"Does Prevagen Really Work?"
Over the last twenty years or so,
Big Pharma has invested more than a half trillion dollars
into dementia treatment research, but so far to little avail.
In light of this, many have turned to supplements.
An AARP commissioned survey found that 36% of those 74 years and older
take a supplement for brain health, to the tune of billions of dollars a year.
The most commonly marketed brain supplement
was one I’d frankly never heard of before: Prevagen.
Prevagen contains a protein derived from a luminescent jellyfish
the company claims "has been clinically shown to improve memory."
According to the company website,
“A landmark double-blind and placebo controlled trial
demonstrated Prevagen improved short-term memory,
learning, and delayed recall over 90 days.”
But when you actually pull up the study,
not only did Prevagen fail to improve memory, learning, or recall over placebo,
it failed to show a significant improvement
in any of the nine measured cognitive tasks tested.
As an inquiry into Prevagen published by the Center for Science in the Public Interest
was titled, “How Can This Memory Supplement Flunk Its One Trial
and Still Be Advertised as Effective?”
And not just as effective but the #1 pharmacist recommended brand.
Considering the lack of sound clinical evidence, how is that possible?
Presumably, they’re just as blitzed with the same kind advertising as everyone else.
It’s no surprise the supplement didn’t do anything
since the company’s own studies showed the jellyfish protein
was rapidly digested by stomach enzymes.
Of course, that didn’t stop them from raking in more than $20 million a year.
Claiming the “marketers of Prevagen preyed on the fears of older consumers
experiencing age-related memory loss,” the Federal Trade Commission
and New York State’s Attorney General filed a consumer protection complaint,
charging the company with making false and unsubstantiated claims.
The AARP weighed in, accusing the company of “deceiving millions of aging Americans.”
In a move straight out of the Big Pharma aducanumab playbook,
the company went back and conducted more than 30 post hoc analyses of the data
and found a few positive findings on a few tasks for some subgroups.
This cherry-picking of subgroups after-the-fact
is a classic example of manipulation sometimes called “p-hacking”
or “data dredging” that can be described
as “placing a bet on a horse after watching the race.”
The makers of Prevagen settled a class action lawsuit in 2020 with the FTC
over deceptive business practices and false advertising.
Remarkably, though, the settlement allows them to continue to market it
with the court-approved disclaimer that claims
are “based on a clinical study of subgroups of individuals …”
But with the amount of slicing and dicing of data they did,
the chances of finding at least one false positive
was estimated at 80 percent.
Prevagen may be more than just a waste of money.
The manufacturer was cited for failing to report
more than a thousand adverse events related by consumers
to the Food and Drug Administration (FDA).
Regulators can’t have it both ways, though.
If the jellyfish protein is digested away, how can it pose a safety risk?
Because dietary supplements are too often adulterated with contaminants.
FDA inspectors specifically cited Prevagen’s manufacturing facilities
for “objectionable conditions or practices.”
A 2019 survey by Pew found that more than half believed
that the Food and Drug Administration requires supplements be tested for safety,
but that isn’t true.
One study of 24 supplements sold as cognitive performance boosters
found that most claimed an ingredient on the label
that wasn’t actually in the supplement,
and worse, 38 percent contained ingredients
not allowed in supplements like prohibited drugs.
Another study of a dozen so-called “brain health supplements”
similarly found 8 out of 12 were misbranded
(missing an ingredient promised on the label),
and 10 out of 12 were deemed adulterated
(containing unlisted compounds, for example caffeine
in a product that explicitly highlighted all-caps ‘‘DECAFFEINATED’’ on the label).
Only 1 out of 12 was certiﬁed to contain what it said it did.
The bottom line for Prevagen:
there is no acceptable evidence that it's effective.
Patients should be advised not to take it.