Archive for September, 2013

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.

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HHS Strategic Plan, Goal number 4? Not implemented

HHS has a strategic-plan which it updates every four years. Goal # 4 of the current plan (2010-2015) is about increasing efficiency, transparency and accountability of HHS programs.

Part of Goal # 4 reads as follows (emphasis added):

HHS also embraces the power of Open Government, recognizing that with openness comes responsibility and accountability for results. Through Open Government, HHS is promoting transparency, participation, and collaboration—vital enablers of success in the HHS mission to improve the health and well-being of all Americans. 

HHS’s Open Government efforts will break new ground in enabling the public to give feedback to HHS programs. HHS can help stakeholders contribute knowledge and experience to help it do jobs better, and HHS can support new kinds of collaborative teamwork that will deliver better results for our citizens.  HHS will move forward toward new strategies, new tools, and a new culture of public participation and collaboration in its affairs.http://www.hhs.gov/strategic-plan/goal4.html

We are currently three-quarters of the way through 2013, so one would assume that the strategic-plan begun in 2010 would, by now, be close to completion.

Yet we have been provided no evidence of HHS engaging with ME stakeholders so that our knowledge and experience can help HHS do its job better.

In addition, one can only assume that HHS’ mention of collaborative teamwork only refers to HHS and does not apply to stakeholders because again, we have no evidence of collaborative teamwork between HHS and the ME community.

The reference to “a new culture of public participation and collaboration” is interesting in that the HHS culture actually seems to be one of increasingly LIMITED public participation and collaboration, rather than MORE public participation and collaboration between HHS and the ME community. As such, it is difficult to understand how limiting public participation and collaboration leads to a more transparent, participatory and collaborate environment.

Had HHS had an engaged, and open relationship with us before now, the news on Sept 23rd 2013 from the CFSAC ListServ about the IOM study (“We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month…..”) might have been a nice surprise present.

Instead, coming on the heels of so many recent instances that have added to the ME community’s distrust of HHS, it is difficult to have trust and confidence that HHS has our interests at heart.

This very worthwhile post on Occupy CFS http://www.occupycfs.com/2013/09/26/trust/ has a time-line of some of HHS’ “mis-steps” this year, and more details about some of the recent instances contributing to MEcommunity’s mistrust of HHS.

 

 

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!

23 Sept 2013 approx 6pm eastern time CFSAC listserve sent the following

“We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month.  This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.”  Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them.  The NIH is convening an Evidence-based Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.

The Office on Women’s Health/HHS is co-sponsoring the IOM study with several agencies that participate in CFSAC.  A group of voting and non-voting members of the committee participated in the development of the Statement of Work.

The IOM has agreed to perform the following tasks over the next 18 months:

·         Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;

·         Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians,using a consensus-building methodology;

·         Recommend whether new terminology for ME/CFS should be adopted;

·         Develop an outreach strategy to disseminate the definition nationwide to healthprofessionals.

 

To accomplish these tasks, the IOM has also agreed that:

·         the IOM committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields, particularly with expertise in ME/CFS, including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology; and scientists and physicians with experience in developing clinical case definitions.  The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee.

·         the IOM, in addition to the committee meetings, will sponsor open meetings to enlist the comments and concerns of patients, family members and other caretakers, health educators, health care professionals, and advocacy groups.  During these meetings, an open phone line and email address will be available to those who cannot attend in person.

·         as the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC multi-site clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.

·         the committee will distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.

 

HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email.  It is our hope that a widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic translational research for ME/CFS. “

 

Act NOW! Act often! Share widely! Time Critical!

HHS wants to turn Nancy Lee’s use (at CFSAC meetings) of the phrase “Nothing about us, without us” into “Everything about you, without you” particularly when it comes to defining ME and keeping ME stakeholders and experts out of the equation.

The Federal fiscal year ends Sept. 30th, so the contract would need to be signed by then.

We continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria.  When the contract is finalized, we will provide additional information via the CFSAC listserv and website.”

HHS is moving ahead on the IOM contract unilaterally – with total disregard for the overwhelming opposition from the ME community. HHS is undermining the work of ME experts while patients are suffering and dying.

Tell HHS to Stop the IOM Contract to Redefine ME(cfs)!

Subject line (variations encouraged): Stop the IOM Contract to Redefine ME/CFS!

Send emails to : Kathleen.Sebelius@hhs.gov

CC: howard.koh@hhs.gov , txf2@cdc.gov , Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov , margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov , collinsf@mail.nih.gov , richard.kronick@hhs.gov , cfsac@hhs.gov , MEACTNOW@yahoo.com

Sample email (feel free to adapt)

Dear Secretary Sebelius,

I strongly urge the Department to abandon its plan to contract with the Institute of Medicine (IOM) to define its own clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Researchers and clinicians with years of experience in studying and treating this disease have already created peer-reviewed case definitions – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. These definitions are supported by clinical guidelines for medical practitioners, guidelines also created by experts. These definitions are well regarded by patients, ME doctors, and ME researchers. The CCC has been used both clinically and in research for years.

