ME/CFS Orgs Push Secretary of Health Sibelius For Strategy Meeting

July 2, 2012

Posted by Cort Johnson

For more than 25 years, the Department of Health and Human Services (DHHS) has known how debilitating chronic fatigue syndrome (CFS, known as myalgic encephalomyelitis or ME/CFS) can be.  Studies have shown that ME/CFS is common, afflicting perhaps 1 million people in the U.S. and the CDC reports ME/CFS “can be as disabling as multiple sclerosis, lupus, rheumatoid arthritis, heart disease, end-stage renal disease… and similar chronic conditions.”

Compounding the personal devastation is the effect on our country’s economic well-being. ME/CFS drains our workforce and costs our country an estimated $18 – $23 billion annually.

ME/CFS has devastated the lives of more than one million Americans along with the lives of their families. Patients have been left sick for decades, often homebound and bedridden with no help and little attention from the federal government.

Yet virtually nothing has been done. All the studies showing high rates of prevalence and high economic costs haven’t made a dent in the governments commitment to ME/CFS.   Twenty five years later, there is still confusion around the definition, NIH funding is lower in real terms than it was 20 years , the CDC Physician Toolkit is abysmal, and no FDA approved treatments exist.

It’s time to take a stand;  it’s time for the United States government to embrace this disease with the seriousness and vigor that characterizes it’s fight against many other chronic illnesses.

Organizations and Advocates Request High Level DHHS Meeting

On June 6, 2012, a group of 14 ME/CFS patient organizations and 19 independent advocates submitted a joint letter to the Department of Health and Human Services requesting Secretary Sebelius to convene a meeting between the ME/CFS community and DHHS to discuss the our concerns patients and to begin formulating a strategic, coordinated and fully-funded response to the challenge of ME/CFS.

The letter was sent to Secretary Kathleen Sebelius, Assistant Secretary Howard Koh, M.D., Deputy Assistant Secretary Nancy Lee, M.D. and the CFSAC. The full letter can be read here.

The letter constituted the largest joint advocacy effort that we can know of.  Phoenix Rising  signed the letter because we strongly believe that only by working together will we win the battle to end government neglect and give us the opportunity to get our lives back.

FDA Stakeholders Meeting

You may be wondering how this letter fits in with the  successful letter writing campaign to request the FDA to convene a stakeholder meeting.  Accelerating the delivery of drugs through the FDA is one of the 4 priorities outlines in the DHHS letter we’ve sent to federal officials and all of those involved in the FDA action signed the DHHS letter.

The First Step – Sending this letter to Secretary Sebelius requesting a strategic, coordinated and fully funded response to ME/CFS is just the first step. We must now prepare more fully for the requested meeting and also define other efforts to advance our cause. If you have any suggestions please let us know at mecfsaction@yahoo.com.

The Petition

Please take a minute to sign the petition calling on Secretary Sebelius to convene the meeting and formulate a strategic response to ME/CFS and please ask your family and friends to sign the petition on your behalf. This is important. The more people who sign the petition, the greater our chances of success.

ME/CFS doesn’t have to be a neglected disorder; other disorders have risen from neglect to prominence and we will too. Together, we can make this happen and change our futures!!

 

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14 comments

{ 14 comments… read them below or add one }

Sasha July 3, 2012 at 6:35 am

Fantastic, Cort – I recommend everyone to read the letter, it's brilliant.

Thanks to you and everyone else who contribute to this.

Cort July 3, 2012 at 8:11 am

I think it is brilliant (even though I had little to do with it). I think getting all the orgs together is brilliant as well – I don't think that's ever been done before (at least not in the last 10 or 15 years..). Let's get that petition signed!

Sasha July 3, 2012 at 8:36 am

Hi Cort – I haven't been following whether the petition was annonced earlier as I'm not a US citizen and presumably can't sign but it's an unusually important petition – would it be worth giving it it's own thread in case people don't read your article (or just skim it and miss the bit about the petition)?

Denise July 3, 2012 at 9:05 am

Hi Sasha,
Everyone can sign the petition, regardless of where they live.
It would be great if everyone who signed got as many other people (friends, family, co-workers, etc..) as possible to sign. Please spread the word.

Sasha July 3, 2012 at 10:07 am

Hi Denise – thanks for that – maybe that could be added to the article or the title of any new thread on it (that non-US people can sign).

Looking at the petition page, it seems familiar – could I have signed it already? Has it been up a few weeks?

medfeb July 3, 2012 at 3:44 pm

Hi Sasha,

I added a note to the petition indicating that those outside of the U.S. can side. The petition has been up for a few weeks so you may have signed earlier.

Thank you for spreading the word

Mary

Gemini July 4, 2012 at 10:54 am

Cort, you make great points about DHHS's management of ME/CFS. Note DHHS operates on the basis of a "triage system" in fact NIH uses the jargon "triaged" to refer to how their grant applications are managed. (ER's also triage their patients).

Your statement "CDC considers ME/CFS as disabling as MS, Lupus, RA, heart disease, end-stage renal disease…and similar conditions" means that in a properly working "triage system" ME/CFS should be classified at the same level as these diseases in terms of funding, staffing, time & attention and total DHHS resources applied which is NOT the case.

In a strategic meeting with DHHS, you might consider using the triage concept with your great funding charts.

Cort July 4, 2012 at 4:48 pm


jace

Suzy, that is such a cute piccy. Aaah.

I think some of the problem is what researchers want to work on, sadly enough. Unless the NIH provides researcher the assurance that they are going to get funded researchers aren't going to flock to ME/CFS. It wouldn't take alot – a grant opportunity called an RFA – that guarantees 4-5 million dollars in funding a year would be a big boost but DHHS officials aren't willing to consider even that small amount.

