Transcript Pharmaceutical promotion

What can be done
about commercial
drug promotion?
Porto Alegre
14 October 2005
Dr Peter Mansfield
Founder, Healthy Skepticism
www.healthyskepticism.org
[email protected]
GP, Dept GP, Adelaide Uni
This talk is different
• My first talk was a jigsaw puzzle of new
pieces that do not fit together.
• This talk is based on my 2 hour seminar
developed over 25 years which is effective
for changing GP’s beliefs and plans at least
initially.
• Thanks for helpful constructive criticism
from Dr Hans Hogerzeil.
2
Topics
A. Problems
1. Bad news
2. Are you influenced?
B. Solutions
1. What can one person do?
2. We need to change the system
3. Healthy Skepticism
3
A1. Bad news
• I will oversimplify because of lack of time.
• Conclusions mostly apply to “average”
doctors so they may not apply to you.
4
Intelligence vs bad news
• "When a man finds a conclusion agreeable,
he accepts it without argument, but when he
finds it disagreeable, he will bring against it
all the forces of logic and reason."
-Thucydides
• But perhaps the conclusion is wrong.
• It is difficult to know.
5
Bad news
•
•
•
•
Doctors are human
Drug companies are companies
We have a system problem
People are being harmed
6
Doctors are human
“Medical men are subject to the same kinds of
stress, the same emotional influences as effect
laymen.
Physicians have, as part of their self image, a
determined feeling that they are rational and
logical, particularly in their choice of
pharmaceuticals.
The advertiser must appeal to this rational
image, and at the same time make a deeper
appeal to the emotional factors which really
influence sales.”
7
Smith MC. Principles of pharmaceutical marketing. Philadelphia: Lea & Febiger 1968
8
9
Companies are companies
“if, indeed, candor (honesty), accuracy,
scientific completeness, [etc] came to be
essential for the successful promotion of
[prescription] drugs, advertising would have
no choice but to comply.”
Garai PR. Advertising and Promotion of Drugs. in: Talalay P. Editor. Drugs in
Our Society. Baltimore: John Hopkins Press; 1964.
10
We have a system problem
• Doctors and drug companies encourage
each other to do the wrong thing in a
vicious cycle.
• If companies over-promote their drugs
effectively, doctors reward them via higher
drug sales.
• If doctors over-prescribe drugs, companies
have more money for gifts and more money
to persuade doctors that they are doing the
right thing.
Sweet M. Doctors and drug companies are locked in “vicious circle”. BMJ Oct
11
2004; 329: 998.
Blame
• Normal to blame individuals/
groups/companies.
• But the main determinate of behavior is the
situation (the system of inputs).
“The situation makes the thief”.
• If we improve the information and
incentives that actors receive then their
behavior is likely to improve.
12
People
are
being
harmed
13
Good news
•
•
•
•
The Zeitgeist (the current set of shared
beliefs in society) is changing.
There are some ideas for system reform
that might work.
If so, all will benefit including drug
companies who could have good returns
with lower risk.
There are some simple things that you can
do to be part of the solution.
14
A2. Are you influenced?
Survey of 105 of 117 internal medicine
residents in the USA.
“I am not influenced”: 61%
“Other doctors are not influenced”: 16%
(p< .0001).
Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and
practices of medicine housestaff toward pharmaceutical industry promotions.
Am J Med. 2001 May;110(7):551-7.
15
Promotional meetings
Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician
prescribing patterns: there’s no such thing as a free lunch. Chest 1992;102:270-3.
16
52 Observational studies:
Exposure to promotion
does more harm than good.
Becker MH, Stolley PD, Lasagna L, McEvilla JD, Sloane LM. Differential education concerning
therapeutics and resultant physician prescribing patterns. J Med Educ 1972;47:118-27.
Mapes R. Aspects of British general practitioners’ prescribing. Med Care 1977;15:371-81
Haayer F. Rational prescribing and sources of information. Soc Sci Med 1982;16:2017-23.
Bower AD, Burkett GL. Family physicians and generic drugs: a study of recognition, information
sources, prescribing attitudes, and practices. J Fam Pract 1987;24:612-6.
Cormack MA, Howells E. Factors linked to the prescribing of benzodiazepines by general practice
principals and trainees. Family Practice 1992;9:466-71.
Berings D, Blondeel L, Habraken H. The effect of industry-independent drug information on the
prescribing of benzodiazepines in general practice. Eur J Clin Pharmacol 1994;46:501-505.
Caudill TS, Johnson MS, Rich EC, McKinney WP. Physicians, pharmaceutical sales representatives, and
the cost of prescribing. Arch Fam Med 1996;5:201-6.
Caamano F, Figueiras A, Gestal-Otero JJ. Influence of commercial information on prescription quantity in
primary care. Eur J Public Health. 2002 Sep; 12(3):187-91.
