Okay, there is a lot of talk about patients needing more frequent b12 injections. There is also a lot of talk that there is not enough evidence to prove the same.
There is a way around this:
Pharmaceutical companies are responsible for the efficiency of their products. Both doctors and patients can report issues with products.
Pharma companies have to record these and act accordingly.
I have direct experience of being one of those that reported issues with another product and subsquently, and quite quickly, the product directions were changed.
Most people think of issues with products being related to side effects - although this is an, obviously important issue, it should also be reported if the product is not being as effective as it should be. Meaning the pharma companies have to re-visit their research and guidelines.
When it comes to b12 in the UK you will find on b12 product data sheets that the guidelines referring to 3 monthly jabs are in respect of treating anaemia only. For many b12 deficient patients they never get the anaemia and the neurological symptoms and permanent damage long precede anaemia. Yet the product does not refer to this. It should.
Doctors should be reporting that patients are having returning neuro symptoms with injections at the current rate, but they are not. However patients can report it. This, in effect, makes the pharmaceutical company responsible for any patient suffering neurological damage who has reported their product is not effective.
To do this, ask for your prescription record. On their (there - I found the edit button) it should give the name of the product (B12) you are being given. Look up the data sheet on the internet and locate the producing company. Telephone the company, explain your neuro symptoms come back. They may state that their product is only for treating anaemia. Tell them you still want the problems recording and that you would like a reference number.
If enough people do this, and with pharmaceutical companies it doesn't take many, then they have to start instigating change. Class actions don't appeal to them much.
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Poppet11
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It was the Yellow Card Scheme that I added my comments to about the other product. However I wasn't directed to do so by the pharmaceutical company, I just did that on my own.
I am aware though that when I reported my problems, there were, according to the pharmaceutical company only 3 other reports of the same problems. Yet within 1 year the warnings on the labels had become very, very prominent and doctors could in no way put patient's symptoms down to being hysterical problems as they had originally done in my case.
However how that would work with remaining symptoms relating to inadequate treatment, I don't know. I know the Yellow Card Scheme is for reporting adverse effects only.
The pharmaceutical companies are private businesses and can't afford either the bad publicity or the actions. Yet they are the ones that give out the guidelines on medications and they are the ones that perform the research or fund research.
Isn't it about time they started doing their job properly in respect of b12 treatment?
And the unfortunate bottom line is, that as individuals, patients have got no other way of getting their voices heard.
As I understand, the Yellow Card scheme is for any side effects. So that could include positive benefits where they are not a recognised part of the spectrum of action of the medicine. However, I could be totally wrong - wouldn't be the first time!
I don't know about that. I would just be concerned that they would interpret recurring symptoms as being negative side effects rather than a return of symptoms.
I've seen in several places where pink urine has been reported as a 'side effect.'
HI,
I'm just reading the (new) PILL online for my B12, they are not advising anything now, it clearly states:
PATIENT INFORMATION LEAFLET
Hydroxocobalamin 1mg/ml Solution for Injection
"Your doctor will decide the correct dose for you depending on your circumstances.
You will be given a starting treatment and then maintenance."
Just to clarify: is this your prescribed medication or one that you buy privately?
Also, just underneath the 'doctor will decide...' It states "the injection may need to be repeated depending on your response."
Question them on this.
You can only discuss with them what is in the patient information leaflet not anything that is excluded.
Now when it comes to side effects it states to 'tell you doctor.' Your doctor is supposed to report this to the pharmaceutical company as they are supposed to report ineffectual medicines.
Again, report it to the pharmaceutical company and then put it in writing to your doctor that you are experiencing a return of symptoms.
If you think that it has taken till recently for pharmaceuticals to report that asprin does little or nothing for back pain, you can see how difficult it is to get doctors to report ineffectual medicines (or dosages). The trick is strength in numbers. If doctors don't report it, then patients should.
I'm editing again:
Put it this way: if 400 patients can turn round to their doctor and their pharmaceutical company and say, "I know another 399 people who are saying the same as me," how much more influence does that give the patient over the patient who goes in on their own to their GP to plead for medication?
