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New Breast Cancer Test Approved

Rating

3 Star

New Breast Cancer Test Approved

Our Review Summary

For women with early stage breast cancer, the decision to undergo chemotherapy after surgery is a difficult one to make. This story reports on the recent FDA approval of a genetic test that may help in the decision making process. The goal of the test is to help predict if the cancer is likely to recur. Theoretically, if the cancer is unlikely to recur, then chemotherapy can be avoided. If there is a higher likelihood that the cancer will come back, a woman might decide she wants to do everything she can to prevent that from happening. While this story does a good job of explaining the potential importance of the test, it does not present important information for the consumer, most notably, the lack of evidence that this test improves outcomes in patients.

The story does not describe the cost of the test, does not adequately describe potential harms of the test, nor does the study quote any experts who can put the test in context with existing approaches. The story does not exaggerrate the prevalence or seriousness of breast cancer. However, the story verges on 'treatment mongering' by stating that 'one in seven women in the US will have breast cancer in their lifetime.' While this may be true (although some question the framing of the statistics in this manner), according to government statistics (SEER), fewer than half of these women would be eligible for the test if it can only be used in women under the age of 61 with early stage cancer.

Most importantly, the story does not adequately describe the strength of the available evidence. Specifically, the story does not state that there is no evidence that the test, in combination with treatment, results in better outcomes, such as decreased mortality or improved quality of life. To date, the test has only been shown to predict whether or not the cancer is likely to recur.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention the cost of the test.

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

Satisfactory

The story does state that there was a 23% chance of recurrence in women who were labeled "high risk" and a 5% chance of recurrence in women who were labeled "low risk." The story should have also stated that we still don't know whether this test will translate into better outcomes for the patients.

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

Not Satisfactory

The story does not mention any potential harms of the test. While the story states that the test is "far from perfect," this is not adequate information on harms. The story states that the test is not 100% predictive of recurrence, so there will naturally be some women who will be incorrectly labeled as high or low risk of recurrence and make treatment decisions based on this label. This could have important implications in terms of the psychological and physical wellbeing of the patient.

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

Not Satisfactory

The story does not adequately describe the strength of the available evidence. Specifically, the story does not state that there is no evidence that the test, in combination with treatment, results in better outcomes, such as decreased mortality or improved quality of life. To date, the test has only been shown to predict whether or not the cancer is likely to recur.

Does the story commit disease-mongering?

Satisfactory

The story does not exaggerrate the prevalence or seriousness of breast cancer. However, the story verges on 'treatment mongering' by stating that 'one in seven women in the US will have breast cancer in their lifetime.' While this is true (although some question the framing of the statistics in this manner), according to government statistics (SEER), fewer than half of these women would be eligible for the test if it can only be used in women under the age of 61 with early stage cancer.

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

Not Satisfactory

The story does not quote any expert researchers or clinicians.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does mention the current way in which tumors are profiled – using tumor size, location, whether cancer is present in the lymph nodes and whether they respond to hormones. However, the story could have provided more information about how this new test will fit into current practice and the advantages and disadvantages of this new approach.

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

Satisfactory

The story clearly states that the FDA recently approved the test. The story does not indicate when it will be available and how widely.

Does the story establish the true novelty of the approach?

Satisfactory

The story clearly states that this is the first genetic test of this type.

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

Not Applicable

We can't be sure if the story relied on a press release as the sole source of information.

Total Score: 5 of 9 Satisfactory

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