Please provide feedback and add your voice

Please provide feedback on this letter.

Are your ME/CFS priorities here?

How can we strengthen the letter?

Feedback can be sent to MECFSAction@yahoo.com (or can be left as comments to be forwarded).

To add your name to this joint request, sign the petition http://www.change.org/petitions/department-of-health-and-human-services-formulate-a-strategic-coordinated-and-fully-funded-response-to-me-cfs-3?fb_action_ids=3823261413852%2C3823060448828%2C3822994967191%2C3822946725985&fb_action_types=change-org%3Arecruit&fb_ref=__hIFFOGDKFE&fb_source=other_multiline

Joint Request from the ME/CFS Community for Action Date: June 5, 2012

To: Secretary Sebelius, Assistant Secretary Koh, Deputy Assistant Secretary Lee, and the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Dear Secretary Sebelius, Dr. Koh, Dr. Lee, and CFSAC

We strongly believe there is an urgent need for the Department of Health and Human Services to undertake a strategic, coordinated, and fully-funded effort to address the critical priorities for adequate ME/CFS research, treatment and provider education. Therefore, we respectfully request a meeting to discuss the concerns raised in this letter and to begin formulating a comprehensive plan to address those concerns. We request your response by August 1, 2012.

For more than 25 years, DHHS has known about the devastating impact of chronic fatigue syndrome (CFS, known as myalgic encephalomyelitis or ME/CFS), a disease that the CDC has said “can be as disabling as multiple sclerosis, lupus, rheumatoid arthritis, heart disease, end-stage renal disease… and similar chronic conditions.”(1) ME/CFS has obliterated the lives of more than one million Americans. Patients can be sick for decades, often homebound and bedridden and more likely to die prematurely from cancer, heart failure or suicide than those without ME/CFS. (2)

Former CFSAC member Dr. Nancy Klimas stated: “My H.I.V. patients for the most part are hale and hearty thanks to three decades of intense and excellent research and billions of dollars invested. Many of my C.F.S. patients, on the other hand, are terribly ill and unable to work or participate in the care of their families.” (3)

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. (4)

In spite of all this, virtually nothing has been done, compared to other similar diseases.

The problems are clear: confusion resulting from the definition and name, paltry and misapplied NIH funding, inadequate CDC physician education and an FDA pipeline that has failed to deliver any treatments to address such a serious and life-robbing disease.

We acknowledge some progress has been made. But it has been far too little and far too slow for many patients who have suffered for decades. To make the progress needed, we require a significant, sustained and coordinated commitment from DHHS to address the following four key priorities:

1. Resolve the definition, name and classification confusion (5) (6) (7) (8) (9)

2. Provide a fair share of research funding, focused on biological pathologies, biomarkers and treatment (10) (11) (12) (13, 14)

3. Educate the medical community (15)

4. Accelerate the FDA pipeline for ME/CFS (16)

See Appendix 1 for specific details on the issues associated with these priorities.

While there are other priorities, these four are the most critical priorities today. And they have been for the last 25 years.

Many of us have literally lost decades of our lives from this lack of progress. As patients, family and friends of people with ME/CFS, we cannot allow our lives to be destroyed any longer. As a country, we can ill-afford the economic costs.

It is time for the United States government to embrace this disease with the seriousness and vigor that characterized the fight against HIV/AIDS. The Department of Health and Human Services is the one organization positioned to provide the leadership needed to undertake a strategic, coordinated and fully-funded response to the challenge of ME/CFS. We ask you to schedule a meeting between a group of ME/CFS patient representatives and key representatives from across DHHS to discuss the concerns raised in this letter and begin to formulate a comprehensive plan.

Please respond to Mary Dimmock by August 1, 2012 regarding the scheduling of this meeting or if you need additional information.

Signed by

ME/CFS Patient Organizations

CFS Solutions of West Michigan	New Jersey CFS Association, Inc.
CFS Knowledge Center, Inc.	PANDORA
CFS/Fibromyalgia Organization of Georgia, Inc.	Phoenix Rising
Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago	Rocky Mountain CFS/ME and FM Association
Coalition 4 ME/CFS	Speak Up About ME
The Connecticut CFIDS & FM Association, Inc.	Vermont CFIDS Association, Inc.
Massachusetts CFIDS Association, Inc.	Wisconsin ME/CFS Association, Inc.

