This story reports on a drug in development for people with Alzheimer’s disease. While providing a lot of detailed information about the molecule under study and how the drug is better tolerated at lower doses, this story failed to provide any insight as to the benefit one might hope to obtain from taking this medication. Indicating that the drug might show promise gets the readers hopes up without any framework for what it is they might expect.
The graying of the population means that the concern about Alzheimer’s disease looms large – for the elderly, people who care for elders, and those paying the bills.
As the drug is still under development, there was no discussion of costs.
This is a humanized monoclonal antibody and the story might have mentioned some of the drugs currently on the market to treat other disorders such as bevacizumab (Avastin) or adalimub (Humira). This could have led to some discussion about costs because these are not inexpensive medications.
The story merely mentions that this drug had ‘shown promise’ and that the studies reported are ‘encouraging’ because they indicate that people can tolerate the drug for 2- 4 years without safety concerns.
Promise of what? What does the drug do? Although the story mentions amyloid accumulation, it failed to explain that though amyloid accumulation is seen in Alzheimer’s disease, it isn’t clear whether it causes symptoms or is secondary to the disease process.
The story would have added valuable context by at least mentioning the results of the placebo-controlled study from which the patients in this extension study were drawn. http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-newsArticle&ID=1166655 That study found that the drug had no effect on symptoms in the study group overall, although specific subgroups seemed to benefit in an after-the-fact analysis that was not part of the original study design.
The story indicated that some patients taking the higher does of the drug experienced headache, memory loss, hallucinations, reduced coordination or other symptoms. From the information in the story, it appeared that 8% (21/262) of patients participating in a second study using the lower dose of the medication had some anomalies on MRI scan but no reported symptoms.
At the end of this story, it was reported that the results had only been presented at a meeting and therefore considered only as preliminary until they were reviewed. In addition, the story indicated that the study reported on was an open-label trial.
But it doesn’t explain what open-label means – hardly a consumer-friendly term. Wanna do a poll on how many readers know what it means?
(In an open-label trial, both the clinician and patient know what it is that they are taking; the potential impact of that on results should be obvious.)
Nonethless, we’ll give the story the benefit of the doubt, largely on the back of one of the expert sources being quoted: “it is too early to tell from the data from this small Phase 2 safety trial.”
(Although, again, do we expect that most readers know what a Phase 2 trial really means?)
Barely satisfactory.
The story did not engage in overt disease-mongering.
The story included a quote from Dr. Ian Murray who did not appear to have a role in the studies reported on as well as comments from Dr. Salloway, lead author of the study. But we’re going to rule it unsatisfactory because the story should have noted that Dr. Salloway, according to previous disclosures available online, has received research funding and has consulting relationships with numerous drug companies, including Pfizer, which makes bapineuzumab.
The story failed to explain how patients taking bapineuzumab compared with those who did not take the drug. Without this information, it is impossible to evaluate the value this medication may have to patients. The story also should have put the findings seen with bapineuzumab in context with those of the other approved drugs (Aricept, etc) that have limited efficacy or perhaps mentioned the other drugs that are in testing.
The subject of the story is the drug bapineuzumab, which was reported as not yet available to consumers.
It would have been useful to include a link to Clinicaltrials.gov so that readers who might be interested could learn about the other trials being conducted.
This story did not overstate the novelty of the drug reported on. But the story also could have mentioned that there are several similar drugs undergoing preliminary testing.
This story did not rely solely on 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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