Introduction: Pharmaceutical sales visit claims of drug efficacy can influence physician prescribing. Efficacy claims may be susceptible to exaggeration in promotions for drugs approved on the basis of surrogate outcomes. They may also be different in countries with different sales visit regulations.
Objectives: To compare the frequency of physician-reported claims of serious morbidity or mortality benefit in promotions for drugs approved on the basis of surrogate outcomes (where claims are unwarranted) with those approved on the basis of serious morbidity or mortality. Additionally, to compare the frequency of unwarranted claims of serious morbidity or mortality benefit by country of promotion.
Methods: From 2009 to 2010, primary care physicians in Canada, France, and the United States reported via pre-set questionnaires on claims of serious morbidity or mortality benefit in consecutive cardiovascular drug promotions. Promoted drugs were either 1) approved on the basis of surrogate outcomes, or 2) approved on the basis of serious morbidity or mortality. Using generalized estimating equations, the frequency of reported efficacy claims was compared between the two promotion types. The frequency of unwarranted claims drug benefit was also compared by country.
Results: 448 promotions were analyzed. Claims of serious morbidity or mortality benefit were reported in 156/347 (45%) promotions for drugs approved on the basis of surrogate outcomes and 72/101 (71%) promotions for drugs approved on the basis of serious morbidity or mortality, p<0.001. Despite stricter sales visit regulations, unwarranted claims of serious morbidity or mortality benefit for drugs approved on the basis of surrogate outcomes were reported most frequently in France (59%) compared to Canada (46%), p=0.2 or the United States (26%), p=0.02.
Conclusions: Across countries, unwarranted claims of drug benefit were frequently reported in promotions for drugs approved on the basis of surrogate outcomes. These claims amount to off-label promotion and contravene national sales visit regulations. / Thesis / Master of Science (MSc)
| Identifer | oai:union.ndltd.org:mcmaster.ca/oai:macsphere.mcmaster.ca:11375/17216 |
| Date | January 2015 |
| Creators | Habibi, Roojin |
| Contributors | Holbrook, Anne, Global Health |
| Source Sets | McMaster University |
| Language | English |
| Detected Language | English |
| Type | Thesis |
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