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Provenge vaccine prolongs life in prostate cancer patients

Rating

3 Star

Provenge vaccine prolongs life in prostate cancer patients

Our Review Summary

This story provides many of the key details readers need to understand the results of the trial of Provenge – being evaluated as a treatment for advanced prostate cancer – but the overall tone of the story emphasizes the good news while soft-peddling the caveats.

Even though the story points out that only a third of men receiving the experimental approach were alive three years after they entered the trial, it would be understandable if readers concluded that Provenge is a dramatic advance in prostate cancer treatment and offers substantial advantages, with no disadavantages, compared to the chemotherapy typically offered similar patients.

This USA Today story was about half the length of the AP report we also reviewed. Important facts were omitted that undercut the usefulness of the story; for example, the failure to note that the lead researcher owns stock in the company developing the drug or that the FDA declined to approve this drug two years ago because of concerns about potential side effects and questions about its actual effectiveness.

While some cancer experts quoted elsewhere termed the trial findings an "incremental" advance, all of the comments included in this story portrayed the results as a dramatic advance.

The story did not explain that the results have not been peer-reviewed and that independent experts have yet to see the raw data.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story merely said the cost has not been announced without noting (as many other stories did) that other biotech treatments cost thousands of dollars per month.

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

Not Satisfactory

The story does report that 32 percent of the men receiving Provenge were alive three years later, compared to 23 percent of the men who received placebo infusions. However, it does not explain that the four month survival advantage in the lead sentence is derived from comparing the median survival of 26 months among men in the treatment arm to 22 months among men in the placebo arm of the trial.

The story implies an exaggerated sense of the effect of treatment when it features the founder of a prostate cancer patient advocacy group who "knows men who have died waiting for Provenge to be approved." The statement obscures the fact that more than two-thirds of the men receiving Provenge died within three years and that there was no effect on disease progression.

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

Not Satisfactory

The story reports that 1 percent of study participants dropped out due to side effects and that the most common problems were short-term chills, fever and headache. The AP story – which we also reviewed – had a more complete listing of side effects observed in the trial. 

The story should have also noted that Provenge was denied approval two years ago, in part because of concerns about possible side effects, including a possible increase in stroke risk, even though no difference was seen in this trial.

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

Not Satisfactory

The lead of this story stated that Provenge helps cancer patients live longer without answering the question, "Longer than what?" Only later did the story point out that this study used a placebo control and did not directly compare Provenge to standard treatment with chemotherapy

The story mentioned that the participants had advanced cancer, but it should have also emphasized that this treatment has not yet been shown to improve outcomes for men earlier in the course of the disease.

The story also included a puzzling reference to another experimental prostate cancer vaccine that extended survival by more than eight months, according to the quoted source. The story does not explain this apparent contradiction with the lead that says Provenge is the first cancer vaccine to extend survival. 

Does the story commit disease-mongering?

Not Applicable

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

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

Not Satisfactory

The story quotes a researcher not connected with this trial. However, while it points out that the company developing the drug announced the trial results, it failed to point out that the company paid for the trial and that the lead researcher quoted in the story owns stock in the company.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does point out that chemotherapy is the standard treatment for similar patients. It also makes clear that this trial did not directly compare the experimental therapy with standard chemotherapy. However, readers are likely to come away with the impression that the new therapy has been shown to help patients live longer than standard treatment.

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

Satisfactory

The story states that the company plans to apply for FDA approval later this year.

Does the story establish the true novelty of the approach?

Satisfactory

The story pointed out that after decades of expermentation this is the first cancer vaccine to demonstrate a survival benefit. However, this story did not mention that this same treatment was denied approval two years ago.

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

Satisfactory

The story does not appear to rely primarily on a press release.

Total Score: 4 of 9 Satisfactory

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