​The Open Medicine Foundation are thrilled to announce that their esteemed Scientific Advisory Board member, Dr. Robert Naviaux, has been awarded the highly prestigious Vanguard Award by the United Mitochondrial Disease Foundation (UMDF). This remarkable accolade, which recognizes pioneering work and unwavering dedication in the field of Mitochondrial Medicine, is the highest award bestowed in this discipline.
 
The award was presented at the annual UMDF meetings last week. Each year, the Foundation meticulously selects one individual whose transformative contributions have substantially advanced the field of Mitochondrial Medicine. The Vanguard Award was first given in 2013 to the pioneering visionary, Dr. Billi DiMauro at Columbia, and Dr. Naviaux has joined the ranks of such eminent professionals.
 
Dr. Naviaux’s dedication, profound scientific curiosity, and groundbreaking contributions have consistently expanded the understanding of mitochondrial diseases. Currently, Dr. Naviaux is also using his mitochondria expertise, especially in metabolomics, to look for a biomarker and potential treatment for ME/CFS.
 
His research continues to inspire the medical community and instills hope in those affected by these diseases. His recognition with the Vanguard Award is truly well-deserved.
 
The Open Medicine Foundation, extend heartfelt congratulations to Dr. Naviaux for this significant achievement. They are honoured to have such a passionate and dedicated pioneer amongst their collaborative network of researchers working to end ME/CFS.

COVID-19 Vaccines
 December 15, 2020 /  Charles W. Lapp, MD /  Ask The Doctor
Q: Should I take the COVID-19 vaccine when it becomes available?
A:            Many PWCs (Persons with CFS or FM) have developed a flare or relapse after vaccination with live viruses, so we have always recommended avoiding immunization with influenza vaccine, the MMR, and Hepatitis B, if feasible. The question is:  how safe are the COVID-19 vaccines?
                Currently there are at least 52 COVID vaccines in clinical trials according to the WHO, two of which will be imminently available in the USA.  These are produced by Pfizer and Moderna here in America.  Products by Astra-Zeneca and Johnson & Johnson are not far behind.   
                The Pfizer and Moderna products are not made from live virus, so they are not likely to cause flares or relapses in our PWCs. They both require two doses 21 to 28 days apart.  It takes about 2-3 weeks to develop a 50% level of immunity after the first dose, and that level persists for just a few weeks so the second immunization is necessary.  The vaccines are about 90-95% effective, but there is no data yet on how long such immunity will last.  Side effects of the vaccination include injection site soreness and fever in most cases, increased fatigue (up to 60%), headache (up to 50%), muscle aches (37%), and chills (32%), especially after the second jab. These symptoms resolve in 24 to 48 hours, and a minority of individuals has to take Tylenol or other remedies for them.
                Our concern is not the short term effects, but long term.  The Pfizer and Moderna vaccines have been administered safely to thousands of individuals already, but new issues are likely to arise after millions of individuals have been immunized.  Time will tell.  This is currently a moot point since the vaccines will be provided first to medical providers, health care workers, nursing home residents, prison inmates, and first responders.  It will probably be many months before they will be available to the public, so we will probably have a much better idea about long term effects by then.
                Because COVID-19 is such a severe disease we currently recommend that high risk individuals strongly consider vaccination. These include individuals with high blood pressure, diabetes, obesity, asthma or pulmonary disease, cardiovascular disease, and immune deficiency.  The vaccines have not been adequately tested in pregnant or lactating women, or in children under 16 years. 
                Since PWCs frequently suffer immune dysregulation, many wonder if they should be considered “immune deficient.”   Our opinion is that many patients have an UP-regulated immune system and fend off viruses readily, so they rarely fall ill.  If you are the type of individual who “catches every virus that comes along,” then you are probably in the minority of DOWN-regulated patients and should highly consider the vaccination when it is available.
                Despite immunization there is still a small but significant chance one could contract COVID-19; therefore, prevention is KEY.  Dr. Lapp has just reviewed dozens of past epidemics and one point is clear: frequent washing, hand sanitizing, face masks, and isolation are crucial for avoiding infection.


