We are always leery of stories reporting on very preliminary clinical research, especially for conditions such as Alzheimer’s disease where there are no effective treatment options. These stories frequently raise hopes to a level that is not justifiable given where we are in the scientific evaluation process. In its report on an early study of the use of inhaled insulin for Alzheimer’s disease, the New York Times is careful to emphasize the limitations of this small pilot study and warns readers that the findings might not hold up. These caveats are offered early in the story and are helpfully reiterated toward the end by an independent source. However, the story should have been more discriminating when reporting on the size of the benefits observed and whether they merit much optimism. Early studies of new therapies often find large, clinically important benefits that are typically reduced when larger, more rigorous studies are conducted. Even at this early stage, however, the benefits of inhaled insulin are were, according to the study authors, “small in absolute terms” and had “unclear” clinical significance.
The World Health Oganization estimates that there will be 34 Million people suffering from Alzheimers Disease by 2025 with about 70% residing in the developed world. Given the magnitude of the disease worldwide in terms of lives lost and cost, any advancement in its treatment is newsworthy. Reporters need to be especially careful in reporting on treatments especially those in the early stages of research. Attention to our 10 criteria can help reporters stay grounded.
The story did not mention the cost of insulin. This information is readily available and would have provided valuable context. There will also be the cost of the specialized inhaler.
The story says that insulin-treated patients “either improved slightly or remained the same in tests of memory and assessments of their ability to handle day-to-day activities.” The statement is not misleading, but it is not detailed enough to satisfy this criterion. Unfortunately the story did not place the study results into context. How relevant to the patient were the changes seen and would they or their family members notice the improvement? The story could have described the scales that researchers used to measure function, and provided the actual values for the treatment and placebo groups. This would have given readers a more objective accounting of how “slight” the improvement was. Notably, the researchers acknowledge in their paper that “although we achieved statistical significance for our primary outcome measure, the observed effects were small in absolute terms, and thus their clinical significance is unclear.”
The story references potential adverse effects, and notes that this study was too short and small to reliably document the potential harms of treatment. However, it didn’t mention the adverse effect data — limited though it may be — that was reported in the study. Adverse events were more common in the insulin-treated groups and were reported by 72% of patients receiving 20 IU of insulin, 68% receiving 40 IU, and 57% receiving placebo. The most commonly reported adverse event was a stuffy nose, but headaches and nosebleeds were also more common with insulin treatment.
The story provided a reasonably detailed and accurate description of the study, with appropriate attention to limitations. It cautioned readers about the small size of the study and the preliminary nature of the data in several places, including high up in the piece. We liked that it referenced previous experience showing that early findings such as this “often fall apart” in larger, longer tests.
The story did not engage in disease-mongering.
The story includes quotes from the lead researcher on the study as well as an expert who was not affiliated with the research. The comments from the independent expert help drive home the need for caution when interpreting these results.
The story notes that there are no effective ways to prevent or delay the progress of Alzheimer’s. However, it should have mentioned that the FDA has approved some medications for the treatment of individuals with Alzheimer’s disease. Although these drugs do not affect the course of the disease, they may have a small effect on preserving the functioning of patients in the early stages of the disease. It also could have noted that there are other drugs in late-stage testing for Alzheimer’s disease.
The story notes that this treatment is experimental and that the device used to administer insulin deep inside the nose is not on the market. It urges readers not to rush out and take insulin for the treatment of Alzheimer’s disease. The story closes with the implied promise of a larger study in which “many” people might have access to the intranasal insulin therapy, which sets an overly optimistic tone. Only a small fraction of people who might benefit from this therapy will be eligible to participate in any future studies. On the whole, though, the story’s message on availability is correct and merits a satisfactory.
The story describes the earlier research that laid the foundation for the current study, and does not overstate the novelty of this approach.
The story contains enough independent context that we can be sure it wasn’t based on a news release.
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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