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But Suzanne Parisian, who briefly served as the FDA's chief medical device officer in the mid-'90s, says the warning letters should be taken seriously.
"You have  people with epilepsy that had this implanted device that the FDA was never told that they died, and the company never did an investigation as to why they died, and the company's contending that the device is safe and effective," she says. "It's very unlikely that anybody will do any kind of an examination in these patients to find out why they're dying, and then you're asking them to expand the indication to depression patients."
Moreover, she says, the FDA is set up to put products on the market, not to play detective. Reviewers are dependent on manufacturer reports; officers base their decisions on paperwork -- they never see the actual devices. The agency also depends in large part on pharmaceutical and medical device companies' funding. Drug companies have paid steep "user fees" since 1992; medical device companies since 2002. In exchange, the FDA promises to expedite the decision-making process. It's supposed to buy efficiency, not approval, but Parisian calls it quid pro quo.
In the case of Cyberonics' approvable letter, "It's being done, No. 1, on the company's guarantee that they're going to be good boys because they're going to tell FDA everything," she says. "And yet we have a company with a history, that hasn't been telling FDA everything. So it doesn't really make sense, does it?"
"Very early on, there was a hint that there's something happening here that's very good," says James Wheless.
Fans of the short-lived series Houston Medical may remember Wheless as the tall, skinny guy with a beard. But in medical circles, Wheless is an authority on epilepsy and director of the Texas Comprehensive Epilepsy Program.
When Wheless talks about VNS, he's like a kid describing the world's coolest PlayStation game. In 2002, Wheless contributed to a series of articles on VNS therapy's first five years, published in a supplement to the journal Neurology.The non-peer-reviewed supplement, funded by Cyberonics, stated that VNS therapy had proved itself as an effective, mainstream treatment for treatment-resistant epilepsy.
Wheless's article states that while the therapy is not approved for patients under 12, the therapy is "particularly attractive for use in this population" because drug-related side effects are avoided. In 2002, more than 3,600 VNS patients were under 18; half were under 12.
Today, Wheless is excited about VNS therapy for depression, explaining that mood disorders are common in 40 percent of epileptic adults.
"Their current therapy is just so bad," he says. "Any help at all is a huge step up."
Wheless is not worried about Cyberonics' more recent warning letter, chalking it up to the FDA's "subtle concerns" over "relatively minor things."
Despite the FDA's lack of approval for children under 12, Wheless says the procedure is safe for young kids. Moreover, it can give them a better quality of life early on, he says.
"Why make someone suffer for 15 to 20 years with poorly controlled seizures?" he asks. Within the few first years of a child's life, doctors can tell if meds will control the epilepsy. And that's why most state Medicaid programs and major HMOs pay for procedures in kids under 12, he says. The $15,000 to $20,000 price tag might be a heavy initial cost, but by keeping patients out of ICUs and off expensive meds, the device is cost-effective.
Neurologist Gregory Holmes, president-elect of the American Epilepsy Society, believes in VNS efficacy for epilepsy. A professor at Dartmouth Medical School, Holmes says he's referred hundreds of patients for the treatment. He's also clear to state his endorsement is his personal opinion and not that of the epilepsy society.
"It's been very unusual in our hands, to have someone that becomes totally seizure-free with the device, but in the majority, it does reduce the seizure frequency or the intensity and sometimes seems to even improve the alertness and behavior of the patients," he says. "It's a good alternative; it's not a miracle, but it's good. I would be upset if it was pulled off the market for some reason. The harm of that would be quite, quite extensive."
In early March, Cummins told the Houston Chroniclehe expected to field buyout offers from major pharmaceutical and medical device firms.
"I think any time somebody comes and recognizes the value of what has been created, that is very good for shareholders," he said. "There is always a right price for everything."
Meanwhile, the company is gearing up for TRD market domination, recruiting sales representatives and technicians across the country. If it does get full approval, its sales and technical force will get a taste of the $60 billion market. Now might be just the time to get a job at Cyberonics.
Those who sell the device must have a bachelor's degree and at least three years' experience.
Those who investigate product failure, assist in corrective and preventive action, and help develop test methods and quality inspection techniques must have a high school degree or the equivalent.
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