Rituximab: Norwegian multicenter study fundraising

[Tuha]

waverunner - here is an article which explain maybe a bit all the case - it´s in MS but it will be the same for ME:

http://neuroimmunology.wordpress.co...ful-story-of-rituximab-in-multiple-sclerosis/

 

[Sasha]

waverunner - here is an article which explain maybe a bit all the case - it´s in MS but it will be the same for ME:

http://neuroimmunology.wordpress.co...ful-story-of-rituximab-in-multiple-sclerosis/

Fascinating - thanks, Tuha.

 

[Waverunner]

waverunner - here is an article which explain maybe a bit all the case - it´s in MS but it will be the same for ME:

http://neuroimmunology.wordpress.co...ful-story-of-rituximab-in-multiple-sclerosis/

Thanks. In my eyes, this is the biggest problem we face in drug approval. Get rid of Phase III and a lot of problems are gone. The patients and doctors need to decide, what drugs they use, not government and gigantic regulation.

"So, what have we now? Rituximab, an extraordinarily effective therapy, used for quite a long time now, pretty safe but that will never be approved for MS if phase III trials are not performed (and phase III trials are not planned to be performed) because that drug has become unprofitable. On the other hand we have an equally effective therapy, tested in phase II trials, to date showing a pretty less safe profile (to the point of having been stopped in other diseases) but potentially profitable if the company overcomes the safety issues. Guess wich one will be approved in a few years."

 

[Aileen]

By the sound of this article, perhaps we could get some support (and money) from MS groups for the Norwegian trials. I would think that an ME trial that they are crowdfunding for now would indirectly benefit MS patients too. Have any MS organizations been contacted? especially in Norway?

 

[Maria Gjerpe]

By the sound of this article, perhaps we could get some support (and money) from MS groups for the Norwegian trials. I would think that an ME trial that they are crowdfunding for now would indirectly benefit MS patients too. Have any MS organizations been contacted? especially in Norway?

No, MS organization has not been contacted.

Please, read how to donate, invite and spread the word

http://www.meyou.no/how-can-i-help-spread-meandyou-across-the-world/

 

[Living Dead]

Thanks. In my eyes, this is the biggest problem we face in drug approval. Get rid of Phase III and a lot of problems are gone. The patients and doctors need to decide, what drugs they use, not government and gigantic regulation.

A few points:

• Phase 3 trials are important the first time a drug is aproved because severe but rare side effects are often noticed at this time. We really need this phase 3.
• Once a drug is approved for one condition it has a known safety record and is much easier to get approved for a second condition. Thus all phases are much shorter and phase 3 is not such a hurdle any more as only efficacy need to be proven.
• Rituximab is currently available for all doctors for all conditions. It need not be specifically approved for ME to be used for ME. This is called "off-label use" and is perfectly legal. Rituximab is used off-label for lupus all the time. The idea behind off label use is that the patients and doctors have the right to decide.
• Currently doctors are saying "no" because there is no proven efficacy. But there is no government regulation in place to stop the doctors from saying "yes".

 

[Waverunner]

A few points:

• Phase 3 trials are important the first time a drug is aproved because severe but rare side effects are often noticed at this time. We really need this phase 3.
• Once a drug is approved for one condition it has a known safety record and is much easier to get approved for a second condition. Thus all phases are much shorter and phase 3 is not such a hurdle any more as only efficacy need to be proven.
• Rituximab is currently available for all doctors for all conditions. It need not be specifically approved for ME to be used for ME. This is called "off-label use" and is perfectly legal. Rituximab is used off-label for lupus all the time. The idea behind off label use is that the patients and doctors have the right to decide.
• Currently doctors are saying "no" because there is no proven efficacy. But there is no government regulation in place to stop the doctors from saying "yes".

A few comments.

I disagree. Severe but rare side effects are always possible. It should be the patients and the doctors choice, if they take or prescribe a drug after it has finished Phase II and therefore is safe in the short or medium run. The phase III criterium leads to gigantic costs and delays the approval of drugs.
Efficiency is always nice, the question is, how you measure it. If 10 patients out of 1000 have a special gene and this gene is the reason, why a new drug works perfectly for them, current standards would claim it to be inefficient because there are other drugs, which work for 50 of the 1000 patients. Efficiency makes no sense, unless you take genetics into account.

In addition to this, the big question is not, what you see, but what you don't see. It costs around one billion dollars and takes 10-15 years till a drug gets approved and this is the main reason, why we have these problems today. There are thousands of interesting studies, breakthroughs etc. every year but next to none of these findings get transformed into drugs. Why? Because it is much too expensive and takes much too long. The pharma market is flawed, only big pharma companies can afford to take part. Cost is created mainly by government regulation. How many patients have to suffer, because a drug they would benefit from, is not created, because the approval process takes much too long and is much too expensive? How many patients die, because new treatments are not available? How many pharma companies are not interested in curing a patient, because they need to get back the one billion dollars, they had to pay for the approval process? How many innovative testing methods get blocked because government regulation is so rigid and inhibits innovation?These are the questions we should ask and not if a drug finished phase III and therefore is more effective than another drug.

 

[Living Dead]

It costs around one billion dollars and takes 10-15 years till a drug gets approved and this is the main reason, why we have these problems today.

When you say "these problem" I assume you mean no drugs for ME. This is not true. Rituximab is available for ME today and has been since 1997 when it was first approved. Just get your doctor to prescribe it. He won't, and that's the problem, not the phase 3 trials.

If 10 patients out of 1000 have a special gene and this gene is the reason, why a new drug works perfectly for them, current standards would claim is to be inefficient because there are other drugs, which work for 50 of the 1000 patients.

Drugs can and do get approved even if there is no benefit over current drugs. There are dozens of antidepressants, all but a few are equally efficient to within +/- 10%. Reboxetine was newly approved here, it helps 16% of patients. Even though we have dozens of drugs that helps 30% of patients for the same condition it was approved. Also it is common to run trials on patients who are nonresponders to current treatments in this type of scenario.

 

[Waverunner]

True, but why don't they conduct a trial for CFS patients?

 

[Snow Leopard]

I think it´s because their patent for rituximab is on the end and they will not do much money from it anymore.

At the same time, each generic has to go through it's own approval process. CFS is also a huge untapped market, even given potential competition by generic drugs.

They aren't doing trials either through ignorance, or that they are fed up with issues (re: MS etc).

 

[Bob]

I think it´s because their patent for rituximab is on the end and they will not do much money from it anymore.

That's my understanding of the situation as well.
If a patent is at the end of its life, then the drug company cannot invest any more money into the drug, because it will not see a return on its investment.
However, quite often, drug companies create very similar drugs, that have exactly the same effect, but are slightly chemically different, and so they get a new patent, for almost the same drug. (Is there a word to describe this process?) So perhaps this might happen at some point in the future, and then the drug company can carry on investing.

Also, I'm pretty sure that I've read that various other, similar, drugs are in the pipeline, and are in various stages of development.

In the mean time, we have to get our funding from elsewhere.
It was thought that the Norwegian government might still fund the research, in their next funding-round, but we haven't heard any more about that recently.

 

[Bob]

The Norwegian Research Council is now meeting to decide the next funding round.
Drs Fluge & Mella have again applied for funding for their Rituximab study.

The decision is expected to be published in a week's time.

MEandYou have posted info about it here (read below the second photo for English text):
http://www.meyou.no/forskningsradet-the-norwegian-research-council/

Fingers crossed!

As has always been promised, whatever happens with the research council, MEandYou have a promise and a contract to give all the donated money to the Haukeland hospital. (See their promise at the bottom of their webpage.)