In talking with experts and reviewing the drugs that have been approved over the past couple of years, we believe it is our right to ask Congress to hold a hearing to review the denial of Ampligen. Below is a draft letter along with the email addresses where the letter should be sent. It is clear the drug provides benefits and we know that once a drug would be approved other treatments would soon follow.
A Congressional Hearing – to review what can be done to get Ampligen out to the ME/CFS Community
We will be meeting with Congressional leaders on the hill on this request. Please, join us in this campaign.
Robert Miller, Lori Chapo Kroger, Billie Moore, Pat LaRosa, Cort Johnson, Anita Patton
The FDA has found creative ways to get other drugs out to other “medically underserved” patient groups, yet it has chosen not to do so with Ampligen.
Even after the FDA agreed that safety – the key concern at the FDA hearing – is no longer an issue, no movement has been made in making this drug available.
Advocates recently played a key role in having the FDA reverse a similar decision on a multiple sclerosis drug. Please use the letter below to help us call for a Congressional hearing to illuminate how the needs of the ME/CFS community are not being met.
Cort Johnson
The Letter
Please note that the email address belong to congressional staff members (Monica Volante – Rep Pitts, Sarah Curtis – Rep Kennedy, Mark Ratner – Rep. Upton, etc.)
Email to: Monica.volante@mail.house.gov; sarah.curtis@mail.house.gov; Elizabeth.brown@mail.house.gov; dennis.sills@mail.house.gov; mark.ratner@mail.house.gov; james.pauskiewicz@mail.house.gov; brad.grantz@mail.house.gov; thomas.power@mail.house.gov; janet.woodcock@fda.hhs.gov; Margaret.hamburg@fda.hhs.gov; HearUsMECFS@yahoo.com
The Body of the Letter
- To: The Honorable Congressman Joseph Pitts. Chairman, Energy and Commerce, Subcommittee on Health
- To: Representatives Kennedy, Castor, Butterfield, Upton, Burgess, Murphy, Bilirakis
- Cc: Janet.Woodcock, Director, Center for Drug Evaluation and Research
From: _________________________________
Subject: Request for Hearing on ME/CFS treatment denial
I am writing to you on behalf of one million patients in the US and 17 million more worldwide that are disabled and suffering from Myalgic Encephalomeylitis, (poorly identified as Chronic Fatigue Syndrome), ME/CFS. We are writing to request that you conduct a hearing to examine the denial of access to treatment for this disease by the FDA. One drug over the course of 20 + years has demonstrated that it can improve the lives of a significant proportion of the patients suffering from this life-robbing illness, and yet we are still denied access to the drug.
We believe that a hearing and or independent adjudication is the only path to justice. Below are a few of the critical issues that must be addressed:
1) The experts in the field and the FDA advisory panel say it is safe for approval. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research and members of the current Rheumatology Division agreed at a meeting with experts, patients and the drug company that safety was not the issue; but are simply unclear on efficacy.
2) The FDA has stated that this is a serious, life-threatening and complex illness. The FDA has the regulatory authority to provide expanded access via approval with conditions. Experts with decades of experience with the disease and the drug are willing work with the FDA to design the conditional studies. The drug manufacturer has offered to implement an extensive REMS (Risk Evaluation and Mitigation Strategy) program that would educate physicians, patients, and pharmacists on the diagnosing and treating ME/CFS and the safe and appropriate use of the drug.
3) The drug has been used in patients for more than 20 years and over 100,000 doses. Experts agree that they have seen improvement in approximately 40% of the patients using the drug.
4) Seven hundred patients provided testimony at the FDA advisory meeting for this drug’s approval. Four thousand signed a petition requesting the drug be approved. That was in 2012. Patients have been suffering for decades at a cost of $22 billion a year.
5) The small bio-tech company is the only company that recognized the severe nature of this disease has been shuffled through five FDA divisions, with each division applying new and different standards and requirements for approval. After the denial, the FDA lead reviewer admitted at a public meeting she did not understand the disease.
6) FDA’s appeals process is highly flawed. A top regulatory law firm, Hyman Phelps, stated in presentation that any company utilizing this path would require deep pockets and years without necessarily any hope of approval.
