Magnets for Depression?
This letter was published in the Sacramento Bee.
Re “Magnets offering jolt out of dark” (Page A1, Dec. 9): The article about a novel device for treating depression fails to include an important detail: transcranial magnetic stimulation, or TMS, remains a therapy of unproven effectiveness.
In the sole randomized, controlled trial conducted on this device, TMS conferred no benefit on the main measurement of depression the company had specified before the trial. This is why the Food and Drug Administration initially rejected TMS as a treatment for major depression.
Furthermore, the FDA’s subsequent clearance of TMS to treat certain depressed patients (those who have failed one antidepressant) appears to hinge on an after-the-fact subset analysis of this trial, as alluded to in the article. This type of analysis is unreliable, often misleading and generally undertaken only to guide future research.
Moreover, such analyses are even less appropriate when there is no difference between groups in the full study, as was the case here. Clearance of this device based on discredited statistical techniques reflects poorly on the FDA, particularly if patients are diverted from clearly effective therapies.
– Jonas Hines and Peter Lurie, Washington, D.C.