People have been waiting for three years to learn more about a yogurt-based drink that showed some positive results in a memory-loss study by Harvard and Massachusetts Institute of Technology researchers. Coverage of that study mentioned prominently that the nutritional drink was made by Dannon, the yogurt company. Something that tastes good and also helps you remember where you put your keys? What’s not to like? But this update to that study received a bewilderingly opaque treatment in this news release. We have to wonder why the release avoided spelling out cost, benefits, risks, and the overall contours of the study. There is a lot of space spent on the organizations involved in the study and far too little on what they actually did and, most importantly, found.
The release notes that the research was presented as a “late-breaking presentation” at an international medical meeting but offered no easy way to access the research. The release directs us to the LipiDiDiet website for more information on the study, but there we are told:
“15 October 2015
We are pleased to note that there is considerable interest in the LipiDiDiet clinical trial. Data from the LipiDiDiet clinical trial are currently being analysed. We will make the results public through various channels, including through this website.”
When clicking on promising headlines that looked like they might take us to actual studies, we’re told to click on another news release.
Finding a treatment for Alzheimer’s dementia, in its many stages, has proven to be a frustrating exercise with no clear options at the moment. That is what makes the potential for a nutritional approach that might delay or reduce the disease effects so appealing. It is that appeal that makes reporting on results of studies critically important.
This particular release is important as the makers of the product are knocking at America’s door. If the product is dubbed a “medical food” as opposed to a supplement, the FDA may regulate it and require it be available by prescription only.
Presumably, the aim here is to make an over-the-counter nutritional drink along the lines of Ensure for people to take as they age to stave off memory loss. If that’s the case, the release should explain what something like this costs to make and what it might cost on the shelf.
We had to read the release three times to make sure, but, rest assured, there are no useful numbers about the benefits found in this study. Let’s be clear, the study did not meet its expected primary outcome related to cognitive function and only three of the host of secondary outcomes. So, from the purely scientific approach, Fortasyn Connect did not demonstrate a predefined clinical effect. The Australian not-for-profit, NPS Medicine Wise group concluded in a 2014 report that Fortasyn failed to demonstrate a significant effect in cognitive decline based on three previously published studies.
We don’t know the possible risks associated with drinking an amalgam of different food products. And this release provides no insights. Previous studies have suggested that the nutritional product is well tolerated and did not appear to cause any harms. That being said, we think that this should have been noted in the report.
The presentation of evidence seems particularly weak in this release. The release begins with a number of secondary outcomes and doesn’t note that the primary endpoint was negative until the third paragraph. That’s spin — and an attempt to distract from the most relevant findings and highlight less important ones that happened to be positive. And even when the release does get around to acknowledging this, it speculates that the main reason the drink didn’t work is because “Cognitive decline over the study period was less than originally expected.” Well, maybe, but then again maybe the effect of the drink was less than expected and that’s why it didn’t work. Presenting the results at a medical conference and sending a news release (but not providing access to the study so research peers and journalists can review and accurately report on it) does not instill a lot of confidence in the findings.
The news release liberally applies hype on a narrowly focused area called “early dementia” and focuses on the purported benefits of this drink for this phase of mental disorder. It is important to note that not all people with mild cognitive impairment (what the release calls early dementia) go on to develop full blown symptoms of Alzheimer’s.
The release focuses on the involvement of the European Commission, but it omits the involvement of Dannon, the massive food company, which holds the patent on the nutritional drink being studied.
While the release makes it clear — and accurately so — that there are no pharmaceutical treatments for dementia, it also states “We have known for a while that diet can reduce the risk of developing dementia.” We disagree. No diet has ever been shown to reduce the risk of dementia. The best we’ve got are epidemiological studies that show an association between diet and dementia risk. That’s not the same as reducing risk. The release also says that “single nutrients simply aren’t powerful enough to fight a disease like Alzheimer’s alone.” That’s a gross oversimplification that could lead people to think that more is better when it comes to vitamins and dementia.
The release doesn’t state whether the product is available in the United States. It is not. However, the product is marketed widely in Europe under the brand name Souvenaid.
The release claims novelty with this statement: “This is the first time a randomised, double-blind, clinical trial has shown that a nutritional intervention can help to conserve the ability of patients with very early AD (pre-dementia) to carry out everyday tasks, such as paying bills, or finding your way around, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) – a combined measure for the ability to think and perform everyday tasks.” While a nutrition drink to improve memory in people with early Alzheimer’s disease would certainly be a novel addition to the treatment tool chest, we think the novelty boat already sailed three years ago when there was significant coverage of the three previous double-blind studies.
The release includes some statements that raise a red flag when we see them and the evidence provided in the release doesn’t support them. Some examples:
“This is exciting because it shows that in the absence of effective drug options, we really have found something that can help slow down some of the most distressing symptoms in very early AD (pre-dementia); especially in those who started the intervention early. Indeed those patients who have lost the least cognitive function, have the most to gain.”
“The LipiDiDiet study illustrates that this nutritional intervention can help to conserve brain tissue and also memory and patients’ ability to perform everyday tasks – possibly the most troubling aspects of the disease.”
The evidence presented doesn’t demonstrate that the nutrition drink “can help slow down” early Alzheimer’s memory loss nor that it “can help to conserve brain tissue.”
But while this is a close call, we’ve already come down hard on this release for similar issues and these statements arguably aren’t egregious enough to merit another ding here. So we’ll rule it Satisfactory with reservations.
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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