7) Currently there are no approved treatments, and it will be years if not decades before any other treatment may be approved. AZT was far from perfect, yet once approved it opened the gate for other drugs for HIV/AIDS; within 9 years 13 drugs were approved. Today AIDS patients live long and fruitful lives. ME/CFS patients cling to a tiny bit of hope.
As a patient that has endured this disease for ___ years, I am willing to take the risks and want the right to choose, with the help of my physician, to use Ampligen. Why are only those who can afford allowed access to it through trial programs? The obesity drugs were approved with conditions, a recently approved Multiple Sclerosis drug has severe sometimes fatal side effects, and a Leukemia drug was just approved with only a Phase II study. Why is my life worth less than those patients’ lives?!
You are our only recourse. The FDA has swept us into a dark closet. We believe the FDA must be brought to the table, and a HEARING would allow for the experts to be heard by a fair and impartial group. We also believe this process will shed light on many other drugs and diseases where FDA is failing to provide public health.
This is America, but not an America we can participate in because of ME/CFS. Please call a hearing and listen to the experts. Give us the chance at the health care we deserve.
This is fantastic! However I’m confused by the list of email addresses vs the typed out names/titles you’ve listed in the To: and Cc: sections. They don’t seem to match up… Can you clarify?
Thanks!
I’m checking up on it!
My Question is , Which Lobby Group is paying off the FDA?
Yes, will send with clarification on addresses. Thank you!!!
I apologize for the problems – I’m trying to get clarification on it.
The email addresses belong to the staff members for the representatives cited – they’re fine to use. Sorry about the confusion.
The addresses are fine – they are to the staff members of the representatives :). Thanks for asking so that it could be cleared up. (I obviously had not sent the letter out yet :))
EMAILS sent! Thanks Cort!
FYI …. I received this message back when I tried to send the email to the following address:
…….. Delivery to the following recipient failed permanently:
james.pauskiewicz@mail.house.gov
Technical details of permanent failure:
Google tried to deliver your message, but it was rejected by the server for the recipient domain mail.house.gov by hydrus.house.gov
I looked it up – it sure looks right to me: this is what I got – james.pauskiewicz@mail.house.gov
Maybe the server just messed up.
I believe his name is spelled Paluskiewicz, When I used this spelling it went through; however, I got an “out of office” reply.
Thanks Tina!
the news of experimental Ampligen info derived from FDA, Ampligen is practically safe to human life.
a Congressional Hearing should be granted.
-Martin Ho
Does anyone know if there is a petition site for this we could direct people to? One of my non-ME friends just asked and I do not have the strength to set one up myself…
Hope. We deserve to have treatment, and we deserve more than $6.00 per year, per person for research. Thanks Cort.
This is great Cort!
I would add that FDA has an accelerated drug approval process as well. Since it was discussed a couple of years ago or longer, nothing has accelerated in approving Ampligen.
One more idea! I think seeing if PWME Jeannette Burmeister(Attorney at Law) might be of interest would help. Especially after she won her FOIA for approximately $150,000.
1. Check into the FDA accelerated drug approval process.
2. See if Jeannette would be interested in helping.
I think the letter is fantastic. I just sent the e-mail. I’m just trying to use all resources available.
What do think Cort? Worth exploring? -Toby
AND if Hemispherx BioPharms’s Ampligen(R) is approved for ME/CFS patients it clears the roadblocks to prescribe it to Ebola patients. US Army scientists just completed a mouse study with control group using a mouse modified Ebola strain and Ampligen(R). Ebola 7-day post infection study cure rate: 100% Study ontrol group mortality: 100% Results published February 2, 2015. http://globenewswire.com/news-release/2015/02/02/702052/10118040/en/Hemispherx-U-S-Army-Scientists-USAMRIID-Find-Ampligen-R-Produces-100-Survival-Rate-in-Ebola-Virus-Rodent-Study.html
And new Ebola cases are showing a first rise in 2015 http://www.bbc.com/news/health-31140987
US FDA Approve Ampligen(R) NOW!
Penny, the sister of an ME sufferer has opened a petition on the White House Gov site also asking for a hearing or removal of FDA roadblocks. The site is https://petitions.whitehouse.gov/…/remove-fda…/NX8yBcps
Same issue as Nita ~ failure to deliver james.pauskiewicz@mail.house.gov Looks like the others went through. I’ll try sending a copy just to James. Thanx for the info & body of the letter. I high-lighted & personalized a bit here & there. Together we “stand” stronger; time to be heard!
