Saturday, 3 October 2015

PoliticalSpeak: quote of the week

Is there really an ongoing debate about the use of DMTs in early MS? Or is this debate limited to the UK? #MSBlog #PoliticalSpeak

Dr Paul Cooper, Salford Royal Foundation Trust

Excerpt from: Smitha Mundasad. Multiple sclerosis drugs should be offered earlier. BBC News 30 Sept. 2015


Quote(s) of the week: ".... although disease-modifying drugs have a role in established relapsing, remitting disease, there is still debate about their use early on in the condition......"

"..... these drugs are potent with potentially long-term side-effects and consequences, therefore we have to balance the risks and benefits....."

"....... NICE is looking into these issues but the analysis is not yet complete and the data needs to be looked at carefully......."

"..,.... there are other things that can help people with multiple sclerosis, including better accesses to specialists and physiotherapy......."


Dr Paul Cooper, English Neurologist who advises the National Institute of Health and Care Excellence (NICE).

"MouseDoctor took me and DrK to task over this quote. I think we need to put the quote into context and understand that the real issue is not whether, or not, early treatment is indicated, but whether the current costs of DMTs make this treatment policy cost-effective. In other words is it not more cost-effective at a societal level to let MSers wait a few years to see who develops more active disease before offering DMTs? This wait and see approach will expose less MSers to the risk of the DMTs, save the NHS resources, which could potentially be invested in other MS-related services, and identify MSers with 'benign disease' who may not need DMTs."

"The downside of the wait and see approach is the damage, which may be hidden, that is occurring in MSers who are not on treatment but simply waiting for their disease to re-manifest clinically. Please note that in the UK MRI monitoring of MS disease activity is rarely done therefore ongoing hidden damage will not be taken into account by this approach. In our policy document we try and address the cost-effectiveness issue and recommend exploring innovative ways of making DMTs accessible in a cost-effective way."

"As you know these issues are very close to my heart. On my sabbatical I was appalled at how few MSers in resource-poor countries were on DMTs. This prompted me to generate my essential off-label DMT list. The latter has caused problems for me; for example Prof Allyson Pollock, head of our health policy unit, said to me 'Gavin you can't go around promoting off-label prescribing it is simply not evidence-based'. The difference between her and me is that she didn't see the MSers ravaged by this disease, when they didn't have to be if they had had early access to effective DMTs. Isn't it better to use an off-label drug, supported by some evidence, albeit it not an official endorsement of a regulatory agency, than no treatment at all?"

"Please note a lot of the issues raised by this debate will be covered in our policy document and at the launch. If you haven't signed-up to attend the launch on Tuesday please do, it is promises to be an interesting evening."

CoI: multiple

43 comments:

  1. I thought this debate was finally put to bed when the ABN guidelines were revised this year. Clearly not though given that champion statement. It's done no favours at all, harmful even. The MS Society are banging on about it too I can see although their consensus statement published on Wednesday seems a bit late in the day.

    I get so frustrated with all the talk of DMT risks. What about the risks of MS! So much research now evidences the need to start early yet still we get this. The benign argument doesn't cut it for me. You've said yourself there is really no such thing.

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    1. I would like to reiterate that we don't agree with the wait and see policy; if MSers have active disease, defined clinically and/or on MRI, and fulfill NHS England Guidelines for DMTs they should be offered treatment. It is not our role to act as NHS gatekeepers.

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  2. Its just you penny pinching poms....in Oz our neuros think positively

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    1. I emigrated to NZ when I was 11 years old. I was bullied in the playground by kids calling me "Pom.. Pom..", it was not a nice welcome. I was quick thinking and said "I bet your grandparents have British roots". One kid approached me over the next days and said "your right, they do". That stopped all that Pom malarkey.

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    2. The Australian healthcare system and the NHS are different. Medicare do not pay for some services that the NHS pay for. Such as dental care.

      https://www.medicare.gov/what-medicare-covers/not-covered/item-and-services-not-covered-by-part-a-and-b.html

      The NHS could save money by not offering dental care and some other services but dental care is very important to the health of a person.

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    3. So in this case we're not being whinging poms?

