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Stem cells reverse blindness caused by burns

Rating

3 Star

Stem cells reverse blindness caused by burns

Our Review Summary

The report glosses over remaining uncertainties about the technique and its potential risks. It neglects weaknesses in the trial design, including the absence of a control group, randomization or procedures to mitigate possible bias by evaluators. The reporter also failed to include the fact that some of the researchers have relationships with companies that may stand to benefit from commercialization of their technique.

 

Why This Matters

A lead sentence that calls an experimental treatment “a stunning success” can overwhelm details reported in the body of a story about uncertainties, limitations and remaining hurdles.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Applicable

The technique is experimental; still it would have been helpful to offer some comparison between this technique and standard treatments.

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

Satisfactory

This story accurately and prominently reports that the treatment was considered successful for 82 out of 107 eyes treated. However, the story also includes enthusiast raves, including terming the results a “stunning success” and quoting an independent researcher who says the treatment is “a roaring success."

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

Not Satisfactory

The story does not mention the risk of infection from the procedure, the possibility of damage to the healthy eye used as a source of stem cells, or other potential harms from the procedure.

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

Not Satisfactory

This story notes that the trial involved just several dozen patients; however, it does not point out that there was no control group, that is, the patients who underwent the experimental procedure were not directly compared to similar patients who received either no treatment or an alternative therapy. Also, the story does not explain that this sort of trial, in which the researchers were obviously aware of which eyes had been treated, is less resistant to biased interpretation of the results than trials in which evaluators do not know which patients had received the experimental intervention. Although it is difficult to design a trial of this sort that uses a placebo or sham control, in part because it may be unethical to subject participants to a surgical procedure that isn’t actually intended to offer some benefit, the trial could have included independent evaluators who examined the eyes of people who had the procedure as well as others who had not been treated, without knowing which was which. The story could have done a better job reporting on the limitations of the findings.

Does the story commit disease-mongering?

Satisfactory

The story clearly points out that this blindness treatment is specifically applicable only to people with chemical burns to the surfaces of their eyes… and only in patients with enough healthy tissue to provide a source of stem cells to grow in culture and then graft onto the damaged area.

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

Not Satisfactory

Although the story includes two independent sources and notes that the trial was partially funded by the Italian government, it fails to point out that some of the study authors serve on the boards or consult with companies (Holostem Terapie Avanzate S.r.l and J-Tec L.t.d.) in the business of developing and marketing treatments using stem cells. These disclosures were included in the documents on the New England Journal of Medicine web site and should have been communicated to readers.

 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does mention artificial corneas and cornea transplants from cadavers. However, it presents the alternatives as having inherent disadvantages without also noting that the treatment options have not been directly compared. And while this trial involved some participants who showed improvement with the new technique after not being helped by alternative procedures, the story should have indicated the success rate of alternative treatments for similar burns.

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

Satisfactory

This story makes clear that the technique is experimental and does not offer any predictions about when similar techniques might be widely available. But it would have been useful to indicate what hurdles stand between this step and regular clinical use. The statement that the stem cell transplants “offer hope to the thousands of people worldwide every year who suffer chemical burns on their corneas” encourages readers to believe that this experimental technique may be available soon.

Does the story establish the true novelty of the approach?

Satisfactory

The story notes that this is a “relatively new use,” but readers may get the impression that this trial is the very first attempt to graft corneal stem cells. As the original journal article on the trial notes, the technique has been studied by others, though the authors wrote that this trial involved more participants and had longer follow-up.

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

Satisfactory

The story does not appear to be based largely on a news release.

Total Score: 5 of 9 Satisfactory

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