Ethical Criteria for Promotion of Medicines Technical Briefing Seminar 21 September 2006 Dr Guitelle Baghdadi, World Health Organization, Geneva

3 WHO definition of promotion "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"

4 Examples of promotional tools and target audiences n Prescribers n Discounts n Gifts n Educational events n Monitoring of prescriptions n Pharmacies n Direct to consumer advertising (DTCA) n Medicalisation or "illness promotion" n Support to patient-help organizations n Consumers n Sales Representatives n Education events n Journal advertisements n Gifts n Samples n Enter patients in clinical trials against payment n Physicians or opinion leaders paid as speakers

5 "Imbalance between commercially produced and independent drug information" (1) n Large amount of money spent around the world: ä US: US$ 13 – 15 billion (2000) (1) ä Australia:US$ 1.3 – 2 billions per year (2) ä Italy:US$ 1.1 billion (1998) (1) ä Low-income countries: 20 – 30% of sales revenue (1) n Growth spending on DTCA for prescription drugs ä US: US$ 55 million (1991) to US $ 2.4 billion (2001) (3) n Others figures (US): ä currently 80,000 sales reps (1) ä 314,000 physician events in 2003 (sponsored industry) (1) ä free samples: $ 11 billion (retail value) or $ 2-3 billion (prod. cost) n Only 50% countries have drug information centres (1999) (1) (1) WHO Medicines Strategy 2004 – 2007 (2) (3) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001

6 Increasing evidence that promotion techniques influence physicians' prescribing n Medical journals ad: informational content generally poor (1) ä Headlines can be misleading (32%) ä Lead to improper prescribing if no additional information (44%) ä Little or no educational value (57%) ä Often minimize risks and harmful effects (50% to 60%) n Advertisement material: only 6% material supported by scientific evidence (2) ä 15% of brochures did not contain any citations ä 22% citations listed could not be found ä 63% info correctly referenced but articles did not reflect results n Sponsored medical conferences ä Attendance associated with increased prescribing of sponsored product (3) (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:

7 Sales representatives too often only source of information for health professionals n Interactions start during medical school (2) n 80 – 95% doctors see sales reps regularly (1) ä average 4 times a month (2) ä US: 1 sales rep for 15 to 30 physicians (3) n Seen as important source of info (new drugs) (3) n 10% sales reps statements are inaccurate (3) n 25% doctors recognize inaccurate statements (3) (1) Moynihan R. Who pays for the pizza? BMJ 2003; 326: (2) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283: (3) Ziegler M. & al.. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273:

8 Gifts, trips, dinners influence prescribing habits & power needs to be acknowledged n Most doctors deny gifts influence their prescribing (1) n Recognized as conflict of interest and established "ceilings" (e.g. $ 100 in US) (2) n Small gifts play important role (2) ä Pens, note pads, etc. act as "reminder items" (2) ä Sole or among top reasons to see sales reps (1) n Psychological aspects: indebtedness, reciprocity (2) ä Food, flattery and friendships: powerful tools of persuasion (1) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283: (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

9 DTCA of prescription-only medicines in legal in only US and New Zealand n US since 1980s ä FDA decision 1997: relax restrictions on radio and TV ä 2003: US$ 3 billion per year ä 8.5 m. people request & receive prescription after advertisement n New Zealand ä 2003: GPs launched campaign for ban ä 2005: Health Minister plans to ban it from 2005 (1) n Rejected by EU health ministers in June 2003 and EU parliament in December 2003 n All other countries (internet, satellite, etc.) DTCA raises concerns, despite advocacy that it creates better informed patients: n Increases prescription costs (2) n Misleading statements lead to irrational use and undue risks 1) n Often breach regulation (2) n Strains on physicians-patient relation (2) n No evidence of health benefits (3) n Promotes medicalisation of normal life (2) (1) Mansfield P. & al. Direct to consumer advertising is at crossroads of competing pressures from industry and health needs, BMJ 2005; 330:5-6 (2) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001 (3) Mansfield P. & al. DTCA is more profitable if it is misleading. NZ Med J 2003; 116 (1182)

10 Some DTCA examples

11 Promotional practices have multiple impact n Health impact  irrational prescribing ä Example Rofecoxib (Vioxx) on market l 80, ,000 heart attacks and strokes in US (1) l 27,000 excess sudden cardiac death in US (2) n Economical impact  increase in prescribing cost ä preference of new drugs ä decreased prescription of generics (3) n Image impact ä Trust in pharmaceutical industry ä 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. Vioss, the implosion of Merck, and aftershocks at the FDA, Lancet 2004, 365:1995 (3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:

12 WHO ethical criteria (1988) still relevant today, more than ever n Reliable, accurate, truthful, information, balanced, up-to date, capable of substantiation and in good taste n NOT misleading or unverifiable or omissions n Scientific public data made available n No financial/material benefit offered to health professional n Scientific and educational activities not used for promotional purposes

13 WHO ethical criteria cover wide arrange of promotional activities n Advertising: ä Professionals: min. summary scientific information ä Consumers: help make rational decisions n Medical representatives ä technical knowledge and ethical conduct ä Complete/unbiased information and no offer of inducement n Samples ä Modest quantities for prescription drugs ä Difficult to justify for non-prescription drugs n Symposia and scientific meetings ä Objective scientific content & independent scientists ä Sponsorship clearly stated, gifts secondary to main purpose n Post-marketing scientific studies ä Inform health authorities and validated relevant committees ä "… not misused as disguised form of promotion" Although disseminated widely: n not widely known n not implemented in national drug regulatory legislation n not promoted in universities and professional associations

14 Examples of responses in countries include regulation, policy and training interventions n Increase awareness of physicians n Independent drug information centres (professionals and consumers) n Code of conduct (professional associations, pharmaceutical industry) n Publicly funded continuing education of staff n Training of medical students to critically assess pharmaceutical promotion ä successful experience in Indonesia with long-term impact (1) (1) Drug advertisements: a critical lesson for Indonesian students, WHO, Essential Drugs Monitor, 1997, Issue n° 23, 23

15 Joint-venture with Health Action International