1. Medicines Promotion and the Rational Use of Medicines Conference Selling Sickness Amsterdam 7-8 October, 2010 Kees de Joncheere WHO Regional Office for Europe
2. Key issues Some data on pharmaceutical markets Rational use of medicines , a complex interplay of many factors Promotion of medicines and its effects What next : need for providing pro-actively objective and evidence-based information and for implement codes and regulation
3. The global pharmaceutical market Global sales Global R&D expenditure Development times Global NME output From: CMR International & IMS Health, 2008
8. Medicines in Europe – key data (source Oebig) Number of prescriptions per capita 2000/latest EU average (BE, FR, GR missing): 8.3 changes 1990 – 2000: highest increase in SE (elderly populat.) particular decrease in 90s in DE and IT due to cost-containment no direct connection between the number of prescriptions and extent of public PE EU average expenditure per prescription at the expense of Social Insurance/NHS: € 20,-
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10. "Imbalance between commercially produced and independent drug information" (1) Large amount of money spent around the world: est. 250-300 billion Euro Growth spending on DTCA for prescription drugs US: US$ 55 million (1991) to US $ 3-4 billion (2006) Others figures (US): currently 80,000 sales reps (1) 314,000 physician events in 2003 (sponsored industry) (1) free samples: $ 11 billion (retail value) or $ 2-3 billion (prod. cost) Few countries have comprehensive national programme to improve prescribing (1) WHO World Medicines situation and WHO Medicines Strategy (2) www.healthyskepticism.org
11. WHO definition of promotion : WHO Ethical Criteria for Medicinal Drug Promotion 1988 "All informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs"
12. EU definitions, Directive 2001/83/EC Advertising of medicinal products = any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products Advertising of products to general public… Advertising of products to persons who may prescribe … Visits by medical sales reps … Supply of samples… Provisions of inducements to prescribe or supply… Sponsorship of promotional meetings… Sponsorship of scientific congresses … payment of travel and accomodation…
13. Large body of evidence that promotion techniques influence physicians' prescribing :HAI Drug Promo Data base http://www.drugpromo.info/) Sponsored medical conferences Attendance associated with increased prescribing of sponsored product (3) Medical journals ad: informational content generally poor (1) Headlines can be misleading (32%) Lead to improper prescribing if no additional information (44%) Little or no educational value (57%) Often minimize risks and harmful effects (50% to 60%) Advertisement material: only 6% material supported by scientific evidence (2) 15% of brochures did not contain any citations 22% citations listed could not be found 63% info correctly referenced but articles did not reflect results (1) Wilkes M. Pharmaceutical Advertisements in Leading Medical journals: Experts' Assessment. Ann Intern Med. 1977;87:114-5 (2) Tuffs A. Only 6% of drug advertising material is supported by evidence [news]. BMJ 2004; 328: 485 (3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
14. Sales representatives too often only source of information for health professionals Interactions start during medical school (2) 80 – 95% doctors see sales reps regularly (1) average 4 times a month (2) US: 1 sales rep for 15 to 30 physicians (3) Seen as important source of info (new drugs) (3) 25% doctors recognize inaccurate statements (3) (1) Moynihan R. Who pays for the pizza? BMJ 2003; 326: 1189-1192 (2) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380 (3) Ziegler M. & al.. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273: 1296-1298
15. Gifts, trips, dinners influence prescribing habits Most doctors deny gifts influence their prescribing (1) Recognized as conflict of interest and established "ceilings" (e.g. $ 100 in US) (2) Small gifts play important role (2) Pens, note pads, etc. act as "reminder items" (2) Sole or among top reasons to see sales reps (1) Psychological aspects: indebtedness, reciprocity(2) Food, flattery and friendships: powerful tools of persuasion (1) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380 (2) Katz D & al. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. AM J Bioethics.2003;3:39-46
16. Industry association suspends drug company for entertaining doctors Michael Day London BMJ VOLUME 332 18 FEBRUARY 2006 bmj.com One of the world’s biggest drug companies has been suspended from its UK trade organization after two of its employees went with a doctor to a lap dancing club and for providing other extensive hospitality. Abbott Laboratories has admitted providing senior hospital consultants with tickets to the Wimbledon tennis tournament and trips to greyhound racing. As a result the Association of the British Pharmaceutical Industry has decided to suspend the company’s membership for a minimum of six months —the severest penalty handed out by the organisation in 10 years. In its ruling on 10 February the association said that the behaviour of Abbott’s employees in attending a lap dancing club with a health professional would “bring discredit upon, and reduce confidence in, the pharmaceutical industry.” ……………………………………………………………….
