After my post on the basic process of an Institute of Medicine study, I received a number of questions in the comments and on Phoenix Rising about the definition of “conflict of interest” as distinguished from “bias.” I reached out to the IOM for more information, and they provided me with a copy of their conflict of interest policy. It’s long and a bit technical, so I’ve done my best to distill and explain it here. Disclaimer: I am not an expert, so this article reflects my understanding of the policy and its application. Please do not assume that my understanding is completely correct.
Why Does Conflict of Interest Matter?
The Institute of Medicine (and the other National Academies) pay attention to conflicts of interest for two major reasons: it is required by law and it affects the Institute’s credibility.
The Federal Advisory Committee Act prohibits any U.S. government agency from using recommendations from committees created by the IOM at the request of the government unless certain conditions are met, including several conditions regarding committee membership. First, no individual can have a conflict of interest relevant to the committee (with one exception explained below). Second, the committee membership must be fairly balanced. Third, the final report must be the result of the IOM’s independent judgment. In order for HHS to use the IOM’s conclusions on a clinical case definition for ME/CFS, the IOM has to ensure that these conditions were fulfilled, including no conflicts of interest among the committee members.
The IOM also recognizes that its credibility and the competence of its reports depend on a process free from conflicts of interest. In order for a report to be broadly accepted, it must not only be of the highest quality but must also be “the result of a process that is fairly balanced . . . and free of any significant conflict of interest.” (page 1) This is already an issue for the ME/CFS study. The predicted competence and balance of the panel members has been a significant contributing factor to the protests against the contract. The IOM recognizes that allegations of conflict of interest or a lack of balance will undermine a committee’s conclusions, even if those conclusions are correct. Thus, the IOM pays careful attention to conflicts of interest throughout the committee process.
What Is A Conflict of Interest?
Some of the concern over selection of ME/CFS panel members stems from confusion about what exactly constitutes a conflict of interest. The IOM policy covers this in detail. Here is the key definition:
For this purpose, the term “conflict of interest” means any financial or other interest which conflicts with the service of the individual because it (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization. (page 4)
There are several other important factors in the assessment of conflict of interest, and the IOM policy covers this at length (see pages 4 and 9, particularly). I think this list is a fair summary:
- A conflict of interest is usually a financial interest.
- This applies not only to the individual’s financial interests, but also the interest of others like family members.
- This applies only to current interests. It does not apply to past or possible future interests.
- Conflict of interest must be determined on a case by case basis.
- A bias or point of view is usually not a conflict of interest.
There is one exception to this conflict of interest policy. A person might be allowed to serve on a panel if he/she has knowledge that is particularly valuable to the committee and no comparable person without a conflict can be found. The determination of whether the conflict is unavoidable is made at the Academy executive level, and must be disclosed to the public. (page 8)
Conflicts of interest are assessed in multiple ways by staff and the committee members both before and throughout the study. The goal of all these procedures is to identify “whether an individual . . . has identifiable interests that could be directly affected by the outcome of the project activities of the committee”. (page 9)
What Is Bias?
“The term ‘conflict of interest’ means something more than individual bias.” (page 4) This is an extremely important point to understand. Many of the questions and concerns advocates have raised about the IOM committee relate to the significance of bias. According to the IOM policy, the existence of a bias or point of view does not automatically disqualify someone from serving on a committee.
Bias is usually related to a person’s views or positions that “are largely intellectually motivated or that arise from the close identification or association of an individual with a particular point of view”. (page 3) Researchers or clinicians who have expressed support for the Canadian Consensus Criteria (or other ME/CFS definitions) would generally fall into this category, and are not automatically disqualified. In fact, the IOM policy recognizes that it may be necessary to appoint committee members with potential bias in order to ensure that the committee is fully competent and balanced.
