Norwegian Group Begins Ambitious Fundraiser for ME/CFS Treatment, Rituximab

The Norwegian group, MEandYou, has begun fundraising for an ambitious study on the cancer drug, rituximab (trade name: Rituxan), for patients with ME/CFS.  Their goal is to raise 7 million kroner, or 1.2 million US dollars in three months to support a study headed by professor Olav Mella and Dr. Øystein Fluge at Haukeland University Hospital, Norway. A total of 140 patients will be involved. Rituximab made headlines when Mella and Fluge reported that several ME/CFS patients who had been treated for cancer using rituximab experienced a remission of ME/CFS. (For an excellent summary of the rituximab studies, read Cort Johnson’s article “A Drug For ME/CFS? The Rituximab Story.”)

Below is the full statement and call to action taken from MEandYou’s website.

This is MEandYou

Do you want to be a part of making a medical breakthrough? Do you want your families and friends to have an opportunity to be a part? Invite them.

Millions of people suffer from the disease ME, but today there are no medications to treat them. Scientists at Haukeland Hospital in Bergen have found that a drug might make more of them healthy. It was so startling that it made ​​international headlines in BBC, Der Spiegel, and ABC News. If the findings verified, thousands of patients worldwide have a healthier life.

Scientists at Haukeland need only one study to be able to find out if this is the breakthrough you have been waiting for. 140 ME sufferers have to try out the medication in a research project. It cost 7 million. However, the public authorities have refused to grant money.

We are fundraising the cost for 140 ME-sufferers to Haukeland Hospital, cancer ward, to be a part of a clinical trial on Rituxan. The cost is 1,2 million USD,  55 000 Norwegian kroner each. We are going to do it in 90 days.

The Rituxan study at Haukeland Hospital, presented in PlosOne autumn 2011, showed the most promising results worldwide for ME/CFS-sufferers. 2/3 had good or moderate effect. The bigger RCT-study has not had sufficient economical support from the official health care system to continue their research.

ME/CFS is a poorly understood, but debilitating, neuroimmunological illness with none or little treatment, that affects hundreds of thousands of people world wide. Have you ever thought about how much society would save just by getting a few of those sufferers back to work and as participants of the community?

What if it turns out that the research that you, as an individual, support will be a breakthrough in the medical field? What if you are one of those people who in few years can say that, yes, I was a part of it! This might be your chance. The patients, the families, the friends pass those well-established channels and contribute funds directly to the research projects we want to support, so that they become a reality. Do you want to be a part of it?

We can do it. MEandYou.

Omega-3 Fatty Acids Could Prevent And Treat Nerve Damage, Research Suggests

Research from Queen Mary, University of London suggests that omega-3 fatty acids, which are found in fish oil, have the potential to protect nerves from injury and help them to regenerate.

When nerves are damaged because of an accident or injury, patients experience pain, weakness and muscle paralysis which can leave them disabled, and recovery rates are poor.

The study, published in January, 2012 in the Journal of Neuroscience, suggests that omega-3 fatty acids could play a significant role in speeding recovery from nerve injury.

The study focused on peripheral nerve cells. Peripheral nerves are the nerves which transmit signals between the brain and spinal cord, and the rest of the body.

These nerves have the ability to regenerate but, despite advances in surgical techniques, patients usually only have good recovery when their injury is minor.

Omega-3 fatty acids are vital for the body’s normal growth and development and have been widely researched for their health benefits. Because the body cannot manufacture omega-3 fatty acids, they have to be consumed in foods such as oily fish.

In the new study, researchers first looked at isolated mouse nerve cells. They simulated the type of damage caused by accident or injury, by either stretching the cells or starving them of oxygen. Both types of damage killed a significant number of nerve cells but enrichment with omega-3 fatty acids in cells gave them significant protection and decreased cell death.

Next the researchers studied the sciatic nerves of mice. They found that a high level of omega-3 fatty acids helped mice to recover from sciatic nerve injury more quickly and more fully, and that their muscles were less likely to waste following nerve damage.

