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Procera AVH: A Pill to Restore Memory

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.

The Trigger

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 Problem

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!

The Claims

  • 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

The Testimonials

  • 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.

Similar Ads

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?

The Website

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.

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 JAMA is 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.

Conclusion

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.

 

 

Posted in: Herbs & Supplements

Leave a Comment (17) ↓

17 thoughts on “Procera AVH: A Pill to Restore Memory

  1. Janet Camp says:

    Great work! But most (I hope–although still way too many) people are not taken in by these kinds of “paid advertisement” fake news items. What concerns me more is the vast array of equally useless supplements sold at chain drug stores, Costco,, and other large chains–to say nothing of the ear candles, colon cleansers, homeopathics and other assorted nonsense sold by Whole Foods, some drug stores and other assorted “health” outlets. These products make unsupported claims all over their labels with the FDA warning in the very smallest type. Many of the same stores carry an array of supporting “literature” that discredits the FDA along with “western”, “allopathic”, or “mainstream” medicine to the point where the warning is largely ignored anyway.

    I think this air of legitimacy conferred by the lack of oversight (largely the result of the disastrous DSHEA) by the FDA is a much larger problem–not that you said otherwise.

  2. mousethatroared says:

    Excellent article Harriet Hall. I really enjoyed how you took us through the different steps of checking out a supplement. Seems one could take a similar approach with many interventions you see advertisements for.

    Occassionally I have a period of insomnia and end up watching TV through the night. I think your brains goes into some sort of altered state, because somehow, those products look so much. more impressive at 3:00 in the morning. :) A few times I have gone online in the morning after a couple of cups of coffee, to check out some diet or exercise plan and found many disgruntled buyers with automatic credit card payments that they had trouble getting rid of.

    I suppose if your company plans on repeat billing your customers in the hopes that they won’t notice for several months, choosing a target market of older people with memory problems is a clever business plan.

  3. qetzal says:

    I think ‘maybe it works, maybe it doesn’t’ is far too generous. A more appropriate assessment would be ‘maybe it works, but much more likely it doesn’t.’ We already know that most small but seemingly positive exploratory clinical studies will turn out to be wrong upon replication. Given all the red flags here, that’s even more likely.

    One interesting thing I noticed in that trial. Look at their Table 1. In every case where the Procera group showed a significant improvement over time, it’s because that group started out much worse than placebo at baseline, and then improved to be similar to placebo after 30 days. IOW, the Procera group never gets better than the placebo. All they do is stop being worse.

    The authors never comment on the non-equivalence at baseline, and the present all their data as change of each group relative to its own baseline (normalized to 0). Combine that with the poor design and formatting of Table 1, and it’s not hard to overlook all this.

    That doesn’t necessarily mean the changes in the Procera group are meaningless. It just means they’re uninterpretable, because the groups weren’t well matched at baseline. (Which of course is one of the big problems with small studies.)

  4. Joe Cannon says:

    I wanted to say thanks to Harriet for mentioning me in her well written review of Procera. It was pleasant surprise and I really do appreciate it :)

    With respect to qetzal who thought I was too generous in my view of whether Procera worked or not, since I have not seen any published peer reviewed evidence one way or the other on the product, that I think was the best I could say for the moment. That said, I believe most people, looking at the totality of information I disseminated in my review are in a better place to decide for themselves if Procera was right for them or not. At least that’s what people have been telling me.

    Again, thanks much Harriet!

  5. qetzal says:

    Well, I’m a bit confused. I wasn’t commenting on your view; I was commenting on Dr. Hall’s final paragraph. And no offense, but I don’t see your name mentioned anywhere in the post. If you have also reviewed Procera on some other site, I’m glad to hear it, but I’ve not seen your comments.

    Regardless, perhaps it’s worth reiterating my point. You seem to be suggesting that, absent published peer reviewed evidence one way or the other, we can’t say whether a product like Procera is likely to work. I respectfully disagree. I content that, absent strong clinical evidence of efficacy, we should assume such products do NOT work.

    That’s not to argue that they can’t possibly work. It’s always possible that an untested or poorly tested product actually does what it claims. But we know from vast experience that the majority of new things people develop with the intent of having some beneficial effect in humans don’t actually work. 90% of new drug candidates that go into clinical testing fail. Most of the anecdotal claims for beneficial herbs and vitamins, when studied carefully, have been disproved (echinacea & vitamin C don’t cure colds, shark cartilage doesn’t treat cancer, vitamin E & selenium don’t prevent prostate cancer, etc).

    So, I argue that the default for any product making claims like Procera should be disbelief, unless there is strong supporting clinical evidence.

