Transcript Slide 1

Commercial myths, drug
promotion, and public
health: 1981 to 2006
Barbara Mintzes
Health Action International (HAI Europe)
Amsterdam, Oct 26-27, 2006
Therapeutics Initiative, University of British Columbia
[email protected]
Major drug disasters linked to regulatory
change were fuelled by promotion
In 1953, DES
(diethylstilbestrol) is
promoted for routine
prophylaxis.
In 1958, Grunenthal launches its new
sleeping pill, Contergan (thalidomide) as
“astonishingly safe… fully harmless.”
Regulation of drug promotion
• In 2004, 89 countries (46%, WHO survey)
reported that they regulated drug promotion
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Often delegated to industry self-regulation
Few resources: for example, in Canada less
than 1 full-time dedicated staff person, no
fines or sanctions since 1978
Pills, Politics and Practice
25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY
Commercial vs. scientific influences on
prescribing behaviour
Avorn et al, American Journal of Medicine 1982
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Physicians reported that they relied on scientific
information sources
At odds with belief in ‘commercial myths’ not
supported by evidence, and prescribing accordingly
Specific cases used: vasodilators for dementia,
dextropropoxyphene for pain
Pills, Politics and Practice
25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY
How much influence do sales representatives
have on your prescribing?
A lot
1%
A little
38%
None
61%
n=102 internal medicine residents
Am J Med 2001; 110:551
How much influence do sales representatives have on
other physicians' prescribing?
None
16%
A lot
51%
A little
33%
n=102 internal medicine residents
Am J Med 2001; 110:551
First systematic review of empirical studies on
effects of promotion: 1994-1999
Wazana, JAMA, 2000
Most outcomes negative:
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Inability to identify inaccurate claims
Rapid adoption of new drugs
Formulary requests for drugs without added value
Increased prescribing volume
Less cost-effective prescribing
One positive outcome in 1 of 29 studies:
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Better knowledge of treatment protocols, complications of Lyme’s
disease (but worse for milder disease).
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1980’s - attention to the need for better
regulation of drug promotion
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1981: HAI forms as network, calls for an
international code of pharmaceutical marketing
1981: IFPMA launches international selfregulatory code
1985: WHO Nairobi Conference, Revised Drug
Strategy – emphasis on rational drug use
Pills, Politics and Practice
25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY
WHO Ethical Criteria for Medicinal Drug
Promotion, 1988
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First international ethical standard
Aim is to support rational drug use, public health
 Specific types of information must be provided in advertising
 Promotion should not take advantage of concern for health
 Should not be disguised as education or science
 Generally, direct-to-consumer advertising of prescription
drugs should not be allowed.
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25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY
“The main objective … is to support
and encourage the improvement of
health care through the rational use
of drugs.”
- WHO
Ethical Criteria for Medicinal Drug Promotion
Pills, Politics and Practice
25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY
Problem Drugs, promotion of irrational use, early 1990’s
South Africa 2003
Schering points her in the
direction of an unnecessarily
risky product, no warnings of
harm from menopausal
hormone treatments.
Brazil 2004
Boehringer
Ingelheim ad for
dipyrone drops:
“Ping-ping against
pain – No Pingping in your
purse”
-BUKO PharmaKampagne, 2004
Study of promotional materials
for GPs in Pakistan:
Bromazepam (anti-anxiety)
claim: restores confidence
Buclizine (anti-histamine)
appetite stimulation and weight
gain in anorexic children.
- Rohra et al, J Pharm Pharm Market 2006
Problem Drugs, promotion of irrational use, early 2000’s
“…claims concerning medicinal drugs
should …not contain misleading or
unverifiable statements or omissions
likely to induce medically unjustifiable
drug use or to give rise to undue risks.”
