Injectable Vitamin B12

Rupa Huq Excerpts

Wednesday 26th May 2021 Westminster Hall

[Dr Rupa Huq (in the Chair)]

I remind hon. Members that there have been some changes to normal practice in order to support the new hybrid arrangements. Well, only one Member is here physically, so I do not think that I need to read all of this out. If everyone present here in the Boothroyd Room could clean their spaces before using them and before leaving the room, that would be great. I remind Members that Mr Speaker has stated that masks should be worn in Westminster Hall—apart from by me in the Chair, as I may need to speak at any second.

[Jane Hunt (Loughborough) (Con)]

I beg to move,

That this House has considered proposals to remove classification of prescription-only medicine from injectable B12 vitamin.

It is a pleasure to serve under your chairmanship, Dr Huq. First, I thank my constituent Tracey Witty who, since being diagnosed with B12 deficiency in 2012, has worked tirelessly to support others to secure the treatment that they have desperately needed and campaigned for, and to increase public awareness of vitamin B12 deficiency as well as the issues surrounding access to treatment. It is clear that she is making a real difference to the lives of people across the country; and much of the information that I will share today has come from her extensive investigation and research into this disorder.

Vitamin B12 deficiency is a progressive neurological disorder with a wide range of symptoms that affect all body systems and, importantly, people of all ages. Statistics from the National Institute for Health and Care Excellence show that, in the UK, 6% of people below 60 years of age are deficient in B12, and the figure rises to 20% in people aged over 60 years. That means that hundreds of thousands of people are struggling with the symptoms of B12 deficiency, which can have a devastating impact on both physical and mental health, leaving sufferers unable to contribute to either family life or society.

Crucially, and in part because of the wide range of symptoms associated with the disorder, sufferers often struggle to receive the correct diagnosis. They are commonly misdiagnosed with conditions such as Alzheimer’s disease, bipolar disorder, multiple sclerosis, chronic fatigue syndrome, autism, ADHD—attention deficit hyperactivity disorder—and fibromyalgia. That means that they do not receive proper treatment and, in the long term, that can lead to significant complications, including permanent neurological damage.

Over the years, many people have contacted my constituent, Tracey, to discuss their experiences of living with B12 deficiency and the difficulties that they have faced in getting the right diagnosis. I would like to share a couple of their stories The first is of a mother, with three young children, whose serum B12 level first indicated a deficiency nearly a decade ago. Sadly, however, that was overlooked and, despite being unable to physically function because of her disorder, the woman was repeatedly denied access to B12 injectables by GPs. After spending a number of years being passed from pillar to post— seeing a psychologist, endocrinologist, haematologist and gastroenterologist, attending a pain clinic and chronic fatigue clinic, and being sent for a brain scan—the woman felt that she had no choice but to resort to sourcing injectable B12 online. Thankfully, she is now fully functioning, but can she be certain of having a trusted source of injections through the internet?

The second story is of a woman who, following four unsuccessful attempts at IVF decided to explore B12 deficiency as a possible cause of her fertility problems, as she also had a myriad of severe neurological symptoms and a known family history of B12 deficiency. More than a year ago, she found out that she was indeed deficient when her serum B12 test result was flagged as abnormal. However, along with the test result was a note stating that no action was to be taken and so, instead of being treated for a clear B12 deficiency, she was advised to take oral supplements and was referred to a chronic fatigue clinic. This woman is only just starting B12 injections with her GP this week, after repeatedly supplying evidence to them of the need for correct treatment. It is understood that oral vitamin B12 cannot be absorbed when the patient is B12 deficient; it requires an injection to be effective. Even when patients are correctly diagnosed, they often face an uphill battle to access the treatment they need when they need it. As the NHS website states:

“The treatment for vitamin B12 or folate deficiency anaemia depends on what's causing the condition. Most people can be easily treated with injections or tablets to replace the missing vitamins.”

It goes on to state that, “At first”, patients will

“have these injections every other day for 2 weeks or until…symptoms have started improving…After this initial period,”

if a patient’s B12 deficiency is not caused by a lack of the vitamin in their diet, they will

“usually need to have an injection of hydroxocobalamin every 2 to 3 months for the rest of”

their life.

