Injectable Vitamin B12

Nadine Dorries Excerpts

Wednesday 26th May 2021 Westminster Hall

[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.