Tuesday, February 5, 2013

Hemispherx Receives Complete Response Letter From FDA on Ampligen

Readers Digest version: FDA wants more evidence.
At least they're consistent -- for the past 2 decades, I've been hearing every year that Ampligen is 18 months from approval.  Never actually gets there. 
Yes, I'm frustrated, but I'm also mindful of the politics of the situation:
Osler's Web, p.520 (the 1991 chapter) "Cheney noted, 'The FDA is *really* in a bind. If the agency approves the treatment IND application, they will, in one swoop, destroy the credibility of two government agencies."
As long as CDC says CFS is psychiatric, FDA can't approve a medical drug for it.  It's that simple.



"Insanity is doing the same thing over and over again and expecting different results" ~ Einstein

CFS will never make any progress until we are marching/rolling in the streets ACT-UP/OCCUPY style.


CFS Facts said...

Dr. Mark Loveless, who deals with both, observes, a CFIDS patient "feels every day significantly the same as an AIDS patient feels two months before death."

The problem is we're sicker than AIDS patients and less able to march ourselves. Many of our friends/family have bought into the psychobabble and won't march on our behalf.

There have been entire years that I left the house only to go to the doctor. Not only couldn't attend a march, but too sick to make the phone calls to organize one. And no friends willing to even do something as urgent as feed me, without expecting them to do that much volunteer work for a disease they don't believe is real.

Believe me, we've been talking about it for years, but practicality always gets in the way, that no one's really able to get out and do it.