Sadly, however, for many people that maintenance dose is not enough, leaving them to deal with debilitating symptoms while trying to juggle the stresses of everyday life. That was the case for another woman who has been in contact with Tracey in recent months. During lockdown, that woman who had previously been diagnosed with pernicious anaemia, which is one cause of vitamin B12 deficiency, was exhausted, constantly nauseated, stumbling, struggling with brain fog and unable to function properly. She therefore asked her GP whether she could have her B12 injections more regularly than the eight-weekly regime she was on.

Subsequently, however, that woman had her regime reduced to just four injections per year, after her GP took advice from a professor of haematology who it seems incorrectly stated: “A typical dose survives in the body for up to two years and once the patient has the first few injections, there is no ongoing deficiency. We can be confident that these fluctuating symptoms are not related in any way to B12.” That statement is at odds with NICE guidance, which is clear:

“Treatment of B12 deficiency in people with neurologic involvement should include”

injections

“on alternate days until there is no further improvement”.

A single mother who was trying to cope with the additional stresses of home schooling two autistic children due to covid-19 restrictions was left with no other choice but to purchase B12 online from a pharmacy abroad in order to function properly.

It is because of such cases that I presented a petition in the Chamber calling for the classification of prescription- only medicine to be removed from injectable B12, so that those who have been diagnosed with B12 deficiency may access treatment over the counter at pharmacies when they need it. As the petition mentioned, that would bring the UK’s

“approach in line with that of other countries, affording those with B12 deficiency the same dignity and control over their own health as a diabetic using insulin, and reducing the workload and financial burden on GP practices, District Nurses and other NHS services”.—[Official Report, 23 September 2020; Vol. 680, c. 1077.]

The latter point has become increasingly important given that covid-19 has placed significant pressure on NHS services and, in recent months, intensified demand for GP services.

It is also worth noting that, since I presented the petition, Tracey’s Change.org petition on that very subject has garnered more than 96,300 signatures, reflecting the public interest in the matter. I am grateful for the Government’s response to the petition that I presented. However, it raised a number of new issues, which I will put to the Minister now.

The Government’s response stated:

“Clinically urgent treatment must always be provided, with the patient's clinical needs being paramount. Any patient who wishes to discuss their need for vitamin B12 injections can request a review with their GP or other responsible clinician.”—[Official Report, 2 November 2020; Vol. 683, c. 6P.]

In Tracey’s experience, however, and as evidenced by the stories I shared earlier, clinically urgent treatment is frequently denied to those with B12 deficiency. That situation has been worsened by the covid-19 restrictions, when many people with the disorder and pernicious anaemia were told by their GP that they no longer needed B12 injections and could instead take a B12 tablets. Tracey heard how some of the GP practices came to that conclusion after taking blood to check B12 levels. That is despite NICE guidance and The BMJ stating that no testing should be carried out once a patient is on vitamin B12 injections, as there is no indication of what is happening at a cellular level.

The Government’s response also stated:

“Vitamin B12 could not legally be classified as a medicine that can be made available for sale without prescription in pharmacies because it is an injection and because the condition it is licensed to treat, pernicious anaemia, needs a clinician to diagnose it, and monitor its treatment.”—[Official Report, 2 November 2020; Vol. 683, c. 5P.]

It is important to make a distinction here because, as I mentioned, pernicious anaemia is only one cause of vitamin B12 deficiency. B12 injectables are also required by those who are B12 deficient for other reasons. Tracey feels that there is a widespread lack of understanding of this subject among clinicians, which is compounded by the inaccuracy of B12 testing.

As the NHS website acknowledges,

“the current widely used blood test only measures the total amount of vitamin B12”

in a patient’s body, rather than what form the B12 takes. This means that a blood test may show that a patient has normal B12 levels, even though their body cannot use much of it, leaving many patients without access to help or treatment. I would welcome the Minister’s comments on whether the Government will be working with the NHS to further clinicians’ understanding of B12 deficiency, in particular the limitations of testing, to ensure that those who are deficient receive better care.

Finally, I will pick up on the wider point in the Government’s response about the classification of B12 injectables. The response stated:

“Before a medicine can be switched from a prescription only medicine (POM) to a pharmacy (P) medicine, Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription. This means that it is a medicine which no longer meets any of the criteria for a POM.”

