This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (6)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Conflict of Interest  • Statistics and Research Methods  • Adverse Effects  • Drug Therapy, Other  • Humanities  • Medicine and the Media  • Alert me on articles by topic  Social Bookmarking   What's this?

Antonio Nieto, MD, PhD; Angel Mazon, MD, PhD; Rafael Pamies, MD; Juan J. Linana, MD; Amparo Lanuza, MD, PhD; Fernando Oliver Jiménez, MD; Alejandra Medina-Hernandez, MD; F. Javier Nieto, MD, PhD

Arch Intern Med. 2007;167(19):2047-2053.

Background  Evidence regarding the safety profile of drugs may vary depending on study sponsorship. We aimed to evaluate differences between studies funded by the pharmaceutical manufacturer of the drug (PF) and those with no pharmaceutical funding (NoPF) regarding the finding and interpretation of adverse effects of inhaled corticosteroids.

Methods  We assessed the safety reporting of inhaled corticosteroids in 275 PF and 229 NoPF studies identified by a MEDLINE search using prespecified criteria.

Results  Overall, the finding of statistically significant differences for adverse effects was significantly less frequent in PF (34.5%) than in NoPF (65.1%) studies (prevalence ratio, 0.53; 95% confidence interval, 0.44-0.64). This association became nonsignificant (prevalence ratio, 0.94; 95% confidence interval, 0.77-1.15) after controlling for design features (such as dose or use of parallel groups) that tended to be associated with less frequent finding of adverse effects and were more common in PF studies. Among studies finding a statistically significant increase in adverse effects associated with the study drug, the authors of PF articles concluded that the drug was "safe" more frequently than the authors of NoPF studies (prevalence ratio, 3.68; 95% confidence interval, 2.14-6.33).

Conclusions  The type of funding may have determinant effects on the design of studies and on the interpretation of findings: funding by the industry is associated with design features less likely to lead to finding statistically significant adverse effects and with a more favorable clinical interpretation of such findings. Disclosure of conflicts of interest should be strengthened for a more balanced opinion on the safety of drugs.

Author Affiliations: Pediatric Allergy Units, Children's Hospital La Fe, Valencia, Spain (Drs A. Nieto, Mazon, Pamies, Linana, Lanuza, and Jiménez), and Hospital de Queretaro, Queretaro, Mexico (Dr Medina-Hernandez); and Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison (Dr J. Nieto).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Importance of Evidence Grading for Guideline Implementation: The Example of Asthma
Hahn
Ann Fam Med 2009;7:364-369.
ABSTRACT | FULL TEXT