The research was carried out by a group led by Adina Michael-Titus, Professor of Neuroscience at Barts and The London Medical School and lead of the Neurotrauma and Neurodegeneration group in the Centre for Neuroscience and Trauma, Queen Mary, University of London.

She explained: “Our previous research has shown that these fatty acids could have beneficial effects in a number of neurological conditions. This new study suggests that they could also have a role in treating peripheral nerve injuries.

“More work is needed but our research indicates that omega-3 fatty acids can protect damaged nerve cells, which is a critical first step in a successful neurological recovery.”

Reprinted with the kind permission of Queen Mary, University of London

Bee Propolis: Nature’s Wonder Food

Those busy little bees really know what they're doing.

"Health Benefits of Bee Propolis"
By C.L. Davis, Herbal Wisdom Blog

The benefits of bee propolis have been well-known for a long time but, as with many natural remedies, some of this knowledge has been obscured in recent times.

Using natural substances to cure various ailments is something that our ancestors did with much success. Many people are now re-discovering the benefits of using natural remedies, such as propolis.

About Bee Propolis

Honeybees collect more than just pollen when they are buzzing around the yard. Resins are collected from various plants and trees, mixed with beeswax and amino acids and used to form structures within the hive, similar to the way that we use cement. Bees need to protect themselves from disease just like we do and propolis is their solution. As the bees travel through the hive, they rub against the propolis and receive the benefits of the natural antibiotic, anti-inflammatory, antifungal and antiviral properties from their building materials.

Active Ingredients & Uses

Immune Boost
Propolis has antibiotic and anti-microbial properties. Because propolis is high in the vitamin B complex vitamins, has significant amounts of vitamin C, and contains vitamin E, it naturally boosts the immune system. High levels of antioxidants are also found in propolis and these also give our natural immune system functions a boost, as well as doing the same for the bees! Because of its ability to enhance the function of the immune system, Propolis is a great treatment for cold and flu symptoms and even food poisioning. It can be taken in the form of capsules or as a tincture and is easy to obtain.

Wound Healing
Bee propolis also promotes wound healing, making it very useful in topical treatments such as ointments and creams. It is easy for burns, abrasions and lacerations to become infected, but when treated with a strong antibacterial agent the body has a chance to heal quickly and with less chance of scarring. Studies conducted in several different countries show that bee propolis has strong antibacterial and anti-microbial properties. As an anti-inflammatory, bee propolis has been shown to be very effective. This is another way in which propolis can be useful as a topical treatment for wounds.

Anti-Inflammatory
Taken internally, it can also reduce the damaging effects of inflammation in the body. Inflammation is the cause of many diseases, including heart disease, inflammatory bowel disease, some bone diseases, pelvic inflammatory disease and arthritis. Autoimmune diseases such as endometriosis have also been shown to respond well to treatments that include the use of propolis.

Anti-Viral
The anti-viral property of bee propolis is another one of its well-known benefits. Viruses such as herpes can cause painful and embarrassing canker sores but relief has been found by using bee propolis. It can be taken internally to inhibit the action of the virus and used topically to treat blisters and canker sores. The antiviral properties of bee propolis are also what make it so effective in treating colds and the flu. Warts, which are thought to be caused by viruses or deficiencies in the immune system, have also been treated successfully with propolis.

Allergy Relief
Rats were shown to produce less histamine when given propolis, indicating that it has the potential to be effective in providing allergy relief.

Anti-Fungal
Propolis’ antifungal property is another one of its benefits. Common fungal infections include yeast infections of the mouth and vagina, foot fungus and jock-itch. Propolis has been shown to be an effective antifungal agent in a variety of studies. It can be used in the form of a topical treatment, as a tincture or in capsule form. Its effectiveness is due in part to enhancement of the immune system, and in part to its natural antifungal properties.