Its the one I am prescribed: this Patient Information Leaflet (PIL) has been updated (28-Jul-2014 to Current ), not that I get a Patient Information Leaflet (PIL) with my prescribed ampoules, I got this Patient Information Leaflet (PIL) online, my ampoules often come in a white box, or in the right box but without the Patient Information Leaflet (PIL).
Re: "the injection may need to be repeated depending on your response." Surely that is up to your Dr to decide your response, not the product?
What I buy comes from abroad.
I'm sorry, I do not want to be negative, it just looks like the pharmaceutical company are a step ahead, by changing their leaflets and putting all decisions in the hands of Drs.
That is what it looks like to me any way. And I have family members doing fine on the standard maintenance doses of the same B12. I now think I know why I do not do well as there is no doubt I do not recycle much bile so no recycling of injected B12 either.
Nor can I say my GP will not prescribe me more B12, I have a new GP, I've never asked, he may be more open to more frequent B12 jabs now I've had further test results, I have just not bothered asking as I'm currently happy with my treatment and added own supplies.
But they still have to be made aware if there are issues. And certainly the one I reported this year clearly stated that anaemia has to be treated with maintenance jabs every 3 months. Perhaps it is best that each patient checks their own?
I'm not surprised to hear that some people do well on the maintenance jabs - of course each patient is different. This is a progressive illness and response to medication is dependant on when each individual is identified as being deficient and treated.
I think I stated in the other post that I made, some people are picked up as being deficient very early and some are picked up further along the line when neurological degeneration has taken place. Subsequently some patients take longer to repair and some repairs can never be put right.
So you may have a situation whereby patients have severe neurological damage and an injection every 3 months is expected to not only completely repair this damage but also to replete their b12 levels to full capacity.
Which is trying to achieve the impossible.
I suppose, in reading another post that you made, you made the point yourself. You pointed out to your GP that you did better on more regular injections but had to turn to injecting yourself. If you hadn't done this, you have to ask how far your injuries would have progressed? In scientific terms, you are looking at build up of fatty acids on your nerves, demyelination and axonal death.
Many patients go this route before they achieve a diagnosis and even then once b12 levels are brought into the normal range they are presumed to be recovered. Yet dead nerves cannot recover.
The relevance is in understanding the metabolic functions of b12, how this translates into physical injury and the ensuing, quite possibly irreparable damage caused by a lack of it.
It doesn't matter what blood levels show relating to how much b12 is there - because that b12 can not positively affect the nerve damage in axonal death.
So I agree completely, it is never black and white. Each case is different.
I'm also editing to say - I know the current stance in the UK is that there is no evidence that patients would be better on 3 monthly jabs, but I have also yet to see evidence that claims 3 monthly jabs are adequate for all b12 deficient patients.
In UK the guidance for treatment comes from NICE (cks.nice.org.uk/anaemia-b12... and the British National Formulary (BNF) (bnf.org)., but GP is ultimately responsible for the individual patient.
•For patients with no neurological involvement, treatment is with six injections of hydroxocobalamin, 1 mg in 1 mL at intervals of between 2-4 days.
•Subsequently, 1 mg is usually given at intervals of three months. There is as yet no evidence-based guidance as to the optimum regime but the National Institute for Health and Care Excellence (NICE) is considering releasing guidance in due course. It should be remembered that serum B12 is not always an accurate reflection of deficiency at a cellular level.[4] It is perhaps for this reason that some patients become symptomatic if the frequency of their injections is reduced, despite having normal serum B12 levels.
•For patients with neurological involvement, referral to a haematologist is recommended. Initial treatment is with hydroxocobalamin 1 mg on alternate days until there is no further improvement, after which 1 mg should be given every two months for life.[2]
•Care should be taken not to give folic acid (instead of B12) to any patient who is B12-deprived, as this may result in fulminant neurological deficit.
