Pharmaceutical consortium to study genetic side effects link

Source: Healthcare Exec

Date :27/09/2007 09:01:38

Seven of the world’s largest pharmaceutical companies are to join forces to attempt to discover the genetic links to safety problems associated with medicines.

The firms say that they will use their large databases of reports from patients and doctors on how their drugs interact with patients to collectively conduct studies which they hope will provide a map of "genetic markers" linked to serious adverse events, or SAEs.

Databases from universities and other organisations will also be used.

‘Giants’

The companies are Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer, Roche Holding AG, Sanofi-Aventis SA and Wyeth.

Collectively, they will be called the International Serious Adverse Event Consortium, with an official announcement by the Food and Drug Administration due today.

Dr. Janet Woodcock, the FDA's deputy commissioner and chief medical officer, said:

"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."

‘Expense’

"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."

September 27, 2007

Related Links