FROM:
http://www.post-gazette.com/pg/06157/696126-114.stm
Patients seek unapproved depression therapy
Tuesday, June 06, 2006
By Elena Cherney, The Wall Street Journal
Pediatrician Laura Schulman suffered from depression so severe that it forced her to stop practicing medicine five years ago.
A string of drug cocktails over the years failed to help.
Then she read about an experimental treatment called repetitive transcranial magnetic stimulation.
The treatment hadn't been approved for depression, but a clinic in Canada was offering it to U.S. residents, and would even help arrange travel and lodging. So last summer, the Seattle resident dipped into her savings and headed north to a MindCare Centers clinic in Vancouver, British Columbia, where three to four weeks of treatment costs nearly $7,000.
After a few sessions of rTMS, which delivers electromagnetic pulses to the brain via a magnetic coil held against the skull, Dr. Schulman says she felt her depression lifting. As she made her way around Vancouver she started finding it easier to manage everyday tasks that had once felt so burdensome -- such as buying a bottle of water at a corner store. "It was like putting on glasses for the first time if you've been myopic all your life," she says.
Dr. Schulman is one of many desperate patients leaving the U.S. to obtain rTMS after failing numerous antidepressant medications.
. . .
Health
Patients seek unapproved depression therapy
Tuesday, June 06, 2006
By Elena Cherney, The Wall Street Journal
Pediatrician Laura Schulman suffered from depression so severe that it forced her to stop practicing medicine five years ago. A string of drug cocktails over the years failed to help. Then she read about an experimental treatment called repetitive transcranial magnetic stimulation.
The treatment hadn't been approved for depression, but a clinic in Canada was offering it to U.S. residents, and would even help arrange travel and lodging. So last summer, the Seattle resident dipped into her savings and headed north to a MindCare Centers clinic in Vancouver, British Columbia, where three to four weeks of treatment costs nearly $7,000.
After a few sessions of rTMS, which delivers electromagnetic pulses to the brain via a magnetic coil held against the skull, Dr. Schulman says she felt her depression lifting. As she made her way around Vancouver she started finding it easier to manage everyday tasks that had once felt so burdensome -- such as buying a bottle of water at a corner store. "It was like putting on glasses for the first time if you've been myopic all your life," she says.
Dr. Schulman is one of many desperate patients leaving the U.S. to obtain rTMS after failing numerous antidepressant medications. And while some doctors are cautioning patients to wait for the Food and Drug Administration to weigh in, scores of other patients have traveled to U.S. clinics that offer the treatment on an "off label" basis. The technique is approved in the U.S. only for brain research, but doctors can use it to treat depression, just as other drugs and therapies can be used in applications other than those for which they are approved. In Canada, the rTMS device has limited federal approval for safety, but provincial health-insurance plans won't cover it, citing lack of evidence on its efficacy.
The therapy is showing promise in studies. In the first big multisite trial of rTMS, the method was shown to benefit about 42 percent of patients with treatment-resistant depression -- or severe depression that doesn't improve with medication. And side effects were considered mild, mostly consisting of headache. The 300-patient study, released last month, was sponsored by Neuronetics Inc., which is seeking Food and Drug Administration approval for use of its rTMS device in treating depression. A spokeswoman for the FDA declined to comment on the review process.
Many psychiatry experts say rTMS is likely to be approved soon in the U.S. But some doctors note that for now, the clinics in both Canada and the U.S. are operating without direct regulatory authority, and may not be following the same protocols in screening patients that researchers use in their clinical trials. So some patients who aren't appropriate candidates may be paying for pointless treatment, these doctors say, and failing to pursue the treatment that they do need. Since rTMS isn't covered by insurance, patients typically pay thousands of dollars out of pocket.
"The results are very promising, but standards need to be in place" before patients seek treatment, says Sarah H. Lisanby, a lead investigator on the Neuronetics study and a psychiatrist at the Brain Stimulation and Neuromodulation division of the New York State Psychiatric Institute.
Treating stubborn depression remains one of psychiatry's most puzzling problems. About 14 million people in the U.S. suffer from depression, and some 70 percent don't fully respond to the first antidepressant drug they try.
At least one-third of patients still have symptoms after adding a second drug or switching to another medicine, according to recent studies by the National Institutes of Health.
"These are people who've lived their lives in misery or have tried many medications," says Mark George, a psychiatrist at the Medical University of South Carolina, who is an investigator on the Neuronetics trial and has consulted for the MindCare clinics.
Only two nondrug treatments have been approved by the FDA for depression. Electroconvulsive therapy, or ECT, is considered the gold standard in hard-to-treat cases, based on its efficacy. But because it works by causing a seizure, it must be performed in a hospital. And it can have serious side effects, including memory loss and cognitive problems. Dr. Schulman of Seattle, for instance, said she didn't want to try ECT because of the risk of side effects.
Vagus nerve stimulation, approved last year, involves surgery to implant a device in the neck, but is only approved as an add on to medication for chronic or recurrent depression.
In rTMS a strong magnetic field is directed through a coil held against the head for a series of sessions that last less than an hour each. The magnetic force stimulates a part of the brain believed to play a role in depression. The treatment doesn't require anesthesia and produces few side effects, though it doesn't work for as many people, or as effectively, as ECT.
The treatment does carry a small risk of seizure, and the American Psychiatric Association guidelines for research state that rTMS should be supervised by a licensed doctor. In research trials, patients are screened to make sure they don't have medical conditions that could put them at risk for having a seizure. Patients in the studies are also screened by a psychiatrist to make sure that they in fact are suffering from depression.
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Re: Depression (Clinical)
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Re: Depression (Clinical)
Re: Depression (Clinical)
