This broadcast discusses the relatively new and "cutting edge" Deep Brain Stimulation (DBS) for treatment-resistant depression; however, the focus here is on the mechanics of the procedure vs. long-term outcomes for patients. The broadcast provides some evidence upfront that this procedure helped only about half of people in a very small Phase I study (but didn’t explain that Phase I studies really aren’t focusing on efficacy but on safety, dosing, tolerability). And it didn’t explain what "real relief" in those 8 of 17 patients really meant nor how it was measured. There is no discussion of next steps to determine if this is an effective treatment. Preliminary results from a very small study would not necessarily translate into future widespread use of this procedure as a treatment option for severe depression.
The broadcast does not list the cost of this experimental treatment. If DBS is promoted as a potential treatment via positive patient experience, an estimate of the time and energy involved in the operation should be noted. DBS is currently FDA approved for other conditions, but its use for treatment of depression and other psychiatric conditions is considered "investigational".
While the story does emphasize the highly experimental nature of the procedure, there is no discussion of any potential harms. For example, there are potential harms of the device not being placed on the correct portion of the brain, as well as harms of the surgery to implant the device (e.g. infections, bleeding in the brain, negative reaction to anesthesia). Many neurosurgeons have little experience with implantation and follow up procedures for this device. While we don’t yet know the long-term harms of deep brain stimulation when used to treat depression, the broadcast notes that this procedure has been used "safely for two decades to treat tremors in Parkinson’s disease", so we are aware of some potential side effects of the procedure.
Finally, the story needed the perspective of an independent expert, perhaps a neurosurgeon or psychiatrist not involved in DBS research.
The broadcast does not list the cost of this experimental treatment, but notes that this procedure is currently being studied in a very select group of patients. However, if the story is promoted as a potential treatment, an estimate of the time and energy involved in the operation could be noted. The procedure is FDA approved for other conditions, but its use for depression treatment is considered "off-label"; though, it is being studied for this and other psychiatric conditions (e.g. OCD). The story could mention is the procedure is covered by health insurance for people with intractable depression.
The story says the highly experimental approach has been tried "on only 17 patients so far but it’s provided real relief to 8 of them." What does "real relief" mean? How was it measured? This is insufficient information for a story like this.
The story does not mention any potential harms of this "highly experimental treatment". There are potential harms of of the device not being placed on the correct portion of the brain, as well as harms of the surgery to implant the device (e.g. infections, bleeding in the brain, negative reaction to anesthesia). Many neurosurgeons have little experience with implantation and follow up procedures for this device. While we don’t yet know the long-term harms of deep brain stimulation when used to treat depression, the broadcast notes that this procedure has been used "safely for two decades to treat tremors in Parkinson’s disease", so we are aware of some potential side effects of the procedure.
The story does not mention that preliminary results from a very small study would not necessarily translate into future widespread use of this procedure as a treatment option for severe depression. They are basically in phase 1 trials now (safety, dosing, tolerability). There is no discussion of next steps to determine if this is an effective treatment. No discussion of historical response rates with sham treatment. No discussion of the limitations of determining effectiveness with an open label trial.
The story does not engage in disease mongering. The story notes that this "cutting edge" procedure is only appropriate for a small number of patients who suffer severe, intractable depression. They also give data that appear accurate on prevalence and treatment-resistant depression.
The broadcast includes only an interview with a neurosurgeon who performs DBS and a patient who benefited (at least in the short-term) from the procedure. But there were no independent perspectives included – only a single believer at a single institution with a single success-story patient.
The story does list first and second-line depression treatments, including medication, psychotherapy. But the story doesn’t mention ECT (electro convulsive therapy) or the FDA approved device for treatment resistant depression (vagal nerve stimulation) or other experimental treatments with far more, although mixed, evidence for effect (transcranial magnetic stimulation).
The story mentions Deep Brain Stimulation (DBS) is a highly experimental procedure, only for people who have tried other treatments for depression. The story implies that the treatment is not widely available, though it is FDA approved as an investigational device. The story does not mention that a patient would need to be part of a clinical trial and fit certain criteria to be eligible for DBS: E.g. http://www.broadenstudy.com/sb/index.html
The story emphasizes that this is a "new and highly experimental treatment", and it may only be appropriate for certain people with severe depression who have exhausted most long-standing treatments.
We can’t be sure if the story relied solely or largely on a news release. We do know that it interviewed only one physician from only one medical center and only one patient.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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