Magnetic Relief For Depression?

'It Makes You Jump'

Newman's case is striking, but that does not mean it is representative. Indeed, many scientists think the jury is still out on the utility of TMS for depression.

The FDA wrestled with the approval of the magnetic device for years. In early 2007, an advisory committee said it was unimpressed with the results of the trial that Newman participated in. (Newman himself testified before the committee.)

The concern was not about safety -- it seemed clear that TMS was much safer than medication and ECT -- but whether it was really effective. Only about one in six patients who received the treatment were cured over six weeks. So were one in 20 patients who got sham treatment: the sound effects and drama of the magnetic therapy without the actual magnetic fields. The chairman of the FDA advisory committee, Thomas Brott, a Mayo Clinic neurologist in Florida, openly said that a reasonable person could question whether the study had found any benefit at all. Brott declined a request for an interview for this article.

"They certainly had questions about the magnitude of the effect," said Wayne Goodman, director of the Division for Adult Translational Research at the National Institute of Mental Health, the federal institution charged with setting the nation's agenda on mental health treatment. Goodman listened to the entire deliberations of the advisory committee as a member of the audience. "The committee was not persuaded [that Neuronetics, which sponsored the trial Newman participated in,] had made the case."

"What has happened since then to change the mind of the FDA?" Goodman asked. "Why did they now decide to clear it?"

The FDA declined to make officials available for an interview. But in an e-mail, spokesman Scott McFarland said the agency had determined that the treatment seemed especially effective for a subset of patients.

Demitrack, at Neuronetics, said the FDA had told his company that the trial, which involved 301 patients at 23 sites, had shown a "signal" of efficacy and that the agency had asked the company to determine whether there were some patients for whom the magnetic therapy seemed especially effective. Patients who had unsuccessfully tried one antidepressant (as opposed to a large number of prior treatments) seemed most likely to respond to TMS. The FDA approval last month recommends the magnetic therapy for patients who have failed one round of prior treatment.

Demitrack also argued that there is a difference between results in clinical therapy, where both doctors and patients know that patients are getting actual treatment and not sham therapy, and in a clinical trial, where they do not.

Among patients who stayed on the therapy after the main study ended, Demitrack said, nearly one in three were cured after six weeks -- a measure, he said, of what patients might expect in real-world settings.

One such patient was Garrett Aguilar, 57, of Berwyn, Pa. (She and Newman were made available by a public relations firm representing Neuronetics.) Aguilar had also tried many treatments before signing up for the trial. But the TMS sessions did not seem to help her. After six weeks in the study, she said, she felt worse than she had at the start.

"I cried and cried," she said. "I would wander around and look at everything that needed to be done and say I was not capable of doing anything."

But at the end of the six-week period, Aguilar was told she had been in the group receiving the sham therapy. As was the case with all patients getting the sham treatment, she was offered a course of the real therapy. Four weeks into it, she said, she started to feel better.