I have obtained a copy of the Statement of Work (SOW) for the Institute of Medicine study on clinical diagnostic criteria for ME/CFS. I am making that document available to you in its entirety through this link. I am also offering my interpretation of some of the most significant provisions of that SOW in this post.
But first, I want to state up front how I got this document and what I’ve done with it. There have been a multitude of accusations and allegations swirling in the ME/CFS advocacy community over the last week, and I figure that someone somewhere will question my involvement, so I’ll just get this out of the way right now. I requested the SOW from Dr. Nancy Lee by email on September 24th. Dr. Lee’s office responded on September 25th with a brief variation on the original announcement. On September 27th, I responded to Dr. Lee’s office pointing out that I had requested a copy of the actual SOW document, and I attached a copy of the SOW from the IOM’s study on treatments for Gulf War Illness as an example. I also filed an expedited FOIA request for the document. Finally, at 6:20 pm on September 30th, Dr. Lee’s office sent me the Statement of Work document I link to above and that I discuss in this post. Simultaneously with publishing this blog post, I am also sending an email to a number of advocates giving them the links to the document and this post. Let me be clear: this post contains my opinions and mine alone. I did not share or discuss the SOW with anyone (except my husband) before publishing this post.
We have a number of lawyers, doctors and other professionals in the advocacy community. I hope they will examine the SOW closely and offer their own analysis. I also hope that our expert clinicians and researchers (including the 35 experts who signed the Open Letter) will also scrutinize the document. We need open dialogue among all the factions in the advocacy and scientific community. If there is any hope of salvaging the IOM process and shaping it to meet the needs of ME/CFS patients and their families, then everyone needs to share information and communicate with one another. We won’t all agree, but we can stop slitting each others’ throats.
On to my analysis – again, the full document can be viewed here. I want to focus your attention on five issues: what disease is being studied; the requirements for involving experts; the requirements for stakeholder input; the project timeline; and whether I think this whole thing is good or bad.
This SOW is seeking a single clinical definition for what could be multiple disorders.
The first page of the SOW states, “HHS will request that the IOM develop consensus clinical diagnostic criteria for this disorder.” (emphasis added) The term “ME/CFS” is used throughout the document and is defined on page 2 as follows:
For the purposes of this document ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness. (emphasis added)
I submit to you that this statement tells us a great deal. ME and CFS are not two separate diseases in the view of HHS. This is a value judgment that tells IOM that all the entities referred to by those names are really the same thing. Furthermore, all the entities described in the case definitions listed on page two, and the entity(ies) being studied in the CDC multi-site study, are all the same thing. This does not preclude the IOM committee from reaching a different conclusion, but this assumption is a pretty powerful frame for the scope of work.
My experts may not be your experts.
The biggest bone of contention regarding use of the IOM is the open question of how many ME/CFS experts will be involved in the committee. Most advocates, including me, tried to stop this contract because we feared that experts would not comprise the majority of the committee. The CFIDS Association position announced on September 23rd did not oppose the IOM contract as long as the new clinical definition was created by ME/CFS experts. Now that we have the SOW, we can make a better guess about how this will pan out. On page two, the SOW states that the committee shall have expertise in:
- the pathophysiology, spectrum of disease, and clinical care of ME/CFS;
- neurology;
- immunology;
- pain;
- rheumatology;
- infectious disease;
- cardiology;
- endocrinology;
- primary care, nursing, and other healthcare fields;
- health education;
- and the patient/family perspective.
I listed the categories on separate lines based on the placement of semi-colons, which is how the sentence would be understood grammatically. I would also like to point out that this list is different from the description of necessary expertise in the HHS announcement about the contract from September 23rd. Missing is the earlier reference to an expert in behavioral health, but the inclusion of “other healthcare fields” could easily be used as justification for including a psychologist or other behavioral expert. Also missing is expertise in epidemiology and developing clinical case definitions. Finally, I have to point out one additional qualification in the SOW: “Individuals with expertise in other multi-symptom, complex disorders or diseases may also be included on the committee.”
The SOW does not define “expertise,” as in how much experience is needed to qualify as an expert in ME/CFS. In their position issued last week, PANDORA said, “we define an ME/CFS clinical expert as a doctor who has primarily provided clinical care to ME/CFS patients for at least 10 years. We define an ME/CFS research expert as someone who primarily researches ME/CFS, particularly ME/CFS researchers who have published on biomarkers and definitions.” (emphasis in original; page 3 of Position Statement on ME/CFS Criteria). This seems like a logical definition to me, but no such definition is included in the SOW.
Another gap is the distribution of expertise among committee members. The SOW specifies that the expert committee should include 12 to 16 people (the HHS announcement said approximately 15). There is no minimum number of experts for any of the categories, including pathophysiology and clinical care of ME/CFS or the patient/family perspective. A literal reading of the SOW does not even preclude one person from claiming both of those areas of expertise. Not only does the SOW not require that a majority of the committee be subject matter experts, it doesn’t even require more than one of them. And I am certain that I am not the only advocate who finds the reference to “expertise in other multi-symptom, complex disorders” to be ominous.
Stakeholder input is mentioned but not defined.
The SOW includes a requirement for stakeholder input, but a careful reading shows that the requirement is not very specific and could be meaningless. The first topic area of the task described on page two states, “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” (emphasis added). On page three, the SOW describes that process with a bit more detail:
During one or more public meetings, the Committee shall consider the testimony of ME/CFS patients, caregivers, and advocacy groups in addition to relevant subject-matter experts such as clinicians, researchers, service providers, and public health officials.
Sound good? Let’s parse this sentence. First, it specifies “one or more public meetings.” That means only one public meeting is required. There are no requirements as to the duration of that meeting or meetings. By comparison, the public meeting for the IOM’s Gulf War Illness definition study lasted five hours. One hour was devoted to discussion from five patients. Six physicians/researchers had a combined 90 minutes to speak. Open public comment was limited to 30 minutes. I have found no evidence that IOM has employed a comment docket for that panel, like FDA did for the April ME/CFS meeting. Under the terms of this ME/CFS SOW, a five hour public meeting with a single hour dedicated to patients would be sufficient. I don’t know whether the IOM will do a better job in our case, but the SOW does not require it.
