Necessity is the mother of invention… Is idiocy the father of approval?

Necessity is the mother of invention… Is idiocy the father of approval?

In 1997, the FDA approved a vagus nerve stimulator made by Cyberonics for the treatment of epilepsy. It has a variety of common side effects including voice alteration, shortness of breath, neck pain and trouble swallowing, according to the New York Times (Device Won Approval Though F.D.A. Staff Objected). Some patients also reported that their mood changed, which gave Cyberonics the idea to test the device for depression.

In the depression trial, Cyberonics implanted devices in 235 depressed patients and “turned the machines on in half of them,” according to the Times. [Of course since 235 is an odd number it couldn’t have been exactly half!] Three months later, there was no difference in depression changes between the test group and the control group. So Cyberonics turned on the machines in everyone and six months later about 30 percent of the group had real improvements. But of course there was no control group.

Cyberonics decided to submit the device for FDA approval for depression anyway. The entire FDA staff working on the application recommended against it. But the director of the Center for Devices and Radiological Health moved the application forward and the device was eventually approved.

Th[e] approval did follow the backing of a divided F.D.A. advisory committee. Still, [a] 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.

I don’t know all the details of this case, but based on what I’ve read in the Times article, I’m torn about whether the approval was the right one. On one side, this is the only device of its kind available to treat depression. I’m hesitant to block its use for people who lack other options. Cyberonics argues in its response that its focus is on Treatment Resistant Depression, and that the Company has longer-term data showing that the device works. On the other side, there was no real evidence it worked at the time of approval and it could be dangerous, and of course expensive.

February 17, 2006

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