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 MDOctober 29, 2007

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).

Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled TrialCOMMENT This study determined that celecoxib, a COX-2specific inhibitor, when used for 6 monthsis 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

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. Medical Officers GI Review of CLASS

Submission date: June 12, 2000Reviewer: Lawrence Goldkind M.D.http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.doc

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. Submission date: June 12, 2000Reviewer: Lawrence Goldkind M.D.http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.doc Medical Officers GI Review of CLASS

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

Annual Cost of Celebrex, Bextra and naproxenCelebrexBextra (est.)

Naproxen (Rx)Prices from CVS Pharmacy (cvs.com accessed November 1, 2006)Naproxen (OTC)

bextra celebrex naproxen

1200

1200

218

80.3

Sheet1

$1,200

$1,200

$218

$80.30

Sheet2

Sheet3

Pharmacoeconomics 2002; 20 (4): 279-287

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

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

Expanding Statin Use to Help More At-Risk Patients Is Causing Financial Heartburn[Medical News & Perspectives]Volume 290(17) 5 November 2003 p 22432245 Mitka, Mike CountryPercentage of Eligible Patients Taking Statins

United States56%United Kingdom23%Germany26%Netherlands36%Italy17%Switzerland29%

Expanding Statin Use to Help More At-Risk Patients Is Causing Financial Heartburn[Medical News & Perspectives]Volume 290(17) 5 November 2003 p 22432245 Mitka, Mike 25 million patients worldwide (including about 13 million in the United States) are being treated with statins.

OECD, 2003

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

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

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

Health Life ExpectancyHealthy Life Expectancy and Per Person Medical Expenses in 22 OECD CountriesPer Person Annual Medical Expenses

HALE 2002 BY PP EXPENDITURES 20

74.9934705073

73.3228362999

73.1670461711

72.8482847534

72.7056780774

72.5857001517

72.5743950458

72.034653152

71.9946549885

71.9744620334

71.8190049456

71.510567577

71.4113158329

71.1675088293

71.1253977202

71.0921233168

71.0120675572

70.8328116546

70.617118153

69.8470502285

69.7959038633

Japan

Sweden

Switzerland

HEALTHY LIFE EXPECTANCY AND PER PERSON MEDICAL EXPENDITURES

Per Person Health Care Expenditures 2001

Healthy Life Expectancy 2002

HEALTHY LIFE EXPECTANCY AND PER PERSON MEDICAL EXPENDITURES FOR 22 OECD COUNTRIES

Sheet1

http://www.who.int/whr/2003/annex_4_en.xlsACCESSED 5/0904

COUNTRYHALE 2002PP EXP 2001

Japan75.0$1,984

Sweden73.3$2,270

Switzerland73.2$3,248

Iceland72.8$2,643

Italy72.7$2,212

Australia72.6$2,350

Spain72.6$1,600

Canada72.0$2,792

Norway72.0$3,012

France72.0$2,561

Germany71.8$2,808

Luxembourg71.5$2,719

Austria71.4$2,191

Netherlands71.2$2,625

Belgium71.1$2,490

Finland71.1$1,841

Greece71.0$1,511

New Zealand70.8$1,733

United Kingdom70.6$1,992

Denmark69.8$2,503

Ireland69.8$1,935

United States of America69.3$4,887

average no czech71.7

MEDIAN with czech71.5$2,350

MEAN with czech71.6$2,392

Czech Republic68.4$1,106

Sheet2

Sheet3

Health Life ExpectancyHealthy Life Expectancy and Per Person Medical Expenses in 22 OECD CountriesPer Person Annual Medical Expenses

