Drug Makers, FDA Partner on Drug Safety

TRENTON, N.J. -
A rare collaboration of top pharmaceutical companies, regulators and university researchers has begun attacking one of the toughest problems in medicine: why severe drug side effects strike a small percentage of patients.

Dubbed the International Severe Adverse Events Consortium, the project will use genetic data to try to design safer drugs and to identify patients at risk of dangerous side effects because of a variation in their genetic makeup.

"This is what personalized medicine is really about, finding out for the individual, not just the general population ... what their risks are," said Dr. Janet Woodcock, deputy commissioner for operations at the Food and Drug Administration, which is under growing pressure to ensure drugs are safe. "Up until now we've been kind of helpless" in dealing with adverse effects, she said.

Reports of such events are on the rise, jumping 150 percent from 1998 to 2005, a recent study found.

The project, to be officially announced Thursday, could bring breakthroughs that change patient care in as little as five years, the consortium's chief executive, Arthur Holden, said Wednesday. Independent experts agreed, but said the researchers will need a little luck along the way.

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