ME/CFS Patient Advocates

Lori Chapo-Kroger, R.N.	Mike Munoz
Lily Chu, M.D., MSHS	Donna Pearson
Laurie DeDecker, R.N.	Mary Schweitzer, Ph.D.
Mary Dimmock	Meghan Shannon MS MFT
Pat Fero, MEPD	Rivka Solomon
Suzan Jackson	Jennifer Spotila, J.D.
Cort Johnson	Nancy Visocki
Patricia LaRosa, R.N., MSN	Toby Vokal
Denise Lopez-Majano	Charlotte von Salis, J.D.
Robert Miller

SIgners added after June 6, 2012

ME/CFS Patient Organizations

ProHealth

XMRV Global Action

ME/CFS Patient Advocates

Celeste Cooper, R.N.	Jill Justiss
Kati Debelic	Matina Nicolson
Joan Grobstein, M.D.	Leela Play

Appendix 1 – Details on Priorities

These four priorities are not new. They have been stated repeatedly in CFSAC deliberations, CFSAC recommendations and public testimony. However, in spite of bright spots, the overall government response to these priorities has been uncoordinated, underfunded, not sustained and too often misdirected.

1. Resolve the definition, name and classification confusion. With the focus on fatigue, the 1994 Fukuda definition and the 2005 Empirical definition have hopelessly blurred the distinctions between ME/CFS, depression and generalized chronic fatigue. (6,7). They are out of date and lack the requirement for the one symptom considered to be the hallmark of the disease: post-exertional malaise. Use of these definitions has contributed to research results that cannot be effectively compared across studies (6) and has contributed to inappropriate diagnosis and treatment.

In October 2009, the CFS Advisory Committee (CFSAC) recommended that “DHHS recognize a need for and support a national effort to arrive at a consensus definition of CFS that is accurate, standardized and reflective of the true disease.” (7) We support that recommendation. It is long past time to subset Fukuda-defined patients and actively consider the existing 2003 Canadian Consensus Criteria (CCC) or 2011 International Consensus Criteria (ICC) for those patients who suffer from the hallmark post-exertional malaise.

Beyond the definition, the name CFS has been confused with everyday tiredness and “chronic fatigue” ever since the CDC created it in 1988. Yet, many experienced clinicians and researchers recognize the equivalency or close similarity of ME and CFS based on the growth in scientific understanding and have adopted the term ME/CFS. All of DHHS should follow the NIH’s lead and adopt the term ME/CFS as recommended by the CFSAC in October 2010. (8)

Finally, the current version of the ICD-10-CM classifies CFS as a symptom under “chronic fatigue” even though WHO defines CFS to be a neurological disease, and the CFSAC has been recommending the same since 2004. The Coalition 4 ME/CFS submitted a proposal to NCHS in July 2011 to request CFS be reclassified. To date, NCHS has not made the change, communicated their decision or responded to queries on the status. It is crucial that NCHS ensures that the ICD-10-CM classification of CFS is aligned with WHO’s neurological classification before ICD-10-CM rolls out. (9)

2. Provide a fair share of research funding, focused on biological pathologies, biomarkers and treatment. In 2012, ME/CFS NIH funding at $6M is ranked 220 out of 232 diseases, far below that of other diseases, such as MS ($121M) or lupus ($105M) with a similar level of disability and lower prevalence. Even hay fever gets more at $7M. (10) Worse, some of the limited NIH funding available has instead been spent on grants that ultimately were unrelated to the study of ME/CFS or focused on psychological and other tangential issues. (11)

In May 2011, the CFSAC recommended “ME/CFS research receive funding commensurate with the magnitude of the problem.”(12) We similarly are asking the NIH to provide a fair share of funding commensurate with the devastating personal and economic impact of this disease and direct it specifically toward investigation of the underlying biological pathologies of ME/CFS and to identify the desperately needed biomarkers and treatments that will address those pathologies.

Beyond the level of funding, researchers have stated that the available NIH funding options are too restrictive to fund the needed innovative studies. In addition, the SEP lacks the continuity provided by a standing chairperson and resubmitted proposals can end up with new reviewers who lack context. (13,14) The NIH has stated that not enough proposals are submitted. (14) The lack of new researchers entering the field is a concern. Dr. Nancy Klimas suggested that the NIH could make a substantial leap forward by doing what has been done successfully in other disease areas, that is make “a full-court press effort to draw in people from other fields, encourage K awards, encourage training grants and encourage centers and programs.” (14) We ask the NIH to make such a “full-court press effort” for ME/CFS to address these challenges so the needed funding can get to researchers.

Finally, we are concerned that where ME/CFS is housed may affect the amount of funding, coordination and how the disease is perceived. Given what research is now showing about the disease, the NIAID or the NINDS may prove to be a more appropriate agency, in time. Regardless of where it is housed, we ask for a commitment to appropriate funding, cross-division coordination and an effort to decrease the stigma currently experienced.

3. Educate the medical community. With the exception of a handful of ME/CFS experts across the country, most doctors do not understand ME/CFS or even believe it is a physical condition. Some recommend treatments, such as aerobic physical activity that can cause not only temporary exacerbation of symptoms but prolonged disability. Lacking support from doctors, patients are left to search the Internet.

While the CDC has begun to modify their website and provide updated educational material, it is still based on the outdated Fukuda definition. Much more encouraging is the recently released IACFS/ME ME/CFS Primer for Clinical Practitioners, based on the Canadian Consensus Criteria (15). This primer far surpasses anything available for clinical use. We recommend that the CDC adopt the IACFS/ME primer as its new baseline and collaborate with international ME/CFS experts and patient organizations to refine it where needed and to proactively educate the medical community.

4. Accelerate the FDA pipeline for ME/CFS. ME/CFS applications have been shuffled across six different divisions in the FDA (16) and the only drug in the pipeline for ME/CFS has been effectively buried since 1997. Today, patients only have inadequate symptomatic relief. No treatments or biomarkers have come out of the process. A separate letter to Secretary Sebelius and Drs. Hamburg and Woodcock has requested an FDA stakeholder meeting to start to understand the challenges related to drug review and approval and to identify opportunities to accelerate approval. The FDA and ME/CFS stakeholders, including patients, need to work together to find ways to ensure that the process delivers the full complement of drugs and biomarkers needed to effectively diagnosis and treat patients.

Appendix 2 – References

1. CDC Web Site http://www.cdc.gov/cfs/symptoms/index.html
2. Jason et al, Causes of Death Among Patients With Chronic Fatigue Syndrome. Health Care for Women International, 27; 615-626, 2006 http://www.theoneclickgroup.co.uk/documents/ME-CFS_docs/Causes%20of%20Death%20-%20CFS%20Patients.pdf
3. Klimas, Dr. Nancy in the New York Times Health Bloghttp://consults.blogs.nytimes.com/2009/10/15/readers-ask-a-virus-linked-to-chronic-fatigue-syndrome/
4. Jason et al, ‘The Economic Impact of ME/CFS: Individual and societal costs”, Dynamic Medicine 2008, 7:6 http://archive.biomedcentral.com/1476-5918/7/6/
5. Ranciello, Vincent, “A tale of Two Viruses: Why AIDS was Pinned to HIV, but Chronic Fatigue Remains a Mystery. DIscover Magazine, January 2012 http://blogs.discovermagazine.com/crux/2012/01/12/hiv-in-xmrv-out-how-scientists-deduce-what-does-and-doesnt-cause-a-disease/
6. Multiple references have examined the issues with the definitions. Examples include:
   1. Jason et al, “Comparing the Fukuda et al. Criteria and the Canadian Case Definition for Chronic Fatigue Syndrome, Journal of Chronic Fatigue Syndrome, Vol 12, 2004 http://www.cfids-cab.org/cfs-inform/CFS.case.def/jason.etal04.pdf
7. CFSAC October 2009 recommendation to address definition issue http://www.hhs.gov/advcomcfs/recommendations/10302009.html
8. CFSAC October 2010 recommendation to adopt ME/CFS across HHS http://www.hhs.gov/advcomcfs/recommendations/1012-142010.html
9. CFSAC November 2011 discussion on ICD-10-CM http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac_min-11082011.pdf and http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac_min-11092011.pdf
10. 2012 NIH funding, http://report.nih.gov/categorical_spending.aspx
11. Pat Fero and Charlotte von Salis, Analysis of use of NIH funding from 2000-2010
    1. Pat Fero’s testimony to the CFSAC on this analysis is at hour 1.31 on video.

http://www.youtube.com/watch?v=uB8xnB69KaE&feature=youtu.be

12. CFSAC May 2010 recommendations to provide ME/CFS funding commensurate with the problem. http://www.hhs.gov/advcomcfs/recommendations/05112011.html
13. May 2011 CFSAC testimony by Lily Chu on need for flexible funding approaches http://www.hhs.gov/advcomcfs/meetings/presentations/publictestimony_201105_chu.pdf.
14. CFSAC NIH discussion on challenges with getting grants – lack of applications, need for other approaches to funding – see page 29-32

http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac_min-11092011.pdf

15. ME/CFS Primer for Clinical Practitioners, IACFSME, published May, 2011 http://www.iacfsme.org/Portals/0/PDF/PrimerFinal3.pdf
16. Assignment of Drugs Developed to Treat CFS http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm241014.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=cfs&utm_content=2

Thank you

Thank you to everyone who has helped and supported Speak Up About ME. We appreciate you!

