Summary of the IOM Contract Situation

[asleep]

I have attempted to summarize below the salient facts and objections to the IOM contract. Hopefully this can be of help to anyone struggling to understand it from all the different threads or to anyone in need of a simple way to explain it to others.

Please let me know if you have any suggestions.

What Is Happening?

The Department of Health and Human Services (HHS) has recently contracted with the Institute of Medicine (IOM) to redefine Chronic Fatigue Syndrome (CFS).

In October 2012, the CFS Advisory Committee (CFSAC) recommended a workshop to create an improved consensus definition for CFS research and clinical practice. This workshop was supposed to 1) involve CFS stakeholders, 2) be in consultation with CFSAC members, and 3) start discussion with the 2003 Canadian Consensus Criteria (CCC) for ME/CFS [1].

The IOM contract completely circumvents this recommendation by violating all three criteria. Furthermore, after learning of the contract, 35 experts on CFS (clinicians and researchers) signed a joint letter to HHS Secretary Sebelius urging cancellation of the contract and reiterating the need to build upon the CCC [2]. Secretary Sebelius has not even acknowledged this letter.

Despite government shutdown, the HHS is acting with haste and secrecy in pushing forward with the IOM contract in an apparent attempt to head off organized opposition from the CFS community. The HHS has also co-opted the acquiescence of two CFS advocacy organizations (CFIDS Association of America (CAA) and Pandora) to usurp and misrepresent the voices of many patients who are opposed and want the contract cancelled.

Why Is This Contract Bad?

Patients are opposed to this contract for many reasons:

• The great haste and secrecy with which the HHS has set up this contract, which has precluded patient input and timely objection and belies an ulterior motive.

• The precedent set by a similar IOM contract for Gulf War Illness (GWI): The result was a costly panel consisting entirely of non-experts and psychologically-biased participants that ignored research on biological abnormalities and redefined GWI as Chronic Multisymptom Illness (CMI), officially recommending only psychological interventions for a devastating physical disease.

• The IOM’s infatuation with evidence-based medicine (EBM), while laudable in some ways, is inappropriate for the task. EBM is inadequate when confronted with medical ambiguity and will likely serve as a filter that overstates the value of pseudoscientific psychogenic research due to its disproportionately biased funding, as was the case with GWI.

• The IOM’s stated commitment to disallowing “biased” panel members will plausibly be used to exclude expert CFS clinicians and researchers.

• The disrespectful refusal of the HHS to acknowledge or respond to the joint objection from CFS experts.

• The deliberate circumventing of the CFSAC recommendations by the HHS.

• The estimated cost of the contract ($1 million plus) is a waste of the limited and inadequate taxpayer resources allocated to CFS.

• The general mistreatment and marginalization that CFS patients have endured from the HHS over the past 30 years.

Given these concerns and others, there is little reason to believe that the HHS is acting in good faith. And even if HHS is acting in good faith, the secrecy and haste have prevented us from ascertaining whether the process and methodology being used will necessarily produce a biased outcome.

It is inconceivable that the IOM will proceed differently this time with respect to CFS when doing so would highlight and invalidate their reckless and irresponsible work with GWI. Patients anticipate that this contract, if it proceeds, will result in a similarly “official” mischaracterization of CFS as psychosomatic, creating further devastation and setback for CFS patients.

[1] http://www.hhs.gov/advcomcfs/recommendations/10032012.html
[2] http://bit.ly/15npS9B

 

[Nielk]

Its a great summary asleep. The only item I would add to that is the waste of one million taxpayers' dollars.

 

[Andrew]

Thanks for the summary. This will help me compose the letter I plan to write to the President this weekend. Heck, what have I got to loose. I just have to figure out where that webpage it for receiving communication.

If I manage to get it done this weekend I'll post it here. If anyone knows where the White House contact portal is, please let me know.

 

[Nielk]

Thanks for the summary. This will help me compose the letter I plan to write to the President this weekend. Heck, what have I got to loose. I just have to figure out where that webpage it for receiving communication.

If I manage to get it done this weekend I'll post it here. If anyone knows where the White House contact portal is, please let me know.

This is the site to submit comments http://www.whitehouse.gov/contact/submit-questions-and-comments

 

[asleep]

For those who like a bit of dark satire:

Join the CAA and Pandora in support of the IOM contract for ME/CFS!

With your support, or simply indifference, we can help the HHS and IOM:

• Create a new name that is less descriptive and lumps more unrelated ailments under the same umbrella as us. The name "chronic fatigue syndrome" is far too descriptive and restrictive!

• Make it easier to select treatment options by officially limiting our choices to anti-depressants, CBT, and GET. Fewer choices is easier!

• Make it easier to find a doctor who will regard us with contemptuous hostility and disbelief by aggressively publicizing our disease as psychosomatic. No more respect please!

• Make it more difficult for our expert clinicians to treat biological abnormalities without fear of reprisal from insurance companies and medical boards. Drive them underground like Lyme doctors!

