Evidence versus marketing: is there a safety concern?

Abstract text
Background:
Information provided by sales representatives (PSRs) has been shown to influence physicians’ prescribing. To enable safe prescribing, physicians need information on harm well as benefits of medicines.

Methods:
A random sample of primary care physicians who see PSRs was recruited to report on information provided during drug-specific promotions at sales visits in Vancouver, Montreal, Sacramento, and Toulouse, in 2009-10. This prospective cohort study included 255 physicians. The main aim was to compare frequency of information on harms provided by PSRs in different regulatory environments.
In this secondary analysis, we use a case study approach to examine the 10 most frequently promoted medicines, and compare recalled messages with relevant Cochrane systematic reviews and safety advisories.


Results:
Of 267 promoted drugs, 10 represented 20% of observed promotions (346/1692). They include drugs for type 2 diabetes (saxagliptin and sitagliptin), depression (escitalopram and duloxetine), COPD (fluticasone/salmeterol and tiotropium), lipid lowering drugs (rosuvastatin and ezetimibe), an antihypertensive (aliskiren), and a bisphosphonate (risedronate).

Several themes emerged from recalled PSR messages. Serious adverse events (SAE) were rarely mentioned; none were stated for tiotropium or fluticasone/salmeterol. Saxagliptin and sitagliptin were said to be “more effective” than alternatives despite a lack of evidence for positive effects on morbidity and mortality. Messages such as “quick and complete fracture protection” for risedronate are at odds with systematic reviews on bisphosphonates. Unqualified safety claims for ezetimibe are at odds with safety advisories. Duloxetine has adverse effects not shared by other antidepressants and publication bias has exaggerated efficacy however none of this was mentioned by PSRs.


Conclusions:
For frequently promoted drugs, PSRs’ messages were often inconsistent with Cochrane systematic review evidence and failed to adequately communicate harms. Despite this, the physicians judged the evidence positively and expressed readiness to prescribe. These results raise concerns for patient safety.

Authors
Wright JM1, Lo T2
1 Managing Editor, Cochrane Hypertension Review Group
2 Therapeutics Initiative, Canada
Presenting author and contact person
Presenting author: 
James Wright
Contact person Affiliation Country
James Wright (Contact this person) University of BC Canada
Barbara Mintzes (Contact this person) Therapeutics Initiative Canada
Date and Location
Session: 
Oral session B9O1
Date: 
Tuesday 2 October 2012 - 11:00 - 11:20
Location: