by Danya Zucker

From Fall 2011 Forum

What started as "Dear Forum…" Kudos to this publication for possessing and printing the letter written to K. Kimberly Kenny (sic) by Hemispherx Biopharma, Inc. (Heb) regarding a planned article for The CFIDS Chronicle on the status of Ampligen recipients treated at a handful of sites in North America and Europe in the late 1990s, I was particularly impressed as I am one of the Ampligen patients referred to in the letter, none of whom received a copy of it — nor, obviously, did The CFIDS Association of America (TCAA) ever publish it.

Since it was, at that time, quite unlike TCAA to report so specifically on a single treatment for CFS/ME, I think readers of the Forum would like to know why such a feature was nevertheless in production: in the entire history of the Association, there had never been so many simultaneous requests for information about one medication. The piece for the Chronicle was being researched and written board member Patti Schmidt and Chronicle Editor David Hoh; I know because in spring of 1998 I had spoken with Schmidt and Ho more than once, and filled out one of the questionnaires they had composed and distributed to Ampligen patients.

Upon warning from Heb's legal counsel, TCAA met every demand and more; we Ampligen patients each received a short letter (I would include mine here if I could find it!) regarding the crucial destruction of all completed surveys and insisting that, above all else, if they continued to gather or even read any form of feedback, Heb would take legal action requiring a defense too expensive for the non-profit to survive. That made sense to me; obviously CFIDS/ME patients could not afford to lose our largest and most powerful representative institution. About six seconds later, the flaw in my logic was obvious: in their decision to ignore the recording-breaking requests for material about how Ampligen subjects were faring, in addition to breaching their own mission statement, TCAA had instantaneously become a different association altogether, one whose priorities had been hijacked overnight. Like in some science fiction scenario, by taking steps to ensure its survival, the organism had actually guaranteed its own destruction. At the time, honestly I was shocked. Shocked, furious, appalled. I felt like I'd been betrayed… like all TCAA members had been betrayed… like everyone afflicted with CFIDS/ME (and everyone who cared for or about them) had been betrayed, and unnecessarily so.

Since the questionnaire was not in fact "slanted" — it was designed to be as objective as possible, and asked about positive and as well as negative results of treatment — wouldn't Schmidt and Ho have been protected by the First Amendment if Heb had tried to punish them legally? Without their mandate or salary, independent journalist Linda Clement continued to conduct in-depth interviews with almost all of the 1997-1999 patients in the most professional investigative study of Ampligen since Hilary Johnson's Osler's Web. Less the corporate, political, legal and financial support available to Kenney, Clement did not abandon her integrity and concern for CFIDS/ME patients in the face of shoddy intimidation tactics.

In Forum-assisted hindsight I am even more disgusted by TCAA's immediate and complete surrender of ethics and accountability. Shouldn't the heavy-handed threat sent to Kenney and the directors have signaled the importance of the subject? Didn't anyone on the board wonder what Heb was clearly so anxious to prevent from appearing in print? Why would a pharmaceutical company that had issued so many press releases about one drug over the course of several decades not covet the additional publicity that could be afforded by the Chronicle? The rest of the missive is almost amusing. Regarding the attempt "… to solicit information from various patients on Ampligen…" none of us were compelled to provide any feedback to TCAA. Surveys were filled out and returned on a strictly voluntary basis. We all know that the patient confidentiality referred to and "preserved by various Federal and State Laws" is ours to control, and if we choose, to release. We don't need the likes of Ransom Etheridge to protect us. He did, however, know something about activity that "…violates general statues (sic) and regulations governing the implementation and administration of clinical investigations in the United States", possibly reinforced when his client was repeatedly cited by the FDA for exactly that. (See www.fda.gov, search "Ampligen".)

Before I took Ampligen I read everything about it available to me and spoke with as many previous patients and physicians as I could. I discovered far more negative experiences than positive ones, but I persevered because I thought that I could not get any sicker believing that, at worst, the stuff would have no effect. Many others felt the same way. But I was wrong. We were wrong. Some were dead wrong. I imagine patients currently pursuing Ampligen likely harbor the same combination of hope and desperation that I did. I hope they consider the following:

Ampligen is some sort of extremely potent drug — no placebo, no homeopathic, no question. I became exceptionally ill during the first week of the 24-week infusion regimen, and many other subjects did equally poorly. I suffered less severe but still extreme reactions on every infusion day for the subsequent months, and many others had the same experience. I was told by the physician administering Ampligen to our group of patients — and he was told by Hem's medical director, the only person who has ever been Hem's medical director (b/c carter has dirt on him from Sprayer's research when they were in med school together) — that such side effects were actually encouraging and indicative of a positive final outcome. It was not until week 22 that I was told by 2 separate Heb employees that in candidates for whom pain is a prominent symptom that Ampligen should always be avoided as it is likely to exacerbate pain. Often permanently! Which it did. At the end of my therapy, I was considerably sicker than I ever had been before Ampligen; many other patients had the same experience. Thirteen years have passed, and I remain sicker than I was before Ampligen, right through today. My experience is far from uncommon.

Potential subjects might also seek answers to the following questions, most of which I didn't know enough even to ask. If they are satisfied with the available answers, I wish them good luck and Godspeed toward better health. For members of the NCF who would like further information I gained from that time, they can ask the NCF to let me know.

Questions

What are the documented side effects of Ampligen treatment? Which are temporary and which permanent? Why have some patients and physicians reported side effects that still are not acknowledged by the company or presented to current prospective patients? Have any patients ever chosen to discontinue their treatment — or had their physicians discontinue treatment — before finishing the trial period? Why/why not? Is the data from those subjects included in results presented to the FDA for approval?

Have all Ampligen patients been monitored after their treatment period ends? If so, for how long? If not, why not? Have physicians followed patients post-therapy to evaluate the drug with respect to safety and efficacy and side effects, at least for any individuals whose treatment is part of what has been presented to the FDA in efforts to have the drug approved?

How many years ago did the approval process for Ampligen begin? Is the drug in current Phase 3 trials exactly the same drug that passed Phase 1 and Phase 2 stages? Has the exact same drug been administered to all former patients? For how many years has it been in Phase 3 of the approval process? Has the manufacturing process and/or the necessary raw material for Ampligen production changed at any point since its first administration to humans? Is Ampligen the same drug whether it is sent to clinics in powder, liquid or frozen form?

Why does Heb issue so many press releases concerning a drug not yet approved by the FDA? Do other pharmaceutical companies behave similarly? How many drugs has Heb successfully brought to market? Is there any reason why a pharmaceutical company might want to generate as much press as possible for so many years despite not having approval? Why does Heb hold — and announce — so many patents for unapproved drugs? Is that standard practice in the pharmaceutical industry? Has Heb ever been sued? For what and by whom? What was the outcome in any legal actions?

For what illnesses other than CFIDS/ME has Heb claimed that Ampligen would be an appropriate treatment? What do — or don't — those illnesses have in common? For how many public health risks has the company announced Ampligen as a beneficial agent? Why? Who pays/what does it cost (under each protocol) for Ampligen treatment: for the drug itself, plus administration of infusions, plus the lab tests crucial to monitoring patients before, during and after treatment? Does this vary based on whether or not the patients are part of Phase 3 trials? Who sets the terms of "cost recovery"?

Why are so many press releases regarding the availability and efficacy of Ampligen only issued by CFIDS/ME patients or patient groups? Is that a common practice among pharmaceutical companies? How — and by whom — are participating physicians recruited? How are prospective patients solicited? Who chooses which patients will receive treatment? Have any patients ever been admitted in exchange for helping the company generate publicity aimed at prospective patients, physicians, and investors? Are these processes consistent with other companies' approval processes and/or FDA-dictated laws and regulations?

In June of this year a friend e-mailed me a post from a blog that easily could have been read or written by me when I thought Ampligen was my last and best hope. It reads, in part, "Hemispherx reported that they are taking this seriously. For the first time they have hired a new staff dedicated to the recruiting and approval of new clinics and physicians."

For the first time?

Fourteen years ago we didn't have blogs. Otherwise it feels, to quote Yogi Berra, "Like déjà vu all over again".