Now I'm more confused. I think I'm breaking my personal best for fogginess. Should I move the above thread?
Barb
Should advocates be trying now to get a US rituximab trial started?
- Thread starter Sasha
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Now I'm more confused. I think I'm breaking my personal best for fogginess. Should I move the above thread?
Barb
Your confusion has confused me! And likewise, probably. The issue of the UK situation came up in the course of that general thread on the new rtx study - I think it's fine to continue talking about the UK situation on that thread.
This thread that we're on is to talk about the US situation.
Did that help? I just seem to be spreading chaos this evening...
charles shepherd
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They keep a much lower profile than MRC and one in particular is completely off the radar screen.
I hope you won't mind if I don't name names in a public forum!
Yes, he's advising on a trial initiated by IiME. One of the aims of the trial is to try to identify which patients are likely to be responders. I think the preliminary stage is still ongoing. It's a small trial of about 30 patients, I believe. More info here:
http://www.ukrituximabtrial.org/IIMEUKRT FAQ.htm
All very cryptic! Can you say anything about what type of funder you mean, without naming names?
Fair enough if you can't, but I'm curious!
@Sasha @Scarecrow
Thanks, that helps.
Not to worry about any chaos. I don't remember the last time I was chaos free!
Barb
Thanks, that helps.
Not to worry about any chaos. I don't remember the last time I was chaos free!
Barb
Michelle
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Regarding Sasha's original question, I would think it does sound like a US trial would be helpful. Given @Hutan's comment in the original Ritux research thread that
To be sure we're at a major disadvantage not being part of one of the major institutes (gawd does this need to be rectified...like, yesterday!), but I don't see why we couldn't or shouldn't pressure Genentech (Twitter campaign, email, whatever) to get some "drugs into bodies." I mean, why aren't they jumping on this? I appreciate it's a small study, no clinically validated makers, etc. But, I mean, (with my best Dr. Evil voice) one MILLION patients!
To be sure we're at a major disadvantage not being part of one of the major institutes (gawd does this need to be rectified...like, yesterday!), but I don't see why we couldn't or shouldn't pressure Genentech (Twitter campaign, email, whatever) to get some "drugs into bodies." I mean, why aren't they jumping on this? I appreciate it's a small study, no clinically validated makers, etc. But, I mean, (with my best Dr. Evil voice) one MILLION patients!
Michelle
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Oh, and also, someone has mentioned this in another thread, but the 21st Century Cures Act with its #Cures2015 campaign ("what would a cure mean to you?") would also be ripe for exploiting.
Nielk
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Genentech is not jumping because their patent is expiring soon.
Michelle
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Indeed. But as Hutan pointed out, that isn't stopping them from working with NIH on MG. Moreover if they can get Rituxan approved for ME/SEID (or for MG for that matter), then they could get a new or extended patent for an additional indication (Roche -- which owns Genentech -- has additional indications for rituximab in combination with other drugs listed in its list of drugs in "pipeline"). To say nothing of the potential of other, newer B-cell depleting/anti-CD20 agents, such as Ocrelizumab (which Genentech is also involved in developing -- though I recognize concerns about the safety record of this drug) and emerging 3rd generation anti-CD20s. If I remember correctly (lol -- which is dubious these days), Roche worked with Montoya on Valcyte, so they have a little bit of a history with this disease (for good or for ill, I know not).
Regardless, they are sitting on a drug that could be helpful to millions of people around the world and are doing nothing (that we know of). We need to pressure them to get some "drugs into bodies." At the very least, I should think we should pressure them to offer Rituximab generically for ME/SEID research, which would bring study costs down significantly and presumably make more studies more attainable. Obviously setting up something similar to the NIH/Yale/Genentech study on Rituxan and MG would be ideal (NIH/Stanford/Genentech anyone?). Except not being attached to a national institute would presumably preclude that possibility.
I'm trying to do some homework on drug approval, though I know there are many here and elsewhere who are far more qualified in these matters. I'm at a PR activity level of roughly 1.5 so very basic self-care takes up the bulk of my energy envelope (it why, despite being among the first members of PR, I'm among its least active). But not only do we need to look at what other disease activists have done in the past (e.g. HIV) but also creative actions that no one has done but are more suited to our limitations. We can't do a sit-in at Genentech's offices. What could we do that would be the 2015 equivalent? It's the magic question that, as yet, remains unanswered.
Simon
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Wow, does that mean the enormously high price of rituximab could tumble?
What effect what that have on the cost of trials? I think F&M said at one point that the cost of rtx was a major cost (as opposed to staffing, etc.).
I've PMed you, Charles, about an indirectly related matter.
Nielk
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Yes. But, only if another pharmaceutical company cimes up with a generic. I have not heard of this happening yet.
daisybell
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Genentech have a bit on their website where you can ask them a question...
I don't know if it would help/hinder/make absolutely no difference if lots of people asked about Rituximab for ME...
I asked and got this reply..
"Thank you for your enquiry regarding clinical trials for Rituxan in ME/CFS.
Rituximab is the active ingredient in Rituxan and is marketed in New Zealand by Roche as the brand MabThera. Colleagues at Genentech have forwarded this enquiry to us because you are based in New Zealand.
I don't believe there are any plans for Roche/Genentech-sponsored clinical trials for CFS/ME. I note however there is a Phase III Clinical trial currently ongoing in Norway in patients with CFS/ME and results of this trial should be reported in 2017. Depending on the results of the trial Roche/Genentech may submit this new indication to regulators, allowing the medicine to be used in this group of patients."
I don't know if it would help/hinder/make absolutely no difference if lots of people asked about Rituximab for ME...
I asked and got this reply..