Thank you to everyone who participated in/watched the June 2012 CFSAC meeting.

Thank you to each of you who make a difference each day in the lives of people with ME/CFS!

 

The Joint Request from the ME/CFS Community for Action

This is the text of the letter that was read at the CFSAC meeting on June 13th, 2012.

Please read the letter, think about it and give us feedback on it.

Feedback can be submitted here as comments or can be sent to Mecfsaction@yahoo.com. We hope you will provide input.

What do you think of the letter?

How do these priorities mesh with yours?

Is something missing?

Joint Request from the ME/CFS Community for Action Date: June 5, 2012

To: Secretary Sebelius, Assistant Secretary Koh, Deputy Assistant Secretary Lee, and the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Dear Secretary Sebelius, Dr. Koh, Dr. Lee, and CFSAC

We strongly believe there is an urgent need for the Department of Health and Human Services to undertake a strategic, coordinated, and fully-funded effort to address the critical priorities for adequate ME/CFS research, treatment and provider education. Therefore, we respectfully request a meeting to discuss the concerns raised in this letter and to begin formulating a comprehensive plan to address those concerns. We request your response by August 1, 2012.

For more than 25 years, DHHS has known about the devastating impact of chronic fatigue syndrome (CFS, known as myalgic encephalomyelitis or ME/CFS), a disease that the CDC has said “can be as disabling as multiple sclerosis, lupus, rheumatoid arthritis, heart disease, end-stage renal disease… and similar chronic conditions.”(1) ME/CFS has obliterated the lives of more than one million Americans. Patients can be sick for decades, often homebound and bedridden and more likely to die prematurely from cancer, heart failure or suicide than those without ME/CFS. (2)

Former CFSAC member Dr. Nancy Klimas stated: “My H.I.V. patients for the most part are hale and hearty thanks to three decades of intense and excellent research and billions of dollars invested. Many of my C.F.S. patients, on the other hand, are terribly ill and unable to work or participate in the care of their families.” (3)

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. (4)

In spite of all this, virtually nothing has been done, compared to other similar diseases.

The problems are clear: confusion resulting from the definition and name, paltry and misapplied NIH funding, inadequate CDC physician education and an FDA pipeline that has failed to deliver any treatments to address such a serious and life-robbing disease.

We acknowledge some progress has been made. But it has been far too little and far too slow for many patients who have suffered for decades. To make the progress needed, we require a significant, sustained and coordinated commitment from DHHS to address the following four key priorities:

1. Resolve the definition, name and classification confusion (5) (6) (7) (8) (9)

2. Provide a fair share of research funding, focused on biological pathologies, biomarkers and treatment (10) (11) (12) (13, 14)

3. Educate the medical community (15)

4. Accelerate the FDA pipeline for ME/CFS (16)

See Appendix 1 for specific details on the issues associated with these priorities.

While there are other priorities, these four are the most critical priorities today. And they have been for the last 25 years.

Many of us have literally lost decades of our lives from this lack of progress. As patients, family and friends of people with ME/CFS, we cannot allow our lives to be destroyed any longer. As a country, we can ill-afford the economic costs.

It is time for the United States government to embrace this disease with the seriousness and vigor that characterized the fight against HIV/AIDS. The Department of Health and Human Services is the one organization positioned to provide the leadership needed to undertake a strategic, coordinated and fully-funded response to the challenge of ME/CFS. We ask you to schedule a meeting between a group of ME/CFS patient representatives and key representatives from across DHHS to discuss the concerns raised in this letter and begin to formulate a comprehensive plan.

Please respond to Mary Dimmock by August 1, 2012 regarding the scheduling of this meeting or if you need additional information.

