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Insult, Meet Injury

September 17th, 2013

Did you think that your efforts to tell HHS to freeze the IOM contract to create a clinical definition for ME/CFS were successful? Did you have the impression that your government would listen to your concerns?

Join me in mourning the death of my faith in the process.

We have learned that HHS is not only continuing to pursue this contract, but that they have every intention of signing it by the end of the fiscal year on September 30th. This is not fear mongering or over reaction. We have confirmation that this is true. Furthermore, HHS’s stated intention is to share information with the community only after the contract has been signed.

Yes, I know they just canceled a solicitation for such a contract on September 4th, saying, “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.” And yes, I know they said on September 12th that “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.” That listserv announcement creates the impression that nothing will be finalized before the November meeting if it’s going to be on the agenda, doesn’t it? Nope. That listserv announcement was smoke and mirrors.

There has been no consultation with our community, despite our public objections to their first attempt to do this. Instead, they pulled the first contract when we started to push back, but simply changed tactics and continued to negotiate the contract another way. And we are not the only people being cut out of this process. I have information from multiple sources confirming that the voting members of the CFSAC have not been consulted or informed about the IOM contract at any stage. Not earlier this year when the process began, and not in the last few weeks when it seemed to be blowing up.

I tend to be a reasonable person. I tend to respond to these controversies professionally, giving people the benefit of the doubt. I am not a conspiracy theorist. Today, I am shaking with rage. I cannot come up with a plausible, charitable way to interpret the facts here. They failed to announce the first contract notice, and withdrew it as soon as we objected. They strung us along with we’ll-discuss-in-November. Meanwhile, they failed to consult the people the Secretary has appointed to advise the Department on, among other things, “impact and implications of current and proposed diagnosis and treatment methods for CFS.” (CFSAC Charter, emphasis added). And at the same time, they plan to execute this contract by September 30th so they can obligate the (substantial) funds required out of FY2013 money. Under these circumstances, it is impossible for me to trust that the IOM contract will be structured in my best interest. I pray that I am wrong. I pray that if this case definition process goes forward that it will produce a definition that accurately reflects my disease. But the actions and statements of HHS, particularly the Office of Women’s Health, have given me no confidence in such an outcome.

I ask that you join me in SPEAKING LOUDER until our government hears us and takes appropriate action. Every day, we will be emailing Secretary Sebelius and her key deputies. There are multiple email templates available, including here and here. I’m sharing my email, and feel free to adapt it to your own needs:

 

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

Subject: Stop the IOM Contract to Redefine ME/CFS

Secretary Sebelius,

Your Department, acting through the Office of the Assistant Secretary, is unilaterally pursuing a contract with the Institute of Medicine to redefine ME/CFS, despite the objections of the affected patient community and without informing members of your federal advisory committee for the disease. I have no alternative but to ask that you stop this contract and listen to the subject matter experts on this disease.

OASH recently published a sole source solicitation for the Institute of Medicine to “develop consensus clinical diagnostic criteria for this disorder.” The request was swiftly cancelled after ME/CFS advocates objected to the backroom secrecy, short response time, and the IOM’s patent lack of experience in creating accurate and meaningful case definitions for diseases. Despite those objections, OASH has stated its intention to sign this contract (without publishing a sole source notice) by September 30th.

Your own CFS Advisory Committee recommended that you convene a “stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Document case definition and its utility for diagnosis and treatment of ME/CFS.” CFS Advisory Committee recommendation, October 2012. Not only has the recommendation been ignored, but OASH has concealed the plans for this IOM contract from the voting members of the Advisory Committee.

Your Department is progressing a contract to the IOM with no assurance that the actual clinical and research ME/CFS experts would be the ones staffing the consensus panel. Your Department has concealed its plans from the public and your own Advisory Committee. Your Department is pursuing this despite the overwhelming objections of the ME/CFS community.

I have no confidence that your Department and its agencies will act to protect me or to ensure that I can receive accurate diagnosis and adequate treatment of my disease. Your agencies and personnel have repeatedly ignored the hallmark symptoms of this disease, disregarded the case definitions authored by ME/CFS experts, and resisted meaningful engagement to address the scientific questions that have plagued this disease for decades. This latest episode has only increased, rather than allayed, my concerns. Your Department has failed to act in good faith at every opportunity in the last month, and I have no choice but to oppose this.

