This is an unusual grouping - seven big drugmakers and university researchers with backing from the FDA - are teaming to study the genetic links in some patients to side effects caused by medicines. The International Severe Adverse Events Consortium will use genetic data to try to design safer drugs and to identify patients at risk.

“This is what personalized medicine is really about, finding out for the individual, not just the general population…what their risks are,” Janet Woodcock, FDA deputy commissioner, tells the Associated Press. “Up until now we’ve been kind of helpless” in dealing with side effects.

The project, which will be officially announced this morning, would hopefully foster breakthroughs that change patient care in as little as five years, according to consortium’s chief executive, Arthur Holden. The drugmakers involved will share data among themselves but later make it available to researchers worldwide through an open database. The drugmakers participating include Abbott Labs, Glaxo, Johnson & Johnson, Pfizer, Roche, Sanofi-Aventis and Wyeth. The FDA will advise them on designing research and interpreting results. (Here is the statement).

Drugmakers have a lot at stake, as the AP notes. Serious adverse reactions during testing generally doom experimental meds, and ones that surface after a drug is on sale often lead to it being pulled from the market or having its use restricted. Over the last decade, such episodes have led to mounting litigation and a crisis of confidence in the industry as well as the FDA as a watchdog of public health.

“If you can prevent these types of reactions, it’s going to have a significant impact on health care,” because adverse drug effects cause considerable illness and death, Raju Kucherlapati, scientific director of the Harvard Medical School-Partners Healthcare Center for Genetics and Genomics, tells the AP. He’s not involved in the project.

Holden envisions people getting standardized profiles of key genetic variations, which then could be checked before they are put on a new drug that has known, gene-related risks. He said employers and insurers now spend far more on hospitalization of patients harmed by serious adverse effects than what genetic tests would cost once they are common.

The project initially will focus on two key adverse effects: liver damage and a rare life-threatening skin disorder called Stevens-Johnson Syndrome. Holden already has collected from project partners the DNA samples and medical histories of about 3,000 people. Half suffered medication-related liver damage or Stevens-Johnson syndrome; the other half are a comparison group matched on factors such as age, race and overall health.

The researchers will compare DNA from the two groups to identify the genetic variations linked to the adverse events. The consortium plans to collect more DNA samples and later expand its research to other adverse events, including ones associated with widely used cholesterol-lowering drugs, Holden says.

Franklyn Prendergast, director of the Mayo Clinic’s Center for Individualized Medicine, tells the AP that given the clear evidence that genetic variations put some patients at high risk of bad drug effects, he is sure the project will have a big impact. He adds that making its findings available to scientists worldwide will help “profoundly” in related research.

Holden claims the participating drugmakers together have put up millions of dollars to fund the work. Other partners include Columbia University, which will coordinate and analyze data, plus the European Agency for the Evaluation of Medicinal Products and two academic consortia in Europe, called Diligen and Eudragene.