Posted on Wednesday 26 November 2014

European ombudsman questions European Medicines Agency over AbbVie redactions
by Rory Watson
British Medical Journal. 2014 349:g6904.

The European ombudsman, Emily O’Reilly, has written to the European Medicines Agency asking it to explain by 31 January 2015 the redactions it made in the clinical trial data provided by AbbVie for its best selling drug adalimumab [Humira], used to treat rheumatoid arthritis. The redactions were made as part of the settlement between the agency and the company after AbbVie had gone to court to try to prevent publication of certain clinical trial data.

In her letter O’Reilly acknowledged that “certain redactions may be justified to protect the personal data of patients.” She also accepted that “certain other redactions, which mention the names of companies that provided services to AbbVie, or the names of software used by AbbVie, are not, in my view, problematic, as they may be considered to relate to the confidential business relationships of AbbVie.”

But after examining the original and the redacted versions of the clinical trial data, internal agency communications, and correspondence between the agency and the company, she expressed “doubts and concerns as regards other redactions.” O’Reilly, who opened an investigation into the case in April, identified 16 instances where she wanted the agency to explain why the redactions were necessary to protect AbbVie’s legitimate commercial interests…
I’m impressed with the position of European Ombudsman. She apparently has the necessary power to open investigation of just about anything. This AbbVie suit and settlement is the one that got the whole EMA Data Transparency trajectory off-track. Ombudsman Emily O’Reilly goes on to question redactions that don’t seem to relate directly to either Patient Confidentiality or to Commercially Confidential Information. Kudos for her promptness in acting and the specific nature of her complaints. It’s only through speedy and focused investigations of this sort  that we will make genuine progress in cleaning up the Clinical Trial process. We could use a US equivalent, an American Ombidsman, doing the same things here.

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