Chronic Fatigue Syndrome Treatment Moves Toward Possible Approval
The experimental anti-viral drug Ampligen (poly I: poly C12U) has cleared an important hurdle with the FDA, which could pave the way for it to become the first treatment ever approved for chronic fatigue syndrome (CFS or ME/CFS).
Ampligen's manufacturer, Hemispherex Biopharma Inc., submitted a New Drug Application to the FDA back in October. The FDA came back with several questions Hemispherex had to answer before the FDA would officially accept the application, and the company has complied. Now, the FDA can move forward with its review of the data from clinical trials.
Ampligen works by jump-starting your body's natural anti-viral pathway and regulating levels of Rnase L (a substance in your cells that attacks viruses), which can be high in people with ME/CFS. Studies show it's more effective and has far fewer side effects than other drugs in its class. Thirty years in the making, Ampligen first was tested as a possible treatment for cancer, and later for AIDS.
While Hemispherex says trials showed Ampligen is generally well tolerated, it (of course) comes with a risk of side effects. Ironically, they include flu-like symptoms, dizziness and confusion - sound familiar? A complete list of side effects and more information is available at Hemispherex's website.
Suggested Reading:
- Chronic Fatigue Syndrome Treatments: Prescription and OTC Drugs
- Chronic Fatigue Syndrome Treatments: Alternative & Complementary Medicine
- Chronic Fatigue Syndrome Treatments: Nutrition & Exercise
Comments
See the above URL for full text. I was a participant (more like a victim) in an FDA Phase III drug trial for Ampligen in San Diego CA from 1999-2000. Many of us got ill from Ampligen in that study; however, we were listed as drop-outs with no mention of the severe adverse effects of Ampligen. That Ph. III trial was poorly run and a virtual sham - the supervising M.D. refused to listen or record any negative data (there was plenty). The methodology was terrible in that medical oversight and record keeping was superficial and important questions were not asked. During subsequent contacts with the FDA and various CFIDS organization on this matter, it was clear that few or none (most certainly the FDA) did not want to hear any negative data about Ampligen - thus the significant adverse effects of Ampligen were buried, not recorded, and ignored. See the above URL for me detail.