• Give our family and friends officially sanctioned justification for disbelieving and doubting us. Soon they can cite an "IOM study" instead of having to rely solely on their own prejudice!

• Help our insurance companies save money by no longer having to pay for biomedical treatments. That means more payouts for other diseases that are actually legitimate!

• Help our government save money by giving them the tools and impetus to kick us off of disability. We don't want to be scroungers and malingerers anymore!

• Help our government health agencies avoid wasting money researching the biology of our disease. We want more research on coping mechanisms, childhood trauma, hay fever, and bat viruses!

 

[Valentijn]

Make it easier to select treatment options by officially limiting our choices to anti-depressants, CBT, and GET. Fewer choices is easier!

 

[justinreilly]

bumping

 

[justinreilly]

I have made a version with updates and some modifications in case anyone is interested. I have PMd Asleep to make sure this is ok.

The HHS Contract with IoM to Redefine ME/CFS

What Is Happening?

The Department of Health and Human Services (HHS) has recently contracted with the Institute of Medicine (IOM) to redefine Myalgic Encephalomyelitis aka Chronic Fatigue Syndrome (ME/CFS).

In October 2012, the federal CFS Advisory Committee (CFSAC) highly recommended a workshop to create an improved consensus definition for ME/CFS research and clinical practice. This workshop was supposed to 1) involve only ME/CFS stakeholders, i.e. experts, patients and advocates, 2) be in consultation with CFSAC members, and 3) start discussion with the 2003 Canadian Consensus Criteria (CCC) for ME/CFS [1].

The IOM contract completely circumvents this recommendation by violating all three criteria:

1) the workshop comprised only of stakeholders (i.e. experts, patients and advocates) was turned into a panel including 7 non-experts, including a non-expert chair, three psychologists, no patients and no advocates out of 15 panelists;

2) CFSAC has not been included whatsoever in the process, and

3) the panel is instructed to consider several definitions including those which are patently invalid.

Furthermore, 50 experts on ME/CFS (clinicians and researchers) signed a joint letter to HHS Secretary Sebelius urging cancellation of the contract and reiterating the need to immediately adopt the CCC [2].


Why Is This Contract Bad?

Patients are opposed to this contract for many reasons:

• The great haste and secrecy with which the HHS has set up this contract, in an apparent attempt to preclude timely objection by those effected.

• The precedent set by a similar IOM contract for Gulf War Illness (GWI): The result was a costly panel consisting almost entirely of non-experts and psychologically-biased participants that ignored research on biological abnormalities and redefined GWI as Chronic Multisymptom Illness (CMI), officially recommending only psychological interventions for a devastating physical disease.

• The violation of Federal Acquisition Regulations (FARs) due to the failure to open the contract to competitive bidding.

• The further violation of FARs consisting of IOM's strong conflict of interest in not contradicting its extremely inaccurate prior work on ME/CFS (included in at least five prior reports on GWI) which described it as being a psychological, not physical, illness.

• The IOM’s inflexible commitment to evidence-based medicine (EBM), while laudable in some ways, is completely inappropriate for the present task. EBM is inadequate when confronted with medical ambiguity and will likely serve as a filter that overstates the value of pseudoscientific psychogenic research due to its disproportionately biased funding, as was the case with GWI.

• The IOM’s stated commitment to the use of non-experts on its panels is extremely inappropriate for an attempt to define a very complex disease whose science and prior HHS definitions have been warped by politics.

• The deliberate circumventing of the CFSAC recommendations by the HHS.

• The failure of HHS to yet produce the contract despite several FOIA requests, the first of which it received in late September.

• The estimated cost of the contract ($1 million) is a waste of the limited and inadequate taxpayer resources allocated to ME/CFS.

• The general mistreatment and marginalization that ME/CFS patients have endured from the HHS over the past 30 years.

Given these concerns and others, there is little reason to believe that the HHS is acting in good faith. And even if HHS is acting in good faith, the secrecy and haste have prevented us from ascertaining whether the process and methodology being used will produce a biased outcome.

It is very hard to believe that the IOM will proceed differently this time with respect to ME/CFS when doing so would highlight and invalidate their prior irresponsible and highly inaccurate work with both GWI and ME/CFS. Patients anticipate that this contract, if it proceeds, will result in a similarly “official” mischaracterization of ME/CFS as psychogenic, creating further devastation and setback for ME/CFS patients.


What Can I Do To Help?

Please contact the following Members who chair committees with jurisdiction over HHS: Senators Harkin, Murray and Sanders; and Representatives Upton, Kingston, Pitts, and Ryan (WI). Please urge them to contact HHS Secretary Sebelius today to exhort her to adopt the Canadian Consensus Criteria and cancel the contract with the Institute of Medicine to redefine ME/CFS.


[1] CFSAC, Highest Recommendations from the Chronic Fatigue Syndrome Advisory Committee, May, 2013 http://www.hhs.gov/advcomcfs/recommendations/cfsac-recs513.pdf

[2] http://bit.ly/15npS9B

an Asleep and Justin Reilly Production; December 11, 2013