But rather than adopt these expertly defined disease criteria and the associated medical guidelines, HHS has promoted its own overly broad view of ME that does not require the hallmark symptoms of ME. HHS has questioned these hallmark criteria and misrepresented our disease in its medical education. HHS has even unilaterally reclassified “CFS” to be a subtype of chronic fatigue, in complete opposition to the standards set by the World Health Organization and all other countries that classify this disease as a neurological disease.

Now, HHS is intent on defining its own new criteria for ME using the IOM, an organization whose only effort to define a disease was harshly criticized by Gulf War Illness Advocates for redefining the disease too broadly and for using non-experts to define the disease. HHS has repeatedly stated their intent to use non-experts to define ME. This is a very serious concern for patients who face widespread disbelief every day from the general medical and research community. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report on Gulf War treatments failed to accurately represent ME and listed CBT and GET as treatments, treatments that our experts have said can be harmful.

HHS is progressing the IOM contract unilaterally and with disregard for the overwhelming opposition from the ME community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.

I strongly urge HHS to abandon its plans to contract with the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt a definition that our experts have created and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

(sign your name)

 

 

 

 

Make your voice heard – every day! Action Alert

We remember Nancy Lee saying “Nothing about us without us”…

In Chronic Fatigue Syndrome Advisory Committee (CFSAC) discussions Designated Federal Official (DFO)Nancy C. Lee, M.D. has used the phrase “Nothing about us without us” implying that stakeholders should be involved in all things regarding ME/CFS.

But (on Sept 12th) HHS says:

We continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria.  When the contract is finalized, we will provide additional information via the CFSAC listserv and website.  This topic will be included as an agenda item for the November webinar.”

Yet CFSAC members, ME experts and ME stakeholders have been shut out of the HHS/IOM contract development and process.

Sooooo, how exactly is that “Nothing about us without us”? (Just to be clear — the question is in jest.)

Because the reality is that HHS is moving ahead on the IOM contract unilaterally and with total disregard for the overwhelming opposition from the ME community. HHS is undermining the work of ME experts while patients are suffering and dying.”

Take action today(!) and everyday (if you can).

Share widely and encourage others to act!

Tell HHS ENOUGH IS ENOUGH!

Subject line (variations encouraged): Stop the IOM Contract to Redefine ME/CFS

Send (daily) emails (from many people from any country) to:

TO: Kathleen.Sebelius@hhs.gov

CC: howard.koh@hhs.gov , txf2@cdc.gov , Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov , margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov , collinsf@mail.nih.gov , richard.kronick@hhs.gov , cfsac@hhs.gov , MEACTNOW@yahoo.com

Email templates can be found here:   http://www.occupycfs.com/2013/09/17/insult-meet-injury/#comments

and here:   https://www.facebook.com/events/705280782832088/

(MEACTNOW@yahoo.com is used to tabulate emails sent)

Dear Secretary Sebelius,

I strongly urge the Department to abandon its plan to contract with the Institute of Medicine (IOM) to define its own clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Researchers and clinicians with years of experience in studying and treating this disease have already created peer-reviewed case definitions – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. These definitions are supported by clinical guidelines for medical practitioners, guidelines also created by experts. These definitions are well regarded by patients, ME doctors, and ME researchers. The CCC has been used both clinically and in research for years.

But rather than adopt these expertly defined disease criteria and the associated medical guidelines, HHS has promoted its own overly broad view of ME that does not require the hallmark symptoms of ME. HHS has questioned these hallmark criteria and misrepresented our disease in its medical education. HHS has even unilaterally reclassified “CFS” to be a subtype of chronic fatigue, in complete opposition to the standards set by the World Health Organization and all other countries that classify this disease as a neurological disease.

Now, HHS is intent on defining its own new criteria for ME using the IOM, an organization whose only effort to define a disease was harshly criticized by Gulf War Illness Advocates for redefining the disease too broadly and for using non-experts to define the disease. HHS has repeatedly stated their intent to use non-experts to define ME. This is a very serious concern for patients who face widespread disbelief every day from the general medical and research community. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report on Gulf War treatments failed to accurately represent ME and listed CBT and GET as treatments, treatments that our experts have said can be harmful.

HHS is progressing the IOM contract unilaterally and with disregard for the overwhelming opposition from the ME community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.

I strongly urge HHS to abandon its plans to contract with the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt a definition that our experts have created and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

(sign your name)

Background info for those sending emails   (do not include with email) —— https://dl.dropboxusercontent.com/u/89158245/Action%20Alert%20Sept%2017%20HHS%20on%20IOM.pdf

We encourage you to take action and to share widely

We direct your attention to these posts on Occupy CFS and Twenty Years and Counting

http://www.occupycfs.com/2013/09/16/cut-back-or-cut-out/

http://twenty-years-and-counting.blogspot.com/2013/09/tell-dhhs-to-stop-all-attempts-to.html

http://twenty-years-and-counting.blogspot.com/2013/09/tell-congress-president-no-to-iom.html

Take action.

Share widely.