Depression Treatment Device Sparks Debate

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HOUSTON - A tiny device about the size of a pocketwatch has treated hundreds of depression patients in clinical trials across the country. It's on the verge of being the first depression treatment device to be approved by the U.S. Food and Drug Administration.

But the progress comes amid questions about whether the device's Houston-based manufacturer, Cyberonics Inc., has sufficiently proven that it's safe and it works.

At age 3, Karmen McGuffee would spend sleepless nights worried about whether her little sister was still breathing.

It wasn't until her late teens, after her mother found her on the floor in a fetal position, bleeding from self-inflicted deep scratches, that she was diagnosed with severe depression.

"Medications would work for six months to a year. Then (doctors) would have to start all over or add another one or decrease one. That roller coaster went on from 19 until I was 28," said McGuffee, now a 34-year-old mother who lives in the Dallas suburb of Garland.

The Vagus Nerve Stimulator finally helped, McGuffee said.

The stimulator, which weighs less than an ounce, is similar to a pacemaker, delivering mild electrical pulses for 30 seconds every 5 minutes to the vagus nerve, a long nerve in the neck that carries information to many areas of the brain that control mood, sleep and other functions.

Cyberonics originally spent 10 years and $70 million developing the device as a therapy for epilepsy, gaining FDA approval in July 1997. The company later learned that stimulating the vagus nerve also helped relieve depression.

Nearly 19 million American adults suffer from depression, according to the National Institute of Mental Health. Nearly 10 million of these adults experience major depression, which is often resistant to treatments such as psychotherapy, medications and shock therapy.

The stimulator is implanted under the skin on the left side of a patient's chest. Another small incision is made in the neck to wrap small wires from it around the vagus nerve. The implant and surgery costs about $20,000.

Side effects can include voice alteration, scratchy throat, cough and shortness of breath.

"The effectiveness of the treatment improves over time and the nuisance side effects associated with the therapy decline over time, opposite most antidepressants," Cyberonics CEO Robert Cummins said.

Although the device gave her a gravelly voice that quivers, Marna Davenport said the effects were worth it.

Davenport, a 51-year-old college instructor from Columbia, S.C., had tried about 30 different kinds of medication combinations since she was 22, as well as shock treatment, but nothing worked.

"It sort of robbed me of all the color in my life," she said of her depression. "I felt that one day it would kill me."

Davenport got the device in January 2001, but didn't feel the full effect until 18 months later. She now considers herself the "happiest girl you ever met," but still takes antidepressants, eats well and exercises to control her depression.

Davenport said she looks forward to final FDA approval for the device so others can benefit.

In June 2004, an FDA advisory panel voted 5-2 to recommend approval for patients with major depression. But six of the seven panel members were concerned about Cyberonics' two main studies on the device in which the patients were not randomly assigned to receive the treatment or a placebo. Random assignments prevent those conducting the study from manipulating who gets the treatment and who gets a placebo.

Cummins said the studies were conducted thoroughly enough to prove the treatment effective.

Richard Malone, a professor of psychiatry at Drexel University in Philadelphia and one of the two FDA panel members who opposed the device's approval, criticized Cyberonics for not doing a true double-blind study, where neither the doctor nor patient knows if they are getting treatment or a placebo.

"For most drugs, if you don't show efficacy in double blind studies, you haven't shown that it's effective," Malone said.

The FDA went against its panel's recommendation and decided in August not to approve the device, saying it was concerned about the quality of the studies and that some patients' depression worsened even with the device.

When Cyberonics gave the FDA more data showing that 18 percent of patients were depression free, 35 percent had reduced depressive symptoms by half and 57 percent had some benefit after two years of treatment, the FDA gave the stimulator preliminary approval in February.

Final approval was expected by the end of May but continuing debate could delay that.

On May 11, the consumer group Public Citizen wrote the FDA, opposing the approval of the device because it "does not come close to meeting FDA's approval standards, and may well do more harm than good."

Cyberonics said the Senate Finance Committee was also examining the FDA's handling of the device's approval process. FDA spokeswoman Kathleen K. Quinn declined comment because the device's application is pending, and a committee spokeswoman did not return a call seeking comment.

Final FDA approval could mean $1 billion in revenue by 2010, compared to $300 million in revenue for the device's treatment of epilepsy, Cyberonics predicts. The company's stock price has also dramatically risen and fallen during the approval process. The stock fell 27 cents on Friday to close at $37.51. It has traded in a range between $12.78 and $46.71 over the last year.

John O'Reardon, an assistant professor of psychiatry at the University of Pennsylvania, said he would use it with patients.

"It's had a rocky road to approval," he said. "I would say it probably does mean there is some question mark, but there is always some question mark when a new treatment is approved."

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