Researchers or clinicians who have committed to a position through public statements, publications, or other activities are usually seen as having only a bias. It is also not uncommon for committee members to have their own published and professional work be part of the literature review for the committee. Neither of these potential biases rise to the level of a conflict of interest. (page 5)
But sometimes bias can be so significant or extreme that it does preclude service. For example, if a person’s employer has taken a fixed position on an issue, that might be a sufficiently direct interest of the individual to create a conflict of interest. (page 6). Another example is when the central purpose of a committee activity is to review and evaluate an individual’s own work, then that individual is deemed to have a conflict of interest. However, that individual can still provide relevant information to the committee. (page 5)
The test is whether the person is “unwilling, or reasonably perceived to be unwilling, to consider other perspectives or relevant evidence to the contrary”. (page 4) As with conflicts of interest, the specific circumstances of the individual and his/her positions must be considered in making this assessment.
Examples
Thee policies may be easier to understand through examples. These are my own hypothetical illustrations. I have not discussed any examples with IOM, and the disclaimer I stated at the outset applies here as well.
- Does an ME/CFS clinician have a conflict of interest because a new case definition may increase or decrease the number of patients? No. While this could be a financial interest because more patients might equal more business, it is not a current interest. The effect of a case definition on future business is speculative, and does not create a present conflict.
- Is a signatory to the expert letter barred from the IOM committee? On its own, signing the expert letter is a publicly expressed position that constitutes a bias but does not prohibit service. However, if the person is unwilling, or reasonably perceived as being unwilling, to consider other perspectives then that could be significant enough to preclude service on the committee.
- Are the authors of any of the ME/CFS case definitions prohibited from serving on the committee? Potentially yes. In order to fulfill its purpose of creating a clinical case definition, the committee will critically evaluate the existing definitions. This might create a conflict of interest for some or all of the co-authors because it involves reviewing one’s own work. (page 5) The IOM will have to determine the significance of this risk on a case by case basis. However, even if case definition co-authors cannot be appointed to the committee, they can still provide relevant information. There is also the option of the conflict of interest being waived and publicly disclosed, if it is determined that an individual has unique and essential expertise.
Assessing Conflicts of Interest and Bias
While the IOM pays close attention to conflicts of interest and bias, that does not guarantee that they get it right every time. Here is where ME/CFS advocates can play a role. The public will have twenty days to comment on the provisional committee slate. That will be our opportunity to express concerns about the committee balance, potential conflicts of interest, and potential bias. We must invest the effort and energy to identify and submit those concerns. The IOM recognizes that the credibility of a report can be undermined if the process was not competent, balanced, and free of conflicts of interest. Our perceptions of these issues matter, and we have to convey that to IOM.
Here are two hypotheticals to illustrate my point:
- A chronic pain researcher was paid for consultant services to a disability insurance company five years ago. This would not constitute a clear conflict of interest because it is a past financial interest, not a current one. But given the significance of a new case definition to disability insurance companies, I would argue that this creates a significant risk of perceived conflict of interest and the person should be removed from the committee.
- A researcher has made repeated public statements that ME/CFS is simply deconditioning and poor coping skills, and has repeatedly dismissed evidence to the contrary. IOM may consider this a bias, but not significant enough to prevent service on the committee. I would argue that the dismissal of contradicting evidence creates a significant risk that the researcher can be reasonably perceived as unwilling to to consider other perspectives, and should be removed from the committee.
As advocates, we must understand how IOM defines and applies its conflict of interest standards. We must voice our concerns over the provisional slate when it is announced. We have knowledge that IOM does not, and we should not withhold that information from the process.
