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FDA votes against approving chronic fatigue drug

In New Jersey and across the country, as many as 4 million workers suffer from a disabling condition called chronic fatigue syndrome. CFS is a disorder characterized by fatigue or flu-like symptoms that last six months or more without other explanation. It is often accompanied by dysfunction in several areas, including the immune, nervous and endocrine systems. Many CFS patients also experience cognitive difficulties, such as problems with short-term memory or concentration.

CFS can be difficult to diagnose, due in part to the variety of symptoms exhibits by patients. For some, symptoms are fairly consistent on a daily basis. For others, however, their condition may fluctuate from day-to-day, or even week-to-week. The combination of symptoms can also vary among patients, despite sharing a common disorder.

One study suggests that CFS could be an autoimmune disease. In the study, researchers found that people with CFS had higher numbers of some types of B cells than the control group. B cells are a type of immune cell responsible for creating antibodies. Higher numbers in CFS patients might be an indicator of autoimmune activity, where the immune system mistakenly identifies a type of healthy tissue as an infectious agent and works to destroy it.

What is shared among CFS patients is difficulty in performing work duties when symptoms are flaring up. Taken alone, symptoms of debilitating fatigue, widespread achiness, dizziness, headaches, or impaired mental processes can each make a difficult job that much harder. When combined, those symptoms may make work impossible.

At present, there is no drug expressly approved by the Food and Drug Administration for treating the disabling condition. Unfortunately, an FDA advisory committee recently voted against recommending approval of Hemispherx BioPharma's new drug application for Ampligen, which was intended to treat CFS.

The Social Security Administration requires documented medical evidence of a CFS patient's diagnosis and symptoms before determining eligibility for federal assistance. While a diagnosis alone is generally insufficient to qualify for Social Security disability benefits, a demonstration of impaired functionality may be a step towards obtaining a winning SSDI claim.

Source: Philadelphia Business Journal, "FDA panel nixes Hemispherx's Ampligen drug," John George, Dec. 21, 2012

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