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Rituximab for ME: I am patient pilot

Friday 7 December 2012

 

From Norwegian ME/CFS sufferer Maria Gjerpe on her blog Marias Metode (translated from Norwegian via Google Translate):

 

Marias MetodeRituximab for ME: I am patient pilot

Posted on 2 December, 2012 by maria method

English version at the bottom!

I've waited a long time to say this:

I am so lucky that I am one of the first ME patients in the world who have received infusions of Rituximab at Haukeland Hospital, where I have been patient for pilot testing of Rituximab for ME patients. I've had great positive effect of the treatment. On the one hand I pinch my arm and almost do not believe it's true. On the other hand, it is as if I have never been sick. We humans are fortunately so made that we quickly forget what was and quickly adapt to a new situation. Thus in any case I made.

So far, I had so much I
I actually have to remind myself how little I did before and how sick I was, record and assess to remember what it was like to spend a whole day making dinner for her daughter, not clear fetch wood in the basement because the stairs were too heavy and should carry a few planks besides, was too much - and that it was flatly impossible to go on a shopping center without collapsing completely, usually after half an hour. I have attended various events, been helped and run from door to door and mobilized all I had, and really some. There does not appear through the radio or the minute a TV recording items.

Could I then imagine that today I would drive through the city streets, Gaul with radio on full blast? Hardly. Or: It was not that I thought about it and found out that it would never work. It just was not something that was in my vocabulary. Just like collecting stamps is not my style. If you understand? I have not yet started the process of vigorous exercise, but it will be the next phase for me. Guess if I wait? Yay! I'll write more later about how my world has changed in the last six months in a later post, and how I am now approaching a healthy, normal life.

Fresh with disease?
Now, I see myself as close to fresh, but during recovery after prolonged illness.Fresh with disease, I suggested the Facebook page of this blog for a while.Although I now have a treatment that makes me begin to approach the resolution of symptoms, the body remains a disease. Treatment is preliminary symptom regulating, even if it is someone who has been healthy for 2-3 years after Rituximabinfusjon. As for arthritis patients who receive this treatment, it looks as if it requires maintenance doses to maintain efficacy, but this is something scientists are trying out.

What it means to me to have been treated, I will write more about in future posts.

Funding for further research sought
Study at Haukeland Hospital has applied Research about 9 millions Norwegian kroner to complete the final phase of the study, in which 140 ill be included. If Haukeland Hospital is rejected, which of course happens because there are many others, good research, I crowdfunde research by establishing a foundation. If there is interest mix sick, families, researchers and others looking to 'diffuse disorders "or autoimmune disorders in / autoinnflammatoriske spectrum. As I see it, from my medical professional backgrounds, researchers are able to discover the mechanisms that have important range far beyond ME / CFS.

I've written about the ongoing research in the post "Sensational Breakthrough shows the way in ME research." and TV2 have made ​​collect pages with lots of information.

Photo

April fool without
April 2, 2012 I received the first Rituximab infusion at Haukeland Hospital. Now, five infusions and 8 (!) Months, I have what I consider to be a "new life." In March, it was measured that I mean was 21.5 hours a day (which was a big surprise for me to discover. One of my coping strategies is this: Focus on what I can do, and not what I do not get to. It was tough to see the black-on-white how bad I was.)

During monitoring of Dr.Fluge, Dr.Mella and nurse Helle I've got my regular doses of Rituximab. When I came into the department, I had to be helped from wheelchair to bed, I could not answer in complete sentences, I was lying with sunglasses or a blindfold and earplugs, curtains drawn over, got physical pain if someone was unfortunate enough to be caught in my bed - and to get me to the department I was running in the tunnels under the hospital orderly. Insult to capitulate and be transported along with the 94 year old men going the same way, but, slop. That was it. I had taken a bike test that produced all my CFS symptoms half an hour earlier. Not least, I had to have me follow 24 hours / day to manage the trip and everything belonged. It's a world I possibly not recognize me in today and almost have reminded existed for only a few months ago.

Effect
After about 2 months I noticed the results and I marked effect on all of my CFS symptoms at once. What I have been doing for the last 6 months, as I said tell me more about in another post. I have not been able to tell anything until now because it has been imperative that physicians are convinced that I have a safe response.It's the curse bone confident now! Hooray!

