Joel (snowathlete) talks with Dr Derek Enlander about a range of topics including Ampligen, the FDA, GcMAF, Methylation, and the various research programs at the Mt. Sinai MEC.
Dr Derek Enlander is an internationally recognized expert in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Fibromyalgia. Born in Belfast, Northern Ireland, he became a fellow of Stanford University Medical School in the USA and later took up other prestigious positions including Physician-in-Waiting to the British Royal Family on their visits to New York, and it was here that he set up his private practice, in Manhattan.
His interest in ME/CFS began when a childhood friend in Ireland contracted the illness and asked him for help. He has been researching, treating and advocating for this illness ever since.
In 2011 he opened the ME/CFS Center at Mount Sinai School of Medicine (Mt. Sinai MEC), New York.
Dr Enlander kindly took time out from his very important work to answer some questions on a range of topics including Ampligen, the FDA, GcMAF, Methylation, and the various research programs at the Mt. Sinai MEC.
Dr Enlander, you’ve been treating ME/CFS patients for over 25 years now and have a great deal of experience with the illness. Before you began looking at ME/CFS, you were working in oncology, exploring a possible link between Epstein Barr virus (EBV) and Hodgkin’s disease. Some people think there is a link of some kind between ME/CFS and EBV or other Herpesviridae. What are your thoughts on this?
“I initiated my research in virology at Stanford University in 1966 when I tried to research the relationship of Epstein Barr virus (EBV) to lymphoma. An Irish researcher, Dr Burkitt, many years ago had shown a relationship to a lymphoma in Africa, later termed Burkitt’s lymphoma. My thrust was towards Hodgkin’s Disease, unfortunately I couldn’t prove the relationship of Hodgkins to EBV. However as life goes round in circles, I eventually ended up looking at EBV in ME and CFS. Then from EBV to CMV and HHV6, all three are Herpes virus, a DNA family of virus.
The unanswered question, “do these DNA viruses change the immune system? If so, how?” That is one of the questions that our team at the Mt. Sinai MEC are trying to answer. I have a great support with Eric Schadt, the great geneticist and Miriam Merad, the super immunologist in our team.”
Until recently one of the treatments you offered to patients was Ampligen. With the recent decision from The Centers for Disease Control and Prevention (CDC) not to approve Ampligen, does that bring an end to that particular research program?
“No, we’re not quite sure exactly what the FDA’s plans are yet, but meanwhile the present research that is ongoing, will continue in our clinic.”
That’s reassuring. Presumably you found Ampligen to be effective; do you think the FDA got it wrong in not approving the drug, or do you think Hemispherx were partly to blame for its rejection?
“I think it is a complex question, in that the FDA requested more data, and then elaborated that the data that was presented was not convincing. In my opinion we need a larger population for the initial research. The problem is that presently patients self-fund the research, which reduces the potential research population due to the high cost of Ampligen. We must raise funds for this research so that the patients are not levied.”
The FDA Workshop
Following the Ampligen rejection and a lot of good campaigning, there is now going to be an FDA sponsored workshop this spring focused on drug development for the disease. What are your thoughts on this and do you foresee treatments for the illness resulting from this effort?
“I, and some of the other researchers in the Ampligen project were not invited by the FDA to this workshop. I’m not sure what their thoughts were in this. There are five centers involved in the study (in California, New York, Utah, Carolina, Florida) and without the experience of all the five research centers – of which only two are being represented – the total experience will not be presented.”
It is disturbing to hear that you and other specialists have been excluded from the FDA workshop. I know that the patient community is keen to help when they are able to – do you feel it might be helpful if the patient community lobbied their political representatives and the FDA with a view of correcting this bizarre decision?
“Yes, ask the FDA why? Who advised them of who to invite and who to leave out?”
GcMAF, Methylation and Rich Van Konynenburg
Another treatment you provide to patients is GcMAF; an oral pro-biotic version – MAF 878 – which you developed yourself, and an injectable version. It looks like it’s a good treatment, can you tell us more about that and what the future might hold in this area?
“It is very early in the research cycle, MAF as you well know was originally researched by Dr. Yamamoto in the 1990′s, it seems like a fertile method to explore especially if you believe that there is immune dysfunction in this disease.”
Another part of the treatment protocol that you offer is focused on methylation. With the sad passing of your friend Rich Van Konynenburg last year, it is a comfort to know that his contribution to the ME/CFS community is not forgotten. How important is this area of your treatment protocol?
“Rich Van Konynenburg was a wonderful researcher. His death is a tragic loss to me personally as well as to the ME/CFS research group in general. His work was more or less overlooked by a majority of the CFS community, he was relegated to poster sessions at most of the conferences. I asked him to speak at the Sinai research conference in 2011 – he did a wonderful job. I have constructed a treatment method based on his methylation cycle research. A number of workers in the field believe that the immune system is dysfunctional, which is reflected by the use of the term ‘chronic fatigue immune dysfunction syndrome’ (CFIDS) that was coined some years ago. Kutapressin, an amino acid complex, was used by the Texas researchers, Sternbach et al 10 or 15 years ago. We have continued this line of research, using similar Nexavir / Hepapressin and certain additives – including glutathione – which are part of the methylation cycle. We have shown some success with this method.”
I understand that you recently began recruitment for a treatment trial of a nonsteroid anti-inflammatory drug in ME/CFS?
“Yes, we are looking at a brand new nonsteroid anti-inflammatory drug, we will perform a double-blind trial later in the year.”
Mt. Sinai MEC
Your Mt. Sinai MEC in New York brings together a talented team of researchers and clinicians; it’s a real systemic approach. Can you tell us about the center and your team?
