February 5, 2005
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May Curb Gambling in Manic-Depressives
reporter Jayson Blair will speak at Glendale Library
Cyberonics device 'approvable' for depression.
Houston Chronicle (Houston, Texas) (via Knight-Ridder/Tribune Business News); 2/4/2005
Byline: Anne Belli
Feb. 4--Shares of Cyberonics rocketed 42 percent Thursday after the once down-on-its-luck company announced that the U.S. Food and Drug Administration gave conditional approval for it to sell its implantable medical device to treat major depression.
In heavy trading, shares of the Houston-based company closed at $39.01 a share, up $11.53.
Wednesday night the company announced that the FDA reversed an earlier decision and issued an "approvable letter" for its vagus nerve stimulator, which has been used to treat epilepsy since 1997. Approvable status means that the FDA is likely to grant approval if certain conditions are met.
The VNS device, which looks much like a pacemaker and is implanted in the patient's chest, sends intermittent electrical pulses to the vagus nerve, which leads to the brain.
In August, Cyberonics stock dove after the FDA rejected the company's application for approval of the device for use in hard-to-treat depression, which afflicts roughly 4 million adults each year. The company appealed in September.
The news shocked many analysts, who rushed Thursday morning to upgrade their stock ratings.
It also encouraged the severely depressed.
"This has exceeded all of my expectations," said 34-year-old Garland resident Karmen McGuffee, who has been a test patient for the device since February 1999.
Unresponsive to long-term use of medications, McGuffee was severely debilitated by depression when she agreed to have the device implanted.
"I was not living, I was barely existing," she said. "I was in the deepest, darkest depths of depression. Now I am happy. I am married. I am raising a daughter."
Cyberonics Chief Executive Robert "Skip" Cummins said he hopes other patients like her will be able to begin using the device by May. He estimated that the company's revenues could grow from $100 million a year today to $1 billion based on use of the device for major depression.
"There is a long line of patients and psychiatrists who cannot wait for this to be approved," he said.
A spokeswoman for the FDA declined to comment except to confirm that the letter had been sent to Cyberonics.
Cummins said conditions for final approval included final labeling, an agreement on final protocols and a resolution on various matters outlined in a warning letter sent to the company in December.
Cummins said company officials have been in weekly if not daily contact with the FDA since the summer, and it expects all outstanding issues to be settled within a few months.
He's so confident, he said, that the Cyberonics sales force already has begun training to begin marketing the device to the psychiatric community. His goal is to launch the device at the annual meeting of the American Psychiatric Association in May.
Keay Nakae, a senior medical device analyst with CE Unterberg, Towbin in New York, said the FDA letter was good news for Cyberonics at a time when the company needed some.
"The odds were against them since they had the decision in August," he said. "Now, with approval seemingly just on the horizon, this does open up to them a fairly substantial market."
Another analyst, Alexander Arrow with Lazard Freres, speculated that the news increases chances that Boston Scientific Corp. might make a bid for the company, Reuters reported.
In the past, Cummins has rejected any suggestion of a takeover.
Lydia Lewis, president of the Depression and Bipolar Support Alliance in Chicago, welcomed the device's eventual approval.
"It is so disheartening for those of us who have this refractory depression to have to try treatment after treatment just to get better for a little while and succumb again," said Lewis, who suffers from a major depressive disorder. "This could give people a quality of life worth living."
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MEDICAL EDGE: ASK THE MAYO CLINIC.
Seattle Post-Intelligencer (Seattle, WA); 2/3/2005
Dear Mayo Clinic:
I read with great interest about Mayo Clinic's research using brain scans to identify specific brain chemicals related to bipolar disorder. My daughter is bipolar, and I have classic bipolar symptoms. Is the procedure available to the public?
Answer: The procedure you read about is magnetic resonance spectroscopy, and, if our study results are replicated, a diagnostic test for bipolar illness could be available within three to five years.
In the study, we used MR spectroscopy - a special form of MR imaging that allows researchers to analyze the chemical properties of tissues - to examine the brains of 21 previously diagnosed bipolar patients (who weren't using any medication) and 21 normal volunteers.
The scans showed that bipolar patients had consistently different levels of five chemicals that are believed to be present in abnormal quantities in people with the illness. The areas of the brain that control behavior, movement and sensory information were affected. These chemical differences were clearly visible within the brain based upon the mood state of the patient.
Also, patients with severe bipolar disorder had different chemical patterns from patients with only mild to moderate cases, suggesting that severe bipolar disorder may require a different or more aggressive treatment.
This is exciting preliminary work that we hope will lead to a clinical test for bipolar disorder. The next step is to study patients being treated for bipolar disorder to determine if MR spectroscopy can detect changes in brain chemistry in response to treatment.
Here's some background on bipolar disorder that may help you as you consider care for yourself and your daughter: About 2.3 million Americans suffer from this condition. It is characterized primarily by wide emotional swings - from the euphoria of mania to the listlessness of depression. In many cases, only the depression phase of the illness is recognized, not the manic phase, making bipolar disorder difficult to diagnose. This is important because the therapies used for bipolar disorder differ from those employed to fight depression.
Since most diagnoses are made based on discussions with the patient, a clinically useful diagnostic tool such as MR spectroscopy would greatly help the psychiatric community diagnose bipolar disorder.
At this time, medication and psychotherapy are the main treatments for bipolar disorder. You should continue to work with your medical team to determine the best course of treatment for you and your daughter.
John D. Port, M.D., Ph.D., Diagnostic Radiology, Mayo Clinic, Rochester, Minn. Medical Edge from Mayo Clinic is an educational resource and doesn't replace regular medical care. To e-mail a question, go to www.mayoclinic.org, or write: Medical Edge from Mayo Clinic, c/o TMS, 2225 Kenmore Ave., Suite 114, Buffalo, NY 14207. For health information, visit www.mayoclinic.com.
COPYRIGHT 2005 Seattle Post-Intelligencer. All rights reserved. Reproduced with the permission of the Dialog Corporation by Gale Group.