This story reports on a small case series showing that a drug intended for type 2 diabetes (which typically affects adults and doesn’t require insulin injections) seems to benefit individuals with the type 1 form of the disease (which usually presents in childhood and requires insulin replacement therapy). The findings are certainly newsworthy because better glycemic control could help prevent the long-term consequences of type 1 diabetes, such as heart disease and kidney failure. However, they shouldn’t be communicated to a consumer audience without strong caveats about the preliminary nature of the research. This story didn’t meet that standard.
Small, uncontrolled studies often report tantalizing benefits for new treatment approaches. Sometimes these benefits are real, but often they reflect factors that have nothing to do with the new therapy. Patients may get better simply because they think they are getting a useful new treatment (i.e., the placebo effect). Or, they may improve because the study researchers give them more attention and education than they were getting before. Another possibility is that patients become motivated to manage their disease more carefully while they are in a study. Controlled studies limit the influence of these factors and are important for determining the true value of a new treatment.
The story does not discuss costs. Adding Victoza to a diabetic’s treatment regimen would cost an additional $350 per month, according to coverage of the study by MedPageToday. This is not a trivial sum.
The story attached numbers to some of the benefits reported on. We learn that patients taking the drug had less need for mealtime and all-day insulin (reductions of 7 and 8 units, respectively); that their HbA1C dropped from 6.5% to 6.1%; and that they lost an average of 10 lbs. However, no numbers are provided to back up the claim in the second paragraph that patients “felt much better overall” after treatment.
This one is close, but since the story emphasizes the drug’s effects on how patients feel (in the third paragraph, the lead researcher on the study says patients experienced a “delightful improvement” in well-being), we felt that some data should have been provided to substantiate this.
The story pays appropriate attention to potential harms. It notes that the weight loss caused by the drug could be detrimental to thin patients, and that the drug causes abdominal pain, nausea, and vomiting. The study author notes that adverse effects cause about 5% of type 2 diabetes patients to stop taking the drug. The story probably should have mentioned that the drug is administered by injection, something which can’t be very appealing to type 1 diabetics who may already be giving themselves multiple injections daily or, as in this study, are using insulin pumps that only require a needle to be inserted every few days.
We found several problems here:
In addition, while the outcomes reported in this study — insulin requirements, blood sugar levels, etc — are clinically important, it’s not clear if they will ultimately reflect improvements in the primary long-term problems associated with diabetes, such as blindness, amputations, and heart attacks. The story could have mentioned this uncertainty.
The story notifies readers that this study was conducted without drug company support, but that a corporate-funded trial is in the works. The story could also have notified readers that the lead researcher, Dr. Dandona, disclosed numerous relationships with pharmaceutical companies in the abstract for this study — although none with Victoza manufacturer Novo Nordisk.
The story fell short of the bar when it failed to obtain feedback from an expert who wasn’t involved with the research. Context is everything, and even hearing from a practicing diabetes expert would have been helpful.
The story mentions that another drug in the same class as Victoza might have similar benefits in type 1 diabetes. The story might have included more information about the importance of testing blood sugars, frequent insulin changes, and careful dietary monitoring in improving control of diabetes.
The story states that the drug is not approved for use in type 1 diabetes, but that it could be used off-label in this population by a diabetologist since it is approved for use in type 2 diabetes.
There’s a good description of how the drug works and why it hasn’t previously been studied in individuals with type 1 diabetes.
The story acknowledges in a footnote that a news release from the Endocrine Society was used as source material. However, we could not locate a copy of this release online to evaluate it. Since there were no expert sources cited other than the lead researcher on the study, we can’t be sure to what extent this story relied on the Endocrine Society release for its content. We’ll rate this one not applicable.
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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