An effort that joins major drugmakers, regulators and academics will be launched on Thursday to study the genetics of people who develop serious side effects from prescription drugs.
The information may eventually help doctors determine which people are at risk for complications before prescribing a drug, another step toward "personalized medicine."
It also may allow pharmaceutical companies to bring to market new medicines that in the past would be scrapped because of serious problems in a small number of patients, officials said. The drugs might still be able to be used if genetic tests could identify in advance who might develop bad reactions.
"My hope is we can dramatically influence the safe use of drugs in the clinic but also in development," Arthur Holden, chairman and chief executive of the new group, said in an interview.
Called the International Serious Adverse Events Consortium, the nonprofit effort is funded by millions of dollars from seven drugmakers, Holden said, declining to provide an exact figure.
Initial work will focus on drug-induced liver injury and a rare skin reaction called Stevens-Johnson Syndrome, which causes a life-threatening rash and blisters.
Researchers will analyze genetic information from patients who developed either problem and compare it with others who did not. They will search for any genetic variations common to people who suffered the complications.
Results will be made available to the public for use in developing diagnostic tests for the genetic patterns.
"This provides us, for the first time, the opportunity to see if some of these serious drug reactions actually have a genetic basis. That would allow us to identify people who are at risk for these things," said Dr. Janet Woodcock, an FDA deputy commissioner and chief medical officer.
The FDA is providing scientific advice on the research projects and study designs, Woodcock said.
Abbott Laboratories, Pfizer Inc, GlaxoSmithKline PLC, Johnson & Johnson, Roche Holding AG, Sanofi-Aventis and Wyeth have joined the project. Holden said he expected other pharmaceutical companies to sign up.
The group is one of several recent efforts to improve the detection of dangerous side effects following a series of drug-safety controversies. President George W. Bush is expected within days to sign legislation designed to strengthen the FDA's oversight of drug risks.