Dr. Bateman, from the Bateman Horne Center recommends the following:

"We [the world] certainly need COVID-19 vaccines desperately and everyone who is healthy enough for the vaccine should get vaccinated, starting with those at highest risk of COVID exposure.  This includes healthy family members of vulnerable people. For the ME/CFS/FM population, my advice is to stay safely quarantined and wait a couple of months while the vaccine is distributed and broadly administered.   Because of the large numbers and close monitoring, we should know fairly quickly how people do with the vaccines.  This advice will apply as each new branded vaccine is approved and rolled out.  In general, the people who should be most cautious are those who have previously had allergic reactions to vaccines or are prone to severe allergic reactions in general.   If you decide to get the vaccine, be rested and stable prior to the vaccine, and plan on resting/relaxing for at least 72 hours afterward.  Supportive care will include anything you usually do for flu symptoms, PEM, allergy flares, worsened orthostatic intolerance, etc.  If anything, including a vaccine, makes you sick enough that you are unable to maintain adequate fluids and nutrition, or results in fluid and electrolyte losses (sweating, diarrhea, etc), it is always appropriate to seek IV fluids as a primary intervention."

Earlier this week we spoke to a journalist who had written a piece about chronic fatigue syndrome or M.E. for RNZ's online site The Wireless. We received a huge amount of feedback from sufferers and their families about their experiences with the debilitating illness.
Many sent in questions they wanted answers to, some hoping for treatment options. We decided to get an expert in to explain the illness a little more in depth.
Dr Ros Vallings has spent decades dedicated to helping those with CFS, she has a clinic in Howick and has taken a break from patients to respond to our listeners. 

Listen to radio interview here.

​ME Association Statement: Negative phase III clinical trial result from Norway for Rituximab in ME/CFS | 27 November 2017 


By Dr Charles Shepherd, Hon. Medical Adviser, ME Association.
“I was disappointed to learn – while at the Royal Society screening of the documentary, Unrest, in London last Thursday – of the preliminary (but unpublished) results from the phase III clinical trial of Rituximab, that has been carried out in Norway.
“This large, multicentre, ‘gold standard’ clinical trial, involved 152 people with ME/CFS receiving either Rituximab or a placebo, with initial treatment followed by maintenance treatments at 3, 6, 9 and 12 months, and a two year follow up.
“The ME Association has consistently taken the position that Rituximab could be one of the most promising developments in the search for a safe and effective drug treatment that is targeted at the underlying disease process in ME/CFS.
“We also know that the physicians involved in this research – Drs Oystein Fluge and Olav Mella from the Haukeland University Hospital in Norway – have taken great care in the way that they have devised the protocols for the clinical trials that have been carried out and reported.
“Despite the headline negative finding, we believe that this trial will still provide useful insights and contribute to a better understanding of M.E., and we also have the results from the Cyclophosphamide clinical trial to look forward to. We are very pleased that this knowledgeable, and valued, research team will continue with their work, trying to find answers to the M.E. puzzle.
“The ME Association Ramsay Research Fund had set aside around £60,000 to help support this research, or to help fund a clinical trial of Rituximab here in the UK, if such funding was required, and applied for by a reputable research or clinical trials group. No research grant applications have been received.
“It is difficult to comment further on these very basic preliminary results, and my understanding is that no further comment will be made by those involved until the study is published early next year. However, we do believe that it is correct and helpful for the patient community to be notified about the disappointing key conclusions prior to publication.
“Any decision – including if it is going to be sensible for the charity sector to be raising or spending further large sums of money on research involving the theoretical basis to this treatment (i.e. immune system dysfunction, involving the B-cell component of the body’s immune system), or further clinical trials to assess the safety and efficacy of Rituximab – will have to wait until more detailed information becomes available about the outcome of this phase III clinical trial, and the scientists involved have expressed their opinion as to whether further such research is justified.
“Based on the results from the clinical trials that have been published so far – along with the rather mixed evidence from people with M.E. who have been prescribed Rituximab outside formal clinical trials – it does appear that this type of immunotherapy could still be relevant to at least a sub-group.
“If it is agreed by experts in this area of immunotherapeutics (and we will be seeking expert advice), that we should continue to explore the role of Rituximab as a possible treatment for ME/CFS – and try to find immune system biomarkers that could help to identify the sub-group of people with M.E. who are most likely to respond to such treatment – the ME Association will continue to invite applications for research grants to the Ramsay Research Fund.
“Medical journals are less enthusiastic about publishing negative research findings or negative results from clinical trials. However, given the enormous amount of interest in Rituximab, from both people with M.E. and the medical community, I am confident that these results from Norway will be accepted for publication in due course.
“The ME Association is currently considering a number of other research applications – some of them quite large – and trustees will discuss the latest news about the Rituximab clinical trial at their Board meeting in December. A decision will then be made as to whether the £60,000 currently set aside, should remain as a ring-fenced sum for funding Rituximab research, or used for other biomedical research applications.”
Dr Charles Shepherd,
Hon Medical Adviser, ME Association.

