10/24/2011 - There's an arms race going on, Sen. Richard Blumenthal said Monday, and we're losing.
"We're in an arms race with pathogens that are evolving faster than we are developing drugs to treat them," the Connecticut Democrat said during a press conference at Hartford Hospital.
He was there to tout his support for a measure aimed at encouraging drug makers to develop new antibiotics that can combat drug-resistant bacteria. The GAIN Act--Generating Antibiotic Incentives Now--would extend the patent on antibiotics by five years, giving drug companies more time to exclusively market the medications they develop. It would also give qualifying drugs priority review by the Food and Drug Administration, and would allow pharmaceutical companies to seek guidance from the FDA sooner in designing clinical trials.
Sharon Ladin, director of the Pew Health Group's antibiotics and innovation project, noted that between 1935 and 1968, there were 13 new classes of antibiotics brought to market, each of which attacked bacteria in a unique way. Since 1968, as bacteria have continued to evolve, only two classes of antibiotics have been introduced and developed.
There are three main challenges to innovation in antibiotics, Ladin said. They're expensive and difficult to develop, and because they are usually prescribed for short courses, antibiotics tend produce lower revenues than drugs that treat chronic conditions like high cholesterol or high blood pressure.
In addition, Ladin said, it's difficult to develop clinical trials for antibiotics since researchers can't give placebos to patients with active infections as a way to compare the effect of a drug being developed. The regulatory pathways could use more clarity, she said.
Read the full article, Blumenthal Backs Measure to Promote Drug Development, on the Connecticut Mirror's Web site.