Adverse effects of inhaled corticosteroids in funded and nonfunded studies.
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.
Nieto
Antonio
A
Pediatric Allergy Unit, Children's Hospital La Fe, Av Campanar 21, 46009 Valencia, Spain.
Mazon
Angel
A
Pamies
Rafael
R
Linana
Juan J
JJ
Lanuza
Amparo
A
Jiménez
Fernando Oliver
FO
Medina-Hernandez
Alejandra
A
Nieto
F Javier
FJ
D000280:Administration, Inhalation; D016907:Adverse Drug Reaction Reporting Systems; D003627:Data Interpretation, Statistical; D004345:Drug Industry; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D016239:MEDLINE; D010506:Periodicals as Topic; D012109:Research Support as Topic
D005938:Glucocorticoids