By Tom Windler

 

     Pharmaceutical firms receive "The Pink Sheet" which keeps them abreast of all new happenings in the field.  In March, Hemispherx BioPharma made the copy since they have an upcoming filing with the Federal Trade Commission (FDA).  Ampligen has been promoting itself as the greatest hope for those with chronic fatigue syndrome for well over a decade although their own patent exposed that it revs up the tumor necrosis factor (TNF) which is not what you'd want to have done.
 
     CFS (ME) is not the only illness that Hemispherx is running trials with.  They also are testing it on metastic renal carcinoma, HIV, hepatitis B, Hepatitis C, and Hodgkin's lymphoma.  It is a drug in search of an illness.  Have they found the illness?  The Centers for Disease Control and Prevention (CDC) has a website where they report about some adverse events, such as liver damage, is "still completely characterized."  Patients have reported, for years, that the drug has caused many more adverse reactions and some have even found that, although they applied for the trial and were given a diagnosis of "CFS", they had other problems and not that illness.  One found sleep apnea was the only problem!  Many have been told that they are improving based upon testing results but that they were not tested.  Some have been shown Karnofsky scales that were not valid.  A few have found they did have some improvement.

     The drug has had a checkered past.  The FDA put the drug on hold in 1991 during the Phase II trials due to concerns of hepatic toxicity, severe abdominal pain and irregular heartbeat.  The manufacturer, who called themselves HEM Pharmaceuticals, solved that problem by hiring a PR firm!  Indeed, the next year, the FDA allowed Phase II/III to proceed and they were allowed to charge for a "cost-recovery" price.  In 1998, they were again cited by the FDA.  This time they were slapped for illegally promoting Ampligen as safe and effective for CFS and for other illnesses. 

     Hemispherx has made friends in Congress, finding the money they gained from desperate patients and other means could buy influence.  Representative James Greenwood (R-PA) and Representative Joe Barton (R-TX) have been staunch allies.  Hemispherx also hired those most polictically active in the field to be on their various boards such as Anthony Komaroff, M.D., a member of the CFSAC, Staci Stephens, a member of the CFSAC, and Charles Lapp, M.D., a member of the CFSAC.

     Hemispherx is already counting on FDA approval and is building a marketing team in this country.  They acquired a Alferon N Injection from Interferon Biosciences just last year and have already contracted with nearly 100 sales representatives.

     While the FDA representative at the first CFSAC meeting said "about 20" drugs were in the pipeline for CFS, Ampligen appears to be the only one.  While I, for one, have spoken to too many patients who found the drug a terrible experience, FDA approval would not change my mind.  A treatment that is based upon an unknown cause does not impress me.  Even those physicians who insist it has efficacy seem to be monetarily rewarded by Hemispherx.  If politics wins over real science, Ampligen will win FDA approval soon.  Unfortunately, it usually does.

     A letter was forwarded to the National CFIDS Foundation from John Chavez from Chula Vista, California which said:

     I was one of the participants in the Hemispherx Ampligen Phase III trial in San Diego, CA – roughly from June 1989 to February 20000.  Of the approximately 25-30 participants (some dropped out very early) here in San Diego, I know that at least 4-6 people DROPPED OUT of the later stages (i.e. may months after the blind med vs. placebo infusions), me included, DUE TO SEVERE RECURRENCE AND WORSENING OF CFIDS MAJOR SYMPTOMS (e.g. body aches, sever fatigue, flu-like symptoms, sleep problems, cold sweats, etc.).  We made it to and through at least two treadmill tests which caused some of us to relapse further.

     We were given only superficial medical assessment and evaluation exams and the physician pretty much ignored complaints about worsening symptoms.  Those conducting the trial tests refused to give us our own lab and other data from the trial.  We are fairly sure that we were counted as drop-outs or not having completed the trial (true) – however, we doubt there was an indication of our adverse symptoms and our reason for dropping out of the trial (i.e. severe relapse an recurrence of major CFIDS symptoms).

