Ending Medical Reversal

by Vinayak K Prasad

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  Krumholz HM, Bradley EH, Nallamothu BK, et al. A campaign to improve the timeliness of primary percutaneous coronary intervention—door-to-balloon: An alliance for quality. JACC Cardiovasc Interv. 2008;1:97–104.

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  MERIT study investigators. Introduction of the medical emergency team (MET) system:

  A cluster-randomised controlled trial. Lancet. 2005;365:2091–2097.

  Naylor MD, Brooten D, Campbell R, et al. Comprehensive discharge planning and home follow-up of hospitalized elders: A randomized clinical trial. JAMA. 1999;281:613–620.

  NICE-SUGAR study investigators. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360:1283–1297.

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  Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001;345:1359–1367.

  Wachter RM, Flanders SA, Fee C, et al. Public reporting of antibiotic timing in patients with pneumonia: Lessons from a flawed performance measure. Ann Intern Med. 2008;149:29–32.

  6. FINDING FLAWED THERAPIES ON OUR OWN

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  Bolland MJ, Grey A, Avenell A, et al. Calcium supplements with or without vitamin D and risk of cardiovascular events: Reanalysis of the Women’s Health Initiative limited access dataset and meta-analysis. BMJ. 2011;342:d2040.

  Chung M, Lee J, Terasawa T, et al. Vitamin D with or without calcium supplementation for prevention of cancer and fractures: An updated meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155:827–838.

  Clegg DO, Reda DJ, Harris CL, et al. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006;354:795–808.

  Ernst E, Lee MS, Choi TY. Acupuncture: Does it alleviate pain and are there serious risks A review of reviews. Pain. 2011;152:755–764.

  Estruch R, Ros E, Salas-Salvadó J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368:1279–1290.

  Fortmann SP, Burda BU, Senger CA, et al. Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer: An updated systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;159:824–834.

  Guallar E, Stranges S, Mulrow C. Enough is enough: Stop wasting money on vitamin and mineral supplements. Ann Intern Med. 2013;159:850–851.

  Karsch-Völk M, Barrett B, Kiefer D, et al. Echinacea for preventing and treating the common cold. Cochrane Database Syst Rev. 2014 Feb 20.

  Neuhouser M L, Wassertheil-Smoller S, Thomson C. Multivitamin use and risk of cancer and cardiovascular disease in the Women’s Health Initiative cohorts. Arch Intern Med. 2009;169:294–304.

  Schoenfeld JD, Ioannidis JP. Is everything we eat associated with cancer? A systematic cookbook review. Am J Clin Nutr. 2013;97:127–134.

  Turner RB, Bauer R, Woelkart K, et al. An evaluation of echinacea angustifolia in experimental rhinovirus infections. N Engl J Med. 2005;353:341–348.

  Wandel S, Jüni P, Tendal B, et al. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: Network meta-analysis. BMJ. 2010;341:c4675.

  7. THE FREQUENCY OF MEDICAL REVERSAL

  Elshaug A, Watt A, Mundy L, Willis CD. Over 150 potentially low-value health care practices: An Australian study. Med J Aust. 2012;197(10):556–560.

  Ioannidis JA. Contradicted and initially stronger effects in highly cited clinical research. JAMA. 2005;294(2):218–228.

  Prasad V, Gall V, Cifu A. The frequency of medical reversal. Arch Intern Med. 2011;171(18):1675–1676.

  Prasad V, Vandross A, Toomey C, et al. A decade of reversal: An analysis of 146 contradicted medical practices. Mayo Clin Proc. 2013;88(8):790–798.

  8. THE HARMS OF MEDICAL REVERSAL

  Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495–1504.

  Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011;365:993–1003.

  Hartzband P, Groopman J. There is more to life than death. N Engl J Med. 2012;367:987–989. Kjekshus J, Apatrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007;357:2248–2261.

  Prasad V, Cifu A. Medical reversal: Why we must raise the bar before adopting new technologies. Yale J Biol Med. 2011;84:471–478.

