October 2nd, 2007
Jumping Into the Pool
The New York Times, the WSJ Health Blog and others wrote last week about a new consortium that will develop global research programs geared toward determining which patients would be at risk of drug-related serious adverse events.
The consortium, called the International Serious Adverse Events Consortium (SAEC) is comprised of seven pharmaceutical companies, including Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), and academic institutions with scientific and strategic input from the US FDA. The consortium will start by trying to find genetic predictors of that are associated with drug-related liver toxicity and Stevens-Johnson Syndrome.
Hearing about this, I did a bit of digging and learned that J&J PRD got involved in this from the very start, recognizing that by collaborating and sharing data with others in this way, the consortium could generate information that might really have an impact on patient health.
The SAEC will examine the impact genes can have on how individuals respond to medicines and the results from the studies will be made available to the research community. Although the FDA isn’t formally a member of the consortium, the agency will work with the consortium. Janet Woodcock, the FDA’s chief medical office, told the Chicago Tribune:
Given the considerable size and cost of conducting safety studies, a coordinated strategic partnership between industry, academia and government can more rapidly advance this critical science.
It’s the first such collaboration of its kind, and while it’s too early to say what the impact of this will be, pooling knowledge seems a good place to start.