It's no secret that over the years I've been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we've pointed out time and time again, the DSHEA is not about health, and it's certainly not about education. Indeed, perhaps my favorite description of this law comes from blog bud and all around awesome internist Dr. Peter Lipson, who refers to it as a "travesty of a mockery of a sham." Rather, it's about allowing supplement manufacturers and promoters of so-called "complementary and alternative medicine" (CAM, with or without a preceding "s," depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as "dietary supplements" with near-impunity. As Harriet Hall once put it so accurately, the DSHEA is "a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines."
The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as "supplements" without prior approval by the FDA before marketing. As long as the manufacturer is careful enough not to make health claims that are too specific, namely that the supplement can diagnose or treat any specific disease, and sticks to "structure-function" statements ("it boosts the immune system!"), almost anything goes, particularly if a Quack Miranda Warning is included.
Not surprisingly, given what a big business supplements have become in this country largely due to the DSHEA, manufacturers and CAM advocates fight tooth and nail against any attempt to update the DSHEA to correct some of its more unfortunate consequences. Led by supplement industry lap dog Utah Senator Orrin Hatch and Iowa Senator Tom Harkin, who together make up a bipartisan tag-team in defense of the supplement industry and do their best to block any effort to increase its regulation by the FDA. We saw that most recently when Arizona Senator John McCain, of all people, introduced a bill in 2010 to try to tighten up the DSHEA and was thoroughly slapped down by Orrin Hatch. More recently, not satisfied with how good things are for the supplement industry, another bipartisan team of woo-friendly legislators U.S. Representatives led by Utah's Jason Chaffetz (a Republican) and Jared Polis (a Democrat) introduced the Free Speech About Science Act, which basically seeks to allow the supplement industry to make more liberal claims about its products. All it will need is a "peer-reviewed" paper to support it (Mark and David Geier would do!), and you can claim almost anything. Anything to grow the supplement industry, which is currently around $30 billion a year.
That's why it's critical, from time to time, to look at actual evidence, and just last week Maria Elena Martinez, PhD, of the University of California San Diego, and co-authors did in a commentary published online in the Journal of the National Cancer Institute entitled Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms.
As several of us have pointed out before, there are science-based roles for supplementation. For instance, in the case of nutritional deficiencies, and Martinez et al point out the very same thing:
Clearly, dietary supplements are useful for the treatment of nutrient deficiencies; however, with the exception of select subgroups (2,3), such deficiencies are relatively uncommon in the United States and most industrialized countries today.
Of course, if you listen to CAM promoters and supplement manufacturers, you'd think that supplements are not just helpful but absolutely essential to preventing cancer. While it is true that there is increasing evidence that diet has a significant effect on our risk for various cancers, this evidence is nothing new. We've simply concentrated on it more in recent years, and a new generation of "natural health" advocates, such as Dean Ornish, have attributed near magical powers to diet as a tool for preventing cancer (while misunderstanding new genomic technologies). As a byproduct of increasing evidence that cancer risk is influenced by lifestyle choices, it is understandably tempting to think that we could somehow "bottle" what's in various foods as supplements that could reverse or ameliorate diet-associated cancer risks. Ironically, although CAM advocates would never concede it, this sort of thinking is the sort of thinking they themselves decry in conventional medicine when they make the exaggerated charge that all doctors do (or want to do) is to prescribe a pill to deal with health issues. Think about it: Even is supplement did what is claimed for them, is there any real difference between just prescribing a supplement to decrease cancer risk rather than recommending much harder lifestyle interventions and prescribing a statin to prevent heart disease rather than recommending much harder lifestyle interventions?
Martinez et al then go on to summarize the state of evidence as it currently exists for the use of supplements to prevent cancer. They conclude that there is precious little evidence for efficacy and existing evidence for harm. Their assessment of the evidence for antioxidants is particularly withering:
Several early observational studies (10-13) found that diets high in fruit and vegetables were associated with diminished risk of several cancers, including respiratory and gastrointestinal cancers. The importance of β-carotene and other carotenoids was suggested by both retrospective and prospective studies showing that low levels of β-carotene in the serum were associated with higher subsequent risk for lung cancer (14). At one point, research focused on retinoid supplementation, in light of the finding that β-carotene is converted to retinol (13). It was hypothesized that the lower risk associated with consumption of these foods, and with β-carotene, α-tocopherol, and vitamin C intake, might be attributable to the activity of antioxidants. In vitro and in vivo studies suggested that these compounds encourage growth of normal tissue and block growth of abnormal tissue (2). However, human experimental studies have uncovered the following: β-carotene does not prevent non-melanoma skin cancer recurrence (15); β-carotene and α-tocopherol with vitamin C do not protect against adenoma recurrence (16); β-carotene and vitamin A do not protect against lung cancer incidence (17); α-tocopherol and β-carotene do not prevent lung cancer (18); β-carotene does not prevent lung cancer (19); vitamins C and E do not protect against total cancer incidence (20); and α-tocopherol, vitamin C, and β-carotene do not protect against total cancer or cancer mortality (21). Based on a review of trial data, a Cochrane report (22) concluded that there was no convincing evidence that β-carotene, vitamin A, vitamin C, or vitamin E supplements, given singly or in combination, prevent gastrointestinal cancers.
That's not all, though. An article such as this can't go without mentioning the Selenium and Vitamin E Cancer Prevention Trial (SELECT), which was resoundingly negative. Selenium and vitamin E showed no evidence of decreasing the risk of prostate cancer, leading to the trial being halted after approximately 5.5 years of followup. Consistent with the results of SELECT, a Southwest Oncology Group (SWOG) trial showed that selenium supplementation in men with a premalignant precursor of prostate cancer showed no benefit, and another trial showed that selenized yeast does not prevent recurrence of stage I non-small cell lung cancer. As Martinez et al put it, "organic selenium appears to provide no cancer prevention benefit."