For ME patients, it makes no difference how the IOM defines conflict of interest. It does not really matter if the IOM includes some people whom M.E. patients respect as experts (along with the usual suspects such as Suzanne Vernon, who served on the Gulf War Illness IOM panel). Just as the VA controlled what the Gulf War Illness committee did, the HSS and SAA (with the aid of the CDC and CAA and PANDORA) will control what the IOM panel on ME/CFS does). So all this technical information on what the IOM calls conflict of interest is meaningless for M.E. patients. It does not matter. The result of an IOM panel to redefine M.E. is a foregone conclusion! The IOM has already used the 1994 Fukuda definition for M.E. Of course they will do so again, or perhaps they will broaden that definition. See: http://books.nap.edu/openbook.php?record_id=13539&page=97 Everyone should sign the petition: https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME
I think it’s worth remembering that the Federal Advisory Committee Act restricts the degree to which HHS can interfere in this IOM panel. The Act states that a government agency cannot use recommendations from an IOM committee created at the request of the government unless a) the committee was not subject to any management or control by an agency or officer of the government, b) no individual on the committee had a conflict of interest, c) the committee was fairly balanced for its task, and d) the final report is the committee’s independent judgment. You can see the full law here.
Understanding the law is important because we can box them in. If the committee is not fairly balanced (and including only one ME/CFS expert would be unbalanced), then HHS cannot use the resulting definition. If anyone is shown to have a conflict of interest, HHS cannot use the definition. If HHS manages or controls the committee, HHS cannot use the definition. If the report is not the committee’s independent judgment, HHS cannot use the definition. It’s not particularly sexy, but understanding and holding IOM to its own policies, and holding HHS to federal law, could actually be a helpful strategy (if we need it).
The Federal Advisory Committee Act may very well restrict the action of the government agency by its terms, but if we look at what IOM did with the Gulf War Illness committee, we can see how the IOM applies the Act. See: http://www.youtube.com/watch?v=OuNJbPMfrYo
“Question, Mr. Coffman, Chairman:
Mr. Hardie, can you explain in your opinion, why the Research Advisory Committee believes that …why the Research Advisory Committee, in their latest Institute of Medicine report is flawed?
Anthony Hardie:
Yes, thank you for that question. First, I want to recognize that I believe the researchers—distinguished researchers like the gentleman sitting next to me—who served on that committee were well intentioned.
However, VA staff issued a Scope of Work and Committee Charge that radically diverted from the law, that effectively prevented—and also effectively prevented what the committee could consider. I believe that these helped to prevent …prevented the IOM Committee from meeting the expectations of the law.
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. ”
Yes, we can “box them in” just like we have been “boxing in” the CFSAC for the last decade or so. It is absolutely clear that the CFSAC has done exactly what its government employees want it to do, and if any of it is of benefit to patients, it is clearly by accident and not by design.
How are you going to accomplish this “boxing in”? Are you going to be a member of the committee so that your voice will be heard? If so, your appointment will depend on the government agencies. And as a member, what influence would you really have up against all the other members doing the government agencies’ bidding? We are not even allowed to know the number of members the committee will have. Every step of the way what the committee does is controlled by the government agencies. And we can see the result of that control by what was done to sufferers of Gulf War Illness–oops, I mean “Chronic Multisymptom Illness.”
The only reason the government agencies are pursuing this contract with the IOM to redefine ME/CFS is because they can be certain to control the outcome. If that were not
certain, they would never consider such a contract. Look at what they have done for the last thirty years; every action has been designed to placate patients without giving them any real benefit and to continue to hide the fact of the disease and its severity. This IOM contract is just the government’s latest strategy to appear to be doing something for M.E. patients while actually building obstacles to real research and possibly effective treatments. Patients will have no real input into the IOM contract. Do you really think if they wanted patient input that they would have created the IOM contract in secret? And even now, we are unable to even see a copy of the contract to see the terms.
No, this is a government and IOM contract, and it is the interests of the government agencies that will be served; patients will have no part in it and it is very likely that the interests of patients will be irretrievably compromised.
This raises the question of whether writing a protest letter in favor of the CCC places someone into the category of having a fixed position, and makes them disqualified (unless the IOM cannot find someone they consider a replacement).
By the way, the term “bias” has also been part of the discussion in another sense. It comes from the HHS statement that they are using people (the IOM) who are unbiased. And they did this instead of accepting the consensus of the majority of recognized North American experts. So it is not unreasonable to assume that the HHS sees these experts as having their judgment so compromised by bias that their consensus cannot be trusted. And I cannot help but wonder if the IOM is in any way affected by the message this sends.
