Subj:	Another point of view on Ampligen!
Date:	97-02-11

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There were US trials of this drug in 1990-1992. At the beginning,120 patients
participated in the double-blind trials in Charlotte, North Carolina;
Portland, Oregon; Houston, Texas and Incline Village,  Nevada. 

Before the completion of the  trials, 92 participants were dismissed from the
trials and denied further access to the drug. A group of patients sued
individually in federal court in Nevada for continuation of the drug,  and
the court ordered HEM Pharmeceuticals to provide Ampligen to those who had
sued. In February 1993 (Source: CFIDS Chronicle), the last of the
"compassionate care " Ampligen patients from the trials was removed from the
drug.

One of the participants in those trials has told the story of his experience,
and it and other discussions about about the past US experience should be
carefully considered by those considering Ampligen as a treatment. 

The CFIDS Chronicle's Winter 1994 issue ran an article about HEM and the
Ampligen trials entitled "Double Blind: When Healing is a Gamble", by
Portland Oregon author, PWC and trial participant Floyd Skloot. This article,
which appears as Chapter 2 of Floyd's 1996 book called The Nightside
(Storyline Press) , appeared originally in The Sun magazine, Issue 215,
November 1993. Reprints were available from The CFIDS Chronicle, and may
still be.

Hillary Johnson's book Osler's Web also deals with the topic of Ampligen,
including the lack of complete recovery by any of the patients at some sites.
Yet, according to Skloot's book, HEM released findings of its clinical field
trial at the annual conference of the American Society for Microbiology and
proclaimed the trial a great success. The prestigious Journal of the American
Medical Association carried the story. 

Ampligen, HEM's failure to follow through on its promise to maintain trial
participants on the drug, and the company's shaky financial status, were the
subject of angry debate at the 1994 Clinical Conference of the American
Association for Chronic Fatigue Syndrome. The proceedings of that conference
were published, I believe, as the first issue of the Journal of Chronic
Fatigue Syndrome, published by the University of Miami School of Medicine.

At that same conference, a team from the Academic Hospital of the Free
University of Brussels , Belgium, was reporting the drug showed "promise" in
trials with 11 patients. Results in Belgium, after 24 weeks of treatment,
were a 50% increase in Karnofsky Performance Scores, decrease in "symptoms",
and increased oxygen uptake.

People considering Ampligen should ask a lot of questions. Not of me,
please--I am only passing information along, though I was in attendance at
the 1994 national conference and heard the discussions there--but of the drug
company itself, and of doctors and patients who participated in the earlier
U.S. trials, as well as the Belgian and Canadian trials. Here is one thing
Floyd had to say about his experience:

"The paradox is clear; randomized trials like the one I was involved in can
never be reconciled with the best treatment for an individual participant
because of random selection into experimental and control groups......."

I do not know what procedure/structure is proposed for the Ampligen trials
now being sought again in this country. Floyd's suggestion was "to enroll an
adequate number of patients, give them all the experimental drug, and conduct
ongoing studies using disinterested third parties to assess findings." 

I would add the patients should be well-informed.
Further, why not make HEM agree to the CFIDS community's demands? Without us,
there is no CFIDS testing.


Kathleen M. Bogan
Attorney at Law
Portland, Oregon

(No calls or letters please. I am a PWC, retired from practice, am not
involved in these cases. Please direct your inquiries to The CFIDS
Association of America, other national advocacy groups, online sites, and as
suggested above.)