    1. Harriet Hall says:

      Joe Cannon is the “Supplement Geek” I mentioned in my article. I highly recommend his website. Stating probable non-efficacy based on the odds is one thing, but Joe and I were not trying to do that but were simply reviewing the evidence

  6. Scott says:

    I would add to quetzal’s point that it is profoundly unethical (and ought to be illegal) to market such products without said strong supporting clinical evidence. This is for the simple reason that, without it, the manufacturer doesn’t know their claims are true. It’s fraud, to be perfectly blunt.

    Unfortunately it’s fraud that is protected by the powerful legislators they’ve bought. I mean, seriously – if Merck were to give as much money to Senator Schmo as supplement manufacturers give to Harkin, and then Senator Schmo were to sponsor a bill removing all regulation from the pharmaceutical industry, people would go ballistic. But so long as it’s warm fuzzy supplement quacks buying favorable legislation, almost nobody bats an eyelash.

  7. qetzal says:

    @Dr. Hall

    Thanks for clarifying that Joe Cannon = the Supplement Geek. I should have realized that. Sorry for being obtuse.

    On the larger issue, I appreciate your point, but I humbly submit that you haven’t conformed to the principles of science-based medicine. ‘Maybe it works, maybe it doesn’t’ appears to put both possibilities on an even footing That may be consistent with evidence-based medicine (as typically practiced, anyway), but it’s not the appropriate science-based conclusion.

    I have no quibble with your review of the specific evidence. I agree that it’s inconclusive when considered strictly as is. But in making your conclusion, it seems like you haven’t factored in scientific plausibility and prior probability. As I argued above, I think when you do that, the only appropriate conclusion is that Procera is unlikely to work. Failing to make that explicit is, IMO, a disservice to many potential readers. They shouldn’t come away thinking the odds of Procera working are something like 50-50. They should understand that, while it’s possible Procera works, it’s much more likely that it doesn’t.

    All IMHO, of course, and not meant to detract from the overall excellence of your post.

  8. Harriet Hall says:

    “while it’s possible Procera works, it’s much more likely that it doesn’t”

    I certainly agree. I thought regular readers of this blog would understand that without my explicitly saying it. I was afraid that if I sounded too negative, casual readers who don’t understand the role of prior plausibility would only be put off and dismiss me as prejudiced and closed-minded.

    Yes, considering prior plausibility is an important principle of SBM, but an even more important principle is not jumping to conclusions on the basis of poor evidence.

  9. ConspicuousCarl says:

    I like how the “candidate” line is based on the same non-claim formula as BS like “telekinesis has been studied by the CIA” which uses impressive-sounding words without mentioning the outcome. “I’m not the president, but someone once pondered what it would be like if I were, therefore… credibility!”

  10. kalind says:

    @ Dr. Hall,
    I need some clarification on the efficacy of fish oil supplements. On Jan 24, 2012, you had recommended a book named Heart 411. That book states that “Right now, the scientific proof is not strong enough for us to recommend routine omega-3 supplements in people without known heart disease.” However, the website you have mentioned in this article wholeheartedly supports and recommends fish oil supplements. I am referring to the following article – http://supplement-geek.com/fish-oil-supplement-facts/. So whom should I believe? What is actually true?

    1. Harriet Hall says:

      @kalind, The evidence for fish oil supplements (as opposed to eating fish) is mixed. I agree with Heart 411. There’s a pretty good overview on Wikipedia at http://en.wikipedia.org/wiki/Fish_oil#Cardiovascular.

  11. kalind says:

    @Dr. Hall:
    Thank you very much. That clears a long pending dilemma:-)

  12. JonAK says:

    Excellent article, as usual, from Dr. Hall, and I thank her also for the advanced lesson in on-line research. I was at least one of the correspondents that Dr. Hall referred to in the text and had spent sometime on the Internet looking up the credentials, studies, and attributions mentioned in the ProceraAVH “advertorial” that has appeared several times in our local Gannett newspaper. There was never any doubt in my mind that the claims for ProceraAVH were the usual brand of snake oil we see in these kinds of “miracle” ads, but I was curious about the involvement of a “U.S. Surgeon General Candidate”, the cited “Brain Science Institute”, and the “double-blind, placebo controlled study” all cited in the ad. Though I never found the original journal article (it is not in the near-by med school library), it was obvious that it had not been published in a mainstream medical journal and probably for good reason.

    Though I am a scientist by trade, I have also worked in the past as a journalist and a press critic and take a special interest in the responsibility of publications for ads they choose to publish. As a follow-up to my initial interest in the ProceraAVH ad, I conducted a very small informal survey in which I asked participants to read the ad and assess its credibility. The good news is that the flamboyant language of its headline turned off a number of people immediately. But unfortunately the majority of participants were impressed by an endorsement attributed to a “U.S. Surgeon General Candidate” and by what they interpreted as a definitive clinical study from a major research institution and published in a leading medical journal. Like Dr. Hall initially, several respondents who do read technical journals regularly misread JANA as a reference to the Journal of the American Medical Society. Though none of my respondents said they would be willing to send off money for ProceraAVH, two replied that they might be tempted to ask their doctors about the product. (I would be interested in knowing what an internist, shown the ad by a patient, might respond, but my medical friends are largely researchers.) In any case, the ad must work as it reappeared in our paper again last week.

