Is Anyone Else Scared of Rituxan?

[jimells]

You get a crashing headache, a stiff neck and cannot bear to look at light.

Symptoms I experience on a regular basis as part of PEM. Very interesting.

 

[Nielk]

Reposting this here:

http://forums.phoenixrising.me/index.php?threads/new-fatigue-and-pain-lab-at-uab.37804/

This has been funded by a large NIAID R01 grant (yes the NIH institute that someone in this thread is against ME research!)

No matter how many examples of NIH funding for ME/CFS you bring up, it still all adds up to 5 million dollars a year = $5 per patient.
HIV/AIDS which has become a treatable disease, still gets 3 BILLION dollars a year =$ 287 THOUSAND per patient.

So, tell us again, how much does NIH care about ME/CFS patients?

 

[Snow Leopard]

So, tell us again, how much does NIH care about ME/CFS patients?

About $3 per patient.

 

[dannybex]

I wrote to the authors of the study to see if they could help clarify a few things. I asked when the actual study would be finished, and that because some people online are saying patients are going into 'actual remission', does that mean they need to keep getting injections in order to stay in remission?

Here's the reply I received:

"The study that the current RituxME study is built on will be published in PLoS One within 2-3 weeks. The unblinding of RituxME can be done when the latest patient included is finished with 2 years of follow-up. That may be in the end of summer 2017 (presently 125 of the 152 patients have been recruited, but one of the centers is for logistical reasons behind the others and will be rate limiting.

Concerning remissions, we do not want to give any information on that, as we have no knowledge of what patients have been treated with (active drugs or placebo). It is a pity that patients are speculating on this on the Internet – we would prefer that they did not. But yes – the PLoS One study will show that maintenance treatment is important to make remissions long-lasting."

 

[heapsreal]

I wrote to the authors of the study to see if they could help clarify a few things. I asked when the actual study would be finished, and that because some people online are saying patients are going into 'actual remission', does that mean they need to keep getting injections in order to stay in remission?

Here's the reply I received:

"The study that the current RituxME study is built on will be published in PLoS One within 2-3 weeks. The unblinding of RituxME can be done when the latest patient included is finished with 2 years of follow-up. That may be in the end of summer 2017 (presently 125 of the 152 patients have been recruited, but one of the centers is for logistical reasons behind the others and will be rate limiting.

Concerning remissions, we do not want to give any information on that, as we have no knowledge of what patients have been treated with (active drugs or placebo). It is a pity that patients are speculating on this on the Internet – we would prefer that they did not. But yes – the PLoS One study will show that maintenance treatment is important to make remissions long-lasting."

How can they expect someone who has gone into remission not to talk about and being excited about it . Hard to keep the lid on any treatment of any disease that csuses a remission .

 

[dannybex]

How can they expect someone who has gone into remission not to talk about and being excited about it. Hard to keep the lid on any treatment of any disease that csuses a remission .

I'm not sure that's what they're saying. My understanding is that they'd prefer that the patient community doesn't speculate about the actual results of this current study until it comes out later in the year.

 

[Jonathan Edwards]

I'm not sure that's what they're saying. My understanding is that they'd prefer that the patient community doesn't speculate about the actual results of this current study until it comes out later in the year.

I think it is worth considering that quite carefully. I am all for everyone discussing everything and I think people are entitled too. However, it would be a pity if the ME community shot itself in the foot by invalidating the RituxME study. Fluge and Mella are trying so hard to keep the methodology watertight. But it is really very easy to destroy that. I will not say how I think one could, for the obvious reason that then it would be destroyed. I think it worth remembering just how difficult it is to design a good trial in ME. If Fluge and Mella ask for people not to speculate or discuss their experiences in the trial then I think we should try pretty hard to respect that. This is nothing to do with being secretive and all to do with wanting to get the right answer.

 

[Kyla]

I'm not sure that's what they're saying. My understanding is that they'd prefer that the patient community doesn't speculate about the actual results of this current study until it comes out later in the year.