There are many different groups included in the SOW “stakeholder input.” Testimony will be considered from patients, caregivers, advocacy groups, clinicians, researchers, service providers AND public health officials. Seven categories, each with very different skill sets and goals. The FDA April 25th meeting spent most of the four hours hearing from patients and caregivers, with a few groups and clinicians sprinkled in. Furthermore, the April 25th meeting posed a series of very specific questions to focus discussion on what was most relevant to FDA, and also used a facilitation format to identify high priority common themes.
Finally, this part of the SOW says the committee shall “consider” the stakeholder testimony. It does not tell the committee HOW to consider the input or how much significance and weight it deserves. There is no stated goal for considering that input or answering stakeholder concerns. The SOW is intentionally broad, so the committee will have complete discretion to disregard all the input it receives at one extreme or rely on that input to shape the entire outcome at the other extreme.
There is a timeline but no start date.
Page three of the SOW lists a draft timeline of the project stages, but provides no start date for the clock to begin ticking. If we assume that last week’s HHS announcement is accurate, then the start date was some time in September. In that case, the 18 month timeline for this project will conclude by March 31, 2015 (that is also the deadline noted on page four of the SOW). You can see the full timeline in the SOW document, but I want to point out a couple important dates that I calculated by assuming work began at the end of September 2013.
- By December 2013: “Seek committee nominations, assemble committee, begin background research; contact stakeholders” That means nominations to the committee will be due very soon, and we better get ready for that. There is no explanation of how nominations will be collected or what is meant by “contact stakeholders,” including which groups are included or the purpose(s) of the contact.
- January -March 2014: “Hold first committee meeting; plan workshops – identify topics and potential speakers; identify information needs; develop plans for receiving stakeholder input” The SOW does not explain what the “workshops” will be, and obviously there is no stakeholder input by this point because plans for collecting it are still being formulated.
- March-July 2014: “Hold second and third committee meetings with workshops; develop report outline and workplan; hold working group conference calls; seek and receive input from stakeholders” Are the workshops for the committee or for the public? Notice that the report is being outlined at the same time as stakeholder input is being received.
- August-December 2014: “Hold fourth and fifth committee meetings; draft and revise the report; draft recommendations” Presumably stakeholder input has been concluded. Hopefully it will be considered as the recommendations are drafted. Stakeholder input is not mentioned in the timeline after July 2014.
Good Or Bad?
It is important to understand the process that the IOM typically uses in its studies in order to assess whether this SOW is good or bad for us. Detailed information describing that process is available on the IOM website. I highly recommend reviewing that information. A few things stand out to me:
- The sponsor of a study has no control over the study once the “statement of task” and budget are finalized. I have not been able to determine if the SOW I analyze here is the same as the finalized statement of task referred to by IOM.
- Panelists serve without pay.
- Input is gathered in public meetings, but committee deliberations are held in private.
- Select criteria for committees: “The committee must include experts with the specific expertise and experience needed to address the study’s statement of task. . . . Having the right expertise is not sufficient for success. It is also essential to evaluate the overall composition of the committee in terms of different experiences and perspectives.”
At the risk of repeating myself, I will say again that the caliber and prominence of the Institute of Medicine is well-deserved. The conclusions published by the IOM have an extraordinary influence over whatever topic is at issue. My quarrel is with the study defined in the SOW, not with the IOM itself.
While some people may trust that the IOM will select the “right” panel for the ME/CFS clinical case definition study, it is my opinion that this is based to some degree on hope or optimism. There is nothing in the SOW that requires the committee to have a majority comprised of ME/CFS experts. It is entirely possible that IOM will appoint more experts than non-experts, but there is no proof that this will be the case. It could just as easily swing the other way. For people who insist this committee will have the right make up, please show me the data that supports this certainty.
I am very afraid that the IOM will appoint more non-experts than experts to the committee. I can’t prove that I’m right, but the SOW and the IOM process leaves holes big enough to drive a truck through. I am also deeply concerned that the extent of stakeholder input is left to the discretion of the committee, and it’s possible that there will be little opportunity to for us participate. Again, I hope I’m wrong but the SOW does not mandate much stakeholder participation. I also do not have much hope that we can force the cancellation of this study. The government is more than preoccupied with the shutdown and budget woes, and there is scant political will for Congress to act on our behalf.
So for my part, I am focused on two things regarding the IOM: participation in suggesting nominees for the committee, and closely tracking this study to maximize transparency and accountability. I want to hear more from the 35 experts who signed the open letter to Secretary Sebelius. I want to hear more from the experts who did not sign the letter, for any reason. And I want to hear more from my fellow advocates. Pick apart this SOW. Let’s crowdsource analysis and action.
Jennie, does the process the IOM has on their website say the intended members are shown publicly for public opinions before the final designation?
From the IOM website:
Specific steps in the committee selection and approval process are as follows:
Staff solicit an extensive number of suggestions for potential committee members from a wide range of sources, then recommend a slate of nominees.
Nominees are reviewed and approved at several levels within the National Academies; a provisional slate is then approved by the president of the National Academy of Sciences, who is also the chair of the National Research Council.
The provisional committee list is posted for public comment in the Current Projects System on the Web.
The provisional committee members complete background information and conflict-of-interest disclosure forms.
The committee balance and conflict-of-interest discussion is held at the first committee meeting.
Any conflicts of interest or issues of committee balance and expertise are investigated; changes to the committee are proposed and finalized.
Committee is formally approved.
Committee members continue to be screened for conflict of interest throughout the life of the committee.
“For the purposes of this document ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness. (emphasis added)”
REALLY? I stopped right here. This is a whopping big assumption. I understand the attempt is to try to be clear about the”disorder”, but is that not the point? ME and CFS expert doctors and researchers have the expertise to know that patients present differently. There is no clarity…so just lump the terms into one. It’s not logical.
