Accelerating Treatments For ME/CFS: A Call to Action for the FDA

April 23, 2012

Posted by Cort Johnson

For decades, ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) has devastated the lives of patients and our loved ones, leaving us with an alarmingly low quality of life. Today, ME/CFS affects the lives of more than 1 million Americans of both sexes and all ages at an annual cost of at least $21 billion in direct costs and lost productivity.

As patients and loved ones, we have suffered too long with too little research, a disbelieving medical community and no approved drug treatment specifically for ME/CFS.

This has to change!  We know that we need many things, such as more money for research. But right now, an important branch of the FDA is up for reauthorization and legislation is being put forth to accelerate drugs for chronic illnesses. We want to capitalize on this opportunity by calling on the FDA to hold a Stakeholder meeting to discuss approval of ME/CFS treatments.

Stakeholders Meeting –  FDA officials have stated they’re committed to bringing stakeholders together to overcome the challenges drugs face.  

 FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges.”  Dr. Hamburg, Commissioner of the FDA

 We request they honor that commitment and hold a stakeholder’s meeting to find an expedited path forward for drugs for chronic fatigue syndrome. The FDA has a process called ‘accelerated approval’ which allows companies to market drugs for serious illnesses with unmet needs which have proven to be safe before all their effectiveness data is in. We believe drugs under consideration by the FDA for ME/CFS should be given this status. 

A Special Case – Chronic fatigue syndrome is probably the only large disorder in the US without a single medical treatment approved for it. Dr. Woodcock at the FDA has said she is committed to examining treatments for the chronically ill where few or no treatments exist.

Benlystra’s recent approval for lupus may lend some hope. The first drug approved for the disease in over 50 years, Benlystra failed to significantly surpass the effects of placebo after 76 weeks in a clinical study and only 35% of the study participants responded, yet the FDA, citing the lack of treatment options and the effectiveness of the drug in a subset of patients, gave it the go ahead. Ampligen, the only drug currently under review at the FDA, has been shown to be effective (see PlosOne study) and hundreds of patients over the past ten years have shown that its safe.

We need the FDA to hear from as many people as possible to ensure that the Stakeholder meeting happens. Please write and/or call before May 2, 2012 to request the stakeholder meeting. Please ask your families and friends to send letters on your behalf. And please use Facebook, Twitter, etc. to get the word out for ACTION NOW!

A Template for the letter along with Email addresses and other details are below.

Instructions for the email

 

1.  Use the attached template for the letter to Secretary Sebelius/Dr. Hamburg

We ask that you follow this template as closely as possible as that will strengthen our request.

Personalizing the email: The template has space for you to add 2-3 brief sentences about your personal story or information at the end of the second paragraph.

a. Simply replace the personal story in the template with your own story, adding details like how long you have been ill and how ME/CFS has affected your life, work, finances, etc,

If you do add a personal story, please try to keep the overall email length to less than 1 page because it will be more likely to be read. If you want to go more in-depth with personal stories, we ask that you send a separate email as a follow-up after our action is done.

b. If you do not wish to personalize, just remove the personal story from your letter.

Sending the letter:When your letter is ready:

a. Cut and paste your letter directly into the body of your email. Please do not attach as a separate document as it may not get through email systems and is less likely to be read.

b. Add the email addresses by cutting and pasting the following list of emails directly into the “To” box. The one email message will go to all addressees at one time.

2. Email addresses

Kathleen.Sebelius@hhs.gov ,  margaret.hamburg@fda.hhs.gov,  janet.woodcock@fda.hhs.gov , Nancy.Lee@hhs.gov ,  howard.koh@hhs.gov , brian_ahlberg@harkin.senate.gov, Alex_Stern@mikulski.senate.govjeff.carroll@mail.house.govmonica.volante@mail.house.gov ,   Annie_Walden-Newman@murray.senate.gov , mecfsaction@yahoo.com     

The following addresses are included as the contacts for the corresponding legislative leader

Senator Mikulski (Alex_Stern@mikulski.senate.gov), Congressman Pallone (jeff.carroll@mail.house.gov), Congressman Pitts (monica.volante@mail.house.gov), Senator Murray (Annie_Walden-Newman@murray.senate.gov)

The Mecfsaction@yahoo.com address is included to allow us to track the number of letters sent.

