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: When the Facts Aren't True:

What's a Medical Librarian To Do? What's a Medical Librarian To Do?

John Abramson MDJohn Abramson MD

October 29, 2007October 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 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

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 Officer’s 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.




“C[elebrex] did not appear to offer a

unique advantage in high risk patients.”




Annual Cost of Celebrex, Bextra and naproxen

Celebrex Bextra (est.)

Naproxen (Rx)

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

Naproxen (OTC)

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 Officer’s 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 Officer’s 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 2243–2245 Mitka, Mike

United States 56%

United Kingdom 23%

Germany 26%

Netherlands 36%

Italy 17%

Switzerland 29%

CountryPercentage of Eligible Patients Taking Statins

Expanding Statin Use to Help More At-Risk Patients Is Causing Financial Heartburn

[Medical News & Perspectives]

Volume 290(17) 5 November 2003 p 2243–2245 Mitka, Mike

25 million patients worldwide (including about 13 million in the United States) are being treated with statins.

OECD, 2003

OECD, 2003

Morbidity & Mortality: 2002 Chart Book on Cardiovascular, Lung, and Blood Diseases

National Heart, Lung, and Blood Institute; National Institutes of Health

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

Science Science has a distnguished epistemic has a distnguished epistemic standing, but not a privileged one.standing, but not a privileged one.

Susan Haak, Evidence and Inquiry: Towards Reconstruction in Epistemology,

Blackwell Publishers, Oxford, U.K. 1995

Hea

lth L

ife E

xpec

tanc

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ealth

Life

Exp

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Healthy Life Expectancy and Per Person Medical Expenses in 22 OECD

Countries

Per Person Annual Medical ExpensesPer Person Annual Medical Expenses

Hea

lth L

ife E

xpec

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ealth

Life

Exp

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Healthy Life Expectancy and Per Person Medical Expenses in 22 OECD

Countries

Per Person Annual Medical ExpensesPer Person Annual Medical Expenses

Life Expectancy Canada vs. U.S.

1850-2000

Milbank Quarterly 2005; Vol. 83, No. 1

Life

Exp

ecta

ncy

at B

irth

A Three Year View of Overall Ranking

AUSTRALIA CANADA GERMANYNEW

ZEALANDUNITED

KINGDOMUNITEDSTATES

OVERALL RANKING (2007 Edition) 3.5 5 2 3.5 1 6

OVERALL RANKING (2006 Edition) 4 5 1 2 3 6

OVERALL RANKING (2004 Edition) 2 4 n/a 1 3 6

Health Expenditures per Capita, 2004 $2,876* $3,165 $3,005* $2,083 $2,546 $6,102

Commonwealth Fund, May 2007 http://www.commonwealthfund.org/usr_doc/Shea_hltsysperformanceselectednations_chartpack.ppt?section=4039#130http://www.commonwealthfund.org/usr_doc/Shea_hltsysperformanceselectednations_chartpack.ppt?section=4039#130



ZEALANDUNITED

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ZEALANDUNITED

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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, 1982

The 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; 290:921-928

…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.

Association of Funding and Conclusions in Randomized Drug Trial

Als-Neilsen B, Chen W, Gluud C, Kiaergard LL, JAMA, 2003; 290:921-928

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.

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 journals—Annals of InternalMedicine, 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, 2005:2:364-366Richard 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.pdfhttp://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 Analatos

BMJ 2006;332;1061-1064

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

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, Lawrence K. Altman MD, New York Times, New York Times, May 2, 2006May 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.

Behavioral Patterns

40%

Genetic Predispositions

30%

Social Circumstances

15%

Shortfalls in Medical Care

10%

Environmental Exposures

5%

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.

I N S T I T U T E O F M E D I C I N E

Shaping the Future for HealthTHE 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 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


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



Selection of older persons for short-term, primarypreventionApproximately two-thirds of first major coronary eventsoccur 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).


Search for Sources Without Commercial BiasSearch for Sources Without Commercial Bias

•FDA Advisory Committee Briefing DocumentsFDA Advisory Committee Briefing Documents

•The Therapeutics Initiative of British ColumbiaThe Therapeutics Initiative of British Columbia

•The National Institute of Clinical Excellence (U.K.)The National Institute of Clinical Excellence (U.K.)

•Drug Effectiveness Research Project (Oregon Health & Drug Effectiveness Research Project (Oregon Health & Science University)Science University)

•Understand that most of our medical knowledge is now Understand that most of our medical knowledge is now produced and disseminated to fulfill primarily commercial produced and disseminated to fulfill primarily commercial goals. (And that Healthcare providers remain reluctant to goals. (And that Healthcare providers remain reluctant to accept the magnitude of the ensuing distortion of scientific accept the magnitude of the ensuing distortion of scientific evidence.)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