The story highlights the very early and incomplete results of a Phase 1 study of the use of nanoparticles to deliver small interfering RNA to tumor cells in three subjects with melanoma. This approach to the treatment of cancer is new and these early results suggest the model may be of value. However, the story does not note that the report in the journal Nature was in fact a letter to the editor and not a full study report. The results are preliminary and have not been presented or subjected to peer review. As such, some level of conservatism would seem appropriate in reporting. However, the story uses phrases that provide the reader with an inflated impression of the results to date.
The semantics are important in a story about such an early research report. Using words like "early proof"…"might work in people"…"suggesting the RNA had done its job" is troublesome. Even the headline – "robots deliver gene therapy through the blood" – is misleading. It’s not a therapy until it’s proven to work. This is an experiment, not a therapy, at this point.
Malignant melanoma has proven to be a difficult disease to treat especially in later stages. The availability of a new approach to the disease would be welcomed. But what is a person with melanoma supposed to take home from a story like this?
No costs discussed, but we can understand why given the very early stage of this research. Not applicable in this case.
Three sentences from the end, the story says the lead investigator "could not say whether the therapy helped shrink tumors." For that, we’ll give the story a hesitant satisfactory grade on this criterion.
Yet, at the top, the story said this was "early proof that a new treatment approach…might work in people." Indeed, there isn’t much you can say at all after tests on three tumor samples.
One thing you can say is that there isn’t any evidence yet of an impact on outcomes that people really care about – impact on longevity or quality of life, for example. For comparison, a story on The Scientist.com placed this high in the story in the third paragraph:
"It remains to be seen whether the new therapy improves patient outcomes."
The story says this was a phase 1 clinical trial – the main purpose of which is to determine safety of an experimental intervention. Yet the story says the lead investigator could not say if there were any safety concerns. Huh? We can understand not leaping to conclusions after tests on just three tumor samples (although, as noted, the story tended to do anyway), but shouldn’t the story have at least probed for potential safety concerns with this approach?
In fact, the use of siRNA in experiments like this is in its infancy and as such little is known about the existing side effect profile. High on the list is the potential for the agent to have unexpected and non specific effects called off-targeting. Off-targeting is the potential largest liability of the approach, possibly resulting in inadvertent turning off or on of non-targeted genes. This collateral damage is a significant challenge to the use of siRNA even with nano-directed treatments. A more balanced story would have noted the potential downside of the approach.
This is the major failing of the piece. This story was crying out for caveats – and we got none. "Early proof that a new treatment approach…might work in people"? Proof? Some early evidence, perhaps. But not proof! Not after tests on three peoples’ tumor samples.
Not applicable. No discussion of melanoma in any detail.
No independent sources interviewed in the story.
The story acknowledged that other research teams are exploring using fats or lipids to reach the target.
An astute reader can probably figure out that this experimental approach isn’t available yet. But the story never really says that. Instead, rather than calling it an "experimental approach," the story calls it a treatment approach. We think the semantics are important. It’s not a treatment yet. It’s an experiment.
The novelty of this approach is discussed appropriately.
The story says it relied on a telephone interview, so that’s not a news release.
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
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