In the annals of unsavory attempts to exploit vulnerable people with false hope, a new campaign to promote an unproven supplement said to slow the progression of Alzheimer’s disease ranks near the lowest of the low.
A PR company working with the supplement maker is attempting to attract the attention of journalists with claims based on a study published recently in the Journal of Alzheimer’s Disease. That study “may have identified a unique combination of nutrients that slow the progression of Alzheimer’s disease,” according to the PR pitch. But this characterization has prompted an outcry from independent scientists who have condemned the study’s methods and called the researchers’ claims of a “breakthrough” “either naive or deeply cynical.”
The campaign boasts an unusually slick veneer of scientific credibility owing to the participation of academics at the Nutrition Research Centre Ireland, which is part of the Waterford Institute of Technology. But once that façade is scraped away, this initiative looks like little more than a grab for sales and media attention based on the flimsiest of premises.
Some news outlets in Ireland have already passed along terribly misleading messages about this so-called “breakthrough” to unsuspecting readers. North American news outlets should be on high alert and look very skeptically on an upcoming “media availability” featuring NRCI researchers.
A deceptive pitch
It was an email “alert” regarding that event from a New York-based PR agent that initially piqued my interest and might well lure in other journalists. A subheadline of that news release said: “Study Published in the Journal of Alzheimer’s Disease (JAD) Reveals Combination of Nutrients Found in Common Foods May Help Slow the Progression of Alzheimer’s Disease.”
The alert goes on to state:
An 18-month study coming out of Ireland may have identified a unique combination of nutrients that slow the progression of Alzheimer’s disease. The pilot study examined the effects of nutritional compounds found in foods such as broccoli, trout and peppers, on people with the condition, and revealed a ‘statistically significant’ find.
This language will most certainly raise the hopes of patients and caregivers who will understandably grasp at any straw when trying to cope with the effects of this disease. But those hopes are likely built on quicksand.
The researchers in this study took two tiny groups of patients with Alzheimer’s disease – one group with just 12 people, the other 13 – and gave them supplements containing nutrients isolated from common foods. The second group’s supplement also contained fish oil.
Based on nurse-led interviews of each patient’s caregivers after 18 months, the researchers reported less decline in the group receiving the nutrient + fish oil pill compared to the group receiving nutrient-only supplement.
Very small numbers, very high likelihood of bias
While that finding might sound highly promising, it’s not. There are so many holes in this study’s design that the results are “highly unlikely to be true,” independent experts said.
Follow-up coverage from NHS’s Behind the Headlines exposed some of these flaws when the study was initially published in June.
The study compared 2 groups of people given combinations of supplements, all of whom knew what they were being given.
The nurses who carried out the assessments also knew what supplements people were taking. This introduces the strong possibility of bias.
For example, carers would expect to see an improvement with the combined supplement, or would perhaps give a more positive report to the nurses knowing that was what the researchers wanted to hear.
We don’t know exactly how the nurses made their assessments of patients’ status at 18 months.
The researchers didn’t use the standard MMSE test, a screening test used to diagnose dementia, or any more in-depth validated cognitive assessment tools.
That makes it very hard to assess how reliable their division of people into mild, moderate or severe disease categories was.
The study was very small. In a clinical trial comparing 2 drugs, you’d expect to see hundreds or thousands of patients, not fewer than 20 in each group.
Supplements already on sale
In short, the distance between this study and an effective way to prevent Alzheimer’s is cosmic in scope. But that yawning gap wasn’t mentioned in some of the initial news reports about the study.
Darren Dahly, PhD, a statistician and expert on the design of clinical trials at University College Cork, Ireland, told me he was “surprised by the disconnect between this research and its coverage.”
“As noted by other experts, this wasn’t a randomized trial with concurrent controls, but rather three small samples of patients, all recruited from different studies,” he said. “Further, the measurements used to evaluate disease progression were highly subjective, and the quality of reporting in the study publication left much to be desired. Concluding that there was a ‘breakthrough’ is problematic to say the least, especially coming from the study investigators who should know better.”
And yet there’s already a company called Memory Health selling supplements based on the study (a month’s supply costs $ 34.95), which it promotes on its website with claims that the pills will slow Alzheimer’s progression.
It also issued its own news release about the research headlined: “Could this be the solution for Alzheimer’s Disease?”
That release goes on to quote one of the researchers — Alan Howard, PhD — who calls the study “one of the most important medical advancements of the century.” He also says the supplement “which we know is safe, inexpensive and effective, could be life-changing for the millions affected by this disease.”
“Seriously?!?” responded Eilon Caspi, PhD, a gerontologist and dementia behavior specialist with the University of Minnesota nursing school, when asked to comment on that claim. “The lack of rigorous randomized controlled trial and the potential conflict of interest add to the need to remain skeptical about the promise for a ‘breakthrough’ in this study.”
Memory Health is referenced in the upcoming media event as “providing” the interviews with Professors John Nolan and Riona Mulcahy — who are co-authors of the study and referred to in the release as “the talent.”
The release helpfully suggests some questions that reporters might want to ask the researchers such as, “Why do you think these nutritional compounds have shown a positive effect?” and “Why were the nutrients delivered as a supplement?”
In fact, this research doesn’t provide any basis to conclude that there is any “positive effect” from these nutrients or this supplement on Alzheimer’s disease. So perhaps the better question from journalists should be, “Why is this even news?”