Secondly…just as in the CFSSEP, experts in many fields come together to review grants. Perhaps there are 2 ME or CFS experts. on a grant panel and the majority have no interest or understanding of the proposed research. THIS works poorly for our researchers.
I do not think the IOM would do well to select top notch, I mean world class experts, in say, neurology, only to find out that our cognitive problems which can be very disabling, are outside the neurologists’ experience.
Swiss cheese for me, honey. Many issues to consider.
THANKS J…again, good, good thinking and writing. I appreciate it!
While we may want the HHS to backtrack on the contract, I think we need to send a deeper message:
Does the HHS/IOM want to make the same mistakes that the CDC did?
If they fail to listen to the community, they will almost certainly make the same mistakes.
Mistakes include:
A failure to consult practitioners who have the most experience dealing with patients with ME and CFS.
Choosing a name that invalidates the severity of the condition and is deeply unpopular with patients.
Vague case definitions that include everyone under the sun.
Over emphasis on behavioural interventions when these interventions have consistently failed to demonstrate objective improvements in functioning. Non-pharmacological RCTs are not the same standard of evidence and pharmacological RCTs since there is no blinding and as such, higher quality evidence is needed for a convincing evidence base.
We need to speak loud and clear that if they continue to repeat the same mistakes as they did in the past, the patient and advocacy community will uniformly reject their recommendations.
Though not all patients and advocates agree on all issues, we really need to unite (internationally) and listen to one another, decide on issues democratically to see what we really agree on. Then we can finally speak with a single voice with authority.
“Gulf War Syndrome is back
Immediately after the first Gulf War in 1991, this author was an early and outspoken defender of US and allied military veterans returning home with a mysterious and often-fatal disease. Immediately, governments called the victims “crazy”, “financial scam artists”, “cowards” or “hypochondriacs”. Government-funded medical facilities echoed the Clinton administration’s official line that no such disease existed, especially not something being called ‘Gulf War Syndrome’.
Doctors and government officials alike called the tens of thousands of cases of Gulf War Syndrome nothing more than the age-old result of war – battle fatigue and shell shock. But a suppressed, dirty little secret slowly leaked out of the military and veteran community – soldiers’ wives were now experiencing the same symptoms as their infected husbands. Military couples also began reporting their babies being born with Gulf War Syndrome. And then, over the next two decades, the story and the devastated veterans simply faded out of the headlines.
Is it contagious? One victim says yes…”
http://www.whiteoutpress.com/articles/q22013/mysterious-hiv-negative-aids-infects-millions/
Thanks Jennie.
What’s your position/thoughts on this insistence of having a separate clinical and research definition/criteria? Only I for one can’t see why they shouldn’t be the same – given where we are with the research and understanding of our disease at present. And certainly the 35 experts couldn’t either.
Also I am not especially surprised that they seek to condense the various names you have given or been given over the years to this disease: looks like we will not escape from the ‘fatigue’ label anytime soon, and I notice Myalgic Encephalopathy does not feature – though it could be covered I suppose by ‘other terminologies’, but some would argue even that is not an appropriate name for all those with these labels of course.
And that is really the issue at hand isn’t it? A distinct lack of consensus – resulting in the HHS stepping in to quell the squabbles. The lack of transparency, the lack of communication, the (some would say) ‘underhand’ shenanigan’s that have been employed – it’s hardly a recipe for confidence in either HHS or IOM is it?
I do wonder what position CFIDS will take once it has heard back from the 35. Between a rock and a hard place I would imagine, if they decide not to change their position. Is it better to be at the table – or adamantly refuse to take part? Never an easy decision, but I’d be at the table if it were me.
Hopefully, we will hear more detail and substance soon from those involved. I appreciate the SOW, Jennie. Thanks ever so much.
Regarding separate criteria for research and clinical diagnosis: research studies need to have the cleanest possible cohorts. For example, a study might want to exclude people with ME/CFS and fibromyalgia because FM might confound the results. But clinical diagnosis should accomplish some “squishiness” (for lack of a better word) because patients come in with multiple health issues. Someone could have sleep apnea and ME/CFS, but when the apnea is treated the ME/CFS remains. So clinically, that person should be diagnosed with ME/CFS but I understand why a researcher might not want such a person in a study. I think the real question is how different the two criteria will be. I would not want to see PEM required for research and not clinical diagnosis, for example.
Jennie
Thank you for getting this out in the open and for the excellent analysis. Obviously this underscores all the concerns that we raised with HHS’ plans but two stand out the most.
First is the question of what disease this initiative is focused on – ME as patients experience it or all the conditions that fall under any of the CFS definitions. This is a critical question because as you say, it frames the entire discussion to be a single definition for a broad set of unrelated conditions. It also drives what evidence will be considered, including evidence from Oxford studies. As long as the contract specifies the diseases to be covered by the new definition in this way, its hard to imagine how the IOM can deviate and focus on the disease that patients actually have.
No matter how good the panel is and no matter how transparent and accountable the process is, this initiative can not rise above the job that it has been given to do – create a broad definition.
The second issue? Our experts already have consensus on the CCC, a definition with years of experience. This initiative is unnecessary and wasteful, especially when ME research has gone begging for so many years. Our government is in shutdown and this is how HHS chooses to spend money?
Wasteful, unnecessary and harmful! We need to continue to call for this effort to be stopped and for HHS to follow the lead of our experts!
Of course, the irony is that the people we need to go to – our legislative leaders – have been furloughed. So patients may want to save their energy until the staff at the legislative offices go back to work and then contact them.
My comment is missing? Why?
Eco, I double checked. You posted your comment on the “Trust” post and it is there.
It’s really perplexing that our advocacy organization appears to be so supportive of the IOM effort. Going out of their way to call certain ME experts advocating the CCC for any reason at all is seriously disconcerting and really calls into question who exactly the CAA is representing and what their goals really are. This doesn’t pass the “smell test”.
