What can be done about commercial drug promotion

What can be done about commercial drug promotion? Porto Alegre 14 October 2005 Dr Peter Mansfield Founder, Healthy Skepticism www. healthyskepticism. org peter@healthyskepticism. org 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

A 1. 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

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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

A 2. 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, Mc. Phee 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, Mc. Evilla 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, Mc. Kinney 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 18

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

B 1. 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

B 2. 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 Profit seeking Lacks understanding Lacks knowledge but virtuous Regulatory response Remove Costs 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 Ad. Watch 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

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B 3. 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

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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. 50 Mansfield PR. Healthy Skepticism’s new Ad. Watch: 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. 53

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? 55