In this story we learn of a potentially important new development in the treatment of head and neck cancer. The FDA recently approved the drug Erbitux for head and neck cancer after granting the application a priority review, a status only given to treatments it believes represent ‘significant improvement’ over existing treatments. The author presents accurate information on the novelty of the drug, its availability and potential side effects and does not exaggerate the prevalence or seriousness of head and neck cancer. The author also quantifies the benefit of the drug in absolute terms by giving the survival for both arms of the study. However, the story contains phrases that appear identical to some in the FDA’s news release and apppears to rely on this release as the only source of information. No other sources are quoted. In doing so, the story misses some information that was not present in the press release. Most notably, it is still uncertain how Erbitux will compare with cisplatin, the current standard of care for chemotherapy, since the trials did not directly compare them. The author also does not mention the costs of Erbitux, which are likely to be substantial compared to the much cheaper cisplatin.
The author does not mention the costs of the drug, which are likely to be substantial compared to the much cheaper cisplatin.
Quantitative estimates of survival are given for both the drug and the radiation-only groups.
The side effects of Erbitux are accurately presented.
Although there is mention of two studies, the story not describe the study design. Nor does the story explain that the studies did not directly compare Erbitux to the current standard of care for chemotherapy – cisplatin. The fact that there has been no direct comparison between Erbitux and cisplatin makes it more difficult to interpret what the results mean for current practice.
There is no obvious disease-mongering. The story accurate represents the prevalence and seriousness of head and neck cancer.
Only a single source – the FDA – is quoted.
Although the author does mention radiation as the alternative and that the side effects of Erbitux plus radiation are similar to that of radiation alone, there is no mention of cisplatin and other newer chemotherapy drugs that are the current standard of care.
The story accurately states that Erbitux has recently been approved by the FDA
The story is clear that Erbitux was first used to treat colon cancer, but is now approved to treat head and neck cancer.
Identical phrases appear in the story and in the FDA’s news release. The lack of independent sources also suggests that the author has relied on the press release as the only information source.
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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