GSK takes new approach to drug checks

Pharmaceutical giant GlaxoSmithKline (GSK) is blazing a new trail by using pharmacogenetics approaches for post-approval surveillance of new drugs.

Dr Allen Roses, VP of genetic research at GSK, told Australian Biotechnology News at the XIX International Congress of Genetics that the company was developing systems to collect and store DNA samples from the first 250,000 patients to use newly approved drugs, to be tested only if adverse events are recorded.

"It's a Phase IV true risk management commitment," he said.

The system will be designed to provide information about patient populations susceptible to developing adverse events in response to administration of particular compounds.

"We want to say who should not take a particular drug, not who should," Roses explained. "It's fast and affordable, the hardest part is getting the phenotype."

But for adverse events, just a few informative markers are enough to detect a high negative predictive value -- it's not necessary to find all related markers. GSK is already testing the system on drugs in pilot studies using drugs in clinical trials.

Presenting the data at a recent PhRMA meeting in the US, GSK appears to have already persuaded the US FDA of the benefits of the system. And other companies are also interested in the system.

"None of the major pharmaceutical companies batted an eyelash [when we proposed the system to them] -- as long as everyone did it," Roses said.

According to Roses, the system would potentially save pharmaceutical companies millions of dollars, and would cost very little to set up and maintain.

Security of the system would be an important consideration, he said, and GSK is working with a number of biotechnology companies to develop GMP procedures for obtaining and storing samples securely, while maintaining patient privacy.

But at issue still is how to deal with already approved drugs. "If we can do it for new drugs, who will do it for old drugs?" Roses said.