GlaxoSmithKline (NYSE: GSK)announced that it will join with other pharmaceutical companies, academic institutions and the U.S. Food and Drug Administration to research genetic markers that may help predict who is at risk for serious drug-related adverse events.
“Improved technology makes it more possible for us to identify and even predict how patients may react to a particular medicine,” said Dan Burns, senior vice president for pharmacogenetics. “By working together, we can accelerate and expand work already underway to understand how we can use genes to identify what patients will benefit most from which medicines.”
Formation of the group – the International Serious Adverse Events Consortium (SAEC) – was announced today by Janet Woodcock, deputy commissioner and chief medical officer of the FDA, along with Arthur Holden, chairman of the SAEC.
GSK is an industry leader in several major areas of pharmacovigilance and genetic and genomic research that are likely to have a significant impact on patient care in the coming decade.
GSK gathers genetic samples from patients in clinical trials, who have given their consent, to link patients’ genotypes with their responses to medicines. Evaluation of DNA samples, along with analysis of data regarding drug safety and efficacy, may make it possible to correlate patient response to a medicine with specific genetic markers or patterns. The results of this research are likely to affect certain patient subpopulations in the near future.
Genetic research has demonstrated, for example, that many common variations in genes affect the breakdown (metabolism) of medicines in the body. People who carry one of these gene variants may need a higher or lower dose of a certain drug for it to be effective or to avoid serious side effects – or they may need to avoid it entirely.
These genetics-related efforts are part of a larger program at GSK to monitor benefits and risks of medicines. All potential medicines already undergo extensive testing for their ability to cause possible side effects before they are tested in humans. Once drugs are approved and widely available, adverse events are recorded on a global safety database and clinical trial database and investigated by GSK’s clinical and pharmacovigilance teams. When appropriate, the company responds to safety issues by changing product labelling and communicating with doctors. In a small number of cases, additional efforts are need to minimize risks.
GSK’s participation in the Serious Adverse Events Consortium aligns with the company’s commitment to patient safety, as outlined in its Patient Safety Charter. The company’s pharmacovigilance effort includes helping predict patients’ responses to medicines so that health care providers can prescribe safer and more effective medicines, resulting in better heath outcomes.
‘’The charter is part of a pharmacovigilence effort that demands an efficient, worldwide monitoring system within the company to detect, assess and understand adverse effects or any other drug-related issue,’’ said Trevor Gibbs, GSK senior vice president for medical governance.