•Oral iron therapy should be given before B12 if iron deficiency is diagnosed by an absence of stainable Fe in the bone marrow or other parameters (eg, serum ferritin <449 pmol/mL)."
I've Just looked up the PIL for another make of hydroxocobalamin (Cobalin-H) I regularly have been prescribed, it also has been changed to state:
"Maintenance dose: Your doctor will check your condition regularly. When he/she feels that your health has improved sufficiently, your dose of Cobalin-H will be reduced to1000 mcg every 2-3 months or as required."
So the responsibility for frequency of injections appears to be with your Dr/GP, not the product, I can not see how not getting enough (frequency related) B12 injections (or late treatment/ diagnosis) can be seen as a problem with the Pharmaceutical company and the efficiency of their products. And quite often its another issue such as having become folate def that often also plays a part in a patient not doing well on current treatment.
Its all a mine field for a GP, then individual trusts (PCTs) also set certain conditions (I believe that to be more financial related, but not sure).
Surely you are simply reinforcing the problems that exist within the UK system. Which is ignorance of the progression of the illness. Ignorance that the illness causes one or a combination of Dementia, neurological damage, anaemia. And certainly ignorance of the limitations and design of the serum b12 test.
There is no point in asking the people who are getting it wrong for their opinion because there is no research to prove what their guidelines are founded on? Yet what they are saying is that there is no research to prove their guidelines are ineffective.
Responsibility relating to the pharmaceutical companies rests on the research they have performed relating to the products effectiveness in treating neurological damage.
They have a duty of care for their products to be fit for purpose. They have to show what steps they have taken to prove the effectiveness of the product. If they have only tested the product in respect of treating anaemia then they can be held responsible when Drs are utilising it to treat neurological damage.
The main problems relate to the misconceptions regarding the serum b12 test. The misconception that once patients blood levels return to within the normal range neurological damage has been repaired - so the powers that be need to be held to account as to the scientific basis as to how this protocol was achieved.
The pharmaceutical companies can also be held to account if their guidelines provide inadequate treatment for neurological damage - and there are products other than the one you use in the UK that do provide guidance for this.
And Drs can be held to account for failing to upgrade their skills and knowledge in accordance with the illness and for failing to report to authorities that patients have reoccuring symptoms on the current regimen.
There are professional duties of care each step of the way and these duties are being breached. You only have to look at the comments on this forum to see that many, many people are suffering neurological damage - whether this is permanent or will continue to degenerate is relevant to individuals - but to state that no one is accepting responsibility or is accountable simply because of individuals or organisations applying obstructive practices and omitting their duties, is not a valid argument.
Because if they were performing and doing their job as it should be done, there would be no need for this forum.
Meanwhile patients are trying to struggle through life with neurological degeneration at many levels and many of them cannot even get their doctors to diagnose them with any kind of illness - because 'Your b12 levels are normal now." Surely this is the most ignorant statement of all. Do none of them know what this test was designed for?
I totally agree with what you write in your post, its just that I can not see the pharma industry/ product to be responsible if your GP does not treat you adequately according to your individual needs. Re: "They have a duty of care for their products to be fit for purpose.", their product is fit for purpose , but needs to be prescribed earlier in some cases and/or more frequently, is how I think I see it. The new The British Committee for Standards in Haematology (BCSH) Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders, should put a stop to the reliance of GPs on the serum B12 test, expect it will take time..
I don't think you will have had time to read my other post but pharmaceutical companies can be held responsible.
Doctors however are liable because they have the patient in front of them. Even the NICE website provides external links for doctors to upgrade their knowledge in this particular area to research performed outside of the UK.
But all of them have a duty of care at several levels. Simply ignoring one or more aspects of the illness does not provide a defence.
I'm replying to myself simply because I would like to say that when I was first diagnosed there were 2 things I found which confused me no end.
1. Was the statement that b12 levels are normal now.
I couldn't understand why doctors would say this when it was clear even from scratching the surface on the internet that a b12 deficiency could result in neurological damage that was permanent irrespective of whether you showed signs of anaemia or not.
