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:
CC: email@example.com, firstname.lastname@example.org, Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov, email@example.com, Mary.Wakefield@hrsa.hhs.gov, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, MEACTNOW@yahoo.com
Subject: Stop the IOM Contract to Redefine ME/CFS
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.
I will keep you informed as things develop. I hope you will join me in this effort!