Bob Miller has been to the Vice President’s office, he’s had one and one meetings with the Director of the NIH, he’s canvassed politicians on the Hill – he’s thrown everything he can into the fight to get this disorder recognition – but this time, the issue – the probable FDA rejection of Ampligen – is too personal, too fraught with ugly implications that he is taking advocacy to a next, very personal level; Bob Miller – longtime ME/CFS patient is going on a hunger strike to emphasize the need for Ampligen approval.
No one who’s experienced this disorder doesn’t recognize the implications this could have for his health but the consequences of inaction could be worse. Bob wouldn’t be where he is without Ampligen; he wouldn’t be able to take care of his boys, he wouldn’t be able to go to Washington to fight for ME/CFS patients, he wouldn’t have anything approaching a normal life; he would be mostly in bed, brain-fogged beyond belief with an cell-phone strapped to his belt, so that for the few times he did venture out, he would have someone to call when he inevitably got lost in his own neighborhood.
Bob’s not an invalid anymore but depending on how the FDA rules, he could be an invalid again and so could Anita Patton, who a year ago was in a wheelchair, and was last seen bouncing around Dr. Klimas conference. (She started Ampligen about a year ago and now she’s at 80%. ) More importantly, you may never get the chance to try a drug that could lift you out of bed, start you exercising again or simply improve the quality of your life.
Let’s make the FDA really think about what they’re doing. Do they really want to deny, very probably forever, patients access to this drug? There are no other ‘Ampligens’ waiting in the wings; kill this drug and it’s probably going to be a long, long wait for another one…
Hunger Strike by Robert Miller, Longtime Chronic Fatigue Syndrome Patient on Ampligen
Contact: Robert Miller 703-554-5575
This week, the FDA is poised to deny the application of the ONLY medication in clinical trials for Chronic Fatigue Syndrome, called Ampligen. Yesterday, I began a Hunger Strike to seek FDA approval of Ampligen, so all CFS patients and their doctors can decide if the medicine works for them. FDA’s decision is due February 2, 2013.
There are NO FDA-approved medications for CFS, and none in the FDA pipeline. Ampligen has been tested safely for 20 years, with more than 95,000 infusions. The FDA Advisory Committee voted in December that Ampligen is safe to market, because the illness is so serious and there is no other treatment.
Last week, I delivered a petition with 3,890 signatures seeking Ampligen’s approval to the FDA and Secretary of Health (http://www.ipetitions.com/
I have been on Ampligen since 1999, and have moved my family twice in those 14 years to access the clinical trial in Reno. If it is denied, about 100 patients and I will lose access to a medication that clearly works for us. Ampligen transforms me from bedridden to being able to care for my twin boys. Importantly, most patients can’t access Ampligen because the FDA has refused to approve it.
Dr. Nancy Klimas, one of the nation’s top expert CFS/ME clinicians, stated in a statement posted on ScienceDaily (http://www.sciencedaily.com/
Last fall, President Obama urged the Secretary of Health and Human Services to “elevate CFS in priority at HHS,” following a promise he made to my wife Courtney at a Reno Town Hall meeting. The first act of the President’s second administration on CFS is the FDA decision on Ampligen.
CFS affects 1 million Americans, costs our government $20 billion annually, and disables approximately 25% of patients, according to peer-reviewed research. FDA’s objections center on the lack of clear biomarkers for the disease and to measure effectiveness of Ampligen. The absence of those biomarkers is the result of negligible research by the National Institutes of Health into the causes and abnormalities of the disease, amounting to a measly $6 million per year.
How Patients can Support Robert’s Effort
Please support access to Ampligen for ALL ME/CFS PATIENTS by sending a note like the one below to the Secretary of Health Kathleen Sebelius, Assistant Secretary of Health Dr. Howard Koh, FDA Commissioner Dr. Margaret Hamburg, and FDA CDER Director Dr. Janet Woodcock and Deputy Director Dr. Sandra Kweder.
Please also email or call your Congressional Representatives and Senators (look them up http://www.
Subject: CFS Patient starts Hunger Strike for approval of Ampligen
“Long-time ME/CFS patient Robert Miller from Reno, Nevada began a hunger strike in advance of the FDA’s Feb. 2nddeadline to decide on Ampligen, the ONLY medication in clinical trials for my illness. I support Mr. Miller, because my life has been stolen by ME/CFS and I need real treatment options. We have waited 20 years, and we can’t wait any longer. The FDA Advisory Committee voted Ampligen is safe enough to market because CFS is so serious and there are NO medications for patients. More than 3,900 people have signed the petition you’ve received. Please don’t let the FDA reject the only medication CFS patients can hope for any time soon.”
I sent my email in as soon as I saw this and it’s worth saying that we should do this immediately, right now, this minute – the FDA decision is expected “around February 2nd” which is of course, this Sunday. The FDA might be making their decision today or tomorrow.
It only takes a minute – less – to send that email.
What a hero Bob is. I hope he’s OK.
Done, keep our fingers crossed. Knowing the FDA just doesn’t care!
Thanks. Lets make them act even if they don’t care :)….I just think they don’t get the picture…This isn’t business as usual…this isn’t a big pharmaceutical company with hundreds of millions of dollars to spend on cancer. This is one small drug company with the only drug ever developed for ME/CFS and if they turn this down…its very likely that drug could go down the drain. I don’t know if they really get that or care about that but they should if they’re really committed to getting drugs out to patients; most of the FDA advisory panel said they felt the data showed the drug was effective for at least a subset of patients – and a rather large subset at that.
I sent emails to my states Senators and House of Representatives demanding that they investigate as to why the FDA would deny the ONLY treatment for CFS. I hope that one million people get involved with this and start demanding that these people get relief!
