Healthy Skepticism Library item: 11597

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Publication type: news

Johnson LA.
Drug Makers, FDA Partner on Drug Safety
Associated Press 2007 Sep 27
http://biz.yahoo.com/ap/070927/side_effects_collaboration.html?.v=1

Full text:

Drug Makers, FDA Start Global Partnership to Make Drugs Safer

TRENTON, N.J. (AP) — 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.

Woodcock called the effort “groundbreaking” because the pharmaceutical companies will share data among themselves and later with researchers worldwide through an open database. Seven of the biggest pharmaceutical companies are participating: Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth. FDA will advise them on designing research and interpreting results.

Pharmaceutical companies have a lot at stake. Serious adverse reactions during testing generally doom experimental drugs, and ones that surface after a drug is on sale often lead to it being pulled from the market or having its use restricted.

“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, said Raju Kucherlapati, scientific director of the Harvard Medical School-Partners Healthcare Center for Genetics and Genomics, who is 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 said.

Dr. Franklyn Prendergast, director of the Mayo Clinic’s Center for Individualized Medicine, said 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 added that making its findings available to scientists worldwide will help “profoundly” in related research.

Holden said the participating drug companies 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.