Desperate Norwegians suffering from Chronic Fatigue Syndrome flies to California to be treated with the same medicine that seems to cure patients with similar diagnosis in Bergen, Norway.
This article was published in Norway’s biggest printed newspaper, Aftenposten and their popular, weekly “A-magasinet”, on Dec. 14, 2012. Reporter: Ola Henmo. Original text in Norwegian can be found at this blogsite.
Maria Gjerpe is 44 years old and has suffered from CFS since the age of 16. 6 months ago she was bedridden for an average of 21,5 hours a day. At present she is full of vigor at the cancer section of Haukeland Hospital in Bergen. At the back of her hand – a needle, on the face – a broad smile and glowing eyes. Next to her stands the senior surgeon Oystein Fluge and cancer nurse Helle Ovrebo. Seldom have they witnessed such transformation in a patients conditions.
“When you first arrived in April, we just managed to transfer you from the wheelchair to the bed. You were shivering, extremely unwell and barely able to communicate”.
Gjerpe herself has only vague memories. This is the fourth time she is at Haukeland Hospital to be administered the cancer medicine “Rituximab”. The ear-plugs and dark glasses she wore on her first strenuous trip from Oslo has long been discarded.
“How are you?” asks dr. Fluge.
“I have to suppress a laughter of joy – never felt better.”
“What’s your level of physical activity?”
“I take walks of approx. 9 km. no-stop without feeling tired. I read, write and give lectures.” Gjerpe proudly answers.
In periods when her medical condition was better, she managed to pass her medical exams qualifying her as a doctor – it took her however, a full 12 years.
“There is no doubt in my mind, you are close to a complete recovery. A full, positive response to the medication administered.”
Nurse Ovrebo feels almost honored.
“I never thought it possible. It is so joyful to be present when people regains their lives. I never envisioned that so many are suffering to such an extent from CFS.”
A CURE STUMBLED UPON
This came as a surprise to Fluge and his fellow professor Olav Mella back in 2004.
They were treating a patient with lymphatic cancer with various regimes of chemotherapy. The patient had an additional condition – she suffered from CFS as well. 6 to seven weeks into one of the treatments, she experienced a sudden passing improvement in her CFS contition.
They analyzed the chemo- mixture administered and concluded that it was most likely that a component had an effect on the B-cells ( a type of white blood cells.) with the resulting effect on the CFS. When cured from her cancer, they decided to administer Rituxmab to deliberately reduce the number of B-cells.
Mella and Fluge knew that Rituximab is used in treating autoimmune conditions such as arthritis and lupus. Maybe the elusive CFS falls in the same category?
After observing response in two more pilot patients, the did a small double-blind test. 15 CFS patients were administered two infusions in a 14 days period. A corresponding number placebo. Neither patient, nor doctor knew who received what. The result was published in the medical journal “Plos one” last fall and raised eyebrows the world over.
10 out of the 15 patients having been administered Rituximab experienced a marked improvement in their general conditions. There where however skeptics to the “breakthrough”.
Like putting fire to a Hornets Nest. They had stepped into a minefield of gigantic proportions. This was the level of the Norwegian CFS debate. In one corner, those who are convinced that CFS is a psychosomatic disease to be treated with cognitive techniques such as “Lighting Process” (LP) or “Mindfullness”.
In the other corner, those who claim that CFS is a clearly defined physical diagnosis which will be cured the day medical science finds the right bio-marker.
A CORRECT MEDICINE
The duels have the outward signs of a boxing match complete with upper-cuts and K.O’s. This making the ring-center where we find scientists like Mella and Fluge – a rather precarious spot to occupy.
– “Our field is cancer science and we had no idea about how contentious the ME/CFS debate actually was”,they tell us. At a ME/CFS conference in London, ME/CFS patients were booing and haggling the panel debating the subject. This kind of aggression is – to say it the least – not common occurrence at cancer conferences, but then again, in the field of cancer, both patients and medical conditions are, to a much larger extent, taken seriously. I stay well clear of all the turmoil on Internet and avoid googling ME or CFS. The “War of Words” is nothing but disturbing. I cannot see how we can be claimed for one side, the biological only in the debate. That underestimate us. The physical and mental aspects both play a part in our opinion.
