Points of Order

Debate between Lindsay Hoyle and Seema Malhotra

Tuesday 5th November 2019 Commons Chamber

[Mr Speaker]

I finished questions earlier, but you have certainly put that point on the record.

[Seema Malhotra (Feltham and Heston) (Lab/Co-op)]

On a point of order, Mr Speaker. May I ask your advice about what may happen during the parliamentary Dissolution? I am particularly concerned about how I may raise the case of Mr Benjamin Williams from my constituency. A wheelchair-bound young man with degenerative spine disease, he has had great difficulty getting the services he needs from Shepherds Bush Housing Group, which seems to have been obstructive in every respect in relation to leaks, the fact that his windows do not close and other matters. Can you give me some advice about how I can raise this issue further, particularly to make sure that he gets the support he needs prior to Christmas?

[Mr Speaker]

You are quite right to raise such an issue on behalf of a constituent, but we can still write to Ministers during that period. I think you need to make sure you get your letter off today, but I do hope they have already been listening.

The National Health Service

Debate between Lindsay Hoyle and Seema Malhotra

Wednesday 23rd October 2019 Commons Chamber

[Mr Deputy Speaker]

I am not going to enter into speculation. I have been very clear, and I have made the point. I am not going to change any more.

[Seema Malhotra (Feltham and Heston) (Lab/Co-op)]

Further to that point of order, Mr Deputy Speaker. Further to some of the comments that have been made, may I seek your advice about the accountability of the Prime Minister? Truly, he is accountable to the Liaison Committee as well as to the House, and in other matters—

[Mr Deputy Speaker]

Order. I have been down that road already, and I am not going to change what I have said.

Maraviroc and Progressive Multifocal Leukoencephalopathy

Debate between Lindsay Hoyle and Seema Malhotra

Monday 30th September 2019 Commons Chamber

[Seema Malhotra]

The hon. Gentleman makes a point that I will come on to about how the decisions need to be made on the medical evidence and with the voice of the consultants being clearly heard by those making the decisions.

There is no cure for this condition, but two years ago my consultant’s neurologist advised that Maraviroc had had a positive effect on patients suffering from PML in relation to her condition, immune reconstitution inflammatory syndrome in multiple sclerosis. An individual funding request was submitted by my constituent’s consultant, national expert Professor Ciccarelli at the National Hospital for Neurology and Neurosurgery. The application was refused and a subsequent appeal was also unsuccessful—this process went on through 2017 and 2018—seemingly on the same basis as was given to me in writing in October by NHS England, which was that the

“use of Maraviroc for this condition is currently seen as experimental as the current evidence is limited to very small observational studies. NHS England has concluded that there is not sufficient evidence to support the routine commissioning of this treatment for the indications listed.”

The effect on Amarjit was heartbreaking. I met Amarjit and her friend and advocate Kartik. She had a wheelchair and a walking stick, and even the most basic activities were a struggle. She had decided to fund the drug privately from her savings. Maraviroc had remarkable results for her—importantly, that was also the opinion of her consultants—without any side effects. Other treatments that the NHS had sought to prescribe, such as MRIs and monthly steroids, were not just neutral but net negative. Amarjit and Kartik explained the impact that Maraviroc had had on Amarjit’s health and quality of life. I was just staggered when she told me:

“I can talk. I can walk. I can go to the bathroom on my own”—

things that we take for granted. Clinically, the PML lesion appeared inactive and there was a reduction in the inflammation around her brain.

The drug costs around £480 a month, but by the end of June this year Ms Rai could no longer afford to pay for it herself, so she has since been without it. Although her health has been stable so far, such is the condition that it could dramatically change at any time.

Aside from the issue of funding, I have been surprised over the past year by inconsistencies in NHS policy and advice. We all believe in an NHS that is free at the point of need. This is a situation where the patient, leading neurologists and all involved in her care agree that she should have the drug. In November 2018, consultant neurologist Dr Michael Gross, who was also supporting Amarjit’s care as an expert advocate, wrote to Kartik:

“Thank you for confirming further information about Amarjit Rai... Professors Johnson and Ciccarelli agree that this is the appropriate treatment for Amarjit. Long term steroids have already generated severe osteoporosis in 2016 and are not her choice.

You will have already proved in what is an N=1 trial that her treatment would appear to be effective. There will almost certainly never be the size of trials in this rare disorder that would allow a definitive statement by a funding organisation.

I think we have to ask who is making the decision, given that there are now three senior consultants confirming this is the right decision… Quite frankly I am appalled by the lack of humanity that is being demonstrated here.”

In November 2018 I wrote again to the Minister. I received a response from Lord O’Shaughnessy in the other place, who helpfully said the following:

“Maraviroc is not licenced for the treatment of symptoms of PML. There are clinical situations when the use of unlicensed medicines or use of medicines outside the terms of the licence, known as off-label, may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence. The responsibility for that falls on healthcare professionals.”

Sadly, this made no difference.

