4/21/2016- Final Report
Charles L Bennett MD PhD MPP, SmartState Chair, Medication Safety and Efficacy.
(bennettc@sccp.sc.edu)
Visiting Scholars Grant
Obstetric and Pediatric Research
Amount of Award: $6,000 (55% of the grant was returned to the Office of the Provost)
Executive Summary: This Visiting Professor Grant supported two visits to the University of
South Carolina of Donald Mattison MD, a member of the Institute of Medicine and an
international leader in pharmaceutical safety research. The result of the Grant was two published
manuscripts and three submitted grants focusing on training awards for junior faulty.
Products of the Grant – two manuscripts:
Bennett CL, Starko KM, Thomsen HS, Cowper S, Sartor AO, MacDougall I, Qureshi ZP,
Bookstaver PB, Miller AD, Norris LB, Xirasagar S, Trenery A, Lopez I, Kahn A, Murday A,
Luminari S, Cournoyer D, Locatelli F, Ray P, Mattison DR. Linking drugs to obscure illnesses:
lessons from pure red cell aplasia, nephrogenic systemic fibrosis, and Reye’s syndrome. A report
from the Southern Network on Adverse Reactions (SONAR). J Genl Intern Med, 2012
Dec;27(12):1697-703. doi: 10.1007/s11606-012-2098-1. Epub 2012 Jun 13.
Chen B, Restaino J, Norris LB, Xirasagar S, Qureshi ZP, McKoy JM, Lopez I, Trenery A,
Murday A, Kahn A, Mattison DR, Ray P, Sartor AO, Bennett CL. A tale of two citizens: a state
attorney general and a hematologist facilitate translation of research into FDA actions. J Oncol
Practice 2012. doi: 10.1200/JOP.2011.000504
This visiting scholar award supported two day-long visits by Donald Mattison MD to the
University of South Carolina. Dr. Donald is currently the appointed Chief Medical Officer and
Senior Vice President of Risk Sciences International and Associate Director of the McLaughlin
Centre for Population Health Risk Assessment at the University of Ottawa- a position he was
appointed to in 2012. Dr. Mattison has held advocacy, academic, clinical and research
appointments, including; Senior Advisor to the Director of the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, Medical Director of the March of Dimes;
Dean of the Graduate School of Public Health at the University of Pittsburgh, Professor of
Obstetrics and Gynecology and Interdisciplinary Toxicology at the University of Arkansas for
Medical Sciences, and Director of Human Risk Assessment at the FDA National Center for
Toxicological Research. Dr. Mattison earned a BA (Chemistry and Mathematics) from
Augsburg College in Minneapolis, MN, an MS (Chemistry) from the Massachusetts Institute of
Technology, Cambridge, MA and a MD from the College of Physicians and Surgeons, Columbia
University, New York, NY. His clinical training in Obstetrics and Gynecology was at the Sloane
Hospital for Women in the Columbia Presbyterian Medical Center in New York. His training in
Pharmacology and Toxicology was at the National Institutes of Health, Bethesda, MD. In 1997,
he was elected a Fellow of the American Association for the Advancement of Science, in 1999, a
Fellow of the New York Academy of Medicine, in 2000 a member of the Institute of Medicine,
in 2005 Distinguished Alumni of Augsburg College and in 2009 a Fellow of the Royal Society of
Medicine.
Dr. Mattison’s visitations focused on providing insights into pharmaceutical safety research and
the FDA initiatives in this area. The visits consisted of one hour one-on-one sessions with junior
and senior researchers affiliated with the SmartState Center of Economic Excellence (CoEE) for
Medication Safety and Efficacy. Brian Chen JD PhD met with Dr. Mattison during these visits
and built on the meetings to develop grant applications for pharmaceutical safety that have been
submitted to the National Institutes of Health (K-award applications that received scores just
below the funding line) and an under-review grant application to the Burroughs Wellcome
Foundation on health policy and pharmaceutical safety.
Dr. Mattison also advised the R01-grant, the Southern Network on Adverse Reactions (SONAR),
on the feasibility of filing Citizen Petitions to support pharmaceutical safety research findings.
This consultation resulted in the filing of two under-review Citizen Petitions with the FDA
related to neuropsychiatric toxicities that occur following ciprofloxacin and levaquin
administration. These Petitions remain under consideration by the FDA. The supporting work
has been described in one journal publication (2016 in the Journal of Community and Supportive
Oncology), 60 news interviews nationally (in most major cities), and at an FDA Advisory
Committee Meeting in November 2015. The Advisory Committee voted 21-0 that the product
labels for the two drugs should be revised- supporting inclusion of the SONAR findings into the
revised labels. Dr. Mattison also led a workshop on pharmaceutical safety that was attended by
faculty and students. This workshop provided an introduction into the FDA and pharmaceutical
safety.
The Visiting Professorship allowed junior and senior investigators to complete about ten
manuscripts on pharmaceutical safety. Two of these manuscripts formally included Dr. Mattison
as a co-author. The manuscripts included as co-authors faculty and post-doctoral students from
the Arnold School of Public Health and the College of Pharmacy.
Overall, this Visiting Professorship was very successful. It is my hope that the pending grant from Brian
Chen JD PhD to the Burroughs Wellcome Foundation on pharmaceutical safety is favorably reviewed.