2. All the referenced guidelines stated that if patients had remaining symptoms they should be referred to a haematologist.
My question was always - why?
What has neurological damage sustained when a patient was deficient got to do with a haematologist?
It took me a long time to uncover the problems.
That Drs, because they are not upgrading skills and knowledge, believe that patients can be ill during the time they are deficient but are restored to immediate health neurologically or otherwise once b12 levels are into the normal range.
Poppycock.
You then have a compounding situation whereby if a patient has remaining symptoms they are sent to a haematologist. And the haematologist is only looking at the levels in respect of diagnosing and treating anaemia, because they too have failed to upgrade their skills and knowledge.
If a patient is lucky they are sent to a neurologist who sees that the b12 levels are normal, presumes the haematologist has upgraded skills and knowledge and declares patients neurological damage to be some form of hysteria.
The guidance provided from the pharmaceutical companies is based, in my experience on treating anaemia.
All any one of them is treating is anaemia. And no doubt some patients may present with anaemia alone or in conjunction with the other symptoms. But many patients don't have anaemia, many patients present with neurological damage which is much harder to treat.
Who is responsible for upgrading skills and knowledge, providing researched guidelines and effective medications - not the patients that is for sure.
And that information is out there - easily accessible.
I found a haematologist good, she tested blood but also did neurological tests, then referred me to neurologist. PA is a blood disorder initially (even when no anaemia), so a haematologist is the first expert I believe, who then refers to other experts such as neurologist and or gastro as required..I believe.
I'm afraid we disagree. B12 deficiency is not a blood disorder. It's a metabolic disorder. The test that identifies the deficiency (whether as b12 or anaemia) is only relevant to the levels it was set at during design to assist both in diagnosis and effective treatment. Simply because b12 is carried through the blood and can, sometimes, be diagnosed through the blood, does not make it a blood disorder.
So, although it may reveal itself through blood tests (which are only as good as the design and purpose) these aid in diagnostics, the blood tests do not define the nature of the illness.
If we diagnosed and treated b12 deficiency through urine, would it be considered a urinary disorder? (Pedantics aside I'm not including the urinary MMA test!)
For you personally I'm pleased to say one of the lucky ones regarding a neurologist recognising that your neurological damage was relevant to your b12 deficiency. But as the posts on this board show most people don't get that.
I know I keep editing, but I think of better ways to explain myself.
Even the anaemia is of a direct result of a disruption of the metabolic process - or at least one of them. Yet there are several disruptions and effects prior (I'm loathe to use this word because the anaemia can appear in isolation) to this particular symptom. So essentially a blood disorder can be one of the effects of the breakdown of the metabolic process.
I think that explains where I'm coming from a little better!
Am sure I agree re: "So essentially a blood disorder can be one of the effects of the breakdown of the metabolic process." It also puzzles me once a haematologist gets involved who then is responsible for the right care, and then if more specialist are involved. Anyway I personally object to the fact that 30 years ago I went to a gastro saying this can not be good for me; food going trough me in no time, no time to take up essential vits/ minerals, but me being send of with IBS, do not eat convenience foods. But one can not change the past. What I do believe is a patient has to stand up for them selves, come back time and time again, to make sure they are being taken seriously. Unfortunately that does not come natural for many, and the believe in GP knows all is misguided, GP just knows a bit of a lot of things.
The unfortunate fact is that things will only change when patients do get involved. To progress from where we are today (which is a very poor situation) then patients must put themselves in a position whereby they challenge the current state of affairs.
I was reading a book last night, on another medical subject, and the doctor concerned said that if doctors refused to patients then they would never learn anything.
The following dosage schemes are suitable for adults and children.
Addisonian pernicious anaemias and other macrocytic anaemias without neurological involvement.
Initially 250 to 1000 micrograms intramuscularly on alternate days for one or two weeks, then 250 micrograms weekly until the blood count is normal
Maintenance: 1000 micrograms every two to three months
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement
Initially:1000 micrograms on alternate days as long as improvement is occurring.
