Ensuring ethical drug promotion--whose responsibility?

1 Chin-Dusting JPF, Dart AM. Age and the treatment gap in the use of statins. Lancet 2003; 361: 1925–26. 2 DeWilde S, Carey IM, Bremner SA, Richards N, Hilton SR, Cook DG. Evolution of statin prescribing 1994–2001: a case of ageism but not of sexism. Heart 2003; 89: 417–21. 3 Whincup PH, Emberson JR, Lennon L, Walker M, Papacosta O, Thompson A. Low prevalence of lipid lowering drug use in older men with established coronary heart disease. Heart 2002; 88: 25–29. 4 Reid FDA, Cook DG, Whincup PH. Use of statins in the secondary prevention of CHD: is treatment equitable? Heart 2002; 88: 15–19. 5 Wagner EH. Meeting the needs of chronically ill people. BMJ 2001; 323: 945–46. concentrations need to be. To us, the implication is that smokers, obese individuals, or those who live a sedentary lifestyle can safely continue to smoke, remain overweight, or take little exercise, provided they take medication to reduce their cholesterol values. Of all the major factors accepted as cardiovascular disease risks, only cholesterol is addressed—the campaign’s stated aim is not pursued. No mention is made of an actual medical product, but the campaign coincided with publication, in The Lancet, of the AngloScandinavian Cardiac Outcomes TrialLipid Lowering Arm study, showing reductions in major cardiovascular events after use of atorvastatin. We believe the campaign could have worried patients, encouraging them to request a prescription for statins. If so, we suggest that the campaign meets the definition of promotion noted in the WHO Ethical Criteria for Medicinal Drug 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”. Moreover, we believe the campaign did not respect several of WHO’s ethical criteria, in that it is neither accurate, informative, or balanced. Finally, we think the information used contained misleading statements and omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. We conclude that this experience underscores the need for health authorities and those charged with reimbursing or for paying for medicines to urgently increase their vigilance with respect to drug promotion. In our opinion, they must also decide how they can play an active and effective part in regulation of promotional activities, and ensure that balanced health information is readily available to the public, so that prescribing is not unduly affected by drug promotion activities.