Posts Tagged 'medicine'

#Millions Missing

Millions of people are missing from everyday life because of Millions Missing from research and Millions Missing of appropriately educated healthcare professionals to care for patients

The #Millions Missing demonstration will take place on 25 May 2016 in select locations across the globe.

#MillionsMissing ME/CFS Protest Demands

  1. Increased Funding and Program Investments

Funding and program investments commensurate with the disease burden

  1. Clinical Trials

Clinical trials to secure medical treatments for ME/CFS

  1. Accurate Medical Education

Replacement of misinformation with accurate medical education and clinical guidelines

  1. A Serious Commitment

HHS leadership, oversight and a serious commitment to urgently address ME/CFS

#MEAction has posted the rationale for the demands.

NOTE –

There is an open community meeting hosted by MEAction on

Wed. May 11th, 2-3:30 pm EDT

to discuss the demands and

hear any questions or concerns you have about them.

More info and call sign-up here:

 https://my.meaction.net/events/millionsmissing-national-call

MEAction says “We are thinking of these demands as a living document. We plan that after the protests (May 25) it will evolve as we get input from the community. MEAction.net will set up a mechanism for receiving that community input. This task, and the evolution of the demands document, will happen after the protests, simply because we lack the capacity to do it while we are organizing the protests.”

MillionsMissing graphic 1

 

 

 

 

 

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Of special interest to those with OI (POTS, NMH, etc)

Dr. Peter Rowe has kindly given permission for his brochure on orthostatic intolerance and its treatment thereof to be posted here: OIinfo2013.

This information should not take the place of your regular medical professional. It could however be beneficial for you and your practitioner to read and discuss to see if treatment modalities described here might be of benefit to you.

(Please note that this is the November 2013 version which is the most current as of 1 April 2014.)

You may also want to check out the easy to print cards on this site to carry with you:

http://www.dysautonomiainternational.org/page.php?ID=164

This one is about OI:

http://www.dysautonomiainternational.org/images/MedicalAccommodationCard_OI.jpg

This one is about POTS:

http://www.dysautonomiainternational.org/images/MedicalAccommodationCard.jpg

Info on IOM Panelists

Info on IOM Panelists

As of today we have 16 days (til 23 December 2013) to submit comment on the IOM panelists.

To give everyone info that may help substantiate comment, info on the “unknown” panelists was posted 2 days ago and today info on the “knowns” has been posted on OccupyCFS blog.

http://www.occupycfs.com/2013/12/07/iom-panelists-the-knowns/

“IOM Panelists: The Knowns

December 7th, 2013 Jennie Spotila Leave a comment Go to comments

In this post, we present profiles of the eight members of the Institute of Medicine ME/CFS definition panel who are known to the ME/CFS community in some capacity. Many, but not all, of them are ME/CFS experts in that they work predominantly in that area. You can read about the team who put these profiles together and the methods we used in this previous post.

Important disclaimer: Many of us know one or more of these panelists quite well. They are our doctors, our colleagues, our friends. We strove to be as objective as possible, and applied all the same research methods and questions here as we did for the other panelists.   ….”

Links to previous OccupyCFS posts on this:

http://www.occupycfs.com/2013/12/03/iom-panel-announced/

http://www.occupycfs.com/2013/12/05/iom-panelists-method-to-our-madness/

http://www.occupycfs.com/2013/12/05/iom-panelists-the-unknowns/

FDA CFS and ME Teleconference – October 16, 2013

 

In case you have not seen it, FDA has produced a report based on the April 25th meeting. You can download it or read it here http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf. Based on the input received at the meeting and from material submitted to the docket, their characterization of ME is quite good.

As a followup to the April FDA meeting, FDA is hosting a teleconference on Wednesday Oct 16th fro 1:30-3pm (eastern time). Details below.

On October 16 from 1:30 PM – 3:00 PM EST, FDA will hold a teleconference that is open to the public. FDA will provide introductory and background remarks then the teleconference will be open for public comment on the following three topics:

1.            Feedback from the CFS and ME public workshop.

2.            Current projects related to drug development in CFS and ME.

3.            Potential methods to catalyze CFS and ME drug development.

Registration (Closes October 11, 2013): https://cfsmeteleconference2013.eventbrite.com/

FDA CFS and ME Activities Website: http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm

Please contact Randi Clark (Randi.Clark@fda.hhs.gov) or Mary Gross (Mary.Gross@fda.hhs.gov) if you have any questions.

Our ME/CFS Experts Have Spoken on the Case Definition

On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

But there’s more.

On the same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have written an open letter to Health and Human Services Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the Canadian Consensus Criteria as the baseline criteria, stating:

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with IOM and chronic multisymptom illness to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, NO MAS!

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the CCC for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into ‘false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the CCC.

We need to send two strong messages to HHS. First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for. Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.

We need to forcefully engage our congressional leaders on this issue. Further information along with the actions to take with congressional leaders will be provided as soon as possible.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here – http://bit.ly/15npS9B

The Sept 23, 2013 CFSAC announcement on the IOM can be found here – http://bit.ly/18m7XlJ

Thanks to Mary D for this information!

Just say NO to tapioca!