HALE 2002 BY PP EXPENDITURES 20

74.9934705073

73.3228362999

73.1670461711

72.8482847534

72.7056780774

72.5857001517

72.5743950458

72.034653152

71.9946549885

71.9744620334

71.8190049456

71.510567577

71.4113158329

71.1675088293

71.1253977202

71.0921233168

71.0120675572

70.8328116546

70.617118153

69.8470502285

69.7959038633

69.2642089947

Japan

Sweden

Switzerland

United States

HEALTHY LIFE EXPECTANCY AND PER PERSON MEDICAL EXPENDITURES

Per Person Health Care Expenditures 2001

Healthy Life Expectancy 2002

Sheet1

http://www.who.int/whr/2003/annex_4_en.xlsACCESSED 5/0904

COUNTRYHALE 2002PP EXP 2001

Japan75.0$1,984

Sweden73.3$2,270

Switzerland73.2$3,248

Iceland72.8$2,643

Italy72.7$2,212

Australia72.6$2,350

Spain72.6$1,600

Canada72.0$2,792

Norway72.0$3,012

France72.0$2,561

Germany71.8$2,808

Luxembourg71.5$2,719

Austria71.4$2,191

Netherlands71.2$2,625

Belgium71.1$2,490

Finland71.1$1,841

Greece71.0$1,511

New Zealand70.8$1,733

United Kingdom70.6$1,992

Denmark69.8$2,503

Ireland69.8$1,935

United States of America69.3$4,887

average no czech71.7

MEDIAN with czech71.5$2,350

MEAN with czech71.6$2,392

Czech Republic68.4$1,106

Sheet2

Sheet3

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

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

AUSTRALIACANADAGERMANYNEW ZEALANDUNITEDKINGDOMUNITEDSTATESOVERALL RANKING (2007 Edition)3.5523.516OVERALL RANKING (2006 Edition)451236OVERALL RANKING (2004 Edition)24n/a136Health Expenditures per Capita, 2004$2,876*$3,165$3,005*$2,083$2,546$6,102

More Medicine Is Not Better MedicineBy 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.

Medical Knowledge has been Transformed from a Public Good into a Commodity

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, 1982The Academic-Industrial Complex

Craig Lambert, Flasks of Cash: Doctored Research, November-December 2003

Association of Funding and Conclusions in Randomized Drug Trial Als-Neilsen B, Chen W, Gluud C, Kiaergard LL, JAMA, 2003; 290:921-928trials 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.

Association of Funding and Conclusions in Randomized Drug Trial Als-Neilsen B, Chen W, Gluud C, Kiaergard LL, JAMA, 2003; 290:921-928Conclusions 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.

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

Nikolaos A Patsopoulos, John P A Ioannidis and Apostolos A AnalatosBMJ 2006;332;1061-1064

Between 1999 and 2004, 31of the 32 most frequently cited trials published were funded by industry

For Sciences 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

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

pie 1

0.4

0.3

0.15

0.1

0.05

Behavioral Patterns Genetic Predispositions Social Circumstances Shortfalls in Medical Care Environmental Exposures

Determinants of Health in the US

pie 2

0.4

0.3

0.15

0.1

0.05


allocation of resources

0.95

0.05

Allocation of Health Care Resources

Myth # 2: Health Care Resources areAllocated to Best Improve Health

Populationwide Approaches to Health Improvement, 5%

Sheet1

Behavioral PatternsGenetic PredispositionsSocial CircumstancesShortfalls in Medical CareEnvironmental Exposures

40%30%15%10%5%

Direct Medical Care ServicesPopulationwide Approaches to Health Improvement

95%5%

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

pie 1

0.4

0.3

0.15

0.1

0.05

Behavioral Patterns Genetic Predispositions Social Circumstances Shortfalls in Medical Care Environmental Exposures

pie 2

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Behavioral PatternsGenetic PredispositionsSocial CircumstancesShortfalls in Medical CareEnvironmental Exposures

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I N S T I T U T E O F M E D I C I N EShaping the Future for HealthTHE FUTURE OF THE PUBLICS HEALTHIN THE 21ST CENTURYThere 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

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

Adapted from NCEP Report, 2001In recent trials, statin therapy reduced risk for CHD in men and women, in those with or without heart disease(Table II.23)

Adapted from NCEP Report, 2001

Adapted from NCEP Report, 2001Selection of older persons for short-term, primarypreventionApproximately two-thirds of first major coronary eventsoccur in persons 65 yearsRecent clinical trials have revealed that aggressive LDL-lowering therapy is effective in reducing risk for CHD (see Table II.23).

Adapted from NCEP Report, 2001

Search for Sources Without Commercial Bias

FDA Advisory Committee Briefing DocumentsThe Therapeutics Initiative of British ColumbiaThe 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.)

The historical fact we have to face is that in modern Western society biomedicine not only has provided a basis for the scientific study of disease, it has also become our own culturally specific perspective about disease, that is, our folk model. Indeed the biomedical model is now the dominant folk model of disease in the Western world.

