Prevagen Again Under Fire

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Last week the New York Attorney General and the Federal Trade Commission jointly filed a lawsuit against Quincy Biosciences, the maker of Prevagen, charging that its claims that Prevagen improves memory are false and deceptive.

 

How Prevagen Works

Quincy Biosciences claims that Prevagen’s active ingredient, apoaequorin, a derivative from jellyfish, has calcium-binding properties. When apoaequroin reaches the brain, it theoretically binds with excess calcium caused by deteriorating cognitive function. By eliminating this excess calcium, it is thought that brain function is improved. The Prevagen website includes the results of the one clinical trial it conducted to prove that Prevagen improves memory. It should be noted that this trial was never peer reviewed, a step considered essential to confirm trial results.

 

What the FTC/New York Attorney General Lawsuit Alleges

The lawsuit challenges the statistical analysis of the clinical trial and the underlying assumptions about how humans metabolize Prevagen, claiming that

  • The data from Prevagen’s clinical trial does not show any statistically significant improvement among those research subjects who took Prevagen;
  • Normal human digestion completely breaks down apoaequorin in the stomach and it never reaches the brain; and
  • There is no data indicating that apoaequorin, even if it survives digestive action, can cross the blood brain barrier.

 

The Position of the Alzheimer’s Association

The Alzheimer’s Association has not taken a position on Prevagen, although its website does address concerns about use of alternative therapies. When NBC asked the Alzheimer’s Association about Prevagen, science officer Maria Carrillo stated,

“The Alzheimer’s Association has serious concerns about people using dietary supplements as an alternative or in addition to physician-prescribed, FDA-approved therapies in an attempt to treat or prevent Alzheimer’s disease or other dementias.”

 

The Position of Quincy Biosciences, Prevagen’s Manufacturer

 Quincy Biosciences issued a statement following the announcement of this lawsuit, alleging that the allegations in the suit were unfounded and inaccurate. You can read the full statement here.

 

Mounting Legal Challenges

 It is worth noting that this is the third time Prevagen has been the focus of legal action. The FDA issued a cease and desist letter in 2012, because Quincy Biosciences was marketing Prevagen as a drug without obtaining FDA approval. Last year, a class action suit was filed against Quincy Biosciences, alleging unfair and deceptive marketing. That case is still pending.

The New York Attorney General has successfully gone after drug companies who have sought to take advantage of those dealing with memory loss. If there is merit to the allegations against Prevagen, one hopes that the New York Attorney General will go the distance on this fight.

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