& : Ampligen and CFS Radio

[Guest guest]

Some information about Ampligen which you may not have been told about is on

the FDA's website at www.fda.gov . Just click on " Biologics " and then do a

search for " Ampligen. " Two of the 8 documents you'll get relate to Ampligen

and CFS: (1) the FDA's rejection of HEM's IND application dated October 4,

1991 based on potentially deadly side effects which happened to some

patients in the trial and the generally poor conduct of the study; and (2)

the warning letter the FDA sent to Hemispherx on October 15, 1998 ordering

them to stop their illegal promotion of Ampligen.

Public record documents from the lawsuit filed against HEM (the old name for

Hemispherx) in 1992 by former Ampligen patients include a 1991 letter from

Kessler, then Commissioner of the FDA, which states, " Severe drug

reactions were not reported to the FDA. For example, [patient

identification deleted] received Ampligen and two hours post-infusion

experienced severe abdominal pain and tachycardia requiring hospitalization.

Hepatic [liver] enzymes were 'severely elevated' and the condition was

diagnosed as 'acute hepatic toxicity' and 'acute drug reaction secondary to

Ampligen administration' ... Other 'severe post-infusion reactions' were

noted on [patient identification deleted] ... this patient experienced

severe flu-like symptoms, severe swelling, redness, and itching of hands and

extremities. Four additional adverse reaction reports were found. " The

letter also states that " Twelve patients out of 45 experienced deterioration

of Karnofsky Performance scores and 16 patients out of 45 experienced

deterioration of Activity of Daily Living (ADL) scores during the course of

[Ampligen] treatment. " Gosh, I can't remember Hemispherx ever saying that a

third of the patients who took Ampligen got sicker, can you?

Another letter from the same court record is from Dr. Gerald V. Quinnan,

Jr., who then was Acting Director of the FDA's Center for Biologics

Evaluation and Research. In the letter he warns Hemispherx CEO Dr.

not to make inaccurate public statements about Ampligen: " A balanced

presentation would require a clear statement regarding the risks of

Ampligen, including a statement that a number of serious and potentially

life-threatening reactions were observed. "

An advocacy project I'm getting involved in is to change federal law so that

patients who take experimental drugs are legally entitled to ALL information

about the drugs, and to give the FDA the power to enforce that law. Right

now all information about any experimental drug is the sole property of the

pharmaceutical company. The FDA is legally prohibited from telling patients

what it knows about any drug that hasn't been approved yet, even if the

patients' lives could be in danger because they haven't been told the truth.

As for CFS Radio: On October 25, 1998 (ten days after the FDA ordered them

to stop their illegal press releases and Internet promotions), Hemispherx

became the sole sponsor of the CFS Radio program. You may have noticed that

nearly all the broadcasts since then promote Ampligen in some way. I have

audiotapes of all the broadcasts, and the broadcasts themselves include the

announcement that Hemispherx is paying for them. However, Carolyn Viviani

deletes those announcements from the transcripts she publishes on the

Internet, so that readers do not know that Hemispherx has paid for

everything they are reading. I don't know why Carolyn withholds this

information, or who may have told her to do so.

, is " Mitch " Mitch Abrams? If so, I suggest you check out his

financial ties to Hemispherx Biopharma. And please, please inform the FDA

immediately about what he has said to you. If you email me at

cfsmail@..., I'll send you the name and phone number of the FDA

person in charge of this.