    My discussions with both advertising and editorial people at newspapers and magazines provides little in the way of encouragement that many, except maybe for very large publications with ad review boards, will self-censor ads. Partly, it is time; partly it is expertise, and partly it is revenue. In one case where I was involved (not ProceraAVH), even an adverse publication from the FDA did not a elicit a promise to refuse future ads for a product.

    I have also pointed out to editors, who tend to refer such questions to the advertising department, that ads for such highly questionable products (miracle diet products are the most prominent) can contaminate the editorial product and taint reader credibility. The usual response is a shrug of acknowledgement and little more.

    Though ProceraAVH will probably not harm anyone other than in their wallets (though Dr. Hall points out the possibility of some adverse drug interactions and the purity of supplement ingredients is largely unregulated), it could deter someone from seeking prompt medical help.

    Again my thanks to Dr. Hall for this excellent article and to SBM and its other contributors for their valuable contributions to public heath and knowledge.

  13. Harriet Hall says:

    I have even tried the legal liability argument. Once I had alerted them to a bogus ad, continued ads meant that the newspaper was deliberately disseminating false information, and they could incur liability and be named as co-defendants in a lawsuit if a patient were harmed by a product they learned about in those ads. They were not impressed. Even Scientific American publishes questionable ads. It’s hopeless. The ad revenue is too important. The only thing our complaints accomplish is maybe to give them a brief twinge of conscience that is quickly suppressed. At least we can do what I tried to do with this article: get criticism of the ads out into the public sphere so that interested consumers have a chance of finding it. Googling for Procera brings up SupplementGeek’s critique as number 2. Googling for another supplement I wrote up, Protandim, lists my article as the 4th hit.

    Good news! Googling also found a class action suit against Procera for false advertising http://www.topclassactions.com/lawsuit-settlements/lawsuit-news/1900-procera-avh-false-advertising-class-action-settlement. I wonder if the newspapers that print the ads would be willing to print the news about the class action settlement. I think I’ll write my local paper again.

  14. JonAK says:

    The “good news” should be tempered by the fact that the class action suit was initially settled back in March, 2012 and the ads, modified to remove some of more blatant claims, are still appearing today (most recently in my Gannett paper on 9/24/2012).

    The text of the class action settlement (http://www.gilardi.com/brlsettlement/pdf/Final%20Judgment.pdf) lists the claims that the company is forbidden to include without supporting research:

    The forbidden claims include ones that the product will “protect the brain following head injury or stroke”, “accelerate the healing of damaged neurons”, “increase levels of nerve growth factor”, “protect the brain or liver from harmful levels of alcohol”, “reduce depression”, “remove or help remove lipofuscin”, “improve or increase IQ”, “prevent, delay the onset of, reduce the effects of, treat or cure Alzheimer’s disease”. They may also not claim that the product or any of its ingredients “are clinically shown to quickly improve energy”, “are key, vital or brain essential nutrients that cannot be obtained from food” and “are deemed safe and effective by the FDA.”

    As bad and as dubious as the Procera ads are today, they apparently were humdingers prior to March of this year. But, as Dr. Hall’s analysis demonstrates, the current ads are still deceptive and, apparently, still hauling in dollars.

  15. JonAK says:

    For a fascinating peek inside Brain Research Labs training and telephone/customer service department, take a look at the company’s training manuals which (at least at this writing) can be accessed on the corporate intranet, surprisingly not closed: https://sites.google.com/site/brlintranet/documents-training.

    The main training module also includes a pitch for the company’s Ceraplex product for brain detoxification (“your brain is 70% fat — that’s where harmful toxins build up”) which “has been shown to slow brain degeneration”. Phone personnel (in the scripts, told to identify themselves as “your brain health specialist”) are encouraged to “cross sell”. At one point, the phone salesperson leads with “The doctor recommends…”

    Although the training PowerPoint presentation does warn of possible drugs interactions, the telephone script to discourage returns fails to provide that caution and instead says Procera is “a non-prescription doctor-developed natural supplement so you can feel safe taking it.”

    If the customer complains about headaches when taking Procera, the telephone script says this is because “Procera is working to detoxify your brain.” If the customer complains about sleeplessness, the script says to cross-sell the company’s “natural” sedative product Gabarest.

    Fascinating and dismaying.

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