Observations Open Data Campaign

We are asking more questions about NICE appraisal of Tamiflu

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8420 (Published 12 December 2012) Cite this as: BMJ 2012;345:e8420
  1. Michael Rawlins, chairman, National Institute for Health and Clinical Excellence

Dear Fiona

Thank you for your kind words as my tenure of office draws to a close. To have had the opportunity to chair NICE, since its inception, has been the most rewarding part of my professional career. Any success, however, has been a result of the commitment and expertise of the staff, the massive contributions of the professions, as well as (of course) support from the BMJ.

Your premise that NICE does not, in its technology appraisals programme, require access to all clinical trial data is wrong. On the contrary, we require full access to all the information that is available to marketing authorisation holders of medicines when they are subject to a NICE technology appraisal. The medical director of the company involved in making an evidence submission to NICE is asked to sign a declaration to confirm “that all relevant data pertinent to the technology appraisal has been disclosed to the Institute.” Pharmaceutical physicians are very well aware of their obligations, and if a medical director were knowingly to …

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