Cyberonics Faces New Hurdle

Less than three weeks away from an expected final decision from FDA on its vagus nerve stimulation (VNS) therapy system for the treatment of cases of depression considered treatment-resistant, Cyberonics Inc. (Houston) received notification from the U.S. Senate Finance Committee (SFC) that it is examining FDA's handling of the company's application for device approval.

SFC's involvement was apparently sparked by Public Citizen (Washington, DC), an organization founded by well-known consumer activist Ralph Nader in 1971. In a letter to Daniel G. Schultz, MD, director of FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD), Public Citizen questioned both the effectiveness of the device and the soundness of the studies submitted by Cyberonics, and said the device should not be approved.

Peter Lurie, MD, deputy director of Public Citizen's health research group, said, “FDA would never approve a drug under these conditions. They certainly shouldn't approve this device.” Nicholas Stine, a researcher at Public Citizen, added, “FDA should not let justified empathy for this patient population lead to the unjustified approval of a device that does not come close to meeting the agency's approval standards and may do more harm than good.”

Acknowledging the SFC inquiry, Robert P. Cummins, Cyberonics chairman and CEO, said “Cyberonics and its advisers believe that SFC's examination will produce no new information and will have no bearing on FDA's final approval decision of the VNS for treatment-resistant depression.” According to Cummins, the letter from SFC “alleges no wrongdoing on Cyberonics' part and informally requests that Cyberonics provide certain information to the committee.” Cummins indicated that the company plans to cooperate with the request.

The Senate Finance Committee, chaired by Senator Charles Grassley (R–IA) and with Max Baucus (D–MT) as ranking member, has not issued any public statement on the Cyberonics inquiry.