You raise a good point that CFS can be difficult to pinpoint, but once again, it really depends on the source of information.The CDC (along with agencies in England) use loose non-specific definitions, with criteria such as extreme fatigue, irritability, and depression; patients have to meet something like 4 of 8 symptoms, with each symptom given equal weight. They're most likely studying a heterogeneous set of patients, who probably respond to treatments differently. They’ve also reported that a large portion of their participants work full-time, which is at odds with CFS’ typical clinical presentation.However, clinicians who treat CFS have a distinct clinical picture of the disease, which has been fleshed out with relevant research. Specifically, the fatigue is defined by post-exertional malaise - fatigue following exertion, which is unproportional to the activity. A sizable portion of the fatigue is often attributable to orthostatic intolerance, which is when your blood pressure fails to rise when you stand up. Orthostatic intolerance causes a unique set of symptoms and behaviors, marked by light-headedness upon standing (or even sitting) and compensatory behaviors, such as crossing one's arms or legs and the need to lie down. Another characteristic of CFS is disturbed and unrefreshing sleep. Cognitive dysfunction (or "brain fog") is also one of the most prominent subjective complaints. Taken all together, CFS can still be tricky to define, but the characteristics above are still distinctive and specific to CFS, to the extent that seasoned doctors often just know it when they see it.Complementary research findings include up-regulated nitric oxide, likely causing or caused by vasodilatation, a hypercoagulable state, and numerous immune abnormalities (lowered natural killer activity, increased Rnase L activity), which are often interpreted as evidence for a hyperactive immune system. In line with all this, beneficial treatments include drugs for orthostatic intolerance, NO scavengers, sleep meds, and drugs to improve cognitive function – these categories of drugs can drastically improve functioning, but none of them (alone or in combination) gets rid of all the symptoms. Nonetheless, their benefit is well documented in the literature, so long as you're reading a study with a good definition of CFS (which is likely to most studies not connected to the government). That's all to say that there is a distinct picture of CFS, despite any misconceptions among the public (which partly stem from the ambiguous name CFS).Ampligen is not a mystery drug – it’s not like one of those psychoactives that help somehow but through an unknown mechanism. It’s been around since the 60’s, and it modulates the immune system by down-regulating Rnase L via cells’ toll-like receptors. Initial studies for Ampligen used very strict criteria and recruited only the most impaired patients from the top CFS physicians around the country – a group that typically doesn’t respond at all to any treatment. The results – at least for 2/3rds of the patients – were nothing short of miraculous. Patients who couldn’t get out of bed for years or even a decade started living normal lives without any sign of remission for years, until they could either no longer afford the drug (at $20,000/yr) or it was no longer available; subsequent studies have found similar results with more patients (all combined to make a sample of 700-800 participants). In fact, the majority of pressure for the FDA to approve Ampligen isn't from Hermispherix, it's from CFS advocacy groups, those patients who once regained their lives on Ampligen, and experts in the field, who estimate that it will greatly benefit 2/3rds of their patients, fulling curing around half of them.Returning to the potential of Hermispherix, 2 conclusions to keep in mind.First, the current estimate of the prevalence of CFS, I think it’s 4 million, is generated by poor epidemiological studies by the CDC. Due to their loose criteria, that’s most likely an overestimate. Ampligen will be marketed towards a more select group of patients than CDC estimates would have you believe.However, CFS (defined properly) is a growing disease with a demand for better treatment options. Most doctors know little about CFS, and those who do typically stumble into the field, either from seeing and treating more CFS patients than usual which generates word-of-mouth reputation, or because of the similarities between CFS and their previous specialties. Treating physicians in the field are often swamped with patients; the number is slowly growing, but treating CFS is rarely profitable (due to the amount of attention that needs to be given to each patient and adjusting treatments) and is often looked down upon by high-brow research institutions. But more importantly, CFS physicians know what they’re doing, they know CFS (without harboring vague ideas about it), and they know how Ampligen is believed to help. *Ampligen’s market for CFS, at least at first, will be among these informed physicians and their patients*.
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