Ethical Criteria for Ethical Criteria for Promotion of MedicinesPromotion of Medicines

Technical Briefing Seminar 21 September 2005

Dr Guitelle Baghdadi, World Health Organization, Geneva

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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"

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Overview

2. Responses to date

1. Promotion of medicines: current challenges

3. Questions for discussion…

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Overview

2. Responses to date

1. Promotion of medicines: current challenges

3. Questions for discussion…

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Examples of promotional tools and target audiences

Prescribers

Discounts Gifts Educational events Monitoring of prescriptions

Pharmacies

Direct to consumer advertising (DTCA) Medicalisation or "illness promotion" Support to patient-help organizations

Consumers

Sales Representatives Education events Journal advertisements Gifts Samples Enter patients in clinical trials against payment Physicians or opinion leaders paid as speakers

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"Imbalance between commercially produced and independent drug information" (1)

Large amount of money spent around the world:US: US$ 13 – 15 billion (2000) (1)

Australia: US$ 1.3 – 2 billions per year (2)

Italy: US$ 1.1 billion (1998) (1)

Low-income countries: 20 – 30% of sales revenue (1)

Growth spending on DTCA for prescription drugsUS: US$ 55 million (1991) to US $ 2.4 billion (2001) (3)

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) Only 50% countries have drug information centres (1999) (1)

(1) WHO Medicines Strategy 2004 – 2007 (2) www.healthyskepticism.org(3) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001

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Increasing evidence that promotion techniques influence physicians' prescribing

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 citations22% citations listed could not be found63% info correctly referenced but articles did not reflect results

Sponsored medical conferencesAttendance 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; 283:373-380

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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) 10% sales reps statements are inaccurate (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

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Gifts, trips, dinners influence prescribing habits & power needs to be acknowledged

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

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DTCA of prescription-only medicines in legal in only US and New Zealand

US since 1980sFDA decision 1997: relax restrictions on radio and TV2003: US$ 3 billion per year8.5 m. people request & receive prescription after advertisement

New Zealand2003: GPs launched campaign for ban 2005: Health Minister plans to ban it from 2005 (1)

Rejected by EU health ministers in June 2003 and EU parliament in December 2003

All other countries (internet, satellite, etc.)

DTCA raises concerns, despite advocacy thatit creates better informed patients: Increases prescription costs (2)

Misleading statements lead to irrational use and undue risks 1)

Often breach regulation (2)

Strains on physicians-patient relation (2)

No evidence of health benefits (3)

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)

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Some DTCA examples

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Promotional practices have multiple impact

Health impact irrational prescribingExample 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 costpreference of new drugsdecreased prescription of generics (3)

Image impactTrust in pharmaceutical industryTrust 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; 283:373-380

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Overview

2. Responses to date

1. Promotion of medicines: current challenges

3. Questions for discussion…

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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

NOT misleading or unverifiable or omissions Scientific public data made available No financial/material benefit offered to health

professional Scientific and educational activities not used

for promotional purposes

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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 conductComplete/unbiased information and no offer of inducement

SamplesModest quantities for prescription drugsDifficult to justify for non-prescription drugs

Symposia and scientific meetingsObjective scientific content & independent scientistsSponsorship 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 implemented in national drug regulatory legislation

not promoted in universities and professional associations

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Joint-venture with Health Action International http://www.drugpromo.info/

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Examples of country practices include regulation, policy and training interventions

Increase awareness of physicians Independent drug information centres

(professionals and consumers) Code of conduct (professional associations,

pharmaceutical industry) Publicly funded continuing education of staff Training of medical students to critically assess

pharmaceutical promotion 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

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Overview

2. Responses to date

1. Promotion of medicines: current challenges

3. Questions for discussion…

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What can be done at the country level?

What can be done to improve implementation of ethical guidelines in your respective countries? Legislation/Regulation?Enforcement?Awareness?

What is the amount spent on independent information vs. promotional activities in your countries?

How many physicians, how many sales representatives in your countries?

Etc.