continued "The problem now is that the FDA doesn't pay for it. The most effective target is the subthalamic nucleus, which is where the stimulators will be placed in the future, but the FDA hasn't approved it for use there yet. This will be released within the next six months by the FDA. We've done several now on younger patients who are not on Medicare. That doesn't mean that it's illegal for doctors to do it. The FDA does not regulate doctors' practices, and we can do what is called 'off-label use.' The doctor has a right to use drugs for conditions other than their primary use. For instance, Viagra was used to treat heart conditions, and they found it had off-label use for you know what! So while many of the medications and things we do in surgery aren't officially approved, it's not against the law, but the federal government won't pay for it."
Deep-brain stimulation is expensive. "The transmitter and electrodes cost between $10,000 and $11,000. With the overnight stay in the hospital and operating room costs, it runs about $20,000 to $30,000. I don't think the hospitals make any money doing it."
Although deep-brain stimulation provides extraordinary relief for Parkinson's sufferers, not everyone is a candidate for the surgery. "The indications are that patients have failed medications -- dopamine -- and are disabled because of that. They must also have Parkinson's disease. There are a number of other degenerative conditions of the central nervous system that look like Parkinson's disease but aren't. They may have some of the signs, but they don't respond well and are not good candidates. They have to have a good response to dopamine. The effect of the stimulator is like the best response a patient has ever had to dopamine without ever having the side effects. It also takes hours to program the stimulators -- Dr. Dee Silver is the neurologist here who does that -- but they have to live nearby and be able to cooperate. It takes between 4 to 16 hours of programming to finally get the correct parameters. Patients can't have any dementia either."
Ironically, Ott performed a similar procedure to this surgery before he entered medical school. "I was a teenage kid in Pasadena and got a summer job in a neurophysiology lab at UCLA, where I was putting stimulating electrodes into cats' brains, doing single-fiber recordings from spinal cords, and so forth. That's how I got into neurology; then I was interested in surgery in medical school so I thought neurosurgery was the way to go. I do a lot of spinal surgery, but as my profession turns, we started the Gamma Knife Center here in town, another incredible technology, which was originally invented to treat movement disorders by Swedish physician Lars Leksell in 1968. As computers and imaging came in, it's now used to treat brain tumors on an outpatient basis. We started that in '94, and I do a lot of brain-tumor surgery with the gamma knife. Then I got back to where I was when I was 16 years old, doing functional surgery."
In spite of Ott's acumen and command, he shows a humility when asked how he feels about the results his patients enjoy. "It's pretty dramatic. Especially the tremors. The bradykinesia and rigidity are less dramatic. They are more disabling, but the tremor is very dramatic. The woman whose stimulator had to be changed had a tremor so bad that she would shake herself out of bed. Can you imagine sleeping with someone shaking so badly all the time? When you turn the stimulator on, the tremor goes away in seconds. It's like a miracle. It's amazing. Obviously, it makes me feel good, because it makes a big change in people's lives and you can see it. When someone has spinal surgery, they'll thank me because the pain in their leg is gone, but you can't see that. With Parkinson's, the effect is much more profound."
Ott believes that the cure for Parkinson's disease will ultimately come from the tests being done on animals. Presently, lab animals are given drugs that induce Parkinson's disease, enabling researchers to explore new treatments. "Some of the work on stimulators and the understanding of how Parkinson's affects the brain comes from the animal model, where we can put an electrode in the subthalamic nucleus of an animal, and the Parkinson's disease goes away just like in a human." When it is suggested that animal-rights activists might not appreciate such experiments, Ott is quick to reply, "They would if they knew what it was like to have Parkinson's disease. You know the saying, 'There are no atheists in foxholes'? Well, my saying is, 'There are no PETA [People for the Ethical Treatment of Animals] members in the National Parkinson's Association.' These experiments have allowed us to understand the fundamental physiology of it and allows us a model with which to treat Parkinson's disease."
Al and Corinne Goodman have been married since 1961. Although he works as an engineer with Ericsson Corporation in the Miramar area, Al's primary job is taking care of his wife, who has suffered with Parkinson's disease for ten years. He is also her spokesman, as the disease has limited her ability to speak. "She has some cognitive impairment, which is a result of the disease. For her, the biggest problems were originally muscle-spasm pain, and her shaking was so severe that she broke the bases of toilets where they bolted to the ground." Corinne was Dr. Ott's first deep-brain stimulation patient; it was her stimulator that he recently changed.
As Al tells the story of Corinne's and his ordeal, she is relaxing in a chair watching television. There is a slight tremor in her right foot. Al quickly points out that it was once far worse.
While tremors are to be expected, Corinne's case was extreme. "Dr. Silver, her neurologist, always considered her to be a rather challenging patient for Parkinson's. As a result of the medications not working after a while, she became a candidate for the deep-brain surgery. To my knowledge, she was the first one done at Scripps Memorial and certainly the first that Dr. Ott had done.