This is Steven Salzberg's blog on science, pseudoscience, medicine, and other topics. I blogged for Forbes for 14 years, but they started censoring me, so I left in October 2024. I'm just here now, uncensored.
Showing posts with label supplement industry. Show all posts
Showing posts with label supplement industry. Show all posts
Dietary supplements and vitamins are a multi-billion dollar business, driven by heavy advertising and constant promises that supplements will somehow make you healthier. For most people, vitamins and other dietary supplements are useless, and when taken in large quantities they can even be harmful. (See my article, "The Top Six Vitamins You Should Not Take" for specifics.)
Now we can add another supplement to the list of those that you shouldn't take: calcium. Calcium supplements are often sold on the promise that they strengthen your bones or prevent osteoporosis. Given that calcium is a major component of our bones, it seems sensible to assume that extra calcium might help strengthen them.
What seems sensible, though, doesn't always turn out to be true. A large new study published recently in the Journal of the American Heart Association shows that taking supplemental calcium leads to an increased risk of heart disease, by increasing the calcification of your arteries. That's a bad outcome.
The new study, led by John J.B. Anderson of UNC Chapel Hill and Erin Michos at Johns Hopkins University, looked at changes in coronary artery calcification over a 10-year period in 2,742 adults. Calcification of the arteries is strongly associated with heart attacks and other life-threatening events; basically, a calcified artery is a dangerously unhealthy artery.
The study found some surprising results that seem at first to be contradictory: people who simply consumed the most calcium through their diet had a slightly lower risk of calcification of the arteries - about 27% lower than the group with the lowest amount of dietary calcium. However, people who took calcium supplements had a 22% higher risk of calcification.
Why are calcium supplements harmful when dietary calcium seems healthful? The authors explained:
"Little of the additional calcium provided by calcium supplements, however, is incorporated in bone by adults."
In other words, if you just take a pill of concentrated calcium, your body can't handle it, and some of it seems to end up in the linings of your arteries, where it makes them rigid and contributes to cardiovascular disease. So rather than strengthening your bones, supplemental calcium might "strengthen" your arteries, but in a bad way. As the study explains:
"Rather than promoting bone health, excess calcium from the diet and supplements is postulated to accrue in vascular tissues."
You don't want more calcium in your arteries. That's too bad for supplement makers, whose claims that calcium supplements "promote healthy bones" (as claimed, for example, by Nature's Way "bone formula" calcium pills) are just not supported by science. You can, though, get plenty of calcium by eating these calcium-rich foods:
Cheese
Yogurt
Milk
Sardines
Leafy greens such as spinach, kale, broccoli rabe, and bok choy
So if you're concerned about osteoporosis or just general bone health, skip the pills, save your money–and protect your heart–by eating a calcium-rich diet instead.
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 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.
Watching ABC's World News Tonight this week, I saw an impressive-looking ad for a pill that claimed to improve memory and cognition. The ad showed several adults, all looking very happy, presumably because they didn’t forget where they left their keys. In appearance, it looked like many of the drug ads that run on the evening news in the U.S. these days.
The ad described a product called Prevagen, which is sold as a supplement, not a drug. This is a critical distinction: supplements are almost completely unregulated, unlike real drugs. The FDA isn’t allowed to regulate supplements and their claims, thanks to Congress and the 1994 DSHEA law.
I was curious about what this memory pill could be. The Prevagen ad, website and packaging make a number of very strong claims, scientifically speaking. The biggest claim is that Prevagen improves memory*, something pretty much everyone would like. The website also includes the more specific claim that “Prevagen can improve memmory within 90 days.*” The package adds that Prevagen “supports healthy brain function*, [a] sharper mind*, and clearer thinking.*"
How can they make these claims if they aren’t true? Simple: every claim has a little asterisk (*) next to it. If you scroll all the way to the bottom of the Prevagen webpage, you’ll find what that means:
“*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.”
Behind this blanket escape clause, supplement makers hide all kinds of unsupported claims. Thus Quincy Biosciences–Prevagen's manufacturer–can state that “Prevagen significantly improves learning,” add the asterisk, and voila! the FDA can’t touch them, as long as they don't make a claim to cure a specific disease.
So what is Prevagen? It’s a pill that contains 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 GFP were awarded the 2008 Nobel Prize in chemistry.
How (you might be wondering) this can be sold as a dietary supplement? After all, we don’t eat apoaequorin, and isn’t a supplement supposed to be related to something we normally eat? It sounds more like a drug. The FDA agrees with me–I’ll get to that below.
Despite Quincy Bioscience’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 this protein and memory is complex, so simply having more of it is not likely to improve memory.
Prevagen isn’t cheap, either. If you order direct from the company, a month’s supply of pills will cost you $66 with shipping. There’s even an “extra strength” version, though I cannot see how twice as much of an ineffective pill will be twice as effective. On the other hand, two times zero does equal zero.
I wrote to ask the president of Quincy Bioscience, Mark Underwood, if his company is claiming that Prevagen will provide any benefits to people suffering from dementia or Alzheimer’s. He didn’t answer that question, but he did respond that “our scientific basis for the claims we make related to Prevagen are on pretty solid ground.” He was careful to qualify this first, though, writing that
“Prevagen is intended to assist people with mild memory issues related to aging. Prevagen is not a pharmaceutical, nor is it approved by the FDA for the treatment of any neurodegenerative disease (Alzheimer’s, Parkinson’s, etc.). We do not wish to confuse mild memory loss related to aging with Alzheimer’s disease or dementia in our advertising.”
I also asked Underwood if he could provide any peer-reviewed studies supporting his company's claims. He sent me several studies, but none of them was peer-reviewed: they include company-sponsored studies that are unpublished, and one published abstract from 2011, in the Journal of Alzheimer’s and Dementia. Abstracts, though, are not peer-reviewed: they are short summaries typically presented in oral form at conferences, and sometimes published (as this one was) in special supplements to journals. This abstract seems to be the basis of the claim on Prevagen’s website that “Prevagen was tested in a large double-blind, placebo-controlled study using computers to assess brain performance. 218 adults over 40 years old participated in the three month study. Prevagen significantly improved learning and word recall.*” (Note the asterisk again.)
Prevagen’s claims should be easy to test. If Prevagen really does improve memory, then it would be relatively cheap to run large, well-controlled studies on randomized subjects, and I’d expect to have seen multiple studies published since 2011. But because Prevagen is being marketed as a supplement, Quincy Bioscience doesn’t have to prove anything. They just have to be careful not to cross the line in their advertising.
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.”
Treating dementia, Alzheimer’s, Parkinson’s, and other age-related brain disorders is truly difficult. If you want to see what real scientists (not supplement maker) are doing to try to stave off or cure dementia, here’s a short video narrated by Dr. Dawson:
Dr. Mark Sager, a scientist at the Wisconsin Alzheimer’s Institute and a Professor at the University of Wisconsin, has been quoted saying that he does not recommend Prevagen “primarily because there’s no evidence that it does any good.” He recommends adopting a Mediterranean diet instead, which does have some scientific evidence to support it.
I’m not the first person to raise questions about Prevagen. In 2012, a class action lawsuit was filed against them in California, in which the plaintiffs argued that the Prevagen didn’t work and that the advertising campaign was false and misleading. Earlier this year, another class action lawsuit against Quincy Bioscience argued that Prevagen’s active ingredient, apoaequorin, "is completely destroyed by the digestive system.” And in 2012, the FDA sent Quincy Bioscience a warning letter (see it here), pointing out that the company was marketing Prevagen as a drug, not a supplement. The FDA stated that:
"Apoaequorin is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet ... nor is it a combination of dietary ingredients. Therefore, the synthetically produced apoaequorin used in your Prevagen products is not a dietary ingredient as defined in section 201(ff)(1) of the Act.... Accordingly, your Prevagen products could not be marketed as dietary supplements even if they were intended only to affect the structure or function of the body and not for use in the cure, mitigation, treatment, or prevention of disease."
Somehow, though, Quincy continues to sell Prevagen as a supplement. Their website claims they are the #1 selling brain health supplement in the U.S. today.
The appeal that Prevagen is making to consumers is a very old one: basically, they want you to think that if a protein is used in your brain, then eating that protein will make your brain healthier (even though apoaequorin is not a human protein). By this argument, I could package up hundreds of different proteins (perhaps thousands–the brain is a complex organ) and sell them as “brain food” This simplistic principle has been used for centuries in folk medicine: it’s the reason why some people think that eating the body parts of bears and tigers will make them more virile. But eating tiger organs doesn’t make you more like a tiger. It's a form of magical thinking, and there's simply no science to support it. In short, it's just wrong.
Human health isn’t that simple. You don’t acquire the properties of the food you eat. Eating chicken won't make you fly, and eating tuna won't make you a fast swimmer. Eating jellyfish proteins (Prevagen's main ingredient) won't improve your memory, nor will it allow you to emit green fluroescent light. There's no magic brain food, or supplement, that will make you smarter. But you can be a tiny bit richer by not spending your money on ineffective supplements.
If the ingredients in your pills don’t really work, does it matter if they’re correct?
Well, yes. Even if that echinacea pill doesn’t cure the common cold, if a supplement manufacturer sells you an echinacea pill, they have to put echinacea in it.
Supplement makers can and do make all kinds of claims about the health benefits of the stuff they’re selling you. They claim that supplements can "boost your immune system," relieve aches and pains, improve memory, and promote "wellness," whatever the heck that means. Most this is nonsense, but thanks to the manufacturers’ special friend in the U.S. Senate, Senator Orrin Hatch, the federal government has almost no power to regulate these claims. Over the years, the supplement companies have been very generous to Senator Hatch, and he has returned the favor by defending them (though of course he denies any quid pro quo).
Even supplement makers have limits: they can’t sell you ground-up house plants, or rice powder, claiming that it’s St. Johns Wort. But as New York attorney general Eric Schneiderman revealed last week, that’s exactly what some of them have been doing. Amazingly, 79% of the supplements tested did not contain the primary ingredient listed on the label. Many of them contained other plant material, including plants that might cause an allergic reaction in unsuspecting customers.
You see, as cheap as most supplements are (compared to real medicine, that is), rice powder is even cheaper.
Attorney General Schneiderman sent letters to four of the largest retailers of supplements in the country: Walmart, Walgreens, GNC, and Target, demanding them to immediately stop selling supplements that were falsely labelled, including echinacea, ginseng, St. John’s Wort, gingko biloba, and others.
What did Schneiderman's office do? Well, they conducted a scientific study, using DNA sequencing to test the ingredients in six types of herbal supplements, looking at different brands from multiple stores. They tested each sample 5 times to ensure accuracy. They collected 78 different samples and ran 390 tests in all.
GNC "Herbal Plus" supplements: gingko biloba, St. John's wort, ginseng, garlic, echinacea, and saw palmetto were tested. Garlic was the only one that consistently contained what the label indicated. One out of four bottles of saw palmetto tested positive, and none of the other four supplements contained the labeled herb. Overall, 22% of the DNA tests identified the labeled ingredient. Contaminants included rice, alfalfa, and houseplant DNA.
Target's "Up & Up" supplements: gingko biloba, St. John's wort, Valerian root, garlic, echinacea, and saw palmetto were tested. Three supplements–garlic, saw palmetto, and echinacea–contained what they were supposed to. The other three had no DNA at all from the labeled ingredient.
Walgreens "Finest Nutrition" supplements: gingko biloba, St. John's wort, ginseng, garlic, echinacea, and saw palmetto were tested. Only one of these, saw palmetto, consistently contained its labeled ingredient. One sample of garlic actually contained garlic, and none of the other samples contained any DNA from the labeled ingredient. Overally, 18% of the DNA tests found the expected ingredients. Contaminants included rice, wheat, daisy, and houseplant DNA.
Walmart's "Spring Valley" supplements: gingko biloba, St. John's wort, ginseng, garlic, echinacea, saw palmetto were tested. Walmart had the worst results: of 90 DNA tests on 18 bottles, only 4% found any DNA from the labeled ingredient. Only one bottle of garlic and one bottle of saw palmetto contained what they were supposed to. Contaminants included pine, grass, citrus, and cassava.
This is pretty stunning, and it's only a sample; see the AG's letters to each retailer for more details. According to the New York Times, the retailers agreed to pull the supplements off their shelves (in New York, at least) after receiving the AG's letter.
Just a couple of years ago, Senator Orrin Hatch successfully fought off an amendment that would have required supplement makers to register their products with the FDA and provide details about their ingredients. As the NY Times also reported, Hatch has received hundreds of thousands of dollars from the supplements industry over the years.
Of course, even if these bottles did contain what they were supposed to, their claims to improve memory, boost your immune system, and fight off colds are entirely unproven. Thanks to a 1994 law championed by Senator Hatch, the FDA cannot require supplement makers to prove that any of their products work, as long as they avoid specific claims to cure a specific disease.
But if they say they're selling you gingko biloba or St. John's wort, they're supposed to put that in the pills. Instead, it seems they are selling ground-up rice and house plants.
One supplement did actually contain what it’s supposed to: garlic pills. Garlic has been investigated for its effect on cholesterol levels, where it seems to have at most a very small benefit. Garlic lovers would argue that you're losing the real benefit if you take it in pills rather than simply eating it.
And garlic does have one unique benefit: it is 100% effective at warding off vampires.
One of my daughters caught a cold last week, and now she's given it to me. We’re giving ourselves the best treatment known to science: rest. But to judge from the products offered at our pharmacies, you’d think there were dozens of options to treat a cold. In local pharmacies and in the medicines aisle at my local grocery store, I’ve found row after row of colorful packages, claiming to relieve cold symptoms, shorten the duration of the common cold,” and more.
Some of these medications actually do treat symptoms, but none of them cure a cold. But mixed among them—sometimes side-by-side with real medicines—I found several products that don’t work at all.
How can a drug manufacturer get away with this? Simple: the products that don’t work are either supplements or homeopathic products. The manufacturers of both these types of “medicines” have successfully lobbied Congress to pass laws that exempt them from FDA regulation. Supposedly they aren’t allowed to make direct claims to cure or treat disease, but unless you read the wording on their packages very carefully, you’d never notice. (Note to older adults: bring your reading glasses to the pharmacy section!)
Most important for consumers: if a treatment says it’s homeopathic, then its ingredients do not have to be shown effective. “Homeopathic” simply means that the ingredients are listed on the Homeopathic Pharmacopoeia, a list maintained by homeopaths themselves. And if it contains supplements or vitamins, they too are exempted from regulation by the FDA, under a law known as DSHEA.
So next time you go searching for something to take for your cold, or for your child’s cold, here are the top 5 cold remedies you should not buy:
1. Zicam is a zinc-based remedy. Zinc is tricky, because there is some evidence to suggest that taking zinc right at the onset of a cold might shorten its duration a little bit, from 7 days to 6. But as Dr. Terence Davidson from UC San Diego explained, if you look at the more rigorous studies, the effect vanishes. Zinc turns out to have some worrisome side effects, too. Zicam's nasal spray and gel versions were linked to a serious loss of the sense of smell (anosmia), which led the FDA to issue a warning letter in 2009. Zicam responded by withdrawing the product for a time, but their website now says “A clinical link between the Zicam® products and anosmia was not established.“ Strictly speaking, this is correct, but there have been published reports suggesting a link, such as this one from 2009.*
Zicam’s website makes the misleading claim that “All of our Zicam® products are regulated by the FDA.” This is a common ploy of homeopathic drugmakers, claiming the FDA regulates them because the FDA could step in (as they've already done with Zicam) if consumers are being harmed. Unlike real drugs, though, Zicam has not been evaluated by the FDA for effectiveness or safety.
2. Airborne. You can find this in the cold remedy section many pharmacies (I did), but Airborne doesn’t cure anything. It’s a cleverly marketed vitamin supplement with no scientific support for any health benefits. How do they get away with it? Actually, Airborne paid $23 million back in 2008 to settle a class-action lawsuit over its advertising. They had been calling Airborne a “miracle cold buster.” According to the Center for Science in the Public Interest’s David Schardt,
“Airborne is basically an overpriced, run-of-the-mill vitamin pill that’s been cleverly, but deceptively, marketed.”
After the lawsuit, Airborne modified their packaging, which now claims only that it “helps support your immune system.” This is one of those vague claims that supplement makers love, because it doesn't really mean anything. Airborne's products also now include a disclaimer that
“These products are not intended to diagnose, treat, cure, or prevent any disease.”
So what the heck are they doing in the “cold medicines” section of the store?
3. Coldcalm is a homeopathic preparation sold by Boiron, one of the world’s largest manufacturers of homeopathic remedies (including Oscillococcinum, an almost laughably ineffective flu remedy). It claims on the package to relieve cold symptoms. What’s in it? A dog’s breakfast of homeopathic ingredients, including belladonna, about which NIH says,
“Belladonna is UNSAFE when taken by mouth. It contains chemicals that can be toxic.”
Another ingredient is pulsatilla, which “is highly toxic, and produces cardiogenic toxins and oxytoxins which slow the heart in humans.” Neither belladonna nor pulsatilla relieves cold symptoms.
Being homeopathic, these ingredients are highly dilute, but I think I’ll pass on Coldcalm.
4. Umcka. Umcka is another homeopathic preparation that claims to “shorten the duration of common cold” and “reduce severity of cold symptoms.” Sounds pretty good—if only it were true. Umcka’s active ingredient is a plant extract called pelargonium sidoides, an African geranium. Interestingly, there have been a few experiments on this extract, some of which showed a small positive effect. However, a review of these studies reported that their quality was “very low," that all of them were conducted by Umcka itself, and that all of them were conducted in the same region of Russia. And remember: homeopathic preparations are so dilute that they contain little, and sometimes none, of the active ingredient.
5. Antibiotics. Okay, these are real medicine, and you can’t buy them over the counter at your pharmacy. But Americans take them in huge quantities to treat the common cold. The problem is, antibiotics don’t work for colds.
When my daughter told her friends she had a cold, they wanted to know why she didn’t go to the doctor. Of course, doctors can’t do anything about a cold, and going to a doctor’s office just puts other patients at risk. My daughter knows this. But her friends were astonished to hear that we never take her to the doctor for a cold. It turns out that most of them had been to doctors many times for colds, often coming away with a prescription for antibiotics.
Antibiotics treat bacterial infections, not viruses. Taking antibiotics unnecessarily can be bad for you: besides wiping out your gut flora, it increases the risk that bacteria will develop drug resistance. Perhaps if we changed the name to "antibacterials," doctors would stop prescribing them for viruses.
I found Zicam, Airborne, Umcka, and Coldcalm for sale at Walgreens and Walmart. CVS and RiteAid don’t carry Umcka (good for them!) but do sell the others.
When you get a cold, you develop immunity to it and you won’t catch it again.We keep getting colds because they're caused by more than 100 different viruses, most of them nasty little buggers that continually circulate in our population. Each time you catch a cold, you’re getting a brand new one. The only consolation is that once you’re over it, you won’t get that one again.
So if you get a cold this winter, save your money. Stay home, rest and drink plenty of fluids. And I have it on good authority that there is one treatment for the common cold that’s inexpensive, widely available, and really, really works: chicken soup.
*In response to my inquiry, Zicam's manufacturer, Matrixx Initiatives, sent me some additional information. They pointed out that subsequent studies have not supported a link between Zicam and anosmia (loss of the sense of smell), and also that they permanently discontinued Zicam intranasal gel products ("Cold Remedy Nasal Gel and Cold Remedy Gel Swabs) in 2009, "despite the absence of any credible scientific data pointing to a potential link." They also argue that "the efficacy of zinc-based formulations is primarily a function of bioavailable dose" and that "Zicam products are formulated to ensure availability of the zinc." Arguing in favor of Zicam's benefits, they pointed to several studies that I'd already read, and I remain unconvinced and, as I pointed out above, Matrixx does not have to prove efficacy to the FDA because they are selling Zicam as a homeopathic preparation, which allows them to avoid FDA regulation.
The first study is a large review by Philippe Autier and colleagues, who found that taking supplemental vitamin D has no effect on a wide range of diseases and conditions. After looking at over 450 studies, the authors conclude:
“The absence of an effect of vitamin D supplementation on disease occurrence, severity, and clinical course leads to the hypothesis that variations [in vitamin D levels] would essentially be a result, and not a cause, of ill health.”
So it appears that we’ve been getting cause and effect backwards, at least as far as vitamin D is concerned. Autier looked at non-skeletal disorders, including heart disease, weight gain, mood disorders, multiple sclerosis, and metabolic disorders, all of which have been linked to lower vitamin D. In trial after trial, supplemental vitamin D had no beneficial effect on any of these conditions. Autier et al concluded that:
“associations between 25(OH)D and health disorders … are not causal. Low 25(OH)D [vitamin D] could be the result of inflammatory processes involved in disease.”
Instead, the researchers found, in study after study, that low vitamin D was the result of poor health, not the cause.
The Autier study didn’t look at the biggest supposed benefit of vitamin D: protection against osteoporosis. We’ve long known that vitamin D is associated with bone health. Fortunately, in the same issue of The Lancet, Ian Reid and colleagues looked closely at this question. They reviewed 23 studies with 4082 participants, all designed to determine at whether supplemental vitamin D improves bone density. Their findings? It doesn’t help. They concluded:
“Continuing widespread use of vitamin D for osteoporosis prevention in community-dwelling adults without specific risk factors for vitamin D deficiency seems to be inappropriate.”
Vitamin D supplements, to put it plainly, are a waste of money.
(For those concerned about osteoporosis, the widely used drug alendronate (Fosamax®), has been shown to increase bone density by about 5%, as explained in a 2011 article by Dr. Sundeep Khosia. But Fosamax has side effects.)
It’s pretty easy to get enough vitamin D in a normal diet. Or, as Dr. Mark Gillinov explained in the Huffington Post last week, just 10 minutes of sunlight gives you about 4 times your daily recommended vitamin D requirement.
So here's my expanded list of the Top Six Vitamins You Shouldn’t Take, with the newest entrant at the end:
What’s left? Well, if you don’t have a deficiency, there’s no reason to take any supplemental vitamins at all. As my Hopkins colleagues Eliseo Guallar, Lawrence Appel, and Edgar Miller wrote last month in the Annals of Internal Medicine : “Enough is enough: stop wasting money on vitamin and mineral supplements.” As they wrote, after looking at three more large studies just published last month,
"most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided."
Save your money. Or better yet, if you must spend it, buy a bit more fresh fruit. You'll be healthier for it.
I used to take vitamin supplements almost every day. Taking vitamins seems like a good idea: after all, we know that vitamins are essential for life, and vitamin deficiencies can definitely hurt you. I always thought that vitamins were an inexpensive way to get a little bit healthier.