In my opinion, the CAA should immediately pass a resolution (or whatever) declaring their support for the 35 ME experts and the CCC as the current baseline for diagnosis of this condition. The IOM is clearly heading in the opposite direction. It’s the least that the CAA can do is state their position on whether diagnosis should be stricter or more open than Fukuda – right now, not some theoretical point in time after “more research has been done”.
Mary Dimmock: “Wasteful, unnecessary and harmful! We need to continue to call for this effort to be stopped and for HHS to follow the lead of our experts!”
Exactly. Focus: all these lengthy discussions miss the point. Our goal is not to analyze what the government has done, but to rise up and oppose them. Until CDC accepts our experts, we are just amusing ourselves with busy work. Act Up, not cooperate.
Why would anyone think that the same institute with the same board and the same charge would produce anything different than they are with GWI or more accurately CMI?
I don’t know if the experts will boycott this activity, but if not there is no reason why the immunologist, infectious specialist, etc. cannot be drawn from the pool of real ME/CFS experts. For example, Klimas is an immunologist, Chia is an infectious specialist, etc. It might even be possible to fill every one of those specialties with a real expert.
OTOH, the IOM could purposely avoid people who are expert and specialist. And if they did make this play, they would be padding the panel with people who have less knowledge and experience. But I think that’s the message the SOW is sending by mentioning ME/CFS experts in a way that suggests they be a minority presence.
I am so happy to read that some people get it. If CFS & MEers’ want to understand what we need to be collectively doing, they should watch this award-winning documentary about how “ACT-UP” was born.
2-minute movie trailed –> http://surviveaplague.com/
As I stated in my recent federal testimony (Washington, DC): “Over the past 9 years, after opening my private foundation, I got the White House to open an investigation, Senator John Kerry to forward my case to the head of the CDC, and the U.S. Global AIDS Coordinator to forward my case to the NIH/NIAID.
Amongst other things, my blood has been to the CDC-Atlanta (twice) and to the Washington-DC pathology labs. I have sat on conference call with the American Red Cross. Facilitated by the United Nations, I have been out of the USA (twice now) to meet with a Nobelist and his colleagues to provide blood samples.”
How did I do all that?
I act-up. I don’t herd around follow government-funded research. I buck-the-system.
I can only imagine the profound possibilities if every CFS & MEer started doing the same. It would be history-altering! “THE PEOPLE UNITED WILL NEVER BE DEFEATED!”
Thanks so much for getting this information and going through it so logically for us, Jennie.
So what should our response be? Ask that the contract be re-written to reflect the importance of including experts in the actual disease and the necessity of reducing misdiagnosis and conflation with other conditions?
(noting the high rates of misdiagnosis of a variety of other diseases especially when using Oxford or the Empirical approach? We have studies to support this. We also have precedent for including a majority of experts from the actual field being studied.)
After researching IOM charter with regard to the Veterans Administration, statements from the Secretary of Veterans Affairs and patient advocates of Gulf War veterans, I believe that this is a coordinated effort from the highest level of government. I believe these policy directives were issued from within the White House. I have no proof other than these changes were order by secretaries of various deparments of the excutive branch so authorization was approved by White House staff.
The fallout from the veterans administration is great among the Gulf War veterans patient community. For the IOM to redefine GWS or GWI as CMI over the objections of Congressionally mandated Research Advisory Committee and than to gut that committee refocusing the VA to research and treat CMI as a psychiatric issue is alarming.
http://www.med.umich.edu/1libr/aha/umcmi.htm
Gulf War illness advocates skeptical of institute panel
http://www.usatoday.com/story/nation/2013/06/26/veterans-institute-of-medicine-gulf-war-illness/2458745/
There are other patient communities that are affected by the IOM contract. In particular not only the GWS but Fibromyalgia, Lyme, MS, Lupus patient communities. They should be made aware of the issues concerning the IOM redefining illness criteria over the objections of researchers and clinicians and the destructive aftermath on the GWS patient community We should reach out and solicit their help in rescinding this contract.
Jennie,
The immensity of your contribution to the ME community cannot be overemphasized. You are a diamond in an otherwise dark coal mine.
Rich Carson
PS. My personal feelings is that patients have more to gain from this adventure than to loose. Our crummy definition already lets people with major depression (only) claim that they have ME, and it is no secret that the CCC and the International ME definition are far better because they are more stringent. My gut tells me that we are going to end up with a much better new definition that looks a lot like CCC. Let’s embrace the change, but steer the results as much as possible.
I agree with Rich.
I am very grateful, Jennie, that you are watching out for us and have dedicated your time and energy and heart to our cause. You have provided excellent coverage of a very complicated political issue.
My positive take on this is that I have hopes for a decent, if not good, outcome for us. The quote below from the statement of work is what gives me the greatest hope. If they accomplish nothing else but eliminating the ‘frank disbelief’ in the medical community, then it will benefit us. It sounds like the spirit of the SOW is in favor of calling ME/CFS a real disease rather than a mental state like depression, but I’m still glad you are monitoring it so very closely!! Thanks you!
From the SOW:
“Clinicians and medical professionals disagree on many aspects of ME/CFS, ranging from frank disbelief in the illness to confusion about the application of clinical diagnostic criteria. In collaboration with CFSAC ex officio agencies (including NIH) HHS will request that the IOM develop consensus clinical diagnostic criteria for this disorder. A widely accepted clinical definition and a clear distinction from clinical trials and research case definitions would aid in advancing clinical care, drug development, and basic and translational research for ME/CFS.”
We certainly need the experts in the science and research of ME/CFS advocating for us on the panel (i.e. of the 35 and others)—NOT experts ‘in general’ that have NO expertise in ME/CFS–’round and round the mulberry bush’ we go . . . to our detriment; viewing ME/CFS with OLD INVALID information. The importance of ensuring that MANY ME/CFS experts are on that panel cannot be understated!!
Our sincere thanks to you, Jennie, in advocating for the ME/CFS community!!!
Thanks for your work!
Whats your opinion on Lucinda Batemans statement?
