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7 Pharma firms join forces to identify patients at risk of adverse events by developing genetic tests
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28/09/2007
www.pharmatimes.com
Seven leading pharmaceutical companies are joining forces to develop gene tests that identify patients at risk of dangerous adverse drug reactions.
The Serious Adverse Events Consortium, consisting of Abbott, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, sanofi-aventis and Wyeth, will begin by searching for genetic links to severe liver toxicity and also the dangerous skin reaction, Stevens-Johnson syndrome.
The industrial collaboration will work with the US Food and Drug Administration and academic partners including the London School of Hygiene and Tropical Medicine, and Columbia University in New York.
The SAEC project is based on the hypothesis that patients' varying responses to medicines have a genetic basis, and that by developing gene tests to identify vulnerable individuals, these can people can be spared the risk, while the majority can continue to benefit from the treatment.
Duncan McHale, a researcher for Pfizer and co-chairman of the consortium's scientific management committee, said the aim of the project was to avoid the situation where "we have to remove drugs that are clearly offering patients benefits because a handful are getting these severe adverse reactions".
The project comes at a time when the number of drug-related deaths and injuries reported to the FDA more than doubled between 1998 and 2005, according to a report in the 10 September issue of the Archives of Internal Medicine.
Fund of $1billion a year
Arthur Holden, the consortium's chief executive, said the companies would fund the project to the tune of $1 billion a year, while the actual research would be done by contractors and academic laboratories.
He added that researchers would largely rely on DNA samples that had already collected from patients who had suffered liver toxicity or Stevens-Johnson syndrome as a result of medication.
Dr Mariam Molokhia, a clinical genetic epidemiologist from the London School of Hygiene and Tropical Medicine involved in the project said: "Identifying genetic variants that influence susceptibility to ADRs has obvious practical applications, and more generally will contribute to understanding of the molecular basis of adverse drug reactions.
She added that by pooling resources, industry and academia would make quicker progress. "As most such ADRs are rare, a case-control design is the only feasible approach, and a multicentre international collaboration is necessary as no single country will generate enough cases of any given ADR within a reasonable time."
Dr Janet Woodcock, the FDA's deputy commissioner and chief medical officer, said: "We are encouraged that this new consortium will play an important role in enhancing drug safety by accelerating and advancing our understanding of genetic variants associated with these adverse events."
The results from SAEC research studies will be made available to the research community for further study. The European Union is also supporting the project. Michael Day
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