Injectable Vitamin B12

Jane Hunt 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.