28; M. Freudenheim, "H.M.O. Costs Spur Employers to Shift Plans," New York Times, September 6, 2000; Parrish, supra note 86; R. Winslow and C. Gentry, "Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan," Wall Street Journal, February 8, 2000, at A1, A12; G. Shaw, "The Defined Contribution Solution," Managed Healthcare News, February 2001, at 1.
170. See Wye River Group on Healthcare et al., An Employer's Guide to Consumer-Directed Healthcare Benefits (2001), available at 〈http://www. ncpa.org/extra/health/wye_full.pdf〉. See also K.E. Martin, Shifting Responsibilities: Models of Defined Contribution (Washington, D.C.: Academy for Health Services Research and Health Policy, 2002), available at 〈http://hcfo.net/pdf/definedcontribution.pdf〉; J. Robinson, "The End of Managed Care," JAMA, 285 (2001): 2622-28; M. Freudenheim, "H.M.O. Costs Spur Employers to Shift Plans," New York Times, September 6, 2000; Parrish, supra note 86; R. Winslow and C. Gentry, "Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan," Wall Street Journal, February 8, 2000, at A1, A12; G. Shaw, "The Defined Contribution Solution," Managed Healthcare News, February 2001, at 1.
171. See Wye River Group on Healthcare et al., An Employer's Guide to Consumer-Directed Healthcare Benefits (2001), available at 〈http://www. ncpa.org/extra/health/wye_full.pdf〉. See also K.E. Martin, Shifting Responsibilities: Models of Defined Contribution (Washington, D.C.: Academy for Health Services Research and Health Policy, 2002), available at 〈http://hcfo.net/pdf/definedcontribution.pdf〉; J. Robinson, "The End of Managed Care," JAMA, 285 (2001): 2622-28; M. Freudenheim, "H.M.O. Costs Spur Employers to Shift Plans," New York Times, September 6, 2000; Parrish, supra note 86; R. Winslow and C. Gentry, "Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan," Wall Street Journal, February 8, 2000, at A1, A12; G. Shaw, "The Defined Contribution Solution," Managed Healthcare News, February 2001, at 1.
172. See Wye River Group on Healthcare et al., An Employer's Guide to Consumer-Directed Healthcare Benefits (2001), available at 〈http://www. ncpa.org/extra/health/wye_full.pdf〉. See also K.E. Martin, Shifting Responsibilities: Models of Defined Contribution (Washington, D.C.: Academy for Health Services Research and Health Policy, 2002), available at 〈http://hcfo.net/pdf/definedcontribution.pdf〉; J. Robinson, "The End of Managed Care," JAMA, 285 (2001): 2622-28; M. Freudenheim, "H.M.O. Costs Spur Employers to Shift Plans," New York Times, September 6, 2000; Parrish, supra note 86; R. Winslow and C. Gentry, "Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan," Wall Street Journal, February 8, 2000, at A1, A12; G. Shaw, "The Defined Contribution Solution," Managed Healthcare News, February 2001, at 1.
173. See, e.g., HealthMarket, at 〈www.healthmarket.com〉; Lumenos, at 〈www.lumenos.com〉; Vivius, at 〈www.vivius. com〉; Definity Health, at 〈www.definityhealth.com〉; myhealthbank, at 〈www.myhealthbank.com〉; HealthAllies, at 〈www.healthallies. com〉.
174. See, e.g., HealthMarket, at 〈www.healthmarket.com〉; Lumenos, at 〈www.lumenos.com〉; Vivius, at 〈www.vivius. com〉; Definity Health, at 〈www.definityhealth.com〉; myhealthbank, at 〈www.myhealthbank.com〉; HealthAllies, at 〈www.healthallies. com〉.
175. See, e.g., HealthMarket, at 〈www.healthmarket.com〉; Lumenos, at 〈www.lumenos.com〉; Vivius, at 〈www.vivius. com〉; Definity Health, at 〈www.definityhealth.com〉; myhealthbank, at 〈www.myhealthbank.com〉; HealthAllies, at 〈www.healthallies. com〉.
176. See, e.g., HealthMarket, at 〈www.healthmarket.com〉; Lumenos, at 〈www.lumenos.com〉; Vivius, at 〈www.vivius. com〉; Definity Health, at 〈www.definityhealth.com〉; myhealthbank, at 〈www.myhealthbank.com〉; HealthAllies, at 〈www.healthallies. com〉.
177. See, e.g., HealthMarket, at 〈www.healthmarket.com〉; Lumenos, at 〈www.lumenos.com〉; Vivius, at 〈www.vivius. com〉; Definity Health, at 〈www.definityhealth.com〉; myhealthbank, at 〈www.myhealthbank.com〉; HealthAllies, at 〈www.healthallies. com〉.
178. See, e.g., HealthMarket, at 〈www.healthmarket.com〉; Lumenos, at 〈www.lumenos.com〉; Vivius, at 〈www.vivius. com〉; Definity Health, at 〈www.definityhealth.com〉; myhealthbank, at 〈www.myhealthbank.com〉; HealthAllies, at 〈www.healthallies. com〉.
179. Health reimbursement arrangements (HRAs) can be rolled over from one year to the next. This guidance was released on July 15, 2002, and applies to Section 105 and 106 of the Internal Revenue Code. See Rev. Rul. 2002-41, 2002-28 I.R.B., available at 〈http://www.unclefed.com/Tax-Bulls/2002/rr02-41. pdf〉 ("Holding: Employer-provided coverage and medical care expense reimbursements made under the reimbursement arrangement that allows unused amounts to be carried forward ... are excludable from gross income under §§ 106 and 105....").
180. Editorial, "Consumer-First Health Care," Wall Street Journal, July 21, 1994, at A12.
181. M.L. Berk and A.C. Monheit, "The Concentration of Health Care Expenditures, Revisited," Health Affairs, 20, no. 2 (2001): 9-18, at 12.
182. For further discussion, see Morreim, supra note 83.
183. Gabel et al., supra note 85.
184. Eisenberg et al., supra note 69.