Millions of Americans apparently agree with me. Close to half of the population in the U.S. takes vitamins, with multi-vitamins being the most popular.* Vitamins are sold in virtually every grocery store, ranging from mega-markets like Wegmans to the organic Whole Foods chain.
The vitamin and supplements industry, which is immensely profitable, relies on the intuition that if a little bit of something is good for you, a bit more can't hurt. Right?
Wrong. If you don't have a serious vitamin deficiency, taking supplemental vitamins doesn't provide any benefit, in almost all cases that have been studied. What's even more surprising is this: routinely taking mega-doses of vitamins might actually harm you.
So here are the top 5 vitamins that you should not take (unless your doctor recommends it):
1. Vitamin C. Perhaps the most popular single vitamin supplement, vitamin C occurs in plentiful amounts in many fresh fruits and vegetables. In the early days of global exploration, sailors often died from scurvy, caused by the lack of vitamin C. Way back in the 1700's, Scottish doctor James Lind famously conducted an experiment that proved that citrus fruit cured scurvy, although vitamin C itself wasn't discovered until the 1930s.
Vitamin C gained its current popularity through the woefully misguided efforts of Linus Pauling, who published a book in 1970 recommending mega-doses of C to prevent the common cold. Although Pauling was a brilliant chemist (and Nobel laureate), he was completely wrong about vitamin C, as Paul Offit explains in detail in his new book, "Do You Believe in Magic?"
Vitamin C doesn't prevent or cure colds. This question has been studied exhaustively: a review in 2005 covering 50 years worth of research concluded that
"the lack of effect ... throws doubt on the utility of this wide practice."
Although Vitamin C is generally safe, megadoses of 2000 mg or more can increase the risk of kidney stones, which can be excruciatingly painful.
2. Vitamin A and beta carotene. Vitamins A, C, and E are all anti-oxidants, which have been promoted for their supposed anti-cancer properties. The evidence doesn't support this: for example, in a large study supported by the National Cancer Institute*, smokers who took vitamin A were more likely to get lung cancer than those who didn't.
Vitamin A plays an important role in vision, but too much vitamin A can be toxic, causing multiple serious side effects. Perhaps the most famous cases of vitamin A toxicity occurred in early polar explorers, who ate the livers of their sled dogs, not realizing that the livers had excessively high amounts of vitamin A. Antarctic explorer Douglas Mawson barely survived, and his companions died, probably of vitamin A poisoning.
3. Vitamin E. Long touted as an anti-cancer agent, vitamin E is a very popular supplement. A large study last year, of 35,533 men, looked at vitamin E and the risk of prostate cancer. The authors found that the risk of cancer increased for men taking vitamin E. In an even larger review done at Johns Hopkins University, Edgar Miller and Lawrence Appel found that the overall risk of death was higher in people who took vitamin E. The Mayo Clinic summarizes the evidence this way:
"Evidence suggests that regular use of high-dose vitamin E may increase the risk of death from all causes by a small amount."
4. Vitamin B6. The B vitamins, including B6 and B12, are present in many foods, and deficiencies are rare. But taking B6 supplements for a long time can be harmful, as NIH's website explains*:
"People almost never get too much vitamin B6 from food. But taking high levels of vitamin B6 from supplements for a year or longer can cause severe nerve damage, leading people to lose control of their bodily movements."
5. Multi-vitamins. This is the big one. With nearly 40% of Americans taking a multi-vitamin, they must be good for you, right? But a huge study that I wrote about last year, looking at 38,772 women over 25 years, found that the overall risk of death increased with long-term use of multivitamins, vitamin B6, folic acid, iron, magnesium, zinc, and copper. Death, one must admit, is a pretty bad outcome.
On the evidence, supplementing your diet with any of these 5 vitamins carries little or no benefit, and may cause you harm. This is why we do science, people. Our intuitions aren't always right: just because a little bit of something is good for you does not mean that a lot of it is even better.
Vitamins don't "boost your immune system," they don't promote joint health, they don't reduce stress, and they don't help prevent colds or other common ailments.
So what should one do? Ignore the marketing, and treat supplements like you would any other medicine: take them with caution. If you are taking regular vitamin supplements, or thinking about it, ask your doctor before doing so.
And by the way, 100 grams of spinach has healthy amounts of vitamins A, C, E, K, several B vitamins, and essential minerals including iron and calcium.
So ditch the vitamins and eat your spinach. Or blueberries. Blueberries are great.
[*The statistics and references used in this article were collected, in part, by the U.S. Centers for Disease Control, the U.S. Department of Agriculture, and the National Institutes of Health, all of which are currently shut down due to the stubborn actions of a minority of Representatives in the U.S. Congress. Thanks, Congress!]
