Showing posts with label snake oil. Show all posts
Showing posts with label snake oil. Show all posts

Can You Improve Your Memory With A Jellyfish Protein?

Some colleagues of mine recently asked me about Prevagen, a supplement that is being advertised heavily on television as a memory booster. It's everywhere, they said–but what is it? And does it work?

Both questions are pretty easy to answer. On the first question, the TL;DR version is that Prevagen's primary ingredient is a protein called apoaequorin, which is found in a species of jellyfish that glows in the dark. These jellies produce two proteins, apoaequorin and green fluorescent protein (GFP), that help them fluoresce. It’s an amazing biological system, and the three scientists who discovered and developed the chemistry of GFP were awarded the 2008 Nobel Prize in chemistry.

Cool science! But what does this have to do with human memory? Not much, it turns out.

First let's examine what Prevagen's manufacturers, Quincy Bioscience, say about it. Their website claims that:
"Prevagen Improves Memory* 
Prevagen is a dietary supplement that has been clinically shown to help with mild memory loss associated with aging.* Prevagen is formulated with apoaequorin, which is safe and uniquely supports brain function.*"
Sounds pretty clear, right? But note the asterisks by each of these claims: if you scroll all the way down (or read the small print on their packages), you'll find out that:
"*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
You may recognize this language: it's what all supplement manufacturers use to avoid getting in trouble with the FDA. It means, essentially, that the government hasn't approved Prevagen to treat anything, including memory loss.

Despite Quincy’s claims, I see no reason why eating this protein would have any effect at all on brain function. First of all, it’s not even a human protein, so it's unlikely to work in humans. Second, even if it did work in humans, eating it would not deliver it to our brains, because it would be almost certainly be broken down in the stomach. And third, the connection between any protein and memory is very complex, so simply having more of a protein is very, very unlikely to improve memory.

Quincy's website points to a single study that they themselves conducted, which they argue showed benefits for people with mild memory impairment. However, others have pointed out that the experiment (which was never published in a scientific journal) didn't show any such thing: overall there was no difference between people who took Prevagen and those who took a placebo, but the manufacturer's did some p-hacking to extract a subgroup that appeared to get a benefit. As Dr. Harriett Hall and others have pointed out, this kind of p-hacking is bogus.

And what about my observation that the jellyfish protein will simply be digested in the stomach, and never make it to the brain? It turns out that the company itself admits that I'm right. On their website, they have a "research" page pointing to several safety studies, designed to show that Prevagen won't cause an immune reaction. One of these studies explains that
"Apoaequorin is easily digested by pepsin."
Pepsin is the chief digestive enzyme in your stomach. So Prevagen's main ingredient never gets beyond the stomach, which is why it's probably quite safe. (Joe Schwarcz at McGill University recently made the same point.)

Back in 2015, I asked Ted Dawson, the Abramson Professor of Neurodegenerative Diseases at Johns Hopkins School of Medicine, what he thought of Prevagen’s claims.
“It is hard to evaluate Prevagen as to the best of my knowledge there is no peer-reviewed publication on its use in memory and cognition,” said Dawson. “The study cited on the company’s web site is a small short study, raising concerns about the validity of the claims.”
Finally, a word to those who are still tempted to try Prevagen: it isn't cheap. Their website charges $75 for a bottle of 60 pills, each containing 10 mg of apoaequorin, or $90 for 30 pills of the "Professional formula," which contain 40 mg. (Note that there's no evidence that taking a higher dose will work any better.)

The FTC sued Quincy Bioscience in 2017 for deceptive advertising, arguing that claims that Prevagen boosts memory are false, and that claims it can get into the brain are also false. Just a few months ago, a judge ruled that the case can proceed. Meanwhile, though, the advertising and sales of Prevagen continue. The FTC case states that Quincy sold $165 million worth of Prevagen in the U.S. from 2007 to 2015.

So the bottom line is: jellyfish proteins are very cool, but eating them won't improve your memory. If you're interested in brain food, perhaps you just eat more fish, which might actually work.

(Note: I wrote about Prevagen in 2015, and some elements of this article are based on my earlier one.)

Feds arrest dietary supplement makers for fraud

In the largely unregulated world of dietary supplements, it's like the Wild West. Dramatic claims abound, most of them unsupported by evidence, and it's hard to know if any of them can be trusted. Supplement manufacturers claim their products cure cancer, Alzheimer's disease, arthritis, and more. They promise miraculous weight loss results, nebulous "boosting" of your immune system, and anti-aging benefits.

Once in a while, though, they get caught. This week the U.S. cracked down hard on several of the more egregious offenders, announcing indictments against half a dozen supplement makers, including criminal charges against one.

It's about time. Consumers everywhere should applaud these actions and encourage more. Here's what happened.

