Articles

Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.

Food, Medicine, or Something In Between?

The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.

Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).

So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1000 times the intended amount.

The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality.

Rational Supplementation

It makes sense to supplement the diet with essential nutrients if the food in the diet is deficient in those nutrients or if the patient is not able to absorb nutrients normally. There are specific situations where that applies, such as providing folic acid to women to prevent birth defects or providing vitamins and minerals to bariatric surgery patients whose digestive functions are compromised. There are FDA-approved sources of nutrients for indications like these.

It is commonly claimed that “food is medicine” but there are very few situations where the evidence shows that specific nutrients are useful as medicine. Niacin for treatment of hyperlipidemia comes to mind.

The following (taken from a supplement website) are not rational reasons for supplements and are not supported by evidence:

  • We can’t get all the nutrients we need from food.
  • Supplements boost the immune system.
  • Supplements help get rid of toxins.
  • Even if you feel well, your health will only be optimal if you take supplements.

The Big Lie

DSHEA is based on a fiction. It prohibits claims that diet supplements prevent or treat any disease and only allows structure/function claims alleging that they “support” health in various ways. DSHEA is a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines. It allows the sale of products that are not intended to prevent or treat disease so people can buy them with the intent of preventing or treating diseases. People don’t buy St. John’s wort to correct a deficiency of SJW in their diet or in their bloodstream; they don’t buy it to “support” brain function; they buy it to treat depression. People don’t buy glucosamine to “support joint health” but to treat their arthritis pain. People don’t buy saw palmetto to “support prostate health” or correct a saw palmetto deficiency, but to relieve symptoms of benign prostatic hyperplasia or to prevent prostate cancer. The FDA’s “Quack Miranda warnings” are routinely ignored even by those few who actually read the fine print.

DHEA (dehydroepiandrosterone) is a hormone that was once approved by the FDA as a prescription drug; then it was taken off the market because the FDA decided it was unsafe. Now it’s available as a diet supplement without a prescription. When the FDA later saw evidence that DHEA was effective for a rare adrenal condition, they re-approved it with orphan drug status. Now the people with that rare disease, and only those with that disease, can get a prescription for the drug, while their perfect healthy neighbor can buy it at any health food store. Does that make any sense at all?

Advocates of CAM complain about “Big Pharma.” What about “Big Supplement” (“Big Suppla”?)? The diet supplement industry is a very profitable multibillion dollar industry that was able to lobby effectively to get the DSHEA passed. BP generates huge profits but it also saves lives. BS (double entendre intentional) has generated huge profits for its investors but hasn’t produced any measurable health benefits to those who use its products.

Yes, Some of Them Work

Some of them do work, but do they work better than prescription alternatives or FDA-approved over-the-counter products with more trustworthy, regulated sources? Are they as safe? They are admittedly cheaper and more convenient than prescription drugs, but is there any other reason to prefer them? One argument is that they are safer, but it isn’t safe to assume that—not until proper large-scale studies are done. Just think of all the prescription drugs that appeared to be safe until careful post-marketing surveillance revealed unexpected problems.

What are the chances that a diet supplement picked at random will turn out to be safe and effective when proper studies are done? Not high. Promising drugs that pharmaceutical companies submit to clinical trials only have about a 5% chance of making it to the market. A few years ago, I went through all the entries in the Natural Medicines Comprehensive Database and tabulated their effectiveness ratings.  Only 5% were rated “effective” and almost all of those were vitamins, minerals, and medicines that are also available as prescription or over-the-counter products approved by the FDA.

There are many products on the diet supplement market that combine multiple ingredients in a kitchen-sink mixture that has no rationale and has not undergone any testing. Maybe the ingredients act synergistically; maybe they interfere with each other. How would we know? Taking such products is a crap-shoot and is like being a guinea pig in an uncontrolled experiment. Many supplement mixtures are sold by multilevel marketing programs and improve health only to the extent that they improve the health of the promoters’ wallets.

Supplements can also harm. Kava has been associated with fatal liver damage. An herbal weight-loss remedy caused kidney failure in dozens of women in Belgium. One fifth of Ayurvedic remedies have unacceptable levels of arsenic, lead and mercury. Most trials of antioxidant vitamin supplements have shown that patients taking them either do no better or do worse than those taking placebos. Vitamin A supplementation increases the risk of fractures in post-menopausal women.

Conclusions

  • As my correspondent put it, “the public mania for nutritional supplements is baseless.”
  • In general, all our nutritional needs can be supplied by an adequate diet.
  • Supplements are beneficial for a few specific evidence-based indications; otherwise, they offer no benefits and may even be risky.
  • Diet supplements are not medicines, but are being used as medicines.
  • DSHEA should be repealed.

Posted in: Herbs & Supplements, Politics and Regulation

Leave a Comment (47) ↓

47 thoughts on “Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

  1. Jan Willem Nienhuys says:

    herbal weight-loss remedy caused kidney failure

    It was a Chinese herbal tea to accompany a weight loss program. The tea contained Aristolochia which got in there because of a name confusion with another Chinese herb. About 100 Belgian women had their kindneys destroyed, and later it turned out they got urothelial carcinoma too, because aristolochic acid is one of the most carcinogenous substances.

    Aristolochia is banned, but one regularly hears from incidents:

    http://en.wikinews.org/wiki/Banned_Chinese_medicine_still_on_sale_in_United_Kingdom

    http://www.dailymail.co.uk/health/article-1254746/Chinese-medicine-caused-kidney-failure-cancer-So-safe-popular-cures.html

    and you still buy this dangerous material (not a garden plant but dried and ready to puty in your tea) from internet:

    http://www.alibaba.com/manufacturers/aristolochia-fangchi-manufacturer.html

    The affair illustrated most painfully that you can’t trust age old remedies (Aristolochia = birthwort), that you can’t trust herbs or herbal preparations because you can’t know how much active substance there is in them and whether the correct herbs are in them. And also: you can’t trust any medicine from China or India.

  2. Monkey Man says:

    How are we going get the large scale studies that these interventions deserve when we have pseudoskepticism ruling the day? Why are you even writing this blog post in 2011 when common sense says that the natural, safer methods should have been ruled out first? You doubt that the drug game is calling the shots? Here’s my anecdotal evidence.

    I was diagnosed with serious bi-polar disorder/schizophrenia, my treatment plan was two interviews to figure out my symptoms and a drug prescription. Serious, dangerous drugs.

    I asked about alternative treatments and was told none existed but being healthy can’t hurt. Throwing me a bone there.

    Meanwhile I discovered copious evidence (http://www.schizophrenia.com/treatments.php) that there were many things I could try in the meantime. I combined the exercise, fish oil, supplements, diet changes (including no gluten) and self-directed CBT and guess what? I was healthy and sane, better than ever. Years of suffering arrested.

    The supplements I used were in the range known to be safe and I had to wait months to even get into the psychiatrist so where was the harm in trying this? It didn’t exist. Where is the rationale for allowing me to flounder, not encouraging me to try this method of treatment? It doesn’t exist.

