Read Original Story

Not exactly what the doctor ordered: Trasylol may be a killer

Rating

2 Star

Not exactly what the doctor ordered: Trasylol may be a killer

Our Review Summary

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention costs of the drug.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

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.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story does not mention if the drug is available or if so, how widely it is used.

Does the story establish the true novelty of the approach?

Satisfactory

The story implies that this is not a new drug.

Does the story appear to rely solely or largely on a news release?

Not Applicable

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. 

Total Score: 2 of 9 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.