Pilot Patient
I am a pilot patient. It means I'm not part of the study itself, but is a sort of guinea pig. All studies have one or more pilot patients. Fluge and Mella has a total of seven pilot patients in their work to find answers on what it is, what mechanisms are used, how the disease can be diagnosed easily and not least, finding effective treatment. As a pilot patient I've gone through a few things that those who come after me let go. On the basis of the experiences they have done for my feedback and my physical response, they have changed a number of protocols for future studies. Protocols are a kind of recipe in detail about how something should be done. I am pilot study patient, it is the plan to include 140 patients in which Haukeland now has applied for funding through the Research Council, so that they can complete the third and final phase of the study.

Ask me!
I will try to describe as good as possible so that the question you reading may have might be answered. I had no contact with either fly or Mella or Haukeland hospital before they published their study in PlosOne , although some conspiratorial Asked Questions about our contact in the wake of the publication and that I wrote about the study on my blog and actively supported the study.

After the study was published, I had participated in a panel discussion and a radio debate with, among other things Fluge, we discussed CFS symptoms, their possible mechanisms, what I thought, as a physician with knowledge of pathology (pathology), nervous system (neurology) and the immune system (immunology) and, not least, as a patient who knows the symptoms of the body and thus has both knowledge and experiential knowledge. It became clear that they needed a pilot patient to study and I was, as you understand, that asked if I would like to be guinea pig. There was no easy answer for me on that question.

Anguish and many thoughts
Even then it was possible to apply to come by as a patient in the study that was published in PlosOne, I knew about it. I actually recommended others to apply themselves, were included. Although I thought that I could not "get" the place of others who might be sicker than me. It was this thought process I had when I was asked if I would be a pilot patient. Was it right for me to say yes? What would happen if I said no? Why should I accept my proposal? After several months I decided that the right thing was to start infusion.

There were three main reasons:

1. It's usually pretty random who will pilot the patient, as long as they otherwise meet the inclusion criteria. I was there right when they decided that they needed one. It could be just coincidence another patient, as has been the 6 other times they penetrated pilot patients.

2. I am able to make suggestions that may benefit other patients and researchers for good, just because I have my medical expertise and understand (as far as wecan understand it) how a body hanging together.

3. I have ability, are willing and have the opportunity to share what's happening, even to the outside world. There are also other patients benefit when I relatively good dispersion can relate what my experience is. Perhaps it helps to change what other people think about this disease? Although I do not want my experience to be a campaign in itself, I think it's important to share them. Perhaps others see that it is wise to research, apply knowledge, know who we are working on, so we can get the right treatment for the right patient, when they see that I, and others, have been as good as we are? We get the people our lives back.

Inside
I've always known that I was given medicine and not placebo. I can not see 100% rule out the possibility that what I am experiencing is the placebo effect, even if I'm at full speed in most ways. The previous participants have been involved in a study that is placebo controlled. The study was known as a strong and steady, even if the words must be extended with even more to be rock steady. (As I thus will write more later.)

This is my story. One anecdote. I tell it this time as a patient who has experienced great improvement in a type of treatment we do not know anything about yet, for a disease we do not know anything about yet. I also want to emphasize that we do not yet know much about how this medication works in the long run for ME patients, even though many other patient groups, such as arthritis patients and Lupus Patients receive medication regularly.

I trust the scientists, who have a lifetime of clinical research experience in the bag, when they state that I have a great and safe response. The scientists told me after having observed over time and they were confident response, I have the exact same response manner, same response, same symptoms, as several of those who have participated in previous studies and has been effective.

Transparent
I have always been committed to being transparent and honest in my work. I have not been accustomed to contact with journalists even to influence them to write what I want them to write. I have not done now, although it will not be long a story in a major national newspaper, which came about after I got in touch and asked my story to disp, if they were curious about what happens at Haukeland Hospital currently. A critical and burrowing journalist was with me during the infusion, along with a talented photographer. I learned a lot from the process and are excited about how the article will look like.

Earlier I said yes to answer journalists' questions, and thus not as' pusher 'or acts as my "health activist" and seeking decision makers. The same applies when I have been asked to speak to medical associations, politicians and others. I have been most keen to talk about the long term and how many experience encounters with the health care system and NAV. Because I am concerned with communication, I have talked about health care use of social media. I did not mention ME and health policy, with the exception of the time I communicated my concern for the blood bank for a couple of years ago.

Defense Tale?
- And now I notice that I am in many ways "defending me." I think it may be because throughout these 3.5 years I have blogged have been subjected to numerous characteristics and I often find that what I write is read by strangers glasses?

