If the Norway Rituximab trials are a success - Will it be available worldwide?

Apple

Senior Member
Messages
216
Likes
682
Location
UK
Possibly to soon to discuss this, but what do you think?

Do you think each country will want to do individual trials like the UK to try and replicate it or do you think that it will become widely available as a treatment around the world?

What are the views where you are?
 
Last edited:

alex3619

Senior Member
Messages
13,798
Likes
37,554
Location
Logan, Queensland, Australia
I am almost sure there will be a fight to make it available globally. That is where advocacy will become very important. This treatment is not cheap, and much will depend on whether or not its possible to determine who will go into long term remission rather than a few months of remission or symptom reduction, or no remission or symptom reduction.

In Australia I think Rituximab use is regulated. We will have to convince the regulators.
 

dannybex

Senior Member
Messages
3,352
Likes
2,351
Location
Seattle
I attended a lecture a couple years ago given by Dr. David Bell, who while excited about the possibilities, thought that even if it did show effectiveness in a subgroup, would probably take 20 years before it's approved.
 

Ysabelle-S

Highly Vexatious
Messages
524
Likes
3,901
I doubt it will take twenty years to be approved, unless the BPS crowd manage to colonise the global healthcare systems. If the drug companies see this drug is helpful, I think they will be looking at how they can cash in. I view them through somewhat cynical eyes - I think profits are their main language, and there are a lot of people with this illness globally. But if Rituximab phase three trial does pan out well, they might be looking to develop a new version of the drug - did they not do this with MS? Of course, developing new drugs will take longer, so it would be helpful to start with what is being tested now, assuming the results of the phase two Cyclophosphamide and phase three Rituximab are successful.
 

BurnA

Senior Member
Messages
2,087
Likes
9,785
If the drug companies see this drug is helpful, I think they will be looking at how they can cash in. I view them through somewhat cynical eyes - I think profits are their main language, and there are a lot of people with this illness globally. But if Rituximab phase three trial does pan out well, they might be looking to develop a new version of the drug - did they not do this with MS?
There are already new B cell depletion drugs being developed. B cell depletion is not specific to ME, so the results of the trial will have no impact on this.

If we want specific ME drugs we need to wait until we understand the illness more. But that is going off topic.

Rituximab is off patent now and any approval filing will not be submitted by a drug company ( they didn't perform the trial) so it's a very unique situation.
 
Messages
2,239
Likes
16,210
Demonstrating both safety and efficacy in one large and well conducted phase clinical 3 trial in another country will NOT be enough to persuade the authorities here in the UK to grant a product license for the use of rituximab in ME/CFS

So you are not going to see NICE adding rituximab to its list of recommended treatments for ME/CFS (i.e. CBT and GET) following publication of the results from Norway - which will hopefully occur before the middle of 2018

If the Norway results are positive, and other independent trials confirm safety and efficacy (which is why I have argued that the MRC should look at funding a large phase 3 clinical trial here in the UK) then the situation will change

But this will take time and if I was a betting man I would not put any money on rituximab being made available here in the UK for at least 4 years

If the results are negative, it's difficult to see interest in this drug being maintained

CS
 

Marky90

Science breeds knowledge, opinion breeds ignorance
Messages
1,247
Likes
4,611
Demonstrating both safety and efficacy in one large and well conducted phase clinical 3 trial in another country will NOT be enough to persuade the authorities here in the UK to grant a product license for the use of rituximab in ME/CFS

So you are not going to see NICE adding rituximab to its list of recommended treatments for ME/CFS (i.e. CBT and GET) following publication of the results from Norway - which will hopefully occur before the middle of 2018

If the Norway results are positive, and other independent trials confirm safety and efficacy (which is why I have argued that the MRC should look at funding a large phase 3 clinical trial here in the UK) then the situation will change

But this will take time and if I was a betting man I would not put any money on rituximab being made available here in the UK for at least 4 years

If the results are negative, it's difficult to see interest in this drug being maintained

CS
Given the premise that it showed effect, that`s ridiculous though. And knowing the U.K on this area, it would probably take even longer. Rituximab is a safe drug, it`s been tested loads of times in other conditions. Theres no need for 3-4 phase 3`s
 

JamBob

Senior Member
Messages
191
Likes
766
How likely is it that other countries like France, Belgium and the Netherlands would make the drug available in clinics on the basis of the Norwegian results?

I could travel somewhere accessible by train but am unable to fly anywhere which rules out Norway.
 

dreampop

Senior Member
Messages
290
Likes
686
20 years is an absurd, out-of-touch estimate. Certainly the resistance in the medical community to treat a presumed not serious condition like CFS with a serious drug like Ritux will be the problem. I guess this question is a little confusing because the drug already is widely available, but is not approved by any insurance to treat CFS. AFAI coverage for M.S. drugs isn't even even great or 100%, so I would expect insurance would only cover a portion. The insurance argument would demand another phase III trial, so probably at least 3 years plus a year of bureaucracy. So 4-5 years. I believe it will be tested in the NIH in-house study, Nath said he wants to try drugs in the second phase and Ritux is the only drug with convincing evidence behind it (given the thread's assumptions).

