At the recent Amaz!ng (no, the ! is not a typo) Meeting in Las Vegas, Dr. Gorski, Dr. Novella, “Dr. Rachie” (Rachael Dunlop of Australia) and I participated in a workshop on “Dr. Google” about how to find reliable health information on the Internet. In my presentation, I described step by step how I researched a typical diet supplement product, Procera AVH. Later, one of our readers wrote to ask us about that very product, so I decided to convert part of my presentation into this blog post.
A half-page spread in my local newspaper proclaimed: “Memory Pill Does for the Brain What Prescription Glasses Do for the Eyes, Claims US Surgeon General Candidate.” It looked superficially like a news report, but it was actually an advertisement for the diet supplement Procera AVH. Closer inspection revealed the words “Paid advertisement” in tiny print, the required FDA disclaimer for diet supplements, a “Call Toll-Free” number and offers of a FREE Bonus Bottle, FREE book, and FREE supply of Rapid Detox Formula for First 500 Callers.
The ad said we lose one-third of our brain power by the age of 40, and 50 percent by the age of 50. The decline is so gradual that we may not even notice how impaired we have become. Do you routinely lose your car keys, forget to call people back, or misplace your TV remote control? Help is on the way!
- Helps restore up to 15 years of lost memory power in s little as 30 days.
- Unique, fast-acting process that pumps the brain full of more energy, improves blood circulation to the brain and increases the key neurotransmitters that are responsible for cognitive functioning.
- 3 clinically validated brain energy nutrients in the formula have been shown to “light up aging brains like a Christmas tree.”
- Revitalizes tired sluggish brain cells with a fresh supply of oxygen and key vital nutrients.
- Clinically shown to quickly help improve memory, focus, concentration and mental energy!
- Time Travel for Your Brain
- I felt like I did when I was younger. I had my mental edge back.
- It helped me speak out more than I used to. I am growing more confident every day.
- I feel so much more focused and with the new energy I’m now ready to tackle the things I’ve been putting off for years.
- Even my husband was impressed with my improved memory.
“Claims US Surgeon General Candidate”
Who is this Surgeon General candidate? In the ad, he is identified as Dr. Paul Nemiroff. Who is this guy? Is he an expert whose word we should trust? An Internet search revealed that he is an MD and PhD with good credentials, but he is also a TV medical journalist and the inventor and seller of his own diet supplement product, Joint Formula 88. The Procera website says he has published “hundreds of articles,” but PubMed only lists eight. The website says he was “invited to the White House where he was considered for Surgeon General of the United States.” I couldn’t find any independent verification of that; but even if it’s true, who considered him, the President or the janitor? Even if a president had seriously considered appointing him to the post, that doesn’t carry much weight. Presidents are not exactly the best judges of a person’s scientific credibility: after all, one of our recent presidents followed the advice of an astrologer.
A correspondent sent me an almost identical ad from his local paper. In that version, the Surgeon General candidate is mentioned in the headline but not in the body of the text. In that version, the picture of Dr. Nemiroff is replaced by a picture of Dr. Robert Heller. In that version, Dr. Heller is quoted as saying word for word what Dr. Nemiroff was quoted as saying in my version of the ad. That’s curious. Plagiarism? Great minds think (exactly) alike? Total fabrication?
I went to the company’s website to see if I could learn more. It features a video with the title “Breaking News” that is obviously intended to make you think it’s from an actual TV news program, with a reporter behind a news desk, but it’s really an infomercial featuring Dr. Nemiroff. The website features the usual testimonials and special offers. It also has a “Clinical Research” tab. I figured if they had any real evidence, that’s where I could find it. But it wasn’t very helpful. It said a study was done but it provided no links, details, or even information that would help locate the study.
I really wanted to read that study, and there were enough clues in the newspaper ad that I was able to locate it after a short detour. The ad said that a randomized, double-blind, placebo-controlled study was published in JANA, “A Leading Scientific Journal.” How many of you read that as JAMA? I’m sorry to say I did. When I googled “JAMA Procera” the first hit was a news story in a Tampa newspaper that pointed out it was not the JAMA but the JANA.
The JAMAis the prestigious Journal of the American Medical Association. JANA is the Journal of the American Nutraceutical Association, an obscure journal that was published erratically (1-4 issues a year) from 1996 to 2009. It’s not even listed in PubMed. The only way to access its articles is to purchase their CD containing all the back issues.