    I used 7 or 8 methods at the same time, I can’t tell what actually made me better, that’s not my fault though.,

    There’s definitely a lot of baloney to be weeded out, a lot of controlled trials to be done, but as it stands, the people who should be working this angle the hardest, they aren’t doing it. They aren’t employing it. I had severe anxiety once and they got me addicted to benzos. It took me researching the internet to discover what cbt was and why it worked, why exercise worked, why changing my diet worked and what supplements to take. Not only did that cure my anxiety that the benzos didn’t even work for, it helped me get over the benzo withdrawal.

    The point is that it sounds like you’re criticizing the public for overusing supplements when it’s clearly just as bad for the medical profession to be underusing them and overusing drugs, which happens to people all the time. How about we simply admit what we don’t know and see if it works.

    You get to criticize the people calling for more research by squawking about the null-hypothesis but to me, the null-hypotheses I’m hearing are biased and useless.

    Look at the horrid history of cannabis research. The FDA wouldn’t even recognize that it had a single medical effect for the longest time. Then the only things being tried were synthetic versions of tongue sprays. Now it’s just commonly known that you will get the best treatment from actual whole extracts into oil or simply smoking it. For those of us who lived through all of those battles, to stand back and say that everyone in the positions of power is taking the highest road at all times, no, I’m sorry, try harder please.

  3. DavidCT says:

    I noticed that the homeopathic products sold at WalMart do not have the “Quack Miranda warning”. It would be up to the customer to understand what 200CK dilution of putrid duck organs means. It is clearly on the label so there can be no direct misinformation.

  4. megancatgirl says:

    This worries me a little. I have to take an iron supplement to prevent anemia. I had assumed it was regulated enough that at least the numbers on the nutrition facts panel are accurate. Now I don’t really have any way of knowing if there really is that amount of iron in each pill, or if there is less or more than what is stated (either could cause problems). I also have no way of knowing if the pills are contaminated with other things. I wonder if I should ask my doctor to give me a prescription for iron pills; at least I would know what I’m getting.

    But OTC painkillers are regulated, right?

  5. Kylara says:

    Dr. Hall,

    What about calcium for premenopausal women, and things like fiber supplements? Should we lump those in with “bad, overused” supplements, or are they more like OTC medicine?

    @megancatgirl,

    My understanding is that the safest thing to do when going with vitamins/etc. is choose a well-known major national brand with strong quality controls (which includes store brands). If Walgreens (for example) can make generic Tylenol safely and to the FDA’s standards, they are probably making my prenatal vitamins safely, and it’s not worth the lawsuit and PR damage for them to fail at adequate oversight of their supplements, when supplements are only a small part of their business and their pharmacy and OTC med business depends on trust and quality control.

    (But yes, you can just get them Rx too.)

    I recall when I researched prenatal vitamins some of the minor brands had APPALLING quantities of vitamin A in the form of vitamin A, when you’re supposed to get it as beta carotene (that your body converts to A as needed) because too much A can harm the fetus (whereas too much beta carotene gets peed out, IIRC). It was shocking, and I really do wish anything “medicine like” was regulated as medicine — and they REALLY need strong action for when contents do not match the label within a certain small tolerance.

  6. WilliamLawrenceUtridge says:

    @Monkey Man

    Your post contains the assumption that these interventions deserve large-scale studies, and that natural methods are inherently safer. Natural things can kill – including “natural” vitamin A (polar bear liver anyone?) If a vitamin must be taken in extremely large doses to have a clinical effect on a condition, any condition (bar vitamin deficiencies themselves) you’re not taking a “natural, healthy vitamin”, you’re taking a dose of a vitamin that is acting like a drug, and can have consequences. Vitamin A can kill you, vitamin C can give you diarrhoea, vitamin D almost killed Gary Null, iron is deadly to small children (and did nasty things to my anaemic wife’s insides). Substances are not automatically innocuous merely because they occur in nature, and there are rarely natural sources of concentrated vitamins like you get in a pill from a pharmacy. Those rare sources can themselves be toxic.

    Your post also assumes that these vitamins-as-drugs are effective. Which ones? Which ones have been tested in clinical trials for schizophrenia and bipolar disorder? Meanwhile, drugs with side effects do appear to be effective, but come with side effects. It may not be your fault that you can’t identify which intervention caused your improvement (if any, even mental ill-health can be cyclical) but proselytizing a cure that worked for you may have serious consequences for someone else they don’t work for. And in the meantime, there’s evidence it can cause premature death.

    There’s a lot of science that needs to be done, on nearly every health condition that exists. As always, the failings or side effects of one medicine or medical approach does not automatically mean another is validated – in other words, side effects from benzodiazepine doesn’t mean supplements work. The orthomolecular approach, using megadoses of vitamins for drug-like effects, is a rabbit hole of shoddy research and case studies. I sympathize with your frustration, any sort of mental illness is extremely hard to treat and makes for a maddening life, but the wheel of progress grinds slowly in science – with its saving grace being by the time it has ground, you normally have an answer you can trust.

  7. Joe says:

    In September 2010, Consumer Reports ran a list of dangerous supplements http://www.consumerreports.org/health/natural-health/dietary-supplements/supplement-side-effects/index.htm

    They ask two suppliers why they sell them, despite known dangers. They were told the FDA has not banned them.

    The best book on the DSHEA is “Natural Causes” by Dan Hurley.

  8. @Monkey Man. You wrote: “…to stand back and say that everyone in the positions of power is taking the highest road at all times… ”

    Dr. Hall didn’t say such thing in this post, and SBM bloggers often criticize “Big Pharma,” mainstream medicine, and sometimes even The Man. This post was about supplements and DSHEA, which are problematic.

    Monkey Man again: “…it sounds like you’re criticizing the public for overusing supplements…”

    That’s what it sounded like to you, but that’s not what’s actually going on here.

  9. The MLM-supplement connection is more alarming than Dr. Hall got into here. It says something about supplements that they are so routinely sold by such scammy methods. Probably every imaginable product has been sold via MLMs, but supplements and snake oils are that industry’s favourite product category.

    Alternative medicine practitioners are a target and often sucked in, simultaneously becoming victims to a scam themselves … and then passing it on to their patients. In my career in massage therapy I encountered many colleagues who attempted to recruit me into an MLM, usually to sell supplements. MLMs practically constitute a subculture of alternative medicine.

    Many people are under the false impression that some MLM schemes are “not really a pyramid” or otherwise okay, but even the best variants are still dubious, distasteful, and harder to make money with than it seems at first; the great majority are fundamentally fraudulent.

    And, as with supplements themselves, legality is a poor guideline — there are many legal scams!

  10. megancatgirl on regulation of dietary supplements: “I have to take an iron supplement to prevent anemia. I had assumed it was regulated enough that at least the numbers on the nutrition facts panel are accurate. Now I don’t really have any way of knowing if there really is that amount of iron in each pill, or if there is less or more than what is stated (either could cause problems).”

    I was told to look for a DIN (Drug Identification Number) in Canada or an NDC (National Drug Code) number in the US. These mean that the product is registered with the government as containing what it says it does. It’s not a guarantee of effectiveness — it could be pure sugar water — but if it’s registered with one of those numbers then there are penalties for inaccuracy.

