Nieto A, Mazon A, Pamies R, et al. Arch Intern Med. 2007;167(19):2047–2053
PURPOSE OF THE STUDY. Evidence regarding the safety profile of drugs may vary depending on study sponsorship. The authors 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. The authors 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 [PR]: 0.53 [95% confidence interval (CI): 0.44–0.64]). This association became nonsignificant (PR: 0.94 [95% CI: 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 findings of adverse effects and were more common in PF studies. Among studies that found 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 (PR: 3.68 [95% CI: 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
REVIEWER COMMENTS. Okay, so maybe this is not a real big shock to most of us. What was surprising to me was the extent that this bias exists with a variety of other drugs including hypertensive agents, pain medications, and cancer treatments. This seems to be related to the study design of the protocols, suggesting that the whole system is “rigged.” The investigator physicians have no clue how the studies are set up or how the data are manipulated. So where is the Food and Drug Administration in all of this?
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