“We have several well-experienced physicians and specialists in the Mt. Sinai MEC. Eric Schadt is a world-renowned geneticist and heads the genetic thrust, Maria Moran is a well-known immunologist, Christian Becker is an experienced pulmonologist. I will look after the clinical side and selection of patients, which will be carefully screened Fukuda / Canadian consensus criteria patients. Ila Singh the virologist has recently joined Mount Sinai and will consult on virology problems.”
I understand that you now have a fellowship scheme for post-doctoral physicians at Mt. Sinai MEC?
“Yes, We have a physician coming in to do research with us from Israel. Dr Schadt is supervising the research element and I’ll be supervising the clinical element.”
You’re engaged in several important research endeavors at the Mt. Sinai MEC. One of these studies is looking at exercise and post-exertional malaise, and looks set to tackle some of the questionable conclusions of the PACE trial – something which is of great importance – but your study promises to deliver even more than that. What can you tell us about it?
“The Mt. Sinai MEC is indeed looking at post-exertional malaise in ME and CFS. We are looking not only at hematology and serology to ascertain general status and immunology, but also liver, kidney and cardiac function.”
“The patient is exercised from 0 to 25 minutes. The importance of the zero means that some patients are unable to exercise at all. These patients have been overlooked in the past; exercise studies or non-exercise studies, and their data has not been looked at.”
“After exercise the blood tests are taken and again at three days post-exercise, as well as a bowel motion sample which will be sent immediately for RNA and DNA genome analysis. This sampling, we hope, may be able to confirm or deny some of Dr Chia’s findings in his study seven years ago. Tests on the patient’s genome will also be drawn for analysis.”
You started recruiting participants for the above study last year, have you got everyone you need, or are you still recruiting? What stage of the study have you reached, and is all the funding now in place?
“One of my patients made a generous donation of $1 million towards our research. We have completed the pilot phase of the study and are analyzing the time points. In the full study we will be recruiting 150 patients and 150 controls later in the year.”
There was talk of you participating in a research initiative to attempt replication of Mella’s and Fluge’s Rituximab findings. Is that still on the cards? And what are your insights on Rituximab as a possible treatment approach for ME/CFS?
“Rituximab is a chemotherapeutic agent and has certain dangers in its use. It cannot be used in a cavalier, outpatient fashion. In order for us to use it we have to undergo IRB approval prior to the study. This is extremely time-consuming. We are looking towards its use in a limited number of patients in this control study.”
You weren’t directly involved in the original XMRV study, but I know that you kept a very close eye on it as it played out. Although XMRV didn’t work out in the end, do you think the ME/CFS community benefited from all that XMRV attention, or do you think it hindered progress?
“This whole epic was quite sad. One benefit was that it generated increased awareness of the disease amongst the general public, including journalists (especially newspaper editors).”
Other promising research
In addition to your own, very promising research initiatives, there is a bunch of other good research occurring elsewhere. The recent discovery of HERV proteins from De Meirleir and Lombardi, the pathogen study from Lipkin’s team and the CFIDS Association’s drug re-purposing study, just to name a few. As patients, we’re excited; hopeful; eager. What is it like from your perspective, and what are your thoughts on these research efforts?
“Kenny De Meirleir will visit me in New York next week, I will talk to him about HERVs and our joint results on GcMAF and MAF 878. Lipkin’s study is interesting in that he has garnered great funds for doing research in CFIDS. No published results as yet, but it’s very encouraging that great researchers, old and new, are now encouraged to enter research into ME and CFS.”
In addition to good research, in the last few years we have exciting new organizations like your Mt. Sinai MEC – the first ME/CFS center at a major medical school – and many of the ME/CFS charities seem to be stepping up to the mark too; campaigning harder, fundraising better, promoting the work of our valued researchers. What areas do you believe us patients should be focusing on when we are able?
“There are a lot of new therapies being suggested and looked at, perhaps research with large populations should be encouraged and established. We have the largest cohort of ME/CFS patients on the East Coast.
Now, Rituximab has been touted as being the up-and-coming method of approach, however this is a chemotherapeutic agent and cannot be used without great caution. GcMAF is more readily available and has fewer side effects, and it has been researched in other fields the last two decades. Our initial observations have been positive not only with the injection GcMAF but also with the pro-biotic oral MAF 878.”
As we’ve talked about, a lot has happened over the last few years, how does the ME/CFS world today compare to when you first stepped into it?
“There’s now a lot more activity going on in the research arena and also in the methods of treatment.”
Some of your early work was on the topic of computers in medicine. How have you seen the use of computers change in the clinical research lab over your career and how much importance do you think they can have when it comes to getting to the bottom of complex diseases like ME/CFS?
“I see that you have done your homework. Yes, I’ve written four books on the use of computers in medicine. I think the use of computers in medicine and medical research has made it much easier to derive information from various studies and determine statistical relevance.”
Is there anything else you would like to make mention of?
“We are investigating the use of an activity monitor, the FITBIT, which shows the amount of activity. Previously, patients subjectively defined the amount of activity that they can do, the FITBIT will objectively show the amount of activity that has been performed. This is an ideal method of making comparisons for diagnosis, treatment and research.”
Thank you, Dr Enlander for your insights and time. We look forward to seeing your research progress.
Joel was diagnosed with ME/CFS in 2009 but struggled with the illness for some time prior to this. He loves to write, and hopes to regain enough health to return to the career he loved and have his work published.
Other articles by this writer
- Borrelia – In the Lymelight
- Zoonotics – a load of cock and bull?
- Important Discovery Exposes Autoimmune Nature of ME/CFS – HERVs Implicated
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