@Rich Carson
One has to ask why now? Why is this so rushed? Why is this being done in tandem with GWI? The initial feedback from the IOM’s work with GWI is not encouraging. In fact, there seems to be evidence that they are going in the wrong direction. Since the government showed up in Lake Tahoe 30 years ago they’ve treated “CFS” with nothing but disdain and ridicule. There’s nothing to suggest that this attitude has changed. It would seem the correct position would have been to delay the IOM contract until after this community could assess how seriously they took that condition and whether the definition turns out to be better or worse. It’s not looking good so far.
An interesting link here about Dr. Bateman ‘of the 35’ changing her mind.
And this GWI ‘waste basket’ treament–Graded Exercise, Cognitive Behaviour Therapy and Anti-depressants . . . Realllly–how shameful–WHAT a cover-up–and WHAT a DIS-service to the military who sacrificed it all! Those ‘treatments’ are what have been (in the past) recommended for ME/CFS. Those are NOT bona-fide treatments–they are a farse in a cover-up in NOT wanting the science to get to the truth and the answers about the/se diseases.
Let us NOT be BURIED in these harmful ‘politics’ AD NAUSEAM.
http://thoughtsaboutme.com/2013/10/02/perfect-is-the-enemy-of-good/
In the fall of 2009, there was much attention given to ME/CFS in the news with the announcement of Retrovirus XMRV.
Although XMRV was subsequently found to be the results of ‘cross-contamination’ (??), between then and now, 2009 and 2013–much research is happening worldwide with resounding results of a serious chronic debiltating biological disease–tho unfortunate to have been MIS-labelled with a ridiculous dismissive name/label of ME/CFS.
Fast forward to today, four years later–‘politics’ are threatening to throw CREDIBLE science out the window and take us back to square ‘none’. Politics . . . looking for the ‘weakest link’ . . . This is all SOOOOOO WRONG!!!
The only other definition the IOM has taken on is on Gulf War Illness. The chairman of the project and former Institute of Medicine President, Dr. Kenneth Shine, said he couldn’t remember the last time the OMI produced a definition. They’re not exactly experts… Only three of the sixteen panel members had any experience in GWI, and of those, only Suzanne Vernon didn’t have a psychological bias toward it. They enlarge the patient population to include non 1991 Gulf War veterans. I can see the same thing happening with the ME patient community including the Oxford, Holmes, Reeves, Fukuda patients.
The IOM disregarded all scientific data from the Congressionally mandated Research Advisory Committee and remanded the treatment back to psychiatric treatment modalities through redefinition of patient criteria from GWS to CMI.
The CFIDS organization and all patient advocacy organzations, members of the CFSAC, all clinicians and researchers, patient organizations should openly oppose, boycott and disassociate themselves from the IOM committee to redefine this illness until there is absolute assurance that the board clearly represents the views of the ME/CFS clinicians and researchers and accepts in the record the 4,500 published scientific research articles to date. By being a participant, they legitimatize the process.
After the last few years of advancement in legitimizing this illness among the scientific community, CAA actions is so irresponsible because it places the patient population at risk once again in being marginalized by the medical profession. Their actions are reprehensible.
@lemonfoundation But you’ve never said what came of these further government investigations. Did you hear anything back, or did the health authorities keep the data to themselves?
@Eco ‘Not sure about WH, but Gulf War and Health is a sick read. IOM openly started with Fukuda’s crap; then, like IDSA does with Post-Lyme, they talk about CMI, CFS, FM, as IBS as distinct wastebaskets without clearly telling the difference. Lots on somatization, pain thresholds, stress (i.e., child abuse), and anti-depressants though, with a mention of inflammation and the HPA and “gut-brain” axes just to say it’s not all in their heads but it’s not the war’s fault.
I didn’t see anything at IOM’s site specifying who selects panelists. Of 15 for that report, five were psychiatrists/psychologists, two had a GI pedigree, three were neuros/rhemies, and the rest were epies, pharmies, or just general docs or health policy types. One was Airborne and another from Walter Reed, but few had any military interest. No one was versed in chemical warfare or radioactivity. GW I researchers like Golomb, Haley, and Barinuik were left out. In fact, page 1 notes that “GW” includes I and II. So it’s not just the media’s fault that today’s vets are confused, also claiming to have GWI; it’s VA’s intent. It may not be Shinseki’s intent, but after that congressional testimony he’s cleaning out the wrong house.
Our docs made it very hard for us to recommend them ourselves. Dr. Batemann may get some research money, but she’s not enough to greatly influence the definition outcome alone. CAA thinks they’re in with DoD; big deal. DoD’s been in no hurry to help.
Ohhh, dear—and just look at what IOM has done with and to the Gulf War Illness definition 🙁 They surely are NO experts as observed above. All scientific data disregarded, etc., etc.–those ‘people’ suffering with GWI — hung out to dry with GE, CBT & anti-depressants as the answer to a biological disease. We do NOT need these people @ IOM in charge of ME/CFS—are we kiddddding!!!!!! This is NOT progress; this is the complete opposite–and worse than that–it is potentially very damaging–at who’s insistence . . . ?? I also hope that the GW sufferers can reverse the damage done to their community with this latest chapter 🙁 CRIMINAL!!! @Eco
I am truly concerned about the IOM contract. When I read on the IOM’s website about how they choose their committees, I got very worried and disheartened. I don’t think they are interested in looking for experts in ME/CFS. They want someone trained in neurology, immunology, pain, cardiology, etc. who may know nothing about ME/CFS other than the many biases and misinformation that is rampant out there in the medical community. And, from what I understand from reading the IOM website, doctors being accepted for the committee don’t have to be free of these biases. The people who choose those to be on this committee have full control over this situation. DHHS’s contract does not spell out that the neurologist, immunologist, cardiologist, etc. have to be expert ME/CFS physicians or researchers. Look at the track record when appointing the GWI committee — a disaster. Look at what happened at the FDA Advisory Committee for the tentative approval of ampligen. I will never forget the one guy who spoke up saying, “They have cognitive behavioral therapy.” — Like we should be satisfied with that. The memory of that remark and the attitude behind it still haunts me. I understand that this committee to be appointed by IOM will be evaluating the literature. Just think about all the literature out there filled with the psychobabble that surrounded this illness for a long, long time and caused us great, great harm. How much time and thoroughness will they give to reviewing current research, some of which is not yet published? How much effort will they make to learn from ME/CFS experts who have spent years treating ME/CFS patients and truly understand this illness? Much of the knowledge gained by their experience is not in published journals, and this experience and knowledge is probably the most valuable aspect in writing a definition. That is why experts in any disease are the ones charged with writing a definition for that disease. Should this standard be different for ME/CFS? How much time will they devote to listening to patients and really hear and understand our reality? From what I’ve read, they certainly didn’t pay much heed or give much time to input from GWI patients. In theory, if done right, coming out with a good end product, the IOM has the capability to speak to the medical community with authority and finally put an end to the bias, ignorance, and disbelief we face from much of the medical community and the general public. But that’s only if it’s done right. And right now I see SO many pitfalls where things could go drastically wrong and set us back for a long, long time to come. I hope in the end I am pleasantly surprised and all my fears were for naught. However, after three decades of being either ignored or shafted by those in authority my fears are very real.
