This is an ambitious original work of health journalism designed to explore the dangers of Avandia beyond what current research and government action allow. It also suggests that the data it gathered, by its very nature, illustrates weaknesses in the government post-market surveillance system.
It’s an excellent example of enterprise work. Getting documents under the Freedom of Information Act requires considerable time and effort. Both AP and the reporter should be recognized for their commitment to this story.
Having said all that, the article fails to convey key information about the true size of the benefits and risks of the drug to people with type 2 diabetes. It does not mention other treatment options. As a result, the story may unnecessarily frighten Avandia users.
The article fails to report how much the drug costs, especially as compared to generic or other alternatives. If it is a relatively expensive drug, this would provide useful context.
The article should have made clear the absolute risks of the most severe cardiac outcomes in the Type 2 population in general and in Avandia takers specifically. This is especially important given the data the article focuses on clearly misrepresent prevalence. The author cites a 43 percent increase in heart attacks attributed to Avandia in the original New England Journal of Medicine article, but Nissen’s original NEJM report shows that the numbers of heart attacks and deaths were quite small.
The article makes clear the range of side effect severity, properly focusing on the most serious: heart-related hospitalizations and deaths. More information on the benefits of this class of drugs would provide better balance.
The article makes clear that the data it is examining are limited by the anecdotal, voluntary nature of the reports to the federal government. But it fails to specify the harms and benefits of the treatment as reflected in previous research.
The risks of Type 2 diabetes itself and of taking Avandia are real. Still, the citation of a 43 percent increase in risk to Avandia takers, without context and proportion, creates a potentially misleading impression of the drug’s harm.
The article makes clear the affiliations and potential conflicts of interest of key experts interviewed. A small oversight is the failure to mention that the original NEJM piece discloses that author Steve Nissen of the Cleveland Clinic has received research support from a number of diabetes drug makers, none of which is GlaxoSmithKline, Avandia’s maker. That study mentions that consulting fees he gets from various drugmakers (it is not revealed whether that group includes GSK) are donated directly to charity.
The article fails to mention that there are cheaper, effective alternatives to Avandia on the market.
The article makes clear that Avandia is widely used, and that 1 million Americans take it. Given the intent of the article, however, it would have been useful to include an estimate of the drug’s market share, or at least compare the one million to the national type 2 diabetes population.
The author makes clear that the treatment is in widespread use.
The reporter has undertaken considerable original research to do this article.
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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