Business World: Cyberonics and Neurostimulators (Vagal Nerve Stimulator [VNS])
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.
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19 May 2005
07 April 2005
04 February 2005
Anthony H. Risser | neuroscience | neuropsychology | brain