Eating fish is good for you, especially fish that contain omega-3 fatty acids. So I was surprised last week to read a new study in the Journal of the National Cancer Institute that found that omega-3 fatty acids increase the risk of prostate cancer. The risk for both high-grade and low-grade cancer was increased with higher levels of omega-3 fatty acids. This is a carefully done study, and the results should make anyone who is taking fish oil pills reconsider.
One reason this study caught many people off guard is that there has been much evidence showing that a diet rich in fish that contain omega-3 oils is good for you. The Mayo Clinic says that "eating fish helps your heart", especially fish like salmon that contain omega-3 fatty acids. The American Heart Association (AHA) elaborates:
"Omega-3 fatty acids benefit the heart of healthy people, and those at high risk of — or who have — cardiovascular disease. Research has shown that omega-3 fatty acids decrease risk of arrhythmias (abnormal heartbeats), which can lead to sudden death. Omega-3 fatty acids also decrease triglyceride levels, slow growth rate of atherosclerotic plaque, and lower blood pressure (slightly)."
This all sounds great. Because of the evidence about the benefits of fatty fish, supplement manufacturers have been marketing and selling fish oil pills for years, with great success. As I described back in 2010, GlaxoSmithKline even created a high-dose omega-3 fatty acid pill called Lovaza that has FDA approval.
But the evidence for that you can get the same benefit from supplemental omega-3 fatty acids — taking a pill, that is — is much weaker. In fact, a large review published last year in the Journal of the American Medical Association found no connection at all between supplemental omega-3 and a lower risk of heart attacks, strokes, or death in general. Other studies have reported similarly negative results. So it appears that fish oil pills may not have any heart benefits.
And now, with this new study, we learn that supplemental fish oil might increase the risk of prostate cancer.
The bottom line: the AHA recommendations about eating fish are probably still good ones. The AHA website says:
"We recommend eating fish (particularly fatty fish) at least two times (two servings) a week. Each serving is 3.5 oz. cooked, or about ¾ cup of flaked fish. Enjoy fish baked or grilled, not fried."
But popping a fish oil pill is not going to cut it. As we've seen before, supplements often fail to show the benefits that a healthy diet offers. So save your money and stop buying those fish oil pills — and fire up the grill and throw on a few salmon fillets for this weekend's barbecue.
Cold cure manufacturers continue to push zinc as a cure, despite the lack of evidence. Today, the Washington Post reported, not for the first time, that taking zinc will shorten the duration a cold by three days in adults. Sounds pretty good! Only it's wrong.
The Post reporter apparently didn't really get past the abstract for the new study, which isn't actually a study at all, but just a review of 17 other studies. The review appeared on May 8 in the Canadian Medical Association Journal.
ALL of the studies were funded by the companies that make zinc supplements, mostly large pharmaceutical companies. (Big Pharma or Big Supp, they are often the same companies.) Here's a partial list of the sponsors: Warner Lambert, McNeil Consumer Products, Weider Nutrition, Truett Laboratories, Bristol Myers, Berko Ilac, and Quigley. Not that there's anything wrong with that!
One problem with the Washington Post summary is that the benefit wasn't really three days, even if you believe the results. Although the study looked at 17 trials, the core analysis only used eight of them, all of which used patients with naturally acquired colds. The average benefit was 1.6 days, not 3 days, and it was highly variable. Reuters and Fox reported the story more accurately as "one and a half days" and pointed out that the effect was just over two and a half days in adults.
Somehow, though, the benefit disappeared in children. Could this be because children don't care so much about telling the investigators what they want to hear?
And what about those trials that didn't use naturally occurring colds. As I pointed out in a recent blog post, if you look at only the studies where the researchers intentionally gave people a cold, the effect vanishes.
"The more rigorously scientific studies, where you took a group of people and gave half of them zinc and half a placebo and inoculated their nose with a cold virus, found there were no differences," said Terence Davidson, director of the UC San Diego Nasal Dysfunction Clinic in a February interview.
None of this stops ProPhase (NasdaqGM: PRPH), maker of ColdEeze zinc products, from making this claim on their website:
"Cold-EEZE® has been clinically proven to shorten the duration of the common cold by nearly half."
As evidence, their website points to three studies from 10-20 years ago. They conveniently ignore the more recent studies that showed far less (possibly no) benefit.
The authors of the latest review article graded the quality of evidence for five different outcomes. Their report card on these studies has one "Moderate" and four "Low" grades. Moderate means "further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Most of the grades were "low," which means
"further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate."
So the authors themselves don't really trust their own study! In the end, they conclude that "there is only a weak rationale" to recommend zinc. And previous studies, not funded by supplement manufacturers, showed no benefit. Who are you going to believe?
