Wednesday, 25 September 2013

IiME/UCL Rituximab Clinical Trial Status Update

When Invest in ME announced in June that we were planning a UK trial of rituximab for ME there was a great deal of interest raised.

The rituximab trial follows the exciting work which has been, and is being performed in Norway by the Haukeland University hospital researchers Professor Olav Mella and Dr Oystein Fluge.

Since these excellent Norwegian researchers came to present at the Invest in ME conferences in 2011 we have followed their progress, and invited them back every year for our BRMEC researchers meetings and IIMEC conferences.

The research work has been backed up by impressive and dedicated patient advocacy by the Norwegian ME Forening which has raised the profile of ME in Norway and throughout the world. Their tireless work has encouraged IiME. The more recent success of the ME and You campaign to raise funds for the Norwegian research has created real hope amongst patients.

At the IIMEC7 conference IiME announced our intention to work toward establishing a clinical trial of rituximab in UK (click here).

In updates published through July and August IiME has stated that all that is required for the trial to proceed is the funding. In the spirit of cooperation we have stated that support for the trial was welcome and that IiME would acknowledge all such support.

Our supporters have risen to the occasion and valiantly supported the IiME/UCL trial with wonderful enthusiasm. The imaginative Let’s Do It For ME campaign has continued to produce ideas to raise funds and awareness and The MATRIX is an example of a unique method of achieving both.

We have had donations from around the world, ranging from £1 to £3,000. We have had a very generous donation of £25,000 from a foundation and this has allowed the funds raised to grow to £59,000 in a very short space of time. We have also had fantastic moral support from a great many.

As such, IiME and our supporters have managed to initiate and organise something which many thought was not possible.

IiME made it clear from the beginning that we welcomed support for the IiME/UCL clinical trial from other organisations. Our objective is to ensure that a clinical trial of rituximab is allowed to be performed by the best researchers possible and to ensure that this trial makes a valuable contribution to the collective research pool. This is why we have been keen from the beginning, and since our inception as a charity, to initiate collaboration with other like-minded international charities and organisations, and build collaborations between ME researchers across continents.

We believe in achieving results by the most direct method, where possible. For IiME the issue of making rapid progress in ME research is important, it is personal. The need is here - the need is now.

We arranged a specific web site which has been set up to inform on all aspects of the UK rituximab trial. This is at -

and we reiterated the current status (click here)

We have the facilities available.

We have the researchers available.

We have the best expertise possible available.

We have the means of fundraising for this trial available (see The MATRIX) and we have a campaign to raise funds

We have emphasised that the only remaining element required was funding

We have reached this position thanks to the vision, efforts and help from Professor Edwards, Dr Cambridge, UCL and our supporters.

Thanks to the amazing efforts of our supporters we have been able to agree already to initiate a preliminary study on B-cells at UCL.

Professor Edwards will shortly visit Bergen – a trip arranged by IiME as part of our collaborative attempts to unite researchers and build on experience.

We can now announce that IiME have been given a pledge of £200,000 from a foundation to supplement the amount we have raised already.

This would bring our rituximab fund to almost £260,000 – that is over two-thirds of the requirement for the clinical trial to proceed.

The foundation has two conditions to this pledge

That IiME continue to be the lead patient organisation steering this trial

That IiME continue to raise funds for the remaining £90,000 that is required for the full trial to proceed

The trustees of IiME have accepted these conditions willingly.

We are thankful and grateful for this extraordinarily generous offer from the donating foundation. It is an amazing gesture from compassionate and caring people who want to make a difference. It allows the hopes of many patients to become a reality – allows a vision to be maintained that there is a future for ME patients and that we, patients and families, can make a difference.

We have communicated this to the UCL team with whom we are working to make this trial a reality.

We are now distributing this information to our supporters.

There were many who doubted that IiME and our supporters could achieve this. Though we knew this would be a daunting task we have never doubted it was possible.

We continue our efforts to raise the remaining funds.

To our supporters who have been with us since the beginning and everyone who has contributed in so many ways to this trial we want you to know this is your result. It is what you have achieved. It is what we have achieved together.