Not every trial was negative. One exception noted by Martinez et al is a 20 year old prevention trial in China consisting of 30,000 subjects. This study showed a 13% reduction in cancer mortality, including a 21% reduction in gastric cancer mortality, compared to placebo controls in a randomized trial testing a combination of β-carotene, vitamin E, and selenium. This is, at best, a modest effect. However, similar studies looking at such cocktails were even less convincing, including a companion study of 3,000 subjects examining a supplement that contained 14 vitamins and 12 minerals, including β-carotene, vitamin E, and selenium. No statistically significant effect on cancer incidence was observed.
The counterweight to the weight of existing high quality evidence looking at antioxidants and cancer, which suggests no benefit in the vast majority of cancers studied this far and equivocal evidence even in the handful of studies that suggest a benefit is a cohort of studies that suggests the real possibility of harm due to antioxidant use:
Several antioxidant trials (17,18,30,31) have actually reported increased risks with supplementation. The most prominent example, β-carotene and lung cancer, was tested in two RCTs (17,18) in high-risk populations of heavy smokers and asbestos-exposed individuals. Individuals randomly assigned to β-carotene in the Beta-Carotene and Retinol Efficacy Trial (CARET) trial had a 39% increase in lung cancer incidence compared with those in the placebo arm (17); the ATBC trial found a 16% increase in risk of lung cancer associated with β-carotene (18). With prolonged follow-up, NPC investigators found that selenium supplementation statistically significantly increased the risk of squamous cell skin cancer by 25% and total non-melanoma skin cancer by 17% (30). The increased risk was particularly marked among individuals in the highest tertile of circulating selenium levels just before the start of the trial. The most recent illustration of the possibility that pharmacological doses of antioxidants may not have the intended effect comes from the extended follow-up in the SELECT trial, which reported that α-tocopherol increased risk of prostate cancer by a statistically significant 17%; these results led the authors to conclude that consumers should be skeptical of health claims related to unregulated over-the-counter products (31).
The authors then looked at folate supplementation. The state of the evidence for whether folate can prevent cancer is similarly disappointing. In fact, it can be described as largely negative. Worse, like the case with antioxidants, contrary to the hypothesized benefit of folic acid supplementation, there is evidence that it can contribute to some cancers. For instance, there is one trial that showed that long-term supplementation with folic acid increases the risk of advanced colorectal adenomas (relative risk = 1.67) and the risk of developing three or more such adenomas (RR = 2.32). An elevated risk of prostate cancer was also observed. These results are consistent with preclinical studies in animals suggesting that folic acid can increase the risk of cancer, as well as observational studies that have linked higher dietary intake with an increased risk of prostate and breast cancer. Ironically, in the U.S. and other countries, the government has mandated folic-acid fortification of the food supply, which makes the question of whether folic acid supplementation is doing more harm than good particularly pertinent. True, there's strong evidence that folic acid supplementation of the diet in pregnant women can decrease the risk of birth defects, particularly neural tube defects, but that is short term supplementation compared to long term supplementation. The question, then, is, as always: Is the balance of benefit versus risk due to folate supplementation favorable? There's enough evidence out there to be concerned that the answer to that question might very well be no, except for pregnant women.
Finally, Martinez et al take on the case of vitamin D and calcium. Anyone who's been reading CAM-friendly websites these days probably knows that vitamin D is currently viewed by many in the alternative medicine world as some sort of panacea that prevents all cancer. Heck, to listen to some CAM advocates tell it, vitamin D is supposedly so awesome that it prevents influenza more effectively than the influenza vaccine. Of course, as has been pointed out before, the picture is, as is usually the case, more complicated than that, and Martinez et al try to communicate that complexity, referencing the Institute of Medicine's recent recommendations for vitamin D and calcium intake published in 2011, in which the IOM concluded that there is insufficient evidence to conclude that there is a causal association between low vitamin D intake or low blood 25 hydroxy (OH) vitamin D [25(OH)D] levels and cancer. Martinez et al sum up this data thusly:
There have been many epidemiological investigations of blood 25 hydroxy (OH) vitamin D [25(OH)D] concentrations and cancer-related endpoints (45-49), and meta-analyses of these have shown statistically significant inverse associations between serum 25(OH)D and colorectal adenoma (46,49) and colorectal cancer (45), whereas the results for prostate cancer have largely been null (45,48). For breast cancer, the relationship with serum 25(OH)D levels varies by study design; case-control studies generally demonstrate inverse associations, and prospective studies have been null (45,47,50); because blood levels are collected after the onset of cancer in case-control studies, the potential for bias in these studies must be considered (47,50). Clearly, clinical trials are needed to elucidate any preventive effect of vitamin D (51,52). To date, three short-term RCTs of vitamin D and cancer endpoints (52-55) have been completed; one showed no direct effect of vitamin D supplementation on cancer mortality (53), the second showed no reduction in breast or colorectal cancer incidence by a vitamin D/calcium combination (54,55), and the third showed a reduction in total cancer incidence by a calcium/vitamin D combination vs placebo (56). As concluded in a recent meta-analysis, because of the potential confounding inherent in observational studies and the limited data from clinical trials, evidence is currently insufficient to draw conclusions about the efficacy of vitamin D supplementation for cancer prevention (57).