Save your money and use it to buy chicken soup instead.*
*The author receives no financial backing from the makers of chicken soup, although he does like it and would appreciate a free sample.
We've known for a long time that vitamins are good for you. Perhaps the best example is vitamin C, which completely cures scurvy, a disease that has plagued mankind for millenia. (It was described by Hippocrates some 2400 years ago.) Scottish doctor James Lind described how to cure scurvy with citrus fruit back in 1753, but it wasn't until 1932 that scientists Albert Szent-Gyorgyi and Charles Glen King identified vitamin C as the essential nutrient behind the cure for scurvy. (Szent-Gyorgi gave vitamin C the name ascorbic acid because of its anti-scurvy properties.)
Many other vitamins and micronutrients are required for good health, such as vitamins B and D, iron, folic acid, calcium, and potassium. Deficiencies in these vitamins cause all sorts of diseases, some of them very serious.
So it seems intuitively obvious that if a little bit of these nutrients is good for you, then a lot should be even better. Right? This intuition is the basis for the a huge and powerful nutritional supplements industry, which makes billions of dollars each year selling multi-vitamins and high-dose supplements in a bewildering variety.
The problem is, our intuition is wrong. Two separate studies published this past week, involving tens of thousands of subjects, showed that high doses of vitamins and supplements, rather than being helpful, can sometimes kill you.
In the first study, Jaakko Mursu and colleagues have been following 38,772 older women since 1986. The women in the study, whose average age was 62 back in 1986, have reported their use of multivitamins and supplements for the past 25 years. The news was not good: the risk of death INCREASED with long term use of multivitamins, vitamin B6, folic acid, iron, magnesium, zinc, and copper. The risk of death only decreased with the use of calcium. They also noted that in other studies, calcium had the opposite effect.
The authors concluded that there's
"little justification for the general and widespread use of dietary supplements,"
In the second study, Eric Klein and colleagues studied 35,533 men over the past 10 years, looking at whether vitamin E or selenium would decrease the risk of prostate cancer. Both supplements have been claimed to have benefits, so the researchers randomly divided the subjects into four groups, giving them daily doses of (1) vitamin E only, (2) selenium only, (3) vitamin E and selenium, and (4) nothing (in the form of placebo pills).
The result: the risk of cancer INCREASED for the men taking vitamin E, selenium, or both. Although the increased risk is small, it is abundantly clear that neither of these supplements is helpful against prostate cancer.
Not surprisingly, the supplements industry hasn't taken this news lying down. The Council for Responsible Nutrition is an industry lobbying group representing the supplements industry (don't be fooled by the name). They released a statement by their vice president, Duffy MacKay (a naturopath, which is a form of quackery I'll have to treat separately in the future), grasping at the fact that, in the study, the increased risk of cancer from vitamin E plus selenium wasn't quite as big as the increase from vitamin E alone.
"This reinforces the theory that vitamins work synergistically," said MacKay.
Aha! So if I take even more supplements, perhaps my risk of cancer will go up only an eensy-teensy bit?
The Council released a second statement about the study on multivitamins, saying
"CRN maintains that nutrients may be robbed of their beneficial effects when viewed as if they were pharmaceutical agents, with scientists looking to isolate those effects, good or bad."
I see... so the benefits of supplements will disappear if we treat them as drugs: wouldn't that include taking vitamins and supplements as pills?
The supplements industry (Big Supp?), which is largely unregulated, has a darker side too: countless hucksters, many operating primarily through the Internet, who are making a fortune selling overpriced supplements (and advice on how to use them) that they claim will cure cancer, diabetes, and a host of other diseases. These include internet quack Mike Adams, who posted a response to this week's studies on his Nature News website, claiming:
"Recent attack on vitamins a fabricated scare campaign."
In Adams' response, he starts by arguing that the American Medical Association"has a long and sordid history of openly attacking vitamins and nutrition," a bizarre claim that has nothing to do with the study results even if it were true (it's not). He goes on to claim that the
"study data were ALTERED!"
(the all-caps is his) and
"voodoo statistics [were] used to alter the outcome."
I looked at the numbers he extracted from the paper to support these claims, and he failed - badly - to understand the data. Apparently for Mike Adams, statistics that he doesn't understand are just "voodoo."
So I'm afraid the news boils down to this: eat lots of fruit and vegetables, and a balanced diet, and you'll get all the micronutrients and vitamins you need. Supplements are only needed if you have a demonstrable deficiency. For most people, multivitamins and other supplements are a waste of money, and they might even be harmful. But hey, apples are in season right now, and spinach can be kind of tasty if you prepare it properly.