17. Drug firms a danger to health - report International research exposes flaws in £33bn marketing budget Sarah Boseley, health editorMonday June 26, 2006The Guardian Drug companies are accused today of endangering public health through widescale marketing malpractices, ranging from covertly attempting to persuade consumers that they are ill to bribing doctors and misrepresenting the results of safety and efficacy tests on their products. In a report that charts the scale of illicit practices by drug companies in the UK and across Europe, Consumers International - the world federation of consumer organisations - says people are not being given facts about the medicines they take because the companies hide the marketing tactics on which they spend billions. "Irresponsible marketing practices form a serious, persistent and widespread problem among the entire pharmaceutical industry," says the report, which analyses the conduct of 20 of the biggest companies, two of which are British. It calls for tougher government controls and for the companies to put their house in order. Scandals such as the withdrawal of Vioxx, a drug to relieve pain and inflammation in arthritis, show that unethical drug promotion is a consumer concern, says the report. Merck withdrew the drug in September 2004, but
18. BMJ 2008;336:1208-1209 (31 May), News Merck to pay $58m in settlement over rofecoxib advertising Fred Charatan Merck & Company has agreed to pay $58m (£29m; 37m) to settle allegations that advertising for its analgesic rofecoxib(Vioxx) played down potential health risks. The civil settlement ends investigations by 29 US states andthe District of Columbia into Merck’s previous advertisingpractices for the drug. Tom Corbett, attorney general of Pennsylvania,said that the agreement is the largest in a multi-state consumerprotection case involving drugs. Mr Corbett said that in 1999 Merck had launched "an aggressiveand deceptive advertising campaign which misrepresented thesafety and improperly concealed the increased risks associatedwith Vioxx." Hundreds of thousands of consumers demanded prescriptionsfor the drug before doctors had a chance to understand the sideeffects, he added. "Consumers need clear information about the risks associatedwith prescription drugs so that they can make well informeddecisions about their health care," Mr Corbett said. "This settlementaddresses all of our concerns and will restrict Merck’sability to deceptively promote any of their products."
20. Promotional practices have multiple impact Health impact irrational prescribing Example Rofecoxib (Vioxx) on market 1999 - 2003 80,000-139,000 heart attacks and strokes in US (1) 27,000 excess sudden cardiac death in US (2) Economical impact increase in prescribing cost preference of new drugs decreased prescription of generics (3) Image impact Trust in pharmaceutical industry Trust in medical profession (physicians, academia, etc.) (1) Lenzer J. FDA is incapable of protecting US "against another Vioxx". BMJ 2004; 329 (News) (2) Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA, Lancet 2004, 365:1995 (3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
21. WHO ethical criteria (1988) still relevant today, more than ever Reliable, accurate, truthful, information, balanced, up-to date, capable of substantiation and in good taste Information should NOT be misleading nor unverifiable, and there should be no omissions Scientific public data made available No financial/material benefit offered to health professional Scientific and educational activities not used for promotional purposes
22. WHO ethical criteria cover wide arrange of promotional activities Advertising: Professionals: min. summary scientific information Consumers: help make rational decisions Medical representatives technical knowledge and ethical conduct Complete/unbiased information and no offer of inducement Samples Modest quantities for prescription drugs Difficult to justify for non-prescription drugs Symposia and scientific meetings Objective scientific content & independent scientists Sponsorship clearly stated, gifts secondary to main purpose Post-marketing scientific studies Inform health authorities and validated relevant committees "… not misused as disguised form of promotion" Although disseminated widely: not widely known not well implemented in national drug regulatory legislation not used in universities and professional associations
23. Responses in countries include regulation, policy and training interventions Independent drug information programmes - professionals and consumers – i.e. IQWiG in Germany Code of conduct (professional associations, pharmaceutical industry IFPMA, EFPIA, ABPI …) Publicly funded continuing education of staff. i.e. Institute for Rational Pharmacotherapy (DK), NL IVM Training of medical students to critically assess pharmaceutical promotion Others i.e. Italian levy on marketing expenditure to be used for “public good” research Financial disclosure , i.e. USA, Croatia
24. WHA 60.16 2007 Resolution Members governments are urged to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion on medicines, to monitor drug promotion, and to develop and implement programmes that will provide independent, non-promotional information on medicines
