Sunday, December 6, 2009
Ethical aspects of Medical writing
The practice of hiring ghost medical writers is on increase both by the Pharmaceutical Industry as well as by the medical practioners as well. Recently I have come across a publication of a report which should serve as an eye opener for all of us . The details of the report are as given below:
OpEdNews: Robert Davidson - Writer By Robert Davidson, M.D., Ph.D.
November 27, 2009
The newly disclosed scourge of ghost written clinical research publications should not only be banned prospectively, but retracted retroactively. The FDA bases its decisions as to safety, efficacy, and whether to grant an NME (“new molecular entity”) expedited market approval under the Prescription Drug User Fee Act (“PDUFA”), in part, on clinical research publications. The FDA identifies “new risks” of marketed drugs and biologicals, on the basis of these articles and the AERS ("Adverse Event Reporting System"), and modifies the product's package labeling, accordingly. Most physicians base their clinical practice upon evidence found in these publications.
A Merck-funded study which appeared in the Annals of Internal Medicine in 2000, “Oral Montelukast Compared with Inhaled Salmeterol to Prevent Exercise-Induced Bronchoconstriction,” Jonathan M. Edelman, et al. Ann Intern Med.2000; 132: 97-104 (http://www.annals.org/cgi/reprint/132/2/97.pdf), involving the Exercise Study Group, is a case in point.
This is more required to be understood by non medical report writers who in my opinion may not appreciate the value of such findings in any study.
Such trends will be harmful for the patients at large.
Careers
Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.