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Prostate patients protest FDA
June 04, 2007
In Washington today, cancer patients running out of hope and time protested the FDA’s refusal to approve a radical new treatment for advanced prostate cancer.
Our Review Summary
The story reports on an experimental treatment for advanced prostate cancer that early research has shown may prolong life by an average of 4 months. While the story does a good job of describing the availability and novelty of the new treatment and does provide benefits in absolute terms (even though this could have been improved by a discussion of the relatively small gain in life duration), it also misses some important criteria. Viewers don't know the strength of the study findings. For instance, it's not clear whether the results are from randomized trials, or some other less strong study design. Alternative treatment options are also not discussed. Yet the story posed Provenge as a last and only option - saying about one man: "All his hopes were pinned on this cuttin-edge, experimental treatment." And, the story did not interview independent experts to comment on the study findings. Unfortunately, the only comments included are those from actual patients, who sound like they are about to die, and who provide very biasing and one-sided testimonials.
Click on Criteria for definitions.
The story states this latest experimental treatment for advanced prostate cancer is not approved by the FDA.
Costs are not mentioned. Some projection of costs is possible, and it is likely to be expensive given the individualized, targeted nature of the approach.
The story doesn't really give an unbiased picture of advanced prostate cancer, because only men who currrently have the disease and appear to not have long to live are interviewed. The story doesn't provide good, balanced information about the nature of the condition, how many men die from this each year, or that many more men will be diagnosed with prostate cancer than will actually die of prostate cancer.
The story does not describe the nature of the studies on which the findings are based. Viewers don't know if the trials are randomized trials--the gold standard--or some other less strong trial design.
The only harms noted are "mild, flu-like symptoms." While, it's hard to believe any cancer treatment would have only "mild" side effects, there may not be published data to confirm or refute this. Nonetheless, the story takes this claim at face value without emphasizing the early stage of the research, and without seeking independent perspectives.
The story states the treatment is new and experimental.
The story does provide benefits in absolute terms--on average men lived 4 months longer and that some lived 2-3 years longer. The story could have been improved by a discussion that an average life gain of 4 months, is relatively small, but that only a patient could decide if or how meaningful this life gain would be based on his quality of life.
The story does not appear to have relied solely or largely on a news release.
Several sources are obtained, although these are only patients providing biasing anecdotes. There is a comment that some doctors question the research, providing some balance, but it's not clear if any of these doctors were actually contacted to comment on the results. No names are provided.
The story does not provide any alternative treatment options for advanced prostate cancer, the mainstay being androgen deprivation, or hormone treatment, which does eventually stop working in many men. Yet the story posed Provenge as a last and only option - saying about one man: "All his hopes were pinned on this cuttin-edge, experimental treatment." And the dramatic ending: "But the FDA needs prooof and for men running out of time and hope the wait is agonizing."
Total Score: 4 of 10 Satisfactory
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