A Dose of Our Own Medicine: Alternative Medicine,Conventional Medicine,and the Standards of Science

Campion E.W. , “Why Unconventional Medicine?,” N. Engl. J. Med., 328 (1993): 282–83, at 282.

Angell M. Kassirer J.R. , “Alternative Medicine — The Risks of Untested and Unregulated Remedies,” N. Engl. J. Med., 339 (1998): 839–41, at 841.

Schneiderman L.J. , “Alternative Medicine or Alternatives to Medicine? A Physician's Perspective,” Cambridge Quarterly of Healthcare Ethics, 9 (2000): 83–97, at 91.

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>.

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 Snyderman R. Weil A.T. , “Integrative Medicine: Bringing Medicine Back to its Roots,” Archives of Internal Medicine, 61 (2002): 395–97.

Marcus D.M. Grollman A.R. , “Botanical Medicines —The Need for New Regulations,” N. Engl. J. Med., 347 (2002): 2073–76; DeSmet P.A.G.M. , “Herbal Remedies,” N. Engl. J. Med., 347 (2002): 2046–56; Eisenberg D.M. , “Credentialing Complementary and Alternative Medical Providers,” Annals of Internal Medicine, 137 (2002): 965–73.

Hall J.B. , “Use of the Pulmonary Artery Catheter in Critically Ill Patients: Was Invention the Mother of Necessity ?,” JAMA, 283 (2000): 2577–78; Rapoport J. , “Patient Characteristics and ICU Organizational Factors that Influence Frequency of Pulmonary Artery Catheterization,” JAMA, 283 (2000): 2559–67; Bernard G.R. , “Pulmonary Artery Catheterization and Clinical Outcomes: NHLBI and FDA Workshop Report,” JAMA, 283 (2000): 2568–72; Sandham J.D. , “A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients,” N. Engl. J. Med., 348 (2003): 5–14; Parsons RE , “Progress in Research on Pulmonary-Artery Catheters,” N. Engl. J. Med., 348 (2003): 66–68.

Dalen J.E. , “‘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.

Gellins A.C. Rosenberg N. Moskowitz A.J. , “Capturing the Unexpected Benefits of Medical Research,” N. Engl. J. Med., 339 (1998): 693–97, at 694. See also Feinstein A.R. , “Clinical Judgment Revisited: The Distraction of Quantitative Methods,” Annals of Internal Medicine, 1230 (1994): 799–805.

Lange R.A. Hillis L.D. , “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 Fisher E.S. Welch H.G. , “Avoiding the Unintended Consequences of Growth in Medical Care: How Might More Be Worse?,” JAMA, 281 (1999): 446–53.

Felson D.T. Buckwalter J. , “Debridement and Lavage for Osteoarthritis of the Knee,” N. Engl. J. Med., 347 (2002): 132–33.

Moseley J.B. , “A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee,” N. Engl. J. Med., 337 (2002): 81–88.

Id. at 81.

Kolata G. Petersen M. , “Hormone Replacement Study a Shock to the Medical System,” New York Times, July 10, 2002.

Kolata G. , “In Public Health, Definitive Data Can Be Elusive,” New York Times, April 23, 2002. See also Grady D. , “Scientists Question Hormone Therapies for Menopause Ills,” New York Times, April 18, 2002; Kolata Petersen , supra note 15; Grady D. , “A 60-Year-Old Woman Trying to Discontinue Hormone Replacement Therapy,” JAMA, 287 (2002): 2130–37.

Kolata , supra note 16 (quoting Dr. Deborah Grady, a professor of medicine and epidemiology at the University of California in San Francisco).

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.

Mello M.M. Brennan T.A. , “The Controversy over High-Dose Chemotherapy with Autologous Bone Marrow Transplant for Breast Cancer,” Health Affairs, 20, no. 5 (2001): 101–18, at 110.

Peters W.P. Rogers M.C. , “Variation in Approval by Insurance Companies of Coverage for Autologous Bone Marrow Transplantation for Breast Cancer,” N. Engl. J. Med., 330 (1994): 473–77.

“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)). Hoffman S. , “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 Theodos T.F. , “The Patients' Bill of Rights: Women's Rights under Managed Care and ERISA Preemption,” American Journal of Law & Medicine, 26 (2000): 89–108.

