‘The tank’s empty but I can smell petrol so you have 90 days more driving ahead of you’ …..

If this advice were given by a garage we’d know they were kidding –  but a similar instruction is given in the UK to too many B12 deficient patients regarding their treatment.

NICE and BNF Guidelines advocate a maintenance dose for patients with neurological symptoms is one injection every two months. This is very often ignored and a move straight to a three monthly maintenance dose (after a 6 injection loading dose), is the norm. This is based on NO CLINICAL EVIDENCE whatsoever yet it appears to be set in stone.

I have spent quite some time trying to find the research for the bizarre idea that four B12 injections per year as a maintenance dose is ‘optimal treatment’, since this restricted regime harms those who are in dire need of a nutrient their systems are starved of. The term ‘optimal treatment’ is used to describe our quarterly maintenance dose in a series of GP audits which I blogged about earlier this year.
It was decided that district nurses time could be saved by lessening the frequency of B12 injections given, so this was eventually adopted nationally without any care for the patient. Our UK maintenance dose guidelines are based on cash saving exercises.

At the end of this blog post are the replies I have from various agencies; NHS England, Public Health England, Health Select Committee, British National Formulary, NICE, to the question;

“Please can you show me the clinical evidence which states that the three monthly maintenance dosage for B12 deficiency is optimal treatment.”

You will see that everybody addressed passes the buck and thinks that someone else has this elusive information which so many doctors adhere to. The emails take a circular route which, of course, yield no result whatsoever since there is no clinical evidence.

In a letter to my MP, Sir Bruce Keogh of NHS England stated “Most patients respond well to quarterly injections”, but where is his source?

It’s quite obvious that a great many patients do extremely badly on 3 monthly injections. Patients who email me with the subject line; ’Desperate’, ‘please help’ or ‘Am I going mad?’  And the 1000’s of members of online support groups are also testament to this.

A serum B12 level can show as ‘within range’ for weeks or even months after a single B12 injection or even a single oral supplement.  This can fool doctors into thinking there is plenty of B12 circulating and available to draw upon when, in reality, there isn’t any B12 available to the patient.

If you want to understand the complexities of B12 deficiency then this document on the enterohepatic circulation of B12 will help.

This is what Kevin Byrne (author of the above) states –

“The problem arises when you start to believe that the damage accruing from a long term deteriorative process can be fixed with a handful of injections, and when you take serum levels as a direct measure of the functioning of a distant, complex organic process.”

Many clinicians do not understand that;

• When a B12 injection is given, the majority is excreted via the bladder & bowel within 24 hours.
• B12 is water-soluble, non toxic & costs pennies.
• Progression of nerve damage is inevitable in patients who are starved of B12.
• B12 is vital for life, is required to produce healthy red blood cells and for DNA synthesis.

Both patients and clinicians are being led up the garden path;

The vast majority of GP’s are not fully educated on this very common, debilitating condition and they think they are advising patients correctly based on the limited information they were taught.

There are enlightened doctors who know that 3 monthly injections are a tortuous proposition for many patients they see and they treat appropriately by symptoms.

Worryingly there are also doctors who are informed, who want to treat patients appropriately but feel their hands are tied, either by their colleagues or by even more restrictive ’practice guidelines’ which appear to take precedence over National Guidelines. Or, these doctors are terrified of being reported to the GMC for ‘unusual prescribing’, quite bizarre when what we are discussing is a non toxic essential vitamin.

Evidence of this clinical evidence is nowhere to be found, It simply does not exist. It is a myth generated to save time and money and has had the opposite effect, costing the NHS and in turn society, millions if not billions of pounds. This is due to the inevitable misdiagnoses that occur when doctors fail to understand that four injections a year will never be enough to heal damaged nerves in many patients.

Trying to put a forest fire out with a teaspoon of water would be just as futile.

What other group of patients with a serious debilitating condition would be subjected to the same illogical and harmful treatment regime?

