#prevagen

They claim that their patented ingredient – apoaequorin – is a revolutionary new substance that is going to turn the nootropics world upside down.

They say that it has substantial scientific backing.

Yet this same company are currently being sued by the United States government over false claims.

The charge is that Prevagen’s claims are false. According to Uncle Sam, Prevagen is claiming to do things that it has never been shown to do. The makers are claiming things that have no basis in reality.

Prevagen deny these charges – I believe they intend to challenge in court.

So what’s going on here?

Who’s right?

Is Prevagen making claims it shouldn’t be?

Or is the US government being overzealous in taking legal action against this company?

Let’s find out.

Let’s take a look at the evidence offered by Prevagen and see if it is fair to draw the same conclusions that they are.

 The Study

To support the claim that Prevagen helps restore memory function and prevent age-related cognitive impairment, the manufacturer provides just a single study on the main ingredient – apoaequorin.

Not one meta-analysis; we mean a single, standalone study.

Here it is in case you want to see it – it’s hosted on their website and nowhere else; big surprise!

That in itself would be enough to make us sceptical.

But the lack of follow-up studies isn’t even the most ridiculous thing about this whole business.

The thing that leaves me most confused is the fact that the study doesn’t even conclude in their favour!

If you take a look at the study conclusion, you’ll see the following: “No statistically significant results were observed over the entire study population”.

You will then see a table showing the results of the various cognition tests issued to the participants’ sub groups. The annotation reads: “In the AD8 0-2 and AD8 0-1 subgroups, no statistically significant differences were noted in Baseline values between the Experimental and Control groups in any of the nine variables. The randomization was successful.”

No difference between those given apoaequorin and those given plain rice flour capsules.

No difference whatsoever.

In fact, the table shows that some participants must have scored LOWER on the cognition tests after being given apoaequorin!

So at best, this substance does nothing, and at worst, it hinders cognitive function!

How then can Prevagen be using this study to sell their product?

How can they be using this to back up their fantastical claims?

The answer is that they are using a very clever (and extremely dishonest) for of data analysis.

 Post Hoc Analysis & False Conclusions

If you read the details of the study linked above, you might notice something curious. The study itself was carried out between December 2009 and April 2011. Yet the publication date reads August 2016, and it was published on the Prevagen website in early 2017.

Why the hiatus?

As we’ve mentioned, the research found no statistically significant difference in cognitive function between groups given apoaequorin and those given placebo.

But the full results stamen reads as follows: “While no statistically significant results were observed over the entire study population, there were statistically significant results in the AD8 0-1 and AD8 0-2 subgroups. These subgroups contain individuals with either minimal or no cognitive impairment, and are the appropriate population for a dietary supplement intended to support people with mild memory loss associated with aging.”

Clearly, the guys at Prevagen undertook a post hoc analysis of the original data.

A post hoc analysis is when you go back and take another look at a data set with new parameters that weren’t originally specified.

Or to put it another way, it’s where you look at a data set and do your best to find a relationship that the original researchers weren’t looking for.  

They obviously did this in the hope of finding some kind of positive relationship between apoaequorin supplementation and improved cognitive function.

The problem here is that it is almost impossible NOT to find some kind of correlation when you look hard enough and long enough at a data set.

The longer you look at a data set, the more likely it becomes that you will find something…it’s almost inevitable. Correlations exist everywhere, whereas causal relationships do not!

This is why the US FDA does not accept post hoc analyses when considering pharmaceuticals.

Every substance can eventually be shown to positively influence some aspect of health and longevity if we go by post hoc analyses. If we look at a study done on inhalers for long enough, I’m sure we’ll find that they have some sort of correlation with back pain, or near sightedness, or liking spaghetti.

Sometimes post hoc analyses can be useful when they identify an interesting relationship that needs further examination.