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Top pharmaceutical companies, the FDA and university researchers are working together on a pioneering project to discover why some patients suffer severe drug side-effects.
The International Severe Adverse Events Consortium will use genetic data to try to design safer drugs, and identify patients at risk because of variations in their genes.
Dr Janet Woodcock, deputy commissioner for operations at FDA, said: “This is what personalised medicine is really about – finding out for the individual, not just the general population, what their risks are.”
She said that “up until now we’ve been kind of helpless” in dealing with adverse reactions.
A recent study found reports of severe side-effects increased by 150% between 1998 and 2005.
The partnership will initially focus on liver damage and a rare life-threatening skin disorder called Stevens-Johnson syndrome.
The researchers will compare DNA from the two groups to identify the genetic variations linked to the side-effects.
They plan to collect more DNA samples and later expand the study to other adverse events, including ones associated with popular cholesterol-lowering drugs.
Seven of the world’s biggest drug companies are participating: Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, Sanofi-Aventis and Wyeth. The FDA will advise them on designing the research and interpreting the results.
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