Drugmaker Sues Rival & Journal For ‘Fudging’ Data

Drugmaker Sues Rival & Journal For ‘Fudging’ Data

December 6th, 2011 // 2:15 pm @

In response to a perceived conspiracy, a little drugmaker has filed a lawsuit against a larger rival and its foreign parent; the publisher of the Journal of Perinatology; and the authors of a study that ran in the journal, because they allegedly ‘cherry picked’ and ‘manipulated’ data in such a way that its product was unfairly disparaged.

At issue is a study that was published in September and concluded that Curasurf, a drug used to treat neonatal Respiratory Distress Syndrome and sold by Cornerstone Therapeutics and its parent, Chiesi Farmaceutici, significantly reduced the likelihood of death when compared with Infasurf, which is sold by ONY. Another defendant is the American Academy of Pediatrics, because it dubbed the journal its official organ for its section on perinatal pediatrics.

In making it case, ONY charges that Cornerstone and Chiesi Farmaceutici stacked the proverbial deck. The parent sponsored the study, three of the four authors have served as Chieisi consultants and the fourth works for Premier Research Services, which is a Chiesi contractor. Also, two of the four authors serve on the journal editorial board (here is the here is the study and here is a Cornerstone press release).

In its lawsuit, ONY claims that the authors failed to include all of the pertinent data in their study. For instance, the drugmaker charges the study reports a lower mortality for infants treated with Curosurf, but omits information indicating that these babies also had shorter hospital stays, which ONY maintains is a critical distinction that would account for an outcome that is favorable to its rival (here is the lawsuit).

“They purposely fudged the data and engaged in selective distortion to produce bogus conclusions to promote their product,” ONY president Ted Egan says in a statement. “A premature baby with a reported short hospital stay either died early or was healthier because (it was) close to full-term. 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.”

The lawsuit also claims the study authors did not actually write the study, but that it was composed by Cornerstone and Chiesi and undisclosed ‘agents.’ Another charge: one of the peer reviewers allegedly recommended the conclusions were unreliable and the study should not be published. And Egan claims to have contacted the journal directly to seek a retraction, but the journal was unwilling to so. As a result of all this, ONY is seeking $10 million in damages from the defendants.

A spokesperson for Cornerstone says the drugmaker does not have a statement, and a spokesperson for Nature Publishing Group, which publishes the journal, wrote us to say that “we have not received the complaint to date. We do not comment on ongoing litigation.” We have also sought comment from the study authors – Jatinder Bhatia, Rangasamy Ramanathan, Kris Sekar and Frank Ernst. We will update you if, and when, receive any responses.

The retrospective study, by the way, was based on data taken from various hospital and physician databases provided by Premier. The journal authors compared statistical outcomes of 14,173 preterm infants from 236 hospitals across the US who received one of three FDA-approved medications – including Curasurf and Infasurf- to help the infant lungs develop and mature.

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