Whilst the vast majority of clinicians lack up to date knowledge of B12 deficiency & whilst treatment of this condition remains so illogically and harmfully restrictive, it becomes even more essential for patients to be able to access injectable B12 over the counter in the UK.

Patients don’t want more injections than they need, they just want to be able to function and get on with life. It is time once again, to shine a very bright light on exactly why UK patients are kept chronically ill and unable to work on this ridiculously low frequency, based on no clinical evidence whatsoever.

If you are in the UK, you can help by sharing this information with your MP and by asking them to contact my MP, Nicky Morgan (nicky.morgan.mp@parliament.uk) so that they can work together on this urgent issue.

Many thanks Tracey
www.b12deficiency.info

Emails below;

To: Health Committee <HEALTHCOM@parliament.uk> (Dr Sarah Wollaston)
Subject: Re: Clinical evidence for B12 treatment

Dear Victoria

Thank you for your email and the link. However you misunderstood my question. I am asking for “clinical evidence” not “clinical guidelines”.
Please can you point me in the direction of the clinical evidence that states that a three monthly maintenance dose of a 1ml b12 injection is optimal treatment for B12 deficiency? I recall Sarah stating to one of her constituents that she is aware of this evidence.

Best wishes
Tracey
www.b12deficiency.info

Health Select committee (Dr Sarah Wollaston)

<HEALTHCOM@parliament.uk> wrote:

Dear Tracey

I have asked Sarah’s office but unfortunately between us all we can’t track this information, you will need to contact NHS England/Department of Health.

Sorry I couldn’t help.

Best wishes

Victoria

Public Health England;

Hi

Thanks for your email to Public Health England. This falls outside our remit, however we are unsure who you should approach. It might be something NHS England can help you with.

Regards

PHE Enquiries.

NHS England:

Dear Tracey

Thank you for your email of 8 August within which you requested information about the clinical evidence regarding the two and three monthly maintenance doses for B12 deficiency.

NHS England is unable to advise regarding this matter and it is recommended you contact National Institute for health and Care Excellence. Contact details are available at: https://www.nice.org.uk/guidance
Further information regarding B!2 can be reviewed at: https://www.nice.org.uk/search?q=b12

I am sorry I am unable to assist you further and trust the information above is sufficient to progress your enquiry.

NICE;
(Please note I cut a whole load of this enormous email out to save you falling asleep – It was the text from the page highlighted)

Dear Tracey

Thank you for contacting NICE.

NICE produces a range of guidance and information products, including clinical guidelines, which are recommendations on how healthcare and other professionals should care for people with specific conditions. Our clinical guideline topics are referred to us by the NHS England. I can confirm that we have not been asked to develop a guideline relating to the care of people with B12 deficiency.

I believe that the resource that you have located is clinical knowledge summary (CKS) on Anaemia – B12 and folate deficiency. CKS are developed by an external company and we work with the publisher to make them available on the NICE Evidence Services website, as a source of advice for health professionals working in primary care, while they may refer to NICE guidance (if there is any that is relevant), they also use many other sources. It is important to note that they do not constitute NICE guidance.

The evidence behind the recommendations in the CKS is presented underneath the recommendations under a subheading ‘Basis for recommendation’. I hope this is helpful.

Kind regards
Janet

(I didn’t find it helpful obviously, they point towards lots of journals who don’t have the evidence we require and to the BNF; here is their response below; )

BNF British National Formulary

Thank you for your email to BNF Publications.

Unfortunately we are unable to access our archives to check what evidence base was used to determine the 3 monthly dosage of hydroxocobalamin.

BNF content will be reviewed in line with the SPCs for future updates of the BNF.

Kind regards,

BNF Publications

You will see from my previous blog on this subject that I also asked all the Marketing Authorisation holders  who provide injectable B12 in the UK where their evidence for the three monthly maintenance dose came from and each of them drew a blank too.

http://www.b12deficiency.info/blog/2016/02/16/uk-b12-deficient-patients-paltry-3-monthly-maintenance-dose-of-b12-injections-is-based-on-cash-not-care/