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Adverse Effects of Inhaled Corticosteroids in Funded and Nonfunded Studies
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).
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