ENGINEER SPOTLIGHT: Jean Philippe Couderc - Biomedical
Engineer - Ending Pharmaceutical Heartbreak
For pharmaceutical companies, the antihistamine Seldane
is a textbook example of what you don’t want in
a new drug. Seldane hit the market as the first nondrowsy
allergy medication in 1985. It was a stunning success,
quickly becoming one of the top 10 most-prescribed drugs.
But the U.S. Food and Drug Administration started to
get some alarming reports about the drug. By 1997, when
it was pulled from the market, Seldane had been identified
as the cause of serious cardiac problems in 83 people.
Fifteen of those people died.
Seldane, doctors now know, caused certain patients
to develop Long QT Syndrome, a malfunction in the heart’s
electrical signaling system named for a split-second
lengthening in the time it takes the cardiac muscle
to contract and release. The delay can cause the heart
to beat out of control or, in some cases, stop altogether.
A genetic defect causes Long QT Syndrome in between
10 and 15 percent of the population. It’s usually
to blame when an otherwise healthy child dies, usually
while exercising, for no apparent reason. Today more
than 30 commonly prescribed drugs carry a very small
risk of inducing Long QT Syndrome in people without
the genetic defect. More than 70 others are suspected
of doing the same.
Considering that it costs about $900 million to get
a new drug on the market, pharmaceutical companies would
like to learn sooner, rather than later, if their investment
is going to turn into a liability. Jean Philippe Couderc,
a professor of both biomedical engineering and medicine
at New York’s University of Rochester Medical
Center and founder of iCardiac Technologies, is developing
software that will help pharmaceutical companies do
just that.
“The magic words today are ‘translational
research,’ making sure that your research is reaching
the patient,” Couderc says. He specializes in
using digital signal processing to get information from
electrical signals in the body. Couderc hopes to use
his software to pick up on the small changes in the
heart’s electrical system that indicate Long QT
Syndrome or other types of cardiac toxicity are developing.
“We have developed a set of electrocardiographic
tools to do quantitative analysis of signals coming
from the heart,” Couderc explains. Those tools,
he continues, can help them determine the warning signs
of cardiac toxicity with greater precision and long
before the changes are significant enough to pose a
threat to the patient. He recently secured a $1 million
grant from the National Institutes of Health to validate
the software containing a massive data set from FDA’s
past clinical trials.
Ultimately, Couderc thinks that drug companies will
be able to use the software to pick up on the warning
signs of cardiac toxicity much earlier in the approval
process. It could even identify people who are at an
increased risk of developing drug-induced Long QT Syndrome,
so they can avoid potentially dangerous medications
altogether.
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