AMHERST, N.Y., Dec. 2, 2011 /PRNewswire/ -- ONY, Inc., the maker of Infasurf®, a locally developed, FDA-approved drug administered to premature infants to combat Respiratory Distress Syndrome, filed suit in U.S. District Court in Buffalo today, accusing Cornerstone Therapeutics and its parent firm, Chiesi Farmaceutici S.p.A., of "cherry-picking" data to claim its competing drug, Curosurf®, produces significantly lower mortality rates.
"They purposely fudged the data and engaged in selective distortion to produce bogus conclusions to promote their product," said Dr. Edmund "Ted" Egan, President, ONY, Inc.
ONY asserts that the authors failed to include all the data in their study. The paper reports a lower mortality for Curosurf®-treated patients, but omits the critical fact that Curosurf®-treated babies also had shorter hospital stays.
"A premature baby with a reported short hospital stay either died early or was healthier because close to full-term," Dr. Egan pointed out. "The only way the Curosurf® infants could have both a lower mortality and a shorter hospital stay is if those infants were more mature and less ill than Infasurf®-treated babies."
"There have been multiple clinical trials comparing lung surfactants, yet in no completed trial has one surfactant been identified as being superior with respect to the outcome of death," Dr. Egan said.
The data which served as the basis for the article was not based upon an actual clinical study; instead, it was culled from various hospital and physician databases, and the suit says, was purposely manipulated to produce the desired outcome.
In the article, the authors compared statistical outcomes of 14,173 preterm infants from 236 hospitals across the U.S. who received one of three FDA-approved surfactant medications to aid maturation of their underdeveloped lungs. Data was culled from hospital discharge information.
|SOURCE ONY, Inc.|
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