The statement from Haukeland University, Bergen from Professor Mella is a major disappointment for people with ME and their families.
What had looked to be a promising line of research that could lead to an effective treatment for a subgroup of patients defined by the Canadian Criteria and major understanding of the pathology of this disease has proven to be inconclusive.
Naturally, at the charity, everyone is disappointed. We are disappointed for all the ME patients and carers and families and friends.
We are especially disappointed for all of our supporters and all who have made such generous and tireless efforts to raise funds and awareness of our campaign.
We are very disappointed also for the Haukeland research team - a wonderful team who have brought hope to all patients - and, importantly, brought new insight into this disease and new interest from other areas. 
However, we have found, throughout 12 years of trying to change the way that ME is perceived, researched and treated that it is never easy.
It would be easy to give up, to resign oneself to nothing changing, to accept the status quo.
But we think differently.
At the 2017 Colloquium/Conference we invited Karolinska Institutet in Stockholm to present negative results. Because it is important to use negative results for positive effects. Negative results are data and the Norwegian rituximab trial has generated a lot of data that needs to be looked at very carefully. 
When we first engaged Professor Jonathan Edwards into research into ME one of the earliest comments he made was that he was pleased to note that our conference did contain negative results.
We see the positives in this research which has been performed by researchers of the utmost integrity who have not made headlines for the sake of it but have thoroughly conducted outstanding research, and still retained a humility that is to their credit and that of their colleagues and team.
We have an excellent research team in Norway which has served the ME patient community and their families with honesty, integrity, professionalism, determination and an empathy which had never been seen before in this field.
We have established good working relationships between the Norwegian researchers and the UK Centre with input from UCL and UEA/Quadram Institute.
We have data now – more than before.
We have research which IiMER has established and a foundation for the Centre of Excellence for ME.
We have international collaboration in research into ME that will continue.
And we have new plans – already in the making.
The researchers from Haukeland will give more detail on their results and publish a paper or two which will benefit all studying ME. 


For us, we have invited the Haukeland team to Norwich to discuss the way forward.
We remain positive. Another setback, another day.
We have already been in discussion with our advisors and with the Norwegian team and we will meet to clarify the best way forward in the near future with our major funder and researchers.
We still have much good research being funded and being planned and feel our stategy is, and will pay off and lead to the most rapid route to finding cause(s) of ME and effective treatments.
In another age, and in another struggle which has some parallels to that which is forced upon people with ME, these words strike a chord -
“ We must accept finite disappointment, but never lose infinite hope. ” 
- Dr Martin Luther King

Source: http://www.investinme.org/IIMER-Newslet-1711-03.shtml