Signed

ME/CFS Patient Organizations

CFS Solutions of West Michigan	New Jersey CFS Association, Inc.
CFS Knowledge Center, Inc.	PANDORA
CFS/Fibromyalgia Organization of Georgia, Inc.	Phoenix Rising
Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago	Rocky Mountain CFS/ME and FM Association
Coalition 4 ME/CFS	Speak Up About ME
The Connecticut CFIDS & FM Association, Inc.	Vermont CFIDS Association, Inc.
Massachusetts CFIDS Association, Inc.	Wisconsin ME/CFS Association, Inc.

ME/CFS Patient Advocates

Lori Chapo-Kroger, R.N.	Mike Munoz
Lily Chu, M.D., MSHS	Donna Pearson
Laurie DeDecker, R.N.	Mary Schweitzer, Ph.D.
Mary Dimmock	Meghan Shannon MS MFT
Pat Fero, MEPD	Rivka Solomon
Suzan Jackson	Jennifer Spotila, J.D.
Cort Johnson	Nancy Visocki
Patricia LaRosa, R.N., MSN	Toby Vokal
Denise Lopez-Majano	Charlotte von Salis, J.D.
Robert Miller

Viewing numbers matter! WATCH the CFSAC live!

WATCH the CFSAC live!

Viewing numbers count –

Watch/tune in to the CFSAC live to make sure that we continue to have this way to participate in the proceedings as they happen.

According to the CFSAC website,

http://www.hhs.gov/advcomcfs/advcomcfs-cfsacmeeting.html

“On June 13-14, 2012, the meeting will provide a live video stream at http://www.hhs.gov/live  Passcode: CFSAC 2012 ”

Hours both days are 9 AM -5PM (eastern time)

Thank you!

 

Available as audio (only) at 1-888-677-1834.

 

Speak Up About ME will be among the participants in  the CFSAC meeting. Look for us!

one a day til June 25th LETTERS TO THE FDA TO HOLD A STAKEHOLDER MEETING!

CALL FOR THE FDA TO HOLD A STAKEHOLDER MEETING – LETTER!
June 25^th, 2012

To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS: Great job and Thank You!

As a result of your Emails / Letters, patients have been meeting with Congressional offices and support is being gathered from key Representatives.

We do not yet have a meeting set with FDA re: The ME/CFS Stakeholders Meeting.

Therefore, we ask everyone to send in a follow up email / letter.

This letter is directed to FDA Commissioner Margret Hamburg, ensuring that the stakeholder meeting is held. We urge Dr. Hamburg to direct that this critical meeting take place.

PLEASE EMAIL YOUR LETTER DAILY UNTIL June 25^thand urge your relatives and friends to do the same. A sample template letter and email addresses are included below. Copy, Paste, add your name etc at the bottom and Send.

YOUR LETTERS COUNT. Remember – LOBBYING & ADVOCACY is how AIDS/HIV got $3 BILLION a year for research, CFS gets $6 million. AIDS/HIV sufferers now have multiple drugs to fight the disease. We have NONE.  Your previous letter/emails did generate a response, just no confirmed Date.

WE MUST KEEP THE HEAT ON, Those who work for our benefit need to Act!

Thank you everyone for taking ACTION for YOUR HEALTH!

Copy & Paste email addresses into the To: Slot of your email

To: margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov, Kathleen.Sebelius@hhs.gov ,

matthew_prowler@casey.senate.gov,  monica.volante@mail.house.gov

From: Your Name June 25, 2012

To: FDA Commissioner Margaret Hamburg, M.D

cc: Janet Woodcock Director CDERFDA, Secretary of Health Kathleen Sebelius, Senator Casey and Congressman Pitts

Subject: Request for FDA Stakeholder Meeting on Chronic Fatigue Syndrome

Dear Dr. Hamburg

As patients suffering from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), we believe your commitment of the FDA holding stakeholder meetings is critical to the FDA understanding and evaluating treatments, particularly to those of us suffering from debilitating/devastating chronic illnesses. As a patient population we are long overdue for treatments and the movement through six divisions at the FDA has contributed to ZERO treatments being available.

We are asking you to convene a “true” stakeholder meeting to examine the treatments currently in use for ME/CFS both in trial and those being used off-label. We anticipate that this meeting will be at least a full day meeting in order to accommodate the experts, clinicians, researchers, patient advocacy groups and patients as well as FDA expertise from a variety of divisions to ensure understanding of this complex illness. With millions of patients suffering from ME/CFS at a cost to our nation of $23 billion, it more than outweighs any cost to the FDA to convene such a meeting. The goal of the meeting is to examine benefit/risk and develop a pathway for the acceleration of treatment, a pathway that can be agreed upon by the ME/CFS community with a commitment by the FDA to change the course of this disease.