  Reinberg S. Study: “Brain stents” for stroke patients do more harm than good. USA Today. www.usatoday.com/news/health/story/health/story/2011-09-08/Study-Brain-stentsfor-stroke-patients-do-more-harm-than-good/50321642/1.

  Roman B, Asch DA, Faded promises: The challenge of deadopting low-value care. Ann Intern Med. 2014;161:149–150.

  Siontis GC, Tatsioni A, Katritsis DG, Ioannidis JP. Persistent reservations against contradicted percutaneous coronary intervention indications: Citation content analysis. Am Heart J. 2009;157:695–701.

  Smith CM. Origin and uses of primum non nocere—above all, do no harm! J Clin Pharmacol. 2005;45:371–377.

  Tatsioni A, Bonitsis NG, Ioannidis JA. Persistence of contradicted claims in the literature. JAMA. 2007;298:2517–2526.

  Weiss M. Lives will be lost with proposed changes to mammography guidelines. Fox News. www.foxnews.com/opinion/2009/11/17/new-breast-cancer-guidelines-mammograms-guidelines-lives-lost/#ixzz27VJvcTii.

  9. A PRIMER ON EVIDENCE-BASED MEDICINE

  Byer DB, Simon RM, Fridewald WT, et al. Randomized clinical trials: Perspectives on some recent ideas. N Engl J Med. 1976;296:74–80.

  Cnattingius S, Signorello LB, Annerén G, et al. Caffeine intake and the risk of first trimester spontaneous abortion. N Engl J Med. 2000;343:1839–1845.

  Godtfredsen NS, Prescott E, Osler M. Effect of smoking reduction on lung cancer risk. JAMA. 2005;294:1505–1510.

  Grodstein F, Stampfer MJ, Manson JE, et al. Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med. 1996;335:453–461.

  Ioannidis JA, Haidich A, Pappa M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA. 2001;286:821–830.

  Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344:1383–1389.

  Stampfer MJ, Colditz GA, Willett WC, et al. Postmenopausal estrogen therapy and cardiovascular disease: Ten-year follow-up from the nurses’ health study. N Engl J Med. 1999;325:756–762.

  Streptomycin in Tuberculosis Trials Committee. Streptomycin treatment of pulmonary tuberculosis. BMJ. 1948;2:769.

  10. WHAT REALLY MADE YOU BETTER

  Bassler D, Briel M, Montori VM, et al. Stopping randomized trials early for benefit and estimation of treatment effects systematic review and meta-regression analysis. JAMA. 2010;303:1180–1187.

  Borzak S, Ridker PM. Discordance between meta-analyses and large-scale randomized, controlled trials: Examples from th
e management of acute myocardial infarction. Ann Intern Med. 1995;123:873–877.

  Gilbert AT, Petersen BW, Recuenco S, et al. Evidence of rabies virus exposure among humans in the Peruvian Amazon. Am J Trop Med Hyg. 2012;87:206–215.

  Goodman S. Toward evidence-based medical statistics. 1: The P value fallacy. Ann Intern Med. 1999;130:995–1004.

  Ioannidis JPA. Why most published research findings are false. PLOS. 2005;2:e124. LeLorier J, Grégoire G, Benhaddad A, et al. Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med. 1997;337:536–542. Pereira TV, Horwitz RI, Ioannidis JPA. Empirical evaluation of very large treatment effects of medical interventions. JAMA. 2012;308:1676–1684.

  Smith CS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomised controlled trials. BMJ. 2003;327:1459.

  Varadhan KK, Neal KR, Lobo DN. Safety and efficacy of antibiotics compared with appendectomy for treatment of uncomplicated acute appendicitis: Meta-analysis of randomised controlled trials. BMJ. 2012;344:e2156.

  Willoughby RE Jr, Tieves KS, et al. Survival after treatment of rabies with induction of coma. N Engl J Med. 2005;352:2508-2514.

  Worrall J. Why there’s no cause to randomize. Br J Philos Sci. 2007;58:451–488.

