Strict guidelines

September 3, 2009 

Your Aug. 28 editorial "Ghosts, M.D." about medical writing omitted some critical facts.

The three case studies and two letters to the editor about Paxil that are the focus of the editorial concern clinical experiences from individual physicians involving their patients. They are not scientific research studies. The information about the patient necessarily comes from the physician who authored the piece, and these were the physicians' pieces.

Our policy is to work closely with investigator authors. GlaxoSmithKline upholds strict guidelines to ensure that the development of study manuscripts is led by investigators who have made a substantial contribution to the study. That includes drafting the manuscript or revising it critically for important intellectual content, retaining final approval authority.

We have our own guidelines on this topic and they reflect those established by the International Committee of Medical Journal Editors and PhRMA Principles on Conduct of Clinical Trials and Communication of Results. We continually review our guidelines to make sure they cover current issues.

We want to be transparent about whose work is represented and to ensure that the investigator is in control of the contents.

Kevin Colgan

External Communications


Research Triangle Park

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