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New device uses light to screen for melanoma

Rating

5 Star

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New device uses light to screen for melanoma

Our Review Summary

It puts both the potential benefits and potential harms of this scanner used to detect cancerous skin lesions in the proper context. It explains that, while new to the market, the device is not a medical breakthrough. It provides cost information, for both the physicians and patients. And it carefully makes note of all potential conflicts of interest.

 

Why This Matters

Despite the well-known risks of excessive sun exposure, many Americans remain “sun worshipers.” Rates of skin cancer, specifically melanoma, have been on the rise. While most skin cancers represent local disease and do not risk distant spread, melanoma is the exception. It can metastasize and ultimately kill. At biopsy, the depth of penetration is the key feature that is associated with risk of spread. Thus, identifying which lesions are high risk leads to the potential to remove these lesions before they have metastasized. The question is whether this machine does it better than a skilled dermatologist. One can see the potential in this device, but there is no evidence presented that this has saved a life – or done so more efficiently than a dermatologist

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story takes the rare step of talking about costs from three different angles. The cost to the physician. The cost to the patient. And the cost to insursers. “Doctors will pay a one-time fee of $7,500 to lease and receive training on the device. Patients will pay $150 out of pocket for a MelaFind scan, which analysts say may limit use to more affluent patients who are willing to pay extra for the latest medical care. Mela Sciences does not plan to ask insurers to cover the device until several years from now, after it is more widely used.

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

Satisfactory

The story shows that the device is fairly effective at finding cancerous lesions. “In a company-sponsored study published last year involving around 1,300 patients, some with multiple growths, doctors reported that MelaFind correctly suggested biopsies on 125 of 127 melanomas that doctors had removed.”

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

Satisfactory

It’s a bit confusing, but the story explains that the device also makes the wrong call too often, giving too many false positives. “However, the device did not raise an alarm about non-melanoma growths only about 10 percent of the time; that was still better than doctors in the study who correctly ruled out melanoma in less than 4 percent of such cases, on average.” Just presenting the false positive and false negative rates would have been more helpful to readers.

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

Satisfactory

We would have liked to have seen a little more about the latest study of the device, but there was enough information in the story to let readers know that this is the case where the evidence is still not quite settled. It says, for example, “MelaFind underwent a contentious, years-long review by the Food and Drug Administration, which initially rejected the device and concluded it could ‘potentially cause more harm than good.'” And later it says that “an FDA-required follow-up study would help determine how much of a benefit MelaFind represents for patients.”

Does the story commit disease-mongering?

Satisfactory

The story both gives the broader context about melanoma while taking care to pinpoint the appropriate patient population. It says in the second paragraph, “The device is approved only for dermatologists and only for use on growths that don’t have obvious signs of cancer but still have one or two worrisome traits.” It also says, “Nearly all patients diagnosed with early-stage melanoma can be treated and cured, but 85 percent of patients with late-stage melanoma die from it within five years.” The story could have more clearly stated that while many are diagnosed with melanoma only a small number actually will die from it. The late stage cases are a small fraction of the total.

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

Satisfactory

The story does not use a truly independent source because everyone appears to have some sort of conflict, but this is also one of the stories strengths. Rarely have we seen conflicts presented with this kind of detail. For example, the story says describes Dr. Leonard Goldberg as “a dermatologist at the Texas Medical Center and vice president of the Skin Cancer Foundation, a disease awareness group that accepts donations from makers of sunscreen.”

Does the story compare the new approach with existing alternatives?

Satisfactory

The story compares the device to clinicians throughout, and shows clearly that dermatologists are still the ones with the best authority in this area.

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

Satisfactory

The story says clearly that the devices are not currently available in most areas. “But don’t expect to see a MelaFind machine at your next doctor’s appointment. The company plans a limited rollout next year of just 200 dermatologists on the East coast, all of whom must undergo company training before they can begin using the device.”

Does the story establish the true novelty of the approach?

Satisfactory

The story calls the device a “first of its kind,” but it also explains that it is only approved for use in a subset of patients and that much more work needs to be done.

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

Satisfactory

The story does not rely on a news release.

Total Score: 10 of 10 Satisfactory

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