After the publication of the study, Fluge and Mella has received more than 500 letters, calls and mails, many of them heartwrenching from suffering ME/ CFS patients desperate for the new medicine.
-It makes me sick to read about all the suffering – story after story – but at least it provides an incentive to stay on course in search for a cure.
He cannot offer any medicine to the many who contact him. That- however does the American doctor Andrea Kogelnik at the “Open Medicine Institute” outside San Francisco. He has started to admit Norwegian ME/CFS patients for evaluation and treatment.
– We have been contacted by more than a dozen Norwegian patients and a handful of them are now taking part in our research, he tells A-Magasinet.
“Maya” is one of them. She lives in the Oslo area. She is now 28 and has suffered CFS since the age of 16. During the last four years, the disease has taken complete control of her daily life. She is partial invalid, intermittently in need of full day care and desperately feels that for each hopeless day that passes, more and more dreams are crushed. This fall she has been to see Kogelnik twice. Each infusion of Rituximab costs NOK 47000 – money she does not have. On top of this travel and lodging.
She feels the treatment has improved her condition somewhat, but the arduous travel seems to dampen the effect. In January she will return for another round this time in wheelchair with an assistant.
– “ I have to finance this with borrowed money which puts my future in a financial jeopardy. There is no guarantee the treatment will work and the travelling is an almost killer. Still, there has never been a doubt in my mind – I am sure that all in the same situation would act likewise.”
Not only having put “Life on Hold”, she feels scrutinized from all corners by people who think she is play-acting. It is utterly intolerable.
– I cannot let any stone remain unturned. I will do anything to regain my old self.
Unni lives in Mid-Norway. She is another Kogelnik-patient. When the Fluge/Mella study was published last fall, it raised her spirits – hopes that was soon crushed.
– To know there might be a medicine out there that could be of help, but for which I might have to wait years to get, was simply intolerable. I want to live NOW!
Around Christmas, she and her family started looking for treatment with Rituximab outside abroad. They knew it would be immensely expensive, but opted for it anyway.
– For me, picking mail from the mailbox without problems, represents sheer luxury. At times, I have to les still, collect myself just to go and fetch a glass of water. A trip to California seemed out of this world. No guarantee for a cure and what about side effects? Still I decided to give it a try.
So far she has seen Kogelnik 3 times – without improvement. On the contrary – the last month her condition has deteriorated. It is a terrible ordeal. I do not know if the deterioration is due to the medicine, but I cling to my hope.
Next visit to Kogelnik is scheduled for January . So far the family has spent Nok 200 000,- . Unni knows she is lucky. – There is the grand social divide between the “haves” and “Have not’s”. It is a terrible injustice to those who might be helped but cannot afford the treatment.
Since their first study was published October 2011, Fluge and Mella has done another study – this time open with 28 patients aware that they are administered Rituximab.
The results are not yet published, but so far it is known that two out of three patients in this study have very good responses. Kogelnik report results that are very similar.
Further, he is informing us that he is planning doble blind and placebo controlled studies at six to eight different international research centers. – I will coordinate this with Fluge and Mella, he says.
At the same time it has been found that only two out of ten that experienced improvement in Fluge and Mella’s first study has not suffered re-laps. – This indicates that the medicine must be taken over an extended period of time – the way it is used with arthritis patients. If ME/CFS is an immunological disease – as we tend to think – then this would be the norm.
But is this a disorder that can be treated using mental control techniques as well? Mella and Fuge does not reject the fact that CFS sufferers – after three days of “Lightening Process” treatment, gets out of bed and declare themselves healed, but want to balance this against their own Rituximab studies. Their theory is that the CFS symptoms are not always caused by the underlying disease.
– We know that the frontal lobes in the brain – via intense mental activity, can effect and sometimes suppress involuntary nerve systems. That is the main reason why L.P. and other extreme forms of cognitive treatment gives such a rapid response. If the effect becomes permanent, it seems the underlying disease is “burned out” and will not trigger renewed CFS. In other patients, the effect is at best temporary, which tells us that the underlying disease is still active.
