My post on the ‘Damp Squib’ has upset several close colleagues. I need to explain my reasons for doing it; the main one being is that I am very frustrated that change happens so slowly, whereas shit happens so quickly.
The catalyst for our Barts-MS off-label initiative was my sabbatical 5 years ago and kicked-off with a blog post I did on the 3rd October 2014. I am ashamed that it is now 5 years since our first activities in this space and nothing has really changed for people with MS living in resource-poor environments. I can count the number of centres on one hand (excluding rituximab users, which is really a high-cost DMT) that are using off-label DMTs and they are all in high-income countries. As a proponent of ‘Time is Brain’ in MS, and that includes the brains of pwMS living in resource-poor countries, I have to ask myself how many brains have been shredded whilst we procrastinate. We want this campaign to become urgent.
A good analogy would be the anti-retroviral access campaign that was run to get people with HIV living in low- and middle-income countries onto treatment. Why can’t we do something similar for people with MS?
When I criticise my colleagues I want to make it clear that there is likely to be an unconscious bias against off-label prescribing of generics and biosimilars despite a robust evidence base. This is the invisible elephant in the room. Whenever I have attempted to shift this issue to the top of the agenda it gets watered down and put at the bottom of the list of solutions for treating people with MS in low- and middle-income countries. In addition, the term off-label tends to be avoided and replaced by euphemisms, for example, repurposed.
I suggest we avoid off-label and use a neutral term that will be all-encompassing and acceptable to all parties. I, therefore, suggest referring to these treatments as “affordable DMTs”, which is counterbalanced by the term “high-cost DMTs”. Affordable captures everything we are trying to do without stating the obvious. The term ‘affordable DMT’ solves the issue as it not only refers to off-label DMTs, but includes generic, biosimilar, and bioequivalent DMTs, and unlicensed and compounded DMTs and any other variation that emerges. In addition, what is affordable may vary from one country to the next.
It is clear that a lot of people in the MS community don’t want to rock the boat when what we really need to do is capsize the boat. Many of my colleagues, including me, are so conflicted that we tend to toe the Pharma-line because we have been indoctrinated by the system, i.e. the only solution to treat and manage MS is with high-cost innovative DMTs. This is clearly not the case and we need to collect and summarise the evidence to make the MS community realise that there are other ways to manage this disease.
So I want to rebrand this the GRAD Initiative (Grass-Roots Affordable DMT Initiative), which may be more acceptable to the wider community and potentially neutralise our cognitive biases. The plan that I am currently formulating is based on a simple grass-roots movement, starting small and local:
- Identifying local MS champions and creating an international network of these champions.
- Creating and disseminating an essential affordable DMT list with detailed protocols on how to use each agent.
- Modified diagnostic criteria for use in resource-poor environments; these will need to country-specific.
- Protocols for derisking and monitoring DMTs in these environments.
- Creating a platform to allow neurologists and other HCPs from these countries to share their experience.
- Putting in place the suitable infrastructure to collect real-world data to assess the effectiveness of using affordable DMTs in these environments.
We are hoping to try to do something small and local in Africa, India and Pakistan. We plan to visit all these countries/regions in 2020.
Please don’t be shy we need champions and wider engagement from the MS community to make this happen. Please get involved and register your interest.
CoI: multiple
I’m bored of affordable DMTs / GRAD – do a survey and most would agree.
As we approach 2020 I want to hear about MS research – what’s happening to address slowly expanding lesions, smouldering MS etc. Where are we with neuroprotection therapies, remyelination therapies? What has Team G achieved this year?
I suspect the political posts / affordable DMT posts are a smokescreen to cover up the lack of progress in MS research. ECTRIMS 2019 showed that MS research was in the doldrums.
What does Prof G want to be remembered for? The guy who brought to market a treatment to stop Progressive MS or the guy who helped reduce the cost of Copaxone by $2.50 in Turkmenistan?
Don’t even get me started on the Mice doctors. MD 1 is the Pol Pot of the rodent world. Thousands slaughtered for what?
The MS research industry is failing MS patients big time – the experts still haven’t got a clue about this disease. How much longer do you need?
You’re very selfish Mr Angry of TW
My wife and I were discussing the depressing state of British politics whilst walking our gorgeous labradoodle this morning. We were lamenting the extraordinary number of MPs who are standing down and pulling out of frontline politics; particularly the number of women. The reasons they give is the nastiness of the world and the fact that they are being emotionally abused by trolls.