On Tuesday, November 17, the U.S. Justice Department indicted USPlabs, a major supplement manufacturer whose products include Jack3d and OxyElite Pro. The Justice Department alleged that USPlabs "doctored packaging, labeling, and other paperwork to defraud others about what the product was." Further, the indictment points out that USPlabs claims that their products are made from natural plant extracts, when instead, as one USPlabs defendant put it:
"lol stuff is completely 100% synthetic."
The fraud runs even deeper: according to the Justice Department, after an outbreak of liver injuries associated with OxyElite Pro, in which some consumers needed liver transplants to save their lives,
"they [USPlabs] promised the FDA and the public that they would stop distributing the product at issue. They didn’t. Instead, they undertook a surreptitious, all-hands-on-deck effort to sell as much of the product as they could."
The criminal indictment, which led to the arrest of six USP employees and consultants, is just one of a sweeping set of actions over the past week. The Justice Department also filed six civil cases against other supplement makers for illegally claiming their products could cure diseases. The allegations include:

  • Clifford Woods LLC illegally sold Taheebo Life Tea, Germanium, and Organic Sulfur as treatments for Alzheimer's and cancer.
  • Optimum Health (aka Lehan Enterprises) illegally sold a product called DMSO cream for arthritis and cancer.
  • Regenica Worldwide (aka Vivaceuticals) illegally sell their RegeneSlim as a disease cure, and in addition RegeneSlim contains DMAA, an unsafe food additive under the federal Food, Drug and Cosmetic Act, but does not declare DMAA as an ingredient.

Just to be clear: none of these violations have yet been proven in court. But to be even more clear: none of these products treat or cure cancer, Alzheimer's, arthritis, or any other disease.

In addition to the DOJ actions, the Federal Trade Commission indicted three more supplement manufacturers for illegal advertising claims (that's the FTC's purview). One indictment, against Chrystal Ewing and her two companies, Health Nutrition Products LLC and Classic Productions LLC, alleged that:
"In ads for W8-B-Gone, CITRI-SLIM 4 and Quick & Easy diet pills, the defendants featured bogus weight-loss experts. Citing fake scientific studies, the defendants also deceptively claimed to have clinical proof that consumers would experience a 'RAPID FAT meltdown diet program' that lets them shed five pounds in four days with one pill, or up to 20 pounds in 16 days with four pills."
Needless to say, none of those products deliver the results they claim.

It's a jungle out there. As the FTC's Jessica Rich said, "People looking for a dietary supplement to improve their health have to wade through a swamp of misleading ads. Be skeptical of ads for supplements that claim to cure diseases, reverse the signs of aging or cause weight loss without diet or exercise.”

It appears that major supplement retailers such as GNC have dropped USPlabs like a hot potato: I couldn't find OxyElite Pro on any of their sites. However, despite the indictments and arrests, USPlabs is still marketing OxyElite Pro on their own site, where they tout it as the "#1 Selling Fat Burner", with a long list of other claims. What about the liver toxicity cited by the Justice Department? The OxyElite website claims:
"OxyELITE Pro shows no side effects in well over 99% of its users. In fact, USPLabs and GNC have stated that there’s been over a billion servings of Jack3d and Oxy ELITE Pro safely taken with no problems!"
The FDA apparently disagrees: in March of this year, they issued a Medication Health Fraud notice that OxyElite Pro contains a hidden drug ingredient, fluoxetine. Fluoxetine is a type of selective serotonin reuptake inhibitor (SSRI), used for treating depression and other conditions. According to the FDA,
"SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur."
Caveat emptor: these supplements might contain harmful ingredients. There's only one safe way to take supplements: ask your physician. Unless your doctor specifically recommends one, stay away. You'll feel better and your wallet will benefit too.

The 3 Dumbest Products Sold By Whole Foods Market

Whole Foods "Whole Body" products.
I have a love-hate relationship with Whole Foods Market. On the one hand, I love their fresh produce, their baked goods, and many other food choices there. On the other hand, they seem to have embraced anti-science positions in the interest of keeping everything “natural.”

Before describing what they do wrong, let’s start with some things they get right. Their seafood sustainability policy supports fishing practices that allow wild fish populations to survive. This is a shining example that other stores would do well to follow, if we want to preserve remaining stocks of wild salmon, tuna, swordfish, and other fish. Whole Foods stores now mark each fish with a sustainability rating shown as a bright-colored label next to each fish. Bravo!

Whole Foods also offers chicken and beef that was raised humanely, following animal welfare standards that they clearly describe on their website and in their stores. For those who care about the way farm animals are treated, this is a valuable option.

But in some areas of the store, especially their “health” section, Whole Foods wades deep into pseudoscience,  So here are the three of the most egregious examples.

