This is a story about the effects of a drug taken from a small research study about a technique that may prove useful for monitoring plaque in the brains of individuals with Alzheimer’s disease. Although the study did not report on clinical impact of the drug and in fact was not powered to detect changes in function, the story was framed as a sign the "drug is working"…"lifting hopes."
This may have been a business story, but shareholders and patients deserve better scrutiny of claims than this story offered.
It seems cruel to suggest that there is a possible treatment for a serious illness when there is nothing known about the clinical benefits of the treatment. While it is of interest that there may be a new technique that will allow plaque to be measured in brain tissue of living people, the projections about the drug are woefully premature as there is no evidence that it will pan out to help people with Alzheimer’s disease.
There was no discussion of costs, nor was there even any mention that the drug needed to be administered via an injection – which will impact cost of delivery.
The story reported that the impact of the drug was to reduce plaque by 25%. Reporting a relative risk reduction does not provide readers with much information. 25% of what? What is meaningful plaque buildup and what is meaningful plaque reduction?There was no discussion about the clinical significance of this amount of reduction.
The story stated: "The treatment was generally well tolerated, although two patients on the highest dose had transient brain swelling. The drug’s developers have since dropped the top dose from large ongoing Phase III trials." Well, what does generally well tolerated mean? And what’s happening at the lower doses? This is confusingly incomplete.
While the research the story was based on was focused on a new method for assessing the size of plaques in the brains of living individuals, the story focused on the difference in the measurable outcome in those receiving an experimental drug. The story failed to mention there was no difference in cognitive function or capacity to complete activities of daily living in those taking the drug. By focusing on something that can be readily measured (surrogate endpoint) rather than a clinical outcome, the story made the impact of the drug seem greater than it might really be in peoples’ lives.
The story did not engage in overt disease mongering.
The story included a quote attributed to Sam Gandy at New York’s Mount Sinai School of Medicine without explaining what expertise he might bring. Nonetheless, he was enthusiastic about the potential benefit from the measurement technique the study used. And though the story was focused on an Alzheimer’s treatment, he mentioned that it’s too early to say anything about effectiveness to treating Alzheimer’s disease.
The story did report that the study was funded by the manufacturer of the drug being studied.
There was no discussion of other approaches to treating Alzheimer’s disease.
Bapineuzumab, the drug reported on, is experimental and not available for use outside of clinical trials. The story mentioned the experimental status once, but the fact that it is not available was probably lost on many readers who may have been swept away by the enthusiastic reporting: "potential game-changer because it could be the first drug to treat the underlying cause of the degenerative brain disease."
The drug reported on, bapineuzamab, is currently the focus of a number of clinical trials, many of which are recruiting participants. (www.clinicaltrials.gov). The focus of this story was on a very tiny study which was more about methodology for assessing Alzheimer’s disease. So while the story made it seem like it was reporting on a study of a novel drug, it failed to mention the much larger studies of this drug that are currently in the works.
The story does not appear to rely on a news release.