Accordingly, I asked one of our researchers Caramia Hartley to work on preparing a more detailed response. I thought that many of our customers might be interested in this response so we are sharing it with you here.
Here it is...
Thank you for giving us the opportunity to clarify your concerns and to establish the facts.
We have carefully reviewed the Annals of Internal Medicine editorial and information about the studies. We offer the following comments. To ensure nothing was missed, we have inserted our comments in the relevant sections of the copied editorial.
Quote #One from Annals of Internal Medicine editorial:
Three articles in this issue address the role of vitamin and mineral supplements for preventing the occurrence or progression of chronic diseases.
First, Fortmann and colleagues (1) systematically reviewed trial evidence to update the U.S. Preventive Services Task Force recommendation on the efficacy of vitamin supplements for primary prevention in community-dwelling adults with no nutritional deficiencies. After reviewing 3 trials of multivitamin supplements and 24 trials of single or paired vitamins that randomly assigned more than 400,000 participants, the authors concluded that there was no clear evidence of a beneficial effect of supplements on all-cause mortality, cardiovascular disease, or cancer.
We suggest that the entire premise for these studies is flawed: Why are supplements being tested for their ability to treat chronic diseases?
The aim of supplements is precisely to supplement the diet NOT to treat the sort of chronic disorders tested for in the studies. Most people who take supplements know that a simple low-dose multivitamin won't properly address serious illness. They take multivitamins to keep their nutrition level high and to help prevent disease from occurring in the first place.
- Moreover the very premise of Dr Miller’s third study was bizarre: He wanted to know if multivitamins helped prevent second heart attacks. Do you think a low-dose multivitamin has the ability to prevent heart attacks in someone who has already had a heart attack? Of course not!
Quote #Two from Annals of Internal Medicine editorial:
Second, Grodstein and coworkers (2) evaluated the efficacy of a daily multivitamin to prevent cognitive decline among 5947 men aged 65 years or older participating in the Physicians’ Health Study II. After 12 years of follow-up, there were no differences between the multivitamin and placebo groups in overall cognitive performance or verbal memory. Adherence to the intervention was high, and the large sample size resulted in precise estimates showing that use of a multivitamin supplement in a well-nourished elderly population did not prevent cognitive decline.
Grodstein and coworkers’ findings are compatible with a recent review (3) of 12 fair- to good-quality trials that evaluated dietary supplements, including multivitamins, B vitamins, vitamins E and C, and omega-3 fatty acids, in persons with mild cognitive impairment or mild to moderate dementia. None of the supplements improved cognitive function.
- The quoted “trial evidence” is classed in the study description as “fair” and “good quality trials”. What does that mean? No explanation is given. Would you be comfortable basing your supplementary choices on ‘fair’ trials?
- There is no evidence to prove an unbiased randomisation.
- There is no evidence describing the quality, form and potency of the multi-vitamins / vitamins. All we know is that the following were used: Vitamins A, B1, B2, B6, B12, C, D, and E; calcium; iron; zinc; magnesium; niacin; folic acid; ß-carotene; and selenium. But were they in the most bio-available form? Were they natural or synthetic? The form, potency, dosage and bioavailability of vitamin ingredients make a huge difference to their efficacy. (For examples please see 3.2 below)
- Individual vitamins should rarely be taken in isolation or with just one or two others. It is best that they are a component part of a broad spectrum of synergistic vitamins and other nutrients.
- In terms of dosage, the studies “required supplement doses to be lower than the upper tolerable limit set by the U.S. Food and Nutrition Board.” The key question is ‘how much lower’? Too low, and there will be no effect at all, especially if the form and potency are poor. Take Vitamin D for example. The U.S. Institute of Medicine recommends 600 IU per day. But countless studies show that a dosage range of natural (not synthetic) Vitamin D3 should be between 6-8,000 units daily in order to attain healthy vitamin D levels.(Although we disagree with high dose Vit D. Much better to get your Vit D needs from sunshine.)
- In this second study Dr Miller conveniently forgets to mention one critical finding: this showed a statistically significant reduction in cancer rates. If a drug got these same results, it would be big, positive news.
- There is no information about the qualifications, background and affiliations of the two investigators involved in these studies. They may well have been affiliated to Big Pharma in some way. Similarly, the claim is that “additional references from outside experts” were obtained. Which experts… what are their affiliations?
- In this context, this cautionary information about medical studies is worth noting.
Quote #Three from Annals of Internal Medicine editorial:
Third, Lamas and associates (4) assessed the potential benefits of a high-dose, 28-component multivitamin supplement in 1708 men and women with a previous myocardial infarction participating in TACT (Trial to Assess Chelation Therapy). After a median follow-up of 4.6 years, there was no significant difference in recurrent cardiovascular events with multivitamins compared with placebo (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]). The trial was limited by high rates of nonadherence and dropouts.
Once again, we would suggest the premise for this study is flawed: can one realistically expect to see any improvement in cognitive ability with just a multi-vitamin on its own? Unlikely. To get improvements in this area, the health of your neuro-transmitters need to be improved, and for this they need more assistance than they can get with straight vitamins.
We also have no idea about the quality, form, potency, bioavailability and dose of this multi-vitamin.
For example, take Vitamin E. The form is critical to its efficacy. Most multi-vitamins use synthetic vitamin E in the form of alpha-tocopherol. But on its own, this has little effect. The most bioavailable Vitamin E is natural and contains a synergistic balance of eight health boosting nutrients: four tocopherols (Alpha, Beta, Gamma, Delta) and four tocotrienols (Alpha, Beta, Gamma, Delta). This combination has been shown to quench peroxynitrite, the vicious free radical which plays a major role in the development of age-related memory decline!
Therefore, you need a balance of all eight nutrients to experience the maximum power of Vitamin E.
Another example relates to Vitamin B6. Its full healing power can only be realised if it’s in the most bio-available Pyriodoxal-5-phospate form
It is highly unlikely that the natural combined component Vit E and the Pyriodoxal-5-phospate form were used because they are more expensive than the synthetic versions. You can be sure that if they were used the study authors would have made a point about it!
Some experts have argued that this study is very unrepresentative of the American population (as well as other populations), For example, Gladys Block, a professor of nutrition and epidemiology at University of California Berkeley, points out that the group of men followed in the cognitive study were all physicians with no health problems. She says: "These are very well-nourished, very health-conscious people, who do not represent the American population as a whole. In fact none of the studies accurately represents the American population” Therefore, the conclusions drawn are of limited validity and relevance.
Quote #Four from Annals of Internal Medicine editorial:
Other reviews and guidelines that have appraised the role of vitamin and mineral supplements in primary or secondary prevention of chronic disease have consistently found null results or possible harms (5-6).
The same issues described in 3.1 and 3.2 apply here: those of a false premise, and nature of the multivitamins
The results are questionable. Even the study author’s (Dr Millar) said: “With more than 50% of patients dropping interpretation is very difficult,"”
Quote #Five from Annals of Internal Medicine editorial:
Evidence involving tens of thousands of people randomly assigned in many clinical trials shows that ß-carotene, vitamin E, and possibly high doses of vitamin A supplements increase mortality (6-7)
This refers specifically to studies looking at how multivitamins prevent cancer and chronic disease. Again the fundamental premise is flawed: multi vitamins are not designed to prevent cancer or chronic disease.
Quote #Six and Seven from Annals of Internal Medicine editorial:
…and that other antioxidants (6), folic acid and B vitamins (8), and multivitamin supplements (1, 5) have no clear benefit.
Despite sobering evidence of no benefit or possible harm, use of multivitamin supplements increased among U.S. adults from 30% between 1988 to 1994 to 39% between 2003 to 2006, while overall use of dietary supplements increased from 42% to 53% (9). Longitudinal and secular trends show a steady increase in multivitamin supplement use and a decline in use of some individual supplements, such as ß-carotene and vitamin E.
The decline in use of ß-carotene and vitamin E supplements followed reports of adverse outcomes in lung cancer and all-cause mortality, respectively.
No the study did not conclude that! The exact words are: “Beta carotene, vitamin E, and higher doses of vitamin A may be associated with higher all-cause mortality.”
Note: “may be”NOT that they definitively “ increase mortality”
We have the same issue as in 3.2. regarding the quality, form, potency, bioavailability and dose of these supplements
High doses of anything can be fatal!
Quote #Eight from Annals of Internal Medicine editorial:
In contrast, sales of multivitamins and other supplements have not been affected by major studies with null results, and the U.S. supplement industry continues to grow, reaching $28 billion in annual sales in 2010. Similar trends have been observed in the United Kingdom and in other European countries.
No evidence is provided for this comment: ‘The decline in use ß-carotene and vitamin E supplements ….”
No evidence is provided of the supplement forms, dosage etc.used
Quote #Nine from Annals of Internal Medicine editorial:
The large body of accumulated evidence has important public health and clinical implications. Evidence is sufficient to advise against routine supplementation, and we should translate null and negative findings into action. The message is simple: Most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided. This message is especially true for the general population with no clear evidence of micronutrient deficiencies, who represent most supplement users in the United States and in other countries (9).
Perhaps people are less gullible and more able to read between the lines than the ‘expects’ expect?!
Quote #Ten from Annals of Internal Medicine editorial:
The evidence also has implications for research. Antioxidants, folic acid, and B vitamins are harmful or ineffective for chronic disease prevention, and further large prevention trials are no longer justified. Vitamin D supplementation, however, is an open area of investigation, particularly in deficient persons. Clinical trials have been equivocal and sometimes contradictory. For example, supplemental vitamin D, which might prevent falls in older persons, reduced the risk for falls in a few trials, had no effect in most trials, and increased falls in 1 trial. Although future studies are needed to clarify the appropriate use of vitamin D supplementation, current widespread use is not based on solid evidence that benefits outweigh harms (10).
The last sentence is fundamentally flawed. It is a known fact that “the general population… who represent most supplement users in the United States and in other countries” do have micro and macro nutrient deficiencies”
Quote #Eleven from Annals of Internal Medicine editorial:
With respect to multivitamins, the studies published in this issue and previous trials indicate no substantial health benefit. This evidence, combined with biological considerations, suggests that any effect, either beneficial or harmful, is probably small. As we learned from voluminous trial data on vitamin E, however, clinical trials are not well-suited to identify very small effects, and future trials of multivitamins for chronic disease prevention in well-nourished populations are likely to be futile.
In conclusion, ß-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful. Other antioxidants, folic acid and B vitamins, and multivitamin and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases. Although available evidence does not rule out small benefits or harms or large benefits or harms in a small subgroup of the population, we believe that the case is closed— supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.
This negative perspective of Vitamin D supplementation does not represent the facts. Nor does it specify what form of Vitamin D3 is referred to.
The health benefits of Vitamin D, especially natural vitamin D in the form of sunlight are overwhelmingly positive. In supplement form, the combination of Vitamin D3 Calcium and Vitamin K2 has very positive effects. Please see:http://www.medicalnewstoday.com/articles/161618.php
In conclusion, at best, the editorial is a poor interpretation of the facts. At worst, it's a collusion with the drug companies to undermine the integrity of supplements. Or, in Warren’s words: “Please don't be phased by this latest round of negative 'press'. Things are not as they are being portrayed.”
We hope this addresses your concern. Please ask if you have any more questions, or say how we may assist you further.