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Even outspoken FDA watchdog Public Citizen, a group that has weighed in extensively on the recent controversy over Vioxx, Celebrex and Bextra, said it has no staff members familiar with vagal therapy.
Fortunately, there are online forums where current or prospective Cyberonics patients can share information. Up until February 2004, Cyberonics had its own forum. But the company shut it down, explaining that "Increasingly the message board has been an instrument for abuse by certain individuals."
According to former forum members, the shutdown came on the heels of a patient posting a link to the FDA's database of product problems. The database lists 500 adverse events for Cyberonics between May and December 2004 and 1,414 for 2002. Data for 2003 is not available online. Events range from increased seizures to death, which is often described as "sudden unexplained death in epilepsy." In many cases, Cyberonics reported that surgeons refused to provide in-depth information so the company could find the cause of the problem. In one case of an inverted device, a neurologist "asked that he not be contacted regarding the event, as he has a limited staff and is subsequently not able to respond to mfr's request for additional info."
Cyberonics received a similar cold shoulder regarding a patient who died five days after implantation. In the case of one patient who developed a wheezing problem, the company could not investigate because whoever reported the problem forgot the patient's name. Some of the cases in which Cyberonics could figure out what went wrong are troubling as well, including the instance of a surgeon who implanted the device when it was already on. The device is not supposed to be activated until two weeks after surgery.
A week after Cyberonics removed its forum, former VNS patient Donna Baum launched what has become one of the Web's most popular alternatives. Baum, 50, had her pacemaker turned off after she experienced constant pain in her arm. She says the device reduced her seizures, and cut her postseizure recovery period from days to hours. But she also suffered breathlessness and nights where she'd wake up with vomit in her lungs. She says the device also eliminated her auras, which are signals some epileptics get of oncoming seizures.
Baum had her surgery before 2001, the year that Cyberonics placed its patient's manual online. Like many others on her forum, she didn't know a patient's manual existed until she was handed one after surgery. She says she wants her forum to be a place where current and prospective patients can get the kind of information she never got.
"I've never said the device is bad," she says from her home in Las Vegas. "I never said it needs to be pulled off the market. What I stated is 'research, research, research.' You need to know more than your doctor."
Naïveté and desperation play too big a role in prospective patients' decisions, she says.
"A lot of these people, they don't even think about it. They trust their doctor. You're raised to trust your doctor And some of them are looking for the Holy Grail. They've had horrible, devastating lives with epilepsy, and here you've got a rep saying, 'Hey, y'all, guess what, we've had patients that are seizure-free; we have patients that are completely off medication.' Now what does that imply to you, when it's said like that?"
But Alicia Kaminsky, whose seven-year-old son, Robby, has the device, says Baum's board is filled with nothing but people who are bitter because nothing -- not even VNS -- works for them.
Kaminsky, who lives in Florida, can't make it clearer: "Cyberonics has saved Robby's life."
One-year-old Robby was swimming with his older sister in the family pool when he experienced his first seizure. He went mute and sank to the bottom. That three-hour seizure landed him in the hospital for a week. Robby started his drug regimen at 18 months, and after several years Kaminsky didn't know how much longer she could take it.
"I cringe at feeding this child Valium before sending him off to kindergarten," she says.
Kaminsky, who also suffers from epilepsy, got in touch with a Cyberonics rep who referred her to a nearby neurologist. She says Cyberonics, which sets aside thousands of dollars a year for special-case patients who can't afford the operation or don't have insurance, paid for Robby's operation. She says the therapy has stopped at least 71 seizures since last September, allowing Robby to compete in his beloved motorcycle racing.
She says that prospective patients who research and locate the right doctor should have no trouble finding success with VNS. And she feels that even though Robby was younger than the approved age, the risk was worth it.
"When you've got children so severely seizuring chances are they're going to go into cardiac arrest and die and you're left with no other option," she says. As for the warning letters, Kaminsky says she read neither and doesn't plan to.
"If a parent were to read those things, it would drive them crazy," she says. Then she puts it this way: "If a man were to read the warning labels on a bottle of Viagra, he'd never have sex again."