Norwegian Research Council with 30 mill NOK (3,7 mill USD - 2.9 mill GPB) to ME-research

[Marky90]

probably jinxed us all now,

watch out PACE-authors im coming for your brains (yeye i know im getting sued now)

 

[RogerBlack]

By the way: No one in the literature have gotten PML by rituximab alone.

Can you link?

 

[Marky90]

Can you link?

Took me a while to find, dont remember the exact article. But it was in a table

 

[alex3619]

It takes years to plan and then run a trial. The Norway Rituximab trial will need replicating. Its good to get things under way early, or there will be several years more delay.

PS They can always abandon a trial if its not warranted, but if they don't get ready to start one then the delays could be very long.

 

[RogerBlack]

It takes years to plan and then run a trial. The Norway Rituximab trial will need replicating. Its good to get things under way early, or there will be several years more delay.

PS They can always abandon a trial if its not warranted, but if they don't get ready to start one then the delays could be very long.

Recruitment and preparation is unfortunately a not insignificant amount of the funding.

 

[Jill]

As my partner who is room bound said recently about rituxan - his only question would be which arm do you want ????

17 years lost - doesn't give a damn if treatment kills him he has no life now . Would sign his life away just to try anything that has got people back on their feet

 

[Kalliope]

An English version of the announcement from The Norwegian Research Council will be available during this week (or early next week).

 

[RogerBlack]

An English version of the announcement from The Norwegian Research Council will be available during this week (or early next week).

To be clear - do you mean there will be an announcement that happens to be in english, or do you mean there has been one in Norwegian, and there will later be one in English?

 

[Kalliope]

To be clear - do you mean there will be an announcement that happens to be in english, or do you mean there has been one in Norwegian, and there will later be one in English?

Sorry for any confusion.. there will be an English translation of the announcement available soon from The Norwegian Research Council.

The Research Council writes in their (Norwegian) announcement that national and/or international cooperation across expertise and professions is important and will be considered as positive in an application for funds.

 

[slysaint]

international cooperation across expertise and professions is important and will be considered as positive in an application for funds

Please God, don't let P.White be tempted out of retirement

 

[mango]

Where does this money come from, Forskningsrådet or the government? Was it a decision by the authorities or a political decision (myndighetsbeslut eller politiskt beslut) to earmark 30 million?

 

[Kalliope]

Where does this money come from, Forskningsrådet or the government? Was it a decision by the authorities or a political decision (myndighetsbeslut eller politiskt beslut) to earmark 30 million?

The money comes from the government, but the Research Council decides themselves how it should be administered, so it is their decision.

I think it has been quite uncontroversial among politicians, as several political parties seem to agree that "more research on ME is needed". The problem is most of them don't understand how important biomedical research into ME is (luckily the Research Council did).

 

[snowathlete]

Rituximab is not that dangerous at all really. People get prescribed more dangerous drugs to treat much less severe illness than ME. But no treatment is risk free; it's about a balance of risk against reward.

 

[RogerBlack]

Rituximab is not that dangerous at all really. People get prescribed more dangerous drugs to treat much less severe illness than ME. But no treatment is risk free; it's about a balance of risk against reward.

A percent or so of people get really severe reactions to it, and about one in a thousand die due to it.
That's not hugely safe.
The above numbers may not work out the same for CFS patients, for various reasons, but it's by no means 'safe'.

 

[snowathlete]

A percent or so of people get really severe reactions to it, and about one in a thousand die due to it.
That's not hugely safe.
The above numbers may not work out the same for CFS patients, for various reasons, but it's by no means 'safe'.

It's likely that a similar proportion of patients will have severe reactions as in other diseases where the drug is used, I agree, and it might be that the same number of serious consequences will occur as a result but for most people the drug is safe, and one in a thousand is clearly considered a reasonable risk in lots of other diseases where the drug is used, so I'm not sure why it would not be worth it in the case of ME/CFS. I think the majority of patients with anything but mild disease will consider that risk perfectly acceptable. No one is saying the drug is 100% safe, but very few drugs are. The harm profile for rituximab isn't that bad compared to many drugs, it's pretty safe really. We need to see how that pans out in the case of ME/CFS as there may be differences.

 

[RogerBlack]

The harm profile for rituximab isn't that bad compared to many drugs, it's pretty safe really.

Perhaps in the context of moderate/severe ME/CFS from patients understanding all the risks.

I note Vioxx was withdrawn with rather lower risks.
Acceptable risk in the context of CFS/ME - perhaps. 'Pretty safe' - no.

 

[snowathlete]

Perhaps in the context of moderate/severe ME/CFS from patients understanding all the risks.

I note Vioxx was withdrawn with rather lower risks.
Acceptable risk in the context of CFS/ME - perhaps. 'Pretty safe' - no.

Vioxx is a totally different drug. It's a COX-2 inhibitor and it was often used on a long-term basis as a pain killer, which is obviously very different to how Rituxmab is used. In the case of Vioxx it caused severe consequences and the drug company withheld information on adverse effects which became apparent once it had been in clinical used for a few years. Rituximab has been in use for much longer without the same kind of problems. It's totally different and the risks with Vioxx were not lower, they were much much higher causing loads of cases of severe heart disease.

It's fine that you consider Rituximab not to be safe though, we'll just have to disagree on that.

 

[BurnA]

Acceptable risk in the context of CFS/ME - perhaps. 'Pretty safe' - no.

@RogerBlack there are quite a lot of threads already on the topic of rituximab - not sure if you've read them or not but if you haven't they are a great source of information. Also, it might be more relevant to discuss the topic on one of those threads.

Regarding your statment above I would suggest you have it backwards The risk to ME CFS patients is unknown at this stage, other than the phase 2 trials which didn't have many patients, there is no data.
Regarding safety profile in general, it has been on the market for a long time now so the safety profile is well understood for those indications.

 

[Kalliope]

Here is the announcement from The Norwegian Research Council in English.

The BEHOV-ME scheme will provide funding for research on chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), which is a serious disorder with unknown causes (aetiology) for which there is currently no effective medical treatment.

The Research Council is introducing a new funding instrument for user-identified research. The aim of the funding instrument is to launch research projects in areas that users of health care services have identified as particularly pressing. It is a stated objective that the research results can be applied in the health care services relatively quickly.

 

[AndyPR]

Experience from the UK has shown that user-identified research increases knowledge that is of significance for public health and provides health care services and the authorities with a better basis for decision-making. Involving users and the general public in publicly funded research is also a means of democratising research.

How ironic. I'm surprised there is no "as long as you ignore the PACE trial fiasco" caveat right at the start of that paragraph.