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3-D breast scan seen as breakthrough

3-D breast scan seen as breakthrough

Our Review Summary

We are pleased when we see a major newspaper willing to devote 1300 words to an important story about breast cancer screening. This in-depth Philadelphia Enquirer piece about a new 3-D mammogram puts the extra column space to reasonably good use, but it could have done better. Importantly, it zeroes in on the likely benefit of the new technology — reducing false positive screens — and explains that the test will not help us solve the larger problem of determining which cancers need to be aggressively treated and which ones don’t. But there was room in this article to include some truly independent voices, which this story did not seek out. There could have been a better characterization of costs, too. We also wanted to see more detail about the harms of the new test, as well as the studies that formed the basis for the FDA approval of the device. Readers should also be informed of the expected availability of this new test, which was vaguely described.

 

Why This Matters

Screening for breast cancer remains an important public health issue given the prevalence of the disease and the fact that cancers detected earlier are easier to treat. The problem of false positive testing in mammography is a big one, and new technology to improve this rate will have direct patient benefit. As the story points out, the inaccuracy of 2-D mammography leads to many women undergoing follow-up X-rays and biopsies that cause significant anxiety. The new 3-D test will be valuable if it can reduce the need for that extra testing, but we should be aware that finding more cancer may mean more treatment of tumors that would never cause a problem. There is a pressing need for tests that distinguish the aggressive cancers from the slow-growing ones.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The article says that upgrading an existing 2-D system made by Hologics to 3-D can be accomplished with the purchase of $150,000 worth of software. It also quotes a company official who says the upgrade would cost about $4 more per patient compared with the existing test over 5 years. While we applaud the story’s attempt to put some kind of price tag on the new technology, we doubt that the $4 estimate represents a realistic assessment of the final cost to payers or consumers. Imaging centers will be looking to capitalize on their investment in this technology to bolster their marketing and increase profits. They likely won’t be content to simply cover the costs of the new software by raising their fees by $4 — which is what the estimate provided implies. Imaging centers will also be looking to pass along the costs of training radiologists to read the new scans. The story might have provided a more realistic figure had it asked one of the imaging center radiologists it interviewed what they plan to charge for the new tests compared with the old ones. Also, what does a 2-D test cost now?

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

Satisfactory

Mixed bag here. The story says that the cancer detection rate with the addition of 3-D imaging was “a bit better” than with 2-D alone. Numbers should have been provided. The story also describes the benefits observed in one study as similar to findings from “university studies,” a confusing reference since these “university” studies are not mentioned anywhere else in the story, and it’s not clear what the writer is talking about. On the plus side, the story says the major benefit of the new test is its ability to reduce false-positive tests, which lead to additional testing and biopsies and which cause a lot of unnecessary anxiety. The story puts a number on this benefit when it says the new test “could cut the false-positive recall rate by more than a third – so five or six women [out of a hundred] would be unnecessarily freaked out instead of nine.”

Since the story came through on this where it counted most — the absolute reduction in false positives — we’ll give the benefit of the doubt and award a satisfactory.

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

Not Satisfactory

The story mentions that women will endure double the radiation they would experience with a single 2-D mammogram because they have to be X-rayed twice, but it dismisses the potential harm from this by saying the dose will still be below the FDA limit. We think that’s inadequate considering some evidence that high-risk women may increase their risk of getting cancer because of frequent mammograms. The story also doesn’t really give readers the full picture on the overdiagnosis problem and how the new technology might exacerbate it. With a more accurate test, it is conceivable that doctors will now be able to find even more small tumors than they could before, leading to treatment of more tumors that never would have spread or caused a problem. This means more unnecessary surgeries, chemotherapy, and other very invasive tests and treatments. The article makes it clear that the 3-D test is only approved for use in conjunction with a traditional mammogram, which picks up milk duct cancers that might be missed by 3-D scans. So the net effect seems likely to be an overall increase in cancer detection, which will probably worsen — not help with — our current problems with overdiagnosis.

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

Satisfactory

This story went to considerable lengths (about 1,300 words) to provide readers with an in-depth view of the issue. The result is an informative but uneven look at the problems with current mammography and the implications of the new technology. Our wish list for this story includes more details about the studies that were the basis for FDA approval.The story says adding the 3-D technology  improved accuracy compared with a standard 2-D mammogram, but we never learn important information that might tell us how strong the data are and how broadly they can be applied outside of the study. How many women were included in the studies? How old were the women? Did they represent groups  that may have trouble getting an accurate reading — such as obese women or women with dense breast tissue?

Still, the fact that the new device was approved by the FDA provides considerable assurance regarding the quality of the evidence. And the story does do a good job of putting the technology in the appropriate context considering current controversies about breast cancer screening — arguably the more important task here. Examples:

  • The story cautions that the technology won’t “solve the dilemma of overdiagnosing and overtreating tiny, early malignancies that may never progress.”
  • The story notes that performance with 3-D improves only when radiologists get extensive training in how to use the new machines.
  •  The story concludes that the impact of 3-D make take a decade to shake out. Even then, “3-D may not settle the debate over how many lives early detection saves, and whether this ‘benefit’ outweighs the risks and costs of false alarms.”

We think the strength of the story’s larger perspective makes up for the deficiencies in its coverage of the individual studies, so we’ll award a satisfactory.

Does the story commit disease-mongering?

Satisfactory

The story does contain some questionable assertions. For example, it states that digital mammography is an unequivocal “leap forward,” even though expert groups say there isn’t enough evidence to determine whether its benefits outweigh the harms. Still, we don’t think it crossed the line. The story does a nice job of stating the number of cases of breast cancer per 100,000. The story overall is well balanced and does not cheerlead for early detection, which is a problem in some screening stories.

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

Not Satisfactory

Many different sources are interviewed and they offer a variety of perspectives on the technology. But just about everybody quoted in the story seems to have some kind of intellectual or financial stake in this 3-D technology, and this might have biased the story. We hear from many different radiologists and other researchers who have helped develop the technology or are adopting it for clinical use. And it seems that one of the experts quoted in the story — Yuri Parisky, MD, who is identified as the vice president of the National Consortium of Breast Centers — has a relationship with Hologics Corporation that should have been disclosed. (According to this disclosure statement, he is or has been a member of the company’s scientific advisory board.) There was certainly room to include the perspective of a truly disinterested  breast cancer screening researcher or a practicing breast radiologist, which would have been helpful.

Does the story compare the new approach with existing alternatives?

Satisfactory

The main objective of the story is to compare the new technology with current mammography. It does this well enough to earn a satisfactory.

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

Satisfactory

The article states that the new imaging system was just recently approved by the FDA for use in the United States, and that it is already in use in some other countries. It also notes that several hundred U.S. imaging centers could be upgraded to the new technology, and that the manufacturer is seeking insurance coverage for the test. Readers can deduce from this that the technology is not yet widely available and probably won’t be covered by insurance. The story could have stated more directly that it is not clear when this test will be widely available to the public (or estimated when it will be available). Also, it could have clarified whether patients need to ask for the test or if it is expected to become the new standard.

Does the story establish the true novelty of the approach?

Satisfactory

The story describes what is new about the test: it provides spatial detail similar to a CT scan with a smaller radiation dose. Although the machine described in the story is the first to be approved by the FDA, the story notes that other manufacturers are racing to develop their own systems.

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

Satisfactory

This story wasn’t based on a news release.

Total Score: 8 of 10 Satisfactory

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