My main message
My main message when I've written about ME, which after all is the small number of my blog entries, has been and is: The right treatment for the right patient. This involves increasing our knowledge. This means that we have to investigate. If we are to benefit from the research, we must know who we are researching. To know that, we must have narrow criteria and as narrow as we can get - and we must apply the same criteria - every time. Why this is so controversial, I can not comprehend. For me, as a doctor, this is so obvious to all other diseases and conditions, and that's it for me when it comes to ME too.

In addition, I have been concerned that the Lightning Process in a period seemed to be uncritically embraced by health professionals and health arenas, where the government is responsible for the content. This I have criticized, as for me, again as a doctor's strange that we are not critical to a treatment that is not performed by medical staff, who are undocumented, private, and where patients need to spend large sums of their personal finances. When the addition is promoted in a way I think is unethical, I find it my duty to point out this.

What I wish could have been done differently
During this period I have been a patient at Haukeland Hospital, I have written 35 posts. In 28 of them, I've written about other topics than ME.

In 2 of the 35 items I mentioned Rituximabstudien in relation to Lynprosessen / Lightning Process (LP) in conjunction with the Public Health applied for funding to conduct research on LP. In the records I've done my best to address the issues with a medical professional attitude and assessed the applications and different trials against each other purely descriptive. My dual role as ME patient and physician is familiar and something I've focused on being open at all times, so that all may know my background.

These are the records I wish I had had the opportunity to say that I even received Rituximab treatment. That said - I have even no benefits, as far as I can see - to get this trial through, other than that I obviously want as much knowledge about the disease and its mechanisms for this patient group and that I've always talked about the need for more biomedical research. Also long before this study from Haukeland Hospital came. I am also far from being in a position where I have the power to grant or directly affect a grant of a penny.

Perspectives: first, first
So, dear friends - I'm a little happy dance for what I experienced. Here I made it on top of a small mountain a few weeks ago:

Photo

I hope also that we will soon have a place where all who are sick get the right treatment for the right to their disease. Meanwhile crosses I still all I have means for the third phase of Rituximabstudien, so that it is complete. If funding does not come from the public, I promise here and now that I will do all I can, with the energy and the commitment I have to make sure that the money is still the way to Haukeland Hospital. I can not possibly "go ahead" and turn back to my ME sufferers colleagues, when I have tasted what this medication can do with a sick body. It's just that I have to do something about the situation, so that it will be better for as many people as possible.

Together we will go in this country!

English version / information: I know that English Speaking Patients are interested: I am a Norwegian ME (CFS)-ill patient and a medical doctor, had 5 Rituxan injection with very good effect, as an pilot patient for Rituxan-study at Haukeland Hospital, Norway. My first injetion was in April, 2012. I am now at 80% of my capacity, from being horizontal positoned for 21 hours a day. I will write more about the effect on my body and a little about the treatment later.

The scientists working on this study are respected cancer scientists and clinician in Norway at the second biggest research hospital in the country - Haukeland University Hospital. Professor Olav Mella is head of the Cancer department at the hospital and has published Several studies in good scientific journals Wed cancer.Publications from Dr. Oystein Fluge is the head scientist on the study.

The scientists behind the original Rituxan Findings that was published in PLoSONE in October 2011 have been working extensively Wed putting up a bigger randomized clinical trial, a third phase. They have now Applied for funds from the Norwegian funding agency for medical research for a trial with more than a 100 Patient (involving at least two hospitals - a multi-center trial). The total cost will be around 2 million USD (a bit less) You may read about the paper in PLoSOne: Benefit from B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study and that the hompage for the national channel TV2 in Norway: Everything about the Rituxan-study .

There are a very small minority of applications that actually get funded through the Medical Research Council in Norway. If this study is not funded, I will do my very best two fund it through a private initiative. I find this study very interesting, not only for ME (CFS) patient, but also for other illness that seem to be blurred and unsolved at the time being. Even if Rituxan is not the whole and only answer for everybody, a third phase study showing good results, will show wooden direction to go in futher studies Regarding these diseases.

Thank you for sharing and caring - togheter we can make a difference. I'll keep you posted about the results and funding of the study.

____

Read more about my experiences in the next post / Read more about my experience in next post:
6 months in Rituximab-trip - six months on Rituxan-tour

 

The above originally appeared here.

Maria's original post in Norwegian is here.

 


 

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