Don't assume Ampligen will be approved just because it has no side effects, either. Here's what Hemispherx says about Ampligen safety:
"We believe that Ampligen has been generally well-tolerated with a low incidence of clinical toxicity, particularly given the severely debilitating or life threatening diseases that have been treated. A mild flushing reaction has been observed in approximately 15%-20% of patients treated in our various studies. This reaction is occasionally accompanied by a rapid heart beat, a tightness of the chest, urticaria (swelling of the skin), anxiety, shortness of breath, subjective reports of 'feeling hot,' sweating and nausea. The reaction is usually infusion-rate related and can generally be controlled by reducing the rate of infusion. Other adverse side effects include liver enzyme level elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash, transient visual disturbances, slow or irregular heart rate, decreases in platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function tests, occasional temporary hair loss and various flu-like symptoms, including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and vomiting. These flu-like side effects typically subside within several months. One or more of the potential side effects might deter usage of Ampligen in certain clinical situations and, therefore, could adversely affect potential revenues and physician/patient acceptability of our product.
What's worse, Ampligen's side effects or CFS? Sounds like a toss up.
I wrote previously on the ways in which
Hemispherx has improperly massaged data from Ampligen clinical trials
. I also warned about the company's
recent use of at-the-market stocks sales
The FDA advisory panel convened to review Ampligen is scheduled for next Thursday, Dec. 20. The FDA's briefing documents on Ampligen will be posted to the agency's web site on Tuesday, Dec. 18.
Unlike Celsion, Hemispherx has been a poor "run-up" stock into the panel meeting -- not a reassuring sign.
Next week's Mailbag will be the last for 2012 before I take a short break and re-energize for 2013.
-- Reported by Adam Feuerstein in Boston.