Andrew, I looked and could not find a statement by HHS that they believe the IOM is unbiased. Can you point me to the source for that?
Wow! Thank you Jennie. As a newbie advocate I’m finding this information to be invaluable. I’ve had a very interesting (and overwhelming) few months trying to come up to speed on what has been happening in the ME/CFS community. It’s been quite a steep learning curve. I appreciate the argument being made that the IOM definition could be a huge disaster in a long history of huge disasters, but it’s moving forward whether it should or not and I want to be a part of trying to steer it into the least disastrous course possible. Without your insights and hard work I’m afraid I’d just yank my paddle out of the water and pull the covers back over my head.
Thank you, Darlene! It’s very kind of you to say. Welcome to advocacy! *offers you a paddle*
@Andrew Bokelman
Oops, I see my first paragraph was already addressed. Please skip to the second one.
Just to be clear here, IOM (and I am NOT affiliated with IOM or any government agency) has started to send out out notifications to people who were nominated for the Committee asking them if they are interested in serving. As far as I know, at least two people signing the letter protesting the contract were asked. Now there is still a selection process that will take several stages so just because they’ve been nominated and noted by IOM doesn’t mean they will be selected. But what this means to me is that signing the letter didn’t automatically disqualify someone from the Committee.
Also, the point made about considering other perspectives is important. Not regarding definition but regarding CBT/GET, if one reads those papers, you find that the authors don’t discuss any of the basic science data, trials (e.g. Nunez, 2011), or patient surveys that found CBT/GET to be ineffective or harmful. So that angle could be used as a means of protesting a particular researchers’ perspective in regards to work re: definition.
That’s good news. I knew one person had been asked. Hopefully it’s more than two!
I remember seeing it as part of an HHS announcement on a web page. But I cannot find the web page, nor is this in their email. So until/unless I am able to confirm this, I am retracting this and I apologize for causing you this extra work.
Thanks, Andrew. I checked again too, without success. It will be interesting to see what they say at the CFSAC meeting.
IOM using 1994 Fukuda definintion for ME/CFS–HELP!! This is 19 years later–with MUCH research info ‘since’ then–including CCC. Their NONsense makes NO sense!
Sooo–to the ‘balance’ on the committee–IOM cannot stack ‘their deck’ (??!!)–and they will also NOT want the committee stacked with ME/CFS experts—how NUTS is that–we need the experts — not those that are NOT experts!! Non-experts do NOT represent the best interests of ME/CFS people/patients.
Nite-nite and thank you for all the work you did on this piece, Jennie–what a great help!!
Jennie, you said this above:
“The IOM recognizes that the credibility of a report can be undermined if the process was not competent, balanced, and free of conflicts of interest.”
Clearly the IOM does not recognize this as they start out. Otherwise, the Gulf War Illness study would not have raised the furor it has, primarily because of the choice of panelists. That poor choice resulted (surprise surprise) in a dreadful conclusion.
Everyone, please keep (polite) letters going to Ms. Kate Meck, Associate Program Officer of IOM, kmeck@nas.edu., indicating the essential need of the IOM staff that the MAJORITY of the study group be ME/CFS experts – clinicians and researchers. If, on the other hand, the IOM staff choses the majority of the study group from those who have expertise in various medical specialties who have great backgrounds in those specialties but no or very little ME/CFS experience, the study results will be attacked by the ME/CFS community for being just what we expected – a waste of money and time.
Whether these letters will have any real effect on member selection remains to be seen, but at least we will have been on record, in good numbers, as having given the IOM ample warning from the beginning about what we consider to be a requisite basis for a valid study.
Billie
Thank you for that contact information, Billie.@Billie Moore
Sharing info . . . covering all bases.
Ms. Kate Meck
Associate Program Officer
Institute of Medicine, USA
Dear Ms. Meck,
With regard to the IOM contract for Myalgic Encephalomyelitis (M.E.) / Chronic Fatigue Syndrome (CFS), it is imperative that the VAST MAJORITY of the study group be ME/CFS experts – clinicians and researchers.