    So that’s what I do.

  11. ConspicuousCarl says:

    Monkey Man on 22 Feb 2011 at 8:22 am
    How are we going get the large scale studies that these interventions deserve

    Most of them don’t deserve large-scale studies. But there is an obvious reason why you think that they do…

    common sense says that the natural, safer methods should have been ruled out first

    “Common sense” means absolutely nothing. Common sense is what you declare when you have no logical argument.

    You have a dogmatic assumption that “natural” things work well and are safer. If you acknowledge that studies have not been done, why do you declare that they are safer? It’s nonsense.

    I asked about alternative treatments and was told none existed

    The problem is that the word “alternative” is by definition meaningless except as a tag for unproven or even disproved junk.

    But for you it probably means an alternative to the big shot-calling drug conspiracy in your head.

    I used 7 or 8 methods at the same time, I can’t tell what actually made me better, that’s not my fault though.

    Not only can you not tell which made you better, you can’t tell if ANY of them made you better.

    You get to criticize the people calling for more research by squawking about the null-hypothesis but to me, the null-hypotheses I’m hearing are biased and useless.

    I don’t think you understand what “null hypothesis” means. It means that, absent evidence to the contrary, there is a hypothesis that two things, such as a drug and a disease, have no relationship. You don’t make any progress by believing any damned thing which people think up. There is no limit to the ideas people propose, and most of them are wrong.

    Look at the horrid history of cannabis research.

    This drug was a specific target of a political movement, and has no value in criticizing demands for scientific standards for medicine.

    Then the only things being tried were synthetic versions of tongue sprays. Now it’s just commonly known that you will get the best treatment from actual whole extracts into oil or simply smoking it.

    If research on extracts and standard delivery methods has been so limited, how do you know that smoking the whole plant is the best option?

    to stand back and say that everyone in the positions of power is taking the highest road at all times, no, I’m sorry, try harder please.

    Nobody said or implied that. If you honestly think that is anyone’s argument, then you really need to re-think your declaration of successful self-treatment.

  12. Jeff says:

    Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies?

    The new supplement GMPs have been fully implemented since June, 2010. As the FDA’s website makes clear, accurate labeling is one of the agency’s key concerns when conducting inspections of supplement manufacturing plants.

    I agree with Dr. Hall when she states that post-marketing surveillance is important. The FDA’s own statistics tell us that dietary supplements have a remarkable record of safety, especially when compared to pharmaceuticals. I believe DSHEA is good law – It strikes a sensible balance between appropriate regulation and consumer access.

    Dr. Hall is certainly right that some will try saw palmetto extract as a treatment for BPH, but is this really so bad? American law permits consumers to purchase the product after doing their own research. They might discover that several studies have shown saw palmetto extract to be effective for BPH. Some European countries (Germany for example) use saw palmetto as a first-line treatment for BPH.

  13. Esteleth says:

    I have always found the “take supplements!” cry more than a little overblown.
    Take, for example, the endless hoopla about ascorbic acid. Is it a molecule required for the proper functioning of the human body? Yes. Should people thus make sure they get enough in their diet? Yes.
    but:
    Does the average person get enough in their diet without supplements? YES. Does an intake of too much ascorbic acid have negative consequences? YES.

    As far as I can tell, the only people who need ascorbic acid supplements are people who are not getting enough in their diet. Like 18th century sailors.

    Oh, and the “support your immune system! It’s good for you!” nonsense-peddlers can kiss my autoimmune-disorder affected ass. Srsly.

  14. ImperfectlyInformed says:

    While I agree that some supplements are good and others are very bad, I don’t agree that the “public mania” for supplements is baseless or harmful. Far from it. Adverse effects are not common for most supplements, and beneficial effects are often reported. Take a look at depression, for example. SAMe (see http://archive.ahrq.gov/clinic/epcsums/samesum.htm) and St. John’s Wort (which admittedly one must be careful with) have less reported adverse effects with comparable clinical effect sizes and evidence bases. 5-HTP and tryptophan for depression have not been well-studied, but the mechanism is clear and the lack of side-effects is also clear compared to conventional antidepressants. SAMe also has fewer side-effects and comparable evidence for osteoarthritis (see above, or search in GScholar). There are dozens of other highly promising or well-tested supplements with rare side effects, whereas with prescription drugs side effects are the rule.

    It’s also not true that we don’t “need” supplements. The IoM’s recent vitamin D conclusion basically requires that we take a vitamin D pill unless we’re loading up on fish, as the panel admitted in their press conference (altho recent discoveries related to eggs allow us to feast on eggs). See this table (http://www.pnas.org/content/103/47/17589/T1.expansion.html and http://www.pnas.org/content/103/47/17589.long) for the NHANES data on what percent of the population is consuming below the RDA for various minerals and vitamins.

    Basically, I have to agree with Monkey Man. There’s much ado about relatively little and not enough serious scientific attention to relatively innocuous safety-wise yet surprisingly effective substances. It’s not a “scam” to say that relatively few people die or even face serious side effects from supplements. The fact is that the most commonly-used (echinacea, saw palmetto, vitamins and minerals) rarely have serious side effects, and to imply otherwise is misleading. It’s also certainly not true that the weight of the evidence doesn’t support efficacy for most of these supplements, or that very little basic science has been done on them. Interestingly, I have seen very little discussion of these topics which go deeper than the bare surface.

  15. ImperfectlyInformed says:

    Also: obviously if you tailor your diet perfectly, you don’t need supplements. And if you spend a decent amount of time outside in the sun, you probably don’t need vitamin D. But I don’t know anyone (including myself) who watches their diet to make sure that it contains the right amounts of vitamins and minerals.

    Plus, given that most of these minerals are supposed to be naturally in cereals, yet we’re seeing a huge secular decline in the amounts actually in the cereals (see e.g. http://www.ancient-minerals.com/magnesium-sources/dietary/ and http://articles.glenns-garden.com/Art/1776/93/The-Scientific-Evidence-of-Mineral-Deficiency-in-Food.html), it is impossible to be sure that we’re getting our requirements.

    Most primary doctors aren’t even aware that plasma or serum levels of many nutrients cannot diagnose mild deficiency (e.g., magnesium and zinc). It’s hard to OD, but it’s easy to get the minimum requirements from a pill.

  16. JJ from Cowtown says:

    ImperfectlyInformed, you’re treading a fairly narrow line there. You state that:

    - most people don’t “tailor” their diet to get the right nutrition
    - doctors can’t diagnose “mild deficiency”

    ..which creates the impression that the majority of people suffer from some form of nutritional deficiency without knowing it.

    I’d like to see some supporting evidence of this claim. But the argument itself dodges that request – after all, if doctors “can’t diagnose” it then it won’t be reported in the literature! How…convenient.

  17. Jeff says:

    @JJ from Cowtown: There is one study showing the result of an American diet highly deficient in Omega-3 fatty acids:

    The Preventable Causes of Death in the United States: Comparative Risk Assessment of Dietary, Lifestyle, and Metabolic Risk Factors

    This study was funded by The Centers for Disease Control and concluded that in 2005 low consumption of Omega-3s caused the deaths of 84,000 people.