Following the lack of progress, I wrote again to the Secretary of State in March 2019. I quoted the helpful response that I had received from Lord O’Shaughnessy. The Health Minister in the other place, Baroness Blackwood, responded in May and referred again to the individual funding request process. She stated that the IFR can be considered only if the patient can be demonstrated to be clinically exceptional. She said that

“an IFR can only be considered if the patient can be demonstrated to be clinically exceptional compared to the wider group of patients and is likely to derive greater benefit from the treatment.”

At face value, all of this would appear to be true for my constituent, but the use of Maraviroc is an area where policy appears to be in some confusion.

In response to a parliamentary question I asked in July about the assessment that NHS England has made of the availability of Maraviroc to patients with PML, a third Health Minister, the hon. Member for South Ribble (Seema Kennedy), wrote:

“We are informed by NHS England and NHS Improvement that it does not commission Maraviroc for progressive multifocal leukoencephalopathy… NHS England and NHS Improvement have published a do not commission policy for ‘Natalizumab-induced progressive multifocal leukoencephalopathy in relation to immune reconstitution inflammatory syndrome in multiple sclerosis.’”

That response seems to contradict earlier responses and advice. First, “does not routinely commission” is different from “does not commission”. Secondly, it made no reference to the IFR process, which two Ministers had previously mentioned.

I tabled a further parliamentary question last week to ask what assessment the Secretary of State had made of the effectiveness of Maraviroc in patients with PML. A fourth Health Minister, the Under-Secretary of State for Health and Social Care, the hon. Member for Mid Bedfordshire (Ms Dorries), responded to my question. The response I received today was mind-boggling:

“Maraviroc is currently authorised for the treatment of patients who are infected with HIV type 1. The Medicines and Healthcare Products Regulatory Agency which is responsible for the regulation of medicines in the UK is not aware of any application for use in patients with PML and therefore cannot comment on the efficacy of this drug in patients with PML.”

It might be helpful if I highlight for the Minister findings from wider medical journals that the House of Commons Library has helped me to compile. In December 2016, the American Academy of Neurology published an article entitled “Severe early natalizumab-associated PML in MS: Effective control of PML-IRIS with maraviroc”. A summary of a case involving a 55-year-old Caucasian HIV-negative man diagnosed with relapsing, remitting MS in 2013 shows that that led to a subsequent diagnosis of PML. Clinically, the patient deteriorated rapidly, according to the article. Oral Maraviroc was initiated six days after his admission. Eight days after Maraviroc initiation, MRI follow-up revealed stable PML lesion size. Over the following weeks, the patient improved continuously. After 25 weeks of Maraviroc treatment, the John Cunningham virus DNA was no longer detectable. Maraviroc was continued and well tolerated at a stable dose. The patient survived both PML and IRIS.

A subsequent article was published by the American Academy of Neurology entitled “Maraviroc as possible treatment for PML-IRIS in natalizumab-treated patients with MS” in December 2016. It cited a 34-year-old man treated with Natalizumab for three years without previous immuno-suppression. After a period of time, the patient was admitted with seizures, headaches, and impaired memory, and an MRI scan subsequently confirmed PML. Twelve months after diagnosis with PML and six months after the start of Mariviroc, PML-IRIS lesions were resolved, and no new MS disease activity was detectable.

An article in 2017 by Steiner and Benninger published by the American Academy of Neurology built the medical explanation for why Maraviroc had been effective in cases of PML in MS sufferers. In summary, the condition for which the cause is believed to be the John Cunningham virus, which infects the central nervous system in patients with low immune conditions, became more prevalent and was observed in around 5% of patients with HIV prior to the availability of highly active antiretroviral therapy, or HAART. The article goes on to describe how the era of

“monoclonal antibodies for immune-mediated conditions such as Natalizumab for MS and Crohn disease heralded another context for PML. As of November 2016, there have been 698 reported cases of PML under natalizumab.”

The research goes on, and it is true that some research such as that published in The Journal of the Neurological Sciences in July 2017 confirms that it does not work in all circumstances, and steroids may be more effective in some patients. However, an article in Neurology Times in January 2018 states that in PML treatment options are limited. Maraviroc has been used successfully in some PML patients to avoid IRIS, although not all patients respond to Maraviroc. It recommends further research and testing in identifying patients at risk of IRIS and tailoring treatments accordingly.

In that context, let me make reference to the urgent clinical commissioning policy statement on Natalizumab-induced PML, which was published by NHS England in March 2018. It said:

“It has been assessed that the development of a full policy is not needed at this time as there is currently little evidence into its effectiveness for this indication”.

I do not believe that that policy statement takes account of all the research available or indeed that which has appeared subsequent to its publication. The research is more nuanced, the medical benefits for my constituent are undeniably clear, and the denial of funding is inexplicable to her and renowned experts in the country.

Maraviroc, or Celsentri, as defined by the European Medicines Agency—formerly in London, it is now based elsewhere in the European Union—is a medicine that is routinely prescribed for HIV. Although it does not cure HIV infection or AIDS, it may hold off the damage to the immune system and the development of other infections and diseases.

