Transcript Slide 1

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
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
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
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
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
Annual Cost of Celebrex,
Bextra and naproxen
$1,200
$1,200
$1,200
$1,000
$800
$600
$400
$218
$200
$0
$80.30
1
Celebrex
2
Bextra
(est.)
3
Naproxen
(Rx)
4
Naproxen
(OTC)
Prices from CVS Pharmacy (cvs.com accessed November 1, 2006)
Pharmacoeconomics 2002; 20 (4): 279-287
…
Pharmacoeconomics 2002; 20 (4): 279-287
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]
Percentage of Eligible
Patients Taking Statins
Country
United States
United Kingdom
Germany
Netherlands
Italy
Switzerland
Mitka, Mike
Volume 290(17)
56%
23%
26%
36%
17%
29%
5 November 2003
p 2243–2245
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
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 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
HealthyHEALTHY
Life Expectancy
and
Per
Person
LIFE EXPECTANCY AND PER PERSON
Medical
Expenses
in 22
OECD
MEDICAL
EXPENDITURES
FOR
22 OECDCountries
COUNTRIES
76.0
Japan
Healthy Life Expectancy 2002
Health Life Expectancy
75.0
74.0
Sweden
Switzerland
73.0
72.0
71.0
70.0
69.0
68.0
$0
$1,000
$2,000
$3,000
$4,000
$5,000
Per Person
Health Care
Expenditures
2001
Per Person
Annual
Medical
Expenses
$6,000
Healthy Life Expectancy and Per Person
Medical Expenses in 22 OECD Countries
76.0
Japan
Healthy Life Expectancy 2002
Health Life Expectancy
75.0
74.0
Sweden
Switzerland
73.0
72.0
71.0
70.0
United States
69.0
68.0
$0
$1,000
$2,000
$3,000
$4,000
$5,000
Per Person
Health Care
Expenditures
2001
Per Person
Annual
Medical
Expenses
$6,000
Life Expectancy Canada vs. U.S.
Life Expectancy at Birth
1850-2000
Milbank Quarterly 2005; Vol. 83, No. 1
A Three Year View of Overall Ranking
AUSTRALIA
CANADA
GERMANY
NEW
ZEALAND
UNITED
KINGDOM
UNITED
STATES
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#130
A Three Year View of Overall Ranking
AUSTRALIA
CANADA
GERMANY
NEW
ZEALAND
UNITED
KINGDOM
UNITED
STATES
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#130
A Three Year View of Overall Ranking
AUSTRALIA
CANADA
GERMANY
NEW
ZEALAND
UNITED
KINGDOM
UNITED
STATES
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#130
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.
Medical Knowledge has been
Transformed from a Public Good
into a Commodity
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
Craig Lambert, “Flasks of Cash: Doctored Research,” November-December 2003
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
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
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
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
For Science’s Gatekeepers,
A Credibility Gap
“Journals have devolved into informationlaundering 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
Myth
# 2: Health
Care
Resources
Allocation
of Health
Care
Resourcesare
the U.
S.
Allocated toinBest
Improve
Health
Populationwide
Approaches to
Health
Improvement, 5%
Direct Medical
Care Services,
95%
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.
Shortfalls in
Medical Care
10%
Environmental
Exposures
5%
Social
Circumstances
15%
Behavioral
Patterns
40%
Genetic
Predispositions
30%
McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy
attention to health promotion. Health Affairs. 2002;21(2):78-93.
INSTITUTE OF
MEDICINE
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
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)
Adapted from NCEP Report, 2001
Adapted from NCEP Report, 2001
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
Adapted from NCEP Report, 2001
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.)
The Need for a New Medical Model:
A Challenge for Biomedicine
“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.]