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    4. Maybe some Oz neuros think positively, but the Australian Medicare system is now rationing Vitamin D testing - there have been a few recent posts on one of the forums where quite a number of PwMS in Aus have gone to get their regular Vit D test done and found that it will not be covered under Medicare.

      Not long ago I found an article on the Australian GP website stating that the evidence in favour of testing Vit D was virtually non-existent, and that the standard 50 nmol bottom end of the reference range in Aus was quite appropriate. All fine and dandy (maybe) providing you don't have MS and don't need to monitor your Vit D levels. Where do most of us with MS have to go to get out blood test referrals - yup - our GPs!

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    5. I guess we will see after tonight?....England v Australia Rugby World Cup

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    6. Vitamin D ,15min in sun gives you alot

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    7. Every time I you post the vitamin D argument, I can hear my first Australian neurologist in my ears saying "have you been to the beach?" This was London late seventies, so maybe he was ahead of the game. It was almost the first thing he asked.

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    8. In Oz and live in some states you really need to get ambulance insurance or an ambulance subscription or you can end up paying a large fee if your a patient needing an ambulance call out. Each state in Oz if different.

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  3. Vitamin D is cheap. Some MSers in Brazil take it under medical prescription with better effectiveness than Crabs.

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    1. RE: "Vitamin D is cheap. Some MSers in Brazil take it under medical prescription with better effectiveness than Crabs."

      This statement is not evidence-based; we have not data showing that vD is a DMT nor do we have any head-2-head studies comparing vD to CRABs. We recommend that our patients with MS take vD and keep themselves replete for bone health and not because vD is a DMT.

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    2. Prof G I know you recommend vit D for bone health and not as a DMT but what do you think about the conclusion of this paper?

      http://www.ncbi.nlm.nih.gov/pubmed/26319134
      Vitamin D supplementation to patients with frequent respiratory tract infections: a post hoc analysis of a randomized and placebo-controlled trial.
      CONCLUSION:
      Vitamin D supplementation was found to significantly increase the probability of staying infection free during the study period. This finding further supports the notion that vitamin D-status should be monitored in adult patients with frequent RTIs and suggests that selected patients with vitamin D deficiency are supplemented.


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    3. Interesting, if Vitamin D reduces RTI's then it could have a knock on effect of reducing relapses driven by infections so is it not anti-immunological but know pro-immunological

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    4. That's what I thought MD that it could reduce relapses drive by infection. The study was those taking 4000 iu of vit D a day.
      I would say that many of my relapses have an infection behind them. The window of vulnerability varies from having the infection same time as relapse or even as long as 6 weeks before the relapse.

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  4. Will this be a satellite event and is it just health professionals who can sign up?

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    1. Re: "Will this be a satellite event and is it just health professionals who can sign up?"

      The launch is not a satellite symposium; it was meant to be an official ECTRIMS satellite symposium but when ECTRIMS found out that it was a multi-sponsored (Abbvie, Biogen, Genzyme, Novartis & Roche) event we couldn't hold it during the official conference due to ECTRIMS regulations. Official ECTRIMS satellite symposia can only have single sponsors. As our launch is now outside the official ECTRIMS programme it is open to all people to attend and they don't have to be registered with the official conference. So it is open to all comers.

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  5. I have a colleague whose wife was diagnosed over two years ago with RRMS. The neuro said then they should just wait and see what happens before deciding whether she should have a DMT. Since that appointment she has seen a MS nurse once and had no further MRI's etc.

    I've suggested they take a look at this blog or other reputable websites to empower themselves with knowledge but the MSer prefers "not to think about the future".

    I worry that once she or her neuro think it's time for her to have a DMT she will have long-term damage.

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    1. I have been to MANY MS events over this past 6 months and heard from Neuro's, MS Nurses over and over. I have not heard a single one of them say that on onset of diagnosis that someone should not be on a DMT. Quite the opposite in fact, they all state one should be on a DMT and attempt save as many neurons as they can until a cure is found.

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  6. Well, I'm one who suffered because of the wait-and-see approach. It's also ended up costing society as I Have been awarded PIP, disability-related Tax credits and am now not a tax payer because the MS was unchecked. Do NICE consider the whole cost to society or a short-sighted sub-section? An argument for cutting benefits? But handing out suicide kits would save more.

