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When the Facts Aren't True: What's a Medical Librarian To Do? John Abramson MD October 29, 2007

When the Facts Aren't True: What's a Medical Librarian To Do? John Abramson MD October 29, 2007. THE COXIBS, SELECTIVE INHIBITORS OF CYCLOOXYGENASE-2

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When the Facts Aren't True: What's a Medical Librarian To Do? John Abramson MD October 29, 2007

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  1. When the Facts Aren't True: What's a Medical Librarian To Do? John Abramson MD October 29, 2007

  2. THE COXIBS, SELECTIVE INHIBITORS OF CYCLOOXYGENASE-2 The difference in major cardiovascular events in the VIGOR trial may reflect the play of chance. The end point was prespecified, and the difference in the frequency of events was statistically significant, but the absolute number of cardiovascular events was small (less than 70).

  3. Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial COMMENT This study determined that celecoxib, a COX-2–specific inhibitor, when used for 6 months…is associated with a lower incidence of combined clinical upper GI events than comparator NSAIDs (ibuprofen and diclofenac) used at standard therapeutic dosages…. JAMA.2000;284:1247-1255

  4. Submission date: June 12, 2000 Reviewer: Lawrence Goldkind M.D. Medical Officer’s GI Review of CLASS Summary comments on statistical plan The sponsor has not adequately justified the value of an analysis limited to 6-month data nor adequately justified replacing the original analysis with this post hoc analysis. http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.doc

  5. Submission date: June 12, 2000 Reviewer: Lawrence Goldkind M.D. Medical Officer’s GI Review of CLASS Overall Conclusions The sponsor has failed to demonstrate a statistically significant lower rate of CSUGIEs (traditional or alternate) compared to NSAIDs as a group or either individual comparator. http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.doc

  6. Submission date: June 12, 2000 Reviewer: Lawrence Goldkind M.D. Medical Officer’s GI Review of CLASS “C[elebrex] did not appear to offer a unique advantage in high risk patients.” http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.doc

  7. Annual Cost of Celebrex, Bextra and naproxen Celebrex Naproxen (Rx) Naproxen (OTC) Bextra (est.) Prices from CVS Pharmacy (cvs.com accessed November 1, 2006)

  8. Pharmacoeconomics 2002; 20 (4): 279-287

  9. … Pharmacoeconomics 2002; 20 (4): 279-287

  10. Pharmacoeconomics 2002; 20 (4): 279-287

  11. Hugo E. Gallo-Torres, M.D., Ph.D., Medical Team Leader, Division of Gastrointestinal and Coagulation Drug Products, Medical Officer’s Review, NDA 21-153, September 21, 2000, p. 3

  12. Hugo E. Gallo-Torres, M.D., Ph.D., Medical Team Leader, Division of Gastrointestinal and Coagulation Drug Products, Medical Officer’s Review, NDA 21-153, September 21, 2000, p. 90

  13. Expanding Statin Use to Help More At-Risk Patients Is Causing Financial Heartburn [Medical News & Perspectives] Percentage of Eligible Patients Taking Statins Country Mitka, Mike Volume 290(17)             5 November 2003             p 2243–2245

  14. Expanding Statin Use to Help More At-Risk Patients Is Causing Financial Heartburn [Medical News & Perspectives] 25 million patients worldwide (including about 13 million in the United States) are being treated with statins. Mitka, Mike Volume 290(17)             5 November 2003             p 2243–2245

  15. OECD, 2003

  16. OECD, 2003

  17. Morbidity & Mortality: 2002 Chart Book on Cardiovascular, Lung, and Blood Diseases National Heart, Lung, and Blood Institute; National Institutes of Health

  18. Banks J, Marmot M, Oldfield Z, Smith JP, JAMA. 2006;295:2037-2045

  19. Science has a distnguished epistemic standing, but not a privileged one. Susan Haak, Evidence and Inquiry: Towards Reconstruction in Epistemology, Blackwell Publishers, Oxford, U.K. 1995

  20. Healthy Life Expectancy and Per Person Medical Expenses in 22 OECD Countries Health Life Expectancy Per Person Annual Medical Expenses

  21. Healthy Life Expectancy and Per Person Medical Expenses in 22 OECD Countries Health Life Expectancy Per Person Annual Medical Expenses