Steinberg E.P. Tunis S. Shapiro D. , “Insurance Coverage for Experimental Technologies,” Health Affairs, 14, no. 4 (1995): 143–58, at 150. See also Kolata G. , “Women Rejecting Trials for Testing a Cancer Therapy,” New York Times, February 15, 1995, at C8; Kolata G. Eichenwald K. , “Hope for Sale: Business Thrives on Unproven Care, Leaving Science Behind,” New York Times, October 3, 1999, at A1.

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 Eichenwald , supra note 22.

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 Rennie D. , “Thyroid Storm,” JAMA, 277 (1997): 1238–43.

Gavras I. Manolis A.J. Gavras H. , “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 Goodwin J.S. Goodwin J.M. , “The Tomato Effect: Rejection of Highly Efficacious Therapies,” JAMA, 251 (1984): 2387–90; Goodwin J.S. Goodwin J.M. , “Failure to Recognize Efficacious Therapy: The History of Aspirin Treatment for Rheumatoid Arthritis,” Perspectives in Biology and Medicine, IS (1981): 78–92; Lederle F.A. Applegate W.A. Grimm R.H. Jr. , “Reserpine and the Medical Marketplace,” Archives of Internal Medicine, 153 (1993): 705–06.

Sepsis is a devastating blood infection in which the body's normal inflammatory response to infection goes out of control, threatening major organ systems.

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. Warren H. S. , “Risks and Benefits of Activated Protein C Treatment for Severe Sepsis,” N. Engl. J. Med., 347 (2002): 1027–30, at 1030. See also Mannis B.J. , “An Economic Evaluation of Activated Protein C Treatment for Severe Sepsis,” N. Engl. J. Med., 347 (2002): 993–1000; Siegel J.P. , “Assessing the Use of Activated Protein C in the Treatment of Severe Sepsis,” N. Engl. J. Med., 347 (2002): 1030–34.

Burton T.M. , “Why Cheap Drugs that Appear to Halt Fatal Sepsis Go Unused,” Wall Street Journal, May 17, 2002, at A1, A7, at A7.

For a considerably more detailed discussion of these points, see Morreim E.H. , Holding Health Care Accountable: Law and the New Medical Marketplace (New York: Oxford University Press, 2001): At Chapter 5.

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. Hillman A.L. , “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 Nelson A.F. Quiter E.S. Solberg L.I. , “The State of Research Within Managed Care Plans: 1997 Survey,” Health Affairs, 17, no. 1 (1998): 128–38; Friedberg M. , “Evaluation of Conflict of Interest in Economic Analysis of New Drugs Used in Oncology,” JAMA, 282 (1999): 1453–57; Krimsky S. , “Conflict of Interest and Cost-Effectiveness Analysis,” JAMA, 282 (1999): 1474–75.

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.

Kolata G. , “Research Suggests More Health Care May Not Be Better,” New York Times, July 21, 2002.

Wennberg J.E. Fisher E.S. Skinner J.S. , “Geography and the Debate Over Medicare Reform,” Health Affairs, at <http://www.healthaffairs.org/WebExclusives/Wennberg_Web_Excl_021302.htm> (posted February 13, 2002).

See also Bodenheimer T. , “The American Health Care System: The Movement for Improved Quality in Health Care,” N. Engl. J. Med., 340 (1999): 488–92; Schuster M.A. McGlynn E.A. Brook R.H. , “How Good Is the Qualify of Health Care in the United States?,” Milbank Quarterly, 76, no. 4 (1998): 517–63; Chassin M.R. , “Is Health Care Ready for Six Sigma Quality?,” Milbank Quarterly, 76, no. 4 (1998): 565–91.

For a broad survey with numerous references, see Morreim , supra note 29.