I was in a clinical trial for Ampligen in 1999 at UMDNJ (University of Medicine and Dentistry, New Jersey). Several of us were hooked up to IV bags for about three hours, twice a week. While I was in the study, reports came out online of people getting significantly worse on the drug. I remember one woman’s story of her ending up wheelchair bound from the drug. After reading that, I became terrified and dropped out of the study early. Since the internet was relatively new at the time, there was not a lot of info out there about the drug. All I can say is that the woman who wrote her story seemed credible. I have no idea if there was any kind of smear campaign going on against Hemispherx and don’t know what would cause one. I also remember reading that Ampligen was a failed drug for AIDS patients, so they decided to try it on CFS patients. I’m guessing I may have gotten the placebo since it seemed to have no effect on me.
I’m just relating my experience. I have no idea if it’s a good or bad drug. I would sincerely suggest you (or a healthier loved one) do as much research as possible before allowing yourself to get hooked up to an unknown liquid being pumped into your veins.
Like all of us, I was desperate to get well but decided I wasn’t willing to risk becoming worse than I already was/am.
Good luck.
I can’t speak to that person’s experience but that’s certainly not the experience of doctors who have used the drug many times. I don’t think calling it an “unknown” liquid is very accurate. It’s been used for years by well-known and well thought of doctors under a special provision for years and it’s gone through clinical trials. While any drug can have side effects – LDN is touted as side-effect free but I’ve heard many people who started out too high and had side-effects – I would be really cautious about reports that someone ended up in a wheelchair because of it.
Cort I hope this is OK to share here….
My lovely sister put together this petition to get support for removing FDA roadblocks…
Now all of YOU – you lovely people – wherever you are in the world – I need you, people with my illness need you, to go sign this and help us… PLEASE share and sign – thank you.
https://petitions.whitehouse.gov/petition/remove-fda-roadblocks-and-approve-ampligen-use-treating-me-myalgic-encephalomeylitis/NX8yBcps
It’s perfect to share her – thanks 🙂
This is a great additional way to get attention. If we reach the threshold number of signatures within one month, the White House must give a public response.
But since the threshold to getting that response is getting 100,000 by March 7th, it would be very helpful if people could quickly spread this petition to other CFS/ME sites and of course, social media. I only frequent a couple of CFS/ME sites. A public (usually written, but sometimes video) response by the White House on a CFS/ME drug would be invaluable.
Thanks to your lovely sister.
Hi Helen. Please tell your sister “thank you” for putting this petition together. Something odd, though, is I tried searching for the petition (in the petitions.whitehouse.gov website) and it will not come up. I tried using key words such as: Myalgic, Encephalomyelitis (spelled correctly, and incorrectly as Encephalomeylitis as it appears in the petition), Demand, FDA, Ampligen, etc. I looked at the individual petitions under “All Petitions” and under the category of “Health” and it simply does not appear as an “open petition.” This means that only those people who use your link to go to the petition will have access. Or, worse yet, it may mean that your sister’s petition is no longer “open.” Anyway, I just wanted to mention it because it might be good for her, since she created the petition, to check into why it can’t be searched for or found in the “open petitions.” Thanks again. (and I will sign it if it will let me.)
Jenny,
I read through the Petition FAQs and terms, yesterday. White House petitions are only searchable once they reach 150 signatures.
It does need publicizing though.
I wonder if you can add search terms like CFS, etc.
CORT , FOR SEVERAL DAYS NOW , FB HAS “LABELED” YOUR SITE AS A “THREAT ” & UNSAFE WEBSITE .
BUT I DO STILL RECEIVE YOUR E-MAILS .
COULD THAT BE WHY SOME PEOPLE ARE UNABLE TO GET THEIR E-MAILS THRU TO THE DIFFERENT PEOPLE YOU LISTED .
I NOT COMPUTER SAVY ENOUGH TO BE ABLE TO SHARE YOUR LETTER .
BUT I SUPPORT YOU IN SPIRIT .
I just got the same message about your site as being unsafe. I reported to Microsoft that their report is wrong! Are we stepping on Big Bro’s toes again??? I will send the emails.
🙂 – it appears to be linked to two spammers who got onto our new Forums before they were made public (lol). Thanks for reporting that to Microsoft.