    It is fundamentally true that things other than DMT can help people with multiple sclerosis. Physiotherapy helps with management of symptoms but progression of symptoms continues. Even if symptoms are managed well, there can be costly loss of physical function - not to mention cognitive function loss.

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    1. May be it's to do with short term budgets?
      Do hospitals look at their budgets for DMT's over a short term rather than long term?

      I wondered this because when I discussed Lemtrada with my MS nurse (some time ago) she said it's normally considered when other DMT's have not worked. I found out later this is not correct.
      The higher cost initial outlay of Lemtrada compared to other DMT's.

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    2. A friend of mine was told similar by her nurse, told Lemtrada is used for only severe MS. She was offered Injectable's. Her MS is pretty active too, much more than mine. So sad. I've encouraged her to change to my hospital who are on the ball but she trusts her nurse. She was only diagnosed last year and has already accumulated lasting disability. Supporting young children too. I fear for her.

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  7. It sure is not fair. Here in the colonies (USA) most everyone I run into is on a DMT be it an older interferon to newer DMT's. For those unable to afford them Pharma really works hard to make it happen for them. There are hoops to be sure. But neuro's and these companies make it happen and make it mutually beneficial for Pharma as businesses, the health care system at large by staving off much prospect future expenditure as people's health would deteriorate and trying to keep people productive rather than see them on full disability insurance. One can be partially disabled, still work and make ends meet. The American Disabilities Act has been of great help and organizations such as The Kessler Foundation are simply fantastic as they are not simply using past data in an evolving world but instead creating new information and data as well as paths for long term changes.

    Yes, there are people all over this world in nations where poverty suffer MS and other disabilities.

    Yes, there are issues in many nations where price is put before people.

    Yes, there are those who suffer greatly due to these forms of issues and others when it comes to MS or other disabling diseases.

    On behalf of MS Unites, me and mine, our followers we commend you.

    Your research and the work you and the staff at BARTS do everyday for all of us not just in the UK but really for people all over the world makes a difference.

    You letting people know they can find medicines to help regardless of "The systems" is more than commendable. Its kind, its caring and it is the right thing to do. MS isnt about systems, its about people who need help where systems impact what is "Right To Do" by placing priority over people. Yet, if it were not for people they would not have priorities now would they.

    The fact people such as yourself will place what is "Right To Do" as priority is a beautiful display of humanitarianism in the face of a disease that does not recognize national boundaries or systems.

    While some may attempt defile that beauty through intent, means or system boundaries that is their cross to bare. Love, kindness, caring for people you do not even know displays a level of compassion seldom found and even more seldom actionable.

    Know this sir, there is not a single person with multiple sclerosis... Over 2.4 million of us globally that would not want shake your hand or give you a hug. It is people such as yourself that display to all 2.4 million+ of us afflicted with this miserable disease that someone thinks that we are each individuals. We are each someone. We are each special.

    You are not a faceless entity within a "system". You are a well respected intelligent man that is a light in a disease that knows much darkness.

    You will see things from your perspectives. Those of us with MS will see things from our perspectives. But there is not one of us with MS of which would say your ability to help people through your skills and kindness is wrong.

    God Bless You and Yours.

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  8. I would like to reiterate that the evidence that RRMSers/CISers treated early do better than those who have delayed access to treatment is irrefutable. I am not aware of any of placebo-controlled studies showing the placebo group coming through without a handicap from delayed access to treatment.

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  9. Living in the U.S. I used to be a proponent of a single payer health care system. But reading these post's about NICE and the difficulty there is in getting MSers treatment I'm glad that I was dxed in the US.

    I'm so sorry for those British MSers who are being denied treatment.

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  10. Prof Pollock knows that you need trials to show evidence that the off-label drugs work as well as the expensive licensed DMD...who would fund these trials? The NHS? The MS charities?

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    1. The cladribine fits the bill...There is phase III oral cladribine. data This is 40% bioavailable compared to intravenous and subcutaneous cladribine which is 100% bioavailable.