Maintenance:1000 micrograms every two of three months.
Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and strict vegetarianism
1000 micrograms every two or three months.
Tobacco amblyopia and Leber's optic atrophy
Initially:1000 micrograms or more daily by intramuscular injection for two weeks then twice weekly as long as improvement is occurring.
Maintenance: 1000 micrograms monthly.
You see, they are advising as if a b12 deficiency manifests as an anaemia. The more patients (or doctors) who report neurological problems the more likely it is they will look into the matter further.
It's an interesting discussion but I think what is being missed is that we are talking about a vitamin and not a drug or medicine which has been researched, developed and tested by a pharmaceutical company and about which specific claims are being made. I may be wrong, but I suspect what happens is that a health authority, e.g. the NHS, decides that it will treat B12 deficiency with hydroxocobalamin and then invites potential manufacturers to quote for supply. The chosen manufacturer, therefore, is simply supplying a generic, unpatented product which it has not researched or developed and the manufacturer therefore makes no claims whatsoever as to its efficacy for curing specific problems such as B12 related neuropathy. The effective use of the product is the responsibility of the health authority and its representatives i.e. the doctors.
The Patient Information Leaflet provided with hydroxocobalamin in the UK simply reflects the way in which has been licensed for use and is prescribed in the UK, not any research carried out by the manufacturer. Hydroxocobalamin sourced from Germany comes with different information.
Hmm, an interesting point but b12 was researched quite some time ago by a pharma company. What happens is they discover an illness, they identify the cause, then the treatment, then they, usually, replicate the treatment. So, I'm presuming guidelines can be different depending not only on pharma research but also on research sourced within each nation.
Germany does better research - the UK funds little or none. The pharma companies won't fund it because there isn't enough money in b12 and the Government won't fund it because they don't listen to patients and don't understand the condition.
In the UK they certainly make claims about treatment regarding anaemia - but they exclude claims about neuropathy (unless accompanied by anaemia) The fact remains that they are selling a product which is to treat a b12 deficiency, the fact they haven't done their homework does not preclude them from responsibility. If we are being told we are being treated for b12 deficiency and subsequently informed that we are well because b12 levels are normal now, doesn't mean we as patients have to take responsibility for the professionals getting it wrong. We place our trust in them to know their profession.
Then, I'm presuming, NICE etc pull in everyone's guidelines haemo bods, BNF etc and source according to price or whatever.
Is it not a sad reflection on modern medicine/science (at least within the UK) that they are still responding to the illness as an anaemia, in spite of the fact that many, many patients report remaining symptoms after treatment?
There are, admittedly, other things I could say, or rather information I could provide, but for reasons I'd rather not go into I can't say at the moment.
As an afterthought - what about calcium? There are guidelines and warnings on calcium and that not a prescription drug, whereas b12 in the UK as an injection, is.
It's a genuine question - you might think of something that I've missed.
I think there is one comment that I would like to mention. It was made by a medical professional in the 1940s when talking about giving patients enough b12 - although at the time it was still liver extract.
"It really is no kindness to cure a patient of anaemia and then let them die through spinal cord injury."
Yet today's professionals believe it is only necessary to treat the anaemia (or corresponding b12 deficiency)
Something, somewhere has gone terribly, terribly, wrong - and it is neither the fault of the patients nor their responsibility to remedy it. And what we also have to remember is that it is these patients that in many cases, are not even recognised as being physically ill - their injuries are being put down to hysteria.
The principle of informed consent could very easily be applied here. As I see it, you should be able to ask and, as part of the informing, be told, not only the make but also be shown the Summary of Product Characteristics and Patient Information Leaflet.
Of course, you could be seen as awkward even asking (I would strongly disagree with that) but you'd have to consider exactly how you handle it to minimise this possibility.
Do you really think there is a way to minimise it Rod? At some point, if you aren't happy with your treatment, then you are going to have to take a standpoint that will be viewed as being non-compliant (this NHS phraseology). Any questioning, at any point, will change the arena.
I think the Ashya King case showed that situation up.
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