If, on the other hand, the IOM staff chooses the majority of the study group from those who have expertise in various medical specialties, and have great backgrounds in those specialties, but no or very little ME/CFS experience and expertise, the study results will be attacked by the ME/CFS community for being just what we expected – a waste of money and time — and precious more time of our lives being lost as ‘the dance continues’ holding back scientific answers to this debilitating BIOLOGICAL disease, decade after decade.
Consider a parallel with another disease like cancer, for example–and that a study group is set up without a majority of experts in cancer–but uses a majority of ‘experts’ in other fields, non-specific to cancer–the results of the study will most certainly have a different outcome and conclusion than had the VAST MAJORITY of the experts been specific to cancer. Such a study would be detrimental and a complete INjustice to the cancer patients.
The same principle holds true for a study group for Myalgic Encephalomyelitis (M.E.) / Chronic Fatigue Syndrome (CFS). In searching for the truth and the scientific answers to crack the code of this biological disease it (only) makes clear and logical sense to use scientific ME/CFS experts–clinicians and researchers–as the VAST MAJORITY in the group. To do otherwise would be detrimental and a complete INjustice to the Myalgic Encephalomyelitis (M.E.) / Chronic Fatigue Syndrome (CFS) people / patients / community.
We are seeking the IMPERATIVE MAJORITY INPUT for the Myalgic Encephalomyelitis (M.E.) / Chronic Fatigue Syndrome (CFS) people / patients / community by the ME/CFS Experts on this IOM study in getting rapidly to the scientific answers. Please help (us) with this JUSTICE.
With sincere thanks,
Remember–we can always ask for ‘read receipt’–this could be helpful in documentation.
It looks like IOM thinks they already know a thing or two. This might not qualify as a bias, but it does make me wonder.
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
And look at the sources they site. See the pattern?
The IOM contract to re-define ME/CFS
There are legitimate concerns and worries being expressed about the IOM contract to “re-define ME/CFS”. The IOM has an official position on ME/CFS. It was published this year and its included below:
http://books.nap.edu/openbook.php?record_id=13539&page=98 http://books.nap.edu/openbook.php?record_id=13539&page=99 http://books.nap.edu/openbook.php?record_id=13539&page=100 http://books.nap.edu/openbook.php?record_id=13539&page=22
MORE sharing; two e-mail responses to me from Ms. Kate Beck, IOM– 1st reply FROM Ms. Kate Beck dated November 7, 2013 below . . .
“Thank you for your email and for sharing your perspective on the committee composition. We are reaching to many ME/CFS experts that we hope will be willing to serve on the committee.
I cannot share any more information until the provisional committee slate is approved and publicly posted. If you are signed up for our Listserv, you will be notified of the public posting. If you are not signed up, you can do so at our website.
Best,
Kate Meck ”
________________
***I wrote a brief note back to Ms. Kate Beck bescause of a confusion with a partial e-mail sent from her office and this was her 2nd response. This response makes me VERY nervous and EXTREMELY concerned–in line with the IOM information gathering/reference that is being used as quoted above . . . The IOM contract is NOT being ‘set up’ in our favour, i.e. ME/CFS right out of the starting gate 🙁
________________
2nd response back from Ms. Beck below: (to which I have offered no further response)
“I don’t know where the incomplete email came from, but the email I sent last night at 5:20pm was the only email I composed to send to you.
I have been receiving lots of emails from the patient and advocate communities, so I certainly recognize and understand the shared perspective you offered.
The IOM staff are working to convene a committee that includes ME/CFS experts, as well as those who are less familiar with the disease, but capable of objectively approaching and understanding the scientific evidence and experiences of the ME/CFS experts and the patient community.
Ultimately, the diagnostic criteria recommended by the committee will be used by physicians/clinicians with and without experience in ME/CFS, so the participation of committee members from both perspectives is very important.
