"Lytt, del, delta og tenk nytt! Det gir gode, effektive løsninger. Jeg skriver om helse, samfunn og kommunikasjon." - Maria Gjerpe

Maria Gjerpe

Fra innsikt til endring. Jeg er lege, utdannet fra Universitetet i Oslo, og har egenerfaring som syk med langvarig sykdom. Marias Metode har mottatt prosjektmidler fra Fritt Ord. Her skriver jeg om kommunikasjon og sosiale medier, helsepolitikk, langtidssyke og samfunn. Les mer

"Lytt, del, delta og tenk nytt! Det gir gode, effektive løsninger. Jeg skriver om helse, samfunn og kommunikasjon." - Maria Gjerpe

Update from Haukeland – English version

6

Skrevet den 8. november, 2013 av mariasmetode

Del innlegget: TW FB

Norsk versjon finner du i en tidligere bloggpost.

I decided to find funding for the next phase of the study at Haukeland Hospital when The Research Council in Norway in November 2012 said no to finance further studies of the medication I had received. At the last day of the campaign period The Research Council announced that they would finance part of the study – and I had achieved all the goals I had set myself with «MEandYou»

12 fresh millions for the Rituximab study
The Stoltenberg administration (the former Government) did propose a continuation of the economic support to the studies of CFS/ME by Helse Vest. Helse Vest have been granted funds for a national clinical multi centre study of CFS/ME both in 2012 and 2013. The proposal is to continue the support pursuant to cap. 781, post 79. This is understood to imply that the two millions that are now granted by the government budget are for the Rituximab study at Haukeland Hospital, as the four millions that have been granted over the government budget at an earlier stage. There are no comments or signals that indicates otherwise. This means that in total six million NOK have been granted over the government budget.

Last week, the news was out that The Research Council had finally decided the spesific number of their contribution to be 10 million NOK. That means that it´s now 19 million NOK for the multi center Rituximab-study. 10 from The Research Council, 3 from MEandYou and 6 through the governmental budget.

Multi center study
The coming study is a multi center study. This means that several centers will, in accordance to a common protocol, treat a predetermined number of patients with Rituximab to study the effect. The datas with the results will be collected and treated at one location, with the participation of, and transparent to, all participating centers

Where will the studies take place?
As of today there are five centers that each will be in charge of a group of patients. Who will be part of the groups, and how many patients at each location, have not been decided yet. The locations are Oslo, Trondheim, Notodden, Tromsø and Bergen

When will the studies start?
When the studies will start at the various locations have not as of today been decided, but most probably during spring 2014. The researchers are in contact with each other and are doing the final work on the protocol for the study, in addition Forskningsrådet have not yet decided on how much their contribution to the study will be

What is a protocol?
A protocol describes in minute detail how the study is to be carried out. That the protocol is thorough and closes any holes that can be questioned at a later time are of uttermost importance. This takes time – but it pays to wait a bit extra to achieve a solid study that produces valid results

How many have applied to take part?
Don´t write more letters! We have received more than a thousand letters and referrals. So many, that it have been impossible for the researchers to reply individually. Your letter has been read even if you have not received a reply. All applications have been read, roughly classified by region, and will be forwarded to the nearest of 5 institutions

How many patients are needed?
It looks like 144 of this 100 will participate in the study. Half of these will receive medication, and the other half salty water (this is called placebo).

Who will be selected? 
The decision is made by the institution as long as it is within the numbers that have been agreed upon. All the selected patients have to qualify according to the Canadian criteria, and have to be residents of Norway. Patients that have received Rituximab at an earlier time can not take part in the study. Although all the patients will be Norwegians, the results and knowledge found in this study,  will be of benefit for both patients and doctors abroad.

What happens with those participiants who do not receive medication?
Half of the participants will not receive medication, but a small dose of salt water. This has no effect on the disease itself. At the same time we know that ME, over time in some patients, will improve without treatment. We want to control for this effect by the use of a placebo group in the study. If it turns out, after the study have been analyzed, that Rituximab have effect, and the cost of medications can be covered. those who received salt water will get Rituximab, possibly in a new study. That may only take place when the current planned study have been done and analyzed. This might take three years

How will I know if I have been selected?
Those who might be candidates will be contacted when the day of selection approaches. Then you will be called in for a pre-examination, then you will be notified whether you are selected or not

Do we need more studies after this?
For a medication to be approved for the use for a specific disease the use must be approved by «legemiddelverket» in Norway, and/or FDA in the US. If the result of this study turns out positive Rituximab will be much closer to approval. Whether the study is enough depends on the quality of the protocol – and consequently how reliable the result is. This is one of the reasons for the time and work spent on the reliability of the protocol.

How much time before we might receive treatment with Rituximab?
First all the patients have to go through the study, this will take two years starting when the last patient is included. All data will then have to be controlled, analyzed and published. FDA and the Norwegian «Legemiddelverket» will evaluate the data and decide wether there may be a new indication for Rituximab. This will at least take 4 years, possibly more. Rituximab will certainly not be a medication for all ME patients. As with any kind of illness or condition it is probable that different ME patients need different kind of treatments and medication

Work is done on symptom directed treatment
Do not despair! The researchers are aware of how horribly ill patiens are and how difficult life is for ME patients. Intense work is done paralell to the rituximab study to find symptom directed treatment for the patients as patients. Several different medications are being tried.

Thank you, Elise, for translation of my Norwegian article :-)

6 kommentarer til Update from Haukeland – English version

  1. Ian couch sier:

    Hi

    How much time before we might receive treatment with Rituximab?

    Regarding the above question, you answered that it’s 2 years for the patients study, but is it 4 years for evaluation on top of the 2 years, ie 6 years? or at least 4 years from the start of the patient study?

    Regards

    • mariasmetode sier:

      Hi Ian,

      First of all – it IS impossible to know, of course, and everything concerning time will be far from accurate. That said, I will recon there will be about 4 years on top of the 2, yes. It could be less, it could be more.

      I know that this sounds, and is, a unbearable long time to wait to get the results, and maybe treatment- but the alternative is worse: Never.

      Best wishes,

      Maria

  2. Ian sier:

    Hello

    I respect it must be incredibly hard to predict timescales.

    I completely agree with your last point. But what this drug has done to the ME community which provides great comfort and that word is «hope»

    Regards

  3. Annie sier:

    Thanks for sharing this and for all you have done in getting this study off the ground, simply wonderful. Sorry I haven’t been able to work out is the 19 million kroner now raised through the government, research council and patients enough to cover the study? Many thanks

  4. Daniel Nordström sier:

    Hi Maria,
    I have a question – when you estimate the time to access Rituximab treatment to 2 + 4 years, do you refer to a publicly funded treatment in Norway or in general (public or privately funded)and in a global perspective? I would have hoped that it can maybe move further faster in other countries, at least if you can pay for the treatments privately. Such as in the US, potentially. Do you think such possibilities can emerge? Very happy to get some feedback on this!

    You have done a great job and given us hope, thats so much worth for us! thanks

    • mariasmetode sier:

      Hi Daniel!

      I have to point out that this is ONLY an estimate and nothing else and is the estimated and EARLIEST time possible if everything goes without any delay with the publicly funded treatment in Norway.

      This is a bit complicated and we will not know before the results are there, if a positiv multisenter trial is enough or not to get the approval as a treatment for ME.

      I also have to underline that we often see that we are NOT able to see as good results in bigger studies, as in small ones. The first study had only 30 participants. Now there will be 144 and we will be closer to an answer; is Rituxan something that has effect on a bigger share of the ME-patients, or not?

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