An incomplete and overly optimistic story about a new and potentially useful treatment option. While it gets a 3-star score, it failed on our most important criteria.
This was a story originally published in The (Nashville) Tennessean newspaper and, for some reason, republished on the USA Today website. The story did not provide any semblance of balance in its reporting of the device.
Depression is a chronic condition that waxes and wanes in its intensity. Although clinicians have a myriad of drugs available and newer approaches to the treatment of resistant depression, new treatments are welcomed. Transcranial magnetic stimulation is a novel and FDA-approved approach that is likely to benefit a segment of the population with depression. We think that stories on new medical devices need to be balanced and need to provide the reader with the correct context in which the device might be useful.
The story provides the reader with information on the cost so it meets the criterion. We would have liked a bit more information. For example, how durable is the response and will patients need repeated treatments? Based on the literature to date, patients may need to undergo treatment every 2-3 months. We are told that each treatment costs about $400 and the total cost is $8-12,000. That means each patients receives 20-30 treatments. There are ancillary costs associated with each trip that we would have liked to have included. Nonetheless, we’ll give the story the benefit of the doubt.
The story describes a single patient anecdote and does provide us with some information about the NIMH sponsored clinical trial: “Both Cochran and West cite high patient response rates. A clinical trial funded by the National Institutes of Health revealed a “significant effect of treatment” when patients received TMS treatment. It compared outcomes of patients who actually received the magnetic pulses against patients in a “sham” group, who sat down in the treatment chair for fake sessions.”
Here is what the lead author of the NIMH funded study said about the results (http://www.nimh.nih.gov/science-news/2010/magnetic-stimulation-scores-modest-success-as-antidepressant.shtml) performed in 190 patients with depression who failed standard drug therapy::
Hardly the results suggested by the story
The story doesn’t provide any specifics about potential harms of the treatment, We are told, “…treatments are more effective than medications with far fewer side effects,” “…but for the most part, it is safer in general than taking a medicine. You’ve got less seizure risk than taking a medicine. You’ve got less side effects than taking a medicine.” Exactly what are the risks and how often do they occur? Here is a listing of side effects from the NIMH website:(http://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies.shtml )
“Sometimes a person may have discomfort at the site on the head where the magnet is placed. The muscles of the scalp, jaw or face may contract or tingle during the procedure. Mild headache or brief lightheadedness may result. It is also possible that the procedure could cause a seizure, although documented incidences of this are uncommon. A recent large-scale study on the safety of rTMS found that most side effects, such as headaches or scalp discomfort, were mild or moderate, and no seizures occurred. Because the treatment is new, however, long-term side effects are unknown.”
We are not provided with any details supporting the physician advocate’s comments. As we noted previously, the NIMH study is briefly described but in rather glowing remarks that can give the reader an inflated view of the success of the device.
No disease mongering here
Besides the glowing comments by a psychiatrist who uses the device and the originator, we do have a comment from a spokesperson from an insurance company who does not as yet provide coverage. Given the controversy in this 15 year old technology, we would have liked to have seen comments from an expert in the field.
The story does provide some insight into the alternative approaches including drug therapy and electroconvulsive therapy. No useful information is provided about ECT, Vagal nerve stimulation or magnetic seizure therapy. The comparisons however are provided by devotees of the technology and no references are provided.
The story makes it clear that the device and thus the treatment is available. The story does provide some insight into insurance coverage as well.
The story makes it clear that the device approved in 2008 is novel as is the underlying approach to treating depression
The story does not rely on a press release