Monday, 24 October 2011

Norway's Directorate of Health Apologises for Treatment of ME Patients

http://www.euro-me.org/news-Q42011-003.htm

The Norwegian Directorate of Health has apologised for the way in which ME patients in Norway have been treated. This follows the publication of the ground-breaking research from Haukeland University in Bergen (click here).

After the publication of the Rituximab study by Fluge et al (2011) and extensive media coverage since then the Norwegian Directorate of Health gave a short statement on TV2 channel, see TV2 Nettavisen (click here).

A statement from the Norwegian Directorate of Health has been received where they apologise for not having provided the necessary and proper health services to persons with ME.

Such a public apology from a governmental health agency has never occurred before.

Bjørn Guldvog, Deputy Director General of the Norwegian Directorate of Health made the following statement

"Jeg tror at vi, i for liten grad, har klart å møte menneskene som har kronisk utmattelsessyndrom på en god nok måte. Jeg tror at det er riktig å si at vi ikke har utviklet en god nok helsetjeneste for disse, og det beklager jeg."
"I think that we have not cared for people with ME to a great enough extent. I think it is correct to say that we have not established proper health care services for these people, and I regret that."

Patients have thanked Norwegian channel TV2 for their massive media campaign - click here.

The TV2 channel has set up a web page containing all media coverage they have had – which includes easy access to writings and video clips - click here.


The Norwegian research project referred to has, at long last, got a mention on the BBC website -

Immune system defect may cause ME http://www.bbc.co.uk/news/health-15401746

Researchers in Norway believe Chronic Fatigue Syndrome (CFS), also known as ME, may be caused by a wayward immune system attacking the body.

The illness, the cause of which is uncertain and has no known cure, has attracted significant controversy.

A small study, reported in PLoS One, showed a cancer drug, which inhibited the immune system, relieved symptoms in some patients.

The ME Association said the findings were "very encouraging news".

Doctors in Norway stumbled across their first clue in 2004 when treating a patient with both Hodgkin's lymphoma, a cancer of the white blood cells, and CFS.

When she received cancer treatment, her fatigue symptoms improved for five months.

'Dramatic'

The latest study, carried out at the Haukeland University Hospital in Bergen, built on the previous discovery by testing 30 patients with CFS.

Half were given two doses of Rituximab, a cancer drug which eliminates a type of white blood cell, while the other half were given a fake treatment.

In those patients receiving the drug, 67% reported an improvement in a score of their fatigue levels. Just 13% showed any improvement in the sham group.

Øystein Fluge, an oncology consultant at the hospital, told the BBC: "There was a varied response: none, moderate, dramatic relief of all symptoms.

"Two had no recurrence [of their symptoms], their life was turned completely around very dramatically."

Their theory is that a type of white blood cell, B lymphocytes, are producing an antibody which attacks the body.

The drug wipes out the lymphocytes which in some cases may "reset the immune system", however, in other patients the fatigue symptoms would return when more B lymphocytes were made.

Caution

Mr Fluge said: "I think the fact that patients responded to treatment, improved cognitive function, fatigue and pain makes us believe we're touching one of the central mechanisms.

"But we're scratching at the surface, I would not characterise this as a major breakthrough."

The researchers are now investigating the effect of giving more doses over a longer period of time.

If their hunch is right it will throw up more questions, such as what is the immune system actually attacking and whether or not an actual test for CFS/ME be developed.

Dr Charles Shepherd, the UK ME Association's medical adviser, said: "The results of this clinical trial are very encouraging news for people with ME.

"Firstly, they help to confirm that there is a significant abnormality in immune system function in this disease.

"Secondly, they indicate that altering the immune system response in ME could be an effective form of treatment for at least a subset of patients.

"We now need further clinical trials of such anti-cancer agents to see if other research groups can replicate these findings."

Wednesday, 19 October 2011

Chronic fatigue syndrome eased by cancer drug

http://www.newscientist.com/article/dn21065-chronic-fatigue-syndrome-eased-by-cancer-drug.html

An anti-cancer drug could hold the key to treating chronic fatigue syndrome (CFS). Symptoms of the disease eased in 10 of 15 patients given rituximab, an anti-lymphoma drug.