Avorn J. Solomon D.H. , “Cultural and Economic Factors That (Mis)shape Antibiotic Use: The Nonpharmacologic Basis of Therapeutics,” Annals of Internal Medicine, 133 (2000): 128–35; Gold H.S. Moellering R.C. , “Antimicrobial-Drug Resistance,” N. Engl. J. Med., 335 (1996): 1445–53, at 1445–46; Gonzales R. , “Decreasing Antibiotic Use in Ambulatory Practice,” JAMA, 281 (1999): 1512–19; Joshi N. Milfred D. , “The Use and Misuse of New Antibiotics,” Archives of Internal Medicine, 155 (1995): 569–77; McKay D.N. , “Treatment of Acute Bronchitis in Adults Without Underlying Lung Disease,” Journal of General Internal Medicine, 11 (1996): 557–62; Hueston W.J. , “Antibiotics: Neither Cost Effective nor ‘Cough’ Effective,” Journal of Family Practice, 44 (1997): 261–65; Fraser G.L. , “Antibiotic Optimization: An Evaluation of Patient Safety and Economic Outcomes,” Archives of Internal Medicine, 157 (1997): 1689–94; Nyquist A. , “Antibiotic Prescribing for Children with Colds, Upper Respiratory Tract Infections, and Bronchitis,” JAMA, 279 (1998): 875–77; Schwartz B. Mainous A.G. Marcy S.M. , “Why Do Physicians Prescribe Antibiotics for Children with Upper Respiratory Tract Infections?,” JAMA, 279 (1998): 881–82; Chassin Galvin , supra note 34; Gonzales R. Steiner J.F. Sande M.A. , “Antibiotic Prescribing for Adults with Colds, Upper Respiratory Tract Infections, and Bronchitis by Ambulatory Care Physicians,” JAMA, 278 (1997): 901–04; Culpepper L. Sisk J. , “The Development of Practice Guidelines: A Case Study of Otitis Media with Effusion,” in Boyle PH , ed., Getting Doctors to Listen: Ethics and Outcomes Data in Context (Washington, D.C.: Georgetown University Press, 1998): At 77–85; Dowell S.F. , “Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper Respiratory Tract Infections,” Pediatrics, 101, suppl. (1998): 163–65; Dowell S.F. , “Otitis Media — Principles of Judicious Use of Antimicrobial Agents,” Pediatrics, 101, suppl. (1998): 165–71; Fix A.D. Strickland G.T. Grant J. , “Tick Bites and Lyme Disease in an Endemic Setting,” JAMA, 279 (1998): 206–10.

Ewigman B.G. , “Radius Study Group. Effect of Prenatal Ultrasound Screening on Perinatal Outcome,” N. Engl. J. Med., 329 (1993): 821–27; Berkowitz R.L. , “Should Every Pregnant Woman Undergo Ultrasonography?,” N. Engl. J. Med., 329 (1993): 874–75.

Krumholz H.M. , “Thrombolytic Therapy for Eligible Elderly Patients with Acute Myocardial Infarction,” JAMA, 277 (1997): 1683–88; Pashos C.L. , “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; Frances D.C. , “Outcome Following Acute Myocardial Infarction,” Archives of Internal Medicine, 159 (1999): 1429–36.

In another study, “less than 50% of cardiologists' patients were taking β-blockers.” Donohoe M.T. , “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.

Legorreta A.R. , “Compliance with National Asthma Management Guidelines and Specialty Care,” Archives of Internal Medicine, 158 (1998): 457–64; Harten T.V. , “Inadequate Outpatient Medical Therapy for Patient with Asthma Admitted to Two Urban Hospitals,” American Journal of Medicine, 100 (1996): 386–94; Havranek D.P. , “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.

Weiner J.P. , “Variation in Office-Based Quality: A Claims-Based Profile of Care Provided to Medicare Patients with Diabetes,” JAMA, 273 (1995): 1503–08; Leape L.L. , “Translating Medical Science into Medical Practice: Do We Need a National Medical Standards Board?,” JAMA, 273 (1995): 1534–37; Harris H.M. , “Disease Management: New Wine in New Bottles?,” Annals of Internal Medicine, 124 (1996): 838–42; Newcomer, supra note 39; Epstein R.S. Sherwood L.M. , “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.

Donohoe , supra note 39.

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. Bischoff W.E. , “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.

Newcomer L.N. , “Medicare Pharmacy Coverage: Ensuring Safety Before Funding,” Health Affairs, 19, no. 2 (2000): 59–62, at 60 (citations omitted).