As far as cancer is concerned, there just isn't a whole lot of data from well-designed randomized clinical trials testing the effect of vitamin D supplementation on cancer risk to hang one's hat on. The same is true of calcium supplementation, only more so. Observational studies have, as Martinez et al almost drolly characterize it, "yielded diverse results." In any case some of the diverse results with respect to vitamin D suggest a correlation between high vitamin D concentrations and pancreatic cancer, while a recent meta-analysis suggests a reduction in risk. In the case of prostate cancer, however, a recently published study suggests a statistically significantly increased risk of prostate cancer (RR = 1.56 for men in the highest quintile) among men who have the highest levels of 25(OH)D, a finding that was more striking for aggressive disease, leading the authors of the study to advise caution in recommending vitamin D for cancer prevention. Puzzlingly, these results are in contrast to a lot of basic science research that supports a beneficial role for vitamin D compounds in prostate cell proliferation and differentiation, prostate cancer cell growth and invasion, and tumorigenesis. Clearly, as we say in the biz, more research will be needed to sort this out and figure out for which diseases, if any, vitamin D supplementation is helpful for prevention, what the potential risks might be in terms of increasing the risk of other diseases, and when it is appropriate to use. One thing's for sure: It's not going to be as simple as the alt-med quacks and supplement hucksters try to present it in their propaganda and advertising.
To say that the state of evidence in support of the use of various dietary supplements as cancer preventatives is unsettled is a gross understatement. Martinez et al discussed supplements that have been studied the most and, let's be frank, that involve the purest supplements, most of which contain only a single ingredient, and they found little evidence of efficacy in preventing cancer but some evidence of potential harm. That's not even counting the near innumerable supplements now being sold that are not pure substances but some form of extract from plant, fungi, yeast, or even animal origin. As I've said before time and time again, supplements that "work" (i.e., have some sort of biological effect) are drugs. They're impure, adulterated drugs with highly variable potency because of their highly variable content of active ingredient. Obviously, supplements that don't have such a biological effect are worthless (except for lining the pockets of supplement manufacturers). That's why supplement manufacturers very much want consumers to believe that their supplements have a whole range of beneficial biological effects, and the DSHEA allows them to imply that, as long as they don't do it too explicitly.
Martinez et al put the blame squarely where it belongs: On the DSHEA and another law. They also explain how supplement manufacturers get around even the weak prohibitions in the DSHEA:
Even without such direct statements, anticancer effects can be implied. For example, even though the manufacturers of Pill X cannot openly advertise that it prevents prostate cancer, they can create an advertisement that states that prostate cancer is a major health problem, that Pill X has a role to "support prostate health," and that a particular study found that the compounds in Pill X reduced the growth of prostate cells in culture. Their website can then be accompanied by advertisements for Pill X and can contain links to testimonials that are free to expound the benefits of Pill X as experienced by real people. The absence of credible scientific evidence that taking Pill X confers anti-prostate cancer properties in men can be easily obscured by this constellation of claims that collectively suggest anticancer effects. As a result of limited regulatory authority, manufacturers who cannot overtly claim anticancer benefits of supplements without scientific proof are nonetheless free to imply those benefits in ways that make it difficult for the consumer to discern innuendo from scientific fact (82).
Indeed. Another recent review concluded that, with the possible exceptions of vitamin D and omega-3 fatty acids, there are no data to support the widespread use of dietary supplements in Westernized populations and that such supplements can even be harmful. Another recent study finds no effect from supplements on all-cause mortality and even found a negative effect from folic acid supplementation, consistent with yet another study. The bottom line is that, at present, it is quite probable that most supplements probably do more harm than good in otherwise healthy people with no nutritional deficiencies.
So why do so many people take supplements? Martinez et al also quite correctly point out:
Undoubtedly, use is driven by a common belief that supplements can improve health and protect against disease, and that at worst, they are harmless. However, the assumption that any dietary supplement is safe under all circumstances and in all quantities is no longer empirically reasonable. Believers in supplements are sometimes quick to discredit caution over supplement use, as they suggest that the tendency of mainstream science to ignore nonconventional evidence is tainted or that mainstream science is somehow corrupted by its link to a medical-industrial complex that seeks to protect profits rather than prevent disease.
Right on cue, our favorite quack apologist and supplement hawker, Joe Mercola, chimed in with an article entitled Over 60 Billion Doses a Year and Not ONE Death, But Still Not Safe? In it, Mercola in his usual frothing-at-the-mouth style (although not nearly as frothy as another favorite quack apologist Mike Adams) rants that a recent survey from the American Association of Poison Control Centers' National Poison Data System reveals, there were zero deaths linked to nutritional supplements in 2010, amusingly citing the Orthomolecular Medicine News Service as its source. Orthomolecular medicine, you might recall, is a form of supplement quackery originally embraced by Linus Pauling when he concluded that high dose vitamin C was the cure for the common cold and cancer.
Never let it be said that Mercola isn't good at intentionally confusing short term toxicity with long term effects in his eagerness to attack a straw man. He seems to think that when scientists point out that supplements can be hazardous that they are claiming that supplements will kill you fast when in reality most potential problems with supplements are long term health effects, although, I would point out, certain supplements can certainly cause serious problems more acutely. In any case, when Mercola asks, "Where are the bodies?" I'd answer that if a supplement increases the risk of a common cancer by 25%, that's a lot of potential bodies. They just won't be directly linked to supplements. Particularly amusing is Mercola's outrage that the FDA is trying to impose the same limits on supplements as on aspartame, monosodium glutamate, and sodium nitrate.
