"Finally she found an expert who was willing to help her, and relief came in the form of an antiviral drug, Ampligen. According to the article, she now leads a nearly normal life." [See the letter below and the comments afterwards]
From Tired All the Time by Ronald L. Hoffman, M.D. - page 209
http://www.cfs-news.org/ampligen.htm -
http://www.geocities.com/cfsdays/beforamp.htm - Article below is from this site:
Before You Seriously Consider Taking Ampligen . . .
This is an important open letter from the very first patient taking Ampligen The incorrect folklore around my experience with Ampligen is frustrating. I have tried to keep a low profile but I will explain to you why I am now speaking out. I am trying to clear things up -- and hopefully still keep that low profile. I have been told numerous times about the exaggerations by Hemispherx and some of the P.I.’s (principal investigators) regarding my “successful recovery” and I chose to ignore them and spend my time getting well -- not getting even.
However, if someone calls me and asks me a direct question concerning the drug -- they will get an honest and direct answer. That is my style. I am really concerned about the false impression they are giving about my five years on Ampligen. It incorrectly influences people who are considering hocking their life’s savings and their health by what they are told about me and what Ampligen is capable of accomplishing. After 5 years on the drug (400 mgs 3xs a week) and a lot of side effects -- plus not getting well -- no one should know better than I do -- what this drug can and can’t do.
The last straw was when a friend of mine sent me a copy of the U.S. patent (number 5,958,718) which was filed by Hemispherx and granted by the U.S. Patent Office. In their application Hemispherx claimed patient 00 (me) was a professional golfer and was now “leading a normal life fully self-sufficient.” Seeing as I had an 18 handicap back many years ago when I was able to play golf (not bad for a sweet little old lady), I would hardly qualify for professional golfer status. Professional golfer’s handicaps are 0 -- thus no handicap is used when they play in tournaments. Not to mention they play for money.
As far as "leading a normal life and am self-sufficient" -- I should be so lucky.
Ask my husband, who cares for me (even though he has Parkinson’s Disease), how correct that statement is. Those are bold face lies and it bothers me. We are seriously considering going to our lawyer ( who is a very good one, I may add ) and ask him to write a letter to the FDA and the U.S. Patent Office telling them the truth. I doubt if we would sue at this point — just inform both agencies...but if I hear any more of that sort of thing -- they had best watch out!! Lying to the government is not one of my strong points. U.S. Senator Pete Domenici (R-N.M.) was very instrumental originally — in 1988 — helping me to obtain Ampligen on a compassionate care basis. He is a very powerful senator and one of those rare politicians who is extremely honest and keeps a very personal relationship with his constituents.
In fact, I may go to him with this issue. I respect his honesty and excellent reputation so he deserves the truth and so does the FDA and Patent Office. Now -- let’s see if I can answer your questions. Does Hemispherx, FDA, Dr. Peterson, or Dr. Levine, etc. --- have my correct address ---- yes, absolutely --- and the same for most of the others. In fact, Dr. Peterson wrote to me several years ago and offered me the opportunity to go back on the drug. My answer was a resounding and emphatic ---- NO!! To be honest with you -- if I had it to do over again, I would not go on it the first time around knowing what I do today. I was astounded when I reported the heart problems to the doctor who was my principal investigator -- and his answer was “Ampligen couldn’t have caused that” and that was it. How would he know, and shouldn’t it have been reported anyway?
At this point NO ONE in the original study with whom I am acquainted -- or those in the following double blind placebo study — is well. (The double blind placebo study is jokingly called the "double cross" placebo study as Hem did not keep their word.) I was on the drug the longest. NOT ONE, including myself, of the participants I know (and I exchange info on a regular basis with MANY OF THE ORIGINAL RECIPIENTS) has been contacted in ANY way by Hem or the FDA, etc. Scary, isn’t it? I know one of the first 10 Ampligen patients has Mantle Cell Lymphoma, and a second person who was one of the original 15 has stage 4 cancer.
Another of the first 10 has found a lump in her breast and is seeing an oncologist next week. Two of the first 10 have committed suicide. I had a hemangioma tumor removed from my liver in November, plus all the heart complications. Nothing has been documented. Seeing as many of us were on the drug 4 or 5 years -- I find this disinterest amazingly careless, or maybe they don’t want to know or admit to developing problems. Who knows -- but is this how all drugs are approved??? I hope not. You would think that would be of interest to the FDA seeing as we were all on Ampligen for years.
It seems logical we would be of great interest to those people responsible for both the safety and efficacy of this drug, such as Dr. Levine. As far as the arrhythmias and mitral valve prolapse --- no, I did not have either before I took Ampligen. They were diagnosed by the Johns Hopkins cardiologists, after I was off Ampligen, who found I also had NMH. I was treated by a cardiologist (electrophysiologist) in Albuquerque for all those complications. We have the arrhythmias calmed down now, but it took several years. You asked about intolerance for alcohol -- yes, I have always been intolerant.
