Panorama da Propaganda de
Medicamentos: Aspectos Legais e
Outras Experiências
Healthy Skepticism about
regulation of drug promotion in
Australia
Brasilia
5 April 2005
Dr Peter R Mansfield
peter.mansfield@adelaide.edu.au
Healthy Skepticism
www.healthyskepticism.org
Topics
1.
2.
3.
4.
5.
Thank you
Introduction to Healthy Skepticism
The problem
Current regulation in Australia
Ideas for better regulation
2
1. Thank you
• Traditional owners
• ANVISA and PAHO
• My family, employer and Healthy Skepticism
especially A/Prof Chris Doecke
• Brazilian Embassy in Canberra
• Translators
• Audience
• Brazilian Citizens
3
2. Introduction to Healthy Skepticism
Countering misleading
drug promotion
www.healthyskepticism.org
4
History
• 1981-82 Bangladesh
• MaLAM (Medical Lobby for Appropriate
Marketing)
• Letters to drug companies based on
Amnesty International
• Effective in the 1980s, less so in the 1990s
• Now exploring many strategies
5
“The best defense 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:
6
John Hopkins Press; 1964.
Healthy Skepticism
• Philosophy: Accepting claims that are
justified, rejecting those that are not,
regardless of comfort.
• Aim: Improving health by reducing harm
from misleading drug promotion.
• Methods: Research, education and
advocacy.
7
Recent major publications 1
Mansfield PR, Vitry AI, Wright JM. [letter] Withdraw all COX-2selective drugs. MJA 2005; 182 (4):197.
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.
Jureidini J, Tonkin A, Mansfield PR. [letter] TADS study raises
concerns. BMJ. 2004 Dec 4;329:1343-4.
Allen K, Mansfield P. Changing attitudes to 'the change'. Aust Fam
Physician. 2004 Nov;33(11):939-40.
Mansfield PR, Henry D. Misleading drug promotion-no sign of
improvements. [editorial] Pharmacoepidemiol Drug Saf
2004;13(11):797-9.
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.
8
Recent major publications 2
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
Svensson S, Mansfield PR. Escitalopram: superior to citalopram or a
chiral chimera? Psychother Psychosom 2004 Jan-Feb;73(1):106.
Mansfield PR. Healthy Skepticism’s new AdWatch: understanding
drug promotion. MJA 2003; 179 (11/12): 644-645
Jureidini J, Mansfield P, Menkes D The statin wars. [letter] Lancet
2003 Nov 29; 362(9395)1854
Katz D, Mansfield P, Goodman R, Tiefer L, Merz J. Psychological
aspects of gifts from drug companies. [letter] JAMA 2003 Nov
12;290(18):2404-5
9
Harry Potter 3: Professor Lupin
• Poor but honest
• Defense against the dark arts teacher
10
The Matrix 1: Morpheus’ choice for Neo
Believe what suits you or face the evidence
11
Bad news
1.
2.
3.
4.
5.
6.
Doctors are human
Drug companies are companies
We have a system problem
People are being harmed
No proven solutions
No one solution will be enough alone
12
Good news
• There are ideas for solutions supported by
evidence from other fields
• Some solutions may be sufficient alone but
still necessary thus worthwhile
• The zeitgeist is changing
• Perhaps we are near a tipping point
13
Beware attribution errors
• Not very useful to blame individuals or
companies.
• The main determinate of behavior is the
situation.
• If we improve the information and
incentives that the actors receive then their
behavior may improve.
14
Treat the cause (main causes)
• Drug companies are rewarded for increasing
sales regardless of impact on health.
• Doctors are human decision makers who are
vulnerable to being misled.
• Drug companies are rewarded if they
mislead.
• They can feel better if they believe their
own propaganda via groupthink.
15
Adelaide
16
17
Visitors to
www.healthyskepticism.org
51% Non-Profit Organisation
17.6% US Commercial
9.6% Network
7.8% Unknown
4.8% Australia
2.5% Brazil
1. 7% Canada
1% US Educational
0.6% United Kingdom
0.3% Netherlands
18
3. The problem
Promotion is a tool for good or ill.
Good to focus on promotion that may increase
inappropriate prescribing and thus do harm.
Direct harm
Opportunity costs
19
Misleading promotion: main types
• False information - Who knows the truth?
• Ambiguous information – Who says what it
means?
• Omission of information – How do you detect it?
• Irrelevant information – How do you prove it is
harmful?
• Triggering short cuts (eg newer if better) - How
do you prove it?
20
Vioxx
being able to
once again
take a
grandchild
for a walk is
a major
victory.
21
Estimated toll from Vioxx
“…the increased risk of 16 events per
1000 patients treated for up to 3 years…
…a potential excess of several thousand
cardiovascular events caused by rofecoxib. This
may represent an underestimate of the number of
events caused by rofecoxib, because patients with
inflammatory arthritis are likely to be at higher
baseline risk of cardiovascular events than the
“low risk” population included in APPROVe.”
Langton PE, Hankey GJ, Eikelboom JW. Cardiovascular safety of rofecoxib (Vioxx): lessons learned and unanswered questions. Med J Aust 2004; 181 (10): 524-525.
22
When you are misled you don’t know it
•
•
•
•
•
Difficult to detect.
Difficult to prove.
Denial by companies and their staff.
Denial by health professionals.
Patients don’t know they have been harmed.
23
Promotion does more harm than good:
Observational studies
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.
Linn LS, Davis MS. Physicians’ orientation toward the legitimacy of drug use and their preferred source of new drug
information. Soc Sci Med 1972;6:199-203.
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.
Ferry ME, Lamy PP, Becker LA. Physicians’ knowledge of prescribing for the elderly: a study of primary care
physicians in Pennsylvania. J Am Geriatr Soc 1985; 33:616-21.
