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Ask Secretary Sebelius to start NIH Clinical Trial of Ampligen
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Contact: Robert Miller 703-554-5575, Courtney Miller 631-834-4681
A noticeably thinner Bob Miller in the 8th day of his hunger strike to approve Ampligen urges patients to act
In day 8 of his hunger strike, Chronic Fatigue Syndrome patient Robert Miller decried the FDA’s decision (announced hours ago) to disapprove Ampligen, the only medication in clinical trial for him and a million ill Americans. Mr. Miller is asking Secretary of Health Kathleen Sebelius to conduct clinical trials of Ampligen at the National Institutes of Health.
Because there is NO FDA-approved medication for CFS, and none in the pipeline, FDA’s denial forecloses any potential of an approved medicine for patients for years to come. Given the serious, life-threatening nature of CFS, as acknowledged by FDA, this denial creates an obligation for the Department of Health and Human Services and NIH to fill the 25-year void in drug development.
Dr. Nancy Klimas, one of the nation’s top CFS clinicians, stated in a statement (http://bit.ly/VHmIdM ) “The data shows that a subgroup of CFS/ME patients showed marked improvement, even recovery on the drug.” Until last year, Dr. Klimas was a member of the Secretary of Health’s Chronic Fatigue Syndrome Advisory Committee.
Miller has been on Ampligen since 1999, and moved his family twice in 14 years to access the clinical trial.
“Now the 100 or so patients on Ampligen like me risk losing the only treatment that clearly works for us. Ampligen transforms me from bedridden to being able to care for my twin boys.”
NIH promotes its ability to conduct clinical trials, and it has proudly launched the National Center for Translational Science to “bridge basic science and human medicine” and accelerate the process for developing therapeutics. “It is the perfect place to pursue larger clinical trials of Ampligen to understand how to identify responders and learn from the mechanism of the drug on patients’ immune systems. Imagine what we could learn,” said Miller.
Cleve Jones, founder of the AIDS Quilt, noted:
“CFS patients suffer without any treatments, and I can remember those days in my life. I urge Secretary Sebelius to apply what we learned with HIV about getting treatments to untreated patients like every minute counts.”
Anita’s Patton’s energy is at 80%; last time this year, before she went on Ampligen, she was in a wheelchair.
Anita Patton, a CFS patient who has been on and off Ampligen at different times over 15 years, was outraged. Last year, Patton was in a wheelchair, unable to prepare her own meals.
“After a year of Ampligen, I have my life back. I was there at the December hearing, where the FDA staff listened to my story and turned to the Advisory Panel and said Ampligen doesn’t work.”
Thousands petitioned FDA for Ampligen’s approval.
Last fall, President Obama urged Secretary Sebelius 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 to reject this only medicine.
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 to measure effectiveness of Ampligen. The absence of those biomarkers is the result of negligible research by the NIH into abnormalities of the disease, amounting to a measly $6 million per year.
Email your federal officials asking them to start an NIH trial for Ampligen: margaret.hamburg@fda.hhs.gov, howard.koh@hhs.gov, jarrettpublic@who.eop.gov, Kathleen.Sebelius@hhs.gov
Patients, please call your NBC affiliate to ask them to pick up the Reno KRNV story http://www.mynews4.com/news/local/story/FDA-denies-drug-for-Chronic-Fatigue-Syndrome/SboLsPYRqkekVYQN8cCfsQ.cspxt
- TV news story can be seen here http://bit.ly/XzvFVQ
- Dr. Klimas’ statement in ScienceDaily, http://bit.ly/VHmIdM
- Ampligen Approval News Center – contains links to blogs, testimonials, video’s
- Patient videos online at Facebook page: Hunger Strike for Ampligen Approval for CFS
Will provide contacts who are Expert Clinicians in CFS, and Additional Patients
Thanks for the update and concise summary of the whole situation. The decision was a heart-breaker. My thoughts go out to Bob and his whole family.
The links to the resources are just incredible. It’s coming along very nicely there, Cort. This is turning out to be a really great site to get all the news in one place. Knowing you, I would expect nothing less :).
