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Seeking Objective Solutions

Posted by plosmedicine on 31 Mar 2009 at 00:17 GMT

Author: Mukund Nori
Position: Professional Medical Writer
Institution: Envision Pharma, Inc
Submitted Date: December 04, 2007
Published Date: December 4, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

I was disappointed to read Dr. Sismondo’s article attacking the work of professional medical writers by lumping them with “ghost management”. I would expect better from any scientist, particularly those in academia, who envelop themselves in the mantle of being fair and unbiased. As a professional medical writer employed at Envision Pharma, Inc, cited in this article, I take issue with the implication that medical writers lack professional integrity just because we are contracted by the pharmaceutical industry. If we were to follow his broad brush approach, we would not trust any doctor just because some have been found guilty of malpractice.

I would like to shed light on what we professional medical writers actually do,[1] so that future discussions are based on fact. As a bellwether of the increased need and the growth of this profession, several distinguished universities now offer courses and programs in professional medical writing.[2-5]

There are increasing regulatory requirements and time pressures such as those mandated by the recently enacted PDUFA law.[6] As such, neither pharmaceutical companies nor physicians who conduct clinical trials have the resources to evaluate journals, compose the drafts, obtain feedback, collate investigator comments, obtain approvals and submit the manuscripts within the required timeframes. Thus, investigators and companies alike contract with external agencies and professional medical writers (not ghost writers) to comply with these requirements in a transparent and appropriate effort so that healthcare professionals, patients, and the public may have access to all the relevant information as quickly, effectively, and professionally as possible. We consistently adhere to Good Publication Practice[7,8] and the International Committee of Medical Journal Editors[9] recommendations. At Envision Pharma, the investigators and authors are involved in every step of the publications process and no manuscript is initiated, developed or submitted without the explicit approval of all the authors. As professional medical writers we provide them the appropriate editorial assistance to capture and present their opinion and their interpretation of the data as clearly and accurately as possible.

I would welcome the opportunity discuss this matter further, should Dr. Sismondo or others wish to do so, as long as we are focused on finding the solutions to the issues we all face.


1. Woolley, K.L. Goodbye Ghostwriters!: How To Work Ethically and Efficiently With Professional Medical Writers. Chest 2007; 130(3) 921-923.

2. University of Pittsburgh School of Medicine – Graduate Programs. MEDEDU 2140: Medical Writing and Presentation Skills; accessible at:

3. The University of Chicago Graham School of General Studies. Medical Writing and Editing; accessible at: https://grahamschool.uchi...

4. University of Houston – Downtown. MS in Professional Writing & Technical Communication; accessible at:

5. University of the Sciences in Philadelphia: Master of Science in Biomedical Writing; accessible at http://www.gradschool.usi...

6. U.S. Food and Drug Administration. The Prescription Drug User Fees Act IV; accessible at:

7. Good Publication Practice for pharmaceutical companies; accessible at: http://www.gpp-guidelines...

8. Wager, E., Field, E.A., and Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003; 19(3) 149-154.

9. International Committee of Medical Journal Editors; accessible at:

Competing interests declared: Mukund Nori, PhD, MBA, is a professional Medical Writer with Envision Pharma and has worked in drug discovery research in the pharmaceutical industry.