The story reports that the popular diabetes drug Avandia may potentially be linked to a higher chance of cardiovascular disease or death. An important omission in the story is that the evidence upon which the study findings are based is not discussed, which is very important because there are important limitations to the data. Complete data could not be obtained by the study authors. Actual event rates were low and estimates of the risk were pretty wide, which means there is a lack of precision about what the real rates might be. The story makes it sound as if the study conclusions are definite and this is not the case, although the results are certainly concerning. But, caution must be used. It should be a call to the pharmaceutical industry to release the rest of the data. Alternate treatment options were also not discussed, although patients were encouraged to talk with their doctors about the risk-benefit picture. Many other glucose-lowering medications are available and don’t appear to increase cardiovascular risk and should be considered while the safety of Avandia remains uncertain.
The story does not mention any costs of treatment of this drug or other glucose-lowering drugs.
The story describes relative risks only and not absolute risks. (See our primer on this topic.) So, when the story states "the drug increases heart attacks by 43% and heart deaths by 64 percent," the audience and the journalist should be asking 43% of what? 64% of what?
The entire story is devoted to one harm in particular – a potential increased risk of cardiovascular disease with one particular glucose-lowering drug. While other side effects are possible with this drug, they are not mentioned. However, an important potential harm that is new in these study findings is discussed.
The story does not describe the evidence upon which the findings are based, which is very important because the study authors didn’t have access to full data from the 42 studies evaluated. There are important limitations to the study design which are not mentioned at all. For instance, confidence intervals (a way of statistically stating the level of confidence about a result) are wide and actual numbers of events are very low, so having complete data might sway the results. The story calls the results "scathing," making it appear as if the findings are conclusive, yet they are not.
The story describes the increased cardiovascular risks associated with diabetes. And, although there isn’t much background information on diabetes, there isn’t any overt disease-mongering.
The story uses multiple sources.
The story doesn’t discuss other treatment options, namely that there are many other glucose-lowering medications available that don’t appear to increase cardiovascular risk. While the advice for patients to talk to their physicians in the next weeks is sound, the story could have gone further in pointing out that there are options that seem safer given the uncertain cardiovascular risk with Avandia. There are both medication options that have been around for a very long time and behavioral options, such as exercise and weight loss that could improve glycemic control.
The story tells viewers that Avandia is FDA-approved and has not been taken off the market as a result of the latest study.
The story states Avandia was approved in 1999, so it’s clear this is not a new treatment.
The story uses multiple sources and interviews.