The latest example Speth and others are pointing to is the supplement Prevagen.
Speth, professor of pharmaceutical sciences at Nova Southeastern University College of Pharmacy, said he filed a complaint about Prevagen with the Federal Trade Commission in 2016. His are among the concerns echoed in a lawsuit brought by the FTC and New York State Attorney General. The lawsuit accuses Quincy Bioscience Holding Co. Inc. and its affiliates of making false or unsubstantiated statements about Prevagen’s benefits and clinical validation.
“We are seeking … to stop them from making allegedly unfounded claims, and (also) money for consumer refunds,” said Michelle Rusk, an attorney in the FTC’s division of advertising practices.
Wisconsin-based Quincy Bioscience, Prevagen’s marketer and manufacturer, says the product contains a synthesized version of a protein found in jellyfish, called apoaequorin, that improves memory. Prevagen, carried by most drug store chains and other major retailers, is widely promoted through television commercials featuring scenes of white-coated researchers in a laboratory and happy seniors reading to their grandkids.
Speth calls Prevagen “one of the most fallacious products I have seen come on the market,” and one that, like some other brain health supplements, uses questionable science in promotions aimed at desperate seniors facing brain disorders like Alzheimer’s or other serious medical issues.
“They’re thinking, ‘This guy on television says it will help me. And it probably won’t hurt me.’ A lot of people take these supplements because they can’t afford doctors or don’t trust them,” said Speth, a neuropharmacologist who lectures nationwide on the dangers of dietary supplements.
In a written statement, Quincy Bioscience denied the lawsuit’s allegations and said that the “sole dispute” rested with how the company analyzed the results of its own Prevagen clinical study.
The FTC is attempting to “hold the company to a standard that is unreasonable, scientifically debatable and legally invalid,” the statement said. “Quincy has amassed a large body of evidence that Prevagen improves memory and supports healthy brain function.”
While the number of people who have bought Prevagen isn’t known, court documents said the product has raked in $165 million from 2007 to mid-2015. A bottle of 30 pills sells for $24 to $68, according to the lawsuit.
Prevagen also has drawn fire from the U.S. Food and Drug Administration. In 2012, the agency sent a warning letter to Quincy Bioscience regarding several potential violations of FDA manufacturing, clinical trial and marketing rules. Among them: Prevagen’s advertisements and testimonials implied it would prevent or ease the symptoms of Alzheimer’s disease, a claim that only prescription medications approved by the FDA can make.
The letter allows companies to make corrections or show why the findings are incorrect before facing legal sanctions, FDA spokeswoman Lyndsay Meyer said. FDA investigators conducted inspections at two Quincy Bioscience locations in late 2016, she said.
The FDA could not provide more details or comment further, as the warning letter’s file remains open, Meyer said.
Quincy Bioscience spokesman Todd Olson said the company could not discuss the FDA letter’s status due to the FTC litigation.
In recent years, the FTC has made investigations of supplements and products targeting age-related memory decline a priority, Rusk said. “Our population is aging, so concerns about dementia will be more on the forefront. And more companies will be marketing to those concerns,” she said.
A year ago, Lumos Labs agreed to pay $2 million to settle with the FTC. The trade regulators charged the company’s ads contained unfounded claims that its Lumosity brain games could prevent cognitive decline.
In 2015, the marketers of the dietary supplement Procera AVH agreed to a $1.4 million settlement related to similar FTC allegations.
Speth said Prevagen has been on his radar since viewing one of their infomercials years ago, and seeing the company’s claims that the calcium-binding apoaequorin protein could reduce calcium ion imbalances in the brain that could lead to memory loss.
“It’s crazy. You can’t take a protein that’s been put in a pill that you swallow, have it go into your brain … and bind to any calcium that might have accumulated in your neurons,” he said.
“I have an obligation to try to convince people to use science-based medicines. I take an interest in unproved, untested products that have no scientific evidence to support their claims,” added Speth, who also is a research associate for the Institute for EthnoMedicine in Wyoming, dedicated to finding new treatments for brain diseases.
Among his complaints, which also were cited by the FTC: that Quincy Bioscience tinkered with its study’s analysis, displayed in a chart on their promotions, that showed memory task scores for test subjects taking Prevagen improved dramatically over 90 days. In reality, the placebo group not on the supplement scored slightly better, according to the FTC’s court filings, which also named two of the company’s top executives.
Those who work with Alzheimer’s disease patients and their families say people sometimes turn to supplements hoping something will work against the devastating disease.
“I get upset when people are being misled and think there is a magic bullet,” said Karen Gilbert, vice president of education and quality assurance at Alzheimer’s Community Care in West Palm Beach. “And there is a possibility that ingredients in supplements could do more harm than good when coupled with prescriptions.”
Gilbert said good nutrition is important for all seniors, and that some vitamins or supplements might be helpful. However, older adults always should speak with their doctors first, Gilbert said, and bring their supplements as well as their medications to their medical appointments.
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