ANH FEATURE: Iowa Women’s Health Study: Do supplements kill older women more quickly?

By Robert Verkerk PhD
Executive and Scientific Director, ANH-Intl

KEY POINTS

  1. The research, published in the Archives of Internal Medicine’s Less is More series, was based on self-reported questionnaires completed by older women over an approximately two decade period and data from registers of death 
  2. The findings are one element, linked to vitamin and mineral supplements, taken from the Iowa Women’s Health Study that looked at numerous lifestyle factors which may affect risk of death from heart disease, cancer and other causes
  3. The study generated negative headlines about supplements around the world, yet the negative findings are mainly contentious, were only evident following data adjustment (massage) and may be anomalous
  4. The study shows the strongest associations for calcium, which appeared to reduce the risk of death, and iron, which appeared to increase the risk of death
  5. The study actually finds that vitamin and mineral supplement usage is associated with healthier lifestyles and the authors fail to indicate the outcome of the combined effect of healthy lifestyles and supplement usage
  6. The study is a good example of some of the problems that can result from scientific reductionism, which can then be used, with inadequate scientific basis, to dissuade the general public from using supplements that could be vital to their health and longevity
  7. At the ANH, we don’t believe the study offers any evidence that supplement usage may be dangerous - and we are aware of copious research, and decades of clinical experience, suggesting quite the opposite

 

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A study published in the prestigious Archives of Internal Medicine on October 10 proposes that women over the age of 55 who take vitamin or mineral supplements may die sooner than their supplement-free counterparts. The authors of the paper, led by Finnish researcher Jaako Mursu PhD, set out to test their hypothesis that supplementation would not reduce the risk of death. However, they were only able to generate findings that concurred with their hypothesis by heavily massaging the data, and most of their findings run contrary to previous and higher quality research findings.

The data used in the study were derived from three self-reporting questionnaire surveys starting in 1986 and running over a period of 22 years through to 2008. The starting population of subjects was 38,772 Iowa (USA) women from rural and non-rural settings. Two subsequent surveys of the same cohort were conducted in 1997 and 2004, and, while in all three surveys supplement use was queried, food intake was not queried in the 1997 survey (reasons for this were not given by the authors). Women taking part in the study had to be between 55 and 69 years of age (their average age was 62).

In reading the paper, it is apparent that the authors found that supplement use was often associated with more healthy lifestyle indicators, such as lower body mass index (BMI), lower hip/waist ratio, higher vegetable intake and more exercise. This association has been reported previously by other researchers, and it’s interesting that very few commentaries about the study in mainstream media have made any mention of this.

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Data massage

In Dr Mursu et al’s study, it was only when some of the available confounding factors had been ‘adjusted’ out that a few trends for particular vitamins and minerals, hinting at possible increased risk of death, became apparent. In the firing line were vitamins like B6 and folic acid, as well as the minerals iron and copper.


Many people supplement their diet every day

The key question is: do the adjustments adequately account for the rash of confounding factors, some of which were not even considered by the authors? In other words, are the statistical findings biologically meaningful? And are the conclusions drawn by the authors really warranted? At the ANH, we think not, but more on this below.

Key factors not accounted for by the authors include:

  • Drug intake and adverse reactions or interactions (the single factor most likely to be associated with risk of death)
  • Nutrient status of the subjects (e.g. as derived by blood and urine tests)
  • Duration of supplementation prior to the initial baseline in 1986
  • Form of supplemental vitamin or mineral taken
  • Other ingredients taken as supplements (such as essential fatty acids, botanicals and amino acids)
  • The possibility that increased use of supplements may have been related to perceived or diagnosed ill health, and
  • Whether sub-clinical signs of chronic disease, such as cancer or heart disease, could have already been present in some subjects at the start of the study, over which supplementation would have had little or no effect   

Note: On top of this, let’s not forget that the food questionnaire was not completed in the intermediate survey (1997), vitamin and mineral intake in food being critical because the nutrients studied are delivered both in conventional foods and in supplements.

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While the study has generated negative headlines about vitamin and mineral use by older women around the world, the authors, in their final comment on the study, did indicate possible factors that could have compromised their findings, stating, “We cannot exclude the possibility that some supplements were taken for reasonable cause in response to symptoms or clinical disease. We did not have data regarding nutritional status or detailed information of supplements used.” But, having been able to support their null hypothesis, the authors appear to have had little interest in looking any further at their study’s profound inadequacies.

Perusing the adjusted data closely, this is what we found: For the 15 vitamin or mineral categories studied in each of their three follow-up periods (1986-1996, 1997-2003 and 2004-2008), the mean hazard ratio (HR) for 20 out of 45 of the categories was less than 1. This may suggest that for 20 categories there would be a lower risk of death among supplement users as compared with non-users, while in 25 categories, the risks would be greater the other way around. But such conclusions can’t be drawn because of the variance (spread) of data. Here we must look at the confidence limits, and these were never, in each category, consistently either above or below 1. The exceptions were in calcium, where the HR was always less than 1, and in iron, where it was always greater than 1.

Calcium supplements

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Therefore, in order to take anything away from the analysis of adjusted data, we need to take a closer look only at these two ingredients, calcium and iron. When we do this, warnings immediately start being flagged, given that other studies - supported by plausible mechanisms - suggest that very high intakes of simple calcium supplements, especially in the absence of vitamin D, may increase risk of heart attack and therefore death. Conversely, iron supplements have been shown to be beneficial for pre-menopausal women or those prone to anaemia. However, the possibility of an adverse effect of high intakes of particular forms of iron supplement on older women cannot be ruled out, as there are insufficient data available.

What do the data look like before adjustment?

It must be born in mind that this is an observational study where lifestyle factors, which are known to have a far greater influence on survival outcome than typical vitamin and mineral supplementation, have been ‘adjusted out’. Before this data massage process has occurred, the findings are quite different, and appear to have been largely ignored by a mass media ever keen to find ways of damning supplements to appease their pharmaceutical industry advertisers.

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So here you have it; this is what the study actually found before the data were adjusted…

Supplement users were significantly (statistically) more likely than non-users to:

  • Be non-smokers
  • Be more educated (graduates)
  • Have lower risk of diabetes mellitus
  • Have a lower body mass index (BMI)
  • Have a lower mean hip-to-waist ratio
  • Be more physically active
  • Ingest fewer calories
  • Consume more protein
  • Consume less total fat
  • Consume more polyunsaturated fatty acids
  • Consume more fruit
  • Consume more vegetables
  • Consume more whole grain products

Frustratingly, the authors don’t tell us how these supplement users fared over the years. However, we can assume it’s quite likely that they did rather better than the non-users, and that’s why the researchers have left us only with adjusted data that’s meant to have removed the influence of these all-important lifestyle factors. For those of us more interested in integrated, whole-body, and functional models of medicine, this is of course nonsensical. We are actually more interested in trying to evaluate what combinations of factors deliver the best outcomes, be they best lifestyle practices combined with the best dietary and supplemental practices.

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The bottom line

This study is a classic example of scientific reductionism being used to fulfil a particular need. In this case, it’s supplement bashing, a well-known preoccupation of Big Pharma — and an approach that appears to be central to the protection of Big Pharma’s profit margins.

Our view is that the self-reporting questionnaires, and lack of any supporting data on nutrient status of the study’s subjects, means that the majority of the trends emerging from the adjusted data on which the study’s conclusions were based are likely to be anomalous. This is especially the case given that the most powerful trend, the apparent benefit of calcium supplements, contradicts other findings from much more robust studies.

