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Read Original Story

Kidney cancer drug gets FDA approval

Rating

2 Star

Kidney cancer drug gets FDA approval

Our Review Summary

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of cost and no cost comparison with existing treatments.

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

Not Satisfactory

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.

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

Not Satisfactory

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.

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

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

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.

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

Not Satisfactory

No

mention of funding source or if principal investigator who is quoted received funding from Bayer, the maker of Nexavar.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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)?

Does the story establish the true novelty of the approach?

Satisfactory

Mentions it is a new drug

for kidney cancer.

Total Score: 3 of 9 Satisfactory

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