Device to Combat Depression Was Approved By FDA Official Despite Little Evidence of Its Effectiveness and Unanimous Staff Recommendation that It Be Rejected

On May 24, 2005, reported that: “Although many experts maintain there is little evidence that the device actually works, the FDA may soon approve a ‘vagus nerve stimulator’ manufactured by Cybertronics, Inc., for the treatment of severe depression.”

The pacemaker-like device, which costs $15,000, is designed to be surgically implanted in the left side of the upper chest and wired to the vagus nerve leading to the brain. A magnetic wand is used to turn the device on and off. When the batteries need to be replaced at between three and eight years, the patient must undergo additional surgery.

While proponents of the device claim that it will provide a viable option to patients who have not responded to traditional therapies or medication, critics point to trial results which showed that the stimulator when turned on was no more effective than when it was implanted and turned off.

Public Citizen is wary of an “epidemic of implantation of a device with no proven effectiveness” and aggressive marketing that leads to doctors prescribing it for moderate depression.

In addition to the criticism of the device from outside experts, there was unanimous agreement among the scientific staff of the FDA that the stimulator was ineffective as a treatment for persistent depression and should not be approved.

It seems, however, that the device had one supporter and, in the end, that was all it needed. Dr. Daniel G. Schultz, the director of the Center for Devices and Radiological Health at the FDA, chose to keep the application moving and to overrule his scientists by approving the device.

Those critical of the FDA approval process, including a Senate committee that has been investigating that very issue, have been unable to find any other example of a device being approved over the unanimous objection of staff scientists.

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