     Simply put: AMPLIGEN MADE US SICKER.

     We kept track and in general contact with most of our fellow trial participants here.  It is true that some small portion noticed some improvement.  Of our overall group: Less than 25% noticed some improvement; maybe another 25-35% no noticeable change; maybe 25% slight relapse, and maybe 15-20% with severe relapse.

     "I am not here to argue the numbers (a non-representative statistical population only yields incomplete and possibly erroneous date and conclusions).  I am here to point out that:

     "1. The trial failed to include and count many of those most adversely affected – they/we were simply eliminated from the trial population tabulations and shown as drop-outs, thus leaving mostly the healthy in the trial results.

     "2. A notable number of us got significantly worse some time after the Ampligen was introduced – the onset and deterioration of symptoms was not random. ; Many of us have had CFIDS for 8-10 years by the time of the trials, most of us had achieved some overall equilibrium of the symptoms, and were well aware of normal variations of our symptoms – the onset and severity corresponded mostly to the infusions AND most of us improved somewhat after terminating the infusions.

     "3. The medical interviews and Karnofsky tests to assess condition were very rudimentary and simplistic, and often lacked any reporting of well-known CFIDS symptoms.

     "4. Those conducting the Ampligen trial refused to give us our lab results and medical records.

 

"I find it appalling that this drug, Ampligen, is even being considered for public use.  Given the probability that Ampligen will exacerbate CFIDS symptoms in many, I cannot recommend it to anyone.  The CFIDS community deserves complete data and information.  Those continuing to promote or recommend Ampligen are being misled by faulty trials and data dressed up in the guise of complete and thorough testing. 

     "Be aware.  Be warned."

     A letter sent to the FDA from Estelle Altork, said, "I respectfully request that among the documents you look through to arrive at your decision, you add my letter to those documents. I was in the first group of 25 people in the Phase III Ampligen trial in San Diego, CA. The results that you will look at have been doctored, changed to fit what Hemispherx wants you to believe and are definitely not what has been the facts at the trial site. Of the 25 participants at our site at least 5 people dropped out in the later stages. Some of these people dropped out a week or two before the end of the trial because they were so very ill with worsening symptoms of Chronic Fatigue Immune Dysfunction Syndrome due to the drug. I was one of these people. We made it through to the last treadmill test. The medical supervision given by a Dr. Mercandetti in Hillcrest, San Diego was pitiful and superficial at best. He ignored our complaints, some of them very severe. We were promised our test results two years after the trial was over. Even though we wrote to Hemispherx Biopharma, we never received an answer or the test results.

 

"From our group of 25, there may have been 3 people that were helped, about 25% had no noticeable change, which is probably normal in a double blind test. 25% had a slight relapse and 25% had a very severe relapse. If only one eighth of our group seemed to be helped, does this justify putting a drug on the market? Incidentally, those of us that had a severe relapse, felt that our health got worse after getting off of the drug Ampligen. We are still in touch with those who were on this trial.

 

"We feel that the trial failed to include and count many of those most adversely affected. They were simply eliminated from the trial population tabulations, thus leaving mostly the healthy in the Phase III trial results. There is another very disturbing fact that has come to my attention. Included in the Board of Directors for Hemispherx Biopharma are two CFIDS doctors -- Dr. Anthony Komaroff and Dr. Charles Lapp. These two doctors were working on research and treating CFIDS patients and now they are on the Board of Hemispherx Biopharma?? I feel this is a conflict of interest and something that needs looking into. Thank you for your time and I appreciate your listening to a patient who became more severely ill from the Ampligen trial."
 
 [Ed. Note:  Chavez went from a productive engineer and sales executive to bankruptcy losing his home, savings and retirement (401K) and, ultimately, his marriage of 25 years.  He and Estelle were in the same Phase III trial of Ampligen.]