  11. SCIENTIFIC PROGRESS, REVOLUTION, AND MEDICAL REVERSAL

  Arnowitz RA. Making Sense of Illness: Science, Society, and Disease. Cambridge: Cambridge University Press; 1998.

  Jones DS. Broken Hearts: The Tangled History of Cardiac Care. Baltimore, MD: Johns Hopkins University Press; 2013.

  Kahn IA, Mehta NJ. Initial historical descriptions of the angina pectoris. J Emerg Med. 2002;22:295–298.

  Kuhn T. The Structure of Scientific Revolutions. 3rd ed. Chicago, IL: University of Chicago Press; 1996.

  Kureshi F, Jones PG, Buchanan DM, et al. Variation in patients’ perceptions of elective percutaneous coronary intervention in stable coronary artery disease: Cross sectional study. BMJ. 2014;349:g5309.

  Nabel, EG, Braunwald E. A tale of coronary artery disease and myocardial infarction. N Engl J Med. 2012;366:54–63.

  12. SOURCES OF FLAWED DATA

  Angell M. The Truth about Drug Companies: How They Deceive Us and What to Do about It. New York, NY. Random House; 2004.

  Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302:2679–2685.

  Eichacker PQ , Natanson C, Danner RL. Surviving sepsis—practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med. 2006;355:1640–1642.

  Jefferson T, Jones M, Doshi P, et al. Oseltamivir for influenza in adults and children: Systematic review of clinical study reports and summary of regulatory comments. BMJ. 2014;348:2545.

  Kesselheim AS, Robertson CT, Myers JA, et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012;367:1119–1127.

  Kumar K, Taylor RS, Jacques L. The effects of spinal cord stimulation in neuropathic pain are sustained: A 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63:762–770.

  Lexchin J, Bero LA, Djulbegovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ. 2003;326:1167.

  Lundh A, Sismondo S, Lexchin J, et al. Industry sponsorship and research outcome. Cochrane Library. www.thecochranelibrary.com/details/file/3994131/MR000033.html.

  Muthuri SG, Venkatesan S, Myles PR, et al. Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A H1N1pdm09 virus infection: A meta-analysis of individual participant data. Lancet Respir Med. 2014;2:395–404.

  Pencina MJ, Navar-Boggan AM, D’Agostino RB, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370:1422–1431.

  Prasad V. Statins, primary prevention, overall mortality. Ann Intern Med. 2014;160:867–869.

  Prasad V, Massey PR, Fojo T. Oral anticancer drugs: How limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients. J Clin Oncol. 2014;32:1620–1629.

  Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979–2012. JAMA. 2009;302:2679–2685.

  13. WHY ARE WE SO ATTRACTED TO FLAWED THERAPIES?

  Carman KL, Maurer M, Yegian JM, et al. Evidence that consumers are skeptical about evidence-based health care. Health Aff. 2010:29;1400–1406.

  Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. N Engl J Med. 2007;357:673–681.

  Hu FB, Li TY, Colditz GA, et al. Television watching and other sedentary behaviors in relation to risk of obesity and type 2 diabetes mellitus in women. JAMA. 2003;289:1785–1791.

  Huedo-Medina TB, Kirsch I, Middlemass J, et al. Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: Meta-analysis of data submitted to the Food and Drug Administration. BMJ. 2012;345:e8343.

  Masters RK, Reither EN, Powers DA, et al. The impact of obesity on US mortality levels: The importance of age and cohort factors in population estimates. Am J Public Health. 2013;103:1895–1901.

  Mitchell JM. Urologists’ use of intensity-modulated radiation therapy for prostate cancer. N Engl J Med. 2013;369:1629–1637.

  Kravitz RL, Epstein RM, et al. Influence of patients’ requests for direct-to-consumer advertised antidepressants: A randomized controlled trial. JAMA. 2005;293:1995–2002.

  Slutsky AS. Improving outcomes in critically ill patients: The seduction of physiology. JAMA. 2009;302:2030–2032.

  14. MEDICAL EDUCATION

  Prasad V. Beyond storytelling in medicine: An encounter based curriculum. Acad Med. 2010;85:794–798.

