Unwarranted claims of drug efficacy in pharmaceutical sales visits: Are drugs approved on the basis of surrogate outcomes promoted appropriately?

Abstract

Aim

This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, versus those approved on the basis of a serious morbidity or mortality (clinical) outcome.

Methods

Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse who saw sales representatives as part of their usual practice and served a non-referral population were contacted in blocks of 25 from a randomized list of all physicians practicing in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefit for drugs approved on the basis of surrogate outcomes versus drugs approved on the basis of clinical outcomes.

Results

There were 448 promotions for 58 unique brand name drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR=0.3 (95% CI 0.2, 0.6), p<0.001.

Conclusions

Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators.

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