AUTHORS RESPOND: Postmarketing adverse drug reactions: A duty to report?
EranKlein, Oregon Health & Science University, and Neurology Service, Department of Veterans Affairs Medical Ce, kleine@ohsu.edu
; Dennis Bourdette, Oregon Health & Science University, Neurology Service, Department of Veterans Affairs Medical Center, and MS Center of Excellence-West, Department of Veterans Affairs Medical Center, Portland
Submitted June 21, 2014
Drs. Shubhakaran and Khichar astutely identify 2 important
tensions in the quest to improve drug safety: 1) balancing
commercial and public interest at the point of scientific
translation to clinical care and 2) balancing time-honored
ways of educating and improving clinical care, including
reliance on case reports, with new tools made possible by
the collection of "big data" and electronic communication.
We agree with the commentators that attributing side effect
causation to a medication is a challenging affair and one
that relies on contextual interpretation, which if left
solely in the hands of manufacturers with vested commercial
interests would raise concern. It is preferable for
clinicians to report adverse events directly to the Food and
Drug Administration (FDA) via Medwatch as it removes the
relevant pharmaceutical company from the process. However,
reporting directly to the manufacturer is a reasonable
alternative as FDA regulations on manufacturer reporting of
adverse events standardize what manufacturers must disclose,
significantly reducing manufacturer reporting discretion. As
students of medical history, we find the receding prominence
of the traditional clinical case regrettable, but as
educators we see also an opportunity for the emergence of
new forms of the case report, perhaps ones that are more
timely, standardized, and useful for the practicing
clinician.
Disclosures: E. Klein has received honoraria for speaking at
AAN meetings, serves on a Data Safety Monitoring Board for
the NIMH, receives publishing royalties for Story of
Bioethics (Georgetown University Press, 2003), and received
a geriatric neurology fellowship from the US Department of
Veterans Affairs. D. Bourdette has received educational
grants and speaker honoraria from Teva Neuroscience, Biogen
Idec, Novartis, and EMD Serono, Inc.; serves as an Associate
Editor for Journal of Medicinal Medicine and
Autoimmune Diseases, Section Editor for Current
Neurology and Neuroscience Reports, and on the editorial
board for Neurology; has a patent pending for the
treatment of MS with cyclic peptide derivatives of
cyclosporine; has served as a consultant to Elan
Corporation; is on the Speakers' Bureau for Biogen Idec; and
has received research grants from the NIH/NINDS
(1R01NS057433), the US Department of Veterans Affairs, and
the National Multiple Sclerosis Society.
Disclosures: E. Klein has received honoraria for speaking at AAN meetings, serves on a Data Safety Monitoring Board for the NIMH, receives publishing royalties for Story of Bioethics (Georgetown University Press, 2003), and received a geriatric neurology fellowship from the US Department of Veterans Affairs. D. Bourdette has received educational grants and speaker honoraria from Teva Neuroscience, Biogen Idec, Novartis, and EMD Serono, Inc.; serves as an Associate Editor for Journal of Medicinal Medicine and Autoimmune Diseases, Section Editor for Current Neurology and Neuroscience Reports, and on the editorial board for Neurology; has a patent pending for the treatment of MS with cyclic peptide derivatives of cyclosporine; has served as a consultant to Elan Corporation; is on the Speakers' Bureau for Biogen Idec; and has received research grants from the NIH/NINDS (1R01NS057433), the US Department of Veterans Affairs, and the National Multiple Sclerosis Society.