Many questions remain. Why does some patients respond after 6 weeks but others after 6 months of Rituximab? Why does some patients not respond at all? Neither in the first, nor in the second study. Does the immune system T-cells play a more prominent part that the B-cells in these patients?
– We do not pretend to be CFS experts. Both our studies contains flaws. The first one was very small. The second open, without placebo control group, but regardless of these flaws, we are confident we have stumbled upon something important. This disease is not covered in more mystique than other diseases. When the answers behind the underlying mechanisms are revealed, we will say:” But of course, that’s the way it is”. We know Rituximab works. What remains is to find out why, Fluge adds.
To find the answer, Fluge and Mella applied for NOK 9 million from the Norwegian Research Foundation in order to do an large double blind randomized national study with 140 CFS patients. The application was turned down. The reaction was immediately forthcoming. Patients and next of kin despaired. The conservative leader Erna Solberg called the decision saddening. Both Maria Gjerpe and the CFS association went public to start a nation-wide collection to raise the necessary funds. Laila Daavoy (Cristian Democrat) demanded in Parliment that the government should provide the Nok 9 million without delay. Minister of Health Jonas Gahr Store expressed surprise at the decision of the Norwegian Research Foundation, but without committing any funds. The only two remaining calm in the storm was Fluge and Mella.
– No real surprise. There were a number of very strong applicants for funds this year and I rated our chances at less than 10%. Still we continued planning our study. I am sure funds will be made available one day. 2 million this year and the same for next year are already in the government budgets. Slowly we will accumulate sufficient funds. To Fluge and me, this represents no tragedy but I pity the patients, says Mella.
UP AND DOWN, UP AND DOWN
Mariann Ripel (41) married, 3 daughters.
– I was one of those given Rituximab in Mella and Fuge’s first study. In 2008. The effect came after 7 weeks only. My condition improved at a steady pace. I started going for walks and tried to recapture my social life. Then it turned for the worse. In 2009 I was allowed to join their second study.
The same happened again, only this time, I was administered more dosages and the improvement just continued. In Jan 2011 I received the last dosage. Then I had 10 months without relapse when out of the blue, it said bang and I was back at rock bottom. In January 2012 I was so lucky as to be pilot for the next study and the history has repeated itself. No one can convince me that this is purely coincidental.
I now work 40 % as assistant nurse and train to become qualified nurse. The way it looks, I cannot go on taking this medicine forever. I just hope the disease will burn itself out and try not to think of possible relapses. Nobody knows what the future brings. I might even end in a car crash tomorrow. We cannot pick for sorrows in advance. I have one more dosage to go this time. At least I can look forward to 10 good months after that.
They will be thoroughly enjoyed.
Hanna (30) Married.
When I joined the first study in 2008, I used to sleep 20 hours a day. I felt nauseous and giddy. I wanted desperately for the medicine to work, but knew that I had a 50% chance of receiving placebo.
After one year I was informed that I had gotten placebo. Hurrah. At least there was still a chance the medicine would work.
I was allowed to take part in the follow up study in 2010. Mella and Fluge told me it might take quite some time before I would feel any effect. I did not look for signs, but after infusions in October and November , I felt changes to my body. All of a sudden I felt rested when I woke up after a good sleep.. a few weeks later my husband asked me for a walk –yes this is the way it continued.
I now say and feel 100% recuperated. I have completed my Master degree and work full time – but I have not informed my superiors about my medical history. I am afraid it will affect me negatively if I shall apply for jobs in the future. Therefore i prefer to remain anonymous. There are too many predjudices attached to CFS.
Many thinks it is just a question of getting one’s act together.
I can just imagine how painful it is to read about people like me for those who cannot get access to the medicine. I have received the gift of life for a second time and hope that anyone with the same illness will be given the same chance. I might sound like a “born-again”
But it is beyond description to be able to live and work like a normal human being. I have been in good health for 2 years now and do not fear a relapse.
I am certain the recovery is lasting!