Blondeel L, Cannoodt L, DeMeyeere M, Proesmans H. Prescription behaviour of 358 Flemish general practitioners.
Paper presented at the International Society of General Medicine meeting, Prague, Spring 1987.
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.
Powers R. Time with drug reps affects prescribing. Paper presented at the Society of General Internal Medicine meeting,
1998
24
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000 Jan 19;283(3):373-80
Possible causes
•
•
•
•
•
Profit seeking
Groupthink
Experts
Inertia
Inability
25
Groupthink
26
Profit seeking: evolutionary pressures
• Companies have little choice but to maximise
profits or be taken over by more aggressive
competitors
• Companies are paid more for increasing sales of
more expensive drugs regardless of the impact on
health
• Companies use the methods that are most effective
• If the magnitude and probability of profits exceeds
the magnitude and probability of penalties then
misleading promotion can be expected.
27
“As an advertising man, I can assure
you that advertising which does not
work does not continue to run. If
experience did not show beyond doubt
that the great majority of doctors are
splendidly responsive to current
[prescription drug] advertising, new
techniques would be devised in short
order.”
Garai PR. Advertising and Promotion of Drugs. in: Talalay P. Editor. Drugs in
Our Society. Baltimore: John Hopkins Press; 1964.
28
“And if, indeed, candor, accuracy,
scientific completeness, and a
permanent ban on cartoons 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.
29
The golden handcuffs
30
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 for promotion
reinforcing doctors’ beliefs that they are doing the
right thing.
Sweet M. Doctors and drug companies are locked in "vicious circle“ BMJ, Oct
2004; 329: 998.
31
We need to change the system
a. Increase regulation of drug promotion
b. Improve health care decision making
c. Redesign the incentives for health
professionals
d. Redesign the incentives for drug
companies
32
Redesign the incentives for
companies
• Pay separately by open competitive tender
for separate functions:
–
–
–
–
–
Manufacturing
Research
Education
Promotion
Advocacy
• New Zealand capped annual contracts
33
Redesign the incentives for health
professionals
• Stop the gifts
• Make the connection between more cake for
drug companies and less cake for everyone
else
34
4. Current regulation in Australia
35
Australian Trade Practices Act
Section 52
A corporation shall not, in trade or
commerce, engage in conduct that is
misleading or deceptive or is likely to
mislead or deceive.
36
Misleading
• Ads: perhaps 100% are misleading.
• Reps: At least one “inaccuracy” in
13 of 16 (81%) of visits to Aust GPs
Roughead EE, Gilbert AL, Harvey KJ. Self-regulatory codes of conduct: are they
effective in controlling pharmaceutical representatives' presentations to general medical
practitioners? Int J Health Serv 1998;28(2):269-79.
37
Implementation
• Australian Competition and Consumer
Corporation
• Therapeutic Goods Administration
• Medicines Australia self regulatory Code or
Conduct
38
Regulatory capture
39
Case study - Celebrex
• Dear Dr letter just after the Vioxx
withdrawal.
• “The cardiovascular safety profile of
Celebrex has been extensively studied.
• The data do not indicate significant
cardiovascular safety concerns with
Celebrex.”
40
Timeline
•
•
•
•
Dear Dr letter – 8 Oct 2004
My complaint – 4 Nov 2004
Finding delivered – 28 Jan 2005
“this information is confidential until
notification from Pfizer of any appeal.”
• Appeal – “Possible dates are 21 or 22 April.”
41
Code of Conduct Committee finding
• “Some members considered that it was misleading
to claim that the cardiovascular safety profile of
Celebrex had been ‘extensively studied’, which
implied cardiovascular safety was a primary
endpoint in the studies that had been conducted.
Members concluded that the statement
“extensively studied” was somewhat ambiguous in
its meaning,” but “the letter to doctors should not
be found in breach on the basis of the use of these
words.”
42
E. Ideas for better regulation
Overcome regulatory swamping
• 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.
43
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
44
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
45
Restorative justice
• “a process whereby all parties with a stake in a
particular offense come together to resolve
collectively how to deal with the aftermath of the
offense and its implications for the future.”
• Reintegrative shaming - confrontation then joint
problem solving rather than punishment.
• Evidence from other fields - more effective than
courts for reducing repeat crime despite lower
punishments.
46
Crime prevention
• Crime prevention more likely when offenders :
– perceive sanctions as legitimate
– accept their shame
– bonds with the community strengthened.
• Focus resources not on those who gain most from
crime but on those who gain little but have the
power to stop it.
• They may be motivated to avoid shame even when
not criminally responsible.
47
Education
• Update seminars (preemptive) – no
accusations
• Restorative justice conferences (drug co staff,
victims, advocates)
• Support allies – NGOs, Universities and
Regulatory affairs /research /information
staff, Help them meet.
48
Costs
•
•
•
•
•
Adverse publicity
Time consuming questions
Inspection fees
Small Fines
Large Fines
– magnitude and probability > profits
– avoid the deterrence trap by increasing the
probability so you can reduce the magnitude
49
Incapacitation
•
•
•
•
•
•
•
Cease the one advertisement
Cease promotion of that product for a time
Cease all promotion for a time
Cease promotion permanently
Appoint an internal quality inspector
Suspend or revoke individuals licenses or jail
Removal of the company from the market
50
Self regulation
Company self regulation essential.
Industry self regulation may contribute
IF
the main system is working well.
51
Thank you ANVISA and PAHO
• International leadership – largest meeting on drug
promotion ever.
• “…the possible establishment of partnerships
related to drug promotion”
• “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.
52
Healthy Skepticism
Countering misleading
drug promotion
www.healthyskepticism.org
53