I have never seen anyone on this forum pointing to or speculating about patient recovery in the current trial. there have been discussions about results from the stage one and two trials, and the poster here who has talked about her recovery was not part of ANY trial.
I really hope you will write them back and say as much.

This sounds like they think there is speculation about the current one, and they might have very real concerns about blinding based on that.
However you feel about this trial or about Ritux I hope you wouldn't want to undermine their research.

 

[dannybex]

I think it is worth considering that quite carefully. I am all for everyone discussing everything and I think people are entitled too. However, it would be a pity if the ME community shot itself in the foot by invalidating the RituxME study.

I don't understand how the ME community could invalidate results of a study they weren't a part of. Results are results, aren't they?

If Fluge and Mella ask for people not to speculate or discuss their experiences in the trial then I think we should try pretty hard to respect that. This is nothing to do with being secretive and all to do with wanting to get the right answer.

I totally agree. That's why I posted their reply.

 

[dannybex]

I have never seen anyone on this forum pointing to or speculating about patient recovery in the current trial. there have been discussions about results from the stage one and two trials, and the poster here who has talked about her recovery was not part of ANY trial.
I really hope you will write them back and say as much.

Well earlier in this thread, someone made the positive comment ""there is now a lot of evidence of patients going into actual remission", and it wasn't the person who wasn't part of the trials. I quoted this in my email to them, and that's what they reacted to.

Now perhaps that comment wasn't regarding this current study. I'll reply telling them that's not the case.

This sounds like they think there is speculation about the current one, and they might have very real concerns about blinding based on that. However you feel about this trial or about Ritux I hope you wouldn't want to undermine their research.

Of course not, that's really insulting. And again, I don't know how I could if I wanted to, because results are results.

Sigh...

 

[Kyla]

Maybe they misunderstood my question, as there has definitely been statements in this thread about recovery and remission rates, but perhaps not specifically about this current study. I'll reply assuring them that's not the case.



Of course not, that's really insulting. And again, I don't know how I could if I wanted to, because results are results.

Sigh...

Hi @dannybex
i didn't mean to insult you so I apologize, I did not word that well.

I was trying to point out that there could be serious consequences to them misinterpreting this. Or to anyone else who wants to undermine the trials using this as evidence.

 

[dannybex]

Hi @dannybex
i didn't mean to insult you so I apologize, I did not word that well.

I was trying to point out that there could be serious consequences to them misinterpreting this. Or to anyone else who wants to undermine the trials using this as evidence.

Thanks @Kyla. I didn't word my reply very well, so I edited it while you were replying to clarify a couple things. But I did reply to the study's authors to let them know that it was my understanding that the speculation wasn't about the current trial.

 

[Jonathan Edwards]

I don't understand how the ME community could invalidate results of a study they weren't a part of. Results are results, aren't they?

Dear dannybex,
Let me simply say that I have it in my power to seriously damage this trial by saying things irresponsibly, and so do other members I know of. The fact that you do not understand how we could do that is something we should all be thankful for. Once people realise why the trial is vulnerable we are in trouble. Just don't ask!! Drs Fluge and Mella have actually done more than one might expect to counter the problems but there are certain things they cannot completely protect against. We have a least one member posting who is known to be in the trial who has been very good about not saying more than necessary. Maybe we should embargo all further discussion but I actually think we are OK with this sort of general discussion if we are careful.

 

[Snow Leopard]

Quite right, unblinding of any results will completely compromise the overall findings.

 

[dannybex]

Quite right, unblinding of any results will completely compromise the overall findings.

This I understand. I just don't understand how anyone but those involved in the current study could unblind the results, which they say above won't happen anyway until the end of the year. Even the authors don't know who got the drug or the placebo.

And thanks @Jonathan Edwards as well for your reply. Yes, I still don't get it, but in saying so I am not asking you or anyone for an explanation! Hopefully I'm not the only one stupid enough to not understand.

 

[Jonathan Edwards]

This I understand. I just don't understand how anyone but those involved in the current study could unblind the results, which they say above won't happen anyway until the end of the year. Even the authors don't know who got the drug or the placebo.