What is infuriating Mercola and the supplement industry are draft guidelines from the FDA designed to assess new ingredients in supplements using safety standards similar to what are required for the approval of new food additives, as described in this recent New England Journal of Medicine commentary:
The proposed guidance clarifies the level of evidence the FDA would use to assess safety. Specifically, the safety of supplements would be evaluated according to three key factors: documented history of use (e.g., in foods or in supplements or herbal medicines sold outside the United States), formulation and proposed daily dose (e.g., more or less than was formerly consumed), and the recommended duration of use (e.g., intermittent or long-term). The FDA's guidance provides a thoughtful framework for evaluating the safety of new ingredients (see table Required Safety Testing for New Dietary Ingredients Labeled for Intermittent Use.), and if implemented it would lead to substantial improvement in safety. For example, the FDA would require in vitro, animal, and tolerability testing for products that would be marketed for consumption at doses greater than those historically ingested.
In actuality, however, even these draft guidelines do not go far enough, and the supplement industry is vigorously opposing them, even though they strike me as an eminently reasonable strategy for trying to address at least one of the shortcomings of the DSHEA. After all, don't supplement manufacturers themselves claim that their supplements are food, not medicine? Then why not require that new supplement ingredients without documented historical usage be subject to the same requirements for safety as any other food additive?
It's important to remember that, in the end, supplements that have biological activity are functioning as drugs. As Martinez et al and a number of other studies strongly suggest, there is very little, if any, evidence that supplements improve health, at least in an already well-fed population, with a precious few possible exceptions that are far more narrow than anything CAM advocates or supplement manufacturers claim. Worse, at least as it stands right now, for most supplements, it is disturbingly likely that the harms probably outweigh the benefits for most people. This is one area where we probably do need more studies, but they need to be "strategically designed" studies, as Martinez et al put it, set up in light of existing evidence from previous studies that have been largely negative.
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Er, Polis is from Colorado. I kind of doubt Utah's voters would elect an openly gay Representative unless they were on LSD (and yes, I am trying to make a bit of a pun here).
I can't wait for the new health labeling on cigarettes; there's all kind of peer reviewed literature on how good smoking is for you. Ok, mostly 50 years old and with dubious funding, but it's published, has to be true.
@Mu: Even better, cigarettes are a botanical product (made from tobacco), so it could be argued that they are covered under the proposed law.
No deaths due to supplements--doesn't Mercola recall all the 30-plus deaths due to EMS associated with L-tryptophan supplements back in the late 80's?
Or that in 2009 the FDA forced the recall of 14 Hydroxycut products (marketed as dietary supplements for rapid weight loss) following adverse events which included the death of a 19 year old male in 2007?
Or any of the various deaths associated with vitamin A ovedose as the result of supplementation, including one tragic case where 23 children died 2001 in Assam?
Orac has now officially placed himself on the black list and won't be receiving invites to ANH dinner dances given by any of their affiliate regions: banned on several continents.
For years, woo-meisters have threatened that the medical establishment, following orders from pharma, will exhibit 'tainted' studies to convince the public that supplements are ineffective and even *dangerous* ( that sounds rather like their critique of vaccines) then, will influence peddle their way to governmentally imposed restrictions on the sale of all supplements.
I assume that Martinez is ( mostly) discussing supplements in standard doses. Alt med proselytisers believe that, in order to function as pancaeal nectar-of-the-gods, supplements need to be adminstered at high doses: the studies fail because they use standard dietician-approved doses and most probably, bargain basement *un-natural* products. Unlike their own.
Orthomolecular psychiatry replaces meds with high doses of niacin or b-complex but most anti-cancer regimes rely upon high doses of vitamin C or D. However, the curative power is not restricted solely to cancer but extends across the board to include many other chronic illnesses. Like MS. CV. HIV. And as if this isn't bad enough, they shill an entire range of products that also are given in high doses, unlike what a person might experience through gustatory means; these arcane substances include carotenoids, antho- and proantho-cyanidins, omega-oils, amino acids and a laundry list of other phyto-chemicals. Take a peek at any woo-ful website's store: you'll see what I mean.
Because natural health providers look askance at any and all pharmaceutical products, they need to create alternatives based upon their own deification of Nature. Phyto-ceuticals isolate substances from plants in an un-natural manner as does taking thousands of mg of C daily. I doubt that anyone could ingest that much citrus fruit.
Here are some figures, sure to warm Robert Verkerk's heart:
( from mintel.com)
In the UK, vitamin and supplement sales have grown 14% between 2006-2011 ( 2% real growth, due to inflation)
DESPITE suppression since 2008 due to the financial crisis where usage declined from 41% to 36% of the population. Other factors that contribute to decreased growth include price discounting and competition from functional food and drink products.
However, we can expect more growth because the cohort of core product users ( over age 65) will grow between 2011-2016.
If the government doesn't CLAMP down on supplement sales!
( which is -btw- what RV tells us is happening)
I completely agree with the article and concede that Linus Pauling suffered a somewhat typical "late career Nobel Laureate/prestigious senior scientist descent into advocacy of poorly documented claims" episode.
Still, Linus Pauling is kind of my favorite scientist, so I will note that large doses of Vitamin C may have a role in the treatment of gout http://www.ncbi.nlm.nih.gov/pubmed/21671418 (or may not, but at least what has been noted so far is somewhat interesting). I will also note that Pauling didn't team up with creationists or anything.
No dispute with the general message here is intended.
The bit I love about these magic pills is when people go "Oh but they're all natural"! Uh huh, I'm sure the capsules were hand crafted and filled by Buddist monks and not in a evil western factory.
Out of curiosity, were the various tests of vitamin supplements effacity (or more correctly non-effacity) based on a 'good' diet or the more common large amounts of rubbish food that people unfortunatly scoff down. Given that vitamin supps are only useful if you have a defeciency, supplementing a typical bad diet could possibly have a minor beneficial effect as opposed to expensive yellow pee (Of course fixing the diet would be cheaper and more beneficial, but just speculating).
Not to speak for Orac, but "Foods are simply collections of "adulterated drugs"" puts it a bit too strongly in my opinion.
