The consumer group Public Citizen on Wednesday asked the Food and Drug Administration to reject a surgically implanted medical device from
that treats depression.
The request by the Public Citizen's Health Research Group comes three weeks before the FDA is scheduled to act on the Cyberonics device known as VNS Therapy, which delivers mild electrical shocks to a nerve in the brain.
The Health Research Group says the company's testing of the pacemaker-sized device was inadequate, adding that clinical research didn't prove the device's safety and effectiveness for treating depression.
In 1997, the device was approved by the FDA for treating epileptic seizures. It's approved for treating seizures in a number of foreign markets, and it's permitted in the European Union and Canada for treating depression.
"With so many uncertainties and red flags, it is a serious mistake for the FDA to be prepared to approve this device for use in millions of people for whom it has not been proved to work," the group says in a May 11 letter to the FDA. "Do not let justified empathy for this patient population lead to the unjustified approval of a device that does not come close to meeting FDA's approval standards."
Separately, Cyberonics said Wednesday that it is making "good progress" in meeting the four conditions established by the FDA when the agency granted conditional approval for the device in early February.
"FDA now has all the information necessary to make its final approval decision," said Robert P. Cummins, the chairman and chief executive officer, in a prepared statement. Cyberonics has improved its manufacturing practices, and it has submitted a proposed label for the device as well as provided the agency with a plan to conduct post-marketing research, he said.
A Controversial Product
The complaint by the Health Research Group is just the latest event in a long, tortuous path for Cyberonics' effort to get VNS Therapy approved as a treatment for depression in people for whom traditional therapies -- drugs, psychiatry, electro-convulsive therapy -- don't work. The consumer group's argument echoes the many critical remarks offered previously by FDA staff members and some FDA advisory committee members.
On June 15, an FDA advisory committee voted 5-2 to support the Houston-based company's application. The panel attached six conditions to its vote, ranging from a recommendation that patients fail at least four traditional therapies before using VNS to requirements of special training for surgeons and primary care physicians.
The majority was not persuaded by comments from FDA staff members, who raised questions about the quality of Cyberonics' test data. They said more work was needed to make valid comparisons between VNS and other treatments. The staff also expressed concern about "serious adverse events" -- including suicide attempts -- that were reported in the clinical trials.
The FDA staff routinely provides an analysis of experimental products prior to advisory panels' review of drugs and devices. The staff's concerns were resurrected by the Health Research Group in its May 11 letter to the FDA.
The agency isn't bound by an advisory panel recommendation, and in August, the
FDA rejected the Cyberonics application. The agency criticized some of Cyberonics' test data comparing VNS Therapy to other drugs or placebo.
Cyberonics appealed the verdict, and, in a decision that was more stunning than its overruling of the advisory panel, the
FDA reversed itself on Feb. 3 by granting conditional approval for the device.
On Wednesday, shares of Cyberonics were off 4 cents to $37.19.