Drug firms search for clues to prevent serious side effects

- Business Gaurd

09/28/2007 - Pharmaceutical giants have joined forces with the US authorities and academia in an attempt to use genetics to discover why drugs which are otherwise successful can turn out to have potentially life-threatening side effects for some patients.

The industry has been spurred into action by a series of problems where drugs have been rejected by regulators or pulled from the market (most famously when Merck withdrew its painkiller Vioxx in 2004 over fears it increased the risk of heart attacks) at the cost of millions of dollars in wasted development and clinical trials.

Seven pharmaceuticals groups, including GlaxoSmithKline and Pfizer, have now teamed up with three academic institutions including Newcastle University, and the US Food and Drug Administration to create the Serious Adverse Events Consortium, or SAEC.

It aims to use genetics to understand why different people respond differently to medicine, with the aim of identifying those at risk of a serious problem before they take the medicine.

Existing data on serious adverse events will be collected from the companies and their academic partners, and the consortium will capitalise on knowledge gained through mapping of the human genome.

Safety has become an important issue amongst consumers and the industry, and four out of five attempts to launch medicines on the US market this year have been delayed by the FDA, hitting share prices.

Other drugs failed at a very late stage of development due to serious side effects, and, once on the market such as Vioxx, at a loss of hundreds of millions of dollars. Janet Woodcook, the FDA's deputy commissioner and chief medical officer, said: "The FDA has been struggling for three decades with serious adverse events from drugs. In most cases, we had no idea how these came about."

Arthur Holden, the chairman of the SAEC, added: "Why do we need to throw out a medicine that is very efficient for many people, if we can screen out those people that are at risk of these adverse reactions?"

The SAEC will start by focusing on two problems: drug-related liver toxicity; and a rare but horrific skin condition called Stevens-Johnson Syndrome, which can be caused by almost any medication, including over-the-counter drugs such as Ibuprofen. It will attempt to find specific genetic markers that will be made available to researchers, drug developers and pharmaceutical companies, helping them address safety issues. The aim will then be to research other adverse reactions such as cardiac arrhythmia, weight gain, anemia and renal failure.

Mr Holden said: "Because of the number of patients needed to tie a genetic variant to an SAE [serious adverse event], and the resulting cost of doing these studies, no one company, research centre, or agency can efficiently conduct this research on its own.

"The most efficient way to study drug-related SAEs is to create a global, publicly available 'knowledge base' that will help identify the genetic variations that may predicts SAEs."

Dan Burns, senior vice president for pharmacogenetics at GlaxoSmithKline, said it had decided to participate in the consortium because it was consistent with the work it was doing on patient safety.

But he warned that genetics were probably not enough to ensure safety, and other aspects such as patient compliance had to be taken into account.

The SAEC plans to have information out about Stevens-Johnson Syndrome within a year.

Ennis & Ennis, P.A. is representing individuals that have Stevens Johnson Syndrome due to side effects of prescription drugs. For more information about a Steven's Johnson Syndrome related lawsuit click here to contact our lawyers for a free, confidential case evaluation.