My Oral May 2013 CFSAC Testimony

My name is Jeannette B. I am relatively new to the advocacy world and I don’t have all the Washington insider lingo down yet. So, instead of “FDA” or “NIH,” I will probably say “the FDA” or “the NIH.” And since I am new here, let me just quickly explain that I personally cannot bring myself to use the demeaning, dismissive and ridiculing name “CFS” or even worse, “chronic fatigue,” for a disease that robs patients of virtually everything that makes life worth living

There are three reasons for the fact that I am able to be here today and that I am able to be play any role at all in Aimee’s life, my almost 3-year old daughter: 1. Ampligen. 2. My husband, Ed, who insisted that I give Ampligen a try when I was ready to give up. 3. Dr. Dan Peterson.

There are two people in this room whom I could not feel more grateful towards and they are Alaine Perry and Dr. Gailen Marshall. Ms. Perry and Dr. Marshall, you voted “yes” on all four questions regarding the recommendation for the approval of Ampligen during the FDA advisory committee meeting on December 20 of last year. The committee opined that the drug is safe. You were part of a minority on the committee that also found that the drug is effective. Many of those on the committee who weren’t convinced of its efficacy—after a very antagonistic FDA presentation that, among many other things, counted symptoms of the disease and even a pre-existing case of cancer, as side effects, that faulted Ampligen for not being a cure (unlike diabetes, blood pressure, thyroid and other meds, I guess) and that denied the sponsor the opportunity for a rebuttal—felt that there is something there that is worth looking into further. Why are some patients responding to Ampligen and others are not, something that, by the way, can be said for many, if not all, drugs? Clearly, what we have here is a sub-group of patients and I am blessed to be a model responder. Why is nobody interested in digging deeper into this potentially game-changing break and finding out why I respond and a friend of mine does not? All this talk about the government’s commitment to making progress for ME: show us that you mean it! We have a huge piece of the puzzle right in front of us and that piece is Ampligen. Let’s run the course with it. It’s not like there are all these other exciting drugs waiting in the wings that Ampligen would take resources away from.

Are we really going to watch a safe drug that is extremely effective for a sub-group of patients go away forever? We are talking about a drug for a disease that has no other treatment and none on the horizon, for a disease that is gravely disabling. Could this possibly make sense to anybody? I mean really!  Anybody?

Is the sponsor of Ampligen, Hemispherx, the perfect drug company, whatever that means? Maybe not. But does the drug work? Absolutely, for a maybe significant sub-group. And is it safe? You bet! Even the FDA’s own advisory committee said so. So, for crying out loud, FDA, work with the sponsor to get the efficacy information that you wish to see. And since the sponsor doesn’t have the financial resources for a new trial, let’s get the NIH to help finance that trial that will produce that information. Because if you don’t, future suicides are all but guaranteed!

I attended a very impressive FDA Drug Development Meeting for ME last month and I want to express my sincere gratitude to RADM Kweder and her team for a job very well done. But what we need now are concrete results and some tangible progress. I do feel like we made some ever-so-slight progress at the April meeting. The avalanche of epiphany moments being had by the FDA officials trying to take in the patients’ description of the suffering and the symptoms was oddly shocking and gratifying at the same time.

As an Ampligen patient with astonishing results on the drug, it was quite bittersweet to hear the clinical team leader of the FDA division responsible for not approving Ampligen in February of this year, Dr. Theresa Michele, admit, and stress, that she had not previously been aware of the symptoms of ME as clearly as she was as a result of listening to patients’ testimony at the April meeting. I cannot help but wonder if the decision not to approve Ampligen might have differed had there been a clearer understanding of the seriousness of the disease by the FDA before the decision was made. Given that Ampligen is in grave danger of disappearing as a direct result of the denied FDA approval and the resulting very real risk of the sponsor’s bankruptcy, a predicament the FDA is well aware of, it’s almost intolerable to think that thousands or maybe hundreds of thousands of patients could be helped by an existing safe and effective drug had there just been more understanding of the disease.

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10 Responses to My Oral May 2013 CFSAC Testimony

  1. Laurel says:

    Brava, Jeannette! Very well done.

  2. Ihave3kids says:

    I’m so glad you are reaping the results of this treatment. I’m in the UK, so we are even further away from treatments like this 😦 If we were talking percentages with regards to your functioning, what were you pre ampligen and what are you post / with ampligen? Just out of interest x Hope you continue in your path to good health x

    • it’s so hard to put numbers on this. one reason for that is that i have a fairly big range. i can have an excellent day and a pretty bad day. but more importantly, percentages are always hard for me because they are so subjective. what i can say is that my envelope has expanded quite a bit. i am able to take of myself for the most part: grocery shopping, getting mail, doing laundry, making my bed, etc. i can drive 45 minutes to the airport on most days, although i cannot drive 4 hours to the bay area. i am also able to enjoy my time with my daughter more now and have more meaningful interactions with her. i don’t spend all my time on the couch or in bed anymore and i don’t need a wheelchair at the airport anymore all the time (still do sometimes). i rarely park in the handicap parking spot. stuff like that. so, these things are small for normal-health people, but for us, they are huge. so big in fact that i’d happily take ampligen for the rest of my life should that be an option, even though it severely limits me because i need to be here twice a week for the infusions.

  3. Teri says:

    Jeannette that was an awesome testimony, but after watching the two days of FDA talking about a bunch of red tape, I mean its been ten years, I am left feeling hopeless. Their was only a handful of them that were saying “This is unacceptable”.

  4. Pingback: Thoughts on the May 2013 CFSAC Meeting | Thoughts About M.E.

  5. justinreilly says:

    Excellent testimony, both oral and written, as usual. Thank you! And thanks for using ME not CFS.

    • thanks, justin. i used to feel like a nutcase for insisting on “ME” instead of “CFS.” i no longer feel weird about it. i think people who don’t use ME should feel weird.

      what is fascinating to me is how many folks will continue to use “CFS” in a conversation after i explained to them why it’s really offensive. it’s like i never made my points. it’s an odd experience.

  6. Until we are afforded the proper name for our disease, we will get absolutely nowhere! Anytime someone says CFS, we all need to shout back in unison, “It’s M.E.!” We need to organize and focus our efforts on nothing else but changing the name of this miserable disease back to what it was; back to the name that it is still referred to by the WHO.

    When we have accomplished this, the rest will start to fall in line.

  7. Pingback: Drug Juggler (pt II) and CfSAC testimonies for May 2013. | Thinking Love, No Twaddle

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