Comments on Ampligen Study 511,  data presented at the AACFS Conf. Seattle
and presented in the Feb 7th press Release from Hemispherx.

MMA Feb. 14 2001.

Hemispherx  (their research associates) presented several research abstracts
at the AACFS conference, most of which were on the 37 kDa RNase L.
Many of these were excellent and I have summarized them in a separate file.

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On Ampligen there were 3 abstracts presented and one of them dealt alone with
giving infusions 2 times compared to 3 times a week, which the researchers
concluded gave the same result.

What Hemispherx presented on their second Ampligen poster (no 27) was the
story of 2 (two !) patients who had received Ampligen for an unknown 
(but apparently long) period of time. These patients were doing fine in every way
measured.

On their third Ampligen poster (no 113), the study cited in their Feb 7th press
release, they report on 41 severely debilitated patients from the AMP 511 study,
who received at least 16 weeks of Ampligen. Although the results showed a
statistical significant increase in Karnofsky score for this group (from 50 to 60),
only 13 patients continued to an extension phase of the study receiving at least
64 weeks of Ampligen treatment. These 13 patients showed increased improvements
in cognitive function, vitality and physical activity, Karnofsky score rose to 70.

They state in the conclusion "The treatment was generally well tolerated and the
majority of patients (80%) continued treatment beyond 24 weeks."

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My conclusion:


1) It seems well documented that Ampligen benefits those who can 'take it' for the
number of weeks required (and had the means to participate in the study).  
Ampligen should be available to CFS patients in all countries as one of the offers
of treatment. Hopefully this will be at a much lower price than the present.

2) We need to know the total number of patients who entered the 511 study. There is
no documentation provided on the number (percentage) of fall-outs and for how
long these fall-outs stayed in the study. Did they drop out immediately or along the way ?
We must ask the company to publish these data.

3) It is by no means documented what happened to the fall-outs of the study. What 
were their side effects and how serious were their problems ??. Nor is it documented 
what health situation  these patients were in after receiving Ampligen. 
If some patients were left in a condition worse than prior to their participation in
the study, this information is vital.

4) Research on the biochemical markers (37 kD RNase or others) that will narrow 
down the number of potential candidates for Ampligen treatment should be forwarded
and the results made public as soon as possible.

As much as the evidence favours Ampligen as an attractive treatment offer for some
CFS patients, just as much information points at Ampligen being of little or no use
to others. We strongly urge the company to make all relevant results public.

The company must provide more information before CFS doctors and CFS patients
can take a qualified stand on whether to recommend (or to try) this treatment.

Mette Marie Andersen, M.D. 
Feb, 14th 2001