The talking points for the email about the DHHS/IOM proposed contract prompted advocate Joe Landson (thanks for sharing it Joe) to send this letter:

 

Subject: MECFS definitions

Secretary Sebelius,

As a disabled veteran, and an ME/CFS patient, I am writing to protest the Department of Health and Human Services’ proposed sole-source contract (or grant?) to the Institute of Medicine, towards a consensus definition of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or ME/CFS. I am given to understand that due to ME/CFS community feedback, this sole-source proposal has been shelved. I sincerely hope it has. 

In January of this year, the IOM released a report on Gulf War Illness (GWI), which the IOM terms Chronic Multisystem Illness (CMI), a characterization arguably blander and less substantial than the tapioca pudding provided in many hospital meals. While the pudding can, in theory, be consumed, I am not sure that my fellow patients and I can stomach another attempt to portray our crippling illness as a series of bland generalities and vague complaints, treatable with talk therapy. 

Yes, we need a consensus definition. However I submit that we can best serve patients, clinicians, researchers and policymakers by writing a definition based on actual understanding of the mechanisms and causes of the illness in question. In cases where consensus science does not provide knowledge of illness cause and mechanism, then perhaps the DHHS can fund research that actually produces such knowledge. If DHHS cannot even do that, then perhaps it should avoid the definition-writing process until such consensus science does emerge. First, do no harm. Bad definitions do us harm by misdirecting research, and by exposing us to ridicule and ignorance, from which we suffer daily. 

Thank you for your consideration. Go Jayhawks. 

Joe Landson

No way to guess how this will turn out…..

You probably remember that one of the October 2012 CFSAC recommendations was

CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.”

http://www.hhs.gov/advcomcfs/recommendations/10032012.html

We know that CDC has a definition initiative as part of its multi-site study, and we know that NIH and AHRQ have said they were conducting a research case definition process.

In his letter to the CFSAC on May 1, 2013 Dr. Howard Koh (Assistant Secretary of Health at the Department of Health and Human Services - DHHS) wrote:

The National Institutes of Health (NIH) is convening an Evidence-based Methodology Workshop process  . . . to address the issue of case definitions appropriate for ME/CFS research. However, it will not cover in detail a clinical case definition. The Office of the Assistant Secretary for Health, Department of Health and Human Services, is actively pursuing options for a separate effort that would work in coordination with the NIH process, but result in a case definition useful for clinicians who see patients with symptoms that may be ME/CFS. . . . .” (http://www.occupycfs.com/2013/06/03/perplexed/ )

There was no indication at that time what the options were that were being actively pursued but now we learn that the Office of the Assistant Secretary of Health (Dr. Koh's office) is going to have the Board on the Health of Select Populations at the Institute of Medicine (IOM) set up a committee “of thought leaders and stakeholders to comprehensively evaluate the current status of criteria for the diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).” (https://www.fbo.gov/index?s=opportunity&mode=form&id=fb67835096d2486592952c90cd3acee7&tab=core&_cview=0)

The impact of the clinical diagnostic criteria they develop will be on the ME(cfs) community is a big question.

Earlier this year the IOM Board on the Health of Select Populations produced a report on Gulf War Illness (which they refer to as Chronic Multisymptom Illness or CMI – which is almost as board a categorization as the term chronic fatigue syndrome). (http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx)

That report seemed heavily focused on psychological concerns, and CBT and GET were included in their clinical practice guidelines for treatment of GWI.

This same report talks about chronic fatigue syndrome (that's how they refer to I) as being among co-morbid conditions with GWI, includes the 1994 Fukuda definition (http://www.cfids-me.org/cdcdefine.html) and the “2007 NICE Guidelines for CFS” (http://publications.nice.org.uk/chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-cg53) and has the following pharmacologic and non-pharmacologic treatment recommendations for chronic fatigue syndrome:

Chronic fatigue syndrome

Pharmacologic:

NSAIDs for pain symptoms

Melatonin for problems in sleeping

Antidepressants for depression and to improve sleep quality

Non-pharmacologic:

CBT (cognitive behavioral therapy)

Graded exercise therapy

Lifestyle changes (for example, regular sleeping schedule; avoidance of caffeine, alcohol, and tobacco; and dietary changes)

Alternative therapies (for example, yoga, Tai Chi, acupuncture, and massage)

CPAP for problems in sleeping

This OccupyCFS post http://www.occupycfs.com/2013/08/29/iom-on-the-case/ poses a few of the many questions that come to mind about the IOM initiative on ME(cfs) clinical diagnostic criteria.

Many view the GWI report as heavy on inadequate and inappropriate treatment approaches (for GWI and ME(cfs) among other things) with emphasis on psychological rather than biological processes.

The suggestion in the GWI report that CBT, GET, and a massage or two - or perhaps yoga, will treat our illness(es), and that in chronic fatigue syndrome (again, this is THEIR term, not ours), cognitive dysfunction tends to be mild, and that the report makes no mention of PEM/PENE, one wonders what sort of materials the IOM will be accessing to develop their clinical criteria.

Will the IOM produce clinical diagnostic criteria that accurately captures the complexity of ME(cfs)?

(By the way, it is estimated that an IOM initiative typically costs one million US dollars.)

 

Update 31 Aug 2013:

Thanks to those responsible for getting the response date extended to Sept. 11, 2013 (4pm Eastern time)

and

Hat Tip and MANY thanks to Leela Play for finding the notice.