Source: New York Times
Date: 17 February 2006

Device Won Approval Though F.D.A. Staff Objected

By GARDINER HARRIS

WASHINGTON, Feb. 16 A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.

The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment, said the report, written by the staff of the Senate Finance Committee.

But Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the agency, kept moving the application along and eventually decided to approve it, the report said.

That approval did follow the backing of a divided F.D.A. advisory committee. Still, the Senate committee, which for two years has been investigating the decision-making processes at the F.D.A., could find no previous instance in which the director of the center had approved a device in the face of unanimous opposition from staff scientists and administrators beneath him, the report said.

Dr. Schultz could not be reached for comment on Thursday, but Susan Bro, an F.D.A. spokeswoman, said the device had been approved because many people with persistent depression "are otherwise on their way to institutionalization, because of the seriousness of their illness."

Ms. Bro said top officials did "occasionally overrule staff recommendations after assessing all data, expert opinion and medical need."

Jill Gerber, a spokeswoman for Senator Charles E. Grassley, the Iowa Republican who heads the Senate committee, said, "The report speaks for itself, and Chairman Grassley has no additional comment."

In a 1,900-word written response issued Thursday night, Robert P. Cummins, Cyberonics's chairman and chief executive, said the investigators had failed to interview many experts on serious depression.

Mr. Cummins said his company's device was "the only safe and effective treatment option ever specifically developed, studied, F.D.A.-approved and fully informatively labeled for the treatment of chronic or recurrent treatment-resistant depression."

The vagus nerve stimulator is surgically implanted in the upper chest, and its wires are threaded into the neck. Batteries in the device stimulate a nerve leading to the brain.

The nerve stimulator has been approved since 1997 for the treatment of epilepsy in some patients. Common side effects include voice alteration, increased cough, shortness of breath, neck pain and difficulty swallowing. The device has also been linked to rare reports of death, heart problems and vocal cord paralysis.

When some epilepsy patients reported that their moods had changed after receiving the devices, Cyberonics, based in Houston, implanted them in 235 depressed patients and turned the machines on in half of them. After three months, the two groups were equally depressed. The trial had failed.

Cyberonics then turned the devices on in all 235 patients and determined that 30 percent showed significant improvement after six months or more. Without a control group, however, it was impossible to determine if the device had caused the improvement.

Internal correspondence among F.D.A. reviewers shows that some were bewildered by Dr. Schultz's support for the device, the Senate report said.

"In my opinion, they do not have adequate data, and I don't understand how this can move forward," one reviewer wrote in an e-mail message to a colleague, the report said.

Another wrote, "As an M.D. interested in science, it seems to me that such an approval would be akin to approving an experimental product."

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