Neuroscience
Tomorrow's New York Times includes an article about the current state of FDA consideration of the Cyberonics VNS device for the treatment of depression. The article is notable for the number of interviews across the spectrum of opinion on this pending decision.
F.D.A. Considers Implant Device for Depression
By BENEDICT CAREY
The New York Times
Published: May 21, 2005
[snipped from the article]
The drug agency has given mixed signals about the stimulator. In August 2004, it told Cyberonics in a letter that the treatment was not approvable, saying more information was needed. But in February, after the company provided more data, the agency changed that position, informing the company that the stimulator could now be approved. The company's stock price has fluctuated as investors try to anticipate the agency's decision, which the company is hopeful will come by the end of the month.
The Senate Finance Committee recently began looking into the F.D.A.'s potential reversal, but Cyberonics officials say they have been assured by the agency that this will have no bearing on its final decision.
In a conference call with reporters and analysts on Thursday, Robert Cummins, the company's chief executive, said no other treatment had been deemed approvable by the drug agency for stubbornly depressed patients. Clearly, he said, "the status quo for millions of Americans, their families, psychiatrists and payers is neither safe nor effective."
Still, some patient advocates and other experts are now questioning how the device has come so close to approval with such limited evidence for its effectiveness.
[ ... Read the full article ... ]
~ Earlier BrainBlog posts on this topic:
19 May 2005
07 April 2005
04 February 2005
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Anthony H. Risser | neuroscience | neuropsychology | brain
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- Business World: Cyberonics, Neurostimulator (vagus Nerve Stimulator [vns]), And Depression
News about this controversial issue (See the list at the bottom of this posting for earlier BrainBlog posts.) From the company's press release:FDA APPROVES CYBERONICS’ VNS THERAPY™ SYSTEM FOR TREATMENT-RESISTANT DEPRESSION (TRD) First FDA-Approved...
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The Houston Press, which is an alternative news weekly in Houston, has a feature article this week about Cyberonics and its epilepsy device and its exploration of applications in mood disorders: Exposed Nerve Cyberonics has implanted its pacemaker in...
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Neuroscience
Business World: Cyberonics and Neurostimulators (Vagal Nerve Stimulator [VNS])
Tomorrow's New York Times includes an article about the current state of FDA consideration of the Cyberonics VNS device for the treatment of depression. The article is notable for the number of interviews across the spectrum of opinion on this pending decision.
F.D.A. Considers Implant Device for Depression
By BENEDICT CAREY
The New York Times
Published: May 21, 2005
[snipped from the article]
The drug agency has given mixed signals about the stimulator. In August 2004, it told Cyberonics in a letter that the treatment was not approvable, saying more information was needed. But in February, after the company provided more data, the agency changed that position, informing the company that the stimulator could now be approved. The company's stock price has fluctuated as investors try to anticipate the agency's decision, which the company is hopeful will come by the end of the month.
The Senate Finance Committee recently began looking into the F.D.A.'s potential reversal, but Cyberonics officials say they have been assured by the agency that this will have no bearing on its final decision.
In a conference call with reporters and analysts on Thursday, Robert Cummins, the company's chief executive, said no other treatment had been deemed approvable by the drug agency for stubbornly depressed patients. Clearly, he said, "the status quo for millions of Americans, their families, psychiatrists and payers is neither safe nor effective."
Still, some patient advocates and other experts are now questioning how the device has come so close to approval with such limited evidence for its effectiveness.
[ ... Read the full article ... ]
19 May 2005
07 April 2005
04 February 2005
---
Anthony H. Risser | neuroscience | neuropsychology | brain
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the AP, via the New York Times website: FDA Panel Supports MS Drug's Market Return By THE ASSOCIATED PRESS Published: March 8, 2006 Filed at 11:24 a.m. ET WASHINGTON (AP) -- A Food and Drug Administration panel said Wednesday the agency should...
- Business World: Cyberonics, Neurostimulator (vagus Nerve Stimulator [vns]), And Depression
News about this controversial issue (See the list at the bottom of this posting for earlier BrainBlog posts.) From the company's press release:FDA APPROVES CYBERONICS’ VNS THERAPY™ SYSTEM FOR TREATMENT-RESISTANT DEPRESSION (TRD) First FDA-Approved...
- Business World: Cyberonics And Neurostimulators (vagal Nerve Stimulator [vns])
From Reuters: Cyberonics falls as Senate probes FDA turnaround Thu May 19, 2005 10:07 AM ET CHICAGO (Reuters) - Shares of Cyberonics Inc. fell almost 13 percent on Thursday after the Senate Finance Committee began examining the FDA's handling of...
- Business World: Cyberonics And Neurostimulators
The Houston Press, which is an alternative news weekly in Houston, has a feature article this week about Cyberonics and its epilepsy device and its exploration of applications in mood disorders: Exposed Nerve Cyberonics has implanted its pacemaker in...
- Business World: Neuromodulation
This Canadian National Post report, among many yesterday and today, outlines ANS [company website] and Cyberonics [company website] issues: Advanced Neuromodulation Systems bids US$22 a share for Cyberonics Canadian Press (copyright) Thursday, September...