Thursday, December 10, 2009
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.
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.
Saturday, December 5, 2009
Therapeutic advice Services
Dear All,
We have initiated a new service for all health-care service utilizers. Therapeutic advise is a service which can be availed by a patient as well as the medical practioner to confirm the scientific basis of this/her prescription to a patient. We offer these services online only on post event scenario. No hypothetical prescription will be evaluated on the pharmacological basis. The services are at a cost. I feel that today such services are required when the practice is taking a different shape and becomming more commercial than ethical nature. The details can be viewed at our website www.mmspl.co.in
I would like to know your opinion and suggestions .
Best wishes
Prof.Dr.Sudhir Dagaonkar
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