6 March 2012
Held in the Television Interview Room, House of Lords
6th March 2012 at 2pm
Baroness Byford - Chairman
Dr Charles Shepherd - MEA
Sue Waddle - MERUK
Christine Harrison - BRAME
Janice Kent - ReMEmber
Bill Kent - ReMEmber
Tristana Rodriguez – AfME
1. Speaker: Dr Derek Enlander
Tanya Harrison - BRAME
Sir Peter Spencer - Action for M.E.
Mary Jane Willows - AYME
Dr Jane Colby - Tymes Trust
Baroness Byford welcomed the Group and advised that the Countess of Mar was unable to attend that day and so she had agreed to act as Chairman. She suggested that the meeting focus on Dr Enlander’s presentation and that any matters which affected the continuing work of the Group could be dealt with on the Chairman’s return.
3. Introduction of Dr Derek Enlander
The Chairman said that Dr Enlander had practised as a cancer specialist and as a consultant in nuclear medicine. He was then asked by a childhood friend to look at M.E. and is now on the faculty at Mount Sinai Medical School. He has developed a protocol for CFS and one for M.E., and had an active research programme to which his patients were invited to participate.
Speaker: Dr Derek Enlander: Treating Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM) by Targeting the Methylation Process
Dr Enlander said that he had a long standing interest in virology. He wanted to find a link between Epstein Barr Virus (EBV) and Hodgkins’ disease, based on some indications that there may be a connection. No relationship was proved but his interest in EBV continued. On his return to Ireland he bumped into a childhood friend who told him that he was very poorly with M.E.
Dr Enlander said that M.E. was a physical disease. A number of viruses had been said to be the cause including Coxsackie B, EBV, HHV6 and HHV7. M.E. and CFS were terms that had been thrown at the disease, and whether CFS was an entity or not had not been resolved.
Dr Elander gave an overview of basic cell processes of transcription / translation of DNA. He believed that somewhere in this process was a dysfunction in CFS/M.E. Where this dysfunction happened was what researchers are trying to find out.
The consideration of a viral cause of CFS had led to a number of antiviral and immunological therapies being tried as a treatment. Some of them had been shown to be effective to some people.
Dr Enlander then gave an overview of the methylation cycle. Several researchers including Cheney, Konynenburg and Dr Enlander’s own research had indicated that the methylation cycle should be targeted for future research. A number of treatments had sought to address problems in the methylation cycle including injections of Kutapressin complex.
Another area of research has been gene expression in CFS. Jonathan Kerr had done a pilot gene expression study in 2005 but the further study was not conducted as he wished to return to clinical practice.
The drug Ampligen was also thought to be of potential benefit to the immune system in CFS.
Dr Enlander told the group that M.E. was a multifunction disease. Pathogenesis studies of M.E. had looked at the immune system, infection, nervous system, Cardio Vascular system, psychological dysfunction and a genetic predisposition. The aetiological cause had not been found. There were many physiological manifestations of the disease. Many treatments for the disease had been underwritten by the idea that the disease was psychiatric and psychiatric treatments would cure it.
Dr Enlander said that areas of ongoing research were:GcMaf / Nagalase, an Ampligen treatment study, use of (sublingual methyl B12), a retrospective analysis of Carnitine in CFS, and analysis of urinary H2S with Lead Arsenate. Proposed areas of future research are: Rituximab, CMX 1000, Enbrel, and a pre- and post-exertional malaise study.
A British company had also taken up development of a diagnostic test for CFS.
GcMaf was originally developed by Professor Nobuto Yamamoto and triggered the immune system in HIV. Dr Paul Cheney experimented to see if this would work on other viruses, such as an unknown one which might cause CFS. Some M.E. patients reacted well to GCMaf, Dr Cheney then grew GcMaf in probiotic yoghurt.
Ampligen was also thought to act on the immune system but was not yet approved by the US Food & Drug administration (FDA).
Christine Harrison asked whether these drugs could be used by the severely affected. Dr Enlander said that Ampligen needs to be given by infusion twice weekly under supervision and so that caused problems. The full study of Ampligen was not yet complete.
