My letter to the FDA regarding Ampligen

Dear Sir or Madam:
As someone who has lived with ME for 25 years this January, I ask you to please approve Ampligen for a subset of severely disabled patients. My experience with Ampligen was challenging, but worth it. Unfortunately, because I had to pay for the cost of receiving this drug and I suffered from other neurological complications, I was not able to continue on Ampligen. Nevertheless, I am extremely grateful that I had the chance to benefit from the many postive effects of Ampligen for over seven years. After several surgeries to remove non-essential organs my doctor felt Ampligen was my only hope, if we were going to stop the destructive disease progression.
By the age of 21, I was wheelchair-bound and unable to feed, bathe or clothe myself most days because of my chronic disease. I was bedridden and cognitively disabled - unable to read without being really confused. I had to have someone take care of me 24 hours a day, 7 days a week until I began taking Ampligen. It took months before I began to respond but once I started to get well again the improvements in my health were life changing. I was able to take care of my most basic needs once more and to begin a therapeutic program of chair yoga, and get to the dinner table most evenings. Within a year, I was driving to and from the grocery store and using a cart to get around. My most severe symptoms of sinus node sickness and gastro paresis improved significantly, so much so, that I no longer had to consider the pacemakers that specialists had recommended. Within two years, I enrolled in a yoga program to educate myself about therapeutic yoga to help others. In my third year, I began teaching gentle yoga two days a week. I was able to travel on an airplane for the first time and to see friends and family I hadn't seen in years. I made a decision to go off of Ampligen for an extended holiday to see if I could stay in remission without the drug and sadly experienced a total relapse of my symptoms. Once I began again, the drug worked quicker the second time around. I began to see improvement cognitively and physically within months.
As with many drugs, there were some downfalls to being on Ampligen. I had to be infused two times a week at a location one hour away from where I lived. It was a process - getting IV fluids days before my infusions. The intial side effects were difficult to handle at first, but I was blessed to have a doctor who was willing to help me with them. Even with these disadvantages, Ampligen gave me a glimpse of what my life could be without severe ME. I believe that Ampligen treatments may have saved my life.
Ampligen is not a cure, but for those who respond to its healing effects it is a life line. These patients deserve a chance at some quality of life. Like me, they have experienced profound improvements in their cognitive and physical abilities. Ampligen can be a life saving drug for others who suffer from severe ME/CFS.
Thank you for allowing me to share my story with you. I hope for the sake of many patients, you will consider approving Ampligen for severely ill patients while other more accessible drugs are being developed.

Sincerely,
Former Ampligen Patient

ME Lecture by Dr. Kenny De Meirleir at WPI

 

ME/CFS from Infectious Disease to Autoimmune Disorder

 

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.

 

 

The conversation no one wants to have.....

Recently, I read the article attached below. It really hit home. I hesitated for a moment wondering if I should bring up such a painful subject?  Then as a I began to ponder my own experience with this tragic situation, deep feelings of sadness and frustration came bubbling to the surface. I knew I must write about this. This topic is one that is brushed under the rug or whispered about and may make some uncomfortable; for that I am truly sorry.


Suicide has been published to be one of the top three causes of death in those with ME/CFS. The other two are heart disease and cancer.  It is well known that individuals with chronic diseases, such as MS or lupus, die at younger ages than the general population and it has been reported to be no different for those with ME/CFS.  On top of that, too many of those who suffer with this disease, are not only without effective medical care but they are also without validation of their illness or psychological support.  Left without the hope of their lives improving, some take their own lives to end the unrelenting pain and suffering.  Family members, who watch helplessly as their loved ones suffer without end, still grieve for them at the time of their death.  Those who are gone leave behind confused and grief stricken parents,siblings,friends and often times children.


Anyone who has ever lost a loved one to suicide knows the extraordinary pain it causes.  The pain of losing someone you love is compounded by the fact that they took their own life. The awful feeling of guilt is added to the already painful grieving process. 

Many people working in this field have been hesitant to discuss the subject of suicide for fear that ME/CFS will be characterized as a mental illness.  It has already been proven that ME/CFS is not a mental illness, but rather a very real physical disease.  Yet, when life becomes hopeless, some individuals may decide to give up.  As a result doctors often question whether they could have done more, while other ME patients may identify with those who are gone and feel the loss in a profoundly personal way. 


Despite these possible outcomes, I believe that the very real subject of suicide should be openly and honestly shared with the public in order to help those who are at risk.  Knowing that individuals who suffer from ME/CFS, may be more likely to take their own lives when they are dismissed, should help doctors and other family members, realize the responsibility they have to take these individuals and their illness seriously.  Physicians also have a responsibility to help family members understand the severity of the illness and the hardships patients face when they are medically ignored and/or forgotten by friends and family.   For far too many, this disease causes tremendous physical suffering.  It is cruel and inhumane to add more pain by blaming them for their illness.  


The mischaracterization of this illness as simply fatigue, with the resulting medical disbelief and neglect of those who are ill, has to stop.  It is time to tell the world the truth about ME/CFS.  This disease is real, it is serious and it can have devastating consequences. But that statement does not go far enough.  We must find effective treatments. 

Only when we face those truths and educate the public, will others finally understand why we must dedicate much greater levels of funding for research to find significant answers.  Millions who suffer from this debilitating disease are counting on us to help.


For those of you who may be struggling with these serious feelings there is hope. Please consider reaching out to a trusted friend, your physician, or a loved one and let them know you are in need of their support.

It is also important to know that those of us at the WPI have not and will not give up this search for answers. 

http://www.iasp.info/resources/Crisis_Centres/


ME Drove My Daughter to Suicide
http://www.dailymail.co.uk/health/article-32448/ME-drove-daughter-suicide.html