Another angle is "biomarker" or convincing test for CFS probably plays a role in how willing insurance will be to cover a drug for fatigue. They, and we, don't want somebody who has mild chronic fatigue but not CFS on a drug like Ritux after only 6 months. I'm not sure how the logistics of it would work. This is in the U.S., I have no idea how a socialist country would handle it. I'm sure 4-5 years is a good guess for a country like Norway, but the U.K. could be a lot looonger.

In the short term, I suspect if it works we will be making a trip to a country to take it cheaply and travel there every 6 months or so. I have no idea what the risks or with JVC past a few years, though.

Actually, that's a good question - if the drug works, and say works for me, is it safe to take for a decade until something better comes along? Does anyone know who would have a good answer to that question.
 
Messages
5,866
Likes
12,614
Location
South Australia
Demonstrating both safety and efficacy in one large and well conducted phase clinical 3 trial in another country will NOT be enough to persuade the authorities here in the UK to grant a product license for the use of rituximab in ME/CFS
Since the drug has already been approved for other conditions, there is already an abundance of safety data from the many other trials conducted.

Large trials are not needed to demonstrate efficacy (unless the effect size is very weak), they are only needed to demonstrate safety, since adverse effects are rarer than positive effects. There does however need to be independent replications.

Three double blinded studies along with the auxiliary unblinded studies will provide compelling evidence, if they all have similar results. (The already conducted small Norwegian study, the larger Norwegian study and the small UK study).

Of course the discovery some sort of objective marker associated with improvement will seal the deal, more so than another larger trial.

That said, it will be great if there was another larger study, but I doubt anyone is willing to fund it until at least the larger Norwegian trial results are published (and positive).
 

Valentijn

Senior Member
Messages
15,786
Likes
45,601
How likely is it that other countries like France, Belgium and the Netherlands would make the drug available in clinics on the basis of the Norwegian results?
I don't think there are any clinics in the Netherlands that would be qualified to administer it. It would probably have to happen in a hospital.
 
Messages
45
Likes
202
Location
Spain
I think another issue is that if a government approves this drug, or some hospitals or "M.E. specialists" give it to us, after having mistreated and ingnored us for so long time, then they have to recognize the seriousness of this illness and the negligence they have committed with they denialist and "go and do exercise"-like attitude.

At least I don't imagine my spanish health minister asking forgiveness to us like the Norwegian did...

So it's not only a scientific question, but political too.

On the other hand, if the trial is successful ( we desperately need it to be, but maybe it isn't) I think some Drs who are now waiting for the results of the trial, will consider trying Ritux on their ME patients, even if it's only in some local hospitals and not worldwide. And that will be good anyway.

But in any case, I hope every day that Ron Davis et al find some answers soon. To have safer alternatives if the Ritux trial is successful and not to despair if it isn't.
 

Rvanson

Senior Member
Messages
109
Likes
137
Location
USA
I don't think there are any clinics in the Netherlands that would be qualified to administer it. It would probably have to happen in a hospital.
Likely be the same way in the US, if US doctors start taking ME seriously, that is.
 
Messages
2,239
Likes
16,210
@charles shepherd Thanks for the Rituximab info?

I know you're doing your best but do the MRC pay any attention the MEA or MERUK?

Commentators here aren't exactly enamoured with the self interest shown by CMRC members . :mad::mad::mad::mad:
The simple answer is yes - but we do not always get what we ask for (e.g. another round of ring fenced money for ME/CFS research)

I have fairly regular contact that involves various people who are involved with both ME/CFS at the MRC and the MRC Neurosciences Board (where most ME/CFS research sits)

In fact, I will be at a meeting at the MRC next week that is bringing tougher various groups, including NIH, who are involved in funding ME/CFS research

CS
 

Jo Best

Senior Member
Messages
1,032
Likes
6,229
The simple answer is yes - but we do not always get what we ask for (e.g. another round of ring fenced money for ME/CFS research)
Positive political action by patients/parents got the last round of ring fenced money for ME/CFS research from the MRC.
The 'instigating' patient (Jan Laverick) is featured in the regional ITV news report:
The short debate in Westminster Hall :http://news.bbc.co.uk/democracylive/hi/house_of_commons/newsid_9382000/9382412.stm

The Early Day Motion (778) that earned the Feb 2011 debate:
http://www.parliament.uk/edm/2010-12/778

A few months later (July 2011) Jan Laverick co-founded the 'Let's Do It for ME!' campaign to help raise awareness for the plan by UK charity Invest in ME (Research) to establish a centre of excellence for translational biomedical research and patient care for myalgic encephalomyelitis, and to raise funds for the research (which got underway in 2013) http://ldifme.org/

In June 2013 Invest in ME Research announced their plans for the UK Rituximab Trial.

n fact, I will be at a meeting at the MRC next week that is bringing tougher various groups, including NIH, who are involved in funding ME/CFS research
NIH will be represented in London next week for the 2nd year running by Dr. Vicky Whittemore (as well as Dr. Beth Unger from the CDC this year) at the 12th Invest in ME Conference and 7th Biomedical Research into ME Colloquium organised and hosted by UK charity Invest in ME Research.