The response went on to imply that, as B12 injectables are normally prescribed by a doctor for parenteral administration, they cannot be considered safe to be supplied without a prescription.

That position seems to be at odds with the fact that private clinics are able to provide the very same injectables to clients, provided they advertise them using such terms as wellness, boost or supplement, and do not market them as treatments for B12 deficiency or make any medical claims. That is because the Medicines and Healthcare Products Regulatory Agency does not consider vitamin B12 injectables to be medicines in this instance. Indeed, in a statement to Tracey, the MHRA said:

“Our current advice to private clinics administering vitamin B12 injections which are not licensed medicinal products intravenously for non-medicinal purposes is that we do not regard these to be medicines and that they fall outside of the remit of the MHRA. It must be absolutely clear in the advertising of such products that they do not have a medical purpose.”

Furthermore, staff at private clinics do not need any medical training to administer B12 injectables to clients. The implication of this is that B12 injectables are simultaneously licensed medicinal products, which are not safe to be administered by someone without medical training, and non-medicinal products, which are safe to be administered by someone without medical training. Moreover, unlike with insulin, the risk of toxicity or overdose with injectable B12 is considered to be extremely low, and so would be relatively safe for those with a deficiency to self-administer. I would welcome the Minister’s comments on those points.

That being said, as the Government’s response to the petition rightly highlighted, self-administration would not be suitable for everyone, so it would be only right that patients retain the ability to receive their injection at a GP practice. Tracey has also expressed that pharmacists who are already trained to administer vaccinations should be allowed to administer injections to those with a prescription. That would allow pharmacists to play a greater role in community healthcare, relieving pressures on GP services.

Here is another email I received directly from a constituent: “I suffer from B12 deficiency. At present I require an injection every other day to keep serious neurological decline at bay. I was diagnosed last summer and rapidly declined, to the point of almost being in a wheelchair. I was helped by the GP initially, but would not expect them to continue my intensive treatment owing to resources. However, if they could train us and supply the details, it would be better than as now, when many of us are forced to research this ourselves.

“I currently have to purchase ampules of hydroxocobalamin online from Germany, which I am sure you will agree is an expensive, lengthy and unnecessary process when they could easily be bought over the counter in the UK. The injections have enabled me to regain my peripheral vision, resume driving, function normally in a busy household and even get a new part- time job. I cannot overstate the impact they have had on me, especially since the doctor suggested I might have terminal neurological decline. Please, please state the case for hundreds or possibly thousands of us in the same position, and for those who have not yet been diagnosed and are struggling with poor mental and physical health for the sake of a low-cost vitamin.”

I hope that the overriding message the Minister takes away with her is the desperate situation in which those whose stories I have shared have found themselves—so much so that they have had to source their own injections just to be able to function as she and I can. The debate has been advertised on the “B12 Deficincy.info” Facebook page and, this morning, one lady left the following comment:

“Fingers are crossed. This would be life changing for me and so many others, no more battling with my doctors. I can only dream of what it’s like to feel alive.”

I ask the Government please to reconsider their position urgently.

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

It is a huge pleasure to serve under your chairmanship, Dr Huq, for what I think is the first time. I remember chairing a debate when you were an MP speaking, so the tables have turned. I thank my hon. Friend for bringing forward the debate. She raised many points in her speech, and we have only 15 minutes, so to do them justice in detail I will ask my officials, who are listening in, to provide a detailed answer to each of her questions.

I will speak about something that I have not prepared for, but I will use this time because it is so important and because my hon. Friend said something in her speech that made me think about something else. First, I thank your constituent Tracey Witty, and your constituents and other women who suffer from B12 deficiency. Every time you spoke about an individual case, you mentioned a woman; you did not once mention a man. I furiously fired off a few questions while you were speaking, and it is true that more women suffer from pernicious anaemia and vitamin B12 deficiency than men. That leads me to the women’s health strategy.

On 18 March, we launched a call for evidence for women to tell us about the problems they have in accessing healthcare services. I hope Tracey is listening, but if not, I hope you will get this back to her. Tracey will have a network of contacts of women suffering with this issue and, for it to be addressed, we need to hear those women’s stories. There is a simple link to the women’s health strategy on gov.uk, and it will take three to four minutes to complete a response on a phone or iPad.

