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Dear List: I am proud to confirm that a significant improvement in the treatment of patients with advanced PD, whose medications do not work satisfactorily, has been approved by the FDA with conditions. Deep brain stimulation, already approved for tremor control, can now be used to treat the major debilitating symptoms of PD (tremor, rigidity, bradykinesia, and postural instability). As the "patient representative" with no vote (but a voice) on the FDA panel, I can attest that the decision which was taken is in the best interests of PWP, but not without cautions. A wave of consumer participation appears to be sweeping over Federal Agencies. The FDA is required to have patient reps for some conditions, such as cancer and HIV, but this the first time that the agency has used a patient representative for PD. In addition PD advocates have been substantially involved in developing the NIH PD Research Agenda sent to Congress this week (another story). This participation is an indicator of the arrival of the PD community into the big leagues (politically) which means we get attention from policy makers. Overall, I found the experience to be very positive, because I felt the right decisions were made for patients. Approval of DBS as "safe and effective" here means risks are acceptable and relatively safe (e.g., compared to alternatives such as Pallidotomy) and that significant improvements (25% or more) are likely. The data show dramatic improvement in most patients, in terms of the amount and quality of ON time during the day, but 10% experienced significant adverse effects, primarily due to the surgical procedure, not the stimulater itself. The study design, however, was flawed and may have introduced bias and thus weakened the findings by the way data for drop-outs were handled, by the sample size, by failure to control for documented "placebo" effects from tests of other PD treatments, and by lack of controlled randomization for key questions. Further documentation on these issues will be provided by Medtronic to determine the extent of the bias. My biggest concern was the need to have the procedure performed by a highly qualified and trained surgeon in a well equipped and staffed facility. Even with the best academic surgeons, significant serious adverse effects were observed. The panel felt that training and credentials available currently from the Company and from professional organizations were sufficient. I believe that specific information about the training and experience of individual surgeons and hospitals and some criteria to assess this information will be important for consumers and their doctors to make informed choices. Another concern was the need to specify of the kind of patient that would benefit from DBS. The panel stayed close to the data by indicating only certain kinds of patients were tested (e.g. under 75, not suffering from dementia, etc). The issue of cost and access to this very expensive procedure was not raised in the context of safe and effective, but is an issue for patients, insurance carriers and public policy. Perry Cohen Charlie Myers wrote: Hi again, And thanks for the warm welcome back from so many of my old friend here on the list. I was down and not getting mail again today due to a bad disk sector which included my registry. But all is ok now. MARJORIE i WAS IN FORT Lauderdale. My Mother lives in Coconut Creek and I was there for the 90th Birthday Party of her sister. Sorry we didn't think of getting together sooner rather than later. Charlie What follows is a Medtronics Press release: FDA Advisory Committee Recommends Approval for Revolutionary Application Of Brain Stimulation to Treat Parkinson's Disease If Approved, Medtronic Activa(R) Parkinson's Control Therapy Could be Used In U.S. to Treat All Four Major Motor Symptoms of Debilitating Neurological Disorder MINNEAPOLIS, March 31 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT), today announced that its Activa(R) Parkinson's Control Therapy, which uses bilateral brain stimulation to treat the symptoms of advanced, levodopa-responsive Parkinson's disease, received a unanimous conditional approval for marketing clearance by the Neurological Device Panel Advisory Committee to the U.S. Food and Drug Administration (FDA). Conditions include: a three-year, long-term clinical follow-up, including cognitive and neuropsychological factors; physician instruction on selecting electrodes and programming; and several recommended label changes. Medtronic does not anticipate a delay of marketing clearance based on these conditions. (Photo: http://www.newscom.com/cgi-bin/prnh/20000224/MDTLOGO ) If approved by the FDA, Activa Parkinson's Control Therapy would become the first new approach to treating U.S. patients with Parkinson's disease in more than 30 years. Activa Parkinson's Control Therapy is designed to treat the four major motor symptoms of Parkinson's disease: stiffness (rigidity), slowness or lack of movement (bradykinesia/akinesia), shaking (tremor) and poor balance (postural instability). While tremor is the most widely recognized symptom of Parkinson's disease, it is the combination of symptoms that makes Parkinson's disease such a debilitating condition. More than 500,000 people in the U.S. currently have Parkinson's disease, and approximately 50,000 new cases are diagnosed each year. "Patients in the advanced stages of Parkinson's disease cannot be satisfactorily controlled with currently available therapies and as a consequence, suffer unacceptable levels of disability," says C. Warren Olanow, M.D., a neurologist and movement disorders specialist at Mount Sinai Medical Center in New York and a lead investigator in the clinical studies for Activa Parkinson's Control Therapy. "Patients lose their ability to independently control their activities of daily living, and eventually, they can become completely dependent on others for their care. Brain stimulation can help improve these patients' motor function and can help improve their ability to perform their activities of daily living." Oral medications and irreversible surgical procedures (which destroy part of the brain) are currently the only treatments available for patients with Parkinson's disease. Oral medications, such as levodopa, can gradually lose their effectiveness over time and can induce side effects. Dyskinesia, or a series of abnormal involuntary movements, is one side effect that can be induced by oral medications. Activa Parkinson's Control Therapy is designed to work by stimulating the structures deep within the brain that influence motor control and by blocking brain signals that cause the four major motor symptoms of Parkinson's disease. A medical device called a neurostimulator, which is similar in size to a cardiac pacemaker and implanted near the collarbone, generates mild electrical signals that are delivered to the brain via a thin implanted wire with electrodes attached to the other end. The stimulation can be adjusted non-invasively to meet each patient's needs. In 1997, Medtronic received FDA marketing clearance for Activa(R) Tremor Control Therapy, a unilateral therapy that uses brain stimulation to treat tremor, the only symptom of Essential Tremor and one of the four major motor symptoms of Parkinson's disease. Activa Parkinson's Control Therapy represents an extended application of this technology and has been available in Europe, Canada and Australia since 1998. It is still considered investigational in the United States. Most side effects related to stimulation can be treated by adjusting the stimulation settings. These side effects can include slurred speech (dysarthria), abnormal involuntary movements (dyskinesia), contractions of opposing muscles (dystonia) and paresthesia. Risks associated with the surgery and device can include confusion, intracranial hemorrhage, infection, interruption of stimulation, loss of effect or lead migration. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is http://www.medtronic.com Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report and Form 10-K for the year ended April 30, 1999. Actual results may differ materially from anticipated results. SOURCE Medtronic, Inc.