Heart experts, patients to mull US device standards

By Debra Sherman

CHICAGO (Reuters) – U.S. cardiologists, medical device
makers, regulators and heart patients gather in Washington D.C.
on Friday to discuss how the recall of devices should be
handled and when doctors and patients should be told about
product malfunctions.

The debate over disclosure was stoked earlier this year
following revelations medical device maker Guidant Corp. did
not tell doctors or patients about a potential problem in some
of its implantable cardioverter defibrillators (ICDs) for three
years. The problem was uncovered last spring after a
21-year-old college student died of cardiac arrest after his
ICD short-circuited.

Despite receiving a report from Guidant that indicated the
devices were short-circuiting at a rate of about one per month,
the U.S. Food and Drug Administration did not inform the public
of the risk for four months, citing confidentiality agreements
with the company.

The Heart Rhythm Society, the professional group of
cardiologists specializing in heart rhythms, is sponsoring the
meeting in the hope of eventually establishing standards.

“We’re going to hear a variety of perspectives and it will
be an opportunity for us to share information as openly as
possible,” said Dr. Mark Carlson, who will chair the
conference. “It’s a starting point for further discussions.”

While doctors and patients are expected to push for more
disclosure, two U.S. lawmakers have signaled they plan to
increase scrutiny of the FDA and its processes.

“The public deserves to know whether this is a case of FDA
incompetence and a lack of diligence, or whether the FDA made a
decision to protect the company’s confidentiality over the
public health,” U.S. Rep. Edward Markey said. “Either way, we
have a serious problem on our hands.”

The Massachusetts lawmaker sent a letter to the FDA on
Wednesday asking, among other things, whether the FDA would
have alerted the public to the problems with Guidant’s ICD even
if the company had not.

Guidant is the second largest manufacturer of ICDs,
stop-watch sized implantable devices that monitor and correct
erratic heart beats with a jolt of electricity.

Medtronic Inc., the largest maker of ICDs and pacemakers,
recalled some of its ICDs earlier this year because of a
battery problem. St. Jude Medical Inc. is the number three
maker of ICDs.

The controversy comes as the industry pushes to increase
the number of implants after a study showed 80 percent of heart
patients who could benefit from ICDs do not have one.

Public Citizen has petitioned the FDA to change the current
system that allows companies to delay the removal of a flawed
device as doctors continue to use the remaining inventory.

“This practice benefits the manufacturer, which can deplete
its inventory of older, defective devices, but leaves patients
who receive these inferior products endangered,” the letter
said. “The principle is simple: Patient safety should come
before company profits.”

Merrill Lynch analyst Katherine Martinelli expects the
Heart Rhythm Society to recommend lower thresholds for telling
patients about problems and for recalls, as well as
standardizing communication.

“We view this as a plus for the industry as it will remove
the onus from the companies for determining when a device
problem warrants physician/patient notification in the event
the FDA has not required a recall,” she said.

Martinelli also anticipates the society will move toward
standardizing communication methods and recommend more
disclosure by device manufacturers.