1. Whole Foods sells homeopathic medicines that are little more than snake oil. They make claims for health benefits, both on their shelves and on their website, that are based on little more than magical thinking. For example, they sell “homeopathic flu remedies” claiming that “when taken at the first sign of sickness, these can provide temporary relief of symptoms including fever, chills, and body aches.” This is simply false: no homeopathic treatment has ever been shown to be effective at treating flu symptoms. (I’ve written about homeopathy in more detail here and here.)

It’s ironic that on the one hand, Whole Foods proclaimsWe've long believed that consumers have a right to know what's in your food”. But when it comes to homeopathic remedies, they neglect to inform consumers that these remedies do not contain the ingredients on the bottle at all. That's because homeopathic preparations are so diluted that not a single molecule of the original substance remains. Even more absurd, though, is that even if they weren't diluted to nothing, most homeopathic ingredients have never been shown to have any health benefits to begin with.

2. Whole Foods has an anti-GMO policy, adopted across all their stores, that ignores the science of GMOs. They announced last year that they would label all products in their stores to indicate whether they contained Genetical Modified Organisms. They also have announced that they are trying to eliminate GMOs from their shelves. 

Why is Whole Foods opposed to all GMOs? Their answer is simply: 
Crops are currently modified to survive herbicide treatment, produce their own pesticides and resist certain diseases.“
This answer is a true statement, though it does not describe all GMOs, nor does it explain why we should avoid them. For example, golden rice is a form of rice that’s been modified to contain more vitamin A than regular rice - a modification that is designed to prevent blindness in children, particularly in poor, rural regions where rice constitutes a major part of the diet. Golden rice has even been blessed by the Pope. Is Whole Foods opposed to this form of GMO?

And what’s wrong with engineering a crop to resist disease? Some foods would basically disappear from our shelves if we didn’t have disease-resistant versions. For example, the Hawaiian papaya was nearly wiped out by a virus until, in one of the first uses ever of genetic modification, plant scientists created a resistant variety. This saved the industry, and the papaya itself has exactly the same nutritional value it had before.

I suspect that Whole Foods (and many anti-GMO types) are mostly opposed to Monsanto’s Roundup Ready GMO crops, which are modified to allow farmers to use more of Monsanto’s herbicides. I can sympathize with that position - but not with opposing all uses of GMO technology. That’s throwing the baby out with the bathwater.

3. Whole Foods won’t sell the pain relievers aspirin and ibuprofen, because they’re not “natural." Instead, their Whole Body department sells a wide range of nutritional supplements, for which they make claims such as this
“Not sure which supplement to choose? Grab a full-spectrum wellness or immune support formula. These combinations of herbs, vitamins, minerals and antioxidants are specifically designed to effectively improve overall wellbeing and enhance immune support.“ 
That’s just gobbledygook, but it's carefully worded to avoid FDA regulations. The phrase "enhance immune support" is a common go-to phrase for supplement makers, because it sounds science-y. Not only are supplements mostly useless, but taking megadoses can actually harm you. And there’s no scientific reason to think that “natural” products are better for you. After all, snake venom is 100% natural.

In contrast, ibuprofen and aspirin really work - but you can't buy them at Whole Foods. I continue to shop at Whole Foods for their many excellent food selections. But for anything medical, I shop elsewhere.

Fish oil salesmen

Well, they’re not quite the modern-day equivalent of snake-oil salesmen, but the parallels are irresistible. In the 19th century, snake oil was promoted as a cure for joint pain and other ills, and the figure of the snake-oil salesman was widely ridiculed. (Ironically, snake oil is still used as a treatment in China today, despite the lack of any evidence for its efficacy.)

Today we have a new figure: the fish oil salesman. This modern figure, though, is no joke: he is a polished, sophisticated figure with the full weight of the FDA behind him. Should we buy his product?

Last week, while watching a major sports event, I was treated to a new commercial for a product called Lovaza, which I learned “helps to lower very high triglycerides in adult patients.” It’s a beautiful commercial, with an actor in a lab coat (am I supposed to think he’s a scientist?), carrying a clipboard and walking through a lab surrounded by blue aquariums. (Apparently the lab is under water.) You can see the ad here.

Deceptive marketing of dietary supplements

Without any fanfare, Congress held a hearing recently on how supplements are marketed to the elderly. The Government Accountability Office (GAO) conducted a study of 40 different herbal supplements, looking at what the supplements actually contained as well as how they were being sold, both in stores and online. Not surprisingly, the GAO found that companies have been making deceptive, inaccurate claims about many of the most popular supplements sold in the U.S. (I’m shocked, shocked!)

As reported in last week’s Journal of the American Medical Association, the report was requested by Senator Herb Kohl. The report states that some of the companies involved have been referred to the FDA and FTC for appropriate action. But for some mysterious reason, it fails to provide any specific information about who these snake-oil purveyors are. That’s right: not a single company or website is named. Why not?

Well, thanks to the Internet, I can name a few of them - keep reading.