This short piece (163 words) reports on the publication of a study in JAMA about the potential harms of a drug, Trayslol (aprontin), that is used to control bleeding in patients who have just undergone bypass surgery. This study raises serious concerns about the safety of this drug, however it also may contradict other studies that have not shown the drug to be as harmful.
The reality is that the contention that aprotinin may contribute to excess morbidity and mortality as compared to aminocaproic acid and transexamic acid is not new. The authors of this cited study published an analysis of the short term outcomes in this same population a year ago. The original findings prompted a meeting of the scientific advisory committee of the FDA on the safety of aprotinin. The story of aprotinin has many twists and turns, a fact that is ignored in the story.
This story leaves out important information for the consumer, such as the magnitude of the harms and the strength of the available evidence. Furthermore, this story does not mention that this study was based on people participating in a registry of patients who had bypass surgery. Because they were not randomly allocated to treatment, there may be important differences in patients who got the different medications. This limits the conclusions that can be drawn from this study.
The story does not attempt to quote any independent sources. Instead, the story quotes from the original article and the accompanying editorial. The story should have quoted other experts who could provide some additional perspective.
Again, we want to point out the inherent weaknesses in such a short story. In 163 words, this story leaves the reader with an incomplete understanding of the cited study and fails to provide adequate context.
The story does not mention costs of the drug.
Because this story is about the risks of the drug, the story should have quantified those risks, and the quantification should have been in context with other available drugs.
While the study does note some of the potential harms of using the drug, the unsubstantiated number of deaths quoted by the lead author potentially exaggerates the extent of the problem. In addition, by not providing a context (bleeding risks during surgery, comparative risks associated with other drugs, etc.) a reader is unable to evaluate the harms of treatment based on what's given in the story.
The story does not describe the strength of the available evidence. Specifically, the story does not mention that the results of this study may contradict what has been shown in other studies, including several randomized trials. Furthermore, this story does not mention that this study was based on people participating in a registry of patients who had bypass surgery. Because they were not randomly allocated to treatment, there may be important differences in patients who got the different medications. This limits the conclusions that can be drawn from this study. The limitations of the study design and the contradictory conclusions of several studies are not provided.
The story quotes the senior author claiming, "The bottom dollar is 10,000 deaths over five years." Such an alarming statistic may exaggerate the true impact of the use of the drug in question. However, there was some attempt at balance by inserting a comment from an editorial writer that patients on Trasylol may have been much sicker, contributing to the higher death rate.
The story does not attempt to quote any independent sources. Instead, the story quotes from the original article and the accompanying editorial. The story should have quoted other experts who could provide some additional perspective. Another knowledgeable source might have told the reporter that the authors of ths cited study published an analysis of the short term outcomes in this same population a year ago. The original findings prompted a meeting of the scientific advisory committee of the FDA on the safety of aprotinin. The story of aprotinin has many twists and turns, a fact that is ignored in the story.
The story mentions two similar drugs, but does not name them, nor does the story attempt to explain the advantages or disadvantages of the other drugs in relation to Trasylol.
The story does not mention if the drug is available or if so, how widely it is used.
The story implies that this is not a new drug.
We can't be sure if the story relied solely or largely on a press release as the sole source of information. It could have taken material straight out of the Journal of the American Medical Association, because only a lead author and an editorial writer in that journal are cited.
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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