Would you agree to amending that to read "With rare exceptions foodstuffs incorporate molecules such as vitamins, amino acids, etc., which are known to exert pharmacological effects"?
JGC: I agree with your statement. I was quoting from Orac's post. About plant-based supplements, he says, "They're impure, adulterated drugs with highly variable potency because of their highly variable content of active ingredient." Orac seems to be saying that only single-molecule drugs have value for improving health.
Some researchers think otherwise. For example, curcumin has potential for cancer prevention. Studies are showing that resveratrol can improve cardiovascular health. This review emphasizes that resveratrol is nontoxic to humans, even at high dose levels.
@ Jeff:
The quoted statement is pretty far afield from what you claim it means. It DOES mean that anybody in their right mind should prefer a purified, standardized form of whatever the active ingredient(s) happen(s) to be. There simply isn't value in leaving them in their natural state.
Neither of your examples refutes this in any way whatsoever. The fact that beneficial compounds may be found in natural products does not in any sense imply that said natural product is the optimum form in which to consume said compounds.
I strongly disagree with your interpretation. In fact, almost all drug preparations for humans contain some inactive ingredients, and many preparations contain known amounts of more than one active substance.
The point being made is that knowing precisely what the active ingredients are, how much of them there are per dose, and what else is there, is usually preferable. That point is obvious. The examples you gave are not logically related to your misinterpretation.
I certainly wouldn't.
The line between "nutrients" and "drugs" is not always a clear one.
Nevertheless, it makes more sense to be able to differentiate between them where there is a reason to do so.
Jeff,
Your examples seem to be counter to your statement. Per Wikipedia, Resveratrol is 3,5,4'-trihydroxy-trans-stilbene, so a purified form of it would be single molecule drug. Likewise, curcumin is one of several forms of a single molecule.
One might reasonably argue that there could be a synergistic effect between multiple compounds found in, say, red wine or turmeric that would make them more (or less) effective than the single molecule resveratrol or curcumin. And all one would need to do is conduct tests, determine what those additional molecules are and what proportion provides the most benefit.
Perhaps Orac's original statement should be modified to say "They're impure, adulterated drugs with highly variable potency because of their highly variable content of active ingredients." instead of the singular "ingredient". I don't see that that dramatically changes the thrust of his original statement.
Personally, I find that considering intent tends to clear up many (though certainly not all) cases. If the intent is "I don't get enough of this in my diet" then it's acting as a nutrient. If the intent is "this will have beneficial effect X" then it's a drug.
Tryptophan took the blame for a manufacturing disaster with genetically modified organisms. The Japanese manufacturer, Showa Denko, also injured thousands dumping its mercury catalysts into the public waters.
Mephistopheles O'Brien,
I should have stated it this way: Orac seems to be saying that only synthetic single-molecule drugs have value for improving health.
Both curcumin and trans-resveratrol are sold as standardized plant extracts, not drugs. Although both are single molecules, the most popular supplemental form of curcumin is marketed as a complex of curcuminoids:
http://www.curcuminoids.com/
Don't see how you'd infer this from his blog entry--the meaning I took from Orac's post wasn't that he believes all foods are drugs but instead that supplements are being sold as drug equivalents--impure, adulterated equivalents with highly variable potency because of highly variable active ingredient content just as he describes--by companies pretending they're selling something else in order to avoid regulatory oversight.
I don't see how you could claim this, given that so far you're the only person to even mention naturally occurring versus synthetic molecules in post @17.
Cancer cells are all defective in one way or another; often many ways at the same time. If it weren't for their uncontrolled division, they'd die off without anyone knowing they were there. Isn't it possible that they need dietary supplementation a lot more than your normal cells do, and giving it to them is a bad idea?
Even if some dietary supplement could lower the risk of cancer, that doesn't mean that once cancer appears anyway, that the same supplement is the best way to treat itâthat's apples and oranges, surely.
Maybe terminal cancer patients, who have nothing to lose anyway, should go on a cheetos-and-candy diet and see who wins out in a head-to-head competition: the normal cells or the cancer cells. I've heard one anecdotal case of the kind: "Well, all she wants to eat is chocolate cake and so forth; why not let her have it?" leading to a tumor necrotizing and finally disappearing. In any case, I think all you're doing with mega-vitamins is helping out the most defective cells in your body, which are...anybody? Bueller?
As a long time user of megadoses of Vit B's and C- 1 gram/day and numerous
supplemnets for 40 years, I am 69 and in very good health. Just had my annual
physical- all normal readings. I also eat very little sugar and follow a healthy diet, walk for exercise. I also look 55. Anecdotal of course so I guess my statements don't count. Enjoying my curcumin and reservatrol Omega 3s Vit D.
I quote lilady who said I had SFB to which I reply -Enjoy your blood pressure meds lilady!
Enjoy your empty wallet, lurker. You could drop all of the supplements you've mentioned and still be in the same shape. They contribute nothing. Zilch. Nada. Zero.
New law firm, perhaps?
Travesty Mockery Sham
Kill DSHEA instead.
Count for what, exactly? If we take them at face value they would support your claim that you've been taking megadoses of vitamins B and C and numerous supplements for 40 years and you're 69, look 55 and are in good health.
They wpuldn't, however, argue that the reason you're 69, look 55 and are in good health is because you've been taking megadoses of vitamins B and C and numerous supplements for 40 years.
First, you wouldn't believe the raw garbage that goes into some of these dubious products. I worked one place that was closed by the Feds because they were unable to provide MSDS for most materials used in their plant and they were also unable to provide any information that what they manufactured contained any of what the label said it did. The plant was owned and operated by a large, publicly-traded "whole foods grocery, which quietly shuttered the operation. WRT resveratrol, visit Derek Lowe's In the Pipeline blog for the whole sorry saga of Sirtris, its founders, and the money they made.
