Our review team had a lively debate as to the extent to which this National Institutes of Health news release exaggerates the findings of the study it reports on. We agreed that the release waits far too long to warn readers that this exciting study of potential multiple sclerosis drugs was conducted in petri dishes and mice. One has to read through more than half of the release before that crucial caveat is introduced. But we had mixed opinions about the headline, “Drugs that activate brain stem cells may reverse multiple sclerosis.” Some of us felt this was misleading because readers would assume the release is talking about human disease, and there’s nothing in the release or the underlying study to support a “reversal” of disease in humans. The opposing view is that the headline accurately reflects what happened in the study in mice and is therefore not an exaggeration. According to this view, the release is deficient mainly because it failed to qualify that the findings were from mice in a timely manner (ideally the first paragraph), but not because of the headline. We welcome reader perspectives on this debate in the comments.
The lackluster performance of the pharmaceutical industry in developing new treatments has led to coordinated efforts to repurpose existing drugs for new uses. The research highlighted in this NIH news release is important because it represents one of the earliest examples for this new form of drug development. Multiple sclerosis can be a devastating disease causing significant dysfunction and early death in some patients. Treatments at the moment consist of drugs that target the immune system. While effective, they come with a host of side effects and are very costly. The approach highlighted here provides a potentially new avenue of attack: promoting myelin repair. With that said, this is very early in the game and the drugs — clobetasol and miconazole — have only been shown to work in the test tube and in a mouse model. As we have said on many occasions, success in the mouse model is just that: success in the mouse model.
While one could argue that we should give the release a pass given the early stage of the research, the drugs discussed are commercially available and it would have been easy to provide cost information.
The release provides insufficient detail regarding what occurred in this study and the outcomes that were reported. The release states that “both drugs were effective in activating OPCs to enhance myelination and reverse paralysis. As a result, almost all of the animals regained the use of their hind limbs.” But how many animals were studied, and how many of them regained use of their limbs? Was there total resolution of symptoms or only partial resolution, and how was this measured? The release never quantifies these results.
Dr. Tesar provides a cautionary note related to the potential harms of this approach; “Off-label use of the current forms of these drugs is more likely to increase other health concerns than alleviate multiple sclerosis symptoms.” Given the stage of research, we think this is sufficient to rate this criterion as satisfactory
Our major concern with the description of evidence is that the release waits too long to inform readers that these results were obtained in petri dishes and mice. We have to read more than halfway through the release to learn of this crucial caveat. We also had concerns about the headline as noted above in the Review Summary section.
To its credit, the news release does provide an important cautionary statement: “…more research is needed before miconazole and clobetasol can be tested in multiple sclerosis clinical trials.”
But this statement, coming late in the release, is too little to counterbalance the enthusiasm generated earlier in the release based on an incomplete and possibly misleading description of the evidence.
We are told up front that the study was funded by a division within the National Institutes of Health, and there is no apparent conflict of interest according to the paper.
The news release earns a Satisfactory rating by speaking to the current treatments that are available: “Current therapies for multiple sclerosis include anti-inflammatory drugs, which help prevent the episodic relapses common in multiple sclerosis, but are less effective at preventing long-term disability.”
To earn extra credit here, the release could have provided a comment about other research into improving myelin production. This includes ongoing clinical trials being conducted by Biogen and others targeting myelin production in MS.
The story makes it clear that the two drugs highlighted (clobetasol and miconazole) are available and adds the important precatuionary note, “…are currently approved for use as creams or powders on the surfaces of the body but their safety administered in other forms, such as injections, in humans is unknown.”
This is indeed first of its kind research and that is appropriately noted in the news release.
With the possible exception of the headline — an issue we’ve already addressed elsewhere in this review — no hyperbole is evident.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
Comments (1)
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Earle Holland
April 29, 2015 at 1:21 pmThe main issue here is whether the release exaggerates in its claims. Considered broadly, the answer is definitely yes! It does so in its choice of headlines and in the lede paragraph of the release. Multiple sclerosis is a human disease and while there are conditions in animals that resemble it, therefore providing an animal model to study, only humans are actually afflicted. In vitro and in vivo studies using animals can and do provide valuable insight but they can’t prove results in human disease. Only clinical trials with humans can do that.
Moreover, both the headline and the lede paragraph fall into a common trap — they suggest that the drugs in question “may reverse multiple sclerosis” and “may potentially take on new roles as treatments for multiple sclerosis.” While true, the opposite is also true — they “may not!” That conditionality, while technically accurate, is also misleading.
And this is the real problem: Patients with this disease and their families will desperately grasp at any hope of remediating this condition. Releases that overtout the significance of research findings can send people on a roller coaster of hope and then despair when early findings fail to show promise in actual human treatments. This borders on cruelty since the exaggeration isn’t necessary. Releases can still offer promise within reason if writers, and their organizations, commit to considering readers’ reactions first.
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