That means alot coming from you Polly. Thanks for all your help in the past. Hope you’re doing well.
Thanks for this, Bob – you are amazing. Please take good care of yourself and if you need to stop, stop.
Can I just ask – are you wanting people to email the federal contacts daily, or just once?
I will put out the call on Phoenix Rising and I’d like to be able to give that info.
Thanks for your sharing, it’s a good post, keep going and support you.
Cort, the email addresses for the federal officials are hard to copy and paste because they show as ‘[email protected]’ on my screen, at least – though it’s possible to cut and paste them individually if you hover your mouse over them. Something is a bit weird with Kathleen Sibelius’s at the end! An extra bit has found its way in.
Bob, on your previous email actions you’ve wanted your own email cc’ed in, presumably to monitor the level of response – do you want that now?
I’m sorry to be pummelling you with these questions – I hope you have someone who can post the answers for you if you’re too tired. Don’t bother about it if you don’t think it’s important.
Emailing them daily has them flustered…I would alter between emailing the agencies and you home state Representatives. Remember it makes no difference if you are a Dem. or a Republican, contact those who represent your state, we are contacting Both as they represent the state of Nevada and I am a resident. So keep emailing and call if you can. FDA stated they are getting thousands of emails…If your state Rep. gets a hundred that is overwhelming to them.
Thanks to All,
Bob
Thanks, Bob – I’ve posted that on PR.
I didn’t see a form email for people to send so I drafted up the one below in case anyone is too brain-fogged to come up with their own thing. I’ve posted this on Phoenix Rising also, with a link to this page on Cort’s blog and a request for people to contact their TV stations.
Bob, if there’s something else you’d rather people use, please PM me on Phoenix Rising or post on that thread at http://forums.phoenixrising.me/index.php?threads/bob-miller-calls-for-nih-trial-for-ampligen-email-to-support-his-ongoing-hunger-strike.21699/ and I’ll change it.
To: margaret.hamburg@fda.hhs.gov, howard.koh@hhs.gov, jarrettpublic@who.eop.gov, Kathleen.Sebelius@hhs.gov
Subject: ME/CFS patient on hunger strike for NIH trial of Ampligen
Message:
Long-time ME/CFS patient Robert Miller from Reno, Nevada began a hunger strike on 29 February to show patients’ desperation for the FDA to approve Ampligen for use in ME/CFS.
The FDA disapproved the drug and Mr Miller continues his hunger strike, requesting that the NIH conduct a clinical trial into Ampligen.
I support Mr Miller. The NIH spends only $6 million a year on ME/CFS while the disease affects 1 million Americans, costs the US government $20 billion a year and disables 25% of those whom it afflicts.
I want my life back, just as many of those on Ampligen have had their lives back. Many of us have been sick for decades and we can’t wait any longer. Please start an NIH trial of Ampligen and give us a future.
Your Full Name Here:
Address Here:
Years ill:
Hi Sasha,
you should add Bob’s E-Mail adress for this action!
Otherwise only the government knows how much support is behind him.
Good Luck
Please add 511bobmiller42@gmail.com to keep track, my wife can help with that.
Thanks charly and Sasha
Thanks Bob – we’ve published an article on your campaign today and I’ve added that in the comments. It may take a while to get the article itself updated.
I have a comment awaiting moderation that is a draft email for people to use to email their federal officials and someone kindly pointed out to me just now that in the first para it should say “29 January” not “29 February” that Bob began his hunger strike – I’d be grateful if someone could edit that!
Argh, brain…
I cannot navigate mass confusion. I come here and find a bottom line, one I can trust. I like all my info worth knowing, concise and in one place. Looks like too many cooks in the kitchen to me. When there is an official email consensus, let me/us know..here on Health Rising, not on PRising. Thanks.
kathleen.sebelius@hhs.gov; margaret.hamburg@fda.hhs.gov; janet.woodcock@fda.hhs.gov; sandra.kweder@fda.hhs.gov; howard.koh@hhs.gov; bobmiller42@gmail.com
“I urge you to start an NIH clinical trial for Ampligen for CFIDS patients. We are suffering, but orphaned, sent to die in back rooms unable to find even symptom ameliorating treatment options. Please make CFIDS a priority.”
