Heart experts, patients to mull US device standards
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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.
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