Rituximab works by destroying white blood cells that make antibodies, called B cells. The results of the trial therefore strongly suggest that these white blood cells might be involved in causing CFS – a disorder also known as "yuppie flu" or myalgic encephalomyelitis (ME), and one that has so far defied explanation.

The research was jointly led by Øystein Fluge and Olav Mella at the Haukeland University Hospital in Bergen, Norway. Their team discovered by accident that rituximab might work against CFS after seeing symptoms ease in a patient who had both lymphoma and CFS.

"We think it affects all symptoms [of CFS], so it must touch the central pathological mechanism causing the disease," Fluge says.

Two of the 15 people in the trial appear to have completely recovered since they first received the drug three years ago. "Those two are both back at work," Mella says.

Dramatic results

"It's the most encouraging drug result so far in the history of this disease," according to Charles Shepherd, medical adviser to the UK ME Association. "Although it's a small trial, it's produced dramatic results."

The researchers say that following two doses of the drug being given in the first two weeks of the trial, there was a lag of three to eight months before symptoms began to subside. They say this delayed response tallies with the idea that CFS is caused by autoantibodies – antibodies, made by B cells, that mistakenly attack the body's own tissues.

Rituximab is itself an antibody designed to target and destroy B cells. Mella says that all the B cells are gone within two weeks or so of the treatment, but autoantibodies typically survive in the body for another two or three months. "Washing out these antibodies is the most probable explanation for the time lag in benefits," he says.

The researchers found no trace of XMRV, a mouse leukaemia virus once implicated as a possible cause of CFS. The virus has now been virtually eliminated as a possible cause.

Blind alley

"We looked as hard as we could for it, by several methods, but the search was negative," Fluge says. "We think suggestions it was XMRV [causing CFS] have turned out to be a blind alley, caused by contamination of samples."

Last month, one of the authors of the 2009 paper that implicated XMRV retracted his data from that study after acknowledging that the virus was present through contamination.

"XMRV is dead, a sad and disappointing story that raised a lot of false hopes for patients," says Shepherd. He adds that it is important not to raise hopes again by over-hyping the rituximab results. "We're still a long way from making this drug more widely available, but if someone wants to mount a UK trial, we'd look at that," he said.

Encouraged by the extended remission of two of the people in the trial, the Norwegian researchers are now checking whether further, periodic doses of rituximab could permanently keep the symptoms of CFS at bay. Mella says it is possible that the five who saw no benefits from the trial might have done so eventually if they had received further doses.

Journal reference: PLoS ONE, in press


European ME Alliance Welcomes Ground-breaking research from Norway -
http://www.euro-me.org/news-Q42011-002.htm

The European ME Alliance welcomes the research by Fluge, Mella et al published on 19th October 2011 in Plos One.

This research clearly shows the physical basis of ME.

It also shows that patients had no difficulty in adjusting to normal life - something which makes redundant the previous attributions to psychological problems in this patient group.

Now we encourage public funding bodies in different countries to follow the example of this double blind placebo controlled clinical trial to start seriously investing in biomedical research into ME.

It is time to take this disease seriously and help patients regain their health and normal functioning.

European ME Alliance



Thursday, 6 October 2011

New International Consensus Criteria published in the Journal of Internal Medicine

In July of this year the Journal of Internal Medicine published an online draft of the new Myalgic Encephalomyelitis: International Consensus Criteria which has been written by a panel of 26 experts from 13 different countries. The full, proof-read document is now properly available in both the printed and online versions of the Journal.

To view the abstract click here

A full HTML version can be found here, and to see the PDF version click here

I thought that the following comment in the abstract was particularly helpful to those of us with ME as opposed to CFS -

"The label ‘chronic fatigue syndrome’ (CFS) has persisted for many years because of the lack of knowledge of the aetiological agents and the disease process. In view of more recent research and clinical experience that strongly point to widespread inflammation and multisystemic neuropathology, it is more appropriate and correct to use the term ‘myalgic encephalomyelitis’ (ME) because it indicates an underlying pathophysiology. It is also consistent with the neurological classification of ME in the World Health Organization’s International Classification of Diseases (ICD G93.3)."