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Magnet device aims to treat depression patients

Rating

3 Star

Magnet device aims to treat depression patients

Our Review Summary

For people suffering from severe depression who have not responded to medical treatment, the idea that a non-invasive procedure is now available is welcome news. On October 8, 2008, the FDA announced that they had cleared transcranial magnetic stimulation, or TMS, for patients who had not responded to antidepressant therapy. However, because TMS is not an implantable device, the FDA was merely required to clear the device on the basis that it was "safe and equivalent" to electro-shock therapy. The ruling does not claim that TMS is effective, and many questions remain about just how much benefit TMS provides compared to existing treatments.

This story does not exaggerate the seriousness or prevalence of depression and thereby avoids disease mongering. The story is also clear to point out that the FDA approval is specifically for people who have failed first-line treatment with medication. The story could have done more to explain that TMS is not for people who have mild depression or who have not attempted other forms of treatment first.

The story does a good job of describing the costs of TMS, which are significantly higher than medication, and of describing the novelty of TMS. Although TMS itself is not new, it has only recently been studied as a possible treatment, rather than just a research tool. The story does provide some quantification of benefits of TMS, describing what percentage of subjects scored significantly better on standard depression scores after treatment with TMS compared to sham.  However, it was not clear from the story what "significantly better" meant and if that translates into real clinical differences for the patient.

The story mentions antidepressants and shock therapy but does not mention other very effective treatments for depression, including psychotherapy, either in combination with medication or by itself, and self-help techniques. Nor does the story explain that there are many different antidepressants and if a patient does not respond to one drug, other drugs can be tried before resorting to TMS. In addition, the story misrepresents shock therapy as a "last resort" treatment. While shock therapy isn’t the first choice for many people, it could be a reasonable choice in certain clinical situation. Describing shock therapy in this way may be harmful to patients and families who are considering shock therapy at a time when it is likely to help.

Furthermore, while the story describes the study and points out that the FDA had many concerns about it, the story does not describe what those concerns were. The story does explain that a new study should provide better data, but does not mention that this approval comes after a prior panel found insufficient evidence to support TMS.   That the story focused only on the current study and FDA decision without putting it into context of the whole body of literature on the subject is problematic. Also, the story mentions that TMS was recently approved. However, the story should have emphasized that it is still considered experimental in spite of the approval and its availability is limited to a few research centers.

Finally, the story quotes two experts who are both involved in the research on TMS in depression. The story should have quoted additional experts who do not have a stake in the outcome to provide some much needed balance. The story did not explicitly address whether the researchers had any financial conflict of interest. 

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does a good job of describing the costs of TMS.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story does provide some quantification of benefits of TMS. Specifically, it describes what percentage of subjects scored significantly better on standard depression scores after treatment with TMS compared to sham.  However, it was not clear from the story what "significantly better" meant and if that translates into real clinical differences for the patient.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story describes TMS as "very safe" and lacking the harms of shock therapy, such as seizures or memory problems. While this may be true, the story does not explain that there is a lot we don’t know about the long-term effects of this treatment. Since this treatment is so new and has not been studied in a large number of patients, we don’t know what adverse effects will be revealed when it is used in more people and for longer durations. The story mentions headaches as a side effect of therapy, but does not describe if they were severe or mild or how common they were.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

While the story describes the study and points out that the FDA had many concerns about it, the story does not describe what those concerns were. The story does explain that a new study should provide better data, but does not mention that this approval comes after a prior panel found insufficient evidence to support TMS. That the story focused only on the current study and FDA decision without putting it into context of the whole body of literature on the subject is problematic.

Does the story commit disease-mongering?

Satisfactory

The story does not exaggerate the seriousness or prevalence of depression. The story is also clear to point out that the FDA approval is specifically for people who have failed first-line treatment with medication. The story could have done more to explain that TMS is not for people who have mild depression or who have not attempted other forms of treatment first.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story quotes two experts who are both involved in the research on TMS in depression. The story should have quoted additional experts who do not have a stake in the outcome to provide some much needed balance.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story mentions antidepressants and shock therapy but does not mention other very effective treatments for depression, including psychotherapy, either in combination with medication or by itself, and self-help techniques. Nor does the story explain that there are many different antidepressants and if a patient does not respond to one drug, other drugs can be tried before resorting to TMS. Further, the story misrepresents shock therapy as a "last resort" treatment. While shock therapy isn’t the first choice for many people, it could be a reasonable choice in certain clinical situations. Describing shock therapy in this way may be harmful to patients and families who are considering shock therapy at a time when it is likely to help.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story mentions that transcranial magnetic stimulation was recently approved. However, the story should have emphasized that it is still considered experimental in spite of the approval and has availability limited to a few research centers.

Does the story establish the true novelty of the approach?

Satisfactory

The story does a good job of describing the novelty of TMS. Although TMS itself is not new, it has only recently been studied as a possible treatment, rather than just a research tool.

Does the story appear to rely solely or largely on a news release?

Not Applicable

We can’t be sure if the story relied on a press release as the sole source of information.

Total Score: 4 of 9 Satisfactory

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