--George Engel MD. [Engel GL. The need for a new medical model: A challenge for biomedicine. Science. 1977;196(4286):129-136.]The Need for a New Medical Model:A Challenge for Biomedicine

*Pravastatin and the risk of stroke: 5/6 male, average age 62Women 26% more, >70 21% more, no aspirin 20% more

******Celebrex and bextra cost 15 times what generic otc naproxen costs******NNT = 45 for 5 years*NNT = 45 for 5 years*NNT = 45 for 5 years*Data from 2000, eligibility defined by criteria in 1993 guidelines*****So what explains the 1 year increase in heart attack victims longevity seen with all of the technological advances.TRUE, TRUE AND UNRELATED**Pravastatin and the risk of stroke: 5/6 male, average age 62Women 26% more, >70 21% more, no aspirin 20% more

***** 2003 dataSource: Calculated by Commonwealth Fund based on the Commonwealth Fund 2004 International Health Policy Survey, the Commonwealth Fund 2005 International Health Policy Survey of Sicker Adults, the 2006 Commonwealth Fund International Health Policy Survey of Primary Care Physicians; the Commonwealth Fund Commission on a High Performance Health System National Scorecard; K. Davis, C. Schoen, S.C. Schoenbaum, A.J. Audet, M.M. Doty, and K. Tenney, Mirror, Mirror on the Wall: Looking at the Quality of American Health Care through the Patient's Lens (New York: The Commonwealth Fund, Jan. 2004); and K. Davis, C. Schoen, S. C. Schoenbaum, A. J. Audet, M. M. Doty, A. L. Holmgren, and J. L. Kriss, Mirror, Mirror on the Wall: An Update on the Quality of American Health Care Through the Patient's Lens (New York: The Commonwealth Fund, Apr. 2006).

** 2003 dataSource: Calculated by Commonwealth Fund based on the Commonwealth Fund 2004 International Health Policy Survey, the Commonwealth Fund 2005 International Health Policy Survey of Sicker Adults, the 2006 Commonwealth Fund International Health Policy Survey of Primary Care Physicians; the Commonwealth Fund Commission on a High Performance Health System National Scorecard; K. Davis, C. Schoen, S.C. Schoenbaum, A.J. Audet, M.M. Doty, and K. Tenney, Mirror, Mirror on the Wall: Looking at the Quality of American Health Care through the Patient's Lens (New York: The Commonwealth Fund, Jan. 2004); and K. Davis, C. Schoen, S. C. Schoenbaum, A. J. Audet, M. M. Doty, A. L. Holmgren, and J. L. Kriss, Mirror, Mirror on the Wall: An Update on the Quality of American Health Care Through the Patient's Lens (New York: The Commonwealth Fund, Apr. 2006).

** 2003 dataSource: Calculated by Commonwealth Fund based on the Commonwealth Fund 2004 International Health Policy Survey, the Commonwealth Fund 2005 International Health Policy Survey of Sicker Adults, the 2006 Commonwealth Fund International Health Policy Survey of Primary Care Physicians; the Commonwealth Fund Commission on a High Performance Health System National Scorecard; K. Davis, C. Schoen, S.C. Schoenbaum, A.J. Audet, M.M. Doty, and K. Tenney, Mirror, Mirror on the Wall: Looking at the Quality of American Health Care through the Patient's Lens (New York: The Commonwealth Fund, Jan. 2004); and K. Davis, C. Schoen, S. C. Schoenbaum, A. J. Audet, M. M. Doty, A. L. Holmgren, and J. L. Kriss, Mirror, Mirror on the Wall: An Update on the Quality of American Health Care Through the Patient's Lens (New York: The Commonwealth Fund, Apr. 2006).

***********Where does all the money go?*****POSCH: Ileal bypass surgery for secondary prevention. CARE, LIPID, 4S, PLAC1, and CCAIT are all secondary prevention. ****6 are secondary prvention. POSCH, VAHIT, CARE, LIPID, PLAC1, CCAITUpjohn is from 1978long before statins, average age was 51, WOSCOPS had no-one over 65AFCAPS is the only primary prevention study that had patients over 65*Dr. Drazen says journal editors are "just the middleman in picking what goes out there" and "when there are problems the onus lies with" authors to sound the alert. "If you ask me, it is none of our concern about whether [Vioxx] is a cardiovascular risk in the patients that are on trial," he says. The concern was making sure what was published was correct, he says, and "people could have set the record straight."**95% OF HEALTH CARE RESOURCES GOING INTO BIOMEDICAL CARE

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

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