This story reports on a potentially important development in the treatment of symptomatic multiple sclerosis (MS). MS is a devastating condition and although many different treatments are available, they have side effects and must be injected, leading to non-compliance. The six-month results of the first randomized trial of this drug were published this month in the New England Journal of Medicine. However, since then, the drug company has released newer data that has not yet been published or presented at a meeting. This story reports on the new data released by the drug company.
The story fails to mention treatment alternatives (of which there are several), does not quote any independent sources, and does not mention harms of the drug (including infection, headache, diarrhea, and nausea) or costs. The story also does not adequately describe the design of the study on which the story is based. In reality, this was a randomized trial in 281 patients. But it’s the first of its kind to study this drug, and further study is necessary before it will be used in clinical settings. Furthermore, the story appears to have relied on a drug company press release as its sole source of information. Not only does the story quote the same statistics, but it presents data that is not available from any other source (i.e. has not yet been published or presented at a meeting).
The story was given an “Unsatisfactory” rating on the Quantification of Benefits criteria for two reasons. First, the story presents unpublished data. The September 14, 2006 New England Journal article presents data at six months, which was the end of the controlled trial, whereas this story presents data out to two years. In the study, after six months, those assigned to placebo were placed on the drug, so comparisons to the placebo could no longer be made and the results for the drug would appear to be more favorable. Second, the story provides a main outcome measure, percentage of patients free of relapse at the end of the study, for the drug treatment group only. It does not compare this percentage to the control group. The story should have stated that 65% of patients in the drug group were free of relapse at six months, compared to 23% of patients in the control group.
The story does not mention the cost of the drug.
The story deserves an “Unsatisfactory” rating on this criteria for two reasons. First, the story presents unpublished data. The September 14, 2006 New England Journal article presents data at six months, which was the end of the controlled trial, whereas this story presents data out to two years. In the study, after six months, those assigned to placebo were placed on the drug, so comparisons to the placebo could no longer be made and the results for the drug would appear to be more favorable. Second, the story provides a main outcome measure, percentage of patients free of relapse at the end of the study, for the drug treatment group only. It does not compare this percentage to the control group. The story should have stated that 65% of patients in the drug group were free of relapse at six months, compared to 23% of patients in the control group.
The story does not mention harms of the drug, which include upper respiratory tract infection, headache, diarrhea, and nausea.
The story does not adequately describe the design of the study on which the story is based. In reality, this was a randomized trial in 281 patients, but is the first of its kind to study this drug, and further study is necessary before it will be used in clinical settings.
By accurately describing the prevalence and seriousness of MS, the story avoids disease mongering.
The story does not quote any researchers or clinicians who could have provided some perspective.
The story does not comment on any alternative treatment options, of which there are several.
The story states that the therapy is “experimental” and in “late-stage clinical trials,” suggesting that it is not yet available. The story could have been more explicit.
The story clearly states that the drug is new.
The story appears to have relied on a drug company press release as its sole source of information. Not only does the story quote the same statistics, but it presents data that is not available from any other source (i.e. has not yet been published or presented at a meeting).
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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