Kees de joncheere - Selling Sickness 2010

Medicines Promotion and the Rational Use of MedicinesConference Selling SicknessAmsterdam 7-8 October, 2010Kees de JoncheereWHO Regional Office for Europe

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

The global pharmaceutical marketGlobal salesGlobal R&D expenditureDevelopment timesGlobal NME outputFrom: CMR International & IMS Health, 2008

Medicines expenditures OECD countries (2004)

The use of Statins in Europe 2000(EURO-MED-STAT data)

Variation in outpatient antibiotic use in 26 European countries in 2002Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

Use of innovative medicines 2009From: IMS Health, 2010

Medicines in Europe – key data (source Oebig)Number of prescriptionsper capita 2000/latestEU average (BE, FR, GR missing): 8.3changes 1990 – 2000: highest increase in SE (elderly populat.)particular decrease in 90s in DE and IT due to cost-containmentno direct connection between the number of prescriptions and extent of public PEEU average expenditure per prescription at the expense of Social Insurance/NHS: € 20,-

Kees de joncheere - Selling Sickness 2010

"Imbalance between commercially produced and independent drug information" (1)Large amount of money spent around the world:est. 250-300 billion EuroGrowth spending on DTCA for prescription drugsUS: 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

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"

EU definitions, Directive 2001/83/ECAdvertising 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 productsAdvertising 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…

Large body of evidence that promotion techniques influence physicians' prescribing :HAI Drug Promo Data base http://www.drugpromo.info/)Sponsored medical conferencesAttendance 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 citations22% citations listed could not be found63% 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

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

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

Industry association suspends drug company for entertaining doctorsMichael Day LondonBMJ VOLUME 332 18 FEBRUARY 2006 bmj.comOne 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.”……………………………………………………………….

Drug firms a danger to health - report International research exposes flaws in £33bn marketing budget Sarah Boseley, health editorMonday June 26, 2006The GuardianDrug 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

BMJ 2008;336:1208-1209 (31 May), NewsMerck to pay $58m in settlement over rofecoxib advertisingFred 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."

Promotional practices have multiple impactHealth impact  irrational prescribingExample Rofecoxib (Vioxx) on market 1999 - 200380,000-139,000 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. 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

WHO ethical criteria (1988) still relevant today, more than everReliable, accurate, truthful, information, balanced, up-to date, capable of substantiation and in good tasteInformation should NOT be misleading nor unverifiable, and there should be no omissionsScientific public data made availableNo financial/material benefit offered to health professionalScientific and educational activities not used for promotional purposes

WHO ethical criteria cover wide arrange of promotional activitiesAdvertising: Professionals: min. summary scientific information Consumers: help make rational decisionsMedical representativestechnical knowledge and ethical conductComplete/unbiased information and no offer of inducement SamplesModest quantities for prescription drugsDifficult to justify for non-prescription drugsSymposia and scientific meetingsObjective scientific content & independent scientistsSponsorship clearly stated, gifts secondary to main purposePost-marketing scientific studiesInform health authorities and validated relevant committees"… not misused as disguised form of promotion"Although disseminated widely: not widely knownnot well implemented in national drug regulatory legislationnot used in universities and professional associations

Responses in countries include regulation, policy and training interventionsIndependent drug information programmes - professionals and consumers – i.e. IQWiG in GermanyCode of conduct (professional associations, pharmaceutical industry IFPMA, EFPIA, ABPI …)Publicly funded continuing education of staff. i.e. Institute for Rational Pharmacotherapy (DK), NL IVMTraining of medical students to critically assess pharmaceutical promotionOthersi.e. Italian levy on marketing expenditure to be used for “public good” researchFinancial disclosure , i.e. USA, Croatia

WHA 60.16 2007 ResolutionMembers 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

Kees de joncheere - Selling Sickness 2010

More Related Content

What's hot (20)

Viewers also liked (15)

Similar to Kees de joncheere - Selling Sickness 2010 (20)

More from Gezonde scepsis (15)

Recently uploaded (20)

Kees de joncheere - Selling Sickness 2010