Journal of IiME Ampligen® in Severely for CFS patients. Over its developmental history, this experimental therapeutic has received various designations, including Orphan Drug Product Designation (FDA), Emergency (compassionate) Cost Recovery Sales Authorization (FDA) and “promising” designation by the Agency on Health Research Quality (AHRQ). Hemispherx Biopharma remains committed to the development of Ampligen® as a treatment option for patients suffering from debilitating CFS. Reference 1. DR Strayer, BC Stouch, JC Horvath, SR Stevens, WA Carter and AMP-516 Investigators. Interferon and Cytokine Levels in a Double-Blind, Randomized, Placebo-Controlled, Phase III Clinical Trial (AMP516) of Ampligen® (Poly I : Poly C12U) in CFS. Presented at the 9th International IACFS/ME Research and Clinical Conference, March 12-15, 2009, Reno, Nevada. ME FACTS Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe systemic, acquired illness that is defined by the WHO in the ICD-10 code G93.3 as a neurological illness. In the UK ME/CFS is estimated to be five times more prevalent than HIV/AIDS. ME/CFS has clear clinical symptoms which manifest predominantly based on neurological, immunological and endocrinological dysfunction. While the pathogenesis is suggested to be multifactorial, the hypothesis of initiation by a viral infection has been prominent. A wide range of viruses and other infectious agents, such as EpsteinBarr Virus, Human Herpesvirus-6 and 7, Enterovirus, Cytomegalovirus, Lentivirus, Chlamydia and Mycoplasma have been investigated. Before acquiring the illness most patients were healthy, leading full and active lifestyles. Recent research has discovered a new retrovirus – XMRV – as being implicated in ME/CFS. ME/CFS most frequently follows an acute prodromal infection, varying from upper respiratory infections, bronchitis or sinusitis, or gastroenteritis, or an acute “flu-like” illness. Biomedical research has provided evidence of distinct subgroups within ME/CFS. Invest in ME (Charity Nr. 1114035) Volume 4 Issue 1 www.investinme.org Objective signs in ME/CFS Debilitated CFS Patients (continued) …. despite the Wessely School’s insistence that there are no objective signs of organic disorder in ME/CFS, there are numerous objective reproducible abnormal signs that are discernable by any reasonably competent physician. They include the following: • labile blood pressure (this is a cardinal sign); low systolic BP ‐‐ <100 in 50% • nystagmus and vestibular disturbance (vestibular dysfunction seen in 90%) • sluggish visual accommodation • fasciculation • hand tremor • neuromuscular incoordination • cogwheel movement of the leg on testing • muscular weakness • marked facial pallor • postural orthostatic tachycardia syndrome (POTS) • positive Romberg • abnormal tandem or augmented tandem stance • abnormal gait • evidence of Raynaud’s syndrome and vasculitis (vascular signs cross dermatomes) • mouth ulcers • hair loss • singular reduction in lung function (shortened breath‐holding capacity seen in 60%) • enlarged liver (not usually looked for by psychiatrists) The problem is that many doctors refuse to examine ME/CFS patients – or even to lay a finger on them – because ME/CFS patients are largely despised by the medical profession. Indeed, in 1994 one of the medical trade magazines published an article entitled “GPs despise the ME generation” (GP: April 1994). The article itself said at the time: “studies have shown that that most ME patients rate contact with medical services as unhelpful” and little has changed in the intervening fifteen years. Abnormal findings on testing include flattened or even inverted T‐waves on 24 hour Holter monitoring; abnormal glucose tolerance curves; elevated lactate levels in the ventricular system (seen in 70% of patients); neuronal destruction and elevated choline peaks (seen in 10% of patients); punctate lesions consistent with small strokes (seen in 78% of patients); very poor oxygen transport on pulse oximetry readings (seen in 90% of patients) and an abnormal venous blood gas picture. None of these can rationally be explained as evidence of a behavioural disorder. from “Magical Medicine: How to Make a Disease Disappear”. See http://tinyurl.com/2uv8j95 Page 36/56

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