Congratulations! The email campaign to stop the US Department of Health & Human Services (HHS) from contracting with the Institute of Medicine (IOM) to develop "clinical diagnostic criteria for ME/CFS" was successful! An update posted on September 4th on the contract solicitation notice read: “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.”
BUT WE CANNOT STOP EMAILING NOW! HHS later that day added to this same notice, “...HHS will continue to explore mechanisms to accomplish this work.” No one knows what these “mechanisms” are and it is not at all clear what HHS intends to do. Everything Department officials have said and done points toward simply finding another means of redefining ME (and quite possibly folding it into "Chronic Multi-Symptom Illness"). HHS has repeatedly and publicly stated their intent to use non-experts to define our disease at CFS Advisory Committee (CFSAC) meetings. HHS has even questioned whether post-exertional malaise or post-exertional neuro-immune exhaustion is really required. And most of all, HHS is recreating what experts have already done.
Having non-experts (who most probably at best know of the CDC’s representations of our disease) create yet another definition is dangerous and could set back ME research and clinical care for years. It is also a waste of precious time and dollars that should be spent validating biomarkers and studying treatments.
Therefore, it is vitally important to continue emailing DHHS with a slightly different message. Note that this is a DAILY email campaign until further notice. The sample provided reflects that there no longer is a solicitation for a contract with IOM to develop a definition, but that DHHS is seeking another "mechanism" to do this.
INSTRUCTIONS FOR EMAILING HHS (daily):
1.If you are using the sample email provided below, copy the sample email into the body of an email message.
2. Add your name to the end of the letter.
3. Add the Subject Line “Stop Your Attempts at Redefining ME".
Feel free to change the subject line from time to time to avoid spam filters. Another tip: If you have more than one email account, use one on one day and the other on another.
4. Copy the following addresses into the ‘TO” and “CC” boxes
CC: firstname.lastname@example.org, email@example.com, Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov, firstname.lastname@example.org, Mary.Wakefield@hrsa.hhs.gov, email@example.com, firstname.lastname@example.org, MEACTNOW@yahoo.com
The CC includes addresses for the following: HHS Assistant Secretary Howard Koh, AHRQ Director Richard Kronick, CDC Director Thomas Frieden, CMS Administrator Marilyn Tavenner, FDA Director Margaret Hamburg, HRSA Director Mary K. Wakefield, NIH Director Francis Collins. The email address MEACTNOW@yahoo.com is used to track the numbers of messages sent.
SAMPLE EMAIL - To be copied into the body of an email message.
Dear Secretary Sebelius,
I understand that HHS has cancelled the IOM contract but will “continue to explore mechanisms to accomplish this work”. While I appreciate that the Department has responded to the public by cancelling this contract, I object to the Department continuing to explore other mechanisms to define criteria for "myalgic encephalomyelitis/chronic fatigue syndrome”. The experts have already defined this disease.
I am a member of the ME community and have witnessed firsthand the devastation of this disease. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.
Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. Both are accompanied by clinical guidelines for medical practitioners and are well regarded by patients, ME doctors, and ME researchers. The CCC has been used both clinically and in research. Given that expertly defined and accepted consensus clinical criteria already exist, anything other than officially adopting one of these definitions wastes scarce taxpayer dollars and is unnecessary.
HHS has inexplicably refused to accept what ME experts have produced and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease and conflated it with “CFS”. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.
Instead of secretly and unilaterally exploring mechanisms to to redefine a disease that ME experts have already defined, why not use the funds set aside for the proposed IOM contract for meetings of ME experts to build on and refine the consensus definitions, as recommended by the CFS Advisory Committee? This would allow them (free of interference from government bureaucrats) to agree on biomarkers, testing and treatment -- all of which those affected by ME sorely need NOW.
It’s time to do the right thing. Stop defying President Obama’s Open Government Initiative and set up transparent communications with the ME community. Give ME experts the resources to do their job. Stop redefining my disease and instead follow the lead of our top ME experts on the disease definition.
<Add your name here>
(For your information; not to be included in the letter.)
On August 27, the US Department of Health & Human Services (DHHS) announced its intent to award a sole-source contract with the Institute of Medicine (IOM) to develop new clinical diagnostic criteria for "ME/CFS". An email campaign appears to have stopped this, as there was an update posted the morning of September 4th on the contract solicitation notice which read: “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request." On the afternoon of the same day, the notice was revised to state, “This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.”
Stopping the IOM contract last week is not enough. We all need to be very concerned with what HHS is now planning. Here’s why:
HHS has repeatedly stated their intent to use non-expert researchers and clinicians to create case definitions for ME/CFS. Consider how non-experts view our disease – with disbelief, as laziness, depression, or deconditioning. If they have not heard of it, they will most certainly come across the CDC’s biased website information. How are they in a position to create a better case definition than the definitions that our experts have created?
HHS has repeatedly ignored hallmark symptoms like post-exertional malaise (PEM) and post-exertional neuro-immune exhaustion (PENE) and questioned whether these should even be required. Instead, they have promoted an overly broad view of the disease that encompasses non-specific causes of chronic fatigue. In fact, HHS has reclassified “CFS” to be a subcategory of “chronic fatigue” even though the World Health Organization has classified it as a neurological disease. Dr. Unger, in charge of the CDC’s CFS program, has gone so far as to link us with neurasthenia and other vague “syndromes”.
HHS claims it is responding to the CFS Advisory Committee (CFSAC) recommendation, but this is not the case. The CFSAC recommendation called specifically for a meeting of experts. Additionally, they called for those experts to discuss a case definition useful for research, diagnosis and treatment and for that discussion to *start* with the 2003 Canadian Consensus Criteria.
HHS Secretary Sebelius personally believes government bureaucrats should not be involved in defining diseases. Dr. Nancy Lee, Designated Federal Officer for the CFSAC stated, “In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community...I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She [HHS Secretary Sebelius] basically said that this has to be coming from the medical community.” (CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.)
HHS is acting unilaterally and secretly to advance its objectives. The IOM proposal, in the works for months, caught all of us, including our experts, by surprise. It was not discussed at the May CFSAC. In fact, HHS staff refused to discuss the case definition at all when asked to so by other CFSAC members. HHS staff also resisted requests by CFSAC members to have input on who would be involved in the NIH Evidence Based Methodology, another HHS definition effort. There are numerous other examples, even beyond the definition issue, where HHS has refused to provide information or to engage the ME community as the key stakeholders.
HHS Announcement of the Solicitation for “Study for Diagnostic Criteria for CFS” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1.