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A breast cancer breakthrough?

Rating

3 Star

A breast cancer breakthrough?

Our Review Summary

This article focuses on 3-D mammography and its availability at Massachusetts General Hospital (MGH), which is understandable in a Boston Globe magazine piece.   Hologic, a Massachusetts based company, is the first company to receive FDA approval for its 3-D mammography equipment.  Both the article and Hologic emphasize the improved breast cancer detection capability of 3-D imaging but the story doesn’t go far enough in helping women evaluate the claims.

Most of the quotes come from an MGH physician who helped supervise the development of the technology. So that perspective is far from  unbiased. And there were no truly independent perspectives provided about the technology.

Yes, there are many caveats in the piece but most are juxtaposed with promotional claims:

  • “breakthrough?” in the headline – the ? apparently intended to convey a world of uncertainty but tends to be overwhelmed by the word preceding it
  • “I don’t want to call it a magic bullet” in the lede…followed closely by “The images sort of sell themselves.”
  • “I own no stock in Hologic” (lack of financial conflict of interest)…followed closely by “In my heart I know it’s better” (admission of true-believer-developer conflict of interest)

Women who are being encouraged to embrace 3-D imaging deserve scientific evidence of its possible advantage, not the feelings expressed by a radiologist who helped to develop the equipment.

 

Why This Matters

One of the ongoing problems with mammography is its failure to detect all breast cancers and its false positive rate which increases the number of women recalled for additional screening and biopsies.  Proponents of 3-D mammography believe that it will miss fewer cancers and decrease the number of women recalled.  The article downplays the increased radiation with the combination of 2-D and 3-D imaging and doesn’t even mention the over-diagnosis and resulting over-treatment that may result from use of 3-D imaging.  This article, which had many strong points, unfortunately allowed a new technology’s promoters to have too much say in the final framing of the message.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The piece does state that “the technology does come with costs, financial and medical” but the financial costs only refer to those incurred by the facility purchasing the equipment.  There is no mention of financial costs to the patient who may have a higher co-pay due to the higher cost of 3-D imaging or may have two co-pays because the combo 2-D and 3-D mammograms “confer the most dramatic jump in benefits.”  There is also no mention of whether or not this procedure will be covered by most health insurance, including Medicare.  If 3-D imaging is not covered by insurance, the patient will have to cover the cost.

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

Not Satisfactory

The author fails to quantify the potential benefits of 3-D mammography.  Dr. Rafferty, a consultant on the development of 3-D imaging, and Andy Smith, vice-president of Hologic, sole provider of FDA approved 3-D imaging equipment, provide very positive, glowing quotes about the benefits of 3-D imaging but the story provides no independent, evidence-based information to support these claims of benefit.

The author refers to 3-D mammography trials that Dr. Rafferty has been running since 2007 but there is no specific information about the type of trials, how many women are in the trials, the specific focus of the trials (2-D imaging vs 3-D imaging?), the source of funding for the trials, and the designated endpoint for the trials.

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

Not Satisfactory

The author does mention that a woman who has both 2-D and 3-D imaging, the protocol with the most benefit, would receive twice the radiation of 2-D imaging alone.  While this is still under the FDA’s permitted limit, the piece should also mention that patients need to consider total radiation exposure from increased use of all high-tech diagnostic imaging equipment.

In addition to providing no evidence of improved sensitivity and specificity of 3-D imaging, the piece doesn’t even mention the possibility of over-diagnosis and over-treatment of very early stage breast cancers that may never have needed treatment.  Thus a woman may be harmed physically, emotionally and financially because of over-treatment.

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

Satisfactory

This is a tough call.  But in the end we’ll give it the benefit of the doubt.

Weaker points:

  • The article presents no evidence to support many of the quotes by Dr. Rafferty and Hologic’s Andy Smith about the superiority of 3-D imaging over conventional 2-D.
  • The piece states that “3-D seems to be both more sensitive and more specific” but it includes no evidence to support this statement.

Strong points:

  • It warned readers not to overhype 3D mammography.
  • It stated that “no one yet knows if the new technique will actually save lives.”
  • It ended by saying that the physician who knows “in her heart” that 3D is better can only know this in her heart at this stage.

Does the story commit disease-mongering?

Satisfactory

The piece doesn’t contribute to disease-mongering.  But the two evidence-trained breast cancer advocates who reviewed this story felt it committed equipment-mongering. Nonetheless, following the intent of this criterion, we grade it satisfactory.

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

Not Satisfactory

No independent sources were quoted in this article.  Most of the quotes are from Dr. Rafferty, who helped to develop the 3-D equipment, and from Andy Smith, a vice-president of Hologic, the manufacturer of the equipment being profiled.

While Dr. Otis Brawley of the American Cancer Society and Dr. Daniel Kopans, a radiologist at MGH, are both quoted, their quotes do not refer to 3-D imaging.

Because of the tendency of patients to assume that new imaging equipment is better than exisiting equipment and that the ability to image in 3-D must be better than 2-D imaging, it is important that an article written for the general public be balanced and based on scientific evidence.  While certain phrases in this article appear to be an attempt at balance, there is no true balance that independent observers would provide.  There is no scientific evidence to support the favorable quotes and positive tone of this piece.

Does the story compare the new approach with existing alternatives?

Satisfactory

This article compares existing 2-D mammorgraphy imaging with the new 3-D imaging throughout the piece.  While it does present 3-D imaging as superior because of its ostensibly improved sensitivity and specificity, the article provides no scientific evidence to support that view.

For patients the information that matters most is which imaging mode improves survival.  Both the article and Hologic’s Andy Smith note that a study of whether 3-D imaging improves patient survival versus 2-D imaging will take a long time and “won’t be available for decades.”  Because of that fact, the story had an even greater obligation to provide readers with balanced information about this latest imaging technique and to include any available evidence supporting the superiority of 3-D imaging that this article suggests.

Nonethless, since some attempt at comparison was made, we’ll give the story the benefit of the doubt.

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

Satisfactory

Early in the piece, the story mentions the limited availability of 3-D mammography, which received FDA approval in February 2011.  The technology is currently available in “…at least nine states, three of which have multiple sites.”  The technology is clearly available for the paper’s readers because the piece focuses on Massachusetts General Hospital, which was both a development and a test site for the equipment.

Does the story establish the true novelty of the approach?

Satisfactory

The piece includes information on the novelty of 3-D imaging and its fairly recent approval by the FDA.

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

Satisfactory

Because this article includes includes quotes about mammography in general from Dr. Otis Brawley of the American Cancer Society and about the 2009 mammography guidelines issued by the United States Preventive Task Force from Dr. Daniel Kopans, it does not appear to rely solely on a news release.

Total Score: 6 of 10 Satisfactory

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