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Novel Stem Cell Treatment May Hold Promise for Type 1 Diabetes

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3 Star

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Novel Stem Cell Treatment May Hold Promise for Type 1 Diabetes

Our Review Summary

This story highlights the novelty of an experimental diabetes treatment. Yet despite cautionary statements from an independent source, the story portrays a preliminary safety test as being much more than it is. The story also should have told readers that this approach to overcoming insulin resistance may not be relevant to the overwhelming majority of people with diabetes, who do not use insulin.

It’s also a bit misleading for the story to call this a “clinical trial” since there were only 3 controls and 15 patients.

 

 

Why This Matters

The history of medical research is littered with examples of treatments that seemed highly beneficial when tested in small numbers of patients, but then turned out to cause serious harms or failed to sustain the benefits when tested in larger numbers of people. This test was so small that the patients were outnumbered by the authors of the journal article. It is simply too soon to put much stock in these preliminary findings.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Applicable

We’ll rule this Not Applicable. The research into this potential treatment is so preliminary that it is difficult to estimate cost figures in the story. That said, the story gives readers the impression that the research is much farther along, at a point where we would normally expect some discussion of costs. The error here is the over-stretch on the effectiveness not the omission of cost data.

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

Not Satisfactory

This story does a good job reporting the results of this trial and it notes that patients in this trial reduced their use of insulin, but were not able to discontinue taking insulin shots. It includes cautionary statements from an independent expert who says that the trial didn’t last long enough “to declare victory over diabetes yet.”

But we can’t give it a passing score here because it misleads readers about the important long-term health outcomes that people with diabetes really care about. The story claims that the reductions in blood sugar levels seen in these patients “would” reduce the risk of long-term complications. These researchers did not look at rates of complications. Indeed, the trial was far too short to produce meaningful results about rates of heart disease, blood flow problems, skin ulcers or other complications of diabetes, so any claims about reductions in complication rates are mere speculation.

This should have been framed as a preliminary safety study of a new approach that now needs to be tested in a randomized design with adequate numbers of subjects and duration to be able to truly say something about benefit or harm.  Novel, promising, passed the first safety test.  Period.

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

Not Satisfactory

To claim a treatment is safe after testing it in only a dozen patients at a single hospital in China is to ignore the long history of treatments that appeared to be beneficial after initial tests, then later revealed serious, even lethal, harms. Even though the researchers declare the treatment to be safe in their journal article, journalists should be skeptical of such broad claims that are based on such slim evidence. There is a vast gulf between stating that 12 individuals did not appear to be harmed during a 40-week trial and proclaiming that a treatment would be safe for millions of patients over the course of decades.

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

Not Satisfactory

In many aspects this story does convey the central point: that this small, preliminary trial offers supports for investigating a new way to treat one form of diabetes. However, readers are likely to believe the trial is far more conclusive than it actually is. Only near the end of the story is it mentioned that this trial was designed to look for safety issues. Even though the researchers were very enthusiastic, calling the results “powerful evidence” in their journal article… and the story did include cautionary statements from an independent expert… this report would have been better if it had more specifically alerted readers to the important limitations that are inherent in this sort of small, short-term safety test.

Does the story commit disease-mongering?

Not Applicable

We’re going to rule this one Not Applicable.

Here’s the issue: While not the sort of disease-mongering we usually watch out for, this story leaves readers misinformed by failing to make clear that the patients in this experiment do not have the kind of diabetes that has dramatically increased along with the rise of obesity. This test included only people with the rarer form of diabetes (Type 1) in which patients don’t produce enough insulin. The story should have noted that it is unknown whether this treatment strategy might offer any benefit for the millions of patients with Type 2 (also known as insulin-resistant) diabetes. Yes, the story says the patients in the trial had Type 1 diabetes, but most readers probably don’t know that most people with diabetes have Type 2. The most important outcome measure of this trial was a reduction in insulin use, but only about a quarter of people with diabetes in the United States use insulin. (www.cdc.gov/diabetes/pubs/estimates11.htm) So readers are likely to have a greatly inflated sense of the number of people for whom this research is relevant.

This is a point to consider, but we won’t rule it unsatisfactory because of it.  For the same reason, though, we can’t give it a satisfactory score.

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

Satisfactory

This story includes important context from an independent source. There is no discussion of any potential conflicts of interest of the researchers, but lacking any clear evidence of conflicts, we will give the story a passing grade. However, at least one online biography of the lead authors mentions that he holds several patents. If he or any of the authors own patents or other rights to treatments ultimately developed from this research, readers should be informed. The story did not report that the trial was funded by the University of Illinois (according to the trial registration: http://clinicaltrials.gov/ct2/show/NCT01350219). While academic institution funding may seem benign, many universities are actively engaged in licensing their discoveries or even creating companies to develop and market products of their labs, so even this source of funding may raise questions about financial entanglements.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does of course mention insulin treatment. However, it tells readers that by reducing blood sugar levels this new treatment would reduce complications from diabetes. This trial did not look at complication rates. Until there is evidence developed about complication rates in patients using this new type of treatment it is impossible to claim it is superior to standard therapy. After all, even if patients use less insulin, that fact alone does not guarantee that they will have better long-term health outcomes.

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

Satisfactory

It is clear that this type of treatment is not yet available and no claims were made about a timetable for reaching the market.

Does the story establish the true novelty of the approach?

Satisfactory

It is clear that this treatment is a new approach.

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

Satisfactory

The story does not appear to rely on a news release.

Total Score: 4 of 8 Satisfactory

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