As many of you know, the Arthritis Advisory Committee of the FDA will meet in Silver Spring (outside Washington, D.C.) on December 20, 2012 to discuss the new drug application for Ampligen. I am registered to speak at the meeting as are a few other Ampligen patients, although I am quite worried about taking such a strenuous trip right before the holidays, which means not only a harder travel experience with the big number of travelers and the near impossibility to upgrade using miles to make the trip more bearable, but also a very difficult holiday season, as the trip will most definitely set us all back. However, I am grateful for the opportunity to talk to the committee about my experience with the drug and the illness.
This is a tremendous opportunity for our patient population. Ampligen would be the first approved drug for ME. The approval of Ampligen would mean insurance coverage for the drug as well as a much larger number of Ampligen sites. In other words, most patients would gain access to the drug. Currently, there are less than 50 patients receiving this drug due to the high cost and the limited geographic availability.
Maybe more importantly, getting an immune-modulating drug approved for ME would be a game changer. The domino effect would include more government research money, the end of the abuse of patients by the medical and scientific community and the public in general as well as ultimately the availability of other treatments. There are no other drugs even close to approval for ME. At best, we are looking at several years before say Rituxan might be considered for approval for ME. Ampligen will be our best shot at any treatment for the foreseeable future. Not everybody will be a good candidate for, and responder to, Ampligen, but all patients will benefit from the bigger implications an approval would have.
Those of us traveling to the meeting need your support! In making its decision, the committee will consider written comments sent to it by December 6, 2012. I would like to urge everybody–patients, family, friends–to send an email to the committee at email@example.com about the seriousness of ME and how this disease affects you in all aspects of your lives as well as about the need for approved drugs and particularly the need to approve Ampligen NOW.
Patient advocate Bob Miller has drafted a sample email that will help you in the not always easy task for ME patients to draft something coherent. Please feel free to use Bob’s template. After the sample email, I am posting my own comment. You will see that I, too, have borrowed from Bob’s template.
Here is Bob’s sample email:
Email address: AAC@fda.hhs.gov
Subject line: Treatment for Chronic Fatigue Syndrome – Ampligen
To The Advisory Committee Reviewing Ampligen:
My name is ___________________ I have had CFS for more than ___ years. Before I became ill I had a life that was ______________________. My life since having CFS has been____________________________ . We need treatment. We deserve treatment and the ability to access it. Just like AZT for AIDS or Tysabri for MS or Benlystra for Lupus. We are not second class patients. According to CDC studies, CFS is comparable to MS, late-stage AIDS, Lupus, rheumatoid arthritis, heart disease, end-stage renal disease, COPD and the effects of Chemotherapy. CFS/ME effects every moment of my life. We have seen and heard of patients doing well on Ampligen. Give this community Hope by approving Ampligen. We want our lives back.
(Please cc Bob Miller at: firstname.lastname@example.org since he is trying to keep track of how much pressure the patient community has been able to put on the committee and the FDA.)
Here is my own comment to the committee:
To The Advisory Committee Reviewing Ampligen:
My name is Jeannette. I have had CFS for almost 7 years. Before I became sick with CFS, I was practicing California and German law in the competitive environment of the San Francisco Bay Area office of a multi-national law firm with over 4,000 lawyers in 72 offices worldwide.
These days, my life and that of my family revolve around managing my symptoms, which—in light of the lack of any approved drug treatment for this disease—is a much more daunting task than staying on top of multi-billion dollar cross-border legal transactions. Earlier this year, I moved to Incline Village to receive Ampligen, a drug that was not available in the Bay Area because it is not FDA approved, under the care of Dr. Dan Peterson as part of the Ampligen open-label trial. I visit my family in the Bay Area as much as my condition and the semi-weekly infusion schedule allow, usually an average of every 3 weeks for a long weekend. As a direct consequence of the lack of FDA approval for Ampligen, my 2-year old daughter, Aimee—my only child—is growing up without her mother. My husband, who works and takes care of everything our family needs, including making four 235-mile trips to and from Incline Village picking me up and dropping me off every few weeks, is a single parent.
CFS is a serious and life-threatening disease. According to CDC studies, the suffering of CFS patients is comparable to that of AIDS, MS, lupus, rheumatoid arthritis, heart disease, renal failure and COPD patients and patients on chemotherapy.
After 3 decades, we need a treatment and we need it now. We deserve it just like AIDS patients deserved AZT, cancer patients deserved chemotherapy, MS patients deserved Tysarbri and Lupus patients deserved Benlysta. We simply cannot wait any longer. Nor should we have to. The suffering is indescribable. The suicide rate among CFS patients is high because of the intolerable debility this disease causes. It is time to get serious about addressing the suffering of CFS patients.
Luckily, there is a drug, Ampligen, that has proven its efficacy and safety in trials over the last 24 years. Many of the few lucky patients who were able to receive Ampligen, including myself, will tell you that the drug works and that it is safe. The trial data proves that as well.
As important as an effective and safe treatment is, the approval of Ampligen will also—after all these years—provide some hope that is so desperately needed. Without that hope, we will no doubt see more suicides.
You are holding the lives of at least one million patients and that of their families in your hands. There is only one right decision and that is to finally approve Ampligen, which would give every CFS patient access to it. You can make a tremendous difference here. I am begging you: Make the only right choice by recommending the approval of Ampligen. Give patients their lives back! Give my daughter her mother and my husband his wife back!
Jeannette, Incline Village, NV
PS: I don’t normally use the term “CFS.” However, I felt that this is not the time to fight the name-change fight and I am not sure how familiar the committee is with the name “ME.” I didn’t want to risk my points getting lost by confusing the committee members about the name.