As one of the millions of people suffering from ME/CFS, I cannot even dream about a better quality of life because there is simply no avenue to get there. I live every day with a disease that the CDC has said is as disabling as multiple sclerosis, heart disease, end-stage renal disease and similar chronic conditions; AND YET THERE ARE ZERO TREATMENTS TODAY. As this falls within your responsibility to address this “unmet medical need”, please Act Now.

Your Name

Address

City, State – Zip code

Call to Action re. DSM-5

Call to action – DSM-5 comments needed by June 15, 2012

The Diagnostic and Statistical Manual of Mental Disorders (DSM) is used in the U.S. to categorize mental disorders for patient diagnosis, treatment and insurance. The new version, DSM-5, includes a proposal for Somatic Symptom Disorder (SSD) that will have profound implications for ME/CFS patients. Your input is needed by June 15, 2012 to ensure that the DSM-5 authors understand your concerns.

The SSD proposal:(details in the appendix).

SSD can be diagnosed for any patient that has:

1. somatic symptoms that are distressing or significantly disrupt life
2. an excessive concern with the medical seriousness of his or her symptoms
3. experienced persistent symptoms, typically for at least 6 months

SSD can be applied to patients regardless of whether the symptoms are considered to be medically unexplainable or not. Severity is rated by the count and frequency of somatic symptoms. The “Justification for Criteria – Somatic Symptoms“, issued in May 2011, states that CBT, focused on “the identification and modification of dysfunctional and maladaptive beliefs”, is one of the most promising treatments.

Why this matters to ME/CFS patients

A diagnosis of SSD can be “bolted” onto any patient’s diagnosis. All that is required is for the medical practitioner to decide that the patient is excessively concerned with their somatic symptoms and their health. This is done using highly subjective and difficult to measure criteria for which very few independent reliability studies have been undertaken.

For patients with diseases that are poorly understood and misdiagnosed by the medical community, like ME/CFS, this will be disastrous. Once diagnosed inappropriately with SSD, the implications for diagnosis, treatment, disability and insurance will be profound. 

What you can do:

Please log onto the DSM site by June 15, 2012 and voice your concerns. Also consider encouraging your health care providers to submit comments.

Feel free to draw from the sample letter as you develop your own letter.

How to provide your input:

1. Register on theDSM-5 site (http://www.dsm5.org/Pages/Default.aspx) to make comments. The “Register Now” link is in the upper right hand corner of the home page. You will receive a confirmation email with a temporary password that you will have to click on to complete registration. If you have registered previously, you should still have an account and can log in in the same box. 
2. Provide your comments directly on the SSD page. It is probably easiest to draft outside and then copy in. (http://www.dsm5.org/ProposedRevision/Pages/proposedrevision.aspx?rid=368).

Thank you to Suzy Chapman of http://dxrevisionwatch.wordpress.com for monitoring DSM and for reviewing an earlier draft of this letter.

Sample Letter to APA – feel free to use for ideas for your own letter

To:         DSM-5 Task Force, Somatic Symptom Disorders Work Group

From:     Mary Dimmock (replace with your name)

Subject:  Response on the Proposal for Somatic Symptom Disorder

Date:      June 2, 2012

I am writing to voice concerns with the proposal for “Somatic Symptom Disorder” (SSD). 

During the second review of the DSM-5, numerous individuals raised significant concerns for the potential misuse and misapplication of the “Complex Somatic Symptom Disorder” (CSSD) and the “Simple Somatic Symptom Disorder” (SSSD) categories. The primary concern raised was the use of subjective and difficult to measure criteria to determine that patients were excessively focused on their symptoms and health concerns. A secondary concern was with how such a diagnosis could affect patient treatment, especially with the APA finding that one of the best treatments for SSD is CBT for “the identification and modification of dysfunctional and maladaptive beliefs about symptoms and disease“ and the suggestion to “limit testing and procedures”(1).

The 2012 version combines CSSD and SSSD into SSD but does nothing to address the earlier concerns for the category to be misused. The lack of objective, reliable criteria for determining that a patient has a disproportionate focus on their health is an insurmountable fatal flaw that can only be remediated by abandoning SSD until objective, reliable criteria with sufficient independent validation are in place.