Very convincing letter. Thank you for undertaking this campaign. I have a few questions: Aside from Cort, who are the other people driving this campaign? Also, besides the chair of the subcommittee on health, why are we targeting these specific congress people? Maybe, I missed it, but are they the members of the same subcommittee? Are there any other relevant committees?
One small suggestion to this very well-written letter: This important sentence: ” Currently there are no approved treatments, and it will be years if not decades before any other treatment may be approved.” might be stronger if you add in the illness name. ” Currently there are no approved treatments for CFS/ME, and it will be years if not decades before any other treatment may be approved.” What a striking a sad point it is.
An interesting coincidence, the head of the FDA is resigning. It was announced today. She was asked to stay on, but 6 years is a long time in government years. She is trying to frame her legacy, right now. You can read about her efforts to speed up drug approvals and serve under-served and rare illness populations in this article: http://www.nytimes.com/2015/02/06/health/margaret-hamburg-fda-commissioner-stepping-down.html None of those efforts affected the CFS/ME community. Seems like a good time to apply pressure, whether to burnish her legacy or start her successor on the right path.
Good luck!
Okay, but I’ve sent one of those letters before to no avail.
Is it possible to get Ampligen abroad? I have relatives in Ukraine.
my email rejected all the email addresses you put in the letter?
I have no idea why – anyone?
I would second L.’s question regarding why these specific members of the health subcommittee. I noticed that one of the members of the subcommittee not addressed is from my state (though a neighboring district rather than mine) and I plan to CC the email to him.
A little off-topic — but only a little — is the #Cures2015 initiative that Energy and Commerce are pushing right now (see http://energycommerce.house.gov/cures). Yesterday E&C highlighted a great article in the Wall Street Journal (see http://tiny.cc/wdkntx) that noted the exact same issue that we’ve been having with Ampligen where a small proportion of patients respond really really well to a drug but the larger patient population does not. Under current FDA processes, the drug would not get approved. #Cures2015 wants to change this and many other things that would be to our benefit. It may be a good idea to join forces with them (lol – as much as a group of very sick patients are able to be an asset…). I tweeted back to ECcures, Rep Upton and Rep Schrader (from my state) that FDA has failed us too with regard to Ampligen.
Wow. #Cures2015 sounds promising. I hope the CFS/ME community can catch their attention. Rep. Diana DeGette has a good record on health issues. I wonder if it would be worth sending this letter to her and Rep. Upton.
As to the choice of health subcommittee members for this letter, the full committee membership is listed here (you have to click the orange arrow): http://energycommerce.house.gov/subcommittees/health I noticed that the chair is included in the letter, but the ranking member isn’t. Unfortunately, the list doesn’t include emails. Another search required.
Does anyone know what HearUsMECFS@yahoo.com is?
Some of us in the UK would like to add our support, if there’s any way that could be done.
Can I suggest that maybe we send individual personal emails as well, just a paragraph about ourselves prior to the illness. We really need those 100,000 signatures too, any suggestions on that? If you link from the .GOV website to twitter or FB, it takes you directly to the page on ME/CFS, so you don’t have to look for the petition. I think we need constant pressure for the next 25 days or so, constant email, twitter, all social media. I am so not tech savvy, but I am going to see if I can learn to tweet. If Laura Hillenbrand can tweet Angelina Jolie about this petition then maybe we can hit the mark.
Cort, thank you for drafting this letter.
May I suggest to replace the wrong email “james.pauskiewicz@mail.house.gov” which gets rejected by the email “james.paluskiewicz@mail.house.gov” which goes through in your letter draft above?
Why do other advocates like Robert Miller or Jeannette Burmeister, etc not also post this letter on their facebook site or blog sites? I also have not seen it on other CFS sites?
Will we get enough responses if this is only shared on your website?
I also see that the petition
https://petitions.whitehouse.gov/petition/remove-fda-roadblocks-and-approve-ampligen-use-treating-me-myalgic-encephalomeylitis/NX8yBcps
only has 394 signatures. Everybody (whether they like or not like Ampligen) should be interested that this congressional hearing takes place to heighten the awareness.
What could we do that more patients and advocates participate?
I thought I had fixed that link – I will do it again. Thanks – one thing – the committee drafted that nice letter 🙂