Healthy Skepticism Library item: 1585

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Publication type: news

Wilde-mathews A.
Brain Neurostimulation Shown to Relieve Severe Depression for Some: Ruling on Medical Device Examined
THE WALL STREET JOURNAL 2005 May 19

Full text:

The Senate Finance Committee is examining the Food and Drug Administration’s handling of a medical device that its manufacturer wants the FDA to approve as a treatment for serious depression.

The device, which is called a vagus nerve stimulator and works by stimulating a nerve in the neck, is made by Cyberonics Inc. of Houston. It was approved by the FDA in 1997 to treat epilepsy. The company now is seeking agency approval to market the device for the treatment of patients with depression that hasn’t responded to other therapies.

The FDA rejected the company’s application in August, but in February reversed course, moving the product closer to approval.

In a statement, Cyberonics Chairman and Chief Executive Robert P. Cummins said the company has received a letter from the committee in which the Senate panel said it was “examining the FDA’s handling of” the application and that the FDA’s shift came “despite the strong objections from FDA scientists involved in evaluating the safety and efficacy” of the device’s use. The committee letter, Mr. Cummins’ statement said, “alleges no wrongdoing on Cyberonics’ part and informally requests that Cyberonics provide certain information” to the committee, and that the company plans to cooperate.

This device, made by Cyberonics, sends mild pulses to the vagus nerve to help reduce the frequency of epileptic seizures.

Mr. Cummins in an interview said he doesn’t expect the committee’s activity to affect the company’s bid for FDA approval, and that the company has met the conditions the agency laid out to obtain approval. The Senate’s examination isn’t “material” to the company, Mr. Cummins said.

The FDA changed its view of the device after Cyberonics offered “improved safety and effectiveness data,” he said.

In his statement, Mr. Cummins said the company also agreed to conduct rigorous surveillance if it obtains approval. He also said the company “exercised its legal right to petition Congress…to help us understand why”
the device wasn’t approved. The statement also said several lawmakers “asked FDA for an explanation and provided Cyberonics with advice.”

A spokeswoman for the Senate Finance Committee, which has been investigating FDA’s general handling of safety issues, declined to comment.

An FDA advisory committee that reviewed the device last June voted that it should be approved to treat treatment-resistant depression. The positive recommendation came despite the FDA’s presentation to the panel that Cyberonics’ main clinical trial had “failed,” because it hadn’t shown that people treated with the device had significantly better results than those who had the device implanted but not activated. A different analysis offered by the company also didn’t demonstrate the device was better than standard treatments for depression, the FDA reviewer wrote in the June presentation.

An FDA spokeswoman declined to comment on the device, but said generally, “if a company is issued a ‘not approvable’ letter and the FDA believes the response is adequate to address the issues raised, then FDA may issue an approvable letter.”

Last December, the FDA sent Cyberonics a warning letter that faulted it for failing to follow up on reports of epilepsy patients’ problems, among other practices. In April, Cyberonics announced that the FDA had informed the company that its response to the December warning letter was “complete and adequate.”