[Source: Health and Life Sciences Daily, Sept. 28, 2007]
The New York Times (9/27, C3, Pollack) reported, "Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects." The FDA has "encouraged" the formation of the group, called "the International Serious Adverse Events Consortium." One of its goals is to determine if, by withholding drugs from patients who have a "genetic risk" for side effects, "it could not only protect the patients," but also "help manufacturers get their drugs approved or avoid having to remove them from the market." The group's first task will be to attempt to "find genetic predictors of two side effects -- serious liver toxicity and Stevens-Johnson syndrome, a rare but potentially fatal blistering of the skin. Both effects are associated with numerous drugs."
The AP (9/27, Johnson) quoted Dr. Janet Woodcock, deputy commissioner for operations at the FDA, as saying, "This is what personalized medicine is really about, finding out for the individual, not just the general population...what their risks are. ... 'Up until now we've been kind of helpless' in dealing with adverse effects." The AP noted, "Reports of such events are on the rise, jumping 150 percent from 1998 to 2005."
According to the Wall Street Journal (9/27, D7, Dooren), "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." Then, "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." Should the consortium's first two studies prove successful, it will "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 group plans to share data from its studies with the public and agencies like the FDA.
And, the Chicago Tribune (9/27, Japsen) added, "Drug companies and the FDA alike have been under fire for perceived lax monitoring of prescription drugs once they reach the market." The Tribune continued, "The group hopes to reduce an estimated 150,000 deaths and annual costs of more than $100 billion to the U.S. economy from serious adverse events (SAEs) by addressing more safety issues for drugs before they reach the market." Arthur Holden, the consortium's chairman and chief executive, said, "The traditional research model only provides one piece of the puzzle in understanding the genetic variations that could lead to an increased risk of an adverse event. ... The most efficient way to study drug-induced SAEs is to create a global, publicly available 'knowledge base' that will help identify the genetic variations that may predict SAEs."
