Consortium studies genetic markers, hopes to predict SJS
January 10th, 2009 by Jennifer Walker-Journey
The International Serious Adverse Events Consortium (SAEC) is a global, nonprofit partnership between leading pharmaceutical companies, the FDA and academic institutions. It was organized just more than a year ago. Among its goals, the consortium hopes to identify genetic markers that predict which individuals are at risk for drug-related serious adverse reactions, also known as SAEs.
Currently, the SAEC is conducting a study that addresses Stevens Johnson Syndrome (SJS). SJS is a rare but life-threatening reaction to medication. SJS affects the skin and mucus membranes, causing blisters to form on the skin and the skin to peel off in sheets. Blisters also can form on the mouth and eyes, causing serious eye complications and even blindness. SJS is linked to more than 200 medicines. Most often SJS is linked to ibuprofen, antibiotics and anti-seizure medication.
Researchers for the SAEC project will look for genetic variations linked with SAEs from the SNP Consortium and the Human Genome Project’s Hap Map Project.
“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. Because of the number of patients needed to tie a genetic variant to an SAE, and the resulting cost of doing these studies, no one company, research center, or agency can efficiently conduct this research on its own. The most efficient way to study drug-related SAEs is to create a global, publicly available ‘knowledge base’ that will help identify the genetic variations that may predict SAEs,” SAEC Chairman and CEO Arthur Holden said in a September 2007 announcement in Highlight Health, when the consortium was formed.
The SAEC research study will be made available within 12 months of completion. If initial studies are successful, the consortium vows to study every major SAE to find its genetic cause.