Cochrane group skeptical about latest Roche pledges

(HealthDay)—Following requests from Cochrane researchers, Roche has pledged to release full clinical study reports for Tamiflu, although there appear to be conditions attached, according to correspondence published in BMJ.

Peter Doshi, Ph.D., from the Johns Hopkins University School of Medicine in Baltimore, along with colleagues from the Cochrane group, recently corresponded with Roche as part of the BMJ's open data campaign designed to encourage Roche to honor its 2009 commitment to make the full clinical study reports for 10 trials of Tamiflu available for independent review.

Noting that Roche recently pledged to release full clinical study reports as part of the data transparency program, the authors question these new promises. Roche plans to allow researchers access to a secure system, following agreement, rather than the requested independent review. Three of the four advisors chosen to lead Roche's advisory board, which will grant access to data, have recent financial ties to Roche. In addition, there has been no attempt to correct the scientific record following the 2003 Roche-authored paper claiming the opposite of the U.S. Food and Drug Administration conclusion that Tamiflu has not been shown to prevent serious bacterial complications of influenza.

"Despite our repeated requests for those data, Roche has yet to provide even a single full study report," Doshi writes. "We are independent scientists, not regulators. Doing our own analysis, not dictated by others, is key to what makes us independent."

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