Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital

[Utsikt]

There is no reason to wait for any genetic study since there is already clinical evidence of the drug working!!

A positive unblinded pilot with 10 participants is not evidence that the drug is working. These are exactly the kind of claims we need to avoid to be taken seriously.

Private lobbying is fine, as far as I’m concerned. I was mostly thinking about a publicity campaign.

 

[Rick Sanchez]

Surely some of the bigger international MECFS orgs should be able to contribute something? Or some privileged families who have a MECFS sufferer in them? This seems by far the best bet for a treatment for a subgroup of patients. The improvement in steps per day are especially remarkable. Self-reported fatigue ´´improvements`` in an unblinded study are basically meaningless to me when it comes to MECFS studies.

Hopefully I will have some energy to donate a bit this weekend!! I come from a somewhat privileged family, so I can afford to. Does one just send money to the Norwegian ME org directly? Is that the safest way? Sorry if my question seems lazy, but my brains is completely useless at the moment.

Lastly, genuinely don`t understand why there hasn`t been more hype or urgency to donate to this study. Seen barely anything internationally!! Only learned about this here. Flugge and Mella have clearly learned well from their earlier studies. This is the horse to back in my opinion.

 

[Utsikt]

to. Does one just send money to the Norwegian ME org directly? Is that the safest way?

They have a fund that you can donate to, but I don’t know how that works if you’re not in the Norwegian financial system. Your best bet is probably to email them here: kampanje@me-foreningen.no

According to their site, they will prioritise the Dara study until it’s fully funded. In Norwegian:

Innsamling til daraturumab

Støtt Haukelands banebrytende studie med Daratumumab. Hver donasjon – stor eller liten – bringer oss nærmere en løsning.

www.me-foreningen.no

 

[V.R.T.]

Surely some of the bigger international MECFS orgs should be able to contribute something? Or some privileged families who have a MECFS sufferer in them? This seems by far the best bet for a treatment for a subgroup of patients. The improvement in steps per day are especially remarkable. Self-reported fatigue ´´improvements`` in an unblinded study are basically meaningless to me when it comes to MECFS studies.

Hopefully I will have some energy to donate a bit this weekend!! I come from a somewhat privileged family, so I can afford to. Does one just send money to the Norwegian ME org directly? Is that the safest way? Sorry if my question seems lazy, but my brains is completely useless at the moment.

Lastly, genuinely don`t understand why there hasn`t been more hype or urgency to donate to this study. Seen barely anything internationally!! Only learned about this here. Flugge and Mella have clearly learned well from their earlier studies. This is the horse to back in my opinion.

I agree, I feel like the UK MEA could redeem itself somewhat by reaching into it's coffers for this. OMF raise a lot of money too. You would think that this would be a priority for the community internationally.

If it is discovered how to donate for those outside Norway I would be very interested to know.

 

[Sasha]

They have a fund that you can donate to, but I don’t know how that works if you’re not in the Norwegian financial system. Your best bet is probably to email them here: kampanje@me-foreningen.no

It's a good idea to email and ask, especially for anyone who is thinking about dropping a large sum - not sure if there might be special advice about tax etc.

 

[Utsikt]

It's a good idea to email and ask, especially for anyone who is thinking about dropping a large sum - not sure if there might be special advice about tax etc.

Unfortunately, I think it might be difficult to get tax breaks across borders.

For Norwegians, the organisation handles it and reports everything to the tax authorities, the donor doesn’t have to do anything (other than confirming it when they check their automated taxes).

 

[Hutan]

I agree, I feel like the UK MEA could redeem itself somewhat by reaching into it's coffers for this. OMF raise a lot of money too. You would think that this would be a priority for the community internationally.

If it is discovered how to donate for those outside Norway I would be very interested to know.

There might be a role for ME/CFS charities overseas, to collect donations and allow people to claim a tax break, and then forward the funds on to the Norwegian team.

For an organisation like OMF, a campaign for this need not cost it anything much, and might even bring some new donors onto its contact list.

 

[Kitty]

Lastly, genuinely don`t understand why there hasn`t been more hype or urgency to donate to this study.

Maybe because it's still so speculative? The difficulties getting research funding could be because they haven't got a solid evidence base for using the drug.

Given that we don't yet know what it is we're trying to put right, I'd be surprised if it turned out to be the right therapeutic agent. Delighted, but surprised.

It might give us additional clues as to what is going wrong, though. And because it's such a good team, a null result would at least tell us what doesn't work.

 

[Jaybee00]

my email to Janet Dafoe--hopefully will get a reply.

Hello Janet,

Hope all is well. Dr. Fluge is saying that he does not have sufficient funding to do the complete phase 2 daratumumab trial in Bergen. In a Norwegian article, Fluge says that Johnson and Johnson (Janssen) was not even willing to supply the drug daratumumab to them--in other words they have to pay full cost for the drug, which is expensive. Below is a link to the board of JNJ. Jennifer A. Doudna, Ph.D. is on their board, and I'm guessing that Ron knows her. Assuming that he does, I was hoping that he might contact her to convince JNJ to at the very least contribute daratumumab to the Norwegian trial. Below is a link to a s4me thread that discusses the funding issue for the trial. Thank you for all your great work! JB

Open Post in thread 'Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital'

Thursday at 9:34 PM

An article in Norwegian behind a paywall that talks about funding, among other things. Two patients are interviewed and ask if the government can afford to not fund it.

