FDA approves questionable device

In a statement, Dr. Peter Lurie, MD, MPH, deputy director of Public Citizen’s Health Research Group, declared the US Food & Drug Administration’s decision to approve the Vagus Nerve Stimulator (VNS) for treatment-resistant depression “one of its most questionable regulatory decisions…in recent memory.” He went on to say, “As a  consequence of the FDA’s data-free decision-making, hundreds of thousands of patients with severe depression are likely to undergo surgery to implant a device that has not been proved to work.”

The VNS is an electronic device implanted surgically at the base of the neck that sends pulses of electricity into the brain and elsewhere in the body every five minutes. It was deemed not-approvable by the FDA in August 2004 due to a lack of convincing evidence of its effectiveness and concerns that it may actually worsen depression in some patients.

Its main clinical trial proved a failure for the VNS. The FDA’s statistical reviewer judged the other main analysis – by Cyberonics Inc., the device’s manufacturer – to be “highly questionable.” Safety concerns, stemming from cases of worsening depression, suicide and sudden death among patients who received the device have not been addressed by adequately controlled long-term trials.

Yet, in the absence of substantially new data, the FDA reversed its position and last month approved the device. The Wall Street Journal reported in May that the Senate Finance Committee was examining the FDA’s handling of Cyberonics’ application.

Devices for which medical claims are made should meet the same approval criteria as drugs. In effect, the FDA has lowered the approval bar for this device. Persuasive evidence that the device works is lacking. Unless and until such data are generated, patients are better off without it.

SOURCE: “Approval of Device to Treat Depression Is One of Most Questionable FDA Decisions in Recent Memory.” Statement of Peter Lurie, MD, MPH, deputy director, Public Citizen’s Health Research Group. Public Citizen Media Advisory, July 18, 2005.