Consortium to Study Genetics, Drug Safety
By JENNIFER CORBETT DOOREN
WASHINGTON -- A group of seven pharmaceutical companies and academic institutions today will announce an alliance designed to look for genetic links to safety problems associated with medicines.
The group, known as the International Serious Adverse Events Consortium, will launch two studies to look for genetic markers that researchers hope will predict which people are at risk for serious drug-related adverse events.
The first study, with results tentatively slated for release about a year from now, will look at whether variations in a person's DNA are responsible for the development of a rare drug-related skin condition known as Stevens-Johnson Syndrome. Stevens-Johnson is typically marked by a painful, blistering skin rash that causes the top layer of the skin to die. It can be fatal if a person is exposed to the drug that initially caused Stevens-Johnson again.
The second study will look at genetic variations behind serious drug-induced liver injury. Arthur Holden, a former Baxter International Inc. executive who is chairman of the consortium, said he hoped results from that study would be available in two years.
"Everyone's talking about drug safety, and this is what we need to do to improve drug safety," Mr. Holden said in an interview. The seven companies, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth are providing "millions" of dollars for the research effort, he said.
The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis. The DNA from the individuals with side effects will be compared with DNA from "control" subjects who didn't have drug side effects to see if there are genetic variations among the two groups.
Mr. Holden said that if the first two studies are successful, the consortium would then move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class.
The data from the consortium will be made public and could be used by government regulators such as the Food and Drug Administration.
Janet Woodcock, the FDA's chief medical officer, will work with the consortium, although the agency isn't formally a member. "We want this kind of information," she said of the genetic studies, so the agency can find ways to prevent drug side effects or to better manage them. Dr. Woodcock said it is possible that FDA regulations and guidelines on drug development and approval could change if the studies yield clear results.
Many serious drug side effects, such as an increased risk for heart attacks and strokes seen with Merck & Co.'s withdrawn painkiller Vioxx, don't become apparent until after drugs hit the market and thousands or millions more people are exposed. Most clinical studies used to gain approval for a drug involve several hundred to a few thousand patients.
Already, the FDA is highlighting genetic information to help doctors and patients manage drug side effects. Last month alone, the agency said as many as one-third of people on the blood-thinning drug warfarin metabolize the drug differently than expected and warned that breast-feeding women on painkillers with codeine could expose the infant to too much codeine if they are "ultra-rapid" metabolizers of the drug. However, the FDA stopped short of recommending that patients undergo genetic testing to see how they might process the drugs