Mood machine

Another 7,000 are seeking approval from their insurance companies for the 25,000 operation. More than 3,700 psychiatrists have been trained in the use of VNS, the first device ever approved to treat depression.

It consists of a battery-operated generator attached to an electrode implanted in the vagus nerve in the neck. The generator emits regular pulses of electricity that are supposed to stimulate brain chemicals believed to regulate mood, according to its maker, Cyberonics.

Yet the most basic question about the treatment remains unanswered: Does it work? The only rigorous clinical trial of the device8212;which is approved to treat severe epilepsy8212;failed to demonstrate its effectiveness. That study involved 235 patients. At the end of three months, there was no statistically significant difference. A second study of 174 recipients found 30 per cent showed improvement. But because they received other depression treatments after the device was implanted, there is no way to know whether it was responsible.

Last July, a top FDA official, citing the lack of alternatives for severely depressed patients, had overruled unanimous opposition by 20 members of his staff and approved the device as a depression treatment for adults who had failed four other treatments.

To Philadelphia psychiatrist Richard P. Malone, a member of the panel who voted against approval, such arguments are specious. Pancreatic cancer is a hopeless condition8221; with a much higher death rate than chronic depression. 8220;And we have as much evidence that this works for pancreatic cancer as it does for depression. Why not use it for that?8221;said Malone.

Avoiding Stigma

Some patients with chronic depression say they were willing to try anything that promised relief. Graphic artist Colleen Kelly decided in 2000 that she had nothing to lose by enrolling in an experimental study of VNS. Kelly, who lives in Prince George8217;s County, said medications had not helped her. Nearly three dozen electroshock treatments failed to work and wiped out years of memories, she said.

VNS gave Kelly three 8220;very good years,8221; she said, and then her depression returned. 8220;The past year has been abysmal,8221; said Kelly.

Critics say they are not persuaded by Cyberonics8217;s theory of how VNS works. The company8217;s website says, 8220;preliminary imaging studies suggest that VNS Therapy affects many areas of the brain implicated in mood regulation.8221;

But Malone called the theory 8220;speculative8221;. 8220;This almost has a feel of 18th-century psychiatry8212;having a device and not being able to show how it works,8221; he said.

Washington psychiatrist Wayne Blackmon agreed. 8220;Psychiatry has been burned again and again by overextravagant claims8221; about devices and psychosurgery, said Blackmon, a lawyer and a past president of the DC Medical Society. 8220;The history of psychiatry is plagued by psychiatrists jumping the gun because these poor people are suffering and the argument is we have to do something.8221;

The device has also attracted attention on Capitol Hill. Last month, Senate Finance Committee committee chairman Charles E Grassley, whose panel issued a report highly critical of the agency8217;s approval of VNS, said he was concerned that patients and their doctors were not being adequately informed about the risks, which include cardiovascular problems that can be life-threatening.

Robert 8220;Skip8221; Cummins, Cyberonics8217;s CEO, dismissed criticisms. Many FDA 8220;regulators, politicians and third-party payers8221; know little about resistant depression, he said. 8220;Hundreds of psychiatric thought leaders and patients are rallying around the device8221; for 8220;the worst of the worst8221; cases of depression.

Option of Last Resort

For Paulo Negro8217;s patients, the issue is not stigma, but options. Negro, chief of behavioral health services at Suburban Hospital in Bethesda, said his VNS patients have tried everything, but their depression always recurred. 8220;What would you do if you8217;ve not been getting better? It8217;s a chance to get better. I8217;d take it.8221;

That8217;s what Charles E Donovan III did. The St. Louis resident credits the implant he received five years ago with saving his life.

Others have had far less positive experiences. Among them is Katherine V Coram, 58, of Silver Spring. She frequently lost her voice while talking and felt a persistent constriction in the back of her throat8212;both common side effects of VNS treatment. The device seemed to help at first, but when the doctor turned up the settings, she felt suicidal for the first time in years. Worsening depression and suicide attempts were reported by one-third of patients in one study funded by Cyberonics, according to data presented to the FDA. Coram finally had the generator removed from her chest. But the electrodes in her neck must remain forever; doctors say removing them is too risky because tissue grows around them.

8220;I8217;m still angry about the whole thing,8221; said Coram. 8220;You get desperate when you8217;ve been depressed for years,8221; she said. 8220;This sounds benign, like a pacemaker. My crusade is for people to know a lot more about it before they sign up.8221;

Sandra G Boodman