"Thank you for your enquiry regarding clinical trials for Rituxan in ME/CFS.
Rituximab is the active ingredient in Rituxan and is marketed in New Zealand by Roche as the brand MabThera. Colleagues at Genentech have forwarded this enquiry to us because you are based in New Zealand.
I don't believe there are any plans for Roche/Genentech-sponsored clinical trials for CFS/ME. I note however there is a Phase III Clinical trial currently ongoing in Norway in patients with CFS/ME and results of this trial should be reported in 2017. Depending on the results of the trial Roche/Genentech may submit this new indication to regulators, allowing the medicine to be used in this group of patients."
Michelle
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So, um, did the op's question ever get answered here with regard to working for a Rituxan study here in the US?
In the email Daisybell quotes just above me, a Genentech rep states:
How long would that submission for a new indication take? Would it involve more clinical trials? If so, we can't wait for additional trials that will last for years after already waiting a few years for the Norwegian trial to be completed. We need those trials NOW!
That said, what I'm unclear on is if a campaign is worth the energy required. Is the science far enough along to merit harassing Genentech? Was the recent maintenance trial enough to merit Genentech doing its own research or working with, say, OMI or Stanford? Or a collaboration such as the above mentioned study on Myasthenia Gravis? Should we be harassing NIH as well as Genentech? To be honest, I simply haven't the expertise in how clinical drug trials work to know if some sort of effort is even reasonable at this point. I hate to bug @Jonathan Edwards with yet another question, but I think he -- and a few others on PR with experience in clinical trials -- would be in far better position to address this question.
I'm often highly dubious of social media campaigns, but in this case I do think that hundreds of us bombarding Genentech with some sort of "drugs into bodies" Facebook postings (they only have 9500 or so "Likes"), tweets, instagrams, etc. might get them to sit up and take notice, especially as it doesn't look like they get a lot of patient interaction on a daily basis. But there's no point doing something like this if the science isn't there yet. Or if they are the wrong place to harass.
In the email Daisybell quotes just above me, a Genentech rep states:
How long would that submission for a new indication take? Would it involve more clinical trials? If so, we can't wait for additional trials that will last for years after already waiting a few years for the Norwegian trial to be completed. We need those trials NOW!
That said, what I'm unclear on is if a campaign is worth the energy required. Is the science far enough along to merit harassing Genentech? Was the recent maintenance trial enough to merit Genentech doing its own research or working with, say, OMI or Stanford? Or a collaboration such as the above mentioned study on Myasthenia Gravis? Should we be harassing NIH as well as Genentech? To be honest, I simply haven't the expertise in how clinical drug trials work to know if some sort of effort is even reasonable at this point. I hate to bug @Jonathan Edwards with yet another question, but I think he -- and a few others on PR with experience in clinical trials -- would be in far better position to address this question.
I'm often highly dubious of social media campaigns, but in this case I do think that hundreds of us bombarding Genentech with some sort of "drugs into bodies" Facebook postings (they only have 9500 or so "Likes"), tweets, instagrams, etc. might get them to sit up and take notice, especially as it doesn't look like they get a lot of patient interaction on a daily basis. But there's no point doing something like this if the science isn't there yet. Or if they are the wrong place to harass.
Jonathan Edwards
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As I have said before somewhere I see no prospect of Genentech showing interest in running a trial themselves. And I think PWME would be much better off having rituximab developed for ME without Genentech interfering and screwing up the dosage schedules as they did for RA. The interesting thing is that the Norwegians having got independent funding for phase III have got further along the way to evidence for a license than is usual without company involvement. As it stands applications for licenses seem to come from companies, but there seems to be no good reason why regulators should require this. Why shouldn't NICE approve usage based on academic data? In the past NICE seem to have assumed that they have no responsibility to approve drugs except when commercial interests make adequate claims. It seems to me that they have a responsibility to approve drugs that work. There may be some interesting shifts - for NICE and FDA, and other countries' equivalents.
BurnA
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From a scientific point of view I can see no reason for a regulatory body not to approve a license based on academic data. Would it be a first ? Would applications have to be made to individual bodies and who would make these applications ? I assume safety is not an issue therefore once efficacy can be demonstrated it would be irresponsible not to approve ?
Curious as to why Genentech are not interested themselves - any thoughts ? Surely from a financial perspective the odds are stacked in their favour now - a new indication would mean thousands of new patients and realtively low risk of a trail failure? Also good PR?
Jonathan Edwards
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There are no reasons, it is just that these regulatory bodies do not actually understand the logic of what they are supposed to do. They are clearly supposed to decide what is best for patients within an insurance scheme (public). They seem to think they are there to award business to companies. It is bizarre. This absurdity came up with the RA drugs but because companies were involved nobody actually involved in the process was forced to see the problem.
I am not sure that it would be a first but it would be very unusual.
And yes, I think in law it would be considered irresponsible, or a dereliction of duty of care, not to approve. It is just that nobody seems to have thought about it.
I am fairly sure Genentech are not keen on use of their B cell drugs for disease other than cancer because they make good business out of cancer and nobody worries too much about serious side effects in cancer. The very rare occurrence of progressive mulitfocal leucoencephalopathy after rituximab, to which rituximab does seem to contribute some extra risk is probably their biggest worry. It is probably the reason why the rituximab programme in MS was not pursued earlier. We are probably talking of a risk from rituximab itself of about 1 in 100,000 cases treated. And they wouldn't get a patent since Fluge and Mella invented the treatment, just as I invented the use in RA and at least in Europe the patent was quashed.
Is that why researchers take out a patent on an already approved medicine? To prevent that manufacturer from extending the patent due to new usage? I had wondered.