And thanks @Jonathan Edwards as well for your reply. Yes, I still don't get it, but in saying so I am not asking you or anyone for an explanation! Hopefully I'm not the only one stupid enough to not understand.

Don't worry, it is not a matter of stupidity. Nobody could work it out from scratch.

 

[leokitten]

No matter how many examples of NIH funding for ME/CFS you bring up, it still all adds up to 5 million dollars a year = $5 per patient.
HIV/AIDS which has become a treatable disease, still gets 3 BILLION dollars a year =$ 287 THOUSAND per patient.

So, tell us again, how much does NIH care about ME/CFS patients?

Do you want to know what Dr. Jason, Dr. Klimas and Dr. Natelson all said to me at the NIH P2P??? One of the major reasons that ME/CFS only gets $5-6 million is not because the NIH doesn't care it's because in the U.S. there is almost no one researching the disease and there are actually very few grant applications that ask for money directly under the ME/CFS category.

There aren't many researchers in the U.S. doing CFS research, that's the major reason.

So I'm sorry do you disbelieve all three of them?? And remember that $5-6 million is only for grants funded under CFS, there are many other grants funded under other similar categories where they are also doing studies on ME patients but it's under another category.

 

[Snow Leopard]

Do you want to know what Dr. Jason, Dr. Klimas and Dr. Natelson all said to me at the NIH P2P??? One of the major reasons that ME/CFS only gets $5-6 million is not because the NIH doesn't care it's because in the U.S. there is almost no one researching the disease and there are actually very few grant applications that ask for money directly under the ME/CFS category.

Why are there a lack of researchers? It is a catch-22. The incredible difficulty in obtaining funding (both pilot funding and NIH grants) means they don't apply.

In every other disease where this has been the case in the past, there has been a strong push within the medical community, often times within the NIH itself to build research capacity.

Australia set some 'national health priorities' precisely to build this capacity, but of course ME/CFS was not included due to political prejudice.

Again, if you ask scientists why they didn't apply for NIH grants, they will tell you: because they believe it will be knocked back. And the fact is that ME/CFS applications are knocked back at a greater rate than other applications.

It is a catch-22 and nothing will change until both the NIH and the private medical research community work together to increase research capacity by a magnitude of order. That requires leadership, something that seems to be lacking within the NIH. We need a specific strategy to encourage scientists to move into this area and create spaces (eg. a dedicated government research institute) where this can occur.

 

[leokitten]

Why are there a lack of researchers? It is a catch-22. The incredible difficulty in obtaining funding (both pilot funding and NIH grants) means they don't apply.

It's not exactly that, all three of the experts and I talked about it further and yes there is a catch 22 but not currently because of grants being denied for ME research (though historically this could've been the case). They said because when a researcher thinks about having their lab do ME/CFS research they see the current NIH yearly funding of $5-6 million and they decide to go into another field because they get fearful that they cannot build a career in an field with such low funding. So the catch 22 is that most researchers don't ever go into ME/CFS research.

Again, if you ask scientists why they didn't apply for NIH grants, they will tell you: because they believe it will be knocked back. And the fact is that ME/CFS applications are knocked back at a greater rate than other applications.

I honestly don't believe this is currently the case, historically yes but not currently.

It is a catch-22 and nothing will change until both the NIH and the private medical research community work together to increase research capacity by a magnitude of order. That requires leadership, something that seems to be lacking within the NIH. We need a specific strategy to encourage scientists to move into this area and create spaces (eg. a dedicated government research institute) where this can occur.

I completely agree with this statement and this is very likely what is actually going on. But this is a very different thing than what people have been saying on this thread that the NIH currently is against ME research and doesn't believe that ME is a real disease, which I have been challenging. I appreciate that you see this difference.

 

[Snow Leopard]

I completely agree with this statement and this is very likely what is actually going on. But this is a very different thing than what people have been saying on this thread that the NIH currently is against ME research and doesn't believe that ME is a real disease, which I have been challenging. I appreciate that you see this difference.

It all amounts to the same thing: they are not taking it seriously enough to ensure enough research in the field.