Best,
Kate Meck”
As I say, EXTREMELY CONCERNING!
Jenny wrote, quoting IOM:
“For this purpose, the term “conflict of interest” means any financial or other interest which conflicts with the service of the individual because it (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization. (page 4)”
I have not read IOM’s GWI report (thanks for the links above) but I understand that the ME/CFS community disagrees with IOM’s appraisal of ME/CFS in the GWI report(s?).
So given its prior appraisal of ME/CFS, IOM itself has a conflict of interest. And thus any individual employeed by IOM, by extension, has a conflict of interest? Again, given IOM’s prior appraisal of ME/CFS, hiring anyone who works with IOM, by default, creates an unfair competitive advantage for this organization.
It’s in IOM’s best interest to create a definition which agrees with its ME/CFS appraisal in the GWI report(s). If an individual can be excluded because his/her work will be evaluated in the consensus process – shouldn’t an organization be excluded bc its work will be evaluated in the consensus process?
I’m something of a newby as well. Does our patient community have any lawyers on our side – for big stuff like this? Thanks, Jenny and others for all the info.
Let’s parse this out a little bit.
The IOM issued a report on GWI treatment that included some comments about CFS that most (if not all) of us find objectionable. The concern you raise here is whether IOM is bound in some way by that section of the GWI report and whether it will affect the outcome of the ME/CFS contract. This makes me wonder how IOM addresses this? It can’t be the first time that a report written by one group of experts included comments relevant to a subsequent group of experts’ work. So does IOM see these reports as statements that must be consistent across contracts? Or does each report and its panel stand independently?
The conflict of interest policy applies to the members of a panel. So if one of the authors of that GWI report was appointed to the ME/CFS panel, then I think we have a strong argument for bias. We don’t have a COI argument because remember, the COI applies to financial interests. IOM employees do not serve on panels or author reports. If they did, that might create a conflict of interest. The point you raise about whether IOM has an interest in a specific outcome for the ME/CFS panel to keep things consistent, and therefore whether IOM staff will attempt to influence the panel outcome, is one I am not in a position to answer.
And of course, it seems that being an IOM employee impairs the individual’s objectivity – because an individual employeed by IOM is going to be reluctant to challenge IOM’s existing “authority” regarding ME/CFS as discussed in the GWI report.
I wonder how they will determine which nonexperts are capable of objectively approaching and understanding the evidence and the experiences of experts.
@Andrew Bokelman
I think it is all a bunch of ‘double talk nonsense’ so they can twist and turn things and do what they want. Realllly–IOM makes absolutely NO sense @ all–and we are supposed to be OK with all of this — realllly ?? !!! NO!
Excellent points that Ren has raised!! AND IOM has NO expertise!! Yes–they are completely BIASED!! This train has realllly run amuck!!
I agree with Jenny’s analysis. The IOM itself is now conflicted and cannot under American law be part of any attempt to re-define ME/CFS. Any IOM involvement would mean conflict of interest, bias (in favour of NICE guidelines, CBT, GET, psychiatry, and IOM’s approval of these), and lack of independence. Furthermore, there is additional bias, as IOM failed to consult the 5,000 research papers into ME/CFS detailing biological abnormalities, dysfunctions and infections in the GWI report. From these scientific and legal facts, the IOM cannot be trusted to form a panel, as there are questions relating to the IOM’s conflict of interest, bias and independence. The IOM’s definition of ME/CFS (included below) in the GWI report this year, means the IOM will have to remove itself from the attempt to re-redefine ME/CFS. Thus the IOM cannot participate in its own study.
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
Thank you, David, for these citations. I just used them in a letter to Kate Meck.
Thank you, Ess, for sharing your letters and responses to and from K. Meck.
And particularly, thank you, Jennie, for this excellently written blog – so full of good information from both you and the readers.
Billie
Thank you, Billie! That’s very kind.
Jennie #22 wrote: “We don’t have a COI argument because remember, the COI applies to financial interests.”