Supplements certainly helped. Look at the research for Vit C. My hubby also looks great. Genes of course play a part- how much 25-50%? My Ob-Gyn in SF put me on vitamins when I was pregnant, my children are doing great too.
@JGC
Orac made the statement-"Worse, at least as it stands right now, for most supplements, it is disturbingly likely that the harms probably outweigh the benefits for most people." I just replied with anedoctal evidence for me.
@JGC
Discovery Shows New Vitamin C Health Benefits
http://www.sciencedaily.com/releases/2005/01/050111162230.htm
@ lurky: I don't recall stating that you were a *SFB* Troll...I believe that I tagged another, (Thingy) Troll, with that label.
IIRC...you *flounced off* RI...after your inane *cherry-picked* posts about vaccines and I dissed you about your tactics.
Vitamin C supplementation lurky?...
http://ods.od.nih.gov/factsheets/Vitaminc-HealthProfessional/
Have you got scurvy, lurky?
For a brief and hellish year I was the QC manager for a company that produces two of the major brands of vitamin and herbal supplements. I was specifically brought in because they had been taken to the cleaners over heavy metal contamination in their products. Turns out that their Vitamin C was heavily contaminated with lead, their Vitamin B12 was loaded with arsenic, and mercury was unpredictable but rampant in most of their herbal powders and extracts. Virtually all large supplement companies source their components from overseas and simply trust that the supplier's Certificate of Analysis is accurate and true. Hint, they're not. Suppliers will even re-write and re-fax them on the spot in order to guarantee a sale to you. Supplement companies are under no obligation to test their products for heavy metal contamination, report it to you, or withhold from sale known contaminated products unless you are in California where this is regulated by Prop 65 (the clean drinking water act, which regulates acceptable contaminant levels in all consumables other than drinking water, go figure). Lurker, good luck with your lead and arsenic! Maybe you SHOULD try chelation therapy.
She's citing research from the Linus Pauling Institute, lilady. A fool and her money...
Hey lurky, you might want to know that the paper the link you posted was written about was retracted:
www.pnas.org/content/104/36/14543.3.long
www.ncbi.nlm.nih.gov/pubmed/15608056
Turns out that the complexes they found were misidentified and had nothing to do with Vitamin C. Total fabrication. "...the authors regret that the plasma analyte described in Figs. 3 and 5 was incorrectly identified as ascorbylated 4-hydroxy-2-nonenal. The authors do not claim to have detected ascorbylated 4-hydroxy-2-nonenal in human plasma and, therefore, retract the paper."
Oops!
Thanks Jay What companies?
Oh, I don't know where to begin!
For many years, I've heard woo-meisters praise various substances- including resveratrol, curcumin, mushroom extracts, catechins, indoles - as being *ne plus ultra* panacaea but... the great breakthoroughs never happened. They never replaced standard meds. I could show you literature postulating this from 20 years ago.
About Linus Pauling: woo-meister *par excellence*, Gary Null was very close to him during his final years at the Institute for Applied Biology, I believe. Taught him volumes. Enough said.( Unfortunately, Luc Montagnier appears to be headed in a similar direction).
Re: curcumin- supposedly has been shown to be effective against HIV, Alzheimer's, MS, cancer, hypercholesteraemia, cataracts, arthritis, kidney disease...
It's possible that research might eventually refine its active ingredient but that doesn't stop woo-meisters from making extravagant claims and marketting supplements ( turmeric or curcumin) as prevention and/ or cure *today*.
-btw- I think curcumin should be utilised as part of your diet.. in Indian food.
About looks:
Alt med addresses people's fears about aging as well as their vanity- one area calls itself "anti-aging medicine" and boasts its own (quasi) medical association in the US (AAAAM).
Personally, I'm over 50, play tennis, eat reasonably well ( altho' alt med folk would believe me to be at death's door because of non-organic food et al) and have taken very little supplements. Several people in my family ate diets that dieticians ( as well as woo-meisters) would deem 'un-healthy' but lived to advanced ages without much chronic illness before age 80. It's called the genetic jackpot. We also have very good skin- as long as we avoid the sun.
Woo revenue streams rely upon people attributing good outcomes to supplements not good luck.
@Denice- unfortunately not in my family.
Lurker,
Unfortunately, I am constrained from identifying my previous employer. However, it is a single company that produces two distinct brands and is based in California. That should narrow the field enough for anyone who truly cares.
@Jay Would that be Santa Cruz?
As I said earlier, I am constrained from identifying my previous employer.
@ bad poet:
I must comment on your immensely entertaining
and frighteningly bad poetry:
in fact, it's not even really poetry-
which is good;
however, you usually manage to blithely mock something or someone truly deserving of mockery:
you should be congratulated heartily for your fine work. Hear hear!
Have you ever met the bot? I think you two might get along and comment sequentially in tandem. Like rappers.
Jeff,
As others have mentioned, I can't find the word "synthetic" included in this message string until your post. Naturally, what Orac seems to say depends on your particular vantage point. He can speak for himself on whether he meant to say synthetic. As I read his statement, it refers to the wildly variable content of most supplements (see Consumer Reports for one view of this) and not a reference to the original source for a particular drug.
It's my understanding that there are a substantial number of drugs produced by extracting an purifying chemicals produced by various living things. Digitalis is an example; insulin another. Do you consider these synthetic?
Megadosing on vitamin C, let's see, it's an antagonist for other nutrients like copper, zinc, manganese and calcium. You urinate the excess and it causes "bowel intolerance".
There is no need to megadose on vitamins.
@ Jay Chaplin: Do you mean chemicals such as niacinamide (Vitamin B3)...which is imported by the ton from China?
http://www.alibaba.com/showroom/niacinamide.html
Oh look, the website has an alphabetical listing for other vitamins and chemicals...available by the ton...from the China Mainland.
How about your vitamin C supplement, lurky?
http://www.nytimes.com/2010/05/26/health/policy/26herbal.html
"In recent years, a vast majority of supplement suppliers have located overseas â principally in China. Nearly all of the vitamin C and many other supplements consumed in the United States are made from ingredients made in Chinese plants. Those plants are almost never inspected by the F.D.A. because the agency is not required to do so, has little money to do so and does not view the plants as particularly risky."
@ lilady,
Exactly. In our experience virtually all of the Vitamin C from China was contaminated with high concentrations of lead, and almost all of the Vitamin C used in USA marketed/sold supplements comes from China. That is true for most raw materials that go into supplements, with only a few notable exceptions (fish oil, Coenzyme Q10, etc.) which are sourced from different countries. A large fraction of the materials coming from other places are manufactured in China, relabeled by the middleman, and resold. In essence, there are few suppliers of the bulk raw materials and many formulators - everyone buys the same stuff, mixes their own batch in modified cement mixers, and presses them into tablets or fills capsules. The situation is even worse with things that are tableted and packaged in other countries - Chinese patent medicines are astonishing, I've seen lower contaminant levels in industrial effluent.
GMP and Consumer Labs are a good start to solving the QA/QC problems mentioned.
Unfortunately mickeymoused, Consumer Labs only assays to see whether the right amount of active ingredient is present and does not check for heavy metal contamination or other forms of adulteration and GMP compliance similarly does nothing to insure that the starting materials are clean, it only insures that no defects are introduced in the further manufacturing process. Supplement manufacturers have no requirement to test for or report toxic adulterants in either their starting materials or end products except when marketing those final products in the state of California.
Some companies' industrial effluent is claimed as cleaner than approved drinking water.
Study Finds Supplements Contain Contaminants
http://www.nytimes.com/2010/05/26/health/policy/26herbal.html
Through that same website...here's "Resveratrol" for purchase in bulk from the China Mainland.
http://www.alibaba.com/trade/search?SearchText=resveratrol&IndexArea=pr…
More *cancer-fighting* supplements (Curcumin) for purchase in bulk from the China Mainland.
http://www.alibaba.com/trade/search?SearchText=curcumin&IndexArea=produ…
Has anyone noticed that many supermarkets, including the upscale *Whole Paycheck Supermarket*, are selling garlic bulbs imported from Mainland China?
http://www.isfae.org/scientficjournal/2012/issue1/pdf/environment/e14.p…
I posted this on the other thread, but I wanted to make sure you saw it!!
"Lilady you are awesome!!!! I went over to HP and to be honest there was not much left to say. Between you and Heywood Merton and Dyson you ripped them a new butt. Blackcherry is the worst kind of racist, no different from the KKK.
I did post something but I was so ticked off that I don't think it will get through moderation.
""You Devil"??? You sick, self righteous, ignorant, judgemental racist. How DARE you judge someone by the color of their skin instead of the content of their charactor!!!! How do you know what the racial heritage of lilady is? Just a bigots guess? Here is another surprise, I am not white. ""
âGSK has licensed more vaccines in China than any other global manufacturer and has packaged more than 100 million vaccines at our Shanghai facility. Todayâs announcement represents an expansion of GSKâs long-term commitment to vaccine supply, manufacturing and development in China.â said John Lepore, Vice President and General Manager, Biologicals and Corporate, GSK China."
h ttp://www.gsk.com/media/pressreleases/2011/2011-pressrelease-470377.htm
Yes lurker, we all see the redirect you've tried. Unfortunately for you, vaccines ARE regulated by the FDA and they are tested for contaminants - unlike the supplements that we have been discussing. That was the point of the post. Drugs and vaccines and food, regulated. Supplements, not regulated.
Denice Walter
Pinetop Perkins, the oldest person to receive a Grammy award ate a Big Mac with fries and a Sprite every day. He lived to the ripe old age of 97. So, lurker by virtue of argument by anecdote, you should give up your supplements and start dining at Rotten Ronnie's.
@Jay - Supplements should be regulated. Fortunately for me vaccines are regulated-
however I don't like the idea of outsourcing vaccines to China. Quality control is still an issue in China.
Vaccines for distribution in the U.S. and Europe are not manufactured in China. GSK along with others have manufacturing facilities in China for distribution in Asia.
@ Jay Chaplin, my understanding is that USP compliance is a quality standard that tests for impurities along with several other metrics.
I think that's a complete misreading.
Let me make an analogy. Suppose you are interviewing a job candidate, Lee:
YOU: It says here on your resume that you speak Spanish.
LEE: I do! Well, kinda. I never actually took classes but I love watching the telenovelas on the local Spanish-language station and after watching them for a few years I realized I was starting to understand what they were saying. Pretty cool, hunh?
Now, whether Lee's grasp of Spanish is a good thing or a bad thing depends on which job you're interviewing him for. If you're looking for a counter-worker at a restaurant, Lee's self-taught Spanish is probably a bonus in his favor; it could be useful someday, especially if you have a lot of Spanish-speaking people coming in for lunch.
If you are hiring someone to be your company's representative in Madrid, however, you don't want the self-taught-from-TV Spanish speaker; you want the person who's got the actual proofs of proficiency in the language. What's a nice little extra to get in a counter worker is not enough in an official company representative.
