Adverse Effects in Corticosteroid Studies | Arthritis Information

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Linked to Funding Source.

Duh!

http://www.medscape.com/viewarticle/564646

Hey Pip, this link just took me to a registration page. How about some
good old copyright infringement and pasting the article here?

OK, that's weird, it let me in from google, but the link didn't work from here.  And no unexplained spaces either!

OK!

Adverse Effects in Corticosteroid Studies Linked to Funding Source

Laurie Barclay, MD

October 22, 2007 — Corticosteroid studies funded by the companies that produce the drugs evaluated are less likely to find those drugs to have adverse effects than are those studies funded by other sources, according to a report in the October 22 issue of the Archives of Internal Medicine.

"Inhaled corticosteroids are considered the cornerstone treatment for inflammatory respiratory diseases, especially asthma, even in mild or moderate cases," write Antonio Nieto, MD, PhD, from the Children's Hospital La Fe in Valencia, Spain, and colleagues. "However, they are not free of adverse effects, and concerns have been raised about long-term treatment courses in milder cases of disease or in young children.... Evidence regarding the safety profile of drugs may vary depending on study sponsorship."

The objective of this study was to evaluate differences between studies funded by the pharmaceutical manufacturer of the drug (PF) and those with no pharmaceutical funding (NoPF) in terms of frequency, severity, and interpretation of adverse effects of inhaled corticosteroids.

Using prespecified criteria, a MEDLINE search identified 275 PF and 229 NoPF studies of inhaled corticosteroids that included safety reporting. Finding statistically significant differences for adverse effects between inhaled corticosteroids and placebo 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).

Design features, including dose or use of parallel groups, tended to be associated with less frequent finding of adverse effects, and these features were more often incorporated in PF studies than in NoPF studies. After controlling for these design features, the association of adverse effects with funding source became nonsignificant (PR, 0.94; 95% CI, 0.77 – 1.15).

In those studies that did show a statistically significant increase in adverse effects associated with the study drug, the authors of PF articles concluded that the drug was "safe" more often than did the authors of NoPF studies (PR, 3.68; 95% CI, 2.14 – 6.33).

Study limitations include possible publication bias affecting the included studies, definition of "funding source" based on the authors' own report, and extrapolation of statistical to clinical significance based on subjective criteria.

"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," the authors write. "We postulate that having information on source of funding will help readers of these studies have a better informed and balanced judgment on the authors' interpretations.... Disclosure of conflicts of interest should be strengthened for a more balanced opinion on the safety of drugs."

The authors have disclosed no relevant financial relationships.

Arch Intern Med. 2007;167:2047–2053

Well, excuse my language in advance but no sh*t, Sherlock!

Thanks for finding this and validating what has long been suspected (by me,
at least).
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