This NBC story reports on a tiny “proof of concept” study testing whether it’s safe to give Alzheimer’s patients infusions of plasma from young men. Earlier lab experiments with rodents appeared to show improvement in older animals when getting such plasma. A secondary goal of this “trial” was to see if the infusions improved the mental status of Alzheimer’s patients, which it did not. Aside from the small size of the study, and the lack of any real data it produced, its “conclusions” are basically the observations/opinion of caregivers as to changes in these patients.
Although one of the researchers calls the work exciting, we’re not sure what he’s talking about. The study had less than a dozen participants. There was no measurable data. There is no insight into what, if anything, is in the plasma of young men that might benefit these patients. There has been no peer-reviewed publication describing the work. The beginning of “real” clinical trials is at least a year off and there’s no guarantee that they will take place, and if they do, they’re likely to only deal with whether this approach is safe.
Few diseases are as cruel to patients and their loved ones as Alzheimer’s is. It steals their memories and then their ability to think and communicate, leaving a shell of the person they once were. Therefore, any news about potential treatments is like a life preserver on a stormy sea, and when that news is shown to be premature at best, and reckless at the worst, it is these families who suffer. Stories dealing with this disease, as well as other debilitating illnesses, should always keep in mind the impact they may have on these vulnerable people.
There is no mention of the cost of this new approach in this story. The story does state that whatever product is potentially developed, it will not be whole plasma. Since we know what the cost to patients would be for current whole plasma transfusions, and for whole blood transfusions as well, it seems plausible for some estimate to be made based on what patients are now charged for either plasma or whole blood transfusions.
There is no quantifiable data reported in this story. In fact, there’s little if anything that can be considered to be actual data. The “success” of this approach, the story says, is based on the reported observations of Alzheimer’s patients’ caregivers to the researchers. This is all just subjective opinion, not actual fact. Moreover, it refers only to half of those in the so-called trial, and they were no longer blinded to whether they received plasma or a sham transfusion.
Additionally, the report states that researchers told a conference that, “There was no measurable effect on memory or thinking,” which are arguably the most important effects that Alzheimer’s has on its victims. Given that and the paucity of other real information in the story, its questionable why it was even written at all.
There are no mentions of harms anywhere in this story. Transfusions are invasive procedures and carry with them certain unpredictable risks. While the story does say at the end that any eventual product would be cleansed of components that mandate blood-type matching, there is no other discussion related to potential harms.
The story starts by explaining this so-called “proof of concept trial” involved only 18 Alzheimer’s patients, an incredibly small number from which researchers could draw conclusions. Then the story says what began as a blinded trial was changed to include only half the patients — nine of them — who knew they were getting plasma rather than placebo. The reason: “it (the trial) was taking so much time and effort.” Also, the trial only lasted a single month, an extremely short period to be able to develop behavioral changes among these patients. After the story acknowledges that the only results were basically subjective observations by caregivers, the story clearly states, “But that doesn’t mean there really was an effect. You just cannot tell with a trial of only 18 people.” But remember, the trial really actually only had nine patients who completed it.
Given all this, the decision to publish the story is questionable at best–there’s no news here, the evidence quality is so low it is not worth exciting readers about.
The story doesn’t disease-monger.
We’ll give the story a Satisfactory here since it does quote one source unaffiliated with the research and points out that earlier work led to the formation of a private company which intends to market a product derived from the research. However, the story would have been stronger if it had commentary from an independent expert with a more skeptical perspective.
The story does state flatly that, “There’s no cure (for Alzheimer’s), and treatments that have looked promising have flopped in big trials.”
The story states that the small “proof of concept trial” is just the beginning, and that the company “plans to move forward with formal clinical trials in 40 volunteers next year.” That presumably would be just a phase one trial to show safety so readers should know that any working product would be years away, at the least (and if ever).
The story establishes that the testing of this idea in humans is new.
This story does not appear to have relied on a news release. In this cast, that’s unfortunate since a news release produced by Stanford University is more cautious and comprehensive in its detail than is this NBC story.