Here is a copy of the article in today's New Jersey Star Ledger. Those at the meeting may recall that Lisa introduced the reporter to the auidance.




Missing a beat

Cardiac patients call for timely information after experiencing problems with heart devices
Wednesday, June 08, 2005
BY JEFF MAY
Star-Ledger Staff

Diagnosed since age 8 with a cardiovascular condition that can lead to sudden death, Stacey Titus has a daily ritual that isn't for the fainthearted.

The 20-year-old Farleigh Dickinson University student has a beeper-sized electronic device implanted below her clavicle that ensures her heart beats normally. Once or twice a day, she holds a powerful, round magnet over the defibrillator to test if the battery is still working.

A beeping sound means everything is working fine. No beep, and it's a quick rush to the doctor's office.

This past weekend, there was no beep.

"I basically started having a panic attack," Titus said.

The device turned out to be functioning properly. But the checkup was necessary because the defibrillator had been the subject of a voluntary recall earlier this year by its manufacturer, Medtronic, for unexpected battery drain.

Because Minneapolis-based Medtronic was forthcoming about the problem, Titus and her doctor were able to set up the daily magnet checks until she decides if she wants to have surgery to replace the unit. It's been a different story for some patients with defibrillators from another manufacturer, Guidant, who were kept in the dark until recently about potential defects.

The United States leads the world in the use of implantable cardiac defibrillators. The devices, which deliver a strong shock to restore an unstable heartbeat to a normal rhythm, are generally reliable. But when malfunctions occur, the consequences can be dire, particularly if the problems haven't been adequately disclosed to doctors or patients.

Guidant has come under fire for failing to promptly notify doctors of what it calls a "rare failure" in its Prizm 2 Model 1861 defibrillator. The Indianapolis-based company, which is being acquired by Johnson & Johnson in a $24 billion deal, reported 26 failures of the units to the Food and Drug Administration, one of which led to the death of a 21-year-old Minnesota college student.

But Guidant didn't notify doctors of the potential defect, which affects 24,000 units, until just before The New York Times published a report on the problem two weeks ago. The Guidant case has heated up a debate about the adequacy of notification procedures, and whether they leave too much discretion to manufacturers that have an interest in protecting sales and stock prices.

"It's not a manufacturer's decision to weigh that risk," said Lisa Salberg of Rockaway, Stacey's aunt and the founder of a nonprofit advocacy group for people with hypertrophic cardiomyopathy, a genetic disorder that leads to thickening of the heart wall and increased risk of sudden cardiac arrest. "It's patient's and doctor's decision."

Salberg, who has the same condition as Stacey and also uses a defibrillator, said she recently got a recall notice about a seatbelt bolt in her Chrysler 300, even though she isn't the car's original owner. But when an earlier defibrillator model she had was recalled, she learned about it only by chance from a small newspaper clipping someone left on her desk.

"These are manmade devices," she said. "I accept failure -- I just want to know when they happen. I know we can do better."

In its recent letter to doctors, Guidant said the Prizm 2 problems only affect models made before November 2002. The company, which said the devices remain highly reliable, recommended they not be replaced.

The FDA is reviewing Guidant's records to make sure reporting requirements were met, said agency spokeswoman Julie Zawisza. No conclusions have been drawn yet, she said.

Johnson & Johnson has said little about the controversy so far, other than to express continued support for the Guidant merger. Yesterday, the company repeated its earlier statement that it is "working with Guidant staff to better understand and evaluate information regarding the Prizm 2 defibrillator."

Guidant officials didn't return a call seeking comment. On its Web site, the company says the Prizm 2 "continues to demonstrate exemplary overall reliability performance" and "ranks overall as one of the most reliable (implantable defibrillators) products available."

At a conference this weekend in Morristown sponsored by Salberg's group, the Hypertrophic Cardiomyopathy Association, some participants worried the Guidant issue could inhibit patients who would benefit from a defibrillator.

"We don't want to let that stop us, because this is a very powerful treatment," said Dr. Barry Maron, who heads the Hypertrophic Cardiomyopathy Center of the Minneapolis Heart Institute Foundation.

About one in 500 people suffer from hypertrophic cardiomyopathy, or roughly 500,000 people in the United States. There is no cure, and the disorder is often misdiagnosed.

Titus' mom, Lori, died of complications from it in 1995, and Salberg founded her organization the following year in her memory

Data that Maron collected on 506 patients with the disorder and defibrillators found 20 percent received a potentially life-saving shock from the devices.

Titus has had her defibrillator since the summer of 2003, and hasn't needed an emergency shock. Maron's study showed it can be years before a user needs one, because the disorder is so unpredictable.

"It's described to me as being hit in the chest by a horse, which doesn't sound overly pleasant," Titus said. "But if it's going to save my life, I'll take it."



Jeff May can be reached at [email protected] or (973) 392-4282.