Is There a Genetic Basis for Who Experiences Drug Side Effects?

First Genetic Trust Inc. (FGT), Deerfield, Ill., and GlaxoSmithKline, Brentford, UK, will again collaborate on a study of possible genetic markers associated with adverse drug reactions, FGT announced on May 25.

FGT will provide the software platform, previously developed together with GSK, to collect, manage, and analyze genetic profiles and clinical data. This pharmacogenetic information may show that specific adverse drug effects are more likely for patients with particular genetic markers. This in turn could allow more precise procedures for prescribing the drugs, and an overall reduction in side effects. The pharmacogenetic information can also provide clues about why the adverse effects happen to particular people.

In addition to the scientific information, FGT says their platform securely manages patient data such as enrollment and informed consent information. This is particularly important when handling sensitive genetic data. The system can also enlist patients for follow-up information.

Penelope Manasco, MD, executive vice president and chief medical officer of FGT, says that the "speed and efficiency" of having a common, Web-based interface for study sites across the country allows the study to enroll more people.

But the current program goes further. "We're also developing some innovative approaches to study rare adverse events" that occur after a drug is on the market, Manasco says. "Usually by the time you start to get a signal, it may be too late to be able to do anything about it."

With rare adverse events, there are likely only a handful of occurrences at any one city, in areas all over the country. "How do you enroll people and how do you do this fast enough to [improve] the safety of a drug already on the market? That's the real challenge, and one that nobody has been able to answer yet," Manasco says. "We're hoping that this is the answer."