  18. ImperfectlyInformed says:

    JJ, deficiencies can be tested roughly in many cases – but not using plasma in many cases, which is cheap and easy and what primary docs use.

    For example, magnesium status can be tested through a loading test – you get a big dose of a nutrient, and see how much your body absorbs. There’s plenty of literature on it, see for example http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.1999.00580.x/full. That said, you probably shouldn’t be burdening our health system by having a $2,500 loading test. If you think you’re deficient, it is more efficient to pop a magnesium pill or two. There’s no real overdose potential.

    If you want to get an idea on how widespread inadequate intake is, see the pnas link in my first post. 56% consuming less than the magnesium RDA. And this is from the NHANES survey – its subject to observational biases, and it includes people who can actually keep track of their foods. My brother, who eats pizza, rice, and pop in between his computer gaming, wouldn’t likely participate. Plus, the NHANES survey is possibly confounded by its use of USDA references for nutrients in foods, which may not precisely reflect what the population is consuming depending upon how much sampling the USDA does – did you see the egg’s vitamin D revision http://vitamind3blog.com/2011/02/todays-eggs-have-more-vitamin-d-less-cholesterol-than-in-2002/?

    Ultimately, if you think that you can just magically eat whatever you want and still magically remain perfectly well-nourished, you are naive indeed – and posts like Harriet Hall’s these telling people not to think about their nutrition or proactively address their health confuse more than they help.

  19. delaneypa says:

    FYI, one such independent testing lab that reviews contents of what’s in a given supplement:

    http://www.consumerlab.com

    It is subscription based at $50 per year. It’s a resource to steer people to products that actually contain what is on the label. They do not get into the efficacy for specific indications.

    If there are any others consumer-level labs that regularly publish their findings, please let me know about them.

  20. Angora Rabbit says:

    I’ve been watching to see if I should wade in. The PNAS paper that Imperfectly Informed cites is by Bruce Ames. I admire Bruce’s cancer work, but frankly he is a lousy nutritionist, on par with Uncle Linus. Let me first point out that the article is not peer-reviewed. Bruce is an Academy member and as such can submit his own papers for publication without peer review, as happened in this instance. Critique of this paper is the subject of my last lecture (in two weeks, so I’m about to peruse it again) and final exam to our nutrition graduate students, and they have a gleeful time taking it apart. He can talk a good talk but to those with a nutrition background his arguments are unsupportable. I would not hang a public policy on it.

    There are some micronutrients where insufficiencies are more common in certain US populations, and some where they are essentially nonexistent. But for the most part these are intakes where people are at 70-85% of our best guess at requirement. Does this pose a risk for disease? Probably not, based on observational analysis of that population. Ten years ago I would argued on the other side. But the science-based evidence coming from intervention studies is showing that many of the epidemiological associations are just that, associations that are not causation. Vitamin E and cancer, selenium and cancer, antioxidants or folate and heart disease, the human intervention studies just aren’t showing an effect of “correcting” moderate insufficiencies, as the epidemiology studies and Bruce Ames would claim.

    In fact, a few years ago the Institute of Medicine published findings from a scientific review that, if anything, found that middle and upper class Americans were overfortified in multiple micronutrients. The message was consistent with Dr. Hall’s, that people need to back down from their supplement overdosing.

    I also think it is important in this discussion to distinguish between “supplements” that are required – the vitamins and minerals – and those that are herbals etc. I found it hard at times to figure out what some of the writers referred to, and the arguments for each are very different.

  21. ImperfectlyInformed says:

    Angora, I appreciate someone with your expertise chiming in. You can probably guess that I don’t completely agree, though. As far as Ames, I’d prefer to stick to substantive points, but as far as I know the PNAS doesn’t disclose whether a paper is reviewed or not. So we don’t know. But does he misrepresent any of his sources? Because if he doesn’t, it is difficult to tell what you would find issue with.

    For example, you say that about 75-80% have an adequate level of intake. Why are you using off-the-cuff numbers when we have NHANES numbers available? Do you question Ames’ source for analyzing the NHANES data (Moshfegh et al, citation 4)? Or do you think that the people consuming less than than the EAR balance it out through a change in habits?

    It would be nice to see how your students critique Ames’ paper, but the scope of the paper is so broad that it is difficult to see how they could do it intelligently. For example, Ames’ mentions offhand that “Biotin deficiency is more common than previously thought; ≈40% of pregnant women who do not take a multivitamin show metabolic signs of deficiency (106). Marginal biotin deficiency is teratogenic in mice (106)”. How could your students respond to that? I doubt the clinical data is available to say much about the topic. Are your students prepared to discuss the intricate biochemical differences explaining why mice would be different from humans?

    As far as the intervention studies, I think we (and Ames) can agree: too much of these nutrients is harmful. Lots of the nutritional supplements being sold these days have too much, too. However, we’re in the very early stages of clinical trial data on nutritional supplements. Not long ago money was being spent on observational trials; we figured out that those were misleading. Since then, only a few large clinical trials have been done. In many of these clinical trials, the entire population of well-nourished individuals was supplemented rather than a specifically targeted mildly deficient population. Ethical concerns might make it difficult for us to allow for a “deficient” control group, and a group told that they are deficient would likely try to address their deficiency through diet.

    You mentioned selenium and cancer, which frankly surprised me since that is a great example of the problem I’m discussing above. The Nutritional Prevention of Cancer (NPC) found that those supplemented with selenium had lower cancer. This effect was most significant in the experimental subjects who had the lowest selenium at baseline (fairly deficient). Yet this study was followed up by the SELECT study – a study which supplemented people who were replete in selenium at baseline. Is it surprising, then, that SELECT showed no benefit? Not really. We already knew that nutritional supplements are best for people who are deficient. And, big surprise, the media – including parts of the supposed scientifically-savvy media – concluded that selenium supplementation was a dead-end for cancer. Absurd.

    That’s not to say that nutritional supplementation to address deficiency is the only area where nutrients could be helpful. It’s possible that nutrients can also exert pharmacological effects in high doses, similar to niacin and hyperlipidemia, but that effect is probably pretty uncommon. Potential examples include vitamin B12 for canker sores (http://www.jabfm.org/cgi/content/full/22/1/9); several RCTs of zinc and warts have shown promise; and, of course there’s zinc and the cold.

    I also think it is important to distinguish between the two classes, which is why I’ve used “nutritional”. You probably aren’t as familiar with the research on other supplements such as herbs or amino acids, but I’ll stand by my earlier comment: these often show just as much promise, with generally fewer serious side effects. The depression example is just the most obvious, and doctors who put someone on an SSRI or a tricyclic before trying something like SAMe are probably causing harm. I’ve recently used gotu kola to treat scars (in combination with needling; see clinical trial http://www.mat.or.th/journal/index.php?command=preview&selvol=93&selno=7&selids=2916) and rikkunshito to treat functional dyspepsia (see http://www.hindawi.com/journals/ijpep/2010/283549.html) with outstanding results. In neither of these cases is there an effective pharmaceutical on the market.

