Science in the Triangle

I was one of about two dozen visitors Thursday who took a first look at the new Hamner Institute for Drug Safety Sciences. Also among the visitors was Janet Woodcock, a Food and Drug Administration top executive who oversees the approval and regulation of all U.S. medicines. Woodcock called the opening of the 14,000-square-foot research laboratory in Research Triangle Park a “milestone in drug safety regulation.”

The research lab is the first result of a partnership between the University of North Carolina at Chapel Hill and the Hamner Institutes of Health Sciences, which was estbalished last September with about $10 million in funding.

On the tour, scientists from the Hamner and UNC explained how they are trying to better understand rare but potentially fatal side effects new medicines may have. The goal is to detect the risks specific drugs pose to certain people before the drugs come to market.

The research lab plans to initially look into liver toxicity and then expand into cardiovascular and kidney side effects.

The FDA currently receives about 250,000 reports of serious and unexpected side effects drugs have on people every year, Woodcock said. Regulators have begun to require diagnostic tests that screen out patients particularly at risk for some of the side effects. Also, the FDA is setting up a drug safety surveillance system that taps elecrtonic health records.

But generally, the FDA is limited to listing all possible side effects of a drug in the packaging information even though some patients might be more at risk and should worry more than others.

Headed by Dr. Paul Watkins, a UNC professor of medicine, the Hamner Institute for Drug Safety Sciences will draw from three decades of experience Hamner scientists have accumulated about chemicals’ health effects, a new approach in animal testing, access to genetic information and patients at risk for side effects and a virtual liver, a computer-based simulation of drug-induced liver injuries.

The brand new research lab at the Hamner, which features sophisticated equipment and row upon row of lab benches, has already begun to work with the Shanghai Center for Disease Control to conduct a study in patients who have experienced liver toxicity as a result of taking tuberculosis treatments.

For the first time, Woodcock said, “the science to reduce the worldwide drug safety problem is at hand.”