My husband kiddingly use to called me a “cheap date” because I never ordered an alcoholic drink while we were dating. With all my medical bills now, I don’t fit in the category of a cheap date anymore. You are welcome to share this information with anyone. It is the simple truth, and I think that truth is needed in this vast web of inappropriate information regarding Ampligen. From the CFS BULLETIN January/February 2000 The CFS BULLETIN is a free newsletter (6 U.S. stamps donated each year are greatly appreciated) and published bi-monthly by Jayne A. Hitchcock, P.O. Box 696, Dover, NH 03820-0696. E-mail: awriter@cybertours.com .
I told a CFS discussion group about the above letter - these are some of the comments which bring up some good points:
"This first hand testimonial against Ampligen was interesting but there was no name of the person who wrote it...There was also no way to contact them to verify this information. Therefore, this brings into question the validity of it."
"...this is NOT the typical comments I hear from Ampligen patients. I saw a large group of such patients in Reno a couple of months ago. They are doing well, some very well. Also Ampligen is in Phase 3 trials for cfs.
"As to the side effects being cancer or suicide etc, THESE ARE THE SIDE EFFECTS OF CFS NOT OF AMPLIGEN."
This news story is about Ampligen and the company that developed it being victimized by a man who makes money when stocks go down. In order to make the stock of the company, Hemispherx Biopharma Inc., that makes Ampligen go down, he spreads rumors on the Internet.
"Ampligen is a clear liquid in a small glass bottle that might be good for a lot of things. It might be good for AIDS. It might be good for chronic fatigue syndrome. It might be good for kidney cancer. And liver cancer. And hepatitis. Ampligen might even be good for the war on terror if a smallpox epidemic were let loose on America."
"... Asensio bases his accusations on his own research and opinions. He contends that Ampligen is a useless drug that Carter continually hypes so as to sell overpriced stock in his company, Hemispherx Biopharma Inc., to the public.... And by a tactic called short selling, Asensio made a lot of money on the stock's decline."
UPDATE:
Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA
PHILADELPHIA, Jan. 9, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. announced today that it has formally submitted to the United States Food & Drug Administration ("FDA") detailed responses to all of the 14 questions posed by the FDA concerning the Company's New Drug Application ("NDA") for Ampligen, an experimental therapeutic, to treat Chronic Fatigue Syndrome ("CFS").
http://www.drugs.com/nda/ampligen_080109.html
https://listserv.surfnet.nl/scripts/WA.EXE?A2=ind0301A&L=me-net&D=1&P=7004&F=P
I found a letter to Hemispherx Biopharma from the FDA on the above website - dated 7/17/2000:
"We previously issued an untitled letter, dated October 15, 1998, to Hemisphcrx for promoting Ampligen as safe or effective while the product was under investigation. In our letter, we informed you that your activities were in violation of the Act and applicable regulations. In your response, dated October 29, 1998, you assured us that Hcmispherx would discontinue or revise all materials concerning Ampligen to conform with the Act and regulations."
"Hemispherx promotes Ampligen as safe and effective in several press releases. In addition, Hemispherx fails to reveal facts that are material in light of representations made about Ampligen.
"Safety "In press releases, Hemispherx promotes Ampligen as “generally well tolerated” or “well tolerated” but fails to disclose risk information associated with the use of Ampligen. For example, in your press release dated February 17, 2000, entitled “Hemispherx Files for HlV Emergency Treatment IND and Phase II/III Trials,” you state, “To date, Ampligen has been studied in 126 patients and has been consistently well tolerated in its trials.” However, toxicities that have been reported in dose-escalating studies of Ampligen in HIV-infected patients include, but are not limited to, flushing, chills, fever, chest tightness, nausea, malaise, shortness of breath, flu-like symptoms, leukopenia, neutropenia, and leukocytosis.
"Effectiveness "In your February 22, 2000 press release, you present that, “. ..Ampligen demonstrated synergistic activity with anti-retroviral therapy leading to potential enhanced suppression of replicating HIV virus....” Similarly, in your press release of December 16, 1999, entitled “Hemispherx Announces New Approach to HIV Multi-Drug Resistance,” you state, “...multiple HlV genetic mutations that made the 14 anti-HIV drugs approved by the Food and Drug Administration (FDA) ineffective did not diminish the pronounced anti-viral effectiveness of Ampligen.” These statements make conclusions concerning the effectiveness of Ampligen, an investigational new drug, in violation of the Act and its implementing regulations."