  22. stanmrak says:

    ummm… let’s talk about safety.

    Last time I checked, Big Pharma’s prescription drugs were killing over 100,000 people every year from properly prescribed and administered drugs.

    Natural supplements… was there even one death?

  23. rbnigh says:

    Dear friends,
    In fact, it is just not true that we get all the nutrients we need in their optimal concentrations from the food we eat, particularly if we depend on industrially produced and highly-processed foods. Deficiencies in many micronurtients and biochemicals, that should be present in our foods are common in the American diet (Ames 2006, Tomkins 2001). There are several factors that contribute to this situation. Most obviously, processing removes nutrients from grains and other foods. Often, highly nutritive elements are diverted to other products to increase profits for food processors, as molasses is separated from sugar, leaving a concentrated nearly pure carbohydrate. In fabricating white flour, the germ and covering of the grain are removed, along with most of the vitamin B12, a nutrient whose deficiency is a world-wide problem, especially for people with plant-based diets (Stabler and Allan 2004).

    Another factor contributing to widespread nutrient loss in our food are the techniques of industrial agriculture. Hailed for providing sufficient quantity to ‘feed the world’, the miscalled ‘green revolution’ , with its obsession for achieving higher yields has undermined the nutritional quality of agricultural products and with them the health of animals and humans who eat them. We have several studies that have documented the steady loss of nutrient levels in our principal foods over the past decades as the all out race for increasing yields has depleted the soil of essential nutrients (Davis 2009)

    Much other evidence could be cited to support the observation that our current diet in industrialized countries, based on the consumption of energy-dense, nutrient-poor foods does not supply the elements we need to support vital metabolic functions. The result is that diet-related degenerative diseases—obesity, type 2 diabetes, heart diseace and some forms of cancer, among others—are the principal causes of mortality in developed countries and are quickly becoming so in so-called emerging economies (Kant 2000, among many others).

    Rather than insulting the intelligence of millions of people who take dietary supplements to address these problems in their daily lives, by calling their behavior and beliefs ‘baseless’, a more ‘science-based’ approach might call for more research to answer many questions needing response. What are the optimum levels of nutrient intakes, rather than the ridiculous ‘minimal daily allowances’ now used to make recommendations? What are the interactions in the absorption and metabolic function of different nutrients? Can crops be selected for higher nutritional value, rather than exclusively seeking the highest yields? What are the best strategies for improving the quality of our soil and food?

    I have been following this blog for several months now, as the subjects covered are of great relevance to my research, and much of the discussion and information given is very useful. However, I find your aggressive attitude of automatically ridiculing any view that differs from the rigid paradigm of biomedical science as practiced in laboratories financed by the pharmaceutical companies, tiresome to say the least. A little respect for those who think outside the box would be appreciated.

    Ames BN. 2006. Low micronutrient intake may accelerate the degenerative diseases of aging through allocation of scarce micronutrients by triage. Proceedings of the National Academy of Sciences 103: 17589-94

    Davis DR. 2009. Declining Fruit and Vegetable Nutrient Composition: What Is the Evidence? HortScience 44: 15-19

    Kant, A. K. 2000. Consumption of energy-dense, nutrient-poor foods by adult Americans: nutritional and health implications. The third National Health and Nutrition Examination Survey, 1988-1994. American Journal of Clinical Nutrition 72:929-936.

    Stabler SP, Allen RH. 2004. Vitamin B12 deficiency as a worldwide problem. Annual Review of Nutrition 24: 299-326

    Tomkins A. 2001. Vitamin and mineral nutrition for the health and development of the children of Europe. Public Health Nutrition 4: 91-99

  24. passionlessDrone says:

    Hello friends –

    Very interesting discussion.

    I am largely in agreement with Monkey Man and ImperfectlyInformed on this one; and that isn’t just because they’ve got great handles.

    I’m convinced that some supplements can be useful for specific situations; I’ve got a mix of horse chestnut, butchers broom, and gota kula that I’ve been taking for a while now as a preventative measure for hemerroids. It absolutely works. If there is one condition that is completely impervious to placebo based problems, this is it. The stuff works.

    Now, that doesn’t mean it might not be doing other stuff, but for what I’d like it to do, its golden.

    - pD

  25. hat_eater says:

    I see the alarms at the Big Suppla headquarters started to ring.

  26. Angora Rabbit says:

    I think I may take Imperfectly Informed comments and forward them to the grad students for a challenge. :) It has to be said that the triage hypothesis in the Ames paper is just that, a speculative hypothesis with lots of mays and could bes. Many of his arguments rely on epidemiological associations between intakes and diseases, and as I said before, the actual human clinical interventions as often as not fail to show increased protection when intakes are elevated.

    The other issue that comes into play is that the DRIs are best attempts at identifying a requirement. Because it can be very hard to accurately quantify a particular micronutrient, we do not always know if the published data set is as accurate as it should be (this was an issue in the recent Vit D revisit). It assumes that you are even measuring the best tissue that accurately reflects intake, requirement and stores. Many times the human is not willing to part with the tissue that provides the best portrait of intake. And then there’s homeostasis, as body systems come into play to protect and preserve, and these dynamic systems can alter requirement and need.

    My point is that this idea that a requirement is a hard and fast number is wrong and completely misunderstands the complexity and nuances that go into trying to define a requirement. It is not like engineering where the numbers are hard and the cut-offs are clear. Biology is messy and dynamic and there is seldom a crisp cut off or boundary.

    The Ames paper and related claims about suboptimal intakes are problematic because they often fail to consider that the requirement values are soft and flexible. As Alison has pointed out in past posts, the requirements build into them safety factors to account for potential differences in human variability at 2 SDs from the mean. If the variance is large, then 80% intake of DRI might well be within the true requirement. This is why the Ames paper is problematic.

  27. Dr Benway says:

    I am largely in agreement with Monkey Man and ImperfectlyInformed on this one; and that isn’t just because they’ve got great handles.

    I’m convinced that some supplements can be useful for specific situations;

    pD, It may be true that some supplements work for some conditions. But that point has little to do with what Monkey Man posted.

    How are we going get the large scale studies that these interventions deserve when we have pseudoskepticism ruling the day? Why are you even writing this blog post in 2011 when common sense says that the natural, safer methods should have been ruled out first? You doubt that the drug game is calling the shots? Here’s my anecdotal evidence.

    Monkey man assumes facts not in evidence:
    1. That BigPharma has no interest in studying herbal extracts.
    2. That herbal extracts are safer than drugs with measured active ingredients.
    3. That BigPharma “calls the shots.”

    Dr. Hall reminds us that BigPharma fails to get positive results for 95% of the new drugs it studies. How does your conspiracy account for this?

    Dr. Hall’s point was not so much, “supplements don’t work” but rather, “no double standard!” Dox or GTFO for all claims about substances used to treat health problems.

    pD, you once confessed to shilling for the woo-friendly. When you slip up like this, I wonder what’s up.