3.  Contact your senator or congressman

You may wish to send a letter (or forward this one) to your senator or congressman as well, especially if they are involved in the Health, Education, Labor and Pension Committee or on the House Appropriations Committee, which has a subcommittee for Health.

If you do not have an email address for your senator or congressman, you can use the following links to access the contact forms for those from your state.

Senators – http://www.senate.gov/general/contact_information/senators_cfm.cfm

Congressmen – https://writerep.house.gov/writerep/welcome.shtml

These representative sit on committees that are particularly influential:

EMAIL TEMPLATE:    One Email sent to those listed below 

 

From: John Smith                                                                                                      May  , 2012

To:      Secretary Kathleen Sebelius, Department of Health and Human Services

Dr. Margaret Hamburg, FDA Commissioner

Cc:      Dr. Janet Woodcock, Office of New Drugs, FDA, Dr. Nancy Lee, Director Office of Women’s Health, Dr. Howard Koh, Assistant Secretary of Health, Chairman Tom Harkin, Health, Education, Labor, and Pensions, Senator Barbara Mikulski (D-MD), Senator Patty Murray (D-WA), Congressman Frank Pallone (D-NJ), Congressman Joseph Pitts (R-PA),

Subject: Chronic Fatigue Syndrome: Request for Stakeholder Meeting

——————————————————————————————————————–

I am John Smith and I write to you to request that the FDA hold a Stakeholder meeting to discuss treatments opportunities for Chronic Fatigue Syndrome (also called Myalgic Encephalomyelitis or ME/CFS), a debilitating disease that affects more than one million Americans of both sexes and all ages.

For decades, ME/CFS has obliterated the lives of patients and their families, leaving them with a pitiful quality of life, no hope of treatment and a medical community ill prepared to care for them. Compounding the personal devastation is the effect on our country’s economic well-being; ME/CFS drains our workforce and costs our economy more than $21 billion annually. In spite of all this, little has been done to address our situation. My son is one of those millions with ME/CFS who have been left to rot. His life was cut down by ME/CFS at age 22 and if nothing changes, he will be very sick for the rest of his life, never able to work and more likely to die prematurely.

I am aware of the FDA’s role in “assessing the benefit-risk of new drugs on a case by case basis” and in “shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges”.  Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over a decade.

ME/CFS demands real and significant action today. I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.

Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.

As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen to advance science for all ME/CFS patients!

Sincerely,

John Smith

Waterford, Ct 06385

860-123-4567

 


 

 

18 comments

{ 18 comments… read them below or add one }

Brenda Elliott April 24, 2012 at 4:15 pm

From: John Smith May 2, 2012

To: Secretary Kathleen Sebelius, Department of Health and Human Services

Dr. Margaret Hamburg, FDA Commissioner

Cc: Dr. Janet Woodcock, Office of New Drugs, FDA, Dr. Nancy Lee, Director Office of Women’s Health, Dr. Howard Koh, Assistant Secretary of Health, Chairman Tom Harkin, Health, Education, Labor, and Pensions, Senator Barbara Mikulski (D-MD), Senator Patty Murray (D-WA), Congressman Frank Pallone (D-NJ), Congressman Joseph Pitts (R-PA),

Subject: Chronic Fatigue Syndrome: Request for Stakeholder Meeting

——————————————————————————————————————–

I am JBrenda Lee Brown Elliott and I write to you to request that the FDA hold a Stakeholder meeting to discuss treatments opportunities for Chronic Fatigue Syndrome (also called Myalgic Encephalomyelitis or ME/CFS), a debilitating disease that affects more than one million Americans of both sexes and all ages.

For decades, ME/CFS has obliterated the lives of patients and their families, leaving them with a pitiful quality of life, no hope of treatment and a medical community ill prepared to care for them. Compounding the personal devastation is the effect on our country’s economic well-being; ME/CFS drains our workforce and costs our economy more than $21 billion annually. In spite of all this, little has been done to address our situation. My son is one of those millions with ME/CFS who have been left to rot. His life was cut down by ME/CFS at age 22 and if nothing changes, he will be very sick for the rest of his life, never able to work and more likely to die prematurely.

I am aware of the FDA’s role in “assessing the benefit-risk of new drugs on a case by case basis” and in “shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges”. Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over a decade.

ME/CFS demands real and significant action today. I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.

Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.

As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen to advance science for all ME/CFS patients!

