October 7, 2005

VUMC lands FDA grant to study drug safety

Featured Image

Attending the Clinical Proteomics workshop were: (front row, from left) Ronald Beavis, Ph.D., Beavis Bioinformatics Ltd.; David Friedman, Ph.D., and Amy-Joan Ham, Ph.D., Vanderbilt Mass Spectrometry Research Center (MSRC); Timothy Veenstra, Ph.D., NCI; and Daniel Liebler, Ph.D., director, Vanderbilt Proteomics Laboratory; (back row, from left) David Carbone, M.D., Ph.D., VICC; Martin McIntosh, Ph.D., Fred Hutchinson Cancer Research Center; and Pierre Chaurand, Ph.D., MSRC.
photo by Mary Donaldson

VUMC lands FDA grant to study drug safety

Vanderbilt University Medical Center researchers have been awarded a major government contract to perform drug safety studies using large Medicaid databases from the states of Tennessee and Washington.

The $1.35 million, five-year contract was awarded earlier this month by the U.S. Food and Drug Administration as part of ongoing efforts to improve post-marketing drug surveillance.

Wayne Ray, Ph.D., professor of Preventive Medicine, is principal investigator, and William Cooper, M.D., M.P.H., associate professor of Pediatrics, is co-investigator of the project, which aims to “improve the safe use of drugs in high-risk and under-represented populations.”

The automated Medicaid databases include 2 million enrollees, of whom more than a million are children, 425,000 are African-Americans, 173,000 are Hispanics and 20,000 are Native Americans. Medicaid enrollees were chosen for the study because they are often underrepresented in employment-based insurance databases and pre-marketing trials, the researchers said.

The FDA already receives reports of possible adverse drug reactions. The agency wants to be able to quickly determine incidence rates based on these reports, and whether the reports may signal more widespread drug safety problems.

Ray and his colleagues, including Marie R. Griffin, M.D., M.P.H., professor of Preventive Medicine and Medicine, are well known for their contributions to the field of pharmacoepidemiology — the study of the use and effects of drugs in populations.

Since 1986, they have had a cooperative agreement with the FDA to conduct postmarketing studies, one of which linked the use of ACE inhibitors, drugs used to treat heart failure, to birth defects.

Ray, Griffin and their colleagues also were among the first to report that patients on high doses of Vioxx had nearly twice the rate of serious heart problems, including heart attacks and heart-related deaths, compared to patients not on the drug.

Currently Cooper is leading a collaborative study to determine whether antibiotics likely to be used in the event of a bioterrorism attack are associated with an increased risk of birth defects.