Cancer & Chemotherapy Relief
In some studies, propolis has also been shown to be effective against cancer cells. Propolis was applied as a tincture to cancerous prostate and colon cells, among others and caused significant rates of cancer cell death. Healthy cells were not destroyed, which is what happens in chemotherapy. Studies of the benefits of propolis in treating cancer are ongoing, but show that there is a possibility that some of the devastating effects of chemotherapy could be reduced by making use of bee propolis.

How To Use
Bee propolis is available in a number of forms, such as ointments, lotions, tinctures and capsules. It can be used to heal burns and other wounds, clear up infections, reduce the impact of inflammatory diseases and fight viruses. Some studies have even indicated that bee propolis can be used to treat cancer. Its antibiotic, anti-inflammatory, antifungal and antiviral properties have been known to humankind for ages and proven effective in numerous scientific studies the world over.

Who Took the “ID” Out of CFIDS?

Et tu, Brute?

First published on Blogcritics as "Chronic Fatigue and Immune Dysfunction: Who Took the “ID” Out of CFIDS?"

Does anyone remember CFIDS, aka Chronic Fatigue and Immune Dysfunction Syndrome? Back in the 1990s this was the accepted term for what is now called CFS, or, if you are so inclined, CFS/ME. The ID was quietly dropped by researchers and doctors about 10 years ago in favor of Steven Straus’s infamous legacy: chronic fatigue syndrome. Everyone agrees that CFS is a confusing, misleading and utterly dismissive name for the illness. Not only does it harm people who have CFS, it harms people who don’t.

In a recent study of patients newly diagnosed with MS, nearly one-third had been diagnosed with CFS (or with the even more vague, “fatigue”) for one to two years prior to being diagnosed with MS. Imagine how many other patients with incipient cancer, heart disease, liver disease, diabetes (to name a few “fatiguing” illnesses) have had the catch-all diagnosis of CFS slapped on them simply because they were tired. The term CFS has been just as much a curse to those patients, whose correct diagnoses and treatments have been delayed by years, as it has been to patients with CFIDS.

Who did this? Who managed to drop the all-important feature of immune dysfunction from the name? After all, it is obvious that people with CFIDS have an immune dysfunction. Chronicity is, in fact, the product of an altered immune system. With a fully functioning immune system, the host recovers. Immune dysfunction is not just a feature of chronic disease, it is its definition.

What’s more, the furor over what to call the “Disease of a Thousand Names” has only intensified since the ID dropped about. Prior to the deletion of the ID, people who had been diagnosed with ME (on one side of the Atlantic) and CFIDS (on the other) maintained a cordial relationship. Since the change, they are at each other’s throats. People with ME do not want to be diagnosed with an illness that not only reduces all their symptoms to the “f” word, but is doggedly lumped into some ill-defined category of mental illness.

Who did this? Who managed to divide what was once a unified community into squabbling sororities? The CFIDS community could, and did, accomplish so much when it spoke with one voice: national organizations, political lobbies, well-subscribed magazines. Now, it is factionalized, torn apart by the desire to achieve maximum distance from the stigma of "fatigue."

An even more disturbing consequence of dropping the ID is that supposed friends, clinicians who once championed the cause, have not only slipped into using the term CFS, but are adding insult to injury by dropping the S part and referring to this illness, which not only destroys lives, but can eradicate them, simply as “chronic fatigue.” It’s bad enough that the patients call their illness “chronic fatigue,” but Nancy Klimas, head of the Neuro Immune Institute and world-renowned CFIDS specialist, should know better.

Who did this? Who trivialized this illness among formerly committed researchers and clinicians? Who robbed CFIDS patients of their defenders?

Benjamin Natelson.

In 2002, Benjamin Natelson, noted CFIDS researcher, was given a grant by the NIH to do a meta-analysis of immune studies in CFIDS patients. Meta-analyses are not research studies, they are simply analyses of studies that have been performed in the past. Because meta-analyses basically serve as Cliffs Notes for researchers who are too pressed for time to read the original work, their ultimate value to the research community has been questioned. Natelson’s meta-analysis, entitled “Evidence for the Presence of Immune Dysfunction in Chronic Fatigue Syndrome,” examined 79 studies of immune function in CFIDS patients. Natelson found that that there was no consistent immune dysfunction. Some studies indicated that there were increased pro-inflammatory cytokines, others found increased anti-inflammatory cytokines.