I did the same. Bob………..please take care (((((((HUGS))))))))))) Cee
I’ve emailed the FDA a few times , and I’ll do it again right now. We all have to support Bob on this bold action he has taken. The time is NOW to do what you can to pressure the powers that be. We are fighting for our lives. I have lost 23 years to this illness. I don’t want to lose 23 more.
If you haven’t signed the petition, if you look on top of the website you can see a link to the petition for Ampligen approval
Bob I admire your stand and all that you are doing to help ME sufferer’s throughout the world – I believe that Ampligen is approved for use in Canada is it approved anywheres else??
Thank you so so much- but please look after yourself.
Here’s something I sent out:
The FDA Advisory Board voted 8-5 that Ampligen was safe enough for conditional approval given the study data and 15 years of clinical data and the chronic fatigue syndrome communities needs. Disability rates are high in this condition and no drugs have been approved for it in its 20 years history and no other drugs for the disorder are under development.
Advisory Committee members were clear that the drug was safe enough even if more study data was needed. They offered a clear path for conditional approval that would provide Hemispherx, a small drug company, the ability to fund further studies. Without conditional approval Ampligen will probably disappear and chronic fatigue syndrome patients will lose their best chance at a drug that helps them.
The chronic fatigue syndrome community needs a chance at this drug. Approximately 4,000 patients have signed a petition stating so and over 750 provided written testimony to the FDA Advisory Board. So many patients watched the proceedings that they crashed the FDA’s servers.
Longtime chronic fatigue patient Bob Miller is currently on a hunger strike to emphasize the need for Ampligen approval for this disorder.
Please conditionally approve Ampligen for this community.
Great stuff – I used that as the text of my own email today.
Okay! I’ve added to the phone calls to NBC requesting they plaster Bob’s Reno newstory of the hunger strike across the country and elsewhere. I’ve placed a couple of signed petitions to the necessary recipients from NIH, FDA, etc. Time is running out and we need to make a huge splash in the water here folks.
If I can do it, you can too. Let’s help and support Bob in every way we can. I will now place a phone call to Bob, just to leave him a message of encouragement if he doesn’t have time to answer calls.
Hang tough Bob Miller. You too Judy! Sending prayers for a positive response…..
Brenda Brown Elliott
Oops! That was supposed to be…hang tough Courtney….
I have lost 20 years of my life to this illness, nearly died, and I feel like Ampligen could be one of my very last hopes. I support you one hundred percent, and admire your courage. That you are now able to be there for your twin boys as a father gives hope to all of us who have lost a strong family connection due to this brutal illness. Please remember all of the faces you are fighting for and stay strong in this cause. Peggy
I am also one of the patients improving on Ampligen in Incline. We are furiously emailing and calling and doing what we can. We are with you, Bob.
Bob, thank you so much for all you’re doing to bring attention to our plight. I greatly admire your courage and creative advocacy for us. Take care as you fast and know you have multitudes behind you.
Thanks again! And thank you, Cort for getting the word out. I sent the email immediately on reading your call to action.
Done! Bob, you are the greatest advocate we could ask for and a brave one, thank you! I really hope your actions help to achieve that much needed approval of Ampligen and make things different in so many ways. It makes too much sense to do so, I really hope the FDA will get that. Take care…
I’ve signed hoping too – apparently safe enough so difficult to see the problem.
Here is the correct link, to a news story about FDA and Ampligen HungerStrike Day 4, scroll down the page a bit until you see me in a thumbnail photo and click on that Block # 1, it is the first story is up, also has Dr. Janet Smith with me. http://www.mynews4.com/content/asseenonnews4/news4at6/default.aspx
When will we know what FDA decides? Monday?
Bob posted this on his Facebook page (kindly reposted by Dreambirdie on Phoenix Rising):
“Patients who are able can call NBC News at 212-664-4444 and comment on the story below. Be sure to tell the person who answers why you are calling, they will put you through to a comment line where you can request for them to plesae cover this important News story Nationally, be sure to tell them where you are calling from.
Many thanks to All who are helping, my wife and I could not do this without your help and support.
THIS IS THE STORY he is referring to: http://www.nbcnews.com/id/50666787
You’re fantastic. We’re all behind you.
I’ve signed the petition; emailed the FDA and HHS; and contacted NBC.
Hope your health isn’t too badly affected.
I just want to thank my friend Penny for making the NBC Reno story possible. I forwarded the link to this page to her and she took it from there, making phone calls, including a call to the Reno affiliate. Perhaps others contacted them as well. I really don’t know, but I obviously forwarded the story to the right person. I HOPE this makes a difference, although I’m not holding my breath. Good luck to Bob! Hope he’s O.K.
you are a HERO!
Good Luck and all the Power to you and your family!
We are from Germany and will help whereever we can!
Thanks, especially to NBC / mynews4 for supporting you, PLEASE HELP and do what you can!
My daughter who suffers from this disease, forwarded this information. Thank you Bob for all you are doing. I have contacted each of my Congressional reps and signed the petition. I have also called NBC News. On what program was this first aired? NBC asks that when you call and I couldn’t find that info here. My daughter is greatly affected by this disorder. She has not been able to work for the past two years and with a husband disabled by Rhuematoid Arthritis and four children, life is a daily struggle for her and her entire family. I am forwarding this info to my contact list who are aware of her situation and asking them to call as well. If you could put something on YouTube that would get the most attention, even more than the news channels, I think. We all must do what ever we can to help. Aloha, Nancy
I am so sorry!
” The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.”
Perhaps you guys will like to pressure the FDA to approve the use of long term antibiotics for the treatment of LYME DISEASE, which is clearly what all (or most of you) have. What are you all thinking of? We are being KILLED!!