@Mary Dimmock
“Our experts already have consensus on the CCC, a definition with years of experience. This initiative is unnecessary and wasteful, especially when ME research has gone begging for so many years. Our government is in shutdown and this is how HHS chooses to spend money?
Wasteful, unnecessary and harmful! We need to continue to call for this effort to be stopped and for HHS to follow the lead of our experts!”
I agree completely! Mary, Is there some mechanism by which additional experts, patient organizations and advocates can sign or endorse the letter from our 35 experts, eg in the fashion done with other recent advocacy letters? I know how busy you have been, but I think it is extremely important to do this ASAP. Thank you SO MUCH for your advocacy!!
The letter from CAA to the thirty five signatories, excerpted below, was an obvious attempt to sway the signatories into renouncing their endorsements, not a neutral poll on current attitudes.
“Cindy explained that the letter writing effort started a few weeks ago when there was little information and early skepticism about the IOM contract. However, Cindy now believes that the IOM effort as described more comprehensively in the Monday announcement is a positive course of action. She suggested contacting those of you who signed the letter and see how you feel now as well…
The CFIDS Association wants to weigh all of your input and help bridge communication between our community, the agencies and the media. Given this additional information we have regarding the IOM contract, can you tell us – either on or off the record – where you stand by the terms in the letter? Do you still want the IOM contract to be abandoned and the CCC to be adopted as the official definition? If you have any misgivings about the timing or content the letter, or feel the IOM contract should proceed as now outlined, we need to hear from you …we must give the patients – all patients – the guidance and proper information they so desperately need.”
http://www.research1st.com/wp-conte…ail_IOM-and-the-Clinical-Case-Definition2.pdf
@Justin Reilly
Busted link should have been:
http://www.research1st.com/wp-content/uploads/2013/10/Email_IOM-and-the-Clinical-Case-Definition2.pdf
Emailing the National Research Council Governing Board Executive Committee, should probably be one of our next steps
[quote]
Study Process Overview…
Stage 1: Defining the Study…
The statement of task, work plan, and budget must be approved by the Executive Committee of the National Research Council Governing Board. This review often results in changes to the proposed task and work plan. On occasion, it results in turning down studies that the institution believes are inappropriately framed or not within its purview.
[/quote]
http://nationalacademies.org/studyprocess/
National Research Council
Ralph J. Cicerone, Chair
C.D. (Dan) Mote, Jr., Vice Chair
Bruce B. Darling, NAS/NRC Executive Officer
James F. Hinchman, NAS/NRC Deputy Executive Officer & NRC Chief Operating Officer
http://www.nationalacademies.org/includes/nrc_organization_01012013.pdf
I have been doing policy work in DC since 1987 so from that perspective I think this article and responses are spot on. There is simply no reason for HHS to spend around one million dollars for something the experts have already done. The healthy skepticism of the respondents on this blog is very much warranted. I also have read the statements from the CCA and based on what I know it is pretty clear that are shills for HHS on this. Not sure if there is a national group out there that represents the views of the experts and patients but if not, it’s time.
The letter by Lois Ventura of NAME is spot on (if a little repetitive, but since they haven’t gotten it the first thousand times they’ve been told, I can understand the desire to repeat).
http://www.name-us.org/2013GovtHeedOurExperts2.pdf
I have responded to PANDORA’s Position statement:
CCC must be adopted now!
I read with much interest your Position Statement on ME/CFS Criteria. I heartily agree with all of it- with one big exception: I believe it is absolutely crucial that we all insist as a united front, along with the already published “letter by the 35 experts” and many emails of patient advocates, that the CCC be immediately adopted. We need to immediately end the harm that Fukuda, Reeves and Oxford are doing and that can only be realistically achieved by HHS immediately adopting the CCC.
Of course, your other suggestions such as workshops to create an even better definition with bio markers and subgrouping, etc., are very on point and important, but we must focus on getting CCC immediately adopted first (and then we can improve on it). I hope you will amend your position statement to reflect this (and join on as a signatory to the letter of the 35 experts, both in a seperate letter to HHS and by signing on by the formal process that is said to be forthcoming for all those interested to endorse the letter of the 35 experts). United we can do this!
Thank you for your consideration.
Sincerely,
Justin Reilly, esq.
There is no need for us to guess what the IOM will do for ME/CFS. All we need to do is look at what they have already done to Gulf War Illness–oops, I mean “Chronic Multisymptom Illness.” Just listen to what those who suffer from “Chronic Multisymptom Illness” formerly Gulf War Illness, say:
“VA staff directed the panel to do a literature review rather than, as the law directed, focusing on physicians experienced in treating Gulf War Illness. VA staff knew little such literature exists because VA’s two decades’ of failures to develop treatments have helped to ensure that fact.