If the system were based on need ME/CFS would get alot of funding but it's clearly not based on need….which is why I think it is based on researcher preference – which is pretty sad….

justinreilly July 4, 2012 at 8:46 pm

Cort,

Thanks for this very good article and advocacy.

The main reason researchers don't study this disease is there is very little funding. Fund it and the researchers will come, regardless of the disease or it's reputation. A dedicated fund isn't even necessary. If NIH simply funded more submitted ME applications, a 'signal' would go out and more researchers would apply. This is NIH's fault, not the researchers.

I have sent emails to my entire address book. I urge everyone to do likewise, and to send to Facebook friends, etc. I have included the text below, and as always, feel free to copy some or all of it. Thanks everyone for the good work.

Subject: Please sign the M.E. ("CFS") petition to the government

Please do me a big favor and sign the below-linked petition for the Department of Health and Human Services to respond adequately to the burden M.E. places on America.

As you may know, I have the Neuro-Immune Disease Myalgic Encephalomyelitis (aka "CFS"). Approximately 1 Million other Americans also have M.E., but the Federal Government has ignored and even persecuted M.E. patients for decades. The situation is hard to believe and, in fact, I wouldn't have believed it myself if I hadn't lived it and thoroughly researched it.

Thank you very much for your consideration!

Yours,
Justin

http://www.change.org/petitions/department-of-health-and-human-services-formulate-a-strategic-coordinated-and-fully-funded-response-to-me-cfs-3

justinreilly July 5, 2012 at 5:20 pm

I am now adding the following to my email:

Please also forward this message to your friends, or even better, your whole address book as I have. I hate spam, so I have never before sent out mass emails, but this cause is so important, I must bother you with it. : )

justinreilly July 9, 2012 at 5:23 pm

We're at 721 so far. Racking up those signatures. Good work everybody! Let's keep getting as many as possible.

justinreilly July 9, 2012 at 5:24 pm

If anyone who was so active and great at getting votes in the Chase contest could help out by sending signature requests to the lists of patient orgs around the world you compiled, that would be amazing.

CJB July 10, 2012 at 2:00 pm

Response I received:

Dear CJ B,

Thank you for writing to Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA), requesting a stakeholder meeting to discuss treatment options for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients. Your e-mail was forwarded to the Division of Drug Information for a direct reply.

The Health and Human Services (HHS) and FDA share your concern about safe and effective treatments for CFS and are sympathetic to the sometimes desperate situation of patients with illnesses and conditions such as ME/CFS, for whom there are no available therapies. Based on the letters and e-mails received from ME/CFS advocates, both HHS and FDA have already taken a number of steps to address this request for a stakeholders meeting.

On June 13 and 14, 2012, HHS convened an open public meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) opened by Dr. Howard Koh, MD, MPH, Assistant Secretary for Health. As you may know, the CFSAC is comprised of 10 voting members with clinical or research expertise in CFS, a patient advocate member, and 7 Ex-Officio members from various HHS agencies, including a representative from FDA. During the meeting, the committee heard 3 hours of public testimony that included a presentation by a drug manufacturer. In addition, there were separate presentations by 5 different ME/CFS advocacy organizations: the CFIDS Association of America, Speak Up About ME, PANDORA, Phoenix Rising, and the New Jersey CFS Association.

Separately from the CFSAC, HHS convened the Ad Hoc Workgroup on CFS to develop a Department-wide strategy to address CFS and allow active collaboration among agencies. So far, the workgroup has held two meetings with high level leaders of the following agencies: National Institutes of Health (NIH), Centers for Disease Control (CDC), Agency for Healthcare Research and Quality (AHRQ), Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Administration for Children and Families (ACF). A third meeting is being scheduled for later this summer, where an important agenda item will be a FDA-hosted multidisciplinary scientific workshop on drug and biomarker development for CFS.

FDA is reaching out to individual patient advocates in order to better ascertain achievable goals for a stakeholder's meeting. This outreach has included teleconferences with various leaders of the advocacy campaign, including a call by Dr. Janet Woodcock with the following advocates: Robert Miller, ME/CFS Patient/Advocate; Patricia LaRosa, RN, MSN, New Jersey Chronic Fatigue Syndrome Association; Mary Dimmock ME/CFS Patient representative; Denise Lopez Majano, founder of Speak Up About ME; and Cort Johnson, founder of Phoenix Rising. Based on these calls, FDA plans to host a cross-agency coordinated multidisciplinary scientific workshop to address drug and biomarker development issues in ME/CFS.

As plans for a multidisciplinary scientific workshop on drug development are underway, FDA is continuing calls to stakeholders to assist in the planning of such a workshop. Stakeholders wishing to provide input into the planning of the drug development workshop should contact David Banks, PhD, at FDA at the following e-mail address: oshi@fda.hhs.gov.

Finally, efforts are underway at FDA to improve the infrastructure for drug development in the field of ME/CFS. To overcome obstacles that may be introduced by a fragmented approach to the disease, FDA consolidated all ME/CFS drug applications in the Division of Pulmonary, Allergy, and Rheumatology Products as of January 16, 2011. This consolidation has allowed for development of expertise in ME/CFS among reviewers in the Division, which will facilitate uniform criteria for drug development.

Again, thank you for your request regarding a stakeholder meeting on ME/CFS treatments. As outlined above, please know that HHS and FDA are actively pursuing a ME/CFS strategy in order to address this important issue.

Sincerely,

Mary Kremzner, Pharm.D.
Director, Division of Drug Information

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

liquid sky July 10, 2012 at 2:16 pm

"This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed."

I love the disclaimer on the bottom. Nice of them to answer you though.

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