I have lived with ME/CFS for nearly eight years. I was denied SSDI after three additional appeals as the judicial judge from Mpls, MN named Roger Thomas had never approved any case through my legal representation of CFS or Fibromyalgia. I was forced to live on $203 mthly for several years through social services. You cannot imagine how degrading, humiliating and pitiful it is to be treated like white trash by my own government. This illness needs immediate response with approval being given, for at least the ampligen, to begin some sort of healing process here. I am now married to a Christian man who loves me despite my inability to bring in any income and provides me with caregiving that I lived without for seven (7) years alone. We need your help, your recognition, your care and concern.

Sincerely,

Brenda Elliott

Blomkest, MN 56216

Reply

Cort April 24, 2012 at 4:50 pm

Wonderful Brenda – what a time you’ve been through.

A call went out earlier and Bob told me he’s already gotten a response from someone at the NIH. This is a big deal for CFS. Ampligen has been under-review there for over a decade and its been moved around to five different sections as the FDA has tried to figure out what to do with CFS. We need the FDA to get together with the stakeholders, chart out a path for ME/CFS drugs that get them to the patients as quickly as possible. The FDA says they are willing to do that for disorders with unmet needs and with regards the FDA – NONE of the ME/CFS’s have been met; there is not one drug or other approved treatment option…The FDA should recognize that CFS is a priority and do everything it can to get drugs to patients..

Rituximab or another drug like it – if the next study results are good – may be next….(We should note that the NIH states its a partner for drug approval – not an overlord – and they should be engaged in the beginning to find ways that Rituximab like drugs can be quickly studied, and if found to be safe – given accelerated approval. That gets the drugs out to patients and allows companies to raise money for larger effectiveness trials.

The CAA’s Biovista project may very well uncover a suite of drugs that never been tried in ME/CFS. If its does getting the FDA on board now should speed things up there as well.

Reply

Brenda Elliott April 25, 2012 at 2:26 pm

Thank you for your response Cort. Thank goodness for computers and the internet these days. Just think of how much more time something like this would have taken back when. I am more than happy to advocate for all CFSers with letters to our politicians/researchers/national health agencies, etc. I have been blessed with much improved symptoms in these past couple of years compared to when I spent weeks at a time bedridden. Having positive events in our lives, as I did in meeting my new husband, can have a great positive effect on our symptoms. If you can use me in any volunteer work for Phoenix Rising that involves using the computer, please feel free to contact me. My organizational skills are lacking as most of us experience. I will be seeing a neuropsychologist in one month for a six hour appt. to see what’s going on in this brain of mine regarding my cognitive impairment. I will, however, do anything I can to improve our lives.

Brenda

Reply

BobM April 24, 2012 at 9:40 pm

Brenda,

Thank you for writing your email letter, it did not send properly, so I have forwarded it. I am sorry for what you have endured. I am glad to know you have someone now in you life. Wishing you both peace, health and happiness.

Better Health to You,

Bob Miller

Reply

Brenda Elliott April 25, 2012 at 2:40 pm

Bob,

I genuine thanks for resending my email letter to Senator Harkin. Without each of us doing all we can to make a difference, those who have no means of bringing recognition to this effort will suffer the most.

Thank you for your kind words. Much of my positive attitude also comes from becoming a born-again Christian, something that has worked immensely for me. I don’t know that I can truly remember what it is like to not feel pain and/or fatigue each and every day. A stretch of the imagination is necessary indeed. However, we must not ever give up hope, right?

Bless you Bob Miller!

Reply

Cort April 25, 2012 at 3:03 pm

Where ever these events occur you find Bob at the heart of them…His wife has spoken to the President (that’s THE president), he managed to speak to the Vice President, he snagged a meeting with the head of the NIH….if we had about 10 more Bob’s I think we’d be in really good shape :)

Brenda Elliott April 25, 2012 at 4:24 pm

Hi again Bob,

I’ve sent the same letter to my Minnesota Senator, Al Franken, whose term will not be ending until 2015. In the letter written by you that I used along with my own words, you stated that you would be contacting those we’ve notified in two weeks about the meeting. I went directly to his website to send the email. On his website there is an opportunity to set up a time to meet in person with him to discuss whatever our needs are.