We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.

We continue to welcome support. Please contact IiME directly if you or your organisation would like to assist or contribute.

If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site.

A status is available.

With this trial we can take a huge leap forward in ME research.

If you are also interested in the other research projects that Invest in ME is  organising and/or funding please see our main website and free newsletter.

Let’s Do Research! Let’s Do It For ME!

Thank You.

Monday, 23 September 2013

The RIGHT Stuff  

From the Invest in ME website -

On 16 September 2013 Bristol University issued a press release (click here) which announced a grant of £1.2 million for Chronic Fatigue Syndrome research.

The grant to two researchers included one to Dr Esther Crawley - for research that seems to be effectively performing a PACE trial on children.

“The five-year study entitled ‘Investigating the treatment of paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) has been awarded NIHR funding of over £864,000.”

“Dr Simon Collin, Research Fellow also in the School of Social and Community Medicine, will lead the first study of its kind to investigate CFS/ME in primary and secondary care in England. He will use data from the Clinical Practice Research Datalink (CPRD) to obtain an up-to-date estimate of the number of adults diagnosed with CFS/ME by GPs in England. Dr Collin will collect data from NHS specialist services for adults with CFS/ME, document the different approaches to treatment and investigate long-term outcomes.”

“The three-year study entitled ‘CFS in the NHS: diagnosis of Chronic Fatigue Syndrome in primary care and outcomes after treatment by specialist services’ has been awarded NIHR funding of £321,861.”

IiME comments

After the IIMEC8 conference and the Biomedical Research into ME Collaborative research meeting in London in May there was a real sense of ME entering into mainstream research with new interest from new researchers and focus on collaboration.

To hear of this massive amount of funding to one area, graded exercise - this time on children - is disappointing to say the least and indicates that nothing has been learned from the flawed and non-productive debacle of the PACE trial.

Bristol University still uses the prevalence figures of 600 000 in the press release - an issue that was debated at the MRC/SMC collaborative grouping, of which Dr Crawley is vice chairman. The minutes of that group from 19 July 2013 state that “Charities have met to discuss the information in future press releases re prevalence. This is still being progressed." (click here)

There seems to be no shortage of public funding for GET related studies despite £5 million being spent on the PACE trial which showed no objective improvements in patient outcomes and is clouded in controversy about methods used and claims being made (see PACE Trial Observations).

By now it ought to be self-evident that children should not be coerced into graded exercise when they are ill and unable to attend school. This approach can lead to a great deal of harm - not just for the child but for the whole family.

Even though Invest in ME is not a children’s charity we are contacted by families in distress due to pressures being put on their children to attend school or to perform  activities beyond their capabilities due to the effects of ME.

This often leads to very difficult family situations and instead of listening to and believing the child parents are wrongly led to believe that they are doing the right thing by following a set programme. By the time families realise this is the wrong approach it may be too late and the child’s condition has deteriorated and the families may even break up as a result.

Epidemiological studies are welcomed but one has to be careful as GPs are known to be very poor at diagnosing ME patients. Any data coming out of Dr Collin’s research is likely not going to be accurate without considerable effort being put into trying to find out how patients were diagnosed.

In fact, Dr Clare Gerada, chair of RCGPs, stated at the IiMEC8 conference in June 2013 that GPs know very little about ME.

The adult services in the UK can only offer CBT and/or GET as set out in NICE so Dr Collin's research to document different approaches to treatment is likely to be a simple task. Long term outcomes might be difficult to determine as patients are usually seen by the specialist clinics only for a certain number of times before being sent back to their GPs.

These awards indicate that the understanding of this disease is still poor in those establishment organisations which control funding.

It is a wonder to patients how key funding agencies can get it so wrong.

It seems that in reality there is no shortage of funds available for studies which fit government policy. And this shames those who issue statements talking of funding being available for high-quality studies.

It would indeed be a sad indictment of the society that we ourselves subsidise if what matters is who one knows rather than what one does when it comes to research funding granted for ME - and the devil take the consequences.

