New Group Formed to Investigate Drug Side Effects
A new group has today been formed which will investigate the cause of drug-related side effects at a genetic level. The group is comprised of members from the fields of drug manufacturing, drug regulation and academia. The results of their research, it is hoped, could ultimately assist doctors with assessing risk factors within patients on an individual basis when prescribing them with drugs. On a corporate level, pharmaceutical firms could also benefit from it allowing them to market new medicines that, previously, would have been rejected for causing side effects in a minority of patients.
In other words, the drugs in question could still have a purpose if it could be determined, through genetic analysis, the risk and extent of future side effects within individual cases.
The group's Chairman/Chief Executive, Arthur Holden, stated the following in an interview: "My hope is we can dramatically influence the safe use of drugs in the clinic but also in development."
The group is entitled the International Serious Adverse Events Consortium. A non-profit-making organisation, its funding has been provided by seven drug manufacturing firms. Both these details were given during Mr Holden's interview, although he did not specify at what level the funding was given.
The seven companies involved are Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson Pfizer Inc, Roche Holding AG, Sanofi-Aventis and Wyeth.
The consortium's first work will revolve around damage to the liver caused by drugs, and Stevens-Johnson Syndrome an uncommon skin reaction that can ultimately kill. Those involved in the research element will assess genetic data, both from patients with either of these two conditions, and those without. Once established, the results will be publically available
In an interview given by Dr Janet Woodcock, she highlighted the virtues of the tie-up's aims. This provides us, for the first time, the opportunity to see if some of these serious drug reactions actually have a genetic basis, she said. That would allow us to identify people who at risk for these things.
Dr Woodcock is a Deputy Commissioner within the US FDA.
The formation of the group is a reactionary measure to the recent criticism levelled at the US FDA regarding the standard of its regulation after a raft of high-profile scandals.
Source Pharmaceutical Internationals US Correspondent
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