  Prasad V, Cifu A. A medical burden of proof: Towards a new physician ethic. BioSocieties. 2012;7:72–87.

  15. ACADEMIC MEDICINE

  Brett AS. Coronary assessment before noncardiac surgery: Current strategies are flawed. Circulation. 2008;117:3145–3151.

  Schmitz KH, Ahmed RL, Troxel A, et al. Weight lifting in women with breast-cancer-related lymphedema. N Engl J Med. 2009;361:664–673.

  16. REFORMING THE SYSTEM

  Bleyer AW, Tejada H, Murphy SB, et al. National cancer clinical trials: Children have equal access; adolescents do not. J Adolesc Health. 1997;21:366–373.

  Downs-Canner S, Shaw P. A comparison of clinical trial enrollment between adolescent and young adult (AYA) oncology patients treated at affiliated adult and pediatric oncology centers. J Pediatr Hematol Oncol. 2009;31:927–929.

  Dubner SJ. There’s no such thing as a free appetizer: A new Freakonomics radio podcast. Freakonomics. http://freakonomics.com/2014/06/19/theres-no-such-thing-as-a-free-appetizer-a-new-freakonomics-radio-podcast/

  EJ, Schnipper LE, Kamin DY, et al. The costs of conducting clinical research. J Clin Oncol. 2003;21:4145–4150.

  Lauer MS, D’Agostino RB. The randomized registry trial—the next disruptive technology in clinical research? N Engl J Med. 2013;369:1579–1581.

  Prasad V, Cifu A. A medical burden of proof: Towards a new ethic. BioSocieties. 2012;7:72–87.

  Prasad V, Rho J, Cifu A. The inferior vena cava filter: How could a medical device be so well accepted without any evidence of efficacy? JAMA Intern Med. 2013;173:493–494.

  Sequist LV, Yang JC-H, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31:3327–3334.

  Unger JM, Hershman DL, Albain KS, et al. Patient income level and cancer clinical trial participation. J Clin Oncol. 2013;31:536–542.

  Weiss JP, Parsons LS, Every NR, et al. Does enrollment in a randomized clinical trial lead to a higher cost of routine care? Am Heart J. 2002;143:140–144.

/>   Zhu AX, Kudo M, Assenat E, et al. Effect of everolimus on survival in advanced hepato-cellular carcinoma after failure of sorafenib: The EVOLVE-1 randomized clinical trial. JAMA. 2014;312:57–67.

  17. HOW NOT TO BECOME A VICTIM OF REVERSAL

  Judson TJ, Detsky AS, Press MJ. Encouraging patients to ask questions: How to overcome “white-coat silence.” JAMA. 2013;309:2325–2326.

  18. BEYOND DOGMA

  Grupp SA, Kalos M, Barrett D. Chimeric antigen receptor–modified t cells for acute lymphoid leukemia. N Engl J Med. 2013;368:1509–1518.

  Pneumocystis Pneumonia—Los Angeles. MMWR. 1981;30:1–3.

  Prasad V, Cheung M, Cifu A. Chest pain in the emergency department: The case against our current practice of routine noninvasive testing. Arch Intern Med. 2012;172:1506– 1509.

  Prasad V, Jorgenson J, Ioannidis JP, Cifu A. Observational studies often make clinical practice recommendations: An empirical evaluation of authors’ attitudes. J Clin Epidemiol. 2013;66:361–366.

  INDEX

  abdominal pain, 210–11

  academic medicine, 140, 162–63, 173–82, 183

  excellent academic physician, 182

  patterns of faculty promotion and tenure, 177–80

  superspecialists, 174–75

  thought leaders, 175–76

  useless research, 180–82

  working with industry, 176–77

  ACCORD trial, 33–34

  act now, data later, 149–50

  acupuncture, 25, 69, 71, 72–73, 76, 77

  acute coronary syndromes, 228, 240

  acute respiratory distress syndrome, 230

  acyclovir, 234

  ADVANCE trial, 34

  afatinib, 188n

  Affordable Care Act, 94