Given the fact that one of the hallmarks of CFIDS is waxing and waning symptoms, this "inconsistency" should not have come as a surprise. The immune dysfunction that characterizes CFIDS is that it both under- and over-responds. Immune, as well as neuro-endocrine, swings are the inevitable outcome of the loss of homeostasis that lies at the heart of the illness.

Natelson ignored this aspect of immune dysfunction, just as he ignored the one consistent piece of data he found across these studies – low natural killer (NK) cell function. He concluded that, “the available evidence does not support chronic fatigue syndrome as being due to any consistent immunological dysfunction … we believe that the term “chronic fatigue syndrome” is preferable to the older “chronic fatigue and immune dysfunction syndrome.”

Aside from the damaging consequences of this conclusion, it turns out that Natelson was wrong.

In 2012, a group of Australian researchers headed by Ekua Brenu completed the first longitudinal study of immune function in patients with CFS/ME (CFIDS). This was the first time researchers had examined immune function over a long period of time, in this case, 12 months. The value of longitudinal studies to measure immune function is that the immune system is a moving target. It responds instantly to environmental input. Even the best short-term study of the immune system can’t give researchers more than a snapshot.

The Brenu study found that patients with CFIDS do indeed have an immune system dysfunction. It is the same immune dysfunction that most other studies have found over the past two decades: low NK function. The natural killer cells of CFIDS patients ignore invaders, tumor cells among them (which is perhaps why so many people diagnosed with CFIDS in the 1980s went on to develop lymphomas). The authors concluded that because cytotoxic activity was consistently decreased during the course of the 12-month study it “may be a suitable biomarker for diagnosing CFS/ME.”

Notwithstanding the tantalizing possibility that a biomarker may have finally been found, the real clincher came at the end of the discussion section, where the authors explained why previous short-term studies had been equivocal:

“Cytokine release in CFS/ME patients undergoes shifts during the course of the disease where patients may present with either an amplified or depressed anti-inflammatory or pro-inflammatory cytokine profile. These alterations in cytokine secretion may occur during the course of the disease and at different times causing either a shift towards a predominant Th1 or Th2 immune response in CFS/ME This makes it difficult to establish a unique CFS/ME-like inflammatory cytokine profile. The observed pattern of cytokine distribution among our CFS/ME patients is consistent with equivocal findings in the literature. In adolescents with CFS/ME, cytokine secretions have been observed to be correlated with seasonal variations. Therefore, CFS/ME may be associated with oscillations in pro and anti-inflammatory cytokines, supporting the heterogeneity and multifactorial nature of the disease and the diversity in symptom presentations.”

That paragraph alone should have heralded a new age in CFIDS research. It should have stimulated a lively discussion. It should have prompted a retraction of Natelson’s damning conclusion. It should have reinserted the ID.

But instead of doing any of those things, it was ignored, not just by the broader scientific community, but by CFIDS researchers, clinicians and, saddest of all, by those who would have benefitted the most - the patients. We are now lying in the bed that has been made for us.

And it is a hard one.

References:

Berger JR, Pocoski J, Preblick R, Boklage S. “Fatigue Heralding Multiple Sclerosis,” Mult Scler. 2013 Feb 25. [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/pubmed/23439577

Natelson, Benjamin H., Mohammad H. Haghighi, and Nicholas M. Ponzio. "Evidence for the Presence of Immune Dysfunction in Chronic Fatigue Syndrome." Clin Diagn Lab Immunol. 2002 July; 9(4): 747–752. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC120010/

