FDA approves breast cancer test
Reviewed By
Rating
FDA approves breast cancer test
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
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
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
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
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
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
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
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
The story gives no indication if this test will be widely available.
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
We can't be sure if the story relied solely or largely on a news release.
Total Score: 3 of 9 Satisfactory
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like