Hello from Lisa

[Lisa Salberg]

Hi everyone!
On Tuesday Kelly and I headed North to Boston and the Heart Rythm Society meeting. We leave today and will be back in the office on Monday. I have not had a moment to read the board and see you have all be very busy out here!
To all Newbiies - WELCOME and please call the office next week so we can get you all your starter packets mailed out.

To all moderators - Thanks for holding down the fort!

To the rest - Boy do I have big news to report... but I do not have the time right now!

More later!
Lisa

[Lisa Salberg]

Heart device convention addresses concerns of physicians, patients
BY JIM MCCARTNEY
Knight Ridder Newspapers
BOSTON - Heart patient Lisa Salberg would like to see patients put before shareholders in future disclosures of problems with electronic heart devices.

As it is now, even the news media find out about recalls and warnings before patients and doctors because federal securities regulations require device manufacturers to immediately disclose significant problems to shareholders.

That's not right, Salberg complained Wednesday at the annual scientific session of the Heart Rhythm Society, whose member doctors implant pacemakers and defibrillators.

Her suggestion and those of others were offered at a town meeting attended by about 300 of the some 7,327 doctors, industry officials, patient advocates and media registered at the convention in Boston. Among the attendees' suggestions to improve tracking and reporting on the performance of devices: offering $100 rebates for the return of old devices to manufacturers.

The convention comes after a yearlong series of recalls and warnings shook the confidence of patients and doctors in the heart device industry.

Last month, the Heart Rhythm Society issued a 13-page draft report of recommendations for "strengthening patient and physician knowledge, confidence and trust." The recommendations were at the center of the town meeting.

Salberg also wants to see another word used instead of recall, which is high on the list of the society's report.

"The term recall has psychological, even physical, effects on patients, and we need to change it," said Salberg, head of the Hypertrophic Cardiomyopathy Association, a patient advocacy group based in Hibernia, N.J. "But not including patients in the discussion is like battling both sides against the middle."

While some advocates say the term is necessary to get people's attention, critics argue that "recall" implies all patients with recalled devices should get them replaced even though most often they are advised not to undergo the surgery.

"Banish the word," said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute who served on the task force that wrote the report. "But it's also important not to diminish the seriousness of an advisory."

The task force has suggested using "advisory notice" or "safety alert." One reason is that the term recall may have contributed to the unexpectedly large number of patients who got their devices replaced - about one in five of the 200,000 patients affected by heart device recalls last year, said Dr. Leslie Saxon, a doctor with the University of Southern California University Hospital. Some doctors replaced the recalled devices out of fear they could be sued, she said.

"I know one physician who replaced all of his affected patients due to legal concerns - he probably did more harm than good," said Dr. Eric Prystowsky, an electrophysiologist from Indianapolis.

Prystowsky echoed Salberg's concerns about shareholders getting the news about problems before patients and doctors.

"There needs to be a system that does not make patients scared and running around," he said.

While the U.S. Food and Drug Administration has expressed openness to dropping recall from its nomenclature, officials said such a change would be difficult and that the new term had better be worth the effort.

"The word `recall' is deeply embedded in our regulations and operations and to change it would have broad policy implications," said Bram Zuckerman, director of the FDA's cardiovascular health division. "At this point, I don't think we know a better term or approach."

The FDA plans to hold focus groups at the convention this week to explore alternatives to "recall," Zuckerman said.

Several of the society's recommendations focused on getting more information about how pacemakers and implantable cardioverter defibrillators are performing. Doctors at the meeting expressed hope that advances in wireless monitoring of devices could markedly improve tracking.

"Such comprehensive surveillance could solve many of the problems," said Rachel Lampert, a professor at Yale University.

The big three industry players - Fridley-based Medtronic, Little Canada-based St. Jude Medical and Boston Scientific's Guidant division in Arden Hills - all have or are working on such wireless monitoring devices.

"We are excited about this technology - we will see what we can learn from it," said Kimber Ritcher, an FDA official.

One reason for the lack of performance data is that the devices typically are not returned for examination once they are removed from a patient or the patient dies. The report suggests that physicians, nurses, patients, families, pathologists and funeral home directors be encouraged to return all devices, not just malfunctioning ones. Patients' consent also should be sought for device examinations in case of death.

One doctor suggested an incentive could be offered to those who return the devices.

"What about a $100 rebate to institutions that return them?" said Dr. Daniel Zipes of the Krannert Institute of Cardiology in Indianapolis.