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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 Initiative, University of British Columbia [email protected] Major drug disasters linked to regulatory change were fuelled by promotion In 1953, DES (diethylstilbestrol) is promoted for routine prophylaxis. In 1958, Grunenthal launches its new sleeping pill, Contergan (thalidomide) as “astonishingly safe… fully harmless.” 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 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 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY How much influence do sales representatives have on your prescribing? A lot 1% A little 38% None 61% n=102 internal medicine residents Am J Med 2001; 110:551 How much influence do sales representatives have on other physicians' prescribing? None 16% A lot 51% A little 33% n=102 internal medicine residents Am J Med 2001; 110:551 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 Lyme’s disease (but worse for milder disease). Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY 1980’s - 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 selfregulatory code 1985: WHO Nairobi Conference, Revised Drug Strategy – emphasis on rational drug use 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. 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 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Problem Drugs, promotion of irrational use, early 1990’s South Africa 2003 Schering points her in the direction of an unnecessarily risky product, no warnings of harm from menopausal hormone treatments. Brazil 2004 Boehringer Ingelheim ad for dipyrone drops: “Ping-ping against pain – No Pingping in your purse” -BUKO PharmaKampagne, 2004 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 2000’s “…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 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Vioxx (rofecoxib) Direct-to-consumer advertising and public health Vioxx (rofecoxib): science vs. marketing 1999 to 2004 • More than $550 million spent on DTCA • • No more effective than alternatives • U.S. FDA Warning letter, 2001: stop misrepresenting risks Strong evidence of cardiac risks since 2000, VIGOR trial 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 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Age and sex standardised prevalence of the use of NSAIDs and hospitalisation rates for upper gastrointestinal haemorrhage over time among elderly people in Ontario Mamdani, M. et al. BMJ 2004;328:1415-1416 Copyright ©2004 BMJ Publishing Group Ltd. 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 Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Is Vioxx a ‘red herring’? Early 1980’s – 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 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 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. Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY “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 Prescriptions for gabapentin by diagnostic category Steinman, M. A. et. al. Ann Intern Med 2006;145:284-293 Canada journal ad Comparative clinical significance has not been established. US DTCA: for a free trial offer US $1 billion spent on DTCA for esomeprazole (Nexium) 2000 to 2005 Global sales in 2003: US $3.8 billion http://www.astrazeneca.com/sites/7/archive/Investors/Presentations/2004/astrazeneca-2004-abrcarolyn-fitzsimons-nexium.pdf 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. Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY Tom Toles The Buffalo News, reprinted in the NY Times, June 9, 2002 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. Pills, Politics and Practice 25 YEARS OF PROMOTING PEOPLE-CENTRED MEDICINES POLICY