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.
1 comment:
Hi, probably our entry may be off topic but anyways, I have been surfing around your blog and it looks very professional. It’s obvious you know your topic and you appear fervent about it. I’m developing a fresh blog plus I’m struggling to make it look good, as well as offer the best quality content. I have learned much at your web site and also I anticipate alot more articles and will be coming back soon. Thanks you.
Medical Writing Service
Post a Comment