It is so much less difficult—rather than easier—to change policy if you have the evidence. The default in health is male and I am afraid that it is very difficult to get change for many conditions that affect women. To cite an example, the response by Dame Sally Davies is from, I think, three or possibly four years ago and there has still been no major change. NICE will come forward with recommendations, but that may not be for another 12 or 18 months. It is not fast enough. My point is that that is because it is women, and women’s voices are just not listened to. I am trying to change that. I am trying to put women at the heart of health strategy and health policy.

I am sorry to use a few minutes of my response to get this point over but, as well as you raising this issue here, which is vital, Tracey could have a massive impact if she and the women she knows use the forums and platforms she is aware of to post the link to ensure that women are aware and can respond to the women’s strategy call for evidence. It is vital that my hon. Friend is here raising this on behalf of Tracey, but if we could have hundreds or possibly thousands of women responding, that would be incredibly powerful, because that would give us evidence—data. It would be not one constituent of yours putting a story forward; it would be lots of them.

[Dr Rupa Huq (in the Chair)]

Order. Minister, you will remember the thing about saying “you”—you used to say it—and you have done it a few times. Dame Eleanor Laing, who is our boss nowadays, is quite hard on it and said, “Don’t let anyone get away with it.” I let you do it a few times, but if you can use “my hon. Friend”, that is better.

[Ms Dorries]

When I was in Chair, I told people off all the time for exactly the same reason. I am absolutely sure that because we had a big gap with no debates over covid, I have slipped back into a habit I had prior to becoming an MP 20, 16 or 15 years ago, or whenever it was. I apologise.

[Dr Rupa Huq (in the Chair)]

You don’t look that old!

[Ms Dorries]

Well, I am, I can assure you.

To finish my point, if my hon. Friend could ensure that her constituent responds to the call for evidence, that would absolutely be more powerful and useful than anything I have to say in my response to her speech. We will respond to her points in detail.

I will address some points made by my hon. Friend. She asked specifically about making B12 injections available to purchase from pharmacies. As she said, the MHRA is the body responsible for medicines licensing in the United Kingdom, and it is committed to making more medicines available over the counter, so I think we would be pushing at an already open door. The MHRA is committed to doing that where it is safe to do so, as an important element of the self-care agenda to empower patients.

My hon. Friend mentioned the role of pharmacists. We have seen them step up during the covid pandemic and the vaccination programme. That was an incredibly important point. The Under-Secretary of State for Health and Social Care, my hon. Friend the Member for Bury St Edmunds (Jo Churchill), whose portfolio includes pharmacy, is constantly looking at ways to increase and enhance the role of pharmacists, and this could be a useful way of doing so.

I used to be a nurse and gave vitamin B12 injections years ago. I was trying to rack my brains, but do not remember ever having given one to a man, but I am sure that I did, because men suffer from such symptoms, too. It is a really interesting phenomenon and, with a bit of imagination, working with clinicians and harnessing the expertise and knowledge of pharmacists, we could find a new way of doing this.

The MHRA has an established process and procedure for moving medicines from prescription-only status to over the counter, which I will refer to as OTC, when it safe to do so. An OTC is a medicine that is not likely to present a direct or indirect danger to human health, even when used incorrectly, if used without the supervision of a doctor; or is not frequently and to a very wide extent used incorrectly, and as a result is not likely to present a direct or indirect danger to human health; or does not contain substances or preparations—there is an entire list, which we will include in the letter to my hon. Friend.

To date, the legal classification of all currently authorised medicines for injection, including vitamin B12, is prescription only. Other factors support that position, in addition to the fact that the product is injectable. The main reason why it would not be a suitable candidate for reclassification under existing guidelines is that the product is considered to meet the prescription-only medicines requirements, as set out in legislation.

Pernicious anaemia, or any other cause of vitamin B12 deficiency, cannot be self-diagnosed and requires the expertise of a medical doctor. Contrary to my hon. Friend’s remarks NICE guidance also states that when a patient presents with the signs and symptoms of pernicious anaemia, they should undergo a full blood count as part of the diagnostic process.