I mentioned to my wife that the same thing happens to us on this blog. The comments we don’t let through tell a tale of the hatred and venom and the sad state of what is modern humanity.
On a bitterness scale of 1-to-10, this comment would score about 5 out of 10. So not too bad.
The good news is that we have thick skins and tolerate the mudslinging; it comes with the territory.
P.S. ProfG has a thick skin, I on the other hand…Em ….beware:-) and keep an eye out for the Khmer Rouge;-)
Anyway A of TW…get you bile saved up, as you will soon see what we have been up to this year and some of it you in particular, won’t like.
Our troll from Leicester keeps telling us the “Truths will be out”…it seems this will be the case.
Hey Ho…you can’t please everybody all of the time, it seems some people you can’t be pleased any of the time.
Never admit you have a labradoodle. That’s cannon fodder for trolls. I on the other hand I walk my cat. He loves a good alfresco poo.
I’m pretty sure my cat doesn’t have MS. So, this comment is irrelevant. Feel free not to publish. Or do for some light relief. God knows some of the people replying need a big cat shit chill pill.
Up to you 😾
Wish I could walk my cat, when ever I tried he used to just lie down and play dead…. and I am really sure he doesn’t have MS!
I think there are lots of people who should take a big chill pill with or without the cat shit.
Who is TW and why does he / she make people so angry? I hate a bunch of things (Fox News, pizza with pineapple on it, oysters (they literally feed on shit) but I’m not gonna post under ‘angry at oysters’…
Here’s a thought, use that anger constructively. Help mobilise the MS community, leave a legacy and be part of the solution. Being angry is ok but it’s what you do with it that counts.
I’m sure Prof G is comfortable with his contribution and history of patient advocacy. Can you say the same?
Maybe you would feel differently if you have MS, or a family member of yours had MS, and you lived in Turkmenistan, India, Kenya or any other low- or middle-income country. I suggest you read or reread my recent post called Catastrophe, which tries to put things into perspective.
continue like this Prof G you are a very human and profound person
There are thousands of people in the UK that don’t have access to DMTs. No one ever asks how they have managed, coped or lived without them. Most studies seem to compare efficacy of different DMTs, not to no treatment. Patients in more affluent countries have regular MRI scans and blood tests during their course of the disease. This is not readily available to poorer nations and sometimes patients in the UK if they are not on a DMT.
I would dearly love for someone to find the cause of MS, so that the lottery of whether someone qualifies, or can afford treatment ends. I am not a troll, I am politically homeless. Anyone that watched the Victoria Derbyshire programme on BBC2 would have been close to tears to see the young woman’s situation as heartbreaking.
We may have found a cure already in the form of IRTs, but they have to be used very early in MS. However, regulators, payers and the wider MS community don’t want to adopt IRTs as a treatment strategy for MS. We find ourselves in an interesting position.
Dear Prof G
Do you really believe this is true or at least that it is our best current chance for PwMS?
My wife was diagnosed almost 1 year ago. She is currently not on any DMT because we were trying to get pregnant (and we finally are!), but we are expecting to start treatment just after the baby is born.
I’ve been reading your blog since we got the news (I’m kind of obsessed with it) and I really want to believe you when you say that IRTs might be the closest thing to a cure.
In our country (Spain) cladribine is approved but the neurologist seems quite reluctant to prescribe it to us, since my wife’s simptoms are quite mild right now. I even mentioned your blog and she said that “Prof G is brilliant but he is quite biased when taking about claridbine”. Lemtrada is not an option for us apparently.
We will have to fight a lot in order to convince the neurologist to put my wife on cladribine instead of aubagio or tecfidera… I guess what I want is that you encourage me to keep fighting for claribine because it’s really worth it 😉
Thank you for all the work you and your team do. It is the only source of knowledge for many of us.
Best wishes
How do we use IRTs early in the disease process when MS symptoms go unrecognised / misdiagnosed for years? For example, my wife was diagnosed with MS this year after being diagnosed with ADEM at the age of 21 in the UK. No follow-up at all since the ADEM diagnosis. 17 years later, BAM, optic neuritis and an MRI showing high burden of disease and significant brain atrophy. Little to no symptoms in between. She has completed year 1 alemtuzumab but I fear we have missed the window for functional cure. Time will tell.
