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

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http://www.nytimes.com/2006/02/17/politics/17fda.html?

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February 17, 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. 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

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 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, 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. "