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‘Breakthrough’ in multiple sclerosis diagnostic? Not so fast.

Research pinpoints powerful biomarker of multiple sclerosis

Our Review Summary

multiple sclerosisA study by a group of Australian scientists has found a link between micro-RNA molecules in blood and multiple sclerosis, a chronic disease that remains difficult to diagnose. The release does a credible job of explaining the target focuses of this basic research—micro-RNAs and exosomes, constituents of cells that find their way in the bloodstream—but offers little in the way of methodological details. The text also jumps the gun by labeling the study a “breakthrough” and making claims about treatment benefits that are completely hypothetical at this point. Any blood test resulting from the effort has miles to go before it is ready for clinical use.

 

Why This Matters

If this link between constituents of blood and multiple sclerosis does survive further testing, it could pave the way for earlier diagnosis and earlier treatment of a disease that, according to the National Multiple Sclerosis Society, affects more than 2 million people worldwide.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Although this research is basic stuff, a source in the release is already talking about its diagnostic value. Claims of that sort should be accompanied by at least cursory information about possible cost.

In reality, this test is so far from clinical use that estimating cost would be difficult.

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

Not Satisfactory

A source describes possible benefits stemming from earlier and more accurate MS diagnosis — but these benefits from earlier and more accurate diagnosis are hypothetical. There was no discussion or numerical context relating to the differences in the RNA levels between MS patients and controls. Benefits of the test were not quantified.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The possible debits of this blood test—false positives and false negatives, for example—are not broached. These are very likely to occur in a larger group of subjects.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release does a nice job of describing micro-RNAs and exosomes and their roles in the body, but it offers virtually no information about how these scientists actually uncovered the link between these molecules and MS. The only reference to “how” is a sentence at the end of the release tagging the use of “next generation sequencing and integrative bioinformatics,” references that will be uninterpretable by many journalists and lay readers.

The release claims that the results can differentiate between MS and non-MS, and between MS subtypes, but there are no numbers provided for us to assess that.

Does the news release commit disease-mongering?

Satisfactory

The release doesn’t engage in disease mongering. MS is a chronic disease with serious, disabling consequences for the nervous system.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The funding source is identified. Since the goal is to devise a commercial diagnostic test, we would also encourage releases to point out any potential conflicts of interest. In this case, there doesn’t appear to be any.

Does the news release compare the new approach with existing alternatives?

Satisfactory

Several existing diagnostic elements are mentioned in the release; they are identified as “costly” and as offering only limited help.

We’ll rate this a marginal Satisfactory. More could have been said about the alternatives. What is the sensitivity/specificity and positive predictive value of these alternative tests? How do they compare as far as cost?

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

This research is basic, so one might expect a reader to infer that the blood test is not yet available.  But the text could have reinforced that by indicating what next steps need to be taken in order to validate this discovery and move it into clinical use.

Does the news release establish the true novelty of the approach?

Satisfactory

The text repeatedly notes that this blood test could become the first definitive diagnostic test for MS.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

Unfortunately, the news release labels this diagnostic effort as “a breakthrough study” in the very first sentence of the text. Bad idea.

The release engages in unjustifiable language elsewhere, too. This statement:

“This, in turn may lead to fewer relapses and a slower loss of brain volume, resulting in slowing or potentially halting progression of the disease for the person living with MS. It will also help remove the uncertainty surrounding which sub type of the disease an individual has and therefore be a catalyst for better outcomes for all people with MS.”

is unjustifiably optimistic about a blood test that “might” diagnose a condition and is totally unproved at this stage. Even if the test works well for diagnostic purposes, there’s no guarantee that patients will experience better treatment outcomes because of it.

Total Score: 4 of 9 Satisfactory

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