OBESE KIDS
A N D LU N C H
the genomes of bacteria in order to find new antibiotics.
The FDA is another slow-down for antibiotic
development. The agency’s guidelines for the drug
review process require 20 to 80 human subjects for phase
one testing, a few dozen to three hundred subjects for
phase two testing and several hundred to 3,000 subjects
for phase three testing.
A PEW research report says that the large number of
test subjects required makes it difficult to reach approval
for antibiotics that treat resistant bacteria, because it is
not easy to find test subjects in sufficient quantities who
are sick with resistant bacteria.
“Superbugs are killing people
now,” Mobashery says. “The
alternative of not doing
anything is not acceptable.
There is need for hustle by
everyone.”
A PEW research report says that there are 38
different antibiotics in development right now and
seven are in phase three testing. These drugs have the
potential to treat many different resistant bacteria, as
three of the seven antibiotics in phase three testing will
treat gram negative bacteria, which is the most resistant
type. Unfortunately most of them will not make it
through the review process, as they could be dangerous
to users.
According to the Pew report, about 20 percent of
drugs that make it to phase one will receive approval
from the FDA. The CDC states that antibiotics are
responsible for 20 percent of all hospital visits for
drug complications. Even though the drugs might be
dangerous, there are not many alternatives. As the
resistance of bacteria grows there is a greater need
to take risks. “Superbugs are killing people now,”
Mobashery says. “The alternative of not doing anything
is not acceptable. There is need for hustle by everyone.”
In 2012, Congress passed the Generating Antibiotic
Incentives Now Act in order to speed up the FDA’s review
process by placing antibiotics on a “fast track,” and to
provide antibiotic developers with more assistance from
the FDA. The GAIN ac [