USE OF SURROGATE OUTCOMES IN MEDICAL JOURNAL ADVERTISING IN CANADA
Main Article Content
Keywords
Health Canada, journal advertisements, Pharmaceutical Advertising Advisory Board, product monograph, surrogate outcomes
Abstract
Medical journal advertisements make claims for some products based on surrogate outcomes and do not point out that these drugs have not been shown to influence hard clinical outcomes. Some drugs approved on the basis of surrogate outcomes have later had to be withdrawn from the market because of safety problems. Changing the wording in the Product Monograph would require drug manufacturers to note the limits of knowledge about these products.
References
1. United States Government Accountability Office. New drug approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints. Washington DC: GAO;2009.
2. PAAB. Code of Advertising Acceptance. Pickering: Pharmaceutical Advertising Advisory Board; 2009.
3. Chen DT, Wynia MK, Moloney RM, Alexander GC. U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiology and Drug Safety 2009;18:1094-100.
4. Environics Research Group. Final report: adverse reaction reporting survey with health professionals 2007.
5. Ciani O, Buyse M, Garside R, et al. Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study. BMJ 2013;346:f457.
6. Svensson S, Menkes DB, Lexchin J. Surrogate outcomes in clinical trials: a cautionary tale. JAMA Internal Medicine 2013;Published online March 25, 2013.
7. Health Products and Food Branch (HPFB). Record of discussions - Canadian advertising preclearance agencies and Health Canada - April 5, 2012. 2012; http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/meet-reunion/rod-rdd_2012_04_05-eng.php - a6. Accessed October 8, 2012.
2. PAAB. Code of Advertising Acceptance. Pickering: Pharmaceutical Advertising Advisory Board; 2009.
3. Chen DT, Wynia MK, Moloney RM, Alexander GC. U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiology and Drug Safety 2009;18:1094-100.
4. Environics Research Group. Final report: adverse reaction reporting survey with health professionals 2007.
5. Ciani O, Buyse M, Garside R, et al. Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study. BMJ 2013;346:f457.
6. Svensson S, Menkes DB, Lexchin J. Surrogate outcomes in clinical trials: a cautionary tale. JAMA Internal Medicine 2013;Published online March 25, 2013.
7. Health Products and Food Branch (HPFB). Record of discussions - Canadian advertising preclearance agencies and Health Canada - April 5, 2012. 2012; http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/meet-reunion/rod-rdd_2012_04_05-eng.php - a6. Accessed October 8, 2012.