AUTHORS RESPOND: Postmarketing adverse drug reactions: A duty to report?

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.