Ekua W Brenu, Mieke L van Driel, Donald R Staines, Kevin J Ashton, Sharni L Hardcastle, James Keane, Lotti Tajouri, Daniel Peterson, Sandra B Ramos, and Sonya M Marshall-Gradisnik. “Longitudinal investigation of natural killer cells and cytokines in chronic fatigue syndrome/myalgic encephalomyelitis.” J Transl Med 2012; 10: 88 doi: 10.1186/1479-5876-10-88.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3464733/

The FDA's Response Letter Re: Ampligen

Below is the FDA's response to my email encouraging the FDA to approve Ampligen. Their response is a PR masterpiece. If the FDA, NIH, and CDC spent as much money on researching ME/CFS as they do on their Public Relations efforts, we would have a cure by now. 

Dear Erica Verrillo,

Thank you for sharing your personal testimony as well as your desire for the U.S. Food and Drug Administration (FDA) to approve Ampligen. Please accept this response on behalf of FDA’s leadership, who forwarded your email to the Division of Drug Information for direct reply.

As evidenced by the hundreds of letters, emails, and testimonies submitted to FDA, Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) is a devastating disease with a serious impact on quality of life. We are acutely aware of the seriousness of this disease, that no FDA approved treatments are available, and of the community’s strong desire to see rintatolimod injection (Ampligen) approved.

For many years FDA has worked with Hemispherx Biopharma, Inc. (Hemispherx) on an approval pathway for Ampligen. Since the time of the original New Drug Application (NDA) submitted by Hemispherx for the use of Ampligen to treat CFS in 2007, FDA’s review division has provided many specific recommendations on how best to address deficiencies in the application. In 2009, the review division asked Hemispherx to conduct at least one additional controlled clinical study showing a convincing effect in the CFS population. No new trials were conducted. Hemispherx conducted additional analyses of their existing data, which FDA agreed to review in a resubmitted NDA.

A public meeting of FDA’s Arthritis Advisory Committee (AC) on December 20, 2012, was held to provide FDA with independent scientific and clinical expertise regarding the Ampligen NDA. At the meeting, both Hemispherx and FDA reviewers presented assessments and analyses of the NDA data to the experts, including physicians with expertise in CFS, a CFS patient representative, and an industry representative. The majority of AC members were concerned about the lack of consistency within the clinical trial results, as well as the limited size of the database available to evaluate Ampligen. The members shared FDA’s concerns, as well, about how the studies had been conducted, including multiple discrepancies and gaps in the safety data. At the end of a full day of discussion AC members voted 8-5 against the approval of Ampligen for the treatment of patients with CFS because of insufficient safety and efficacy data.

On Monday, February 4, 2013, Hemispherx announced the receipt of a Complete Response (CR) letter from the FDA for Ampligen. FDA issues a CR letter to convey that our review of an application is complete and we cannot approve the application in its present form. A CR letter describes all of the specific deficiencies that the Agency has identified in an application, allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission. FDA’s decision regarding Ampligen encompassed many factors, including the safety and efficacy data and the advice of the AC. We understand the frustration and pain of ME/CFS patients and their caregivers, and how important it is that we continue to work toward development of treatments.

We want to emphasize that the CR letter issued for Ampligen is entirely separate and distinct from FDA’s support of drug development pathways for CFS – these initiatives remain unaffected and fully supported. ME/CFS is a serious disease and treatments for it represent an important area of unmet need. We will continue to encourage the pharmaceutical industry to develop new treatments in this area. To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.

We express our gratitude to you and the ME/CFS community for your unwavering support of the research and care of those with ME/CFS. We join you in this commitment, and we look forward to exploring how best to facilitate and expedite the development of safe and effective drug therapies for the signs and symptoms of this debilitating disease.

Best regards,

Mary Kremzner, PharmD
Director, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at http://twitter.com/FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

Hillary Johnson's “Chasing the Shadow Virus” – A Review

Article first published as "Hillary Johnson's 'Chasing the Shadow'" on Blogcritics.

