This story discusses FDA approval of a new drug, Nexavar, for the treatment of advanced kidney cancer. There is a claim that it is a “major advance” in the treatment of this type of cancer, but it does not cure cancer and there is no mention if overall survival is improved in patients who took this drug. Nexavar only shrinks cancer in 2%, so it really does not work that well for its intended purpose. There is little information about the study design and no discussion of how many patients received the drug or the stage of their kidney cancer at the time of enrollment in the study. The quantitative results are meaningless here as there is no mention of patient sample size or how a 30% tumor reduction translates into improved quality of life. There is no link between stabilization of cancer growth and improvement in quality of life. There is also no meaningful comparison with existing treatments and no long-term data on the side effects or safety of Nexavar compared to existing drug therapies. Discussion of which dimensions of quality of life are reportedly improved is lacking, as is a comparison of the quality of life of patients who choose not to take the drug. Given that 40% of Nexavar users experienced side effects, these are downplayed in the story. One of the side effects mentioned is diarrhea, which can potentially pose a serious problem for cancer patients. Since this drug is not a cure and does not extend life, the story should have pushed for further data on quality of life measures – an important end point in a study of advanced cancer patients.
No mention of cost and no cost comparison with existing treatments.
The story allows an FDA scientist to call this a “major advance”
in the treatment of this type of cancer, but the story doesn’t even mention if overall survival is improved in patients who
took this drug. The quantitative results that are given are meaningless as there is no mention of patient sample size or how
a 30% tumor reduction translates into improved quality of life.
No quantitative comparison of side effects. There is no comparison
with the side effects of existing drug treatments. No discussion of what constitutes “serious problems” and no discussion on
how side effects may affect quality of life in these cancer patients.
No mention of patient selection, randomization, number needed to treat and
little on study design. 2% of how many patients saw reduced tumors? No mention of possible longer term outcomes, given the
relatively brief study (only 6 months). Also, there is no mention of the study funding. How does a drug that only moderately
shrinks a tumor improve quality of life in kidney cancer? A reduced tumor is still not a cure and there is no discussion of
how patients’ quality of life is improved.
Gives prevalence of kidney cancer. It does not say how many of these progress to advanced kidney cancer or at
what stage Nexavar should be administered.
mention of funding source or if principal investigator who is quoted received funding from Bayer, the maker of Nexavar.
Mentions other drugs, but does not give a comparison with other treatments in
terms of effect on tumor size. The story says that Nexavar is easier on patients, but then says 40% of patients experience
side effects. What is the quality of life comparison for those taking older drugs and those taking Nexavar (or Nexavar and
no drug treatment)?
Story focuses on FDA approval.
Mentions it is a new drug
for kidney cancer.