Will FDA speed up 'path' to treatments?

The Food and Drug Administration hopes to modernize health care in America by smoothing the path between a really promising idea for a treatment and its actual use by a patient. Doing it, though, will take money, new ideas and the sharing of information, says FDA commissioner Dr. Andrew Von Eschenbach.

Sen. Bob Bennett, R-Utah, held a field hearing of the Senate Appropriations Committee at the University of Utah Friday, bringing academics, doctors and government leaders together to discuss the FDA's "Critical Path Initiative."

"We are on the verge of the most profound transformation in the history of medicine," Von Eschenbach said. The medicine of the future "will look no more like the past than a butterfly looks like a caterpillar. It's that profound."

The new frontier looks at genetics as one tool to make people well or even prevent disease. It makes personalized medicine a realistic expectation, according to Dr. David Jones, senior director for early translational research in the Huntsman Cancer Institute.

Critical Pathway takes a drug or medical device from concept to cure, using applied science to help predict and test product safety and effectiveness, as well as who is most likely to respond to the treatment. Genetics and therapeutics are wed in a step toward personalized medicine and, Von Eschenbach said, it should shorten development time and cost.

The initiative is driven in part by a significant and unwelcome decline in new medical products. The road to FDA approval is cumbersome and costly, Bennett said. The goal is to use bioinformation, technology and good ideas to get better treatments to patients in much less time.

They discussed a lung cancer drug found to be so effective for some that they moved from their deathbeds to periods of recovery. But it helped only 10 percent of those who used it. Researchers identified common traits for that 10 percent and developed a genetics test that could help with treatment decisions, but many insurance companies balked at the $500 cost. So some doctors prescribe it at $2,500 a month to all their lung cancer patients, 90 percent of whom gain nothing. Genetic testing would tell them who is most likely to benefit from it.

There are challenges to genetic testing, including fears about confidentiality. Most people don't want their insurance companies and employers to know about their potential to develop a disease in the future, Bennett said.

Dr. Raymond L. Woosley, CEO of the Critical Path Institute, says it costs a fortune to bring drugs from idea to store shelves. The failure rate has doubled. And as many as 4 percent of drugs that make it are later pulled.