Het einde van Ampligen lijkt na een gevecht van meer dan 30 jaar zeer nabij...
In een
vergadering
van een commissie van de FDA,
de instantie die over de goedkeuring van medicijnen in de VS gaat,
werd het bewijs van de werkzaamheid van Ampligen (Rintatolimod),
dat volgens de verhalen van ME/CVS-patiënten (zie hier
en hier) zeer effectief is,
in de meeste stemmingen als onvoldoende beschouwt.
Ampligen werd wel door sommige leden van de commissie als veelbelovend beschouwt,
maar Hemispherx zou in een nieuwe studie overtuigend bewijs moeten leveren.
Aangezien Hemispherx naar verluidt niet het geld heeft om die studie(s) uit te voeren,
lijkt het doek voor de goedkeuring van Ampligen gevallen.
Weliswaar kan het formele besluit van de FDA (2 februari 2013) afwijken,
maar dat is zeer onwaarschijnlijk.
Ampligen, dat bij een deel van de patiënten tot wonderbaarlijke resultaten heeft geleid,
lijkt ten onder te gaan aan wetenschappelijk "amateurisme" en geldgebrek van Hemispherx
en het feit dat CVS een nietszeggende "vuilnisbakdiagnose" is,
waardoor het vrijwel onmogelijk is de werkzaamheid van Ampligen in "CVS" aan te tonen.
Overigens is de goedkeuring van Ampligen politiek zeer beladen.
Toegeven dat Ampligen werkzaam is bij een deel van de ME/CVS-patiënten betekent dat
er bij die patiënten fysiek (immunologisch) iets mis is en
dat de ziekte bij hen niet veroorzaakt wordt door "dysfunctionele gedachten en gedrag".
Eerdere berichtgeving over Ampligen op deze website:
UPDATE 2:
ME/CFS buzz: Ampligen and rituximab smacked ...
Cort Johnson on December 28, 2012
...
Dr. Komaroff and Dr. Unger, on the other hand,
might as well have been from Mars
for all the understanding they gave of the Community’s plight with both voting no
on critical safety and efficacy questions and
on the final safety/efficacy marketing question.
Both know another drug like this could take 20 years,
both surely know Hemispherx doesn’t have the money for big new studies, and
both know Ampligen been used for over 10 years by ME/CFS physicians without issue.
Dr. Unger at least voted for Ampligen once
but Dr. Komaroff voted against Ampligen on every vote.
...
Instead of our putative allies
it was researchers/doctors with little known connection to ME/CFS
who gave the drug the benefit of the doubt.
It was incredible to watch...
...
http://www.cortjohnson.org/blog/2012/12/28/mecfs-buzz-dec-2012-ampligen-and-rituximab-smacked-newtons-nuggets-big-win-at-sanofi/
Het ooggetuige-verslag van Jaenette is zeer onthullend.
Zeker als het gaat om de voor- en tegenstemmers en de houding van prof. Komaroff.
"I have a plane to catch"
My Oral Testimony at the AAC Meeting Regarding Ampligen on December 20, 2012
Posted on December 24, 2012 by Jeannette
...
There is much to say about the meeting,
but one of several things that stood out
were the distressing votes
cast by one of the few ME community's specialist physicians,
Dr. Anthony Kamaroff of Harvard University. Dr. Komaroff
voted "no on all four questions,
even on the one question that the majority of the committee voted "yes" on!
Throughout the meeting, Dr. Komaroff
was hostile and dismissive towards Hemispherx, the sponsor of Ampligen.
Still, his vote came as a shock to patients
many of whom had pegged him as being on our team.
Make sense, right?!
Unlike some of the other committee member who obviously knew nothing about the illness,
Dr. Komaroff is familiar with the disease,
probably more through his research than through clinical work, but nevertheless.
Why would somebody like him sell out the patients he is studying?
...
If "our" specialists do not help us, we are doomed.
If I had to take a guess,
I would bet that
Dr. Komaroff didn't bother to pick up the phone
and call those physicians who,
unlike him, actually know the drug:
first and foremost Dr. Peterson,
but also Dr. Bateman, Dr. Lapp, Dr. Klimas, Dr. Enlander.
...
Patient advocate, Anita Patton, approached Dr. Komaroff
to remind him of his Hippocratic Oath and
to let him know that he had done some real harm to patients with his vote.
Dr. Komaroff's response was, "I have a plane to catch."
He then moved away from Ms. Patton
who, as a member of the public, wasn't allowed behind the red tape and
he proceeded to chat with somebody else in the area off-limits for patients.
...
The FDA presentation consisted of a complete destruction of Ampligen.
In all fairness, Hemispherx didn't have all their ducks in a row
and that was very unfortunate,
but we have no other approved treatment,
no prospect of one in the foreseeable future and no hope whatsoever.
That didn't seem to enter the equation for the FDA at all.
Nor did the fact that
Hemishpherx is a small drug company and, unlike the big pharma hitters,
doesn't have unlimited financial resources
to conduct another 300 patient placebo-controlled, double-blind, randomized study,
as the FDA wants them to do.
...
The FDA struggled hugely
to distinguish side effects of the drug from typical symptoms of the disease.
Seriously, abdominal pain?
Show me an ME patient who doesn't have that symptom as a result of having ME!
And infections?
Infections are one of the hallmark features of ME.
Flu-like symptoms, headaches, fevers, pain, chills,
diarrhea, depression, suicides, suicide attempts:
all part of everyday living of an ME patient not on Ampligen.
...
http://thoughtsaboutme.com/2012/12/24/i-have-a-plane-to-catch/
De tegenstem van Elizabeth ger (CDC) was volgens Mindy Kitei niet verwonderlijk:
In my view,
Beth Unger would vote for Ampligen approval when pigs fly.
...
At the FDA Unger also said in her decision that
more needs to be known about this "subset" of ME patients who respond to Ampligen.
If Unger, the late William Reeves and the rest of the sham scientists at CDC
had bothered to investigate the disease seriously for the past 30 years,
those "subsets" would have been defined by now and drugs would have been approved.
Now, CDC is finally running the study.
Pleassssssssse.
...
Why does the committee think most ME patients aren't that sick?
Could it be the name CFS that CDC coined?
Could it be the useless research perpetuated by same?
Laurence Fishburne, where are you?
Where the hell is the CDC of the movie Contagion?
Not doing ME research, that's for sure.
http://www.cfscentral.com/2012/12/the-oxford-definition-its-baaack.html
Berichtgeving in de media:
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