I urge you to consult with the researchers and clinicians who have actually worked on ME/CFS, and not rely on those with no direct experience or whose expertise is limited to overlapping or related conditions. We need transparency, accountability, and direct consultation with the experts, patients and advocates in order to have any hope of moving forward with an accurate case definition for ME/CFS. At present, your Department is only creating barriers to meaningful progress.

I ask that you stop this IOM contract. I ask that you bring all the stakeholders to the table to address this situation as equals. The climate of mistrust and bad dealing that these actions have created will haunt us for years to come, and a case definition that does not reflect the disease will set back research and treatment efforts for decades. None of us can afford for your Department to get this wrong.

Sincerely,

Jennifer Spotila

I will keep you informed as things develop. I hope you will join me in this effort!

 

  1. Sasha
    September 17th, 2013 at 15:09 | #1

    Done – thanks, Jennie.

  2. Garrett
    September 17th, 2013 at 16:28 | #2

    Speechless.

  3. Janelle Wiley
    September 17th, 2013 at 16:42 | #3

    Thanks for the updates, Jennie. Dismayed.

  4. Valerie
    September 17th, 2013 at 17:24 | #4

    Done, Jennie. I know it is so disheartening and totally out of sync with the last couple years with CFSAC. It is not even remotely excuseable to keep everyone in the dark and then cover it up. It feels like a 20 year regression just because of the lack of transparency, right?

  5. E. Jeanne Samonas
    September 17th, 2013 at 18:20 | #5

    I am not sure what happened to the voice of reason…when does the health of people not have impact on it’s gov’t? Granted I am NOT an American but I do live with MCS and other disabling chronic conditions….so I know what I am talking about when I say What’s it all about???? Why are you not doing the RIGHT thing? Listen do the experts who are trying their best to assist people living with MCS/FM/ME/CFS. Where are your bean counters? Surely it makes more sense to have people get well and back into the work force! This happens when real research can determine what are the issues and what needs to happen to get people well. I don’t care how I am scene by anyone including any gov’t but I do care that ALL GOV’TS ARE NOT DOING THEIR BEST FOR THEIR PEOPLE ILL WITH MCS FM ME CSF. JUST DO THE RIGTH THING AND ASK THE RIGTH PEOPLE TO BE PART OF THE PROCESS. May God Bless Us All in this Process! E. Jeanne Samonas

  6. Gabby
    September 17th, 2013 at 18:32 | #6

    Sent my letter out.

    I wonder how all this plays out in their mind? What is their end game? HHS has been charged wit caring for it’s citizens’ health. Is that what they have in mind by trying to redefine ME/CFS by a panel of non-experts? Is this how they are serving our best interests?

    My blood (whatever is left of it) is boiling too, Jennie. Thank you for another excellent blog and raising awareness of the truth of what is happening and for looking into all the legalities of it all.

  7. readyforlife
    September 17th, 2013 at 18:47 | #7

    Done….Thank you for writing the letter and email addresses. This makes it so much easier for me to send out the email.

  8. Katrina Berne
    September 17th, 2013 at 18:48 | #8

    Jennie, I’m furious right along with you and the ME community and I thank you for posting the template that makes it easy to voice our strong concerns. I have to wonder at the agenda of government agencies. Do they not understand, not care or do they have something to hide? It’s not paranoia when there are real enemies and I’m concerned that this is the case. Jennie, I am so grateful for the work you do to expose such ill-conceived plans as this one.

  9. rivka
    September 17th, 2013 at 20:44 | #9

    well, well. marginalized and delegitimized and ostracized yet again. history repeats itself.

    to make it even sadder, tom hennesey is no longer here to witness this further insult and be shaking with rage with us.

    may all this, including the loss of tom, be a call to action for our community.

    best,
    rivka

  10. September 17th, 2013 at 21:13 | #10

    I’ve written a rather long letter, basically concluding that although it is evident that they are being manipulated by the psychiatric lobby (they will know whether or not this is an inaccurate assumption!), and that the treatment recommendations which follow will undoubtedly deprive us of the chance we have to follow a course towards recovery, if we conserve our energy enough, I am aware that there is virtually no chance that they will have the courage to stand up against it. In the meantime, I have to ask how/why ME/CFS is an illness that is subsumed under ‘women’s health’? Figures indicating that more women than men suffer from it do not in any way imply that it is a ‘women’s health’ issue. Men don’t get ovarian cancer or period pains. They do get ME. But ‘women’s problems’ don’t have to be taken very seriously, do they. So just by being put in this category, our illness is already labelled in a way that makes it easier to dismiss.