Recent events surrounding the FDA's failure to approve Ampligen (yet again) for treating ME/CFS have pushed aside what was left of the media storm precipitated by the discovery, dismissal and ultimate disavowal of XMRV. The disappearance of the retrovirus from the scientific scene does not mean that XMRV is dead. It lives on, regenerated by Hillary Johnson.

The March issue of Discover magazine includes a tour de force of journalism, Hillary Johnson's stunning article on XMRV, the retrovirus that was claimed to cause not just ME/CFS (aka myalgic encephalomyelitis or, as it is known in the US, chronic fatigue syndrome), but some forms of prostate cancer as well. Ultimately, XMRV was exposed as a lab artifact, but not before creating a sensation, which Johnson vividly captures in her article.

In “Chasing the Shadow Virus,” Johnson leads us through the dramatic twists and turns of the XMRV debate, from the original elation at the discovery of the cause of ME/CFS, to the CDC's panic at the horrible prospect of a contaminated blood supply, to the “cottage industry” of researchers who were unable to find XMRV in ME/CFS patients, and finally to the humiliation and public disgrace of the research director of the Whittemore Peterson Institute, Judy Mikovits. Those who followed the XMRV debacle with bated breath already know the story. But do we know its implications?

Midway through her tale, Johnson puts her finger on the true significance of the XMRV scandal:

“After novelistic plot twists that included a police raid, an arrest, and a public tarring and feathering of the outspoken Mikovits, the scientific community is now convinced that XMRV was a false lead. Yet the expenditure of time and money to reach that conclusion was hardly an exercise in futility. The 2009 meeting in Bethesda marked the beginning of a change in the CFS cosmos, with a slew of prestigious scientists entering the field and government officials taking a more serious view of this formerly neglected disease. Moreover, the XMRV saga opened a rare window into the way scientists and government officials respond to findings that not only challenge the status quo but have profound implications for public health.”

Those final words are an echo of what Johnson wrote in Osler's Web, her exposé of the CDC's mishandling of the ME/CFS epidemic during the 1980s. The “window into the way scientists and government officials respond” is the same window that was opened seventeen years ago in Osler's Web, and in its even older predecessor, And the Band Played On. It is a window that reveals a glimpse of a murky and disorganized public health system whose job it is to ignore threats to its own complacency, to squelch any dissent from the ranks of upstart epidemics, and to starve researchers who are bold enough to investigate their causes. This has been the fate of ME/CFS for the last thirty years.

Johnson ends her article on a positive note. Ian Lipkin, the world-renowned virologist who proved that XMRV was not, indeed, the cause of ME/CFS (or anything else), credited Mikovits with “opening Pandora's box.”

“Right or wrong about this particular virus,” he says, “she deserved credit for awakening interest in CFS.”

Johnson's final words reflect that sentiment. “For a disease that has languished in a kind of political never-never land for at least one human generation, leaving millions profoundly disabled,” she writes, “that is significant progress.”

Whether this awakened interest is sufficient to spur concrete actions – the generation of NIH funding for research into the disease, changing the CDC's dismissive name, and convincing doctors that patients who suffer from its crippling effects are not just overworked, neurotic women who should have stayed home rather than enter the work force – remains to be seen.

ME/CFS: From Infectious Disease to Autoimmune Disorder

Dr. Kenny De Meirleir spoke at the Whittemore Peterson Institute on January 28, 2013. The following summary of his talk was posted on January 30 on WPI's blog, Wings of Hope. 

Dr. Vincent Lombardi, WPI Research Director, introduced Dr. De Meirleir as one of the world's foremost experts in ME and primary research collaborator on WPI’s current RO1 federal grant. He also stated that Dr. De Meirleir has authored hundreds of publications and several books on ME/CFS and other medical research topics. Dr. Daniel Peterson, who was in the audience, was also recognized for his outstanding contributions to this field of medicine.

Dr. De Meirleir's talk included years of significant research which is very technical and complicated. Therefore, this review is not meant to be a summary of the underlying science but rather a summary of the practical application of this work. However, we will place a recording of this talk on the WPI website: www.wpinstitute.org, as soon as possible for those who are interested in the actual research data.

