A better understanding of why some people are predisposed to dangerous drug interactions and serious illness when taking new prescriptions will be the charge of a non-profit group being formed by several of the world’s largest pharmaceutical companies and the federal government.
Called the International Serious Adverse Event Consortium, the group will be announced Thursday by the Food and Drug Administration and seven drug making founders of the organization that include North Chicago-based Abbott Laboratories, Johnson & Johnson and Pfizer Inc. The new group’s office will be based in north suburban Deerfield.
Drug companies and the FDA alike have been under fire for perceived lax monitoring of prescription drugs once they reach the market. This was heightened three years ago this Sunday when Merck & Co. pulled Vioxx from the market after a study showed the drug, which had been on the market for more than four years, was associated with an increased risk of heart attacks and strokes.
Drug companies, which have large databases of reports from patients and doctors on how their drugs interact with patients, say they will use their information to conduct studies that will provide a map of “genetic markers” linked to serious adverse events, or SAEs, which can lead to serious injuries or death. Databases from universities and other consortia will also be used.
But because new medications such as expensive genetically-engineered drugs are complicated and costly to develop, these companies and their academic partners in the consortium cannot tackle the issue on their own.
“Patient safety is one of the biggest priorities of the FDA, and we are encouraged by this new consortium that will accelerate and advance our understanding of genetic variants associated with serious drug-related adverse events,” said Dr. Janet Woodcock, the FDA’s deputy commissioner and chief medical officer. “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.”
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 by addressing more safety issues for drugs before they reach the market.
Its first two studies will look at drug-related liver toxicity and Stevens-Johnson syndrome, a severe skin problem that leads to blisters, among other health problems.
“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,” said the consortium’s chairman and chief executive, Arthur Holden, formerly an executive at diagnostic-test maker Illumina Inc. “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.”