Watkins C, Harvey I, Carthy P, Moore L, Robinson E, Brawn R. Attitudes and behaviour of general
practitioners and their prescribing costs: a national cross sectional survey. Qual Saf Health Care. 2003
17
Feb; 12(1)29-34.
Denial justified by “intelligence”
“Doctors have the intelligence to evaluate
information from a clearly biased source.”
- Dr Rob Walters, ADGP chair
Richards D. Guess who’s coming to dinner. Aust Dr. 2004;23 Jan:19-21
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Denial justified by “education”
“Mr Brindell [corporate affairs manager,
Pfizer Australasia] said doctors, who were
obviously highly educated, could sort the
chaff from the wheat.”
Riggert E. Doctors seduced by drug giants: Drug companies’ tactics spark
rethink by doctors. The Courier Mail. Brisbane 1999;July 26:1-2
19
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Your ability to cope with potentially
misleading promotion depends on your
understanding of:
• Medicine
– Pharmacology, Epidemiology, Public Health, Evidence Based
Medicine, Drug Evaluation, Pharmacovigilance
• Social sciences
– Psychology, Semiotics, Economics, Sociology, Anthropology,
Management, History, Politics, Communication Studies,
• Humanities
– Logic, Rhetoric, Epistemology, Linguistics, Literature, Art
• Marketing
– Product Management, Advertising Account Planning, Public
Relations
• Statistics
21
In their shoes
• You are responsible for promotion of a new
drug that is no better than the old ones but
will be sold at a higher price.
• If you do not succeed you will lose your
job. Because you will not be able to get
such a well paid job elsewhere you and your
family will loose your house.
• What promotional methods will you use?
22
Did you plan to tell:
• the truth?
• (without ambiguity)
• the whole truth?
• and nothing but the truth?
23
Harm for patients
• Some corruption
• A lot of unintended bias
leading to
• A little direct harm from sub-optimal drug
use
• A lot of indirect harm from opportunity
costs
24
Damages
patient’s trust
in health
professionals
25
B Solutions
1. What can one person do?
2. We need to change the system
3. Healthy Skepticism
26
B1. What can one person do?
1. Abstinence (Don’t do it)
or
2. Harm minimisation (Do it but use
protection)
Warning: There are no proven methods
to ensure more benefit than harm from
exposure to drug promotion.
27
Your ability to cope with potentially
misleading promotion depends on your
understanding of:
• Medicine
– Pharmacology, Epidemiology, Public Health, Evidence Based
Medicine, Drug Evaluation, Pharmacovigilance
• Social sciences
– Psychology, Semiotics, Economics, Sociology, Anthropology,
Management, History, Politics, Communication Studies,
• Humanities
– Logic, Rhetoric, Epistemology, Linguistics, Literature, Art
• Marketing
– Product Management, Advertising Account Planning, Public
Relations
• Statistics
28
Methods that mislead
• Omission of relevant information
• Irrelevant information
– Appeals to irrelevant desires and fears
– Wrong question
• Flawed information
–
–
–
–
–
False
Benefits overstated, or Harms understated
Ambiguous
Inappropriate metaphor
Overconfident interpretation
29
Observational studies: Inferior
prescribing is associated with:
• Exposure to promotion
• Positive beliefs about relationships with
drug companies
• Using samples (one RCT)
• Accepting gifts
30
Until we
can fix the
system the
best we
can do is
avoid all
contact
with drug
companies
31
B2. Change the system
a. Improve regulation of drug promotion
b. Improve health care decision making
c. Redesign the incentives for drug
companies
d. Redesign the incentives for health
professionals
32
a) Improve Regulation
• Choose a high priority area. (or a few)
• Focus on regulating that area properly.
• When that area is under control then move
on to the next priority.
33
Regulatory pyramid
Incapacitation
Heavy sanctions
Light sanctions
Notification
Modified from Ayers I. and Braithwaite J. Responsive regulation:
Transcending the Deregulation Debate. Oxford: Oxford University Press
1994
34
Match the response to the cause
Cause of non-compliance
Unable
Regulatory response
Remove
Profit seeking
Costs
Lacks understanding
Lacks knowledge but virtuous
Education /
Restorative justice
Notification / Education
Modified from Braithwaite J. Restorative Justice and Responsive regulation.
Oxford: Oxford University Press 2002
35
b) Improve health care decision
making
• Promotion would improve to match
• But there is a limit to how much humans
with limited resources can be expected to
improve.
36
The best defence doctors can muster against this
kind of advertising is a healthy skepticism and a
willingness, not always apparent in the past, to do
homework.
Doctors must cultivate a flair for spotting the
logical loophole, the invalid clinical trial, the
unreliable or meaningless testimonial, the
unneeded improvement and the unlikely claim.
