Our Review Summary
Glioblastoma multiforme (GBM) brain tumor is a very deadly form of primary brain tumor. Despite being the most common primary brain tumor, it occurs in only 2-3 cases per 100,000 people in Europe and North America. Treatment for GBM includes surgery, radiation and chemotherapy, however the survival rate is very low and the treatments are very invasive and have many side effects and risks. Certainly news of a new, less invasive option would be welcome.
This story reports on a phase I safety trial underway at the Cleveland Clinic of a new, minimally-invasive laser treatment for GBM. Unfortunately this story provides little in the way of valuable information to the viewer.
This story fails to describe the availability of the procedure. Although the story states that it has only been used in four patients, the procedure is only availabe in the context of a clinical trial at one institution, the Cleveland Clinic. The story should have stated this explicitly. Nor does the study describe the alternative treatment options. The story mentions surgery, radiation and chemotherapy but does not discuss the pros and cons of these options compared to the new procedure.
The story does not quote any independent experts who are not affiliated with the study or employed by the manufacturer. This is a major flaw of the story. The story also does not mention any harms of the procedure or describe how little evidence there is to support its use.
Finally, the story engages in disease mongering by exagerrating the prevalence of GBM. The story states that that "97,000 Americans are diagnosed with malignant brain tumors every year". While this may be true, this statistic implies that this procedure would be appropriate for all of them. In reality, this number includes a large number of individuals who have metastases from other cancers such as breast cancer or lung cancer. Primary brain tumors, specifically GBM brain tumors, are much more rare, and are the subject of the laser treatment in the clinical trial described in the story.
Criteria
Not Satisfactory
The story does not discuss the costs of the procedure, which are likely to be substantial.
Not Satisfactory
The story does not quantify the benefits of the procedure, nor does it comment on how little is known about the potential benefits.
Not Satisfactory
The story does not mention any harms of the procedure. Earlier laser therapy treatments were not without harms.
Not Satisfactory
The story provides very little in the way of supportive evidence for the efficacy of laser induced thermotherapy. Rather than providing anything approaching a balanced picture, the participants greatly over estimate the results seen in the single patient presented. Early results in 4 patients hardly demonstrates the effectiveness of a treatment regimen. The suggestion that the FDA may render a decision on the general availability of the device adds to the unwarranted impression of the efficacy of the device.
Not Satisfactory
The story states that that "97,000 Americans are diagnosed with malignant brain tumors every year". While this may be true, this statistic implies that this procedure would be appropriate for all of them. In reality, this number includes a large number of individuals who have metastases from other cancers such as breast cancer or lung cancer. Primary brain tumors, specifically Glioblastoma Multiforme (GBM) brain tumors, are much more rare, and are the subject of the laser treatment in the clinical trial described in the story. As a result, the true incidence of the disease and the implications of treatment modalities is overstated.
Not Satisfactory
The story does not quote any independent experts who are not affiliated with the study or employed by the manufacturer. This is a major flaw of the story.
Not Satisfactory
The story mentions surgery, radiation and chemotherapy but does not discuss the pros and cons of these options compared to the new procedure.
Not Satisfactory
Although the story states that it has only been used in four patients, the procedure is only available in the context of a clinical trial at one institution, the Cleveland Clinic. The story should have stated this explicitly.
But the story should have also made clear that thermotherapy for brain tumors has been studied for many years in a number of centers. Energy sources have been as diverse as lasers to microwave to ferronanoparticles. The story should have noted that the general concept of thermotherapy for brain tumor has used mutiple different energy sources.
The story also states that the procedure may be approved within the year, but provides nothing in the way of justification for this claim.
Not Satisfactory
Clearly the laser system in the story is new, however the concept is not. The approach of using heat to destroy brain tumors has been studied since the mid-1990s.
Not Applicable
We can’t be sure if the story relied on a press release as the sole source of information.
Total Score: 0 of 9 Satisfactory
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