  28. Dr Benway says:

    BTW, I see a couple of shibboleths in Monkey Man’s post suggesting that he is not intimately involved with mental health treatment. Imma not saying exactly what because I don’t want to teach the astroturfers how to pass themselves off more convincingly.

    Once companies like HB Gary get their Microphone-type software systems up and running, heaven help the blogs.

  29. passionlessDrone says:

    Hi Dr. Benway –

    pD, It may be true that some supplements work for some conditions. But that point has little to do with what Monkey Man posted.

    Sheesh, I didn’t feel like I had to declare sentence by sentence which parts of Monkey Man’s post I agreed with; but he expressed that he believes he’s helped himself with supplementation instead of pharmaceuticals. I should have been more clear.

    Here’s one thing that Monkey Man wrote:

    Meanwhile I discovered copious evidence (http://www.schizophrenia.com/treatments.php) that there were many things I could try in the meantime. I combined the exercise, fish oil, supplements, diet changes (including no gluten) and self-directed CBT and guess what? I was healthy and sane, better than ever. Years of suffering arrested.

    I think that we have a lot more to learn about how things other than pharmaceuticals can help (or hurt) lots of conditions, though I don’t necessarily need to invoke a conspiracy to get there. That being said, I do think that there is an unstated bias that goes into sites like this; bias that is the result of how many studies we get made available to use, and that availability is in large part driven by what pharma can and does decide to do with its dollars.

    Monkey man assumes facts not in evidence:
    1. That BigPharma has no interest in studying herbal extracts.
    2. That herbal extracts are safer than drugs with measured active ingredients.
    3. That BigPharma “calls the shots.”

    Dr. Hall reminds us that BigPharma fails to get positive results for 95% of the new drugs it studies. How does your conspiracy account for this?

    My line of thought is that it is a lot more complicated than that; I’d say that the regulatory environment, the need to have a patentable product, and most critically, the difficult to overstate complexity of designing drugs, even if you start with a natural substance you think may have an effect, is what is ‘calling the shots’ in this instance; so I guess I disagree with MonkeyMan on this.

    It isn’t a problem of a conspiracy so much as the reality of how pharma works, how that ultimately drives our what research we see, and the subtle bias this might introduce into how well we think we understand things.

    I’d say that pharma has interest in studying herbal extracts, but only if they feel it can be done profitably; and that’s largely difficult territory for pharma these days (herbal based or not). Most of the available conditions without a drug now are available because their targets are either difficult to hit, or impossible to hit without junking up lots of other things along the way. Getting your drug tested for conditions with other treatments available is also troublesome, you need to find people who will decide to participate in a trial when there is something else that works at least OK for your condition.

    To figure out if it is going to work or not, you need to spends tens of millions of dollars before you can think of going to Phase III, and then lots (most?) of compounds still puke out. The recent story here on Avastin is a good example of this, though I don’t think it started out based on a natural product (?).

    The only reason phama pursued Avastin is that there were big, big payoffs if it could be made to work. It doesn’t look like it is going to play out that way, at least for breast cancer.

    The number, and in some cases, quality of studies available to us on what helps conditions is slanted by who conducts those studies (and which studies they release). Pharma drives a lot of this, so we shouldn’t be surprised that lots of what we have available to us in the literature is about pharmaceuticals. The question of “who” “should” be studying things is problematic, but I don’t think that the bias involved in the reality of profit motives driving what gets researched sufficiently is appreciated in many cases.

    pD, you once confessed to shilling for the woo-friendly. When you slip up like this, I wonder what’s up.

    I guess I’d have to know what you are referring to in order to defend myself. I’m trying to learn along the way, and some of my beliefs have likely changed since I took up this monicker; by standards of some of the audience here, I probably still fit the classification of woo-friendly, though hopefully not ‘shill’. (?) Can you be more specific?

    I do, however, appreciate the fact that you think I had somewhere to slip up from; that’s a big step up for me.

    - pD

  30. WilliamLawrenceUtridge says:

    @Imperfectly Informed:

    Magnesium overdose does have adverse effects. Acutely it causes diarrhea and abdominal cramping, which can itself lead to nutritional deficiencies if continued over the long term. Overdose-level amounts of magnesium can be found in single supplements.

    http://ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/

    Selenium is associated in some populations with increased risk of prostate cancer and selenosis, the latter being associated with supplements, not food.

    http://ods.od.nih.gov/factsheets/Selenium-HealthProfessional/

    Nutritional supplements aren’t magic. Humans don’t have a magical “ideal” setpoint, they can operate with more or less of a nutrient so long as it isn’t causing symptoms. Actual deficiency is pretty apparent.

    The media is a terrible source of information. They sell stories, not science, and often get it wrong.

    PNAS and NAS membership in general has been used several times by different authors to flog pet ideas, including Linus Pauling:

    http://scienceblogs.com/insolence/2009/02/vitamin_c_and_cancer_has_linus_pauling_b.php

    Though still regarded as a high-quality publication, publication in PNAS and peer review in general doesn’t mean the opinion is gospel. Particularly when the author is publishing outside of their main field (thanks to Angora Rabbit for the comment, which reminded me of Orac’s earlier commentary on the subject).

    @stanmrakon

    Wheat doesn’t have B12 in it except in the form of contamination frmo bacteria and insects.

    Your comment on “oh, we’ve fed the world but caused nutritional deficiencies” is grating. The green revolution is a triumph of science and a nearly universal good. It cured starvation, a deficiency of macronutrients. In the unlikely event that it somehow caused micronutrient deficiency, I’d say that’s still preferrable to dying.

    Comparing drugs and supplements in such a naive way is stupid. Yes, adverse effects from drugs have killed many people but those drugs also bring benefits and ignoring one at the expense of the other is cherry-picking to support an argument you already agree with. In addition, drugs require adverse events tracking. Supplements aren’t tracked in anything close to the same way, and their actual benefits, beyond deficiency, are far less defined. In addition, they are in some cases associated with increased deaths, bone loss, birth defects and CNS disorders – risks from supplements, not from foods:

    http://ods.od.nih.gov/factsheets/VitaminA-HealthProfessional/
    http://ods.od.nih.gov/factsheets/VitaminB6-HealthProfessional/

    Long-term zinc supplementation can lower immunity, interfere with actual drugs and copper absorption:

    http://ods.od.nih.gov/factsheets/Zinc-Consumer/

    Chromium can interact with a variety of medications even if it has no acute overdose effects:

    http://ods.od.nih.gov/factsheets/Chromium-HealthProfessional/

    Vitamins, particularly vitamin supplements, are not a panacea. Getting them from food is safer and far, far more rational. Saying people don’t get enough of them from processed food is true, but trivial – it’s a reason to eat less processed food and more fruits and vegetables, which along with “lose weight” is probably one of the most common recommendations made by any primary care physician. Telling people to eat more unprocessed foods is very much science-based. I can’t see any doctor telling a patient “Sure pork chop, keep eating chips and candy, but make sure you take a multivitamin.” Pretending doctors don’t make a point of instructing their patients to eat a balanced, nutritious diet of unprocessed foods is a common red herring among the alt med crowd, as is the “Big Pharma” conspiracy-mongering. Settling science prematurely is a flaw irrespective of who’s doing it – big pharma or big supplement.