Dr. De Meirleir presented a comprehensive lecture on the many factors that appear to play a role in the pathophysiology of ME.  In support of his conclusions, he drew information from other well-known researchers in the field including Drs. Chia, Klimas, Peterson, Mella and Fluge, as well as his more recent clinical studies of patients from Belgium and Norway. After the one hour and fifteen minute presentation, interested patients, researchers, doctors, nurses, and medical students were given a chance to ask questions.

Dr. De Meirleir uses a number of diagnostic tests to diagnose his patients’ underlying biological abnormalities and to guide his successful treatment protocols. Biomarkers include abnormally low NK cell number and function, cytokines indicating a shift in the balance of Th1 and Th2 immune responses, up regulation of Th17 immune cells, and abnormal levels of nagalase and elastase activity. He also tests for various active infectious agents including Borrelia, Bartonella, Brucella, mycoplasma, parasites, and various herpes viruses. He stated that environmental and genetic factors contribute to aberrant protein conformation in some patients.  Other diagnostic tests include fecal analysis and tests for levels of LPS or soluble CD14 as an indicator of gut inflammation.

Basic to Dr. De Meirleir’s treatment protocol is a plan that addresses specific dietary restrictions. He reported that many patients are fructose, lactose, casein and/or gluten intolerant. His patients often begin feeling better after eating a diet free of these substances, as they are most likely to cause an inflammatory response. In addition, he includes a fecal microbial analysis to determine whether or not to begin treatment with pulsed antibiotics. Based on the fecal analysis, which indicates whether or not his patients are suffering from a compromised intestinal barrier, he also prescribes specific probiotics, prebiotics such as lactoferrin, and digestive enzymes. When viruses or other pathogens become chronic Dr. De Meirleir prescribes antiviral therapies and/or additional antibiotic treatments.

It is generally accepted knowledge that ME patients have difficulty controlling various herpes viruses and other pathogens, in addition to exhibiting abnormal natural killer cell function. Subsequent searches for immune modulating drugs have included trials of several different products. Gc-MAF is a macrophage stimulating substance that has recently shown great promise.  Dr. De Meirleir highly recommends that patients address any leaky gut issues before beginning treatment with Gc-MAF.  He also mentioned risks that can be associated with this type of treatment.  Risks include a shift to autoimmunity and an immune reconstitution reaction known as IRIS although  none of his patients have developed autoimmune disease as a result of Gc-MAF treatments and less than 20% have experienced IRIS. Dr. De Meirleir routinely monitors his patients for IRIS cytokines after starting them on very low doses of Gc-MAF, as a method of prevention. Other immune supportive therapies include the use of Kutapression/Hepapressin complex (Nexavir), which has been reported to inhibit EBV and HHV-6, and Isoprinosine for those with low serum uric acid levels. Finally, Rituximab, a B-cell depletion immune therapy, has been used successfully in a small trial of patients with ME by oncologists Fluge and Mella. Because of the delayed therapeutic response of two to seven months, the authors of this study remarked that there is a possibility that ME has an autoimmune component. (Note: These two physicians are now looking for collaborative research sites and additional funding to engage in a much larger clinical trial due to their 67% rate of success.)

Dr. De Meirleir concluded his talk with a detailed slide describing the various pathways that are disrupted in ME and several other autoimmune diseases. He spoke about a continuum of autoimmune diseases including ME, lupus, RA, type 1 diabetes, and remitting MS that involve a dysregulation of two important immunological pathways, 2’-5’OA synthetase and Th1/Th2 immunity.

It was evident from his lecture that the key to Dr. De Meirleir’s success with patients is his recognition of the serious infectious and immunological issues facing those with ME. His research provides strong evidence for the support of biological testing and treatment.

WPI is thankful to Dr. De Meirleir for his outstanding commitment to this patient population. We feel fortunate to be able to provide his lecture as part of our mission to support outreach and education. We look forward to sharing more good news with you in the future.