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Commercial myths, drug promotion, and public health: 1981 to 2006 Barbara Mintzes Health Action International (HAI Europe) Amsterdam, Oct 26-27, 2006 Therapeutics.

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Presentation on theme: "Commercial myths, drug promotion, and public health: 1981 to 2006 Barbara Mintzes Health Action International (HAI Europe) Amsterdam, Oct 26-27, 2006 Therapeutics."— Presentation transcript:

1 Commercial myths, drug promotion, and public health: 1981 to 2006 Barbara Mintzes Health Action International (HAI Europe) Amsterdam, Oct 26-27, 2006 Therapeutics Initiative, University of British Columbia bmintzes@chspr.ubc.ca

2 In 1958, Grunenthal launches its new sleeping pill, Contergan (thalidomide) as astonishingly safe… fully harmless. Major drug disasters linked to regulatory change were fuelled by promotion In 1953, DES (diethylstilbestrol) is promoted for routine prophylaxis.

3 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Regulation of drug promotion In 2004, 89 countries (46%, WHO survey) reported that they regulated drug promotion Often delegated to industry self-regulation Few resources: for example, in Canada less than 1 full-time dedicated staff person, no fines or sanctions since 1978

4 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Commercial vs. scientific influences on prescribing behaviour Avorn et al, American Journal of Medicine 1982 Physicians reported that they relied on scientific information sources At odds with belief in commercial myths not supported by evidence, and prescribing accordingly Specific cases used: vasodilators for dementia, dextropropoxyphene for pain

5 n=102 internal medicine residents Am J Med 2001; 110:551

6 n=102 internal medicine residents Am J Med 2001; 110:551

7 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY First systematic review of empirical studies on effects of promotion: 1994-1999 Wazana, JAMA, 2000 Most outcomes negative: Inability to identify inaccurate claims Rapid adoption of new drugs Formulary requests for drugs without added value Increased prescribing volume Less cost-effective prescribing One positive outcome in 1 of 29 studies: Better knowledge of treatment protocols, complications of Lymes disease (but worse for milder disease).

8 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY 1980s - attention to the need for better regulation of drug promotion 1981: HAI forms as network, calls for an international code of pharmaceutical marketing 1981: IFPMA launches international self- regulatory code 1985: WHO Nairobi Conference, Revised Drug Strategy – emphasis on rational drug use

9 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY WHO Ethical Criteria for Medicinal Drug Promotion, 1988 First international ethical standard Aim is to support rational drug use, public health Specific types of information must be provided in advertising Promotion should not take advantage of concern for health Should not be disguised as education or science Generally, direct-to-consumer advertising of prescription drugs should not be allowed.

10 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY The main objective … is to support and encourage the improvement of health care through the rational use of drugs. - WHO Ethical Criteria for Medicinal Drug Promotion

11 Problem Drugs, promotion of irrational use, early 1990s

12 Brazil 2004 Boehringer Ingelheim ad for dipyrone drops: Ping-ping against pain – No Ping- ping in your purse -BUKO Pharma- Kampagne, 2004 South Africa 2003 Schering points her in the direction of an unnecessarily risky product, no warnings of harm from menopausal hormone treatments. Study of promotional materials for GPs in Pakistan: Bromazepam (anti-anxiety) claim: restores confidence Buclizine (anti-histamine) appetite stimulation and weight gain in anorexic children. - Rohra et al, J Pharm Pharm Market 2006 Problem Drugs, promotion of irrational use, early 2000s

13 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY …claims concerning medicinal drugs should …not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. - WHO Ethical Criteria for Medicinal Drug Promotion

14 Vioxx (rofecoxib) Direct-to-consumer advertising and public health

15 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Vioxx (rofecoxib): science vs. marketing 1999 to 2004 More than $550 million spent on DTCA No more effective than alternatives Strong evidence of cardiac risks since 2000, VIGOR trial U.S. FDA Warning letter, 2001: stop misrepresenting risks Global withdrawal September 2004 88,000-140,000 extra heart attacks in U.S. (Graham et al. 2005) U.S. Congressional investigation uncovers company memos for sales representatives: avoid discussing cardiac risks A conservative estimate: 10,000 extra death due to DTCA