Dr Enlander said that in 2009, Dr Judy Mikovitz had published a study into xenotropic murine leukaemia virus related virus (XMRV) but in May 2011 Judy Mikovits was asked to withdraw the article.Christine Harrison said that Jonathan Kerr, who was BRAME’s medical adviser said that the XMRV results with prostate cancer were not replicated in Europe.
There was ongoing research into GcMAf / Nagalese, ampligen, B12 changes with Beta Max, Retrospective analysis of Carnitine in CFS, analysis of urinary H2S with lead Arsenate.
Dr Enlander listed the following as concerns in the UK and Ireland: problems in finding a CFS diagnosis and suitable treatment; Doctors were only given psychiatric methods of treatment CBT & GET,;Research into physical aspect of ME/CFS was neglected and the disability was undercompensated.
Dr Enlander proposed initiation and funding of two fellowships in the diagnosis and treatment of ME/CFS as a provisional solution and told the Group that Mount Sinai had set up fellowship training for 12 months for two post Doctoral physicians The training would be provided at the ME/CFS Centre in New York. Dr Eric Schadt will supervise the research part of the fellowship and Dr Enlander would supervise the clinical part of the fellowship.
Dr Enlander ended by giving an overview of the Mount Sinai medical centre which was set up in Nov 2011 with a donation of one million dollars by a patient of Dr Enlander. He said that it was the first M.E./CFS centre in a major School of medicine. Staff include Eric Schadt, specialising in research in genomics; Miriam Merad, immunology; Ila Singh, virology; Christian Becker, pulmonology, and Derek Enlander and David Bell, clinical diagnosis and treatment.
4. Questions and Discussion
Christine Harrison said that many people were told that they had had Glandular Fever virus. Dr Charles Shepherd said that by the age of 25 so many people have had Glandular Fever they may well test positive but this did not necessarily prove a predisposition to M.E./CFS.
Janice Kent said that Immunovir has shown moderate results in the work of Professor Tony Pinching. Dr Charles Shepherd said he had the impression that there may not be any great interest in Immunovir in the pharmaceutical industry and that NICE did not support it. Janice Kent said that Imunovir was licensed in America but the company could not fund clinical trials.
Dr Shepherd commented that there was a new Jose Montoya Valcyte study, funded by Roche but had heard there might be problem with getting the study published. Valcyte could be toxic to the liver and the blood cells so the balance had to be in favour of treatment. He said that it was important to identify the appropriate patients because his understanding was that those involved believed that this type of antiviral treatment was more effective in people with ME/CFS who had evidence of a significant immune system response to HHV-6 infection along with infective type symptoms.
Dr Shepherd commented that it was important to rule out pernicious anaemia before giving B12. Dr Enlander stated that the Fukuda consensus criteria were that any other diagnosis had to be ruled out before making a diagnosis of M.E. Dr Shepherd also commented that the NICE Guidelines advised against prescribing vitamins, so UK doctors would be very wary of prescribing B12.
Christine Harrison said that heightened sensitivity can cause problems with B12. Her daughter had a tiny dose and had a large reaction.
Dr E described a treatment called Recup, a bovine liver extract containing potassium, sodium, calcium magnesium and a trace of zinc which they have been using at Mount Sinai with great effect.
Christine Harrison asked whether there was risk of Creutzfeldt–Jakob disease (CJD) with bovine liver extract. Dr Enlander said that Argentine cattle were used which had zero contamination with CJD.
Christine Harrison asked what diagnostic criteria would be used by Mount Sinai Medical Centre. Dr Enlander said that the Canadian consensus would be used.
Dr Shepherd reported that he has been looking to get funding into Rituximab but the problem is that this will be extremely expensive, along with any ethical hurdles. He asked whether the study was being replicated at the moment. Dr Enlander said that the research was being considered by the Independent Research Board. This would be very time consuming as Rituximab was a toxic drug which had caused death in previous studies.
Janice Kent said that there were professional groups for M.E. but they were headed by psychiatrists.
Christine Harrison asked Dr Enlander to please continue the genome association study.
The Chairman thanked Dr Enlander for attending the meeting and for a very informative presentation, and closed the meeting.
(See associated PowerPoint slides)