Genius. Forward Thinking. Companionate.
#affordable #off-label #repurposed #compassionate #generic
What’s in a name? Would a rose… ?
I’m absolutely behind this whatever it’s called, we all know what it means. Am only one pwMS, so apart from showing support not a lot to offer.
Re
A good analogy would be the anti-retroviral access campaign that was run to get people with HIV living in low- and middle-income countries onto treatment. Why can’t we do something similar for people with MS?
I think possibly the huge numbers of people involved? HIV is massive across Africa relative to North America and Europe. Conversely MS is highest prevalence in North America and Europe. Which doesn’t make it any better for pwMS in resource poor environments, just less headline-grabbing.
In numbers worldwide:
HIV 37.9 million
MS 2.5 million
Agree grass roots bottom up approach likely to be a good way forward. Web platform? Resources, online conferencing, meetings. 🤔 website other than this blog I think?
I agree that this post deserves promotion.
However, the thing that HIV had going for it in terms of being able to mobilise communities and countries, particularly in low income countries was almost everyone was at risk, it really could happen to anyone, and the later stages of HIV are very tragic and most importantly visible. This made it much easier to gain support for a grass roots movement.
🤔 this post deserves promotion to the featured slot, HSCT been there for over a week
Refreshing. I know people who live in the U.S.A. and can’t afford DMT’S with insurance!
Karen 9:25
Costs for dmts eye watering in the US! How does it work with insurers? Depends on policy type as to how much they’ll pay? So some people have to top up? 🤔uninsured in US in a very bad place, the very people who need #off-label (ok call it #affordable).
Here in the UK have to say NICE consult with prescribers and pwMS (via MS Society and Trust etc) and seem to negotiate effectively with Pharma. 🤔 tell me if am being daft, but why can’t insurers work together and negotiate in similar way? And why do dmts cost more in US than Europe?
Help me out here, comments please!
The US government has created the environment
“Brilliant and biased”, but you can ask on what grounds are the neurologists making their choices.
We know alot about the history of alemtuzumab, sadly we simply don’t have the long-term data with cladribine because of its chequered history. Sadly mud sticks and this no doubt part of the problem, another issue is people can’t understand how it works. This is amazing to me as it is so easy to explain…if you have an open-mind:-(
, but it is such a simple sthe
Because the US government is committed to a free market system where prices for goods and services are self-regulated by the open market and by consumers. In the UK and Australia, drugs prices are covered by by government and / or health authorities after negotiations.
It goes something like this:
Big Pharma- We want $100,000 per treatment course.
Australian government – Tell them their dreaming. How does $15,000 sound for universal access for all Australians. Well pick up the bill.
US physicians – But then US citizens are subsidising your drug costs.
Big Pharma – Deal! We’ll screw American citizens.
The rest of the world – Man, those free market principals are screwing US citizens.
Australians – Yep, but you get what you vote for. Beer anyone?
Are you looking for people in resource poor countries or can anyone join the grass roots movement? For example, I live in Australia where alemtuzumab costs $0 dollars for the patient including hospital fees. What can someone in Australia do to facilitate your movement?
I agree with the Bart’s team and strongly believe that access to high efficacy treatments should be universal and affordable. Perhaps I should grab a couple of vials for ‘redistribution’ when I’m next at hospital? You’d be surprised how easy that would be for me to do (it’s only illegal if you get caught) 😀
🙂
Completely get your comments re cost of drugs at least with Onama care there is the chance of those without insurance getting DMT’s. Cuba health system & the fight for combination therapy present ‘models’ to campaign always remember the way to eat an elephant (figuratively) is one bite at a time but is possible.
The US has some celebrity champions ready made so we have to use the means available to raise the campaign above the parapet but heh the airs better there.
As for the cots of treatment, until Obama care,covered all, in the US health for those covered & those with wealth or determination spent a substantial amount of GDP on health. It should never be a market it should be a right. The market floods out innovation & competition for Pjarma is a nonsense they are to big & have very deep pockets. Sorry I’m simging to the choir.
The point I’m making badly the UK is the 5th or 6th largest economy in the world. So let’s start from Ho,e.
Thank you for you insight & being able to see the woods for the trees.