McGlynn E.A. Brook R.H. , “Keeping Quality on the Policy Agenda,” Health Affairs, 20, no. 3 (2001): 82–90, at 83.

See also Mort T.C. Yeston N.S. , “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).

“[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.” Mangione S. Nieman L. Z. , “Cardiac Auscultatory Skills of Internal Medicine and Family Practice Trainees: A Comparison of Diagnostic Proficiency,” JAMA, 278 (1997): 717–22, at 721.

The chief brand names are Celebrex and Vioxx.

“A month's prescription of either Celebrex or Vioxx costs about $80, many times the cost of generic pain relievers.” Peterson M. , “Study Finding Celebrex Safer Was Flawed, Journal Says,” New York Times, June 1, 2002.

Juni P. Rutjes A.WS. Dieppe P.A. , “Are Selective COX 2 Inhibitors Superior to Traditional Non-Steroidal Anti-Inflammatory Drugs?,” BMJ, 324 (2002): 1287–88; Francis K.L. , “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; Graham D.Y. , “NSAIDs, Helicobacter pylori, and Pandora's Box,” N. Engl. J. Med., 347 (2002): 2162–64.

Avorn J. Chen M. Hartley R. , “Scientific versus Commercial Sources of Influence on the Prescribing Behavior of Physicians,” American Journal of Medicine, 73 (1982): 4–8; Schwartz R.K. Soumerai S.B. Avorn J. , “Physician Motivations for Nonscientific Drug Prescribing,” Social Science and Medicine, 28, no. 6 (1989): 577–82.

Orlowski J.P. Wateska L. , “The Effect of Pharmaceutical Firm Enticements on Physician Prescribing Patterns,” Chest, 102, no. 1 (1992): 270–73.

Feinstein A.R. , “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.

Lantos J.D. Frader J. , “Extracorporeal Membrane Oxygenation and the Ethics of Clinical Research in Pediatrics,” N. Engl. J. Med., 323 (1990): 409–13.

“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.” Friedman M.A. , “The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?,” JAMA, 281 (1999): 1728–34, at 1733.

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 Moskowitz , supra note 10, at 694. See also Feinstein , supra note 10.

DeBusk , supra note 56, at 2740.

Jong P. , “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.

Id. at 1692.

Leape , supra note 41; Woolf S.H. , “Practice Guidelines: A New Reality in Medicine. III. Impact on Patient Care,” Archives of Internal Medicine, 153 (1993): 2646–55, at 2646; Power E.J. , “Identifying Health Technologies That Work,” JAMA, 274 (1995): 205; Feinstein , supra note 10.

Friedman , supra note 55, at 1729.

Delbanco T.L. , “Bitter Herbs: Mainstream, Magic, and Menace,” Annals of Internal Medicine, 121 (1994): 803–04; Gordon D.W. , “Chaparral Ingestion: The Broadening Spectrum of Liver Injury Caused by Herbal Medications,” JAMA, 273 (1995): 489–90; Koff R.S. , “Herbal Hepatotoxicity: Revisiting a Dangerous Alternative,” JAMA, 273 (1995): 502.

Meeker W.C. Haldeman S. , “Chiropractic: A Profession at the Crossroads of Mainstream and Alternative Medicine,” Annals of Internal Medicine, 136 (2002): 216–27, at 222. But see Smith W.S. , “Spinal Manipulative Therapy Is an Independent Risk Factor for Vertebral Artery Dissection,” Neurology, 60 (2003): 1424–28.

Kohn L. Corrigan J. Donaldson M. , 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.

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 Kohn L. Corrigan J. Donaldson M. , eds., supra note 64). See also Leape L.L. , “Foreword: Preventing Medical Accidents: Is ‘Systems Analysis’ the Answer?,” American Journal of Law & Medicine, 27, nos. 2 and 3 (2001): 145–48; Krizek T.J. , “Surgical Error: Ethical Issues of Adverse Events,” Archives of Surgery, 135 (2000): 1359–66.

Lazarou J. Pomeranz B.H. Corey P.N. , “Incidence of Adverse Drug Reactions in Hospitalized Patients. A Meta-Analysis of Prospective Studies,” JAMA, 279 (1998): 1200–05, at 1203.

