Sunday, March 12, 2006

Business More Important Than Health at the FDA

Despite a unanimous recommendation by FDA scientific staff not to approve an implanted device used to treat depression.

Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the agency, kept its application moving up the ladder and eventually decided to approve it.

No Effect On Depression

The device in question is a surgically implanted vagus nerve stimulator produced by Cyberonics Inc. In its one and only clinical trial, it had no apparent effect on depression. This caused FDA scientists to repeatedly recommend rejecting it.

"Safe and Effective"?

Susan Bro, an FDA spokeswoman, claimed that the device had been approved because of the seriousness of persistent depression. Cyberonics argues that the device is the only "safe and effective" option for chronic, treatment-resistant depression.

The vagus nerve stimulator is surgically implanted in the upper chest, and stimulates a nerve leading to the brain. Side effects can include:

Voice alteration
Shortness of breath
Neck pain
Difficulty swallowing
Heart problems
Vocal cord paralysis
Death
Reviewers Bewildered

Internal correspondence within the FDA show that reviewers were bewildered by Dr. Schultz's continuing support for the device after the complete failure of its clinical trial.

Houston Chronicle February 18, 2006

Spartanburg Herald-Journal February 17, 2006

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