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.