Reviewers for HealthNewsReview.org sometimes get asked, “What do you want, a totally boring story?” This piece shows that you can provide the right note of caution while reporting on a scientific study without over-hyping, promising a cure-all, or throwing all caveats out the window.
This piece highlights a novel agent that in an early-stage study showed small benefits of a short duration that weren’t even definitely proven to be related to the medicine. The fact that this study–not even published or presented at a meeting–generates press shows how important and vexing this problem is. The need for new medications that work in different ways than existing medicines available and in the pipeline is clear. However, as this piece highlights, it is uncertain whether this new drug will be investigated further, with studies that involve more patients for longer periods of time.
There are no mentions of costs in the piece. Ordinarily, we expect to see some discussion of what the cost may be–especially when Wall Street is closely watching the drug’s progress. In this case, however, the story makes it abundantly clear that the results were lackluster and so this drug is unlikely to be on the marketplace anytime soon.
Look at the headline of this story: “In small Alzheimer’s study, hints of modest benefit from unusual drug.” Now look at the first sentence: “A little-known drug company announced modestly encouraging results for its experimental Alzheimer’s drug on Monday, a rare but still preliminary glimmer of hope in a field that has been battered by failure after failure.” We had to do a triple take because this level of reflection and circumspection is so rare and so welcome.
The story then goes on to spell out why the reporter used terms like “hints of modest benefit” and “modestly encouraging” and, if you read the links, the story also backs up the history of failure in this field.
When it comes to quantifying the benefits, we’re told, specifically, that “the patients who received all six low doses did the best; their average improvement after the 12 weeks was 1.5 points on the 100-point cognitive test.” It then says, “Patients receiving a placebo (most were also on standard Alzheimer’s drugs) lost 1.1 points.” We’re told the difference was not statistically significant.
The story notes that the study might not have been long enough to detect serious risks with long term use. It says, “If it works, patients would likely have to take Bryostatin-1 for the rest of their lives. The main adverse event was diarrhea.”
The story gets at most aspects of the nature of the study in a very efficient way. And the reporter went into the study to find out how many people finished the study. It says, “Neurotrope enrolled 147 patients with an average age of 72 and moderately severe to severe Alzheimer’s. Some dropped out, so in the end, 33 got a high dose of the drug (known as Bryostatin-1), given intravenously every two weeks; 38 got a low dose, also every two weeks; and 42 got a placebo.”
It also talks about the short duration of the study, how it was not published in a peer reviewed journal, and how it was not part of any scientific convening. Every reporter, when the facts present themselves this way, should just write a similar sentence: “Neurotrope’s results have not been published in a scientific journal or presented at a medical meeting, so outside experts have not been able to evaluate that and other important details.”
There was no disease mongering in the piece. Alzheimer’s is a disease for which there is no cure or effective treatment. The patients studied in this piece had moderate to severe disease–meaning that their living were significantly impacted by the memory disorder.
The story had several independent sources but it didn’t disclose at least one important relationship.
It said “Dr. Sam Gandy…is not affiliated with Neurotrope.” However, he has worked as a consultant for them, as the “industry relationships” section of his bio explains.
Update 5/4/2017: STAT has issued a correction at the bottom of their story: “This story has been corrected to say that Dr. Sam Gandy consults for Neurotrope.”
The story mentions FDA approved drugs: “There are four FDA-approved drugs for Alzheimer’s, which affects 5.5 million people in the US: donepezil (sold as Aricept), galantamine (Razadyne), rivastigmine (Exelon), and memantine (Namenda). But none is a cure, and none affects the destruction of neurons and synapses, which causes the disease’s memory loss and cognitive catastrophe.” It also highlights that this new agent works in a different way from existing medications.
The story explains where the drug is in the regulatory process–still far from being on the market.
And it indicates how likely it is for the drug to get approval, saying, “A 2.6-point edge over placebo may fall slightly short of what the Food and Drug Administration would require for approval of a new Alzheimer’s drug… the FDA typically wants to see a net benefit of at least 3 or 4 points.”
The piece does a good job of describing how this drug is working in a different way than existing medicines and other drugs undergoing clinical evaluation. And how the patients being studied have far more advanced disease than most clinical trial participants.
The story does not overly rely on a news release.
Systematic, Criteria-Driven
@HealthNewsRevu @mcjaklevic HealthNewsReview once again revealing hype that far outstrips reality. I suspect that one day, AI will meaningfully contribute to good patient care. Whether that's in 10 years or 100, I couldn't say. What is clear is that we ain't there yet.
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