COVID 19 is leaving B12 deficient patients unprotected & traumatised….

Gradually, everything that was remotely protective for B12 deficient patients appears to be being deleted, eroded and changed to suit those who seem intent on switching us permanently to tablets which won’t help to repair nerves.

B12 supports the immune system, it is vital for life, injections are required to keep those of us who cannot absorb B12 from food well and functioning. The WHO list hydroxocobalamin as an essential medicine. Humans simply cannot live without it and should not be forced to, but that’s what’s happening now.

Those having injections regularly cannot absorb B12 from food, it is not dietary lack that brought them to their knees it was one of the other many causes of B12 deficiency.

Many are terrified to challenge their GP’s, many who have asked to be allowed to self inject have been ignored. Nurses are calling patients for their agreement to permanently switch their future treatment to tablets only. This must be resisted at all costs, see why below. Patients are already traumatised by COVID, separated from their loved ones and then have to deal without vital treatment because of a distinct lack of understanding of this very common and commonly misdiagnosed condition.

Things are changing day by day and there is no one sensible source of information for our GP’s. Some patients have had letters stating the GP’s are following advice from Public Health England, NHS England, CCG’s, etc and some even say ‘advice from Europe’.

 

The situation is an absolute disaster and needs sorting fast.

Patients need vital injections

Patients can be taught to give injections, we can be trusted, we are adults

Patients can then function, can do their Key work, can look after their families, can maintain mobility, can reduce pain levels and keep mental health problems at bay.

The BMA (British Medical Association) March

In March the BMA produced a traffic light workload prioritisation table for the RCGP.

Stating:
………Past experience has shown that patients will die from non-COVID-19 related illnesses in addition to COVID-19 itself as we divert all of our health care resources towards it (1). General Practice has a huge role to play in maintaining the underlying health of our population in an attempt to prevent this. It is vital that we continue to provide care to all patients if we have the capacity, with workloads stratified to ensure that those at greatest need are prioritised.”

It uses the following headings:

GREEN – CONTINUE      AMBER – IF POSSIBLE       RED – STOP

B12 injections are under Amber as follows;

“Vitamin B12 injections – consider teaching appropriate patients to self-administer and ensure frequency is not more than 12 weekly”

(Not more than 12 weekly eh? That’s not what NICE say – see below!).

BMA April

B12 injections have since been downgraded by the BMA and the headings have been changed, only a few are now considered “Medium Priority” as of April the 10th 2020.

Amber – Medium Priority

“Vitamin B12 injections for post bariatric surgery patients – consider teaching appropriate patients to self-administer and ensure frequency is not more than 12 weekly. Review whether oral supplementation would be appropriate”.

Red – Lower Priority

“Vitamin B12 injections – consider teaching appropriate patients to self-administer and ensure frequency is not more than 12 weekly. Review whether oral supplementation would be appropriate if asymptomatic with a dietary deficiency ” BMJ 2019 https://www.bmj.com/content/365/bmj.l1865

The question is, why during this crisis, isn’t our immunity boosting, life saving vitamin injection for people who can’t absorb B12 from food in the Green band? It simply doesn’t make any sense.

This is what NICE CKS states, that if B12 deficiency is;

Not thought to be diet related — administer hydroxocobalamin 1 mg intramuscularly every 2–3 months for life.
Thought to be diet related — advise people either to take oral cyanocobalamin tablets 50–150 micrograms daily between meals, or have a twice-yearly hydroxocobalamin 1 mg injection.

British Society for Haematology (BSH) is moving goal posts; 

BSH advice during the COVID19 pandemic now decide that those of us who rely on B12 injections can now access our non existent liver stores, here’s an excerpt below;

Liver stores last for a year and hence levels of B12 will not be affected if one to two 3 monthly injection is omitted in patients on maintenance parenteral  B12 supplements.  BSH supports omitting B12 injections even in this group during COVID19 outbreak at least until the surge has passed.

For patients who report symptoms in the weeks  preceding B12 injection, oral B12 50-150 micrograms per day can be offered as an alternative because there will still be sufficient absorption.  If still very symptomatic then B12 injection can be given with clear understanding that the interaction with healthcare increases transmission risk of COVID19. We suggest taking the opportunity to measure B12.

FAO/WHO 2001. Human Vitamin and Mineral Requirements. Chapter 5.
“…..Interruption of this so-called enterohepatic circulation of vitamin B12 causes the body to go into a significant negative balance for the vitamin. Although the body typically has sufficient vitamin B12 stores to last 3-5 years, once PA has been established the lack of absorption of new vitamin B12 is compounded by the loss of the vitamin because of negative balance. When the stores have been depleted, the final stages of deficiency are often quite rapid, resulting in death in a period of months if left untreated.” 

 

Oral B12 research 

Patients during the crisis are now regularly told that they can in fact absorb B12 from cyanocobalamin tablets and yet:

A review from Cochrane; (Wang et al., 2018) details this: …… 

No study reported on clinical signs and symptoms of vitamin B12 deficiency (e.g. fatigue, depression, neurological complications), health-related quality of life, or acceptability of the treatment scheme.”

Authors’ conclusions:  “Low quality evidence shows oral and IM vitamin B12 having similar effects in terms of normalising serum vitamin B12 levels, but oral treatment costs less.  We found very low-quality evidence that oral vitamin B12 appears as safe as IM vitamin B12.  Further trials should conduct better randomisation and blinding procedures, recruit more participants, and provide adequate reporting.  Future trials should also measure important outcomes such as the clinical signs and symptoms of vitamin B12 deficiency, health related-quality of life, socioeconomic effects, and report adverse events adequately, preferably in a primary care setting.

The Difficulties With Vitamin B12

https://pubmed.ncbi.nlm.nih.gov/27009308/?i=5&from=b12

A 22-year-old woman presented with progressive sensory ataxia and optic neuropathy. Previous investigation by her general practitioner had found a low serum vitamin B12, which had been corrected with oral supplementation. Neurological investigations showed raised plasma homocysteine and methylmalonic acid towards the upper limit of normal with a low serum vitamin B12 MRI showed an extensive cord lesion in keeping with subacute combined degeneration of the spinal cord. We treated her with high dose parenteral vitamin B12 and she has made a partial recovery. We discuss the management of patients who present with neurological manifestations of vitamin B12 deficiency; highlighting the fact that parenteral replacement is needed in such cases, even if the serum vitamin B12 level appears to be normal. We also discuss ancillary investigations that should be performed in patients with suspected vitamin B12 deficiency.

Caution note from the B12 institute about oral supplements .

____________________________________

Everyone making the rules is watching the smoke but not one is seeing the fire…..

People in crisis sometimes make bad decisions and stopping B12 injections is one of them, it’s short sighted and harmful and there will be a price to pay if things don’t change soon.

A simple solution would be to allow us to buy injectable B12 OTC as is allowed in many other countries, which leads me to my next blog.

Best wishes and keep safe
Tracey

www.b12deficiency.info

(Thank you Dr Katie Brooks for finding WHO ref)

‘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/