The above are the addy’s I used, along with my text sent in the email. Ok? lol
Just emailed them all requesting a clinical trial, lol. Not that I will ever benefit. Old now. Poverty sticken, bedridden, alone and dammmmmmmmm sick; just lost Medicaid to a $38 increase in income lolol.
sandra.kweder and kathleen.sebelius sent me auto-replies within a split second, lol.
kathleen.sebelius@ hhs.gov; margaret.hamburg@ fda.hhs.gov; janet.woodcock@ fda.hhs.gov; sandra.kweder@ fda.hhs.gov; howard.koh@ hhs.gov; bobmiller42 @gmail.com
jst checking to see if a space after the @ sign in each addy will let them display
Hi Deborah Ann – it’s not my intention to cause confusion and I’m sorry if my posts have done that. I’m very keen to promote Bob’s campaign and I’m aware that many people with ME find it difficult to write emails of their own, which is why I produced that draft.
This is a time-sensitive campaign – Bob has already asked us to email and every hour that we delay and the federal officials don’t hear from us is another hour of Bob having to endure his hunger strike.
I hesitated to post a template email because I agree it would be much better if one was written or approved by Bob. I weighed that against the other factors and decided that the most helpful thing would be to post.
I’m assuming that Bob would naturally post about that here on Health Rising. As I said, he’s welcome to also post or contact me on Phoenix Rising – I’m monitoring Health Rising as best I can but I’m on the other side of the world in a different time zone and may be slow to see it.
my sincere apologies , sasha for watever ‘n everything I may have done, lol…I am extremely ill, cant sit up, texting with one finger, going blind, living in total isolation with no hope for change…time is up for me…no clinical trial for me…no nothing for me…I do well to get groceries, keep the net…never meant to be rude…its just that being alive isnt working for me just yet …I really do appreciate your efforts
No worries, Deborah Ann, we’re all on the same side here and it gets frustrating sometimes! I’m really sorry that you’re so very ill. I hope one day we’ll all get decent medical treatment.
Thanks for sorting the addresses out into a copyable format and for posting that link to find your representative – good stuff.
Just had this from Bob:
Sasha, Thank you. We are working hard here, but as you can understand my abilities are faltering and my wife is running on empty. I would ask All to call their Reps. and call Assistant Secretary Koh at 202-690-7694 it is a direct line in. Tell Assistant Sec. Koh to ask Sec. of Health Sebelius it is time for her to get involved.
Thank you All for the support and Help. Sasha please post this info on Health Rising.
Kindly,
Bob Miller
ty Bob, bunches…take care of yourself, please
find your rep contact info here @ http://www.house.gov/representatives/find/ ( by zip code ) easy stuff
By the way, the message from Bob involved him first quoting my draft email so I’m assuming that the ‘thanks’ there was an indirect OK for the email text if anyone wants to use it.
Good to write your own email if you have energy but the main thing is to just email those people, and to phone Assistant Sec. Koh as Bob is now asking.
already emailed; even posted it here a minute ago, lol.. but its hung up in the server or in some other limbo, lolol ( I sometimes get a ‘dupicate’ error message when posting here, but no worries…Cort’s ‘the man’, lol , ‘n will sort it out; always does )
Done, as all the other mails. Let’s hope the NIH is willing to listen and do what they should have done ages ago….
I have sent an email to Kathleen Sebelius, with copies to Dr. Koh, Dr. Hamburg and Ms. Jarret, urging the initiation of clinical trials for Ampligen through the National Institutes of Health. I have also requested that patients with CFS/ME who have been taking Ampligen and have documented improvement in their symptoms be allowed to continue taking Ampligen.
I became ill with CFS/ME in 1990. This issue matters to me. Perhaps one day I will be given the opportunity to try Ampligen.
Bob, you are in my prayers. Take good care.
Best wishes,
Barbara Dyke
I every time emailed this webpage post page to all my friends, since if like to read it then my links will
too.