      Rituximab is an anti-CD20 antibody that depletes B cells, the safety may be different to ocrelizumab but they are B cells depleters...you need to be able to use you brain and assimilate as well.

      Sadly regulators can't

      Who would fund the trials...sadly I think no one.

      There is only the NIHR in the UK who can do it. Charities can't do. Why not?

      You are not going to be able to do a placebo controlled trial in UK or USA (unless you are pharma of course who can put 600 people on nothing scandelous in my mind) as surely you can not put people on nothing when you have alternatives.

      Therefore the trial has to be a non-inferiority (it is no worse than current active drugs used) against a comparator (current active drugs).

      Your cheap as chips drug is going to be well cheap as chips but what about the comparator. £500/pa x 600 = £600,000 = which is manageable for a charity

      However, you have to ask the company to supply the comparator for nothing.

      They will of course say no. So you have to by the comparator you go for the low hanging fruit so say 600 people on beta interferon at £8,000 per year so for 2 year trial s 600 x £16,000 = 9,600,000 = £10,000,000. in UK. But no the market price is $100,000 in US (no NHS discount) so $60,000,000

      So the only option is to compare your treatment against treatment on the NHS or go to a country where there are no drugs and do placebo which is no NHS friendly and would not go down well.

      Next who is going to hold the licence at £100,000 a year.

      However if you had everything sorted...and could do if for a few million will anyone fund it.?

      Could the insurance company come up with the cash, a benefactor?

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  11. I lost my brother to the 'wait & see' method, currently EDSS 8.5. I was diagnosed last November, been on natailuzmab since then; my stomach reflexes were missing (and had been for years) now back to 60%.

    It is foolish to not be on a DMT, any medical Doctor that advocates this approach is an educated fool.

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  12. couldnt agree more. wait and see til you are worse off is paternalistic rubbish that has cost many of us far too much. Prof G gets this, but not enough other UK neuros do. How many more lives have to be ruined first?

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  13. Team G,
    Am I correct in saying non MS specialist neurologists can only prescribe injectables and only MS neurologists can prescribe the other DMT's (tablets, infusion)?
    Thanks


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    1. I don't think so.... the problem with infusions is that you need an infrastructure to deliver them and some MS drugs need an infrastructutre to monitor them, e.g. blood tests with lemtrada every months

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    2. This is what a non MS neurologist told me in May 2014 in the UK. I was grateful at the time he was honest with me so I asked my GP to change to an MS neurologist, it took a while to change neurologist.

      Perhaps things have now moved on since this and now all neurologists can prescribe all DMT's.

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    3. I will ask a neurologist this question and get back to you, but if you have MS you are best being seen by an MS neurologist, otherwise you could end up being under a epilepsy specialists and we know what they think:-)

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    4. MD is correct. In principle, any neurologist in the UK can prescribe MS DMTs, however national and local (NHS Trust based) commissioning & treatment guidelines control more or less (usually more) tightly what happens on the ground. Having the experience and set-up for treatment initiation and monitoring at hand is key. If you have MS, try and see a neurologist with a special interest in MS to discuss DMT.

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    5. Thanks MD and DrK.

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    6. I was under the care of a UK epilepsy neurologist when I had my first relapse. It wasn't Dr Cooper. I didn't get the care I should of got and needed, I had no idea what was wrong with me at the time. Sad that it was such a traumatic MS journey.
      My current MS neurologist is great and understands me.

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  14. Recently been diagnosed with RRMS with very high lesion load.
    So I really hope my neuro puts me on very effective drugs to halt inflammatory activity in our first appointment next week.
    I already made back up plans if he doesn't share my views.
    I called Cambridge uni and asked to be on the Palifermin+Alemtuzumab trial to prevent secon auto-immunity.

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    1. If you go armed with the knowledge of the pros and cons of each treatment it will be an easier discussion.

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    2. That attitude will serve you wisely. I've learnt to be one step ahead and preparation is key. I've found printing of the relevant policies / guidelines and taking them with me helps too.

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  15. This guy is not even an MS expert. Why don't NICE get advice from an MS expert?

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    1. I suspect because they won't get the answer they want ie sit on your hands, hope for the best and save cash.

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