- WHO
Ethical Criteria for Medicinal Drug Promotion
Pills, Politics and Practice
25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY
Vioxx (rofecoxib)
Direct-to-consumer
advertising and
public health
Vioxx (rofecoxib): science vs. marketing 1999 to 2004
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More than $550 million spent on DTCA
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No more effective than alternatives
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U.S. FDA Warning letter, 2001: stop misrepresenting risks
Strong evidence of cardiac risks since 2000, VIGOR trial
Global withdrawal September 2004
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88,000-140,000 extra heart attacks in U.S. (Graham et al. 2005)
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U.S. Congressional investigation uncovers company memos for
sales representatives: avoid discussing cardiac risks
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A conservative estimate: 10,000 extra death due to DTCA
Pills, Politics and Practice
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Age and sex standardised prevalence of the use of NSAIDs and
hospitalisation rates for upper gastrointestinal haemorrhage over time
among elderly people in Ontario
Mamdani, M. et al. BMJ 2004;328:1415-1416
Copyright ©2004 BMJ Publishing Group Ltd.
The role of physician ‘opinion leaders’
Physicians who attended sponsored presentations by
another physician wrote an additional $623.55 worth of
prescriptions in the next year versus non-attendees.
More intimate discussions were even more effective
(average $717.53 extra sales per physician).
From an internal Merck document, in: Caplovitz A. Turning Medicine into
snake oil. NJPIRG Law & Policy Center, 2006. www.njpirg.org
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Is Vioxx a ‘red herring’?
Early 1980’s – first US DTCA campaigns
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1982: Lilly marketed the arthritis drug benoxaprofen aggressively to
U.S. public and physicians (500,000 prescriptions in a few months)
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1982: Withdrawn 5 months later, liver injuries & deaths
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1983-1985: US FDA moratorium on DTCA
US regulatory experience 2001 to 2005
• Notices of violation for 148 DTC ads, 334 claims
• 137 exaggerated effectiveness or falsely claimed superiority
• 105 minimized or omitted information on harmful effects
• 65 promoted drugs for unapproved uses
Caplovitz A. Turning Medicine into snake oil. NJPIRG Law & Policy Center, 2006.
www.njpirg.org
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“Scientific and educational
activities should not be deliberately
used for promotional purposes.”
- WHO
Ethical Criteria for Medicinal Drug Promotion
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Eli Lilly and the ‘Surviving Sepsis’ campaign
Eichacker et al, New England Journal of Medicine, Oct 19, 2006
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“…because rhAPC [drotrecogine, Xigris] was relatively expensive,
word would be spread that physicians were being "systematically
forced" to decide who would live and who would die.”
$1.8 million unrestricted educational grant for Task Force on “Values,
Ethics and Rationing in Critical Care”
Support for ‘Surviving Sepsis’ Campaign
Funding of treatment guidelines favourable to rhAPC, omitted
negative trial results or risks of serious bleeds.
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“Gabapentin [Neurontin] was promoted by using education and
research, activities not typically recognized as promotional.
“independent” continuing medical education, “peer-to-peer”
selling by physician speakers, and publications…”
Approved use
Prescriptions for gabapentin by diagnostic category
Steinman, M. A. et. al. Ann Intern Med 2006;145:284-293
Canada journal ad
Comparative
clinical
significance
has not been
established.
US DTCA: for a
free trial offer
US $1 billion spent on DTCA for
esomeprazole (Nexium) 2000 to 2005
Global sales in 2003: US $3.8 billion
http://www.astrazeneca.com/sites/7/archive/Investors/Presentations/2004/astrazeneca-2004-abrcarolyn-fitzsimons-nexium.pdf
What these advertisements do not say
“Published comparative trials…used
approximately 2 to 4-fold higher equivalent
doses of esomeprazole (Nexium) than the
comparator drug. No trials have demonstrated
an intrinsic therapeutic advantage …at
equivalent doses.”
- http://www.ti.ubc.ca/pages/letter45.htm
Esomeprazole is essentially the same molecule as
omeprazole (Losec or Prilosec), one of two orientations
in space (the ‘s-isomer’ or ‘s-omeprazole’). Both are
metabolized into the same active substance.
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Tom Toles The Buffalo News, reprinted in the NY Times, June 9, 2002
In conclusion
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The WHO Ethical Criteria remain an important international
standard linked to public health; a standard that is mainly
honoured in the breach.
Regulation of promotion remains inadequate, with little to no
monitoring, corrective actions or sanctions
Key shifts: increased financial ties industry-medicine, growth in
DTCA, new forms of promotion
No regulatory response when the media (or courts elsewhere)
uncover scientific misconduct
Public drug payers and health service providers could play a
much stronger role.
Pills, Politics and Practice
25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY