Health News Review

The FDA approved a new gene test Tuesday to help predict whether women diagnosed with early stage breast cancer will relapse in five or 10 years.

Our Review Summary

The story reports on a recently approved genetic test for predicting a woman’s risk of breast cancer recurrence. The story does mention that the test is not "foolproof", and there is always the risk of false positives and false negatives. However, this test is only used as a guidepost in assessing whether or not to have more or less treatment after breast cancer surgery, usually in the form of chemotherapy. 

 

The story gives no indication if this test will widely available, but makes claims that it "could save lives" and might make "all the difference".  There is no evidence this test could save lives.  Even if a woman chooses additional treatment (i.e. chemotherapy and/or hormone therapy), there is no guarantee she will live longer. Cancer can still recur, despite having the test and subsequent treatment, so having this genetic screening may not make that much of a difference.  It would be the treatment itself that may or may not make a difference for an individual woman. 

 

The story states that this test "could improve the treatment" for women with breast cancer, but it does not state how or what treatment options would be improved.  It is true the test could help tailor treatment, but the treatment options are still the same. The choice of less, not more treatment based on the results of the test is also important, but not mentioned.  If fact, many women might take this test in order to feel comfortable with a decision for less treatment.

 

The story fails to mention the anticipated cost of this test, which is a significant oversight. The cost of gene assays already on the market are typically between $3000-4000 and are only covered by some private health insurers and by Medicaid in a few states. Thus, this new genetic test may not be financially feasible for many women. Because these women would not have has access to this test—at least initially—the story should not include an anecdote claiming the test  "made all the difference".  This is misleading and may cause unnecessary distress for women who feel they are at a disadvantage in their treatment.


Criteria

Not Satisfactory

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story fails to mention the anticipated cost of this test, which is a significant oversight.  The cost of gene assays already on the market are typically between $3000-4000 and are only covered by some private health insurers and by Medicaid in a few states. Thus, the newer genetic test may not be financially feasible for many women.

Not Satisfactory

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

Not Satisfactory

There is no quantification of the benefit of this test, that is the specificity of measuring what it is supposed to measure , i.e. the risk of breast cancer recurrence. In other words, the story didn't explain how good a test it is. 

Satisfactory

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

Satisfactory

The story does mention that the test is not "foolproof", and there is always the risk of false positives and false negatives. However, this test is really used as a guidepost in assessing whether or not to have more or less treatment after breast cancer surgery, usually in the form of chemotherapy.  Cancer can still recur, despite having the test and subsequent treatment. Ideally the story should have explained the rate of false positives and negatives.  Nonethless, we'll give the story the benefit of the doubt on this criterion. 

Not Satisfactory

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

Not Satisfactory

There is no evidence presented in the story regarding the validation of this test.  Approval for this test was based on a study of 302 patients whose were under 61 years with stage I and II disease and who did not have metastases. Positive predictive value was 23% at 5 years and 29% at 10 years; negative predictive value was 95% at 5 years and 90% at 10 years.

Not Satisfactory

Does the story commit disease-mongering?

Not Satisfactory

The story engages in test mongering.  The story really missed the mark in that really the value of these tests is to identify those who can safely forego chemotherapy (predicting those who will not get recurrence).  The story makes claims that it "could save lives" and might make "all the difference".  There is no evidence this test could save lives.  Even if a woman chooses adjuvant treatment (chemotherapy or hormone therapy) there is no guarantee she will live longer. While gene assays may be beneficial for individualizing the decision process following breast cancer therapy, they do not save lives. In fact, a woman at low-risk of a recurrence may decide not to have additional therapy and, thus, she would not reap any potentially life-extending benefits from chemotherapy.  Additionally,  not every woman has access to these tests and to make a claim that will "make all the difference" is misleading and may cause distress for women who may feel that are at a disadvantage in their treatment.

Satisfactory

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

Satisfactory

The story provides interviews with Dr .Gutman a member of the FDA's In Vitro Diagnostic Device Evaluation, but not an oncologist, and a cancer researcher at Dana-Farber.  The story also includes a patient who used the test; however, her personal testimony may bias someone in favor of the test. 

Not Satisfactory

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story states that this test "could improve the treatment" of women with breast cancer, but it does not state how and what the treatment options are.  The choice of less, not more, treatment based on the results of the test is an option (and the reason some women opt for this test). This is not mentioned in the story.  Also the story did not mention that there is another gene test, e.g. oncotype that is also available (albeit without FDA approval and many of the same caveats mentioned above)

Not Satisfactory

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

Not Satisfactory

The story gives no indication if this test will be widely available.

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

The test is first of a particular kind to be approved by the FDA to predict whether existing cancer will metastasize (spread to other parts of a patient's body). Gene assays to help predict breast cancer recurrence have been available for a few years. The test is designed to predict recurrence for stage I or II breast cancer recurrence or metastasis in women with lymph node negative disease.

Not Applicable

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

Not Applicable

We can't be sure if the story relied solely or largely on a news release. 

Total Score: 3 of 9 Satisfactory


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