Additionally, most of the presenters to the panel focused on psychosomatic issues, stress as cause, and things like relaxation therapies as treatments. Ill Gulf War veterans who called in to listen to that meeting were naturally outraged. VA staff were among the presenters to the Committee, including at least one sitting here today. VA staff muddied the waters by directing IO1 to include not just ’91 Gulf War Veterans, as the law directs, but many others.
And finally, all of this involvement by VA staff is a far cry from previous claims that these panels operate independent of bias and influence by the contracting agency. ” http://www.youtube.com/watch?v=OuNJbPMfrYo
and
” The IOM still holds closed-door meetings, accounting to no one what reports they use for their findings used in advising the VA on how to examine and treat veterans who have been exposed to environmental toxins and bad lots of vaccines (mainly anthrax). I find it utterly repulsive that the IOM makes blind decisions regarding the healthcare of Gulf War Veterans based on sanitized information from DoD, then sells their findings online as well: example http://books.nap.edu/catalog/10628.html” See: http://www.thepowerhour.com/news2/testimony_galereid.htm
So we know the IOM can talk a good game about being fair and making stakeholders part of their work, but what do they actually do? We need look no further than the outraged Gulf War Veterans to see that they renamed the illness to an insulting and derisive name, they said the illness was psychological and needed only psychological treatment, and they kept patients and those who really care for them out of the process.
This is what is in store for ME/CFS patients if this IOM contract goes forward. There is no doubt about that. They made all the same promises to the veterans before that IOM too, but look how that turned out.
People who cannot see and acknowledge what is likely to happen with this IOM are either deceiving themselves or attempting to deceive others.
Patricia Carter
It is, as others have noted, an excellent analysis! Very detailed. I certainly agree with all points.
I have a few other comments.
1. Under Task Description: “The Committee will distinguish between disease subgroups….” How can subgroups be determined without some criteria to begin with, and an established expertise to make those judgments? And what or who are the “specific subgroups with substantial disability?” How determined?
2. Also under #2, same heading: IoM will: “Develop evident-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology.” (my emphasis) One could argue that the two good definitions now out there – CCC and ICC – are both consensus definitions. My concern is with the expertise or lack of it of those coming to consensus for this study. Which of course takes us to one of the major points for objection — my #3.
3. Who are the experts? This problem was well delineated in Jennie’s report, and it is, of course, the key issue. It is fatally optimistic to think that the HHS or IoM will convene a group satisfactory to us, the patients and advocates. It will not happen, no matter our input. I am so sure of this because of the way the entire contract was developed, in secret purposely to avoid any discussion with the community. This attitude will not change, so they will also not listen to our advice about experts. I envision about two of the 15 or so that we will find meet our standards for expert.
4. Kick-off date: I am figuring about Nov. 1st. if anyone is working who is required to be part of the kick-off process: “within 30 days of the effective date of the order.” Assuming that was 9/30.
5. The 2007 NICE Guidelines to be included in past efforts at defining ME/CFS???! CBT and GT are good for you, you slouch. This is another indicator of a bad outcome.
6. In #3 of the SOW, I did not understand what they meant by “new terminology.” Is that a new name?
7. #4 – Here’s where we really get in trouble – the idea of disseminating the chosen definition to health professionals nationwide. We have enough problems with the CDC’s Toolkit and manual for doctors. This will only make matters worse if the definition is a poor one. It will take many years to recover from such an action; the doctors will be semi-permanently misinformed.
8. What next? As Jennie suggests, we need to suggest nominees for the committee. And we need to do that very quickly, or they will simply shut us out. However, this is not enough. As I mentioned previously, I think those we recommend will be largely passed over. So when we write with our suggestions, we should, in no uncertain terms, indicate that if they ignore us on this and other facets of the study, it will be unacceptable to the community (what that means that would have some clout, I couldn’t say; we need to think about that).
Billie Moore
I also, even more strongly, agree with Justin Reilly that we should work to get the CCC adopted instead. I just don’t believe anyone would hear us banging on the door. They haven’t so far.
Billie
Mary Dimmock has started a ‘petition’ that we can all sign thanking our 35 experts for standing up for us with their letter. Great idea! I hope everyone will sign:
http://www.thepetitionsite.com/898/238/310/thank-you-to-mecfs-experts/?taf_id=10085720&cid=fb_na
On it re the petition!! Thank you to Mary Dimmock.
I wrote to CAA’s board:
Please forward to CAA Board of Directors
Please cc to CAA Officers and Public Relations/Outreach Director
Members of the Board:
Let me first express my appreciation for the apparent strides CAA has made in the last year or so. In my eyes, these include steps like removing the CDC toolkit and other misinformation from your website, your increased focus on an apparently (to my mind, which has quite limited scientific literacy) well-thought out research plan, the use of “ME” in ME/CFS, increased communication with patients, the inclusion of PEM/PER/PENE as a requirement for contributions to your biological sample bank, the installation of a new CEO, and perhaps other initiatives of which I am unaware.
In my strong and well-considered view, there is still great improvement to be made. I am writing you now because of your expressed support of the contract between HHS and IOM for a new clinical case definition for ME. A few months ago, many organizations and patients signed a petition to HHS to change the name of the disease back to ME and to immediately adopt the CCC. More recently, a great number of patients have contacted HHS and Congress to demand that the CCC be immediately adopted and that the IOM contract not be signed (and now cancelled). As you know 35 (now 34) of the very top ME researchers and clinicians in the world wrote to HHS demanding the same thing- no IOM contract and immediate adoption of CCC.
You are well familiar with the reasons for these demands (If you wish to be reminded, I simply refer you to the letter by the 35, now 34 experts). You stand virtually alone among stakeholders in your approval of the IOM contract. I now strongly request that you change your stance for the good of the whole community.
A year or two ago, in response to a deluge of criticism by patient activists/experts, CAA announces that it was now focused as a “laser” on research and was no longer a patient advocacy organization. I strongly object to your coming out now into the public arena as a supposed patient advocate, by doing such things as stating your support for the IOM contract, contacting the 35 signatories to subtly influence them to change their views, and it seems, responding to members of congress and the press as a patient organization.