A few points to highlight:
1. Half of the cost (26M NOK) is for the drugs.
2. Fluge says that they have secured funding for the «central tasks» in the study.
3. They might not be able to complete it on time if they don’t get the funding soon enough.
4. Fluge says they’ll get it done somehow eventually.
5. Janssen’s only reason for not contributing with a discount is that it didn’t «align with their strategy»...

• Utsikt

• 

Our leadership team

We credit our strength and endurance to a consistent approach to managing our business, and to the character of our people.

www.jnj.com

 

[Tia]

my email to Janet Dafoe--hopefully will get a reply.

Hello Janet,

Hope all is well. Dr. Fluge is saying that he does not have sufficient funding to do the complete phase 2 daratumumab trial in Bergen. In a Norwegian article, Fluge says that Johnson and Johnson (Janssen) was not even willing to supply the drug daratumumab to them--in other words they have to pay full cost for the drug, which is expensive. Below is a link to the board of JNJ. Jennifer A. Doudna, Ph.D. is on their board, and I'm guessing that Ron knows her. Assuming that he does, I was hoping that he might contact her to convince JNJ to at the very least contribute daratumumab to the Norwegian trial. Below is a link to a s4me thread that discusses the funding issue for the trial. Thank you for all your great work! JB

Open Post in thread 'Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital'

Thursday at 9:34 PM

An article in Norwegian behind a paywall that talks about funding, among other things. Two patients are interviewed and ask if the government can afford to not fund it.

A few points to highlight:
1. Half of the cost (26M NOK) is for the drugs.
2. Fluge says that they have secured funding for the «central tasks» in the study.
3. They might not be able to complete it on time if they don’t get the funding soon enough.
4. Fluge says they’ll get it done somehow eventually.
5. Janssen’s only reason for not contributing with a discount is that it didn’t «align with their strategy»...

• Utsikt

• 

Our leadership team

We credit our strength and endurance to a consistent approach to managing our business, and to the character of our people.

www.jnj.com

I wonder if Ron would have that much influence?

 

[Utsikt]

Both Fluge and Mella are part or the Scientific Advisory Board to OMF:

Scientific Advisory Board - Open Medicine Foundation

Ronald W. Davis, PhD, Chair of our Open Medicine Foundation Scientific Advisory Board, brought together world-renowned researchers with a track record of innovation and success to take on the End ME / CFS Project. As part of this board, they are contributing their time, expertise, and brilliant...

www.omf.ngo

 

[Jaybee00]

I wonder if Ron would have that much influence?

He could call Jennifer and ask—worst she could say is no, she can’t reverse their decision. Very tiny effort for potential big pay-off.

 

[V.R.T.]

I think this is a situation where it is frustrating that the forum hasn't got a 'direct line' to a lot of researchers. It would be very useful to know what F&M have already tried, ditto whether RD can be useful here.

This feels like such an open goal for pharma/govts funding wise it's so aggravating.

 

[V.R.T.]

Moved posts

Do drug companies typically provide the drugs these sorts of experimental trials? Iirc for your RA rituximab trial you had to buy it yourself.

I am thinking of the Daratumumab phase 2s struggle to get funding, and wonder if Janssen might be more open to persuasion to discount the drug if they saw the study as potentially being linked to your hypothesis, because as you say above -

Or more obvious like does daratumumab actually work

- discovering whether dara works could be a way to test some of it. Perhaps you and Jo C's history with RA/Lupus might persaude them it could be worthwhile? It's a rather trivial expense for a major pharma company after all.

It's a long shot but it just occured to me.

 

[Jonathan Edwards]

Do drug companies typically provide the drugs these sorts of experimental trials?

It will entirely depend on whether or not it fits their business strategy. And that is decided by their science team, who may have no interest in the disease in question, and their finance team, who have an eye on patents, timelines, bad press news from adverse events outside their main revenue area and so on. Remember that quite a lot of biologics have never been used in trials or stalled development because someone thought more money would be made by leaving them on the shelf. One of the best B cell depleting agents was deliberately bought up by a major company to enaure that it was never used. The reality is not pretty.

I am not presenting any data, so i don't think our hypothesis impacts on this. Things may change if new data emerge.

 

[Sasha]

Remember that quite a lot of biologics have never been used in trials or stalled development because someone thought more money would be made by leaving them on the shelf. One of the best B cell depleting agents was deliberately bought up by a major company to enaure that it was never used. The reality is not pretty.

Why can they make more money by leaving good drugs on the shelf?

 

[Utsikt]

Why can they make more money by leaving good drugs on the shelf?

You earn more by having them use loads of a slightly effective medicine than by only having to use a bit of a better one.

They earn money when people are sick. Not when they are healthy.

 

[V.R.T.]

One of the best B cell depleting agents was deliberately bought up by a major company to enaure that it was never used.

Horrific.

 

[Utsikt]

It will entirely depend on whether or not it fits their business strategy. And that is decided by their science team, who may have no interest in the disease in question, and their finance team, who have an eye on patents, timelines, bad press news from adverse events outside their main revenue area and so on.

The patent for Dara is apparently set to expire next year. A phase 3 for a biosimilar is planned by Celltrion. Which might explain why J&J doesn’t want to spend any money on it.

Mitigating Patent Cliff Fallout

Mitigating Patent Cliff Fallout

www.biospectrumasia.com

 

[Sasha]

You earn more by having them use loads of a slightly effective medicine than by only having to use a bit of a better one.

They earn money when people are sick. Not when they are healthy.

Another project for when I'm a billionaire!