Medical research has identified that the JCV most associated with HIV patients with low immunity has found another context in patients with PML. My constituent’s condition is incredibly rare, affecting, potentially, 10 or fewer people in the country. Given that very few options are available, she is not the only patient for whom, in anecdotal studies, the drug Maraviroc has shown remarkable results. With no other options available, my very ill constituent has been paying £500 a month privately for the past year to fund Maraviroc herself, but she can no longer afford to do so. Amarjit’s consultant neurologist and other specialists support her receiving the treatment. There is an irony in the fact that more is potentially being spent by the NHS in a month on treatment and tests that do not benefit her as much, and have damaging side-effects. The IFR system in the NHS should be able to review and respond to that situation on the basis of medical need, and I cannot see how that has been done in this case.

Will the Minister tell me how her Department liaises with and challenges NHS England on cases such as this, and how well-researched the Department’s responses to me have been? Will she tell me with what medical advice the treatment has been refused, although three of the leading experts in the country support it in this rare case, and whether their advice can be shared with my constituent and her consultant, Professor Ciccarelli? Will she also agree to a meeting with me, my constituent and her consultant, and a senior member from NHS England to discuss the IFR process?

This is a matter of £500 a month, and of demonstrable medical benefits to my constituent. I should be grateful for the Minister’s response, and her advice on how we can move forward.

[Mr Deputy Speaker (Sir Lindsay Hoyle)]

I welcome the Minister to the Dispatch Box. I believe that this is her first outing. She is obviously held in high esteem, given that so many Whips are present at once.

European Union (Withdrawal) (No. 5) Bill

Debate between Lindsay Hoyle and Seema Malhotra

3rd reading: House of Commons & Report stage: House of Commons
Wednesday 3rd April 2019 Commons Chamber

[The Chairman]

I thought it was available, and it should be available. If not, it is still being done. I think the problem we have got is that with the tight timescale, we are trying to play catch-up a little bit. That is why I am trying to help.

[Seema Malhotra (Feltham and Heston) (Lab/Co-op)]

On a point of order, Sir Lindsay. Thank you for repeating the list of amendments that have been selected. Could I ask you to repeat them again a little bit more slowly, because we could not get through the amendment paper fast enough?

Leaving the EU: No Deal

Debate between Lindsay Hoyle and Seema Malhotra

Wednesday 19th December 2018 Commons Chamber

[Seema Malhotra]

I thank the Minister for giving way again. He is being extremely generous in taking interventions. The Speaker said earlier that there was no cap on repetition in the Chamber, but I think that he has won the award today.

My I gently say to the Minister that publishing documents day after day is not preparing this country? We are coming up to Christmas, and in three months we will leave the European Union. Businessmen are busy running their businesses and employing people, and we are approaching the end of the road. The Minister has said that it is not Government policy to extend article 50, but does he agree that it is legally possible to extend or, indeed, revoke it?

[Mr Deputy Speaker (Sir Lindsay Hoyle)]

Order. Many Members want to speak, and we are running out of time. The debate must finish at 7 pm, so please, let us be courteous to everyone.

Exiting the EU: Sectoral Impact Assessments

Debate between Lindsay Hoyle and Seema Malhotra

Wednesday 1st November 2017 Commons Chamber

[Seema Malhotra]

Will the Minister confirm that the list of sectors was not published directly to the House in a ministerial statement, despite more than 120 MPs calling for its publication? Will he also confirm that Parliament’s votes in October and December last year, to which he referred, were on Opposition day motions?

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

Before I bring the Minister back in, I just want to let those Members who wish to speak know that there will be a five-minute limit after the Front-Bench speakers.

Point of Order

Debate between Lindsay Hoyle and Seema Malhotra

Monday 30th October 2017 Commons Chamber

[Seema Malhotra (Feltham and Heston) (Lab/Co-op)]

On a point of order, Mr Deputy Speaker. Last week in his evidence to the Exiting the European Union Committee, the Secretary of State for Exiting the European Union told us that the list of sectors for which an analysis of the impact of Brexit was completed would be made available imminently. He said:

“I have signed a letter to the Lords committee on it, which includes the list. If it has not gone yet, it will go soon.”

On Thursday, when I inquired of Department for Exiting the European Union Ministers, who were then giving evidence, about the list, they said: “I know as much as you do in terms of what the Secretary of State said yesterday. I know that there is a list, and as I think he said it has been signed off to go, so it should be with both your Committees before too long, I suspect.”

A couple of hours ago the list finally arrived in the Lords, buried in a 25-page document, but it has not been sent to the Commons Select Committee for Exiting the EU, as promised. In fact, it only received it after being sent the document from my office.

Given that the publication of this list has been promised “shortly” at least since June in this House, including by the Prime Minister in October; that over 120 MPs wrote to the Secretary of State requesting it just some weeks ago; and that the overwhelming interest that Members of Parliament will have, for businesses and families in our constituencies, in the studies the Government are undertaking on the impact of Brexit on our economy, would it not have been in order for the list to have been, at a minimum, published in a written ministerial statement, so that it is equally and easily accessible by all Members of this House?

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

That is not a matter for the Chair, but it is definitely on the record now. I am sure people have heard what the hon. Lady had to say, and hopefully they will respond as they have done for the Lords.