As the European Food Safety Authority (EFSA) finally approves a health claim for folate supplementation, amid new calls for folate fortification in Europe and beyond, the widespread and associated problem of vitamin B12 deficiency is being overlooked.

Folic acid supplementation can mask vitamin B12 deficiency

EFSA’s approved health claim for folate – in reality, synthetic folic acid, a very different beast indeed – belatedly recognises the nutrient’s key role in preventing neural tube defects (NTDs) in developing foetuses. Positive as this development may be, however, renewed calls for folic acid to be added to foods are somewhat simplistic.

Considering folic acid in isolation is a limited approach that fails to take into account its combined and synergistic action with other nutrients and cofactors, including other B vitamins.  Vitamins B6, B12 and folate, otherwise known as B9, all work together and supplementation of any one of them may lead to a serious imbalance. Deficiency of serum B12 or folate can cause red blood cells to enlarge, a condition known as megaloblastic anaemia.  Taking synthetic folic acid alone can mask symptoms of B12 deficiency, as folic acid can cause the blood cells affected by B12 deficiency to return to normal.  The presence of enlarged blood cells is used to determine vitamin B12 status, despite the fact that deficiency and associated symptoms can occur below the level at which blood cells are affected.  The result, regardless of the presence of enlarged blood cells, is that a potentially serious B12 deficiency may remain undiagnosed.

Vitamin B12 deficiency: the hidden epidemic

A further serious concern is that patients with vitamin B12 deficiency are frequently misdiagnosed, because the condition mimics many other conditions such as depression, psychosis, multiple sclerosis, chronic fatigue syndrome, early Parkinson’s disease, diabetic neuropathy and Alzheimer’s disease.  In babies, B12 deficiency symptoms can mimic those of autism.

The serious problems caused by undiagnosed and misdiagnosed B12 deficiency, compounded by healthcare strategies that exacerbate the problem, reveal that Western healthcare systems are seriously failing patients.  Orthodox physicians are inadequately trained to consider or recognise nutritional deficiencies, even in those who are most at risk.  Diagnostic testing for B12 deficiency is inadequate and inappropriate, with many doctors failing to match blood results with the patient’s clinical picture.  The lower limit of normal for serum vitamin B12 is much too low (see Call to Action, below), and clinical guidelines and protocols are failing to address the problem.

B12 deficiency is emerging as a serious, hidden epidemic among all ages, yet it is an easily preventable nutritional problem — solved simply by ensuring that the patient receives adequate vitamin B12, often given as regular injections, at little cost!


Who is at risk of B12 deficiency?

The most frequent cause of B12 deficiency is malabsorption, which may be caused by low stomach acid, a lack of intrinsic factor and/or suboptimal pancreatic, small intestinal or liver function. Those most at risk include:

  • Those who have adopted a vegetarian, vegan or macrobiotic lifestyle
  • The elderly and people with eating disorders, such as anorexia nervosa or bulimia
  • Those taking certain medications, including laxatives, antacids and metformin, or those who have been exposed to nitrous oxide
  • Pregnant and nursing mothers
  • The offspring of those already deficient
  • Heavy drinkers and smokers
  • Those with high homocysteine
  • Those with gastrotintestinal disorders, including autism, or those who have had gastric surgery
  • Those taking high doses of folic acid
  • Those with autoimmune disorders

Passionate campaigners

As one might expect, there are dedicated people out there who are trying hard to change this sorry situation. Sally Pacholok, a trained emergency nurse from the US, is among the pioneers in the field. Along with her co-author, osteopath and emergency physician Jeffrey Stuart, her book Could It Be B12? An Epidemic Of Misdiagnoses broke new ground when first published in 2005. Pacholok became passionate about the issue of B12 deficiency because, “In 1985, [she] diagnosed herself with vitamin B12 deficiency, after her doctors had failed to identify her condition. As a result, she is passionate about the need to educate the public about the dangerous consequences of this hidden and all-too-common disease.” Today, Pacholok and Stuart run the B12 Awareness campaign, whose mission statement is simple: “Unmasking the epidemic of undiagnosed vitamin B12 deficiency through education and advocacy”.

Sally has taken her cause across the Atlantic. In 2009, she and Stuart organised ‘B12 Awareness Week’ in both the US and the UK, the latter in collaboration with Martyn Hooper, Executive Chairman of the UK’s Pernicious Anaemia Society (PAS). The B12 Awareness Campaign’s strategy, according to Pacholok, is to use the legislative process to make a ‘B12 Awareness Week’ – or even Month – a yearly event in the US. 

A worldwide campaign

In the UK, at least, Pacholok isn’t alone. The B12 deficiency Support Group (B12d), now a charity, was set up in 2006 by UK general practitioner (GP), Dr Joseph Kayalackakom – Dr Chandy to his friends – and his assistant, Mugo Minney PhD, with broadly similar aims to Pacholok and Stuart’s B12 Awareness campaign. Despite some success, it’s clear that there’s still some way to go before B12d realises its aim of wider recognition and treatment of vitamin B12 deficiency on the UK National Health Service (NHS). A recent review of the ‘clinical knowledge summary’ – basically the evidence base – for B12 deficiency concluded there was no need for major revision, despite the present clinical recommendations dating back to 2007–8. But with Dr Chandy enjoying a higher profile both in the UK and his native India, including a meeting with UK Prime Minister David Cameron, things may be looking up.

EU vitamin harmonisation

A number of European Union (EU) Member States, in particular Germany, Denmark and France, have long pushed to ensure an extraordinarily low maximum dosage for vitamin and mineral food supplements. Germany has, for example, been successfully challenged in the European Court of Justice (ECJ), by none other than the EU Commission. In 2005, the German Federal Institute for Risk Assessment (BfR) published a 222-page document justifying what it considered as maximum levels for vitamins in foods. Astoundingly, it proposed a maximum level of 3–9 micrograms (mcg) of vitamin B12, despite copious evidence that dosages well over 1000 times greater than this have never been shown to have adverse effects

Following a case brought to the ECJ against the French Government by Solgar France and other food supplement interests, the European Commission is legally bound to introduce EU-wide harmonised legislation setting both maximum and minimum amounts for vitamins and minerals in food supplements. As exposed in two peer-reviewed scientific papers authored by ANH-Intl executive & scientific director, Robert Verkerk PhD, the methods being considered by the Commission for establishing maximum permitted levels (MPLs) are flawed. ANH-Intl is now imminently poised to commission an independent research institute to help develop a novel, science-based approach to both risk and benefit assessment that could form the basis for harmonisation. We’ll report on this in due course. 

However, one thing of which we can be fairly sure is that such a new approach will not limit vitamin levels unnecessarily or irrationally.  It becomes increasingly clear that Germany and other governments that have limited vitamin B12 in food supplements have done so to protect vested or pharmaceutical interests, rather than for reasons of public safety.

Call to action

  • If you or anyone you know has a constellation of symptoms similar to this, consider B12 deficiency as a priority! 
  • Remember that animal products are the best sources of vitamin B12, especially organ meats, beef, chicken, fish, shellfish, pork, dairy and eggs
  • Orthodox medical diagnosis of B12 deficiency is via a blood test, and Sally Pacholok warns that the reference ranges used are too low. She recommends treating for B12 deficiency below a level of 450 nanograms/L (ng/L); the US lower limit is 200 ng/L (expressed as 200 picograms/mL [pg/mL]) and the UK’s is 150 picomol/L (equivalent to 200 ng/L). If your tests show a level below 450 ng/L, which is approximately equivalent to 340 picomol/L, Pacholok suggests that you consider B12 supplementation after visiting a suitably qualified healthcare practitioner.


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