This story suggests that an experimental drug being tested in an early, small trial for eye cancer could “pave the way for a new class of exquisitely precise cancer therapies” that might be used in a wide variety of cancers.
Although the story does include a paragraph noting how much research remains to be done before the drug’s developer could even apply for FDA approval, the tone includes the type of language journalists generally are urged to avoid. The first two paragraphs suggest that the experimental drug might represent “the Holy Grail of cancer researchers,” a drug that kills cancer cells without damaging healthy tissue, and the third paragraph quotes one of the researchers saying, “This could be a game-changer if it works.”
The story cannot quantify benefits because the research hasn’t yet established what those benefits might be; it also cannot explain harms because the clinical trial it focuses on is meant to test the safety of the drug.
As promising as this new approach might be, this story doesn’t acknowledge the inadequacy of the available evidence supporting the drug’s use.
The story provides no information about costs, in part because the patient who is the focus of the story was participating in a clinical trial and likely received the treatment at no cost. Even if that was the case, however, the story should have discussed how much this type of treatment would cost, if it became available outside the context of a clinical trial.
Because the story deals with one patient who is participating in an early stage clinical trial, there is little concrete benefit information to report. The story says that the doctor conducting the clinical trial found, a month after the first treatment, that this first patient’s tumor “had begun to atrophy,” but it notes that data from animal trials of the drug suggest that it would take “three or four months to gauge the response.” The bottom line here is that because the story focuses on the first human patient in the earliest of three levels of clinical trials required for FDA approval, no one really knows how much benefit this drug will produce. The story should have noted that–strongly.
The story provides no discussion of potential side effects or harms of this treatment approach, other than the patient’s statement that he has had no side effects. He also called the new intervention “a breeze.”
In truth, because the drug’s safety is being evaluated in this clinical trial, the researchers do not yet know what side effects might occur, a fact the story does not address. Also, there were likely some side effects measured in the animal studies.
The story focuses on the use of the treatment in the very first human participant, and it was written before enough time had passed even to know whether the drug would have the intended effect in this one patient. Given that, this is essentially the same as writing a story based on research in laboratory rats. To the writer’s credit, the story does note that much more research will be required before the light-activated drug could receive FDA approval for widespread use. Nonetheless, the overall tone of the story suggests that “the drug’s viral artificial nanoparticles” could be expected to provide effective treatment for “many types of malignant cells.”
The story avoids disease-mongering, noting that ocular melanoma is rare.
There are no independent sources in the story. The only sources are the initial clinical trial patient, the doctor who is conducting the clinical trial and the founding CEO of Aura Biosciences, the drug’s developer.
The story mentions four other approaches to dealing with ocular melanoma, including monitoring without immediate treatment, implantation of a radioactive iodine chip, proton beam and gamma knife therapy (neither of which is explained), and surgery to remove either the tumor or the entire eye. This is sufficient to merit a satisfactory rating.
It would have been useful to highlight the existing options–and quantify the outcomes–so readers would have a sense of what we goals we would be shooting for with a new treatment. Also, we also took issue with how the story frames the existing treatment for ocular melanoma by highlighting its negative side effects in one famous patient (Oliver Sacks) against the experimental therapy’s potential, which is still only based on animal studies.
The author acknowledges that the initial clinical trial, in which the featured patient is participating, will take two more years and that that two additional clinical trials would have to demonstrate safety and efficacy of the drug before it could receive FDA approval. This was a strong point in the story.
The story notes that Aura Biosciences chose to test the experimental drug on ocular melanoma because there currently is no drug useful in treating this disease. It says that the drug’s artificial viral nanoparticles have been shown to “zero in on and bind to many types of malignant cells without harming normal cells” – but only in lab experiments, which suggests that the drug’s use in humans is new.
We could find no evidence that the story relied solely on a news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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