The same applies to food and drugs. It isn't that food doesn't ever have drug-like properties; it frequently does. Eat prunes and you'll be regular; eat chocolate for a bit of a mood lift; eat horseradish to clear out your sinuses, etc. That's okay if what you're aiming for is "food with a little extra added benefit." It's not okay if you have a serious medical need that requires precise dosages of a medicinal compound and you're trying to get exactly the right amount of that medicinal compound from a food or other edible that, even if it has the compound you need, has it at unknown strength along with other compounds whose effects are not necessarily known or helpful.
If supplements are "impure, adulterated drugs with highly variable potency because of their highly variable content of active ingredient," isn't that true of food in general?
While studies have shown no efficacy of various vitamins in preventing cancer, foods containing those same vitamins do seem to have such an effect. Or have I been eating all those nasty green vegetables for nothing?
I think that's a complete misreading.
Let me make an analogy. Suppose you are interviewing a job candidate, Lee:
YOU: It says here on your resume that you speak Spanish.
LEE: I do! Well, kinda. I never actually took classes but I love watching the telenovelas on the local Spanish-language station and after watching them for a few years I realized I was starting to understand what they were saying. Pretty cool, hunh?
Now, whether Lee's grasp of Spanish is a good thing or a bad thing depends on which job you're interviewing him for. If you're looking for a counter-worker at a restaurant, Lee's self-taught Spanish is probably a bonus in his favor; it could be useful someday, especially if you have a lot of Spanish-speaking people coming in for lunch.
If you are hiring someone to be your company's representative in Madrid, however, you don't want the self-taught-from-TV Spanish speaker; you want the person who's got the actual proofs of proficiency in the language. What's a nice little extra to get in a counter worker is not enough in an official company representative.
The same applies to food and drugs. It isn't that food doesn't ever have drug-like properties; it frequently does. Eat prunes and you'll be regular; eat chocolate for a bit of a mood lift; eat horseradish to clear out your sinuses, etc. That's okay if what you're aiming for is "food with a little extra added benefit." It's not okay if you have a serious medical need that requires precise dosages of a medicinal compound and you're trying to get exactly the right amount of that medicinal compound from a food or other edible that, even if it has the compound you need, has it at unknown strength along with other compounds whose effects are not necessarily known or helpful.
Hello, you used to write fantastic, but the last few posts have been kinda boringî I miss your super writings. Past few posts are just a little bit out of track! come on!Jeremy Scott Adidas
What's so great about drugs?
Over 2 MILLION serious ADRs yearly
100,000 DEATHS yearly
ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResource…
So, ken, what supplement would you prescribe to an infant with neonatal seizures that are increasing in frequency and strength? Also, what supplement would you prescribe for Type 1 diabetes? Do tell us what supplement you would prescribe for anaphylactic shock from a bee sting? What supplement would prevent a strep infection turning into scarlet fever?
Never said supplements can replace indispensable drugs-You make everything into an either/or issue. It's just not that simple. I am merely pointing out the fallibility of this type of thinking. You assume everyone who points out negatives (which is all that Orac does) is an idiot. A reminder to watch drug interactions- they are not as harmless as supplements. I have yet to hear of a Vit C overdose.
ken:
Yes, you did when you said "What's so great about drugs?"
Well, considering that many of them have extended the life of millions of people, including those with cancer: well, it seems they are useful after all.
Straw man argument. No one has said that. It is you who are pulling up the "drugs kill with adverse reaction!" bit. Which has nothing to do with the safety or efficacy of supplements (which are themselves are type of drug).
All too often certain drugs like Lipitor are prescribed (which I was prescribed first before mention of diet) to control cholesterol- well I did it by diet.
Ha, ha, ha, ha! Now you are lying, that is not the standard of care. I had to do two years of diet and exercise. My numbers went down, and the my liver decided that I did not have enough cholesterol and the numbers went up. So I have a low dose prescription of generic simvastatin.
And, newsflash: Lipitor is not a cancer medication or a way to prevent cancer.
You are tone trolling off topic.
By the way, there is a supplement made from red yeast rice. It actually has the same chemicals in cholesterol lowering meds, but in varying amounts. It is essentially the same as taking a statin. But the big difference is that one day you would be taking half a tablet worth, the next two tablets work, then perhaps a quarter of a tablet worth of the active ingredient.
It is a supplement that is actually a real drug.
Oops off topic! Your liver decided? I think you caved in! No I'm not lying.
Yes I know my friend is taking it and it's working for him. You have to take CoQ10 with any statins.
ken, learn some biology: cholesterol is made in the liver. And even though I am on statins I still exercise and watch what I eat. Apparently high cholesterol is genetic, and runs in families.
And even if you are not lying, you may have a faulty memory or went to a very bad doctor.
But that does not make supplements better than real drugs. Especially supplements that have the same chemicals as the prescription drugs.
@Chris -Good luck and good night (I know you think I'm an idiot) No hard feelings.
ken:
Citation needed.
People with high cholesterol tend to have lower levels of CoQ10, so CoQ10 has been proposed as a treatment for high cholesterol, but so far there' s no evidence whether it works or not. There is some evidence it may reduce side effects from conventional treatment with cholesterol-lowering drugs called statins, which reduce natural levels of CoQ10 in the body. Taking CoQ10 supplements can bring levels back to normal. Plus, studies show that CoQ10 may decrease the muscle pain associated with statin treatment. Ask your health care provider if you are interested in taking CoQ10 with statins.
h ttp://www.umm.edu/altmed/articles/coenzyme-q10-000295.htm
Effect of coenzyme q10 on myopathic symptoms in patients treated with statins.
http://www.ncbi.nlm.nih.gov/pubmed/17493470
Some patients. Not everyone has myopathy. Again, it is that genetics thing, ken. You are generalizing again.