Above all, doctors must develop greater resistance
to the lure of the fashionable and the new.
Garai PR. Advertising and Promotion of Drugs. in: Talalay P. Editor. Drugs in Our
Society. Baltimore: John Hopkins Press; 1964.
37
Reducing vulnerability to
misleading promotion
Increasing skills
- a little improvement
Increasing perceived personal vulnerability
- a big improvement
Sagarin, B. J.; Cialdini, R. B.; Rice, W. E., and Serna, S. B. Dispelling the illusion
of invulnerability: the motivations and mechanisms of resistance to persuasion. J
Pers Soc Psychol. 2002 Sep; 83(3):526-41.
38
Main educational objective
• To undermine (decrease) selfconfidence
• But not attack self-esteem
39
• Fascinating way to learn
• www.healthyskepticism.org/adwatch.php
• Explains the logical, psychological and
pharmacological techniques in drug ads
• Evidence based recommendations
• Feedback for the AdWatch team, the company
and regulatory agencies.
40
Until we
can fix the
system the
best we
can do is
avoid all
contact
with drug
companies
41
c) Redesign the incentives for drug
companies
Pay separately by open competitive
tender for separate functions
– Manufacturing
– Promotion
– Research
– Education
42
d) Redesign incentives for health
professionals
• Ban all gifts
43
Ban both large and small gifts
www.healthyskepticism.org/library/topics/gifts.php
44
45
B3. Healthy Skepticism
Improving health by
reducing harm from
misleading drug
promotion
www.healthyskepticism.org
46
Methods
• Research, education, advocacy
• Critical appraisal of claims informed by
evidence based medicine, psychology, logic,
economics etc.
47
Media
• www.healthyskepticism.org
– Library 2372 references
•
•
•
•
•
•
Publications
Answer journalists' questions
Meetings
Educational modules
Submissions
Email
48
49
Recent publications
Mansfield PR. Banning all drug promotion is the best option pending major reforms.
J Bioethical Inquiry 2005;2(2):16-22
Harvey KJ, Vitry AI., Aroni R, Ballenden N, Faggotter R. Pharmaceutical
advertisements in prescribing software: an analysis MJA 2005 Jul 18;183(2):75-79
Mansfield PR, Mintzes B, Richards D, Toop L. [editorial] Direct to consumer
advertising. BMJ. 2005 Jan 1;330(7481):5-6.
Mansfield P. Accepting what we can learn from advertising's mirror of desire.
[commentary] BMJ. 2004 Dec 18;329(7480):1487-8.
Mansfield PR, Henry D. Misleading drug promotion-no sign of improvements.
[editorial] Pharmacoepidemiol Drug Saf 2004;13(11):797-9.
Mansfield P, Henry D, Tonkin A. Single-enantiomer drugs: elegant science,
disappointing effects. [editorial] Clin Pharmacokinet 2004;43(5):287-90.
Jureidini JN, Doecke CJ, Mansfield PR, Haby MM, Menkes DB, Tonkin AL. Efficacy
and safety of antidepressants for children and adolescents. BMJ 2004;328:879-83
Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini JN. The ethics of
pharmaceutical industry relationships with medical students. MJA 2004 Apr
19;180(8):411-4.
Svensson S, Mansfield PR. Escitalopram: superior to citalopram or a chiral chimera?
Psychother Psychosom 2004;73(1):10-6.
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Mansfield PR. Healthy Skepticism’s new AdWatch: understanding drug promotion.
MJA 2003;179(11/12):644-645
Educational modules
• with WHO for all medical and pharmacy
schools:
“Understanding and responding to drug
promotion.”
• with Royal Australasian College of
Physicians:
“Update on treatment decision making.”
51
You are invited:
• Free monthly email alerts
• Paid Subscribers AUD$100 / $25
(BRL$ 168 / 42)
• Members
• Contributors to our research, education and
advocacy work
• Local groups
52
Let’s collaborate!
“We are now ready, willing, and able to
collaborate with any governments,
companies, universities, or organisations for
health professionals or consumers who are
interested in improving health while saving
money.”
Mansfield PR, Lexchin J, Vitry A, Doecke CJ, Svensson S. Drug
advertising in medical journals. Lancet. 2003 Mar 8;361(9360):879.
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Healthy Skepticism
Countering misleading
drug promotion
www.healthyskepticism.org
54
Before and after questions for evaluation
of education about drug promotion
• Is it ethically acceptable for you to receive gifts from
drug companies?
• How often is information from drug companies reliable?
• If you are exposed to misleading drug promotion, are
you vulnerable?
• Are your peers, on average, vulnerable to misleading
drug promotion if they are exposed to it?
• From now on, how often will you accept visits from
drug company representatives?
• From now on, how often will you accept gifts from drug
companies?
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