Landro L. , “The Informed Patient: Deadly Errors Dog Procedures at Doctors' Offices and Clinics,” Wall Street Journal, August 29, 2002.

“[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.

Eisenberg D.M. , “Unconventional Medicine in the United States,” N. Engl. J. Med., 328 (1993): 246–52, at 250.

Id. at 248–49.

Modalities showing the greatest increase in use were herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing, and homeopathy. Eisenberg D.M. , “Trends in Alternative Medicine Use in the United States, 1990–1997,” JAMA, 280 (1998): 1569–75.

Moseley , supra note 13, at 81.

Id. at 87. See also Felson Buckwalter , supra note 12; Horng S. Miller F.G. , “Is Placebo Surgery Unethical?,” N. Engl. J. Med., 347 (2002): 137–39.

McGlynn Brook , supra note 45, at 83.

Mello 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 Eichenwald , supra note 22.

Peters Rogers , supra note 20. See also Ferguson J.H. Dubinsky M. Kirsch P.J. , “Court-Ordered Reimbursement for Unproven Medical Technology: Circumventing Technology Assessment,” JAMA, 269 (1993): 2116–21.

Hoffman , supra note 21.

Another example is cerebral revascularization featuring superficial anastomosis of temporal to middle cerebral artery. See Cohen P.J. , “The Placebo Is Not Dead: Three Historical Vignettes,” IRB, 20, nos. 2–3 (1998): 6–8.

Tausk F.A. , “Alternative Medicine: Is It All in Your Mind?,” Archives of Dermatology, 134 (1998): 1422–25, at 1423 (citing Roberts A. H. , “The Power of Nonspecific Effects in Healing: Implications for Psychosocial and Biological Treatments,” Clinical Psychology Review, 13 (1993): 375–91).

Wennberg J.E. , ed., The Dartmouth Atlas of Health Care in the United States (Chicago: American Hospital Publishing, 1996); Wennberg J.E. , “Understanding Geographic Variations in Health Care Delivery,” N. Engl. J. Med., 340 (1999): 52–53.

Wennberg J.E. , “Which Rate Is Right?,” N. Engl. J. Med., 314 (1986): 310–11, at 310.

Wennberg Fisher Skinner , supra note 33.

Morreim E.H. , “Defined Contribution: From Managed Care to Patient-Managed Care,” Cato Journal, 22, no. 1 (2002): 103–20.

Portions of this discussion rely on an earlier publication. See id.

Gabel J. , “Job-Based Health Benefits in 2002: Some Important Trends,” Health Affairs, 21, no. 5 (2002): 143–51.

Winslow R. McGinley L. , “Back on the Front Burner,” Wall Street Journal, February 21, 2001, at R3; Parrish M. , “A New Day Dawns… When Patients Buy Their Own Health Care,” Medical Economics, 78, no. 5 (2001): 95–111; Blumenthal D. , “Controlling Health Care Expenditures,” N. Engl. J. Med., 344 (2001): 766–69; Jacobi J.V. Huberfeld N. , “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; Galvin R. Milstein A. , “Large Employers' New Strategies in Health Care,” N. Engl. J. Med., 347 (2002): 939–42.

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 Martin K.E. , 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>; Robinson J. , “The End of Managed Care,” JAMA, 285 (2001): 2622–28; Freudenheim M. , “H.M.O. Costs Spur Employers to Shift Plans,” New York Times, September 6, 2000; Parrish , supra note 86; Winslow R. Gentry C. , “Health-Benefits Trend: Give Workers Money, Let Them Buy a Plan,” Wall Street Journal, February 8, 2000, at A1, A12; Shaw G. , “The Defined Contribution Solution,” Managed Healthcare News, February 2001, at 1.

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>.

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….”).

Editorial, “Consumer-First Health Care,” Wall Street Journal, July 21, 1994, at A12.

Berk M.L. Monheit A.C. , “The Concentration of Health Care Expenditures, Revisited,” Health Affairs, 20, no. 2 (2001): 9–18, at 12.

For further discussion, see Morreim , supra note 83.

Gabel , supra note 85.

Eisenberg , supra note 69.