“FDA to rule on ‘Lazarus’ drug Llewellyn King Published 4:41 pm, Saturday, December 15, 2012
WASHINGTON –For about a million Americans, Thursday will be a seminal day. That’s when some of them come before the Food and Drug Administration to petition for approval of a potent and controversial drug, a so-called Lazarus drug.
The drug, first synthesized by Hemispherx Biopharma, Inc., of Philadelphia, in the 1970s, is Rintatolimod (tradename Ampligen), which is used to treat chronic fatigue Syndrome, also known as myalgic encephalomyelitis. It is a grim but little-understood disease of the immune system, resulting in collapse, pain, confusion and sensitivity to light and noise.
Patients and their doctors want the drug, but there is concern that the FDA will fault — as it has in the past — the scope of the clinical trials and the documentation of collateral effects.
The FDA is expected to rule early next year.
The patients turn to the government for recognition, but the government turns them into a statistic.”
We are PEOPLE, not statistics.
Please do everything possible to be at the meeting on Dec. 20th, 2012 so that FDA sees people (not statistics)..
The full article can be found here http://www.stamfordadvocate.com/local/article/FDA-to-rule-on-Lazarus-drug-4121250.php