Thank you for this moving testimony, Jeannette! You are very brave to speak about such personal pain of your life and the struggles for your husband and daughter. Thank you for speaking out on behalf of all of us and for the courage that you show. I so admire your strength! love ya, anita!
thank you, anita! if i seem strong, it’s this patient community, and particularly people like you, that make me so.
love you, too!
Poignant and salient comments, Jeanette. It’s time the FDA heard our voices!
i so hope they will hear us!
You are such a brave advocate, Jeannette! xo
thanks, luanne! there are many in the community who have done a lot more than me. but i try to do what i can. one day at a time.
thanks for continuing to support me!
(and thanks for not commenting that this was not brilliant writing 😉 i had a deadline on a bad day. so, just got the job done.)
The Ampiligen approval issue has just gotten even more pressing because today, the Norwegian Medical Research Council has decided not to fund a bigger, multi-center Rituxan trial (double-bind, placebo-controlled trial with 140 patients) for ME in Norway. Approval of Rituxan for ME has just gotten a lot more elusive and it was years away as it was because there are no current trials under way and those take typically years.
Ampligen is our only chance at this point if we don’t want to lose more years, maybe decades.
My husband’s comment:
To The Advisory Committee Reviewing Ampligen:
My wife, Jeannette, has suffered with CFS for the last seven years. Before that, she was a highly functioning lawyer at a prominent international law firm. Her dreams of becoming a partner and continuing her promising career came to a crashing halt when she became unable to sustain a schedule at even 50% or 25% of normal. In fact, on many days, she has been unable to do any productive work.
I want to emphasize the hopelessness of this situation for a young person (Jeannette was 34 years old when she became ill) with family and career dreams and expectations. As we explored treatment options, we were shocked to find that there were no approved drugs to treat this disease and Jeannette was simply left to suffer its debilitating effects. We were able to have a child against all odds. Our daughter, Aimee, is now two years old. I am her primary caregiver along with our nanny whom we are so very lucky to be able to afford.
In April of this year, Jeannette became one of the fortunate few to be able to be treated by Dr. Dan Peterson in Incline Village, NV and to receive Ampligen as part of an open label trial. This is the first hope we have had in the last seven years for some degree of relief of her symptoms and the prospect of our family to be able to lead a more normal life. To underscore the importance of receiving Ampligen, you should know that we are suffering a separation. Jeannette receives infusions twice per week in Incline Village, which necessitates her living there, while Aimee and I live 235 miles away in the San Francisco Bay Area. We are only able to get together as a family every few weeks when I drive to Incline Village, pick up Jeannette and bring her home to be with Aimee and me for a few days. Those of you who are parents might be able to relate to the agony of a mother who is forced to be away from her young daughter almost all of the time.
Jeannette has suffered no significant side effects from the Ampligen treatment over the last seven months and is beginning to experience improvements in her condition. As the Ampligen trials have shown, it takes several months for the drug to have therapeutic effect, so we are optimistic that Jeannette will show more significant improvement over time.
The lack of FDA approval for Ampligen means that the vast majority of patients do not have access to the drug because the experimental status of Ampligen and the necessity to relocate to one of the few Ampligen locations put the drug financially out of reach for most patients, many of whom would benefit from it.
The important decision to approve Ampligen rests in the hands of the FDA and your recommendation to grant the approval will be a pivotal step in that approval process. I can’t tell you what the approval will mean to our family and the many, many CFS sufferers who currently have no other hope for treatment.
Menlo Park, CA
I wanted you to know that I did send an email to the FDA today. I am so proud of you for making the trip to testify….I know how difficult this will be for you.
I am in a horrible crash right now…..worst ever, The pain is excruciating and my head is pounding. I do not realistically think I will be able to relocate to Incline for treatment; my only hope is that the drug will be approved and I can obtain it here in Houston.
Good luck to you on your trip….I look forward to hearing all about it. Ampligen must be doing you some good for you to be able to make such a strenuous trip. Gosh, it takes so long….7 months to get this far. Please take good care of yourself; I would hate for this to set you back.
My best as always, Gretchen
Sent from my iPad.
thank you so much for sending that email. i know it can seem at times like all of our efforts are fruitless, but we never know when something will make a difference.
i am so very sorry to hear about your crash. it is so incredibly difficult to go through this. for you and all the other patients who would like to try ampligen, i hope that the advisory committee and the FDA will make the right decision and finally approve this drug. having had a good 8 days in a row now (with one day that wasn’t so great, but still an incredible streak), it kills me to know that others, too, could benefit from this medication as much as I have–if it was only available to them. yes, it does take a while to work and it’s not a cure and it tethers you to an IV, but it’s so worth it. i tell myself: what else would i have done in those 7 months? it’s been very hard on my family, but we have no regrets. getting on ampligen was the right move, eve though i had my doubts for a long time.
i hope you will come out of this hole very soon.
Good for you, Jeanette! An excellent statement by you and by your spouse to the Advisory Committee. If you two can’t convince them, who can?
I hope this all works and the FDA approves this drug. And if they do, I hope it’s available to Medicare and Medicaid clients, as well as those privately insured.
For some reason I’ve been in a semi-relapse state this week, but staying home with TV on, reading mysteries with food delivered is my very frequent scenario. Thankfully, I live in New York, where this is possible.
I sent in one of those letters with some of my own personal limitations listed.
Hope this all works. Thanks for your and Ed’s contributions to this important effort.
hey kathy, there are no guarantees re insurance and medicare/medicaid coverage, but the way this usually works is that experimental drugs are excluded from coverage and approved drugs get at last some (if not full) coverage. so, i am hopeful for that.
thanks for sending a note to the committee! if the drug gets approved, it will be very gratifying for all of us who did.
i am sorry to hear about your relapse. always hard to deal with, especially emotionally. i am having a mini crash right now. not surprising given how much i’ve been doing recently.
talk to you soon!