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Roche’s Questionable Agreement Of Tamiflu Data

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Roche, a pharmaceutical company, failed to form a multi-advisory board that would have examined and allowed researchers access to its data. The company has announced that it will now work alongside an independent group known as the Multi-party Group for Advice on Science to achieve the same results. The delinquency of releasing full access to its Tamiflu clinical data has plagued Roche with disapproval where critics have even asserted Roche to be stonewalling amidst a growing trend of drug scandals that is associated with missing information. This is according to a revealing article penned by Ed Silverman of Pharmalot.

While Roche has agreed to work with a group of “recognized experts” to approve patient-level data along with the release of case study reports for all of its licensed medicines, a recent development of the “recognized experts” raises more questions than answers. The scientists who comprise this “independent group” were not only consultants but also “scientific advisors” for Roche.

While this detail raises concern, GlaxoSmithKline, who first decided to increase access to pharmaceutical data which Roche imitated, both companies appear to be among the very few who plan on being open with information. Not all drug companies seem to agree with Roche on seeing steps to transparency becoming “an industry-wide initiative.”

Both the Pharmaceutical Research & Manufacturers of America and the Association of British Pharmaceutical Industry denied any participation in releasing patient-level data and case study reports.

Roche’s system in essence, however, is quite authoritarian: it would first determine a request’s “validity” for data, then require regulatory applications, followed by regulatory reviews in both the United States and the European Union. The sensitive data would finally only become available in limited “trials” after the process is fully followed through.

According to Roche, data for 71 of 74 completed trials of Tamiflu are available for public use on its website- three more of the studies are needed to conclude the Tamiflu data. “We understand and support calls for our industry to be more transparent about clinical data with the aim of meeting the best interests of patients and medicine,” said Daniel O’Day, the chief operating officer at Roche Pharma.

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