  31. @rbnigh: If you think that Dr. Hall or any other SBM contributor is “automatically ridiculing any view that differs from the rigid paradigm of biomedical science,” then I find I find it hard to believe that you have actually been “following this blog for several months.” If you think that science is a “rigid paradigm,” you’re not really getting the point of this place, and that sweeping condemnation marks you as being more of an ideologue than those you accuse.

  32. pD on self-prescribing: “supplementation instead of pharmaceuticals”

    Taking responsibility for one’s own health is a great thing, but what do you think the difference between a “supplement” and a “pharmaceutical” is? I can’t see one beyond that in the US a “supplement” is anything that doesn’t offer evidence of either safety or efficacy under any circumstances, and a “drug” is something that is required to offer both.

    If it comes in pill form, for all practical purposes it’s a drug and should be treated with respect.

    I do use supplements. I take a B-complex supplement to avoid the vicious circle of depression > bad eating > low B6 > depression. I don’t have to worry about toxic levels because B vitamins are water-soluble. And I take vitamin D because I live in Canada and use heavy sunscreen out of vanity and because vitamin D is fashionable.

    I stopped taking multivitamins when I read that high copper intake with a high-fat diet raised the risk of heart disease. “High copper” was defined as the amount of copper in my mulitvitamin; and “high fat” was defined as the average fat content of the North American diet. I realized that we just don’t know enough to f*ck around with pills without a strong rationale, even things we think we know fairly well. So no more multivitamins for me.

    What we do know: Eat a mixed diet with lots of vegetables and fruit. Exercise.

  33. Also: if you are worried about the loss of B12 from flour, then you are eating an extremely marginal diet. Kind of like obsessing about dehydrating from eating raisins instead of grapes. Yes of course I can imagine a person who is so badly dehydrated they need grapes. But the trouble this imaginary person is in has nothing to do with the profit motive of grocery stores to stock raisins because they are denser and easier to store.

    There’s a huge leap from “lots of people eat badly” to “I need to take pills to be healthy.” If you don’t want to be among the people who eat badly, then eat well. Pills don’t have to enter into it for most people.

  34. Alison’s “huge leap” paragraph right above: yes yes yes!

  35. passionlessDrone says:

    Hi Allison Cummins –

    Taking responsibility for one’s own health is a great thing, but what do you think the difference between a “supplement” and a “pharmaceutical” is? I can’t see one beyond that in the US a “supplement” is anything that doesn’t offer evidence of either safety or efficacy under any circumstances, and a “drug” is something that is required to offer both.

    Heh. What if I’d changed my sentence to read, “self prescribed instead of physician prescribed treatments”?

    But in my case, I asked my doctor, “what can I do besides diet and excercise”, and he said, nothing; there aren’t prescriptions to prevent your conditions, just treat it once it has occurred. OK. From a FDA approved, prescription model, he was completely correct. I looked up treating varicose veins in pubmed, and found several small studies on some compounds; the studies with humans were positive, and there was a biologically plausible mechanism by which these compounds could exert the expected effect.. OK. I looked up where I could find pills with some of these compounds in them, a vendor showed up, and my doorstep was warm a few days later.

    So, I’ve got no problem calling what I bought a drug; it certainly is having a physiological effect. In one instance, there was no prescription to be written for me, literarly no options, and in the other, there was something with limited evidence and a plausible mechanism of action that I could by from my living room. How we label this, I don’t know. I made the choice to try something. I’m in much, much less pain, I know that much; to the point wherein a possible problem many years down the road is a small price to pay for livability today and tomorrow.

    I realized that we just don’t know enough to f*ck around with pills without a strong rationale, even things we think we know fairly well. So no more multivitamins for me.

    Heh. I feel exactly the same way about lots of things. Context is important here; if Monkey Man’s story is to be believed, he was trying to adapt to schizophrenia, so I’m not sure that your rationale of the possibility of increased heart attack risk and his rationale of being a functional person day in and day out are necessarily equivalent.

    What we do know: Eat a mixed diet with lots of vegetables and fruit. Exercise.

    I’m on board with that, though the skeptical side of this site would tell you that the strength of evidence for low diets low in meat is relatively weak, and in fact, there is no reason that processed foods can’t be as nutritoius as their whole food counterparts. That hasn’t changed my eating habits though.

    - pD

  36. WilliamLawrenceUtridge says:

    @passionlessDrone

    I forgot where I read it, but someone (Ben Goldacre? Edzard Ernst? Orac?) mentioned how uninformed comments or decisions, hastily made, can have horrifying consequences because of a lack of understanding. The example was Doc Spock’s recommendation that babies sleep on their (back? Front? Don’t remember). Several decades later it turned out that position increased the risk of SIDS significantly, causing thousands of premature, preventable deaths. Doctors thought hormone replacement therapy for symptoms of menopause would increase bone density and improve cardiac health, then the Women’s Health Initiative study found a significant increase in strokes, cancers, heart attacks, clots and more.

    You are taking a supplement that was validated in several small studies. It has a probable mechanism and seems to work in your case – that’s fine and you’re fortunate to have found something that works. But science, doctors and governing bodies must withhold approval or recommendation until the evidence is in, if they can at all be considered responsible because until you do the large-scale studies, you’ll never know about the 0.01% chance of acute toxicity/blood clots/strokes/infection/organ failure in a vulnerable population.

    Your doctor, from the FDA approved prescription model, was doing essentially the only responsible thing because to do otherwise places patients at risk. The guy selling you the pills was out to make a buck with no real care for your actual health.

    That’s a bit of a caricature, I admit (on both sides, doctors make recommendations all the time that aren’t based on the best possible evidence available, and most people selling you pills honestly want you to get better) but I think my point stands – recommendation without proof presents risks.

    Well, I’d like to think it stands. I think I talked myself into a corner…

  37. Jeff says:

    @WilliamLawrenceUtridge: In addition, drugs require adverse events tracking. Supplements aren’t tracked in anything close to the same way, and their actual benefits, beyond deficiency, are far less defined.

    The FDA’s reporting requirements are exactly the same for supplements and OTC drugs – serious adverse event reporting is mandatory. Only prescription drugs have to report all adverse events, both serious and non-serious. The last annual figures released by the FDA for supplement AERs were for 2008. During that year the FDA received a total of 672 serious AERs for supplements. During that same year (2008) the FDA received a total of 320,000 serious AERs for drugs.

    Supplement packaging is now required to include contact numbers for the purpose of reporting serious adverse events. It could be argued that supplement AERs are underreported. Maybe so, but there is also considerable evidence that substantial drug AER underreporting is occurring (see “Reporting Adverse Drug Events” at USPharmacist.com, 4/19/2010).

    The fact remains that compared to drugs, supplements have a strong record of safety:

    http://www.orthomolecular.org/resources/omns/v07n01.shtml

    I agree that actual benefits for supplements will take longer to prove. Large, long-term clinical trials are extremely expensive and drug companies undertake them only because of the expectation of patent protection. When a clinical trial does show a benefit from a supplement, it is often ignored by the mainstream media. See:

    “Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren”
    posted in the May 2010 edition of The American Journal of Clinical Nutrition.

