Neuronetics, Inc has submitted a premarket notification (510(k)) to request market clearance for the NeuroStar TMS System for the treatment of major depression.
Depression is a serious and debilitating disease. The use of ineffective treatments can contribute to feelings of hopelessness, which in turn can worsen the symptoms and even result in suicide. It is therefore especially important to make sure that medical products approved for the treatment of depression are proven safe and effective.
The FDA 510(k) process is intended to be for products that are substantially equivalent to other products already on the market. In this case, Neuronetics is claiming that NeuroStar is substantially equivalent to Electroconvulsive Therapy (ECT), even though it is a very different technology.
The FDA responded by requiring the company to prove that the treatment was favorable and comparable to ECT, and that any reduction in effectiveness was counter-balanced by a reduction in risk. It is not clear how that qualifies a product for the 510(k) process.
The data indicate that NeuroStar is probably not significantly more effective than a sham treatment, but is more likely to cause pain, muscle twitching, and several other serious adverse reactions. It is well known that placebo can be an effective treatment for depression. However, that would not justify the approval of NeuroStar, which is considerably more expensive, inconvenient, and risky than many other available placebos.
We have discussed this product with several consumer organizations that are active members of the Patient and Consumer Coalition. They share our strong concerns that the 510(k) process is not appropriate for the NeuroStar, and that the FDA needs to consider the emotional and financial costs to consumers when considering approval of medical devices with questionable efficacy.