The misuse of SSD is a major concern for patients suffering from any disease. This proposal would effectively turn a patient’s justified concern for his or her physical health into a mental illness. This is appallingly bad health policy.

But this proposal is especially problematic for patients who suffer from diseases that are not well understood. An example is Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a complex neuro-immune disease, which is characterized by many of these somatic symptoms. Despite advances in understanding the biological pathologies behind ME/CFS, there are still many in the medical community that considers this disease to be ‘all in the patient’s head’. Combining this lack of physician understanding with the proposal’s lack of objective, reliable criteria will be disastrous for ME/CFS patients and could directly affect the types of testing and treatment provided to the patient and impact insurance payments. It could also cause a parent to be wrongfully accused of ‘maintaining’ their child’s ‘sick role behavior’.

I urge you to seriously reconsider removing SSD from DSM-5 until studies have demonstrated that it can be objectively, reliably applied.

Mary Dimmock (replace with your name)

Reference

1. “Justification for Criteria – Somatic Symptoms”, Published by the American Psychiatric Association, Draft 4/18/2011, (www.dsm5.org/Documents/Somatic/DSM Validity Propositions 4-18-11.pdf).

Appendix A: Background on DSM-5 Proposal for Somatic Symptom Disorders

The Diagnostic and Statistical Manual of Mental Disorders (DSM) is published by the American Psychiatric Association (APA) and is used in the United States to categorize mental disorders, which is used for patient diagnosis, treatment and insurance. DSM-5 is under development.

The proposal for this third draft of DSM-5 is to fold a number of existing DSM-IV categories into a single new category called “Somatic Symptom Disorder (SSD).” “Somatic” means “bodily” or “of the body.”

For the second draft, in 2011, the proposal had been to have two separate categories, Complex Somatic Symptom Disorder (CSSD) and Simple Somatic Symptom Disorder (SSSD). But the Work Group has now decided to combine the two into SSD. In the process, the criteria for a diagnosis of CSSD have been lowered to accommodate SSSD. The Work Group is also proposing to drop the word “Complex” from the disorder name.

1. Justification for Criteria – Somatic Disorders

(www.dsm5.org/Documents/Somatic/DSM Validity Propositions 4-18-11.pdf)

This document, drafted by the APA in early 2011 discusses somatic disorders as a condition of “cognitive distortion” best treated by anti-depressants plus CBT, which enables the “identification and modification of dysfunctional and maladaptive beliefs about symptoms and disease, and behavioral techniques to alter illness and sick role behaviors”. The Justification further recommends ‘interventions with the patient‘s non-psychiatric physician … limiting testing and procedures unless clearly indicated”

Selected quotes include:

“The B-type criteria are crucial for a diagnosis of CSSD. These criteria in essence reflect disturbance in thoughts, feelings, and/or behaviors in conjunction with long standing distressing somatic symptoms.”

“Treatment interventions are similar in this group of disorders. Cognitive behavior therapy (CBT) and antidepressant medications appear to be the most promising therapeutic approaches… Although several variations of CBT have been employed, they share many elements in common. These include the identification and modification of dysfunctional and maladaptive beliefs about symptoms and disease, and behavioral techniques to alter illness and sick role behaviors and promote more effective coping.”

“All of these disorders benefit from specific interventions with the patient‘s non-psychiatric physician (e.g. scheduling regular appointments as opposed to prn appointments, limiting testing and procedures unless clearly indicated) (Allen 2002).”

No later version is available so it must be assumed that this still applies to Somatic Disorders in general and to SSD specifically as the replacement for CSSD and SSSD.

2. 2012 Criteria and Rational for DSM-5 Somatic Symptom Disorder

http://www.dsm5.org/ProposedRevision/Pages/proposedrevision.aspx?rid=368

SSD was created by combining the 2011 categories of Complex Somatic Symptom Disorder (CSSD) and Simple Somatic Symptom Disorder (SSSD) into a single category. In order to accommodate merging SSSD into CSSD, the requirement for the B type criteria has been reduced from “at least two’ to “at least one’ from the three “B” cognitions. Additionally, the severity specifiers have been revised.

The current proposal is:

1. Proposed Revision

Criteria A, B, and C must all be fulfilled to make the diagnosis:  

• Criteria A – Somatic symptoms: One or more somatic symptoms that are distressing and/or result in significant disruption in daily life. 
• Criteria B – Excessive thoughts, feelings, and behaviors related to these somatic symptoms or associated health concerns:  At least one of the following must be present.
  • Disproportionate and persistent thoughts about the seriousness of one’s symptoms.
  • Persistently high level of anxiety about health or symptoms
  • Excessive time and energy devoted to these symptoms or health concerns 
• Criteria C – Chronicity: Although any one symptom may not be continuously present, the state of being symptomatic is persistent (typically >6 months). 

2. Rationale (Selected statements – for the full rationale, see the web site)

The proposed classification for Somatic Symptom Disorders de-emphasizes the central role of medically unexplained symptoms. Instead, it defines disorders on the basis of positive symptoms (distressing somatic symptoms + excessive thoughts, feelings, and behaviors in response to these symptoms).

The group considers that the current DSM-IV somatoform diagnoses … are so flawed that complete restructuring of these diagnoses is required. Change is needed as:

• These diagnoses are based on “medically unexplained symptoms,” but this term is unreliable, especially in the presence of medical illness. Doctors disagree on the use of the term and patient recall of such symptoms is variable, so reliability of these diagnoses is low.
• The lack of positive psychological features in the definition of these disorders means they fail to satisfy one of the criteria for a mental disorder.

The new diagnosis of Somatic Symptom Disorder (SSD) is proposed to overcome these problems with relevant DSM-IV diagnoses. The previous posting proposed diagnoses of Complex Somatic Symptom Disorder (CSSD) and Simple Somatic Symptom Disorder (SSSD). In this revision, we have merged the two disorders, recognizing that SSSD is a less severe variant of CSSD. The work group is considering dropping the adjective “complex” from the name of the resulting disorder and is desirous of feedback.

2. Severity

Severity Specifiers(mild, moderate, severe) 

“Somatic Symptom Disorder is a disorder characterized by persistency, symptom burden, and excessive or maladaptive response to somatic symptoms. There is a considerable range of severity. Typically, the disorder is more severe when multiple somatic symptoms are present.”

In addition to fulfilling criteria A, B and C, the following metrics may be used to rate severity:

• Mild: only 1 of the B criteria fulfilled
• Moderate: 2 or more B criteria fulfilled
• Severe: 2 or more B criteria fulfilled plus multiple somatic symptoms

During the past SEVEN (7) DAYS how much have you been bothered by….
		Not at all	A little bit	Some-what		Quite a bit			Very much
1.	Stomach or problems going to the toilet?				1		2	3		4	5
2.	Pain in your back?				1		2	3		4	5
3.	Pain in your arms, legs, or joints				1		2	3		4	5
4.	Headaches?				1		2	3		4	5
5.	Chest pain or getting out of breath?				1		2	3		4	5
6.	Dizziness?				1		2	3		4	5
7.	Feeling tired or having low energy?				1		2	3		4	5
8.	Trouble sleeping?				1		2	3		4	5

Appendix B: References

1. Somatic Symptom Disorders, DSM website, (http://www.dsm5.org/ProposedRevision/Pages/SomaticSymptomDisorders.aspx) 
2. “Justification for Criteria – Somatic Symptoms”, Published by the American Psychiatric Association, Draft 4/18/2011, (www.dsm5.org/Documents/Somatic/DSM Validity Propositions 4-18-11.pdf). This document does not appear to have an updated version at this time.
3. “Somatic Symptom Disorders”, description published by the American Psychiatric Association, Draft 4/18/2011, http://www.dsm5.org/Documents/Somatic/Somatic Symptom Disorders description April 18, 2011.pdf. This document has not been updated or issued for the third release.
4. Suzy Chapman’s collation of responses submitted during the second review, which ended in July 2011. http://dxrevisionwatch.wordpress.com/dsm-5-proposals/dsm-5-submissions-2011/ – spans multiple pages. Suzy Chapman’s site – http://dxrevisionwatch.wordpress.com – contains a comprehensive history of DSM-5 updates.
5. Selected submissions from May-July 2011.

Note that while DSM-5 Somatic Symptom Disorders have changed by combing CSSD and SSSD into SSD, the issues raised in these letters still stand

1. Coalition 4 ME/CFS – http://www.coalition4mecfs.org/DSM5letter.html
2. Mass CFIDS – http://www.masscfids.org/advocacy/220
3. CFIDS Association – http://www.cfids.org/advocacy/2010/dsm5-statement.pdf
4. IACFSME statement – http://www.iacfsme.org/ – scroll half way down the page

 Thank you very much Mary for preparing this and making it easy for us to voice our concerns.