I don’t know though if the policy says financial or other interest. Perhaps this falls under “other interest”?
Yes, in one place the policy says “financial or other interest” but in another place it says COI is ordinarily financial interest. They don’t define “other.”
A few quotes pulled from the National Academies policy statement – should they help to build a larger argument:
“The technical skills and perspectives of this distinguished and diverse group of individuals are essential to the ability of the institution to *consistently produce accurate* and objective
assessments of national problems, needs, and opportunities.” (p.1)
“Questions of lack of objectivity and bias ordinarily relate to views stated or positions taken that are largely intellectually motivated or that arise from the close identification or association of an individual with a particular point of view or the positions or perspectives of *a particular group.*” (p.3)
“Conflict of interest requirements are objective standards designed to eliminate
certain specific, potentially compromising situations from arising, and thereby to *protect the
individual, the other members of the committee, the institution, and the public interest.*” (p.4)
“*The individual, the committee, and the institution should not be placed in a situation where others could reasonably question, and perhaps discount or dismiss, the work of the committee simply because of the existence of such conflicting interests.*” (p.4)
Based on the above quotes, it could perhaps be argued that divergence by IOM CFS/ME (now) from IOM GWI (newly exisiting GWI report) undermines the academy’s goals of consistancy and accuracy – and its prestige.
Maybe it’s odd to ask, but what I should I do with such concerns? Do people post such things on a larger forum like Phoenix Rising and see if some kind of consensus forms among people? Is this something I/we send directly to a governmental agency? Are there primary advocates who take in such things? Is this blog one such primary advocacy “channel”? Thanks for any help with further understanding.
I certainly hope this blog is a vehicle for advocacy!! Ren, I’ll see if I can get clarification from IOM.
Good work everyone on this MOST very important work of our very LIVES!!
Jennie,
I see a major problem in integrity of this HHS/IOM process. The ‘process’ is claimed to be totally independent with the IOM stating on their website; “The Academies provide independent advice; external sponsors have no control over the conduct of a study once the statement of task and budget are finalized. ”
You state:
“The Federal Advisory Committee Act prohibits any U.S. government agency from using recommendations from committees created by the IOM at the request of the government unless certain conditions are met, including several conditions regarding committee membership. First, no individual can have a conflict of interest relevant to the committee (with one exception explained below). Second, the committee membership must be fairly balanced. Third, the final report must be the result of the IOM’s independent judgment. In order for HHS to use the IOM’s conclusions on a clinical case definition for ME/CFS, the IOM has to ensure that these conditions were fulfilled, including no conflicts of interest among the committee members.”
Yet, on a previous blog, ‘Which paddle’, you state:
“.., even if we could force the rescission of this contract – what then? I know many advocates believe that the Experts’ Letter calling for immediate adoption of the Canadian Consensus Criteria is the solution. But I heard from a highly placed source at HHS that the government will not accept a definition without their own thorough assessment, if not influence. HHS will want to get its hands on any definition before accepting it, and they will not accept CCC as is. So even if we get the contract rescinded, we will be back where we started except everyone on both sides will be even more pissed off.”
HHS does not want to adopt the CCC, at the risk of acting against the medical experts in the field, because they want to control the outcome. Yet, they are willing to spend a million dollars to contract with an independent organization where legally, they will not be able to control the outcome once the process has started? Does this make any sense to anyone?
In addition, the Statement of Work states; “Contractor shall meet with the NIH Task Leader and HHS personnel within 30 days of the effective date of the order as a kick-off meeting. The Contractor shall communicate with the NIH Task Leader and HHS personnel on a monthly basis to discuss the status of the study.”
This seems to be in direct violation of the IOM process of study as stated above.