    Study’s Conclusion: “This study suggests that vitamin D3 supplementation during the winter may reduce the incidence of influenza A, especially in specific subgroups of schoolchildren.”

  38. Jeff says:

    I should have given the vitamin D study’s actual results: children ages 6 – 15 who took 1200 IU of vitamin D per day cut the risk of getting the flu by 50%.

  39. Richard says:

    I realize that DSHEA has created a wild-west atmosphere where almost anything can be sold as a supplement and almost any claim can be made for it. But I believe that a complete repeal would send us back to a paternalistic system where people could only obtain medicines OTC that were approved by the government or obtain a prescription from their doctor (Doctor May-I). I believe that a partial repeal would be better, one that would somehow maximize both freedom and truthful information.

  40. WilliamLawrenceUtridge says:

    @Jeff

    Citing anything with the word “orthomolecular” in the title substantially diminishes credibility. Orthomolecular medicine is based on the Pauling-inspired idea that if deficiency-preventing doses of vitamins is good, enormous, unnatural doses must be magical. Those adverse effects from OTC and prescription drugs come with actual benefits, while the same benefit has largely not been demonstrated for orthomolecular doses or supplements in general. Meanwhile, orthomolecular doctors air commercials, promote their practices and run miles ahead of the research, putting the cart of their practice several counties ahead of the horse of the research base. Actual doctors will acknowledge when research supports extra vitamins. To date, fairly rare and with the kind of benefits and NNT that are easily washed out by people walking an extra mile every day. And I wonder what quantity of those 672 adverse events for vitamins were based on a supplement, versus the kind of doses “prescribed” by orthomolecular practitioners.

    I would describe the media as exactly the opposite of ignoring the research conclusions you cite – “SUNSHINE VITAMIN SAVES LIVES!” But watch out for skin cancer. “VITAMIN D CURES CANCER!” In rats.

    @Richard

    Right now there is a standard of truthful information – you can only claim benefit when benefit has been demonstrated by research. That’s why most supplements are incredibly vague and you have to do the detective work online to figure out what each supplement is “for” at the drugstore. Yet still, there’s thousands of bottles of supplements on shelves, carefully not claiming to cure or treat anything with a nudge and a wink.

  41. Joe says:

    Jeff has been told that the reasons for low adverse effect reporting for supplements include lack of recognition by people who are self-medicating and the fact that most supplements are as biologically inactive as lettuce. He prefers his fairy-tales.

    In September 2010, Consumer Reports ran a list of dangerous supplements http://www.consumerreports.org/health/natural-health/dietary-supplements/supplement-side-effects/index.htm

    They ask two suppliers why they sell them, despite known dangers. They were told the FDA has not banned them.

    The best book on the DSHEA is “Natural Causes” by Dan Hurley.

  42. Jan Willem Nienhuys says:

    recommendation that babies sleep on their (back? Front? Don’t remember)

    (WilliamLawrenceUtridge on 23 Feb 2011 at 4:04 pm )

    In the Netherlands the general recommendation was that babies lie on their belly and sleep so too. This was on the basis of something said on a pediatrician’s congress in Vienna by E. Reisetbauer in 1971. Supposedly the belly position had all kinds of advantages. In 1986 SIDS in the Netherlands ran to 190 cases a year, much higher than it had been. Then it was discovered by an ‘epidemiological study’ that the belly position must have been an important factor: a pediatrician Guus de Jonge was struck by the fact that in a small village five cases happened within a short period. He questioned the parents, and found that in four cases the baby had been sleeping in the belly position. He published his findings in October 1987, and a kind of crusade in favor of the back position was started. The number of SIDS cases started dropping immediately.
    See also:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1792196/pdf/archdisch00663-0074.pdf

    For Reisetbauer see ref. 25 in the article.

    All young mothers were advised to avoid the belly position (and more: avoiding smoking etc.) Now the number of SIDS is back to where it was in 1971: about 11 cases per year. Meanwhile this iatrogenic epidemy of SIDS took about 3500 lives in 35 years in a small country of 17 million people. Multiply by 40 and you get a kind of estimate for the total number of deaths, so 100,000 seems to be a plausible estimate, rather than ‘thousands’.

  43. Dr Benway says:

    But I believe that a complete repeal would send us back to a paternalistic system where people could only obtain medicines OTC that were approved by the government or obtain a prescription from their doctor (Doctor May-I).

    Marketing bullshit.

    “Government” is a proxy for “scientific evidence.”

    Any freedom from evidence is a freedom to be robbed. The only people who enjoy *that* freedom are corporate fat cats who don’t like rules, except for other people.

    De-regulation has led to more layers of corporate crime in America’s financial industry than ever before. If we don’t stop the crazy train we’re on now with a bit more law enforcement, we will find ourselves with a hardened system of hereditary wealth in this country.

  44. Artour says:

    About rational supplementation.
    Statistically, there are 4 most common deficiencies in the Western world: EFAs (fish oil), Ca, Mg and Zn with about 7-12% people deficient. Other studies testify that a certain deficiency worsens many health problems (the URL below provides some related links between missing nutrients and health problems).
    Practically, people and their diets are very different. Hence, one cannot predict the effects of one deficiency unless current symptoms and health problems are known.
    Each missing nutrient is expressed in certain symptoms.
    When teaching my patients, I advice them a 3-day test measuring effects of supplementation on heart rate and stress-free breath holding time test (substitute for breathing frequency and minute ventilation: the less and slower their automatic breathing – the better the results). If a 3-day supplementation produces no effects, it is useless. If it does, find the minimum amount to maintain this effect. More info:
    http://www.normalbreathing.com/l-11-major-nutrients-guide.php

  45. stanmrak says:

    “Are they (supplements) as safe (as drugs)?… One argument is that they are safer, but it isn’t safe to assume that—not until proper large-scale studies are done. Just think of all the prescription drugs that appeared to be safe until careful post-marketing surveillance revealed unexpected problems.”

    You’ve got to be kidding! Comparing nutritional supplements (which kill virtually no one) to drugs that kill over 100,000 users every year, even when taken properly! Hello?

    There are no “safe” drugs, even if studies suggest they are.

  46. stanmrak,

    “There are no “safe” drugs.”

    Exactly! There are only drugs for which the benefits are worth the risks.

    “Supplements” are drugs. Anything in pill form is a drug. They are not safe. Since “supplements” are by definition drugs for which neither the benefits or the risks are well-known, we cannot balance the benefits and risks and it’s not a good idea to take them.

  47. Chris says:

    stanmrak:

    You’ve got to be kidding! Comparing nutritional supplements (which kill virtually no one)

    Oh, really? What about iron supplements? Kids are killed because they think they are candy. What about Gary Null who almost died from overdosing from Vitamin D supplements that he sells? What about Vitamin A poisoning? Why is there something like Dietary Supplement Alerts?

Comments are closed.