US Senate Criticizes FDA Approval of Vagus Nerve Stimulation
A U.S. Senate Finance Committee report says a federal official approved a device to treat persistent depression against the advice of a scientific advisory committee. According to the Senate committee, the official overruled his scientific staff to approve the vagus nerve stimulator device, despite its not having been proved effective against depression in its only clinical trial.
PsycPort carries an article indicating that the controversial vagus nerve stimulation treatment commercialised by the company Cyberonics was reportedly approved by the FDA against scientific advice. (See our earlier articles “FDA OKs Brain Stimulator for Depression” and “Critics Alarmed at Growing Use of Vagus Nerve Stimulation for Depression”.)
According to the article, Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the Food and Drug Administration, overruled his scientific staff to approve the pacemaker-like device. Schultz could not be reached for comment, while the company defended itself:
Robert P. Cummins, chairman and chief executive of Cyberonics, the maker of the device, said in a statement that his company’s device was “the only safe and effective treatment option ever specifically developed, studied, FDA-approved and fully informatively labeled for the treatment of chronic or recurrent treatment-resistant depression.”
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Other articles by Dr Greg Mulhauser, Managing Editor
This article was last reviewed by on Saturday, 18th February 2006. You can leave a response below.
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