The Statement of Work further elaborates that the IOM panel will coordinate with NIH’s Evidence-based Methodology Workshop to “assure that relevant information is shared and key messages are coordinated.” This will give HHS the mechanism to strongly influence what literature is considered as evidence for this broad set of conditions
It is obvious to me that HHS is very confident that they will be able to influence the outcome of this process. That is why we need to fight this till the end. It is not too late. Are we to give up our fight at such an early date, just because the process has begun? Do you think that any civil demonstration/protest should be given up at the first show of disinterest? Should we give up because the government has never canceled an IOM contract before so therefore they will not this time? Should Rosa Parks not have insisted on sitting in the front of the bus because others have not done it before? I’m sorry but, these arguments do not hold for me, personally.
I feel that my civil rights have been violated. The government/HHS has high jacked this disease and is trying to control the outcome of this study to come up with diagnostic criteria for ME/CFS. Why have they not done so with other diseases? (Except GWI – of course) Is my illness as a U.S. citizen less important than an illness of another US citizen? I feel discriminated against. Should I just sit by quietly while this is happening? Is this not the democratic country of the free and brave?
‘A people who extend civil liberties only to preferred groups start down the path either to dictatorship of the right or the left.’
— Justice William O. Douglas
I am also concerned that there is an illusion here that the fight is over. It is not by a long shot. 117 advocates have just signed a letter of support to the letter of 50 experts. Besides, petitions, letters, tweets, calls there are many actions taking place in the background in silence (so far). There is a large group of us who will continue to fight this until the time that this contract is canceled.
For those who would like to help in the fight to cancel the HHS/IOM contract, these are actions you can take now.
Actions to stop the IOM contract in support of the 35 experts.
For U.S. citizens:
Simple instructions for e-mailing your congressional representatives HERE.
For everyone worldwide:
Simple instructions for e-mailing President Obama’s science advisers HERE.
Simple instructions for e-mailing president Obama and vice president Biden HERE.
You can sign the petition to stop the IOM contract HERE.
The petition in support of the expert’s letter is HERE.
Simple tweeting campaign to stop IOM contract HERE.
Gabby, yessss, we MUST continue to fight–there IS a conspiracy here/discrimination–it IS mind-boggling and surely doesn’t seem to fit with the vision for the 21st century and democratic rights. There is a dark element steering this IOM ship.
The links you mentioned are not showing up here . . . Can you fix pls and thanks. Also, in your last reference to ’35 experts’–I think you mean ’50 experts’.
Just wanted to quickly add that a letter to the Inspector General has just been posted on PR and addresses conflict of interest in regard to Federal Acquisition Regulations. (The link below is the PR link, which has the letter’s original link, which I have not yet viewed. Just wanted to try to document what’s happening where.)
http://forums.phoenixrising.me/index.php?threads/call-for-investigation-by-the-inspector-general-of-the-iom%E2%80%99s-conflict-of-interest-with-respect-to-me.26401/
I think this point from Gabby is definitely worth investigating as well: “The Statement of Work further elaborates that the IOM panel will coordinate with NIH’s Evidence-based Methodology Workshop to “assure that relevant information is shared and key messages are coordinated.” This will give HHS the mechanism to strongly influence what literature is considered as evidence for this broad set of conditions.”
Thanks, Jennie and others for helping answer “20 Questions”, so to speak.
I think there is value in stopping IOM even if the HHS will not accept the CCC. The IOM result will put us in a worse position than we are now. That is reason enough.
As for the HHS wanting their hand in whatever criteria is used, it is really not an unreasonable position. They are the department of Health and Human Services. But they have been going about it all wrong. Instead of engaging in power games, they should engage in a cooperative project with the experts to vet the CCC and/or modify it. The cooperation should grow out of both groups working together as colleagues, and not the HHS creating a work dynamic that only they support (as they have with IOM). And if both sides can’t reach an agreement, so be it. But they should try.
Another thing I would like to see is an equal application of the idea of “evidence-based.” As it stands now, places like the CDC are not held to this requirement. All they need is their opinion. If there is going to be cooperation between the public and private sectors, the HHS needs to instruct their branches to follow the same level of proof that is expected from the public sector. And then they need to enforce this.
P.S. We can’t give up—we’re RIGHT—and we are being led by the ME/CFS Experