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April 24, 2006

Meta-analyses Used To Discredit Supplements

Several recent 'studies' on nutrients seem to contradict either what we know from previous research, or what our intelligence tells us should be true. You only have to scan the headlines and pay attention to the "newly found" dangers of this or that natural substance. From St. John's Wort to Kava Kava, from vitamin C to vitamin E, we hear that they are "not effective" or worse - that they may be dangerous.

Nonsense, says Dr Robert Verkerk of the Alliance for Natural Health, those studies are manipulated. There is a new kind of study that is highly regarded these days, the so-called "meta-analysis". It's based on a choose-and-pick approach where older studies are reviewed and analyzed to combine their wisdom. The criteria of inclusion/exclusion of previous studies in the analysis, and the decision of how to give different weights to different results are so rubbery that almost any conclusion becomes possible. One of the more recent studies that attempts to trash nutrients takes on the health benefits of fish oils...


fishes.jpg

Image credit: Boris Peterka


The fact that the meta-analysis throwing doubt on omega-3 fish oils coincides with the launch of a pharmaceutical version of the same type of fats made by chemical giant Solvay reminds me of the tryptophan disaster of more than a decade ago. The amino acid L-tryptophan was being used as a mood enhancer and remedy for migraine headaches and had people excited - finally something that worked. At the same time as Prozac was launched, a mysterious contamination of one batch of the amino-acid made by Japanese producer Showa Denko caused all tryptophan products sold as supplements to be taken off the market. Strangely, the tryptophan sold as a medicine remained on sale. Much the same happened with melatonin, a strong anti-oxidant and regulator of sleep patterns. Press reports praised the supplement no end. Once the excitement got "too much", the health authorities came down heavy handed and removed melatonin from the market in several European countries.

Examples of such strange coincidences abound, but let's concentrate on the present. Here is Rob Verkerk's analysis of some of the more recent meta-analyses that suddenly found problems with supplements...

- - -

META-ANALYSIS: a new tool to discredit natural health supplements?

By Dr Robert Verkerk, Executive & Scientific Director, Alliance for Natural Health


On 24 March 2006, The British Medical Journal published a meta-analysis (a study of other studies) on omega-3 fatty acids [1] that prompted headlines around the world to the effect that “fish oils don’t work”. This is not the first time a meta-analysis has triggered headlines that discredit natural health supplements.

The vitamin E meta-analysis of 2004

In November 2004, Dr Edgar Miller and colleagues published electronically in the Annals of Internal Medicine a meta-analysis [2] that provided headlines as bizarre as “High dose vitamin E death warning” (this headline was run by none other than the BBC on 11 November 2004). The meta-analysis appeared to be pitched to tarnish the reputation of vitamin E, a nutrient in which many are known to be deficient. Among many of its problems, the study failed to show how healthy people would respond to supplemental intakes of vitamin E and it only included studies on synthetic vitamin E (dl-alpha-tocopherol). It therefore omitted any consideration of the effects of the seven other related compounds that make-up full spectrum, natural vitamin E, as found in vegetable oils. Interestingly, the body’s absorption of the most important dietary form (gamma-tocopherol) is hindered by high doses of synthetic vitamin E, and this could have explained the negative results found by Miller et al.

The overall conclusion that high-dose vitamin E causes increased mortality could also have been a statistical artefact, with no biological relevance. Since the study assessed all-cause mortality, and not just cardiovascular mortality, other factors could easily have contributed to the greater death rate in the higher dose vitamin E group found when trials were pooled. It should be noted that the increased death rate was marginal; just 63 additional deaths per 10,000 persons, compared with the control group. Given that the confidence interval ranged from 6 to 119, this increased death rate cannot be said to be statistically significant.

Prior to this meta-analysis on vitamin E, market research data from Frost & Sullivan showed that vitamin E was the second most consumed single vitamin supplement, after vitamin C, in Europe. High-dose Vitamin E could have easily been perceived by Big Pharma as a threat to its huge cardiovascular drug market, comprised of statins, beta-blockers and ACE-inhibitors. In fact, Big Pharma had demonstrated such a strong interest in vitamins that it established an illegal cartel to control the markets and prices of a range of key vitamins, including vitamin E. Fortunately for the consumer, the conspiracy was eventually exposed and pharma companies like BASF and Hoffman-La Roche, as well as some of their top executives, got busted. Fines imposed by the US Justice Department in the US (May 1999) and, separately, by the European Commission (November 2001), which amounted to hundreds of millions of dollars in the US and similar amounts in Europe, are still among the largest ever imposed following an anti-trust investigation. Undeterred by this prosecution, Big Pharma continued its campaign against supplements, with the meta-analysis on vitamin E appearing in the peer-reviewed journal Annals of Internal Medicine just three years later.

The antioxidant vitamin meta-analysis of 2003

A year earlier, in June 2003, another meta-analysis appeared. This one was published in the prestigious medical journal, the Lancet, by Dr Marc Penn and colleagues from the Cleveland Clinic [3]. These authors asserted that beta-carotene, vitamin A and other antioxidant vitamins such as vitamin E, were harmful. These authors re-iterated yet again negative results from a very small clutch of studies on synthetic vitamins like synthetic beta-carotene and vitamin E, which were once more administered to diseased or high risk subjects, and often for inadequate periods of time.

Following the publication of the meta-analysis, the lead author was quoted in the media saying that people should stop taking supplements containing vitamins A, beta-carotene and E. These conclusions, some of which were carried over into the vitamin E meta-analysis the following year, are profound misinterpretations of the existing evidence base, and most certainly cannot be applied to the role of these vitamins in reducing risks of chronic diseases such as cancer and cardiovascular disease in healthy people. Nor can these conclusions be applied to supplements containing natural forms of these vitamins.

Back to the omega-3 meta-analysis of 2006

Last month’s attack on fish oils prompted by the meta-analysis by Dr Lee Hooper and his colleagues, as published in the BMJ, must surely be seen in the same light as the two meta-analyses discussed above. Put bluntly, the meta-analysis appears to be, once more, a vehicle to generate negative headlines. In fairness, even the authors have now conceded that they were “misquoted in much of the press.” [4]

The scientific evidence for long chain omega-3 benefits on lowering triglycerides and other risk factors in heart disease, as well as clear, beneficial immune system modulation and behavioural effects, have been regarded by scientists, doctors and health authorities around the world as conclusive. This evidence has formed the basis of recommendations to consume oily fish or fish oil supplements by many governments. Where governments have stipulated a limit on the maximum amount to be consumed, such as no more than three portions of oily fish weekly, this has served mainly as a means to limit intake of heavy metals like mercury, or other contaminants such as dioxins or PCBs common in most wild fish [5]. Peculiarly, governments have appeared shy of recommending high-quality fish oil supplements which are often guaranteed as being free of any significant levels of these contaminants. This is particularly relevant given that specific batches of several low cost, mass market fish oil product lines have recently had to be withdrawn from the UK market owing to dioxin contamination (e.g. several Seven Seas [owned by pharma giant Merck] fish oil product batches were withdrawn on 14th March 2006, and on 11th March 2006 high street pharmacy chain Boots withdrew two batches of its own brand fish oil product).

In closely scrutinising Hooper et al's paper, one thing becomes apparent: the findings are not nearly as damning as those suggested by the negative headlines on omega-3 fats that rebounded around the world for over a week. In fact, to the contrary; when it comes to the studies with fish oils only, the news appears just as rosy as we had all thought.

Ten out of 12 randomised control trials considered in the meta-analysis that assessed these oils in relation to total mortality point to positive findings. The same can be said for all three cohort studies considered by the meta-analysis authors. That’s thirteen out of fifteen studies showing favourable results for higher intakes of omega-3 fats. The remaining two studies have been presented as showing very slightly negative findings, but in both cases the studies deal with existing disease states, either angina or coronary artery bypass grafts. The negative effects, in both cases, are so small that they could be regarded as having little or no biological relevance (in one study there was half a percent greater mortality in the treatment compared with control, while in the other there was a little over a 2% difference). The meta-analysis authors themselves considered both studies as being of medium to high risk of bias, which might in itself explain or at least contribute to such variations.

So, while the world was assaulted with headlines such as “The benefits of fish and linseed oils as elixir of life are another health myth” (this example being courtesy of The Times newspaper), we could have just as easily, and much more correctly, read headlines along the lines of: “New meta-analysis reinforces the health benefits of fish oils.” But perhaps fewer newspapers would have sold on 24 and 25 March 2006.

Smearing the data with margarine

Even when Hooper and co-workers included studies with plant-derived, short chain omega-3 fats, such as those found in certain vegetable oils (e.g. flax) including margarines, the overall trend still pointed to reduced mortality for those consuming higher intake levels of all forms of omega-3.

The study that was presented as having the most pronounced apparent negative effect was one published in 2002 by Groningen University’s Dr Wanda Bemelmans and colleagues [6]. The study, known as the MARGARIN trial, investigated the effect on heart disease risk of a Unilever margarine enriched with alpha-linolenic acid (ALA), an important short-chain omega-3 found to be rich in Mediterranean diets, well known for their health promoting properties. The study also aimed to assess the effect of group education on the benefits associated with consuming a typical Mediterranean diet. Importantly, the subjects in the study all had multiple cardiovascular risk factors; nearly half were smokers and took anti-hypertensive drugs, while over 40% had family histories of cardiovascular risk.

Bemelmans and colleagues’ own findings, in contrast to their interpretation of these findings in the Hooper et al meta-analysis, are overwhelmingly positive. They demonstrate clearly the beneficial effects of ALA-enriched margarine on reducing heart disease risk. The study also shows that group education led to healthier diets, with increased consumption of fish, and consequently lower heart disease risk factors. These findings are actually fully in line with another major study, the Lyons Diet Heart Study, published in 1994 in the Lancet, which actually provided the inspiration for Bemelmans and colleagues’ MARGARIN trial.

So, how was this study distorted to give the impression that omega-3 fats might be bad for you? This is down to the very small number of deaths recorded, which could just as easily be a function of chance rather than any treatment effect. The study included only four deaths out of 266 subjects in total. The omega-3 meta-analysis authors managed to blacken this study because 3 out of 4 of these deaths (again from all-causes, not just cardiovascular disease) occurred in the high ALA, treatment group, while only one was in the low ALA, control group. This small number of deaths could easily have been a function of random, ‘statistical clustering’, particularly given that risk factors appeared lower in the high ALA treatment group.

Dr Bemelmans has actually gone on public record since the release of Hooper et al’’s meta-analysis questioning the way in which her study has been used, and how her and her co-authors’ positive findings have been used to demonstrate negative findings in the meta-analysis.

Just as importantly, since the omega-3 sources are vegetable oils in margarine, it is not surprising that the benefits are perhaps less pronounced given the inefficient and limited conversion by the human body of plant-derived omega-3s to key long chain fatty acids like eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) that are abundant in fish oils. Additionally, harmful trans fats in margarine could have been an additional confounding factor.

Cutting to the chase

Looking at all of the data in the omega-3 meta-analysis, the only area where it is possible to interpret a tendency towards very slightly negative effects, is in the case of randomised control trials (but not cohort studies) looking at the effects of omega-3 fats on cancer and stroke. However, these results could just as easily be the result of bias or confounding factors, inadequate periods of supplementation, or even the effects of contaminants in fish or fish oil capsules.

For the BMJ’’s own view on the subject, it is worth referring to the Editorial published on 24 March which focuses on Hooper et al’’s meta-analysis. Contrary to the thrust of the meta-analysis itself, and the related media, the Editorial takes a rather positive line on omega-3s, and demonstrates concern over dwindling supplies of marine-derived omega-3s. Citing directly from the Editorial:

“For the general public some omega 3 fat is good for health….. Adequate intake of omega 3 fats is particularly important for women of childbearing age…… We are faced with a paradox. Health recommendations advise increased consumption of oily fish and fish oils, within limits, on the grounds that intake is generally low. However, industrial fishing has depleted the world’s fish stocks by some 90% since 1950, and rising fish prices reduce affordability particularly for people with low incomes. Global production trends suggest that, although fish farming is expanding rapidly, we probably do not have a sustainable supply of long chain omega 3 fats.”

Additionally, there are now many Rapid Responses published in the BMJ which reinforce problems with the authors’ conclusions. These can be found at:
http://bmj.bmjjournals.com/cgi/eletters/332/7544/752.

Let you be the judge. I don’t believe many people who read the full Hooper et al meta-analysis, as well as the BMJ editorial and Rapid Responses, would stop taking fish oil supplements. The problem is that only a tiny proportion of the population will do this. Many more will succumb to the negative headlines triggered by the meta-analysis and, contrary to the vast weight of evidence, they now run the risk of going against government advice to increase consumption of oily fish or fish oil supplements at recommended doses.

Those very few who interrogate the evidence considered by Hooper and colleagues might actually decide to alter their sources of omega-3 fats, shifting in the direction of high quality fish oil supplements and away from vegetarian sources of omega-3 and even oily fish, which runs the risk of contamination. This way, they can be guaranteed specific amounts of long-chain EPA and DHA, as well as being confident they are consuming products that are certified as free from contaminants.

So, despite the headlines, there is no new evidence clouding the efficacy of fish oils or long chain essential fatty acids. In fact, if the meta-analysis had included other health benefits such as immune system function, cognitive and behavioural function and joint health, the case for marine-derived omega-3s would have looked even stronger. So strong, in fact, one wonders if the media couldn’t be sued by fish oil supplement manufacturers for damages. But things are rarely this simple.

We are left wondering about those negative headlines. Could there have been a motive for the negative spin?

Pharma fish oils

Just as we’ve seen Big Pharma control vitamin and mineral markets globally, both legally and illegally, is it not possible that this most recent skewed meta-analysis is part of a plan to discredit fish oils consumed increasingly by the masses?

When you peruse the competing interests declared in the BMJ paper, the only possible link given is that speaker fees have been paid to one of the authors by a company, Solvay, that markets a product called Omacor. Solvay is not a small marketing outfit. It is part of an international chemical and pharmaceutical group, headquartered in Brussels, which employs some 33,000 people across 50 countries. Omacor also happens to be the first prescription-only fish oil. As a licensed medicine, unlike the much more common fish oil food or dietary supplements, it can brandish extensive health and medicinal claims. Omacor, manufactured by Pronova Biocare in Norway (a private, limited company owned by Ferd Private Equity Fund), is prescribed primarily for reducing triglycerides (a major heart disease risk factor) and is positioned firmly as a stable mate with cholesterol-reducing statin drugs. In other words, the evidence for taking high quality fish oils is so convincing, drugs companies perhaps now want a slice of the action.

And the timing for the release of the meta-analysis does appear most fortuitous. In November 2004, Omacor was approved as a drug by the US Food & Drug Administration. In September 2005, Solvay Pharmaceuticals and Pronova Biocare signed a licensing agreement for exclusive distribution rights for distribution into India, Pakistan, Sri Lanka, Thailand, Vietnam, Singapore, Malaysia, China, Hong Kong and New Zealand.

Furthermore, on 1 December 2005, EPAX Sales and Production de-merged from Pronova Biocare to enable Pronova to focus exclusively on the production of prescription-only Omacor. EPAX, also based in Norway, will continue to produce concentrated omega-3 oils for the ‘poor-cousin’, dietary supplement industry.

Is the way actually being paved to encourage patients to elect for the prescription-only fish oil version, resplendent with all the health claims allowed under a drugs regime and banned in the food or dietary supplement sector? Even if these processes are only coincidental, and we currently have no direct evidence to suggest otherwise, the effect is the same.

The crying shame from a public health and disease prevention perspective, is that some of the most robust evidence for taking fish oils relates to their early, protective effects against heart disease. And that’s why the free availability of high quality fish oil supplements is so important; people only take drugs when they become sick.

So now, those people – and there may be many – who have been unfairly frightened away from fish oil supplements might believe that they need to wait until they’re sick in later life before their trusted doctors can prescribe the fish oil supplements they should have been consuming all along.

It is indeed a topsy-turvy world of lies, damn lies — and statistics.

REFERENCES

1. Hooper L, Thompson RL, Harrison RA, Summerbell CD, Ness AR, Moore HJ, Worthington HV, Durrington PN, Higgins JP, Capps NE, Riemersma RA, Ebrahim SB, Davey Smith G. Risks and benefits of omega 3 fats for mortality, cardiovascular disease, and cancer: systematic review. British Medical Journal, 2006; 332 (7544): 752-60.

2. Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Annals of Internal Medicine, 2005; 142(1): 37-46.

3. Vivekananthan DP, Penn MS, Sapp SK, Hsu A, Topol EJ. Use of antioxidant vitamins for the prevention of cardiovascular disease: meta-analysis of randomised trials. Lancet, 2003; 361(9374): 2017-23.

4. Hooper L, Thompson RL, Harrison RA, Summerbell CD, Ness AR, Moore HJ, Worthington HV, Durrington PN, Higgins JP, Capps NE, Riemersma RA, Ebrahim SB, Davey Smith G. Rapid Response in British Medical Journal: Authors reply - omega 3s and health. http://bmj.bmjjournals.com/cgi/eletters/332/7544/752#131349 [last accessed 19 April 2006].

5. Scientific Advisory Committee on Nutrition / Committee on Toxicity (UK). Advice on fish consumption: benefits and risks. Food Standards Agency / Department of Health. 2004. 204 pp.

6. Bemelmans WJ, Broer J, Feskens EJ, Smit AJ, Muskiet FA, Lefrandt JD, Bom VJ, May JF, Meyboom-de Jong B. Effect of an increased intake of alpha-linolenic acid and group nutritional education on cardiovascular risk factors: the Mediterranean Alpha-linolenic Enriched Groningen Dietary Intervention (MARGARIN) study. American Journal of Clinical Nutrition, 2002; 75(2): 221-7.

Contact:

Alliance for Natural Health
The Atrium, Dorking,
Surrey RH4 1XA, United Kingdom
Tel: +44 (0)1252 371 275
Email: info@anhcampaign.org

 


posted by Sepp Hasslberger on Monday April 24 2006
updated on Thursday December 16 2010

URL of this article:
http://www.newmediaexplorer.org/sepp/2006/04/24/metaanalyses_used_to_discredit_supplements.htm

 


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Readers' Comments


NEW META-STUDIES PROVE SYNTHETIC ANTIOXIDANTS ARE HARMFUL

Dr. Alexander Leaf, a professor and his team of scientists at Harvard, had done extensive work on omega-3 fish oils and documented the beneficial effects of this natural oil on health and cardiovascular disease, and an experiment was designed to prove its anti-arrythmic role. Leaf and other researchers cultured neonatal heart cells from rats. Under the microscope, these cells clumped together which as a clump of heart cells beat spontaneously and rhythmically just like the heart as an organ. Toxic agents known to produce fatal arrhythmias in humans were added to the medium bathing the cultured cells, and the effects of adding the omega-3 fatty acids were observed. Increased extracellular Ca2+, the cardiac glycoside ouabain, isoproterenol, lysophosphatidylcholine and acylcarnitine, thromboxane, and even the Ca2+ ionophore A23187 were tested. All of these agents induced tachyarrhythmias in the isolated myocytes (Leaf A Circulation. 2003;107:2646, 2003 American Heart Association, Inc.)

Of particular interest are the effects of elevated perfusate Ca2+ and ouabain on the myoctes. Both agents induced rapid contractions, contractures and fibrillation of the myocytes. When EPA was added to the superfusate, the beating rate slowed, and when the high Ca2+ or ouabain was added in the presence of the EPA, no arrhythmia was induced. Furthermore, after a violent fibrillation was induced in the cells by both elevated calcium and ouabain, addition of EPA stopped the arrhythmias, and the cells resumed their fairly regular contractions. The addition of the dilipidated BSA to remove the free fatty acid from the myocytes resulted in recurrence of the arrhythmia. This indicated two important facts as outlined by Dr. Leaf. First, the EPA could be extracted from the cells in the continued presence of the toxins, and the arrhythmia would return, which indicated that the fatty acids were acting without strong ionic or covalent binding to any constituent in the cell membrane. If they had such binding, we would not have been able to extract the EPA from the cells with the albumin. It appears the free fatty acids act directly on the heart cells and need only partition (dissolve) into the hospitable hydrophobic interior of phospholipids of the plasma membranes of myocytes to elicit their antiarrhythmic actions. Second, when we tested the ethyl ester of the EPA, it had no prompt antiarrhythmic action; only the free fatty acid with its negative carboxyl charge was antiarrhythmic. Herein lies the key in understanding the role of omega-3 oil - its role as an antioxidant (see":WHY OMEGA-3 FISH OIL PROTECTS YOUR HEART AND BRAIN;Health Supreme).

Another study reported in the Annals of Internal Medicine concluded that omega-3 fatty acids can slow the course of atherosclerosis and may reduce the risk of further heart disease. Many studies have come to a similar conclusion.

After several population studies that noted the positive effects of omega-3 fish oils and laboratory evidence, I explained their role as an antioxidant in an article. Now, it was within mainstream science and the growing understanding and popularity of natural biomolecules that are integrated into normal and healthy cellular function and at the same time more people became aware of drug toxicities, I was expecting "studies" to contradict omega-3 fish oil studies, but I expected something subtle like casting a doubt at first and then discrediting it. I did not expected a foolhardy and blatant "fish oils don't work?? in a British Medical Journal.

The fact remains that natural omega-3 fish oil, like many other natural oils are antioxidants that scavenge free radicals in the cell wall and biomembranes and provide an electron to the lipid part of the molecules in biomembranes, that was lost to a free radical and that restores stability and functional integrity to the biomembranes. That sums up, in a nutshell, the antioxidant role of such oils (and) fat soluble antioxidants in restoring healthy function of cells and tissues. These natural antioxidants are an integral part of our evolutionary history whereas synthetic molecules are not.

Please note the use of synthetic vitamin E in the Miller study, and this could have explained the negative results found by Miller et al.
Lancet, by Dr Marc Penn and colleagues from the Cleveland Clinic [3]. Again, note the negative results from a very small clutch of studies on synthetic vitamins like synthetic beta-carotene and vitamin E, which were administered to diseased or high risk subjects. These authors asserted that beta-carotene, vitamin A and other antioxidant vitamins such as vitamin E, were harmful. That conclusion in Lancet, by Dr Marc Penn and colleagues from the Cleveland Clinic is correct and wholly supports what we have been saying - that synthetic molecules are harmful and cannot be incorporated into therapies and diet.

Synthetic biomolecules can suppress the immune system or disrupt the production of natural antioxidants in the body or disrupt normal biochemical pathways in the body.

Natural molecules, such as natural oils, fat soluble antioxidants and natural vitamins have been part of mammalian diet for 65 million years and primate diets for 15 million years of hominid evolution. We read in our primary schools how effective vitamin C was in curing scurvy in sailors. Research in free radical science has already contributed so much knowledge to mainstream science and would any reputable scientist or researcher dare state that natural antioxidants "don't work" and are harmful while only synthetic molecules work and are safer?

History of science is important. History of the use of oils is a part of that history as well as part of the history of marketing. A few deacades ago, a particular association began lobbying and commenced a media campaign against natural tropical oils saying that these oils are highly saturated. Their campaign was designed to get people to switch to vegetable oils that they did not say were in fact, hydrogenated oils and in the body these long chain fatty acids become converted to circulating lipoproteins and hence contrubute to the artery-clogging factor. Their campaign succeeded inspite of the fact, tropical oils are not long chain fattry acids but are medium chain fatty acids that are readily broken in the liver to produce energy and do not become circulating fat molecules and do not contribute to artery-clogging. The other positive information of medium chain fatty acids was never brought to light, including their anti-inflammatory properties and that it is used by the body to produce antimicrobial and antiviral molecules and has cardio-protective function as well.

The success of that campaign against tropical oils contributed to rising rates of obesity, cardiovascular disease and cancers and created an expanded market for a wider range of drugs.

It can be speculated that the synthetic oil starts as a prescripitory medication in order to gain a foothold in the market and later it may 'moved' as a supplement to broaden its market.

The war on natural fish oil is being fought differently. Meta-studies appear to be used as a tool to discredit other scientific works in reputable journals for purposes of possibly altering consumer buying behaviour in favour of a synthetic oil.

I think, it will not work this time because far too many people are more educated than before and too many people know how science is manipulated. And these people put their health above "prescripitory health". They know the difference between the two and it points to the need to improve science literacy in Congress and Parliaments and the need to scrutinize the media that attempts to promote synthetic stuff as superior and better than natural biomolecules while at the same time discrediting other scientific studies that prove or note the benefical function of natural biomolecules in the human body. It also points to the need for a sound health education in primary and secondary schools and as a subsidiary subject in colleges and universities.

BELDEU SINGH

Posted by: BELDEU SINGH on April 25, 2006 07:25 AM

 


Vitamin Safety Review Panel Issues Follow-Up Report
May 26, 2006

Independent Vitamin Safety Review Panelists:

Abram Hoffer, MD
Michael Janson, MD
Thomas Levy, MD, JD
Carolyn Dean, ND, MD
Harold Foster, PhD
Erik Paterson, MD
Woody R. McGinnis, MD
Allan N. Spreen, MD
Michael Friedman, ND
H. H. Nehrlich, PhD
Andrew Saul, Chairman

Vitamin-bashing articles are typically based on studies with faulty design whose conclusions were preordained. One example is the "meta-analysis." A meta-analysis is not new research, but rather a review of existing research. It is not a clinical study, but rather a statistical look at a collection of studies. If you analyze enough failed studies, you will get a negative meta-analysis. If you exclude enough successful studies, you preordain the conclusion.

PROVING EFFECTIVENESS

Low-dose vitamin studies are the ones that get negative results. Most vitamin research is low-dose. You cannot test the effectiveness of high doses by giving low doses. Any time nutritional research employs inadequately low doses of vitamins, doses that hundreds of orthomolecular physicians have already reported as too small to work, vitamin therapy will be touted as "ineffective."

You can set up any study to fail. One way to ensure failure is to make a meaningless test. A meaningless test is assured if you make the choice to use insufficient quantities of the substance to be investigated. If you shoot beans at a charging rhinoceros, you are not likely to influence the outcome. If you give every homeless person you met on the street 25 cents, you could easily prove that money will not help poverty.

PROVING SAFETY

One reason commonly offered to justify conducting low-dose studies is that high doses of vitamins are somehow dangerous.

They are not.

There are those who may not believe this next statement, but it is not a matter of belief. It is a matter of fact: There is not even one death per year from vitamin supplements. (1)

However, there are at least 106,000 deaths from pharmaceutical drugs each year in the USA, even when taken as prescribed. (2) This may be a low estimate. Carolyn Dean, ND, MD, said, "784,000 people are dying annually, prematurely, due to modern medicine." "These are statistics from peer-reviewed journals and government databases." (3)

Abram Hoffer, MD, PhD, who conducted the first double-blind placebo controlled studies in psychiatry, has called for double-blind placebo controlled testing of alleged vitamin side effects. He said, "Let the opponents of vitamin therapy cite the double-blind placebo controlled studies upon which they have based their toxicity allegations. They can't, because there aren't any."

ELIMINATING BIAS

It is ironic that critics of vitamins preferentially cite low dose studies in an attempt to show lack of vitamin effectiveness, yet they cannot cite any double-blind, placebo controlled studies of high doses that show vitamin dangers. This is because vitamins are effective at high doses, and vitamins are safe at high doses.

Health professionals and other interested persons are invited to personally search the literature for evidence of deaths caused by vitamin supplements. You will not find even one death per year. (4)

Physician reports confirm this. A panel of researchers and physicians experienced in high-dose vitamin therapy unequivocally states, "Vitamins are very safe for the public." Woody R. McGinnis, MD, writes: "In my practice, high doses of vitamins and minerals have retrieved hundreds of otherwise desperate patients from severe behavioral disorders without a single severe complication." Adds Michael Friedman, ND: "I have never seen any toxicity with any vitamin prescriptions in my practice."

Michael Janson, MD, said, "In decades of people taking a wide variety of dietary supplements, few adverse effects have been noted, and zero deaths as a result of the dietary supplements." Thomas Levy, JD, MD, said assaults on the theoretical toxicity of vitamins are "ridiculous."

It is the conclusion of the Independent Vitamin Safety Review Panel that high dose vitamin supplementation is strikingly safe and highly effective.

References:

1. Watson WA, Litovitz TL, Klein-Schwartz W, Rodgers GC Jr, Youniss J, Reid N, Rouse WG, Rembert RS, Borys D. 2003 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2004 Sep;22(5):335-404.

2. Lucian Leape, Error in medicine. Journal of the American Medical Association, 1994, 272:23, p 1851. Also: Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA. 2000 Jul 5;284(1):95-7.)

3. Dean C and Tuck T. Death by modern medicine. Belleville, ON: Matrix Verite, 2005.

4. Testimony before the Government of Canada, House of Commons Standing Committee on Health, regarding nutritional supplement product safety (Ottawa, May 12, 2005).

What is Orthomolecular Medicine?

Linus Pauling defined orthomolecular medicine as "the treatment of disease by the provision of the optimum molecular environment, especially the optimum concentrations of substances normally present in the human body." Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomolecular.org

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and non-commercial informational resource.

Andrew W. Saul, Editor.


A more complete report on the review can be found here: REPORT OF THE INDEPENDENT VITAMIN SAFETY REVIEW PANEL

Posted by: Sepp on May 28, 2006 12:05 PM

 















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