  11. Deborah Waroff
    September 17th, 2013 at 22:17 | #11

    We need a lawyer. We need a injunction.

  12. Ess
    September 18th, 2013 at 01:48 | #12

    More politics at ‘throwing this biological disease’ into the waste basket–yet again!! This is BULLYING and CRIMINAL–really–undermining the process of getting to the answers and the cure of this debilitating disease. I’d also say ‘unbelievable’ — but given the ‘track record’ it isn’t (unbelievable) and is taking the progress to date . . . back decades. WHO and WHY would want this ?? This is NOT for the greater good–it is CRIMINAL and UNJUST!!!! The scientific truth will come out despite the cover-ups!!

  13. Joe Landson
    September 18th, 2013 at 06:48 | #13

    Weren’t you the one who tried to break me with a contract?
    Did you think I’d crumble?
    Did you think I’d break down and retract?
    Oh, no, not I!
    I will survive!

  14. Kathy
    September 18th, 2013 at 11:28 | #14

    I’m not surprised. Kathleen Sebelius hid behind the slow, inefficient bureaucratic process to continually deny little Sara, who was dying of cystic fibrosis, a lung transplant. It took a lot of attention from the press before a judge forced her to suspend the rules for children, rather than wait for the long review process required to modify the transplant rules.

    Maybe we should do likewise and appeal to the press. I hate to be negative, but I don’t think she cares.

  15. Ess
    September 18th, 2013 at 13:52 | #15

    Another comment—about government agencies/arms running amuck/out of control with their own agenda/s—take the situation with the IRS currently being investigated and exposed for such actions and cover-ups. This is not unlike the circumstances that the ME/CFS community finds ourselves in, in seeking bonafide answers to this disease. Our good doctors take an oath to ‘DO NO HARM’ in our medical care. However, the ‘politics’ and ‘agendas’ ‘set up’ surrounding ME/CFS are to the contrary–disrespectful and harmful to us as chronically ill patients as well as disprespectful to our good doctors.

    Let’s get to the truth!

  16. Ess
    September 18th, 2013 at 14:39 | #16

    To continue—First and foremost we are PEOPLE; with the unfortunate circumstance of having ‘become’ long-time patients ‘living’ every day with our lives stolen away in all facets because of ME/CFS. It seems being stricken with this ME/CFS chronic disabilitating disease has put us into a whole new category–as patients–not as PEOPLE with equal rights–wanting to gain our health and our lives back!!

    WHY has the ME/CFS people/patient group been targeted and treated in a lesser category of equal rights for human beings??

    This IS discrimination–and the epidemic of ME/CFS is growing.

    Surely, we need to find out what is driving the mindset/politics to NOT find the REAL answers—and correct this gross injustice NOW.

  17. September 22nd, 2013 at 02:07 | #17

    As always, I’m a week (at least) behind the times from a crash (indeed I’m being naughty being online even now). However, I’m confused. Isn’t the CDC doing a multi-site study to do the very thing HHS/NIH seems so determined to spend a bunch of money having IoM do? To be sure, CDC is doing something slightly different by actually gathering evidence whereas IoM would be merely evaluating what’s already there (which isn’t much and what is there isn’t all that great). But the goal — a definition of this disease upon which everyone can agree — is the same. Or, at least, I think it’s the same. Given that there are already too many definitions, why add yet one more unnecessary definition to compete with CDC’s forthcoming definition (and spend a load of our tiny pot of money doing so)?

    Apologies if I’m missing some important distinction, but if this IoM contract really is trying to duplicate what CDC is already in the process of doing, this could be a significant point to clarify for Sec. Sebelius in this era of sequestration.

    • Jennie Spotila
      September 22nd, 2013 at 08:34 | #18

      You aren’t missing anything, Michelle. One of the many criticisms we’ve made of the IOM contract is that it appears to be duplicative. We have asked how this effort fits in with the CDC and NIH effort. They have not answered.

  18. jane
    September 23rd, 2013 at 23:56 | #19

    thanks so much for the templates. outrageous!!!

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