This story unfortuantely reads like a marketing effort on the part of the manufacturer rather than objective reporting on the results of what the authors describe as an early proof of concept trial. The story suggests that the product in question (Souvenaid), "…might be effective in stemming-and perhaps reversing the cognitive tolls of Alzheimer’s. " While this may be true, the published article demonstrated much more limited results, ony demonstrating an improvement in one of six rating scales used.The story presents an inflated view of the study results without any significant provisos.
Readers can see a striking difference between the LA Times story and one on ABCNews.com that had many more paragraphs of concerns, caveats and context.
There are no effective treatments for Alzheimer’s DIsease. While there are numerous drugs available, their value in the memory loss and dementia associated with Alzheimer’s is limited. A new treatment, especially one based on a nutritional approach would be a welcomed option. However – the headline and the tone of this story raises hopes and expectations unrealistically.
There was no mention of costs. While not yet on the market, if there are plans to begin selling it in the spring, then it is likely that the company has some estimate for what it plans to sell it for. Information on this should have been included in this piece.
Subjects receiving Souvenaid only showed an improvement over the control group in one of the numerous scales used. This fact is important since the results may not be related to the Souvenaid but rather simply to chance. The results were not quantified in the story.
The story did not raise the possibility that there might be potential harms associated with this product. Considering that the trial lasted only 12 weeks and Alzheimer’s disease is a chronic condition which individuals may deal with for 10 years or more, it would have been valuable to remind readers about the very different time frame for the study as compared with disease treatment. It would only require a line to say this and would have been a reasonable admonition to include in the story.
The story clearly uses hyperbole in reporting on the study results. In reality only one of the scales used demonstrated a statistical difference between Souvenaid and placebo, the study was in patients with mild Alzheimer’s symptoms and was only for 12 weeks. Suggesting the product is effective or can even reverse symptoms is a giant leap.
While the story does not engage in disease mongering related to Alzheimer’s, it does note that the product may become, "a voguish cocktail for aging smarties" suggesting widespread need to improve memory in the US aging population. It also ends with the line that the product "may be the next big thing among the middle-aged smart set." For these two reasons, we judge this unsatisfactory.
There is information from a company spokesperson and from one of the study authors. There was no discussion of conflicts of interest such as corporate affiliations, patents held by authors, or sources of funding for the study reported on. No independent experts appear to have been consulted to comment for this piece. ABCNews.com, though, as one example had no difficulty including the following in its story:
"I see little evidence to support the use of this beverage to improve memory in [Alzheimer’s disease patients]," said Dr. Paul Aisen, a noted Alzheimer’s disease expert and professor at the University of California, San Diego. "It was a small study of treatment-naïve [Alzheimer’s] patients lasting only 12 weeks." By 24 weeks, the memory differences seen after 12 weeks had disappeared.
The study was published in the most recent issue of the journal Alzheimer’s & Dementia.
Experts also pointed out that some of the memory tests failed to show any improvement in people using the cocktail.
"This is a study which I would look at as negative," said Dr. Constantine Lyketsos, director of the Neuropsychiatry Service at Johns Hopkins Medical Institution. "The major outcome measures showed no effect at any time point."
Dr. Richard Besser, senior medical editor for ABC News, noted some troubling aspects of the study that related to its potential marketing, including conflicts of interest by the authors.
"They hold the patent on the nutritional cocktail and some serve on the advisory board for Dannon. The study was funded by Dannon," he said.
Other experts, too, were critical of the study.
"While everyone would clearly like to have some safe and easy to take method to stave off Alzheimer’s disease, there are several features of this study that should raise concerns," said Dr. Clifford Saper, chairman of the Department of Neurology at Beth Israel Deaconess Medical Center in Boston. "They would include the involvement of the commercial sponsors at every level of this study, including writing the first draft of the paper; and the relatively low level of improvement on a single test out of a large battery of examinations."
The story mentions the drug Aricept approved for the treatment of Alzheimer’s disease. It mentioned that Aricept is not approved for mild cognitive impairment, suggesting that nonetheless people chose to use it for cognitive enhancement considering it to be ‘worth the risks’, without listing the risks. The product reported on was said to have shown no side effects so far by the man who has patented the combination of nutrients being marketed. While this might lead a reader to conclude that the new beverage is safer than the pharmaceutical, it would have been useful to highlight that neither has been demonstrated to be beneficial.
The story mentioned that the product reported on, Souvenaid, was expected to be sold in test markets in the US in the spring. The story noted that since the product is a dietary supplement, it does not need approval by the Food and Drug Administration before it can be marketed.
Souvenaid has apparently been granted a patent, so on that basis it is likely to be a novel combination of products. The concept of a memory enhancing or sustaining diet has been suggested in numerous articles in the medical literature. From that perspective, there is really nothing unique about the approach however. Nonethless, we’ll give the story the benefit of the doubt on this criterion.
We can’t be sure of the extent to which the story may have been influenced by a news release. We do know that the only sources quoted had personal vested interests in promoting the results.