We are also aware that there is a high risk of off-label use by patients. She mentioned that private clinics are injecting for wellness. That is currently authorised for use only in maintenance therapy for pernicious anaemia every two to three months, depending on the type of pernicious anaemia. Anecdotally, we hear that patients consider that a more frequent administration of the medicine would be appropriate to their particular clinical symptoms. Any reclassification of the medicine would not change either the dose or the frequency of the treatment set out in the terms of the product’s marketing authorisation.

I am also led to believe that the evidence of lifestyle abuse of unlicensed formulations of B12, which, although not necessarily relevant to the patient group including Tracey and others whom my hon. Friend mentioned, is also taken into account in determining the legal classification of the medicine. That is an issue that has to be considered: there are people who would abuse those formulations.

Just because there is a particular group that would over-use and abuse the availability, we should say that we are not going to look at this. Although that is not in my speech, and it has not been advised to me, I am making that point. We should not use that as a reason to say, “We don’t go there”. This affects more women than men—I do not apologise for banging on about that point—and therefore we should be pushing those barriers back as part of the women’s health strategy and looking at different ways to deal with it.

Taken together, these issues mean that the criteria for prescription-only medicine have been reached, and changing the classification would therefore not be appropriate—but that part of the information that I have been given needs to be challenged. We need to ask, “Why not?” It is vital that we get the evidence back from the network to the forums that Tracey knows. I note that this issue has been before Health Ministers in recent times, and as I mentioned, Dame Sally Davies, our previous chief medical officer, did engage with the medical royal colleges to raise awareness of the condition. However, it has taken too long—I think Dame Sally retired three years ago.

Following on from that interaction, NICE has worked to develop and publish an updated clinical knowledge summary on pernicious anaemia, which sets out clinical guidance on diagnosis, treatment and management of the condition that should be followed by general practice physicians and others responsible for the care of patients who suffer from this condition. The updated guidance was published in July 2020, and it should now be a regular part of clinical interventions in general practice and secondary care.

I would be interested to know what Tracey’s experience of that is, and whether she believes that the guidance has been implemented, particularly based on the experience of other women that she has been speaking to on these forums. Has it been implemented? Are GPs aware of it? If those women could let us know those answers in their responses to the women’s health strategy, that would be incredibly important. It is also important to evaluate the impact that this guidance has had on the clinical management of pernicious anaemia before considering further regulatory options. NICE usually produces guidelines as quickly as possible—it is an amazing organisation that does very good work—but we need to move a little bit faster on this and other women-related issues.

As for my hon. Friend’s question about private injections of B12, as I said, there are two separate types. Licensed products must be administered by prescription and by a suitably qualified healthcare professional, so that is where we are at the moment. It is important to note that private clinics are not providing the same injectables to clients as GPs are; they are providing injectable vitamin B12 products that are not licensed medicines for general health and wellness purposes. Of course, if clinics make medicinal claims for unlicensed vitamin B12 products that they offer, the MHRA would take action. Also, when classifying products, the MHRA are bound by case law to consider products on a case-by-case basis and cannot automatically classify all vitamin B products as medicine, so they do not all meet the criteria to be classified as licensed medicines. That is another important point.

In closing, I thank my hon. Friend for continuing to raise this important issue on behalf of her constituents and everyone affected by the condition. We will continue to work with and support the NHS and NICE—which are actively engaged with this issue— and clinicians to understand the importance of B12 deficiency and guarantee that patients are receiving the best possible care. I think the women’s health strategy will really help with that and will possibly be the boost we need to move this forward through the evidence we can gather.

I will finish on that point, because Tracey and the others who use the same platforms, my hon. Friend, and others who complete the women’s health strategy could give us important evidence that we need to enable us to push forward. I am not saying that means we do not know what policies we are going to develop from the women’s health strategy, but if enough women respond and say that this is an issue, that gives them a voice and it gives us a lever to pull. However, one of the biggest issues here is the time it has taken to bring about change. The guidelines have gone in; I would be interested to know how they have bedded in, and whether people such as those on Tracey’s forums think they are being used and have led to any benefit. We would also be interested to hear what the problems are with prescribing, and the issues that they have with administration.

Question put and agreed to.