Health News Review

The story raises appropriate questions about evidence for a new genetic test of a woman’s risk of a common breast cancer. Expert interviews suggest that the test may have more cons than pros.
 

Our Review Summary

The focus of the story is a newly available genetic test to assess a woman’s risk of developing of developing one of the more common forms of breast cancer.  The story does not provide any evidence about the test itself (despite alluding to it). The story does mention that this test has not been validated in an external review, so any evidence would be from company-sponsored studies. The story notes that the FDA does not regulate this or similar types of predictive genetic tests, and there is concern about the validity of such tests that have not been subjected to external review.  The test manufacturer CEO’s speculation that insurance companies will eventually cover the test because it’s easy to perform and "any doctor can order the test" is an inappropriate rationale for any screening, especially when such screening may place a woman at risk for unnecessary surgery or other treatments.

The story mentions current prevention guidelines for women who are considered higher than average risk of developing breast cancer. This includes additional surveillance with MRI and mammography, chemoprevention and adopting a healthier lifestyle, namely reducing alcohol consumption and lowering body fat.  However,the evidence of survival benefit for lifestyle and screening is fairly limited. Most of recent decrease in breast cancer mortality is attributed to advances in treatment not necessarily screening.

Currently, breast cancer risk for women who do not carry the BRAC1/2 genes is determined via population-based calculators such as the Gail Risk Model.  This tool provides an estimated 5-year risk and is only validated for Caucasian women, so a well-validated, individualized predictive test would, in theory, be useful for some women.  It is not clear how the new genetic test improves on this current practice, as there was no evidence presented.

Researchers and clinicians interviewed help educate the reader about a new test may have many more cons than pros.  The story does note, via a patient advocate, that some women may still go ahead with the test if they feel it may help guide them in future breast cancer prevention efforts.


Criteria

Satisfactory

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story includes the cost of this test $1,625 and mentions that insurance companies currently don’t cover the cost of the new genetic test for breast cancer. The test manufacturer CEO’s speculation that insurance companies will eventually cover the test because it’s easy to perform and "any doctor can order the test" is an inappropriate rationale for any screening, especially when such screening may place a woman at risk for unnecessary surgery or other treatments.

Satisfactory

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

Satisfactory

It is not clear how this test improves on these current practice as there was no evidence presented about it. The story appropriately expresses caution when presenting the value of this new test to predict a woman’s lifetime risk of developing cancer.  There is a wide range of experts interviewed, all of whom express concern about the current available evidence for the predictive value of this test.  Most experts advise against women taking this test, and the American Cancer Society does not promote the test.

Satisfactory

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

Satisfactory

The story provides appropriate caveats for women who are considering this test. Namely, a lower than average score might suggest a woman could forgo screening.  Women with a higher than average risk score could experience unnecessary anxiety and possibly choose treatments they do not need (such as prophylactic mastectomy). 

Satisfactory

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

Satisfactory

The story does not provide any evidence about the test itself (despite alluding to it). The story does mention that this test has not been validated in an external review, so any evidence would be from company-sponsored studies. Additionally, peer-reviewed studies need to be done to determine the best course of prevention if a woman chooses to take the test and discovers she is at higher risk of developing breast cancer. Because the story raised appropriate questions about the quality of the evidence, we give this a satisfactory score.

Satisfactory

Does the story commit disease-mongering?

Satisfactory

The story lists the annual incidence of new breast cancers and mortality rate.  The story is tempered in reporting about a new genetic test which may or may not be another option for women looking to assess their risk. The story mentions that knowing individual risk may inform a woman’s decision whether to increase surveillance and/or take chemoprevention medication, such as tamoxifen. 

Satisfactory

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

Satisfactory

Several leading breast cancer researchers, a member of the American Cancer Society and a spokesperson for the FDA are interviewed for this story. These interviewees do not have a vested interest in this test–unlike Decode’s chief executive, who is also interviewed, mainly promoting his company’s product.  Researchers help educate the reader about a new test may have many more cons than pros.  The story does note, via a patient advocate, that some women may still go ahead with the test if they feel it may help guide them in future breast cancer prevention efforts.

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions current prevention guidelines for women who are considered at higher than average risk of developing breast cancer. This includes additional surveillance with MRI and mammography, chemoprevention and adopting a healthier lifestyle, namely reducing alcohol consumption and lowering body fat.  However, the evidence of survival benefit for lifestyle and screening is fairly limited. Most of recent decrease in breast cancer  mortality is attributed to advances in treatment not necessarily screening. 

Currently, breast cancer risk for women who do not carry the BRAC1/2 genes is determined via population-based calculators such as the Gail Risk Model.  This tool provides an estimated 5-year risk and is only validated for Caucasian women, so a well-validated, individualized predictive test would, in theory, be useful for some women.  The test discussed in this story has not been studied long enough, nor have results of company studies been subjected to an external review.

Satisfactory

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

Satisfactory

The focus of the story is a new, widely available genetic test. The story says that any doctor can order this test to assess a woman’s risk of developing of developing one of the more common forms of breast cancer. The story notes that the FDA does not regulate this or similar types of predictive genetic tests, and there are questions about the validity of tests that have not been subjected to external review. 

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

The story notes that there are other genetic tests, but this is one of the first for breast cancer for women who do not carry the BRCA1/2 gene. The story does not mention that there are several other risk calculators to estimate a women’s risk.

Not Applicable

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

Not Applicable

The story does not rely on the Decode Genetics press release. There is independent reporting and a balanced review of this new genetic test.

Total Score: 9 of 9 Satisfactory


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