Yesterday I replied to the Chairman of the Welsh Assembly’s Petition Committee who had now had two letters from the Minister for Health in Wales.j0182630

The second of these letters mentioned the fact that the UK’s Under Secretary of State for Health, Jane Ellison MP had been contacted and there are a few words of hope in her reply to the Minister.  Tucked away in the letter is the following sentence:

‘The Department of Health Medicines, Pharmacy and Industry Group (MPIG) is looking at the possibility of persuading pharmaceutical companies to introduce new formulations. I have been given no indication of when these discussions will be undertaken and it is likely to take some time’.

These ‘new formulations’ may well include a high dosage (1-2mg) oral tablet which would be the strength required to potentially treat Pernicious Anaemia (I know that some of our members take high dosage tablets rather than have injections) but it probably also means the introduction of less invasive, and potentially suitable products such as nasal sprays, nasal drops, sub-lingual lozenges, sprays and drops and even trans-dermal patches.  Whilst all of these are available and used by some of our members either instead of replacement therapy injections or as a supplementation in between injections.  The problem is that it is up to the manufacturer of the products to get them licensed for use as a treatment for Pernicious Anaemia.  At present they are sold as ‘food supplements’.

Getting the products licensed would need that they would have to meet the strict compliance regulations of the Medical and Healthcare Products Regulatory Agency and it would take a lot of money and a lot of time.  The benefits in financial terms would not be great and so I don’t see a whole host of product manufacturers rushing to the MHRA anytime soon.

This is a pity because the Pernicious Anaemia Society has had as it’s vision a world where patients are given a choice of treatments at diagnosis.  And when you think about it, a twice daily spray or drop of high potency B12 is a far more natural form of treatment as a normal healthy person will be getting regular hits of B12 throughout the day.  Receiving an injection every three months and hoping that that will suffice to treat the Pernicious Anaemia rather than regular doses suddenly feels very old fashioned.

There will be those, I’m sure, who will now take what I have read as evidence that I support the withdrawal of injections as a form of treatment.  That is not what I am saying; rather I am just pointing out that the treatment used for Pernicious Anaemia today is the same as it was 70 years ago and there must be a more effective delivery method of B12 – and there are, but they haven’t been evaluated.  And there lies the rub – how do you evaluate the efficacy of any treatment, including injections?  Current thinking among medical professionals is that the efficacy of the treatment can be evaluated by examining whether the B12 had raised serum B12 levels in the patient and consequently any anaemia has disappeared.  But this is only half of the story – any evaluation of the efficacy of any treatment must take into consideration how the patient feels.  Do different types of delivery methods of B12 yield differing levels of feelgood in patients?  We know that all of the different delivery methods will increase the patient’s B12 – but that only seems to be one aspect that needs to be considered when analysing the effectiveness of the treatment.

For those in the UK who are worried that injections are going to be replaced by oral supplementation you can seek solace in the words of the new Guidelines issued by the British Committee for Standards in Haematology – here’s what they have to say about injections:

‘However the efficacy and cost–effectiveness of oral treatment in wider population-based settings has yet to be established. There are arguments against the use of oral cobalamin in initiation of cobalamin therapy in severely deficient individuals who have poor absorption, especially due to pernicious anaemia’.

The guidelines also point out that whilst there has been some research to suggest that oral supplementation ‘should’ work the guidelines state that some patients prefer injections (including myself) because I know they work so why should we take a chance on a treatment method that ‘should’ work:

‘On the other hand, some patients may prefer intramuscular injection therapy in order to assure effective treatment

Exactly!