Another very important point is that many factors were not controlled for, and these likely contributed to uncontrolled sources of variation and confounding that were simply ignored.  Among these is the crucial issue of the forms of nutrients taken, none of which were recorded in questionnaires. For example, there are several studies that suggest that long-term use of high doses of synthetic vitamin E, beta-carotene and folic acid may increase the risk of death, these generally having at least some plausible mechanisms. But, where the natural forms are consumed, especially where these nutrients are obtained from dietary sources, quite the reverse is found.

The lack of any clear dose/response trends suggests that high levels of variance and statistical noise have played havoc with the data, and the authors have mistakenly assumed that statistical significance of results should be interpreted as implying biological significance. Worse than this, the authors, by massaging the data in a weak observational study, have tried to attribute the trends they claim to have found as establishing cause and effect. This is, put simply, just bad science, especially when it’s so obvious how the findings will be used by the media. At the time of writing, just two days after the study was published, 299 links to media claiming harmful effects of vitamins could be found on Google news.

A very clear example that should ring alarm bells for any scientist, practitioner or doctor reading the study is that in the case of vitamins, such as vitamin D, where there is overwhelming evidence of benefit, no positive findings emerged. But no, the authors could quietly ignore the huge tranche of empirical and published evidence that abounds, and publish their findings in the knowledge that they had satisfied their null hypothesis. In doing so, they have knowingly, or unknowingly, played into the hands of the pharmaceutical industry, the single biggest contributor to, and controller of, medical research.


Daily supplement organiser

Perhaps most damaging in the longer term is that the study’s results provide further ammunition for regulators to clamp down even harder on consumer access to efficacious supplements — interfering with their ability to manage their own health. As we have seen many times in the past, legislators — most notably the European Commission, as well as the German, Danish and Finnish governments (note that Dr Mursu hails from Finland)  — are only too keen to refer to this kind of evidence when developing needlessly restrictive laws on food supplements. In the EU, we’ve already seen many vitamin and mineral forms rendered illegal because companies have not been able to afford to compile dossiers justifying their safety. Harmonisation of vitamin and mineral maximum (and minimum) levels across all 27 EU Member States is now imminent. Regulators have taken it upon themselves to engage in a particular, and we argue, flawed approach to risk analysis that seeks to remove any risk to the consumer. The unfortunate reality is that — in the process assuming no changes to the European Commission’s approach  — regulators will also prevent large sectors of the public from consuming amounts of vitamins and minerals that are known both to be beneficial and that millions have consumed safely over many decades.

Our advice

Our advice is simple. Don’t let this study influence your decisions about supplementation. We have always upheld that high doses of particular synthetic vitamins, notably synthetic vitamin E (alpha-tocopherol), beta-carotene and folic acid (pteroylmonoglutamic acid) may pose some risk to health in some individuals. But to avoid these risks, simply make sure you supplement with the right forms, at least of these vitamins, such as mixed tocopherols (and tocotrienols) in the case of vitamin E, mixed natural carotenoids in the case of beta-carotene and natural folate (including the 5-methyltetrahydrofolate form) in the case of folic acid.

And remember to maintain that healthy lifestyle: don’t smoke, get plenty of sleep, manage your stress, eat lots of fruit and especially vegetables, drink plenty of clean, unadulterated water — and exercise regularly. Oh, and don’t forget to supplement, as contrary to what most health authorities try to tell us, it’s increasingly difficult to get enough nutrients from our food alone to keep us in optimum health.

But don’t bother telling Dr Mursu and colleagues about this — they’ve closed their minds and shackled themselves firmly to the doctrine of scientific reductionism, which has failed so abysmally to deal with the ever-increasing chronic disease burden. Those who are the forefront of solution-based healthcare, whether they are members of the public or health professionals, have already turned their back on this type of reductionism, realising that, on its own, it leads nowhere other than to a dead end.

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Updated: 12 Oct 2011

A few years ago my husband was told his cholesterol was on the high side and that he should consider taking statins. He was not keen as several friends have suffered very unpleasant side effects from these drugs. Instead he took plant sterols and a further test three months later revealed that his cholesterol was back to normal!

Now who benefits from that result? My husband definitely does and the pharmaceutical companies do not. Enough said - I agree with the earlier posts. We need to know who funded this dubious research.

The above comment makes an interesting point. I know of a well known supplement company that is owned by a pharmaceutical company (as many are!) and they have changed the formulation of some of their products to a less bioavailable form without telling practitioners that prescribe their products, or the general public that purchase their products in good faith.

In my eyes this is sabotage by a very large pharmaceutical company that will continue to make massive profits only if the world stays ill.

Really. There are thousands of careful studies demonstrating the benefits of hundreds of supplements on the market. How can we trust a study like this?

Doesn't this once more raise the question of the extent to which the interests of the AMA and many physicians are entangled with those of big money interests in general, and Big Pharma in particular? (Do physicians have significant financial interests in Big Pharma?)

I know this comment is rather long. But PLEASE, PLEASE, PLEASE, take the couple of minutes it takes to read through it all. For many years I was researching everything possible related to natural, holistic cures for all of the health issues plaguing humanity. I myself, had been ill with minor health issues several times over my lifetime. During my time of researching the unique link between proper nutrition and sickness, I learned a few interesting things. Like the fact that the soil in which our food is being grown is seriously depleted of vital nutrients necessary to grow the highest level of nutritious food. I learned that fruits and vegetables are best when picked during the last few days of their growing cycle. However, in order to get our fruits and vegetables to market in time before they go bad, farmers were picking their produce BEFORE they were fully ripened naturally, thus weakening their nutritious quality and thus providing us with an almost "nutrient free" diet. Unbelievable! Herein lies one of the primary reasons that there is a huge need to supplement our diets in the first place. Even the most health conscious individual who chooses to only eat "healthy", is unknowingly not getting enough nutrition to stave off disease or other health issues. Now there are very good ways to help increase our chances for optimal health. I have learned that Products like [trade name removed - Ed] (for example), which is 100% whole food, concentrated fruits, vegetables and berries. Unlike it's name might indicate, this concentrated food is formulated in capsule form. The company prides itself on unbiased studies and makes all of their research available to the public. So, I have found that this company is one of the best choices for anyone wishing to naturally (not synthetically) supplement their diets. I have also found another company who produces 100% pure, therapeutic grade essential oils. They are called [trade name removed - Ed]. Unlike other essential oil companies found over the internet, the quality oils that [trade name removed - Ed] provides their customers are by far, manufactured and distilled in he highest standards possible. Research has shown that pure essential oils (if distilled properly and grown from regions around the world where the specific oil is know to have the highest standards of quality)have properties that can potentially help cure and in many cases even reverse some diseases thus providing relief from painful and debilitating symptoms that failing health presents to mankind every day. These are just two of several companies that are working hard to enable humanity have access to optimal health. Poor nutrition, stress and poor life style choices have made our lives very sick. But many of us now know that there is a God given natural remedy available on this planet for every illness. So, what stands in our way? MONEY. Unfortunately, money is the PRIMARY issue that stands as a barrier to optimum health and longevity. It's no wonder that it is said that "the love of money is the root of all evil". It is cheaper to eat off of the "dollar menu" than to purchase quality nutrition that our bodies so desperately need. Big Pharma (for one) does NOT want to help us get well. They want to fill us with the illusion of cures and symptomatic relief by commercializing their pills filled with toxic poisons. Poisons that subsequently require us to buy additional poisons in an effort to help with cope with the adverse effects of that the initial poisons have caused us. It is so frustrating to know the truth and yet many of us "in the know" feel so helpless to do anything about it. We are considered to be "conspiracy freaks". Even our meager attempts to eat right by buying organic food items is being sabotaged. First, how do we really know if the organic food is truly, 100% organic. Even being "label readers", there is a small voice in our heads that wonders if we can trust what we're reading. Then, given the state of our economy, how can we justify the expense of eating "right"? How many of us has the time, energy or even the availability to grow our own food in this day and age? Hence, we turn to supplements. Another problem here. Synthetic supplements may say on their label that they are 100% pure of whatever the main ingredient is. But what they don't tell you is that the key ingredient (while stating it is formulated with 100% of said ingredient) may not be from the part of the plant that is able to provide what it is supposed to provide. Did they get their 100% from the stem of the plant that has no benefit at all or perhaps from the beneficial leaf of the plant which in some cases is where the benefit should be derived from? Was the plant allowed to grow to maturity wherein the benefits are at their optimum? As the average lay person tries to comprehend all of this conflicting information and suspects that they are being blinded by propaganda, we are slowly but surely, dying every single day. I myself am now living proof of what happens to a body that is denied proper nutrition, denied the availability of being financially able to purchase nutritional excellence found in products like [trade name removed - Ed] and [trade name removed - Ed] Essential Oils and 100% organic food choices. This is because for the last 2 1/2 years I have fallen victim to closed angle glaucoma, followed by stage 3 Diffuse, Large B Cell, Non-Hodgkin Lymphoma, followed by the debilitating and excruciatingly painful and crippling effects of numerous neuropathy conditions that were brought on by taking Big Pharma's cures of chemotherapy and other supposedly life giving remedies. Like many other victims of disease, I have lost everything. My business, my income, my vehicle and other belongings, and probably in the very near future my home. I am so sick and tired of being so sick and tired! So, yesterday I made a CHOICE to once again go back to what I know is the truth. I must find a way to afford the God given remedies that our planet can provide me. I do not have all of the answers...YET. But I CHOOSE to get up everyday and keep looking, keep trying, keep fighting. I want to make a difference. Not just for myself, but for all of humanity. I am only one person. Still, I CHOOSE to fight even if it is all by myself. I CHOOSE life. I believe I have a right to QUALITY in this life too, don't I? If this post is reaching anyone out there, anyone who is reading this and wants to join me or perhaps to help me in this fight, please feel free to contact me. Because today I stand ready, willing and (hopefully soon)(physically) able to fight back. My life and the lives of millions like me are in the balance. Something must be done and must be done NOW!

In considering the value and credibility of research, the crucial question is always: Who funded it? If it is an organisation that has a vested interest in a particular outcome, the result cannot be impartial and therefore is academically and scientifically worthless. Do we know who funded this particular piece of research?

What about all the harmful effects of drugs promoted by the pharmaceutical industry that are approved by the FDA? The media has never published any research of their ill effects.

What they do is to warn of the effects of causing greater health harm and death in thousands of people, withdraw them from the market, and advise to seek legal assistance to claim money that by no means could return a victim's health of life.

I personally use supplements all the time and at the age of 60 suffer from "0" zero, ailments: No hypertension, no arthritis, no elevated cholesterol, no headaches, not even common colds, etc. No, I do not need "fake research" to convince me that we are nutritionally deficient and that we all need to supplement the mostly junk food that we are ingesting on a daily basis in our modern society.

My theory is that Big Pharma does not want anything, especially supplements, to interfere with their profits. When God created the world, he also made sure there was a natural cure for any and all diseases known to mankind. Since many supplements are plant or organically based, Big Pharma tends to view them as primitive resources, witch doctor remedies, carnival hawkers cures, or just plain worthless. However, it has been proven many times that while supplementation carries none of the deadly side-effects found in prescription drugs, they do eventually cure, and not just mask symptoms as those dangerous unpronounceable poisons the medical industry prescribes. Just watch any TV commercial about the newer drugs, and you'll note that among the horrific side effects, the one most predominantly listed is "death". I often wonder who in their right mind would take such a thing when there are far safer and effective alternatives from Mother Nature? There are naturopathic doctors in most communities. I would suggest seeking them out. This is not a vendetta against doctors, but sadly, most of them have little or no knowledge of nature's remedies.

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