I was able to find a copy of the study online on another Procera website. I asked the four questions Bausell proposed in his book Snake Oil Science as a quick indication of study quality:
- Was it randomized with a credible control? Hard to say. They don’t describe the placebo or the randomization process, and they didn’t do an exit poll to see if patients could guess which group they were in.
- Were there over 50 subjects in each group? No, 43 and 31.
- Was the dropout rate less than 25%? Yes, 18 percent.
- Was it published in a high-quality journal? No.
The study found that compared to the placebo group, the Procera group showed significantly more improvement in 3 areas: working memory accuracy, long term memory consolidation, and one measure of mood. But there were no significant differences in several other measures of mood or in any of the other things they measured, like information processing speed, reaction time, etc. The magnitude of the statistically significant differences was small and probably not clinically significant. And of course, we can’t be very confident that the results are valid, because it was only one study, it was commissioned by the manufacturer of the product, and it has not been replicated.
How the Company Reported the Study
They claimed it showed improved mental clarity, focus, and concentration; improved ability to learn and recall information faster; sharpened thinking and mental quickness; boosted alertness and mental energy; elevated mood and self-confidence; reduced anxiety and stress. It didn’t.
What’s In It?
Procera AVH contains 3 ingredients. The A is Acetyl-L-carnitine, the V is vinpocetine and the H is Huperzine-A. How much of each? They’re not telling. All they disclose is that each pill contains 1515mg of “proprietary blend.” Have any of these ingredients been shown to improve memory? I looked in PubMed, Cochrane reviews, Wikipedia, and the Natural Medicines Comprehensive Database to try to determine what published evidence there was for each ingredient. The Natural Medicines Comprehensive Database gave the 3 components “possibly effective” ratings for dementia (not for memory enhancement in non-demented people). Its safety ratings varied from “possibly safe” to “likely safe;” it listed a number of adverse reactions and warned of interactions with drugs (one “major” warning and 5 “moderate” warnings).
Evidence for Efficacy
Vinpocetine. In a study of 12 healthy volunteers, memory improved with the 40 mg dose. A Cochrane Review found 3 studies in adults with dementia and said they were inconclusive.
Huperzine A. A small study of students in China showed improved memory and higher test scores. Some studies in adults with dementia were favorable, but a Cochrane review found inadequate evidence to draw any conclusions.
Acetyl-L-Carnitine. A Cochrane review found that the only studies were in Alzheimer’s disease, and while there was evidence of benefit on global clinical impression, there was no evidence using objective assessments.
A research section on the Brain Research Labs website lists more studies that supposedly support Procera AVH. They don’t. One study showed that huperzine A improved abnormal lipid peroxidation and superoxide dismutase in aged rats. Another showed an effect of vinpocetine on warfarin-induced inhibition of coagulation. Another study was on oxidative damage and mitochondrial decay in aging. Their list doesn’t contain a single study of Procera AVH — not even the JANA study.
The company’s website says Huperzine has been shown to improve learning and memory at all ages. It hasn’t.
Supplement Geek Digs Up Some Dirt
When I searched the Internet for criticism of Procera, I stumbled upon the very handy website of Supplement Geek, who reviews supplements with a critical eye. I like this guy; I will definitely be re-visiting his site.
He found that the company’s address was in a residential area, that there is no company website other than the Procera website, that the company is not accredited by the Better Business Bureau and that multiple complaints have led to a BBB alert, that money-back guarantees are not honored, that customers are enrolled in an automatic shipment program that continues to bill their credit card until the customer takes action to stop shipments, that Dr. Nemiroff has a financial interest in selling the product, and that there are safety concerns.
Supplement Geek reviewed a deceptive 30-minute TV infomercial for Procera. Its host is the same as the reporter on the pseudo-news website video, a woman billed as “an award winning investigative reporter.” Actually she was a former TV news anchor and guess what? She just happens to be Dr. Nemiroff’s wife!
He also looked for information about the product’s inventor Josh Reynolds, billed as a brain scientist researcher and author as well as a pioneer in the study and science of the brain and cognitive performance. He found evidence that Reynolds had attended college but no evidence that he had earned any college degrees or that he had any medical training or even any background in science.
The evidence for the individual ingredients and for the product is of low quality and inconclusive. Some of the company’s claims are clearly false; others are speculative hype. The advertising is highly deceptive and raises many of the red flags associated with quackery. Does Procera AVH work to improve memory? Maybe it does … if you can remember to take it! Maybe it does nothing. Maybe it does more harm than good. We have no way of knowing. I’m not buying.
This article was originally published in the Science-Based Medicine blog.