16 Copyright ©2004 BMJ Publishing Group Ltd. Mamdani, M. et al. BMJ 2004;328:1415-1416 Age and sex standardised prevalence of the use of NSAIDs and hospitalisation rates for upper gastrointestinal haemorrhage over time among elderly people in Ontario

17 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY The role of physician opinion leaders Physicians who attended sponsored presentations by another physician wrote an additional $623.55 worth of prescriptions in the next year versus non-attendees. More intimate discussions were even more effective (average $717.53 extra sales per physician). From an internal Merck document, in: Caplovitz A. Turning Medicine into snake oil. NJPIRG Law & Policy Center, 2006. www.njpirg.org

18 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Is Vioxx a red herring? Early 1980s – first US DTCA campaigns 1982: Lilly marketed the arthritis drug benoxaprofen aggressively to U.S. public and physicians (500,000 prescriptions in a few months) 1982: Withdrawn 5 months later, liver injuries & deaths 1983-1985: US FDA moratorium on DTCA US regulatory experience 2001 to 2005 Notices of violation for 148 DTC ads, 334 claims 137 exaggerated effectiveness or falsely claimed superiority 105 minimized or omitted information on harmful effects 65 promoted drugs for unapproved uses Caplovitz A. Turning Medicine into snake oil. NJPIRG Law & Policy Center, 2006. www.njpirg.org

19 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Scientific and educational activities should not be deliberately used for promotional purposes. - WHO Ethical Criteria for Medicinal Drug Promotion

20 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Eli Lilly and the Surviving Sepsis campaign Eichacker et al, New England Journal of Medicine, Oct 19, 2006 …because rhAPC [ drotrecogine, Xigris] was relatively expensive, word would be spread that physicians were being "systematically forced" to decide who would live and who would die. $1.8 million unrestricted educational grant for Task Force on Values, Ethics and Rationing in Critical Care Support for Surviving Sepsis Campaign Funding of treatment guidelines favourable to rhAPC, omitted negative trial results or risks of serious bleeds.

21 Prescriptions for gabapentin by diagnostic category Steinman, M. A. et. al. Ann Intern Med 2006;145:284-293 Gabapentin [Neurontin] was promoted by using education and research, activities not typically recognized as promotional. independent continuing medical education, peer-to-peer selling by physician speakers, and publications… Approved use

22 Canada - journal ad Comparative clinical significance has not been established. US $1 billion spent on DTCA for esomeprazole (Nexium) 2000 to 2005 US DTCA: for a free trial offer

23 http://www.astrazeneca.com/sites/7/archive/Investors/Presentations/2004/http://www.astrazeneca.com/sites/7/archive/Investors/Presentations/2004/astrazeneca-2004-abr- carolyn-fitzsimons-nexium.pdf Global sales in 2003: US $3.8 billion

24 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY What these advertisements do not say Published comparative trials…used approximately 2 to 4-fold higher equivalent doses of esomeprazole (Nexium) than the comparator drug. No trials have demonstrated an intrinsic therapeutic advantage …at equivalent doses. - http://www.ti.ubc.ca/pages/letter45.htm Esomeprazole is essentially the same molecule as omeprazole (Losec or Prilosec), one of two orientations in space (the s-isomer or s-omeprazole). Both are metabolized into the same active substance.

25 Tom Toles The Buffalo News, reprinted in the NY Times, June 9, 2002

26 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY In conclusion The WHO Ethical Criteria remain an important international standard linked to public health; a standard that is mainly honoured in the breach. Regulation of promotion remains inadequate, with little to no monitoring, corrective actions or sanctions Key shifts: increased financial ties industry-medicine, growth in DTCA, new forms of promotion No regulatory response when the media (or courts elsewhere) uncover scientific misconduct Public drug payers and health service providers could play a much stronger role.

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