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WSJ story on new nuclear-imaging tests: What about the data?

Rating

3 Star

New Nuclear-Imaging Tests Show Promise in Locating Cancer

Our Review Summary

Mature radiologist consoling patient before MRI scan.This story summarizes the incremental benefits of two FDA-approved and relatively recent commercially available nuclear imaging tests designed to diagnosis prostate cancer and a rare neuroendocrine tumor earlier and more accurately. The imaging technologies in the piece have been the subject  of recent corporate press releases and FDA announcements, and the article makes the most of the opportunity to fill in useful context about the comparative benefits of tweaked nuclear imaging capabilities vs other screening and diagnostic/prognostic testing.

The story focuses mostly on the prostate cancer test, and generally avoids hyperbole and does an overall good job of keeping expectations for the new tests in check. That said, the story would have been strengthened by having a comment from a front-line prostate cancer clinician or general oncologist, especially to weigh in on what the data shows. That’s because the story was lacking in quantitative data from studies demonstrating the tests’ accuracy, benefits and limits.

 

Why This Matters

Earlier and better diagnostics for cancer is a holy grail in medicine, and any news about improvements and advances is likely to get attention from the sick and the worried well. Moreover, as with another gender-specific cancer — breast carcinoma — prostate cancer has been the subject and target of hot debates about the benefits and risks of screening, early detection, radical vs limited therapies, fear-mongering and statistical obfuscation.

Coverage of research about prostate cancer diagnostics and treatments has been at times as murky, contradictory, controversial and confusing as has been the case with breast cancer. No surprise then that men (and, as one book subtitle put it, “the women who love them,” ) are intensely interested in any news about technologies that can improve their chances of finding and surviving this disease. Journalists and news organizations should feel a special obligation, then, to cover purported advances in prostate cancer screening, prognosis and therapy, but to put substantial amounts of context in their stories.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is no discussion about the actual or anticipated added costs of the new nuclear imaging tests compared to current diagnostic tests. Nor is there a sense of the overall costs of treatment.

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

Not Satisfactory

The story offers good narrative explanations and opinions about the added value of the nuclear imaging tests, but no hard data to support the conclusions. The FDA approval processes certainly require data–both preclinical and clinical–and at least some of it should be cited.

The story makes claims about earlier detection of recurrence, but provides no data on how much more likely this is compared to following PSA or other currently available tests, and whether this earlier detection leads to better clinical outcomes. We already have good tests to evaluate spread to bone (advanced cancers) and lymph nodes. We would need data to show whether the new technology is more accurate–and cheaper than current tests.

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

Not Satisfactory

The limitations and harms (from false positives, unnecessary biopsies, and unneeded surgery/radiation) from PSA screening and other current diagnostic procedures for prostate and other cancers are pretty well known. It’s unlikely that the newer nuclear imaging tests described in this article are without limitations and potential harms as well, including exposure to ionizing radiation, but there is no explicit/direct information about them. Also, finding low-risk cancers could pose psychological and physical harms from over diagnosis and over treatment.

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

Not Satisfactory

This was a somewhat tough call, because the article is not, strictly speaking, describing the research behind the newly approved tests. But the article needed at least some indication about the strength or weakness of evidence for the use of these tests; who the best candidates are for the test; how widely they should or could be used; and their limitations.

Also, a big issue for prostate cancer screening is finding tests that better identify aggressive cancers–finding more cancers is not helpful given concerns about over diagnosis–especially low-risk cancers when PSA is <5.  We found some of the discussion misleading: “Prostate-specific antigen, or PSA, is the common way to screen for the disease. But it isn’t entirely reliable because the PSA protein count also rises with age and disease of the prostate like inflammation, and it doesn’t help to determine the location of the tumor. That can be crucial in deciding on treatment.”

When PSA is elevated and/or the prostate exam is normal, cancer will be found through a biopsy performed with ultrasound (or more recently in some centers with MRI). Yes, PSA has false positives, but you can determine that only by performing biopsy–not an imaging study. Depending upon the PSA level, the digital rectal finding, and the biopsies, clinicians have a reasonable idea of whether the cancer is confined to the prostate–potentially curable–so the added value of the new imaging in this scenario is quite unclear.

Does the story commit disease-mongering?

Satisfactory

No disease mongering.

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

Satisfactory

The story quotes two sources independent of the companies’ representative. There do not appear to be conflicts of interest. The article needed more information about where the clinical trials were/are underway.

Does the story compare the new approach with existing alternatives?

Satisfactory

The article does a pretty decent job of talking about PSA screening, conventional (PET) nuclear imaging, and genetic testing, and ultimately defines the new nuclear tests as “complementary” by quoting an independent sources.

However, the story ideally also would have discussed alternatives for staging and determining recurrence, such as bone scans, CT scans and MRI.

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

Not Satisfactory

The article provides no information about the availability of the new tests, either temporally or geographically.

Does the story establish the true novelty of the approach?

Satisfactory

The article describes how the new tests wed radioactive tracing materials with an amino acid (in the case of the prostate cancer) and other molecules, and sufficiently explains how the new tests differ from current nuclear images.

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

Satisfactory

There were news releases issued recently by one of the companies involved in the commercialization of the tests, but the article does not appear to rely on them.

Total Score: 5 of 10 Satisfactory

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