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Study: Prostate cancer vaccine extends survival


5 Star

Study: Prostate cancer vaccine extends survival

Our Review Summary

Given about double the space of the USA Today story we also reviewed, this report includes important information about conflicts of interest and the financial impact of research reports, as well as details that bring the trial results into clearer focus, such as median survival data and the fact that the FDA declined an earlier application for approval of Provenge.

The story meets most of our criteria, and, thus, gets a high rating.  But it has its flaws.

The quotes in this story almost uniformly praise the drug as an advance or even groundbreaking. Only one comment suggests questions remain about side effects. None highlights the point that despite treatment, two out of three participants died within three years. While other stories quoted experts who called the results an "incremental" advance, no such cautionary perspectives were included in this story.

The reporter erred by comparing survival data from this Provenge trial to the typical results of standard chemotherapy. Since the trial merely compared Provenge to placebo, not to standard treatment, it is inappropriate to claim the experimental drug is superior.

Rather than raising expectations by saying doctors "hope for even greater benefit if they give the drug earlier," the story should have simply stated that it is not known what effect this treatment might have if given earlier in the course of prostate cancer. This point is important because if the FDA approves the treatment for advanced prostate cancer, doctors may begin offering it to men with less extensive disease based on belief, instead of evidence, of effectiveness.


Does the story adequately discuss the costs of the intervention?


While no price has been set, this story still confronts cost by pointing out that other biotech drugs cost thousands of dollars per month of treatment.

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


The story included key details about the difference in survival rates and length between the treatment and control arms of the trial.

The story gives both the median survival length and the three-year survival figures for participants in the treatment and placebo arms of the trial. It might have been helpful to say "half the men survived at least" rather than "median survival was."

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


The story lists the serious side effects reported in the trial and the fact that earlier trials raised worries about strokes related to treatment.

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

Not Satisfactory

Although this story, like the USA Today report that we reviewed, stated in the lead that patients receiving Provenge lived four months longer without specifying that it was four months longer than placebo, not standard therapy, it does a better job of detailing the available results.

The story improperly compares the reported survival advantage of the experimental treatment to the expected survival of men receiving standard chemotherapy, implying the two treatments have been tested head-to-head.

The story also includes speculation that Provenge could be more effective when given earlier in the course of the disease, even though there is no evidence to support the statement.

Quotes at the end of the story from leaders of some patient advocacy groups overstated the evidence of effectiveness, but they seem to accurately reflect the perspective of these activists.

Does the story commit disease-mongering?

Not Applicable

The story didn’t discuss the condition of advanced prostate cancer in detail, so this is N/A.

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


The story includes comments from independent experts. It notes that the drug developer paid for the study and that the lead researcher owns company stock. In addition, the story notes how the company stock price was fluctuating; a good reminder that research reports can have substantial financial consequences. The story did not refer to the stock price jump earlier this month that followed the vague company announcement at a meeting with analysts claiming that the treatment extended patient survival.

Does the story compare the new approach with existing alternatives?


The story mentions that chemotherapy with Taxotere is the only approved treatment for patients with advanced prostate cancer. It should not have stated that Provenge produces a greater survival benefit, since the treatments have not been directly compared.

Does the story establish the availability of the treatment/test/product/procedure?


The story points out that Provenge has not been approved by the FDA.

Does the story establish the true novelty of the approach?


The story reported that Provenge is the first therapeutic cancer vaccine "to meet a preset goal for improving survival in late-stage testing."

Does the story appear to rely solely or largely on a news release?


The story included original reporting. However, one comment from a spokesman for the American Urological Association appears to have been taken from a news release without specifying that it was contained in a statement, rather than in an interview.

Total Score: 8 of 9 Satisfactory


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