Funding more GET-related research into ME, is a fatuous  approach. It is monstrously wasteful to throw funding at poor science, based on false views of this disease.

So what of the real research required - the right stuff?

Funding is scarce and the efforts of our supporters to make up what has been lacking from government agencies and research funding organisations have been awe-inspiring.

Patients have worked tirelessly and imaginatively to raise funds for the research proposed by IiME. Currently Invest in ME and our supporters are actually initiating, organising and funding possibly the two most important ME research studies currently in the UK - the gut microbiome project at UEA and the IiME/UCL rituximab clinical trial.

As mentioned in our article which was published at the beginning of April (A Tale of Two Collaboratives) research into ME needs a strategic approach - but it may be destined to fail completely by attempting to establish the way forward on foundations which include so much of what has been wrong in the past.

We have written in the past that we feel it is impossible to marry the views of those who believe in the deconditioning/behavioural and wrong illness belief model of ME with those from the biomedical side. The failed PACE Trial has demonstrably proven that the behavioural view of ME cannot deliver and should not continue to command more funding.

There is another way - perhaps a better way forward for ME research - a clear case to be made for segregating the biomedical from the psychosocial here and now. This could then force a separation of fatigue research from ME research.

A strategy of biomedical research into ME with a biomedical research collaborative into ME being formed consisting of biomedical researchers, using resources and facilities across continents - hooked up to share research and data and crowd fund new research?

Such is the meaning behind our Biomedical Research into ME Collaborative meetings (click here) which have been organised by Invest in ME in cooperation with the Alison Hunter Memorial Foundation. These aim to interest other biomedical researchers to the field of biomedical research into ME, assist those who are undertaking research or planning research into ME, and look for future collaborative projects and funding which could be generated by new ideas. We repeat them in 2014.

Future research into ME must be based on collaboration. But not collaboration at any cost. But it would seem quite meaningless to base the strategy on those failed policies and directions of the past - which have served patients so poorly and caused such suffering (Diane's story - Lili).

There is the wrong way and the right way to progress research into ME.

For ME research there is the RIGHT stuff (Invest in ME research) - funded by patients.

As the grant to the Bristol University has shown - there is also the wrong stuff.

Sadly, again ME research funding by the establishment is taking the wrong course.

Tuesday, 17 September 2013

Hidden evidence reveals statins do more harm than good

16 September 2013

Cholesterol-lowering statin drugs are doing more harm than good, and should be abandoned as the primary therapy for heart disease prevention, a major review has concluded.

Instead, coenzyme Q10 antioxidants are more effective and with fewer—or no—side effects, say researchers at University College Hospital in Galway.

Statins dramatically increase the risk of diabetes and cataracts in younger patients, and cancer and neuro-degenerative diseases in the elderly. And the benefits don’t outweigh the risks, say the researchers. Even for patients with advanced heart disease, the drugs may extend life by a further nine months at best if the drug is taken for 30 years.

Analysing previous studies on statins, the researchers discovered that some had never been published because the results were so alarming, while others had obscured the real risks. One study, the Illuminate trial, was shelved after researchers discovered the statin drug increased the risk of cancer and sudden death. But it’s unlikely the researchers will be heard: the statin market is worth £20bn a year and rising.

(Source: Journal of Endocrine and Metabolic Diseases, 2013; 3: doi: 10.4236 / ojemd.2013.33025).

Tuesday, 10 September 2013


Another poem from "Echoes of Eternity", a collection of Christian poems by Michael R Abbott; used with permission.


Plenteous in mercy,
Abounding in grace:
All of my hope
In the Saviour I place.

Eyes fixed upon Him,
On Calvary’s tree;
Knowing by faith
That my Lord died for me.

Hearing Him calling,
By day and by night,
Peace keeps my soul
And no terrors can fright.

Trusting Him fully:
He never can fail,
Holding me fast
When temptations assail

Talking to Jesus:
He hears my prayer,
Answers in love,
And unburdens my care,

Walking with Jesus
In fellowship sweet;
One day I know
I shall sit at His feet.

Resting in Jesus,
What joy fills my heart;
He is my King
And from Him I’ll not part.