David Baxter PhD
Late Founder
Panel wary of depression device
By TODD ZWILLICH
WASHINGTON, Jan. 26, 2007 (UPI) -- An expert panel took a dim view of a new brain stimulation device for depression Friday, apparently damaging the chances that Food and Drug Administration will approve the product.
Advisors said they were skeptical that the device, called NeuroStar, is effective in depressed patients, or that it poses any advantage over placebo.
The device resembles a dentist's chair with metal electrodes attached to a nearby console. It works on the same principle as electroconvulsive therapy (ECT), a treatment usually reserved for severely depressed patients who do not respond to antidepressant drugs and therapy.
But instead of electricity, the electrodes stimulate the cortex by sending a focused magnetic field into the skull from outside the head. Developers have dubbed the device transcranial magnetic stimulation (TMS).
FDA approved an implantable neural stimulation device made by Medtronic in 2005, although the agency is still reviewing how the device is performing in real-world patients.
Neuronetics, which makes NeuroStar, sought to show FDA that the device is essentially equivalent to ECT, but that it has fewer side effects and is more accessible to patients who find no relief with antidepressant drugs.
"Many patients cannot avail themselves of (ECT), will not avail themselves of this treatment, cannot afford this treatment," said Philip Janicak, a researcher who conducted TMS trials for the company. "So how do we fill this void?" said Janicak, a professor of psychiatry at Rush Presbyterian Medical Center in Chicago, Ill.
But the panel was generally unimpressed with the company's data, which showed a slight statistical advantage in depression symptoms over dummy therapy after six weeks of treatment. Several panelists expressed dismay that patients showed no improvement on some depression scales and only minor improvement on ones that showed a difference.
"The panel seems to be in consensus that the primary analysis did not establish efficacy," said Thomas Brott, the committee's chairman.
"Perhaps a reasonable person could question whether there has been an effect at all," said Brott, a neurologist from Mayo Medical School in Jacksonville, Fla.
The panel did not formally recommend to FDA whether or not the machine should be approved. But the agency scientists suggested at a public hearing that they were also uneasy with the company's results.
Ann Costello, an FDA medical reviewer, questioned whether the mixed evidence of effectiveness in Neuronetics' studies contained "any clinically relevant information."
Peter Lurie, deputy director of Public Citizen's Health Research Group, told the panel that Neuronetics did not show that its device was substantially equal to ECT, a standard that many medical devices must meet for FDA approval. He focused on the fact that patients actively treated with the machine showed mild improvement on only one of three depression scales.
"The magnitude of the finding is trivial from a clinical point of view," he said in an interview.
Steve Newman, executive director of the Washington, D.C. chapter of the National Alliance for the Mentally Ill, was among a handful of subjects from Neuronetics' studies who told experts his deep depression eased after being treated with the machine.
"It was like a light switch (turned) on," he said.
By TODD ZWILLICH
WASHINGTON, Jan. 26, 2007 (UPI) -- An expert panel took a dim view of a new brain stimulation device for depression Friday, apparently damaging the chances that Food and Drug Administration will approve the product.
Advisors said they were skeptical that the device, called NeuroStar, is effective in depressed patients, or that it poses any advantage over placebo.
The device resembles a dentist's chair with metal electrodes attached to a nearby console. It works on the same principle as electroconvulsive therapy (ECT), a treatment usually reserved for severely depressed patients who do not respond to antidepressant drugs and therapy.
But instead of electricity, the electrodes stimulate the cortex by sending a focused magnetic field into the skull from outside the head. Developers have dubbed the device transcranial magnetic stimulation (TMS).
FDA approved an implantable neural stimulation device made by Medtronic in 2005, although the agency is still reviewing how the device is performing in real-world patients.
Neuronetics, which makes NeuroStar, sought to show FDA that the device is essentially equivalent to ECT, but that it has fewer side effects and is more accessible to patients who find no relief with antidepressant drugs.
"Many patients cannot avail themselves of (ECT), will not avail themselves of this treatment, cannot afford this treatment," said Philip Janicak, a researcher who conducted TMS trials for the company. "So how do we fill this void?" said Janicak, a professor of psychiatry at Rush Presbyterian Medical Center in Chicago, Ill.
But the panel was generally unimpressed with the company's data, which showed a slight statistical advantage in depression symptoms over dummy therapy after six weeks of treatment. Several panelists expressed dismay that patients showed no improvement on some depression scales and only minor improvement on ones that showed a difference.
"The panel seems to be in consensus that the primary analysis did not establish efficacy," said Thomas Brott, the committee's chairman.
"Perhaps a reasonable person could question whether there has been an effect at all," said Brott, a neurologist from Mayo Medical School in Jacksonville, Fla.
The panel did not formally recommend to FDA whether or not the machine should be approved. But the agency scientists suggested at a public hearing that they were also uneasy with the company's results.
Ann Costello, an FDA medical reviewer, questioned whether the mixed evidence of effectiveness in Neuronetics' studies contained "any clinically relevant information."
Peter Lurie, deputy director of Public Citizen's Health Research Group, told the panel that Neuronetics did not show that its device was substantially equal to ECT, a standard that many medical devices must meet for FDA approval. He focused on the fact that patients actively treated with the machine showed mild improvement on only one of three depression scales.
"The magnitude of the finding is trivial from a clinical point of view," he said in an interview.
Steve Newman, executive director of the Washington, D.C. chapter of the National Alliance for the Mentally Ill, was among a handful of subjects from Neuronetics' studies who told experts his deep depression eased after being treated with the machine.
"It was like a light switch (turned) on," he said.