I wanted to notify you of my contacting him. Will you automatically be contacting him in two weeks? Would you suggest I try setting up an appt. to discuss the needs of CFSers? Should I be contacting Cort about this question as well? Will await your response…Thanks in advance…

Brenda Elliott

Reply

BobM April 26, 2012 at 3:08 pm

Brenda,

As Senator Franken is your state representative you should attempt to set a meeting with him. You will most likely get his health staffer, which is fine as the staffers do all the leg work anyway. The representatives we have contacted directly sit on an oversight committee that can help direct FDA to do the Stakeholder meeting. If you get a meeting set the main ask of your Senator is to support our request for the Stakeholder meeting.

Much Appreciation for your time and effort to help,

Bob Miller

BobM April 24, 2012 at 9:51 pm

Cort and anyone sending an email Letter,

Tom Harkin email address is supposed to be To: brian_ahlberg@harkin.senate.gov
as Senator Harkins email will not process. If you could change that in the Template that would be great.

Bob

Reply

Sarah Robinson April 25, 2012 at 7:15 am

Thanks, BobM, for clearing up Sen Harkin’s office email address. Mine came back too, and his web site doesn’t make it easy to figure out how to get a message through to him. I’ll re-send it now. Many thanks to all advocates who are keeping up with what we can do to try to change the pathetic political status quo!

Sarah

Reply

Cort April 25, 2012 at 7:32 am

I think everybody might want to consider one more thing…I looked at published treatment trials for the first part of this year; 6 CBT/GET type trials and one none CBT/GET trial (Ampligen)…. CBT has an astonishing hold on treatment trials in CFS that appears to getting stronger over time…

Getting drugs for CFS accelerated approval means giving Ampligen a chance – and giving drug companies the incentive to create similar drugs. Ampligen and its effects would boost research and Hemispherx would have the money to complete the studies the FDA wants…(It doesn’t have the $)

Reply

Sarah Robinson April 25, 2012 at 8:09 am

I don’t know how it can be done, but I’d like for our govenment officials to hear the message: No More CBT/GET trials. None! CBT has been around since Albert Ellis invented it in the 1950s. It does not cure physical diseases.

Would it be appropriate to append such a message to the ones being sent now about having the stakeholder’s meeting? Or would it be better to wait until the meeting happens (ah, optimism) to bring this up?

Sarah

Reply

Cort April 25, 2012 at 8:54 am

I think it would probably be better to wait because most govt officials don’t know anything about CBT etc – best to focus on the need for a stakeholders meetings so that drugs can get to the many people who need them as quickly as possible. I think we have a really good case to make – no approved treatments and alot of sick people = FDA doing everything they can to get treatments to them.

Reply

BobM April 26, 2012 at 3:15 pm

Cort and Sarah,

This is why we are doing the Stakeholder meeting, FDA needs to be educated about ME/CFS. Remember we are in the 5th Division. They most likely do not even know what ME/CFS stands for. If they do I’ll be impressed.

Bob Miller

Reply

Sarah Robinson April 29, 2012 at 12:51 pm

Thanks, Cort & Bob. Will wait to see if support is needed after the meeting materializes.

Reply

Cort May 1, 2012 at 12:34 pm

Keep emailing! Bob has gotten responses and the campaign is working —We are emailing until tomorrow when Bob will contact them about the meeting….-Here is my latest…

My name is Cort Johnson.

Federal studies suggest that Chronic fatigue syndrome costs the US economy approximately 20 billion dollars a year…yet the NIH spends less than $6 million dollars a year on it and there are no federally approved drugs. One drug, Ampligen, produced by a small company has been in the FDA’s pipeline for 15 years. The FDA must take notice of the million Americans with this disorder and produce a stakeholders meeting that results in accelerated drug approval for CFS drugs.

I personally know of people who’s lives have been saved by that drug and the FDA recently approved a drug, Benylstra, which was not better than placebo after a long term trial but which did markedly help a subset of the patients. Why? Because lupus has not had a drug approved for it in over 50 years…Well CFS has never had a drug approved for it. Its time for the federal government to recognize that a million ill Americans do deserve adequate research as well as treatment options..

I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.

Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.

As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen to advance science for all ME/CFS patients!

Sincerely,

Cort Johnson
1657 Rockcrest Hills Avenue
Henderson, NV, 89052

Reply

Sarah Robinson May 1, 2012 at 1:45 pm

Good one, Cort! Thanks.

Reply

Brenda Elliott May 1, 2012 at 1:43 pm

Cort,

Your letter is factual, pointed, informational and determined. Great job! We are so indebted to you for your non-stop efforts to help each one of us.

Brenda Elliott

Reply

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