The first-ever drug developed to treat chronic fatigue syndrome was rejected by the U.S. Food and Drug Administration, HealthDay reports. Though things like exercise, nutrition, yoga and relaxation can help treat chronic fatigue — a health issue that disproportionately affects women, by the way — there is no known cure for CFS, nor any drug treatments.
CSF is a confusing illness, in part because it sounds so plausible to every remotely hypochondriacal type. “Chronic fatigue?” Who hasn’t felt “chronic fatigue” at some point?
But CSF — which affects an estimated 4 million Americans, mostly women — goes beyond the periods of excessive sleepiness or lethargy we all get from time to time. According to the National Library of Medicine, it “refers to severe, continued tiredness that is not relieved by rest and is not directly caused by other medical conditions.” Symptoms must last at least six months and be severe enough to interfere with daily activities; they may also include extreme exhaustion after exercise, serious short-term memory and concentration problems, joint pain, headaches, muscle aches and sore lymph nodes.
The problem with trying to treat chronic fatigue syndrome is that there’s no consensus yet what causes CSF. The prevailing theories are that it’s viral, caused by something known as the ‘Epstein-Barr virus’ or human herpes virus-6, or that it’s caused by inflammation in the nervous system as a result of a faulty immune system response. In other words, it’s either a virus or an auto-immune disease. That’s a pretty big ‘or.’
The drug in question is called rintatolimod (suggested brand name Ampligen). It’s an intravenous drug with a manufacturing cost of about $1,000 a month per patient (it would be more retail) that needs to be infused twice a week and carries side effects such as infection and liver problems. Clearly, not the most awesome treatment choice.
But members of the FDA advisory panel reviewing rintatolmoid told the Wall Street Journal that the drug really seemed to work in some CFS patients, making their decision difficult. They voted Thursday 8-to-5 against approving the drug. “Although the FDA isn’t bound to follow the recommendations of its advisory committees it usually does so,” says HealthDay writer Steven Reinberg.