Originally Posted by Bob Dawson

In a direct challenge to the proponents of disclosing clinical trial data, AbbVie has filed a request for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning its top-selling Humira rheumatoid arthritis treatment, The Financial Times writes.

The filing comes after two Freedom of Information requests were made to the EM last year to release “raw data” on the safety and efficacy of the medication, a ten billion-dollar seller…

Also. ….Last year, Abbott Laboratories which has since spun off AbbVie, filed a citizen’s petition with the FDA to ask that the agency not approve any biosimilar for its Humira treatment for rheumatoid arthritis….

The latest move comes amid a heated controversy over data disclosure…. researchers who argue that results cannot be independently verified unless patient-level data and case-study reports are fully disclosed.
There are, however, cracks showing in the stance taken by the pharmaceutical industry. Last year, GlaxoSmithKline agreed to make patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data. However, the drugmaker has not yet launched its effort…