  22. Life Expectancy Canada vs. U.S. 1850-2000 Life Expectancy at Birth Milbank Quarterly 2005; Vol. 83, No. 1

  23. A Three Year View of Overall Ranking Commonwealth Fund, May 2007 http://www.commonwealthfund.org/usr_doc/Shea_hltsysperformanceselectednations_chartpack.ppt?section=4039#130

  24. A Three Year View of Overall Ranking Commonwealth Fund, May 2007 http://www.commonwealthfund.org/usr_doc/Shea_hltsysperformanceselectednations_chartpack.ppt?section=4039#130

  25. A Three Year View of Overall Ranking Commonwealth Fund, May 2007 http://www.commonwealthfund.org/usr_doc/Shea_hltsysperformanceselectednations_chartpack.ppt?section=4039#130

  26. More Medicine Is Not Better Medicine By ELLIOTT S. FISHER Our study suggests that perhaps a third of medical spending is now devoted to services that don't appear to improve health or the quality of care — and may make things worse.

  27. Medical Knowledge has been Transformed from a Public Goodinto a Commodity

  28. The Academic-Industrial Complex “Scientists who 10 years ago would have snubbed their academic noses at industrial money now eagerly seek it out.” Barbara Culliton, “The Academic-Industrial Complex,” Science 216:960-962, 1982

  29. Craig Lambert, “Flasks of Cash: Doctored Research,” November-December 2003

  30. Association of Funding and Conclusions in Randomized Drug Trial …trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3) compared with trials funded by nonprofit organizations. Als-Neilsen B, Chen W, Gluud C, Kiaergard LL, JAMA, 2003; 290:921-928

  31. Association of Funding and Conclusions in Randomized Drug Trial Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data. Als-Neilsen B, Chen W, Gluud C, Kiaergard LL, JAMA, 2003; 290:921-928

  32. The evidence is strong that companies are getting the results they want, and this is especially worrisome because between two-thirds and three quarters of the trials published in the major journals—Annals of Internal Medicine, JAMA, Lancet, and New England Journal of Medicine—are funded by the industry. Richard Smith (former editor of British Medical Journal), Public Library of Science, 2005:2:364-366 http://medicine.plosjournals.org/archive/1549-1676/2/5/pdf/10.1371_journal.pmed.0020138-L.pdf

  33. Between 1999 and 2004, 31of the 32 most frequently cited trials published were funded by industry Nikolaos A Patsopoulos, John P A Ioannidis and Apostolos A Analatos BMJ 2006;332;1061-1064

  34. For Science’s Gatekeepers, A Credibility Gap “Journals have devolved into information-laundering operations for the pharmaceutical industry, say Dr. Richard Smith, the former editor of BMJ, and Dr. Richard Horton, the editor of the Lancet...” Lawrence K. Altman MD, New York Times, May 2, 2006

  35. Allocation of Health Care Resourcesin the U. S. McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy attention to health promotion. Health Affairs. 2002;21(2):78-93.

  36. Determinants of Health in the U.S. McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy attention to health promotion. Health Affairs. 2002;21(2):78-93.

  37. I N S T I T U T E O F M E D I C I N E Shaping the Future for Health THE FUTURE OF THE PUBLIC’S HEALTH IN THE 21ST CENTURY There is strong evidence that behavior and environment are responsible for over 70 percent of avoidable mortality, and health care is just one of several determinants of health. Institute of Medicine

  38. While ATP III maintains attention to intensive treatment of patients with CHD, its major new feature is a focus on primary prevention in persons with multiple risk factors. Adapted from NCEP Report, 2001

  39. In recent trials, statin therapy reduced risk for CHD in men and women, in those with or without heart disease… (Table II.2–3) Adapted from NCEP Report, 2001

  40. Adapted from NCEP Report, 2001

  41. Selection of older persons for short-term, primary prevention Approximately two-thirds of first major coronary events occur in persons ≥ 65 years…Recent clinical trials have revealed that aggressive LDL-lowering therapy is effective in reducing risk for CHD (see Table II.2–3). Adapted from NCEP Report, 2001

  42. Adapted from NCEP Report, 2001

  43. Search for Sources Without Commercial Bias • FDA Advisory Committee Briefing Documents • The Therapeutics Initiative of British Columbia • The National Institute of Clinical Excellence (U.K.) • Drug Effectiveness Research Project (Oregon Health & Science University) • Understand that most of our medical knowledge is now produced and disseminated to fulfill primarily commercial goals. (And that Healthcare providers remain reluctant to accept the magnitude of the ensuing distortion of scientific evidence.)

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