The announcement by HHS of the IOM contract did very little to address the concerns of patients, clinicians and researchers, despite your claims and those of HHS to the contrary. The contract is at fundamental odds with the request for a stakeholder definition meeting by CFSAC and will be loaded with non-experts who will almost certainly screw things up royally (especially apparent in light of IOM’s recent Gulf War Illness report). Please reconsider your position, I beg you, for the good of everyone.
I very much welcome contact from any or all of the board for friendly discussion. In any event, I look forward to a timely response. Thank you for your consideration.
Sincerely,
/s/
Justin Reilly, esq.
More from Wildaisy:
http://www.mecfsforums.com/index.php/topic,17834.15.html
[quote]
Reply #16
I have contacted as many of the people who signed the Open Letter to Dr. Sebelius as I was able to, and I have gotten some answers. Some people were not contacted by the CAA. Some were contacted and refused to withdraw their support from the CCC. If I receive permission, I’ll post their responses.
It is absolutely clear to me from what they have told me that the CAA was, indeed, attempting to get these signers to withdraw their support from the CCC and to support the CAA in its support for the IOM contract.
[/quote]
Justin, my sources state that the Association was gathering information. No attempt was made to attempt to change anyone’s position.
Of the following, can anyone say what is still a likelihood and what is not?
1- Is there still a chance that the IOM’s contract be soon cancelled and the CCC definition be adopted right there and then, or is this as we speak pretty much ruled out?
2- If ruled out, is there still a chance that MANY of the 35 signatories be part of the process (not just 2 or 3 for the sake of appearances, but 8 or 9 for the sake of science)?
3- Is there still the scary prospect that none of the 35 experts really be involve and that the IOM will produce a “brand new” out-of-date definition of ME/CFS with no strong emphasis on PEM and pulling us backwards for good, – or is this paranoia?
I can only give you my personal, inexpert assessment.
1. There is still a chance the IOM contract could be rescinded, but the bar is pretty high. We need some heavy pressure to force HHS to make such a dramatic move.
2. There is a chance that the IOM panel could contain 8 or 9 experts, although they might not all be signatories on the letter. It’s also possible that only 1 or 2 will be.
3. An IOM definition could be really good, really bad, or in between. I don’t think anyone can accurately predict how it will turn out.
Thank you for your prompt reply Jennie.
Ecoclimber posted this comment on another blog post, but I thought it was more relevant here:
Hi Jennie
You took apart the IOM SOW to inform ME/CFS patients
of your concerns
Take a look at this an tell me if it is impossible based on VA GULF WAR SOW to clearly demonstrate a casual connection
http://www7.nationalacademies.org/ocga/testimony/Gulf_War_and_Health_IOM_Reports_2.asp
• sufficient evidence of a causal relationship between an exposure and a health outcome,
This statement of work has been approved by The National Academies governing body and has been included in the contract between the IOM and the study sponsor. However, in general these statements of work do not detail the specific approach to be used to complete the work, allowing the committee to use its expertise to identify the best approach.
and compare it to the ME/CFS IOM SOW
The committee is never going to find a casual relationship between an exposure and a health outcome. We don’t know, let alone a commitee would be able to determine exact causual infectious agent. Thereby the committee will be required to lump everything as an associations of chronic multi-symptoms. Correct?
The main question I am asking is whether the process they used for transfroming the GWS into CMI will be the same process they will use given our similiar symptoms none of which demonstrates a direct causation to our illness? What do you feel will be the percentages of the IOM redefining ME/CFS into CMI ?
Eco
From reading the testimony the SOW is just a guideline that can be deviated from. That to prove that ME/CFS is not CMI according to the IOM Direct Causation
*****
The link Eco provides is to the 2009 Congressional testimony of Dr. Lynn Goldman from Johns Hopkins. It actually includes a helpful summary of how the IOM panels do their work, so worth a read from that perspective too.
Eco asked about two parts of the testimony: 1) the statement of work for an IOM panel does not specify the specific approach the panel uses to do it’s work and 2) the assignment of evidentiary weight to different categories of causal relationships between toxic exposure and development of GWI.
Regarding #1, that is generally a strength of the IOM. But it does mean that a panel could decide to focus on one type of literature more than others, or could decide to “crowdsource” certain topics like the exposures that vets were concerns about.
Regarding #2, assigning evidentiary weight is a common mechanism of evaluating the strength of studies, and that has not always been to our advantage during systematic reviews of ME/CFS literature. I do not read the testimony as suggesting that a panel will lump ME/CFS in with CMI is they cannot find substantial causal evidence.
I am afraid I cannot assess the percentages on whether ME/CFS will be redefined that way. I wish I could! That would give us a clearer way to proceed, and could bring more people together behind a certain strategy. As I’ve said all along, the makeup of the panel is key. And it is something that we will not have much control over (although I certainly hope we can have input).
Was this SOW (Statement of Work/Request for Proposal) put on the FEDBIZOPPS.GOV to bid on? I read some where that it was put on fedbiz and now I cant find it. I believe that contracts over a certain amount have to be posted out to bid.
If it was put on fedbiz to bid who besides IOM bid on it? Or was this done in secret so that other organizations weren’t aware that they could bid on it?
Readyforlife
https://www.fbo.gov/index?s=main&mode=list&tab=list&tabmode=list
The contract was originally put out on FedBizOpps on August 27th, and was withdrawn on September 3rd (I think) after we objected so strenuously. It was then put through on NIH’s standing contract with the National Academy as a separate task order. They were not legally required to publish that in advance, so we had no opportunity to submit a competing bid or take any other action.
WOW they are smart. they knew when we found out about it being on the FEDBIZ site that the secret was out and others would bid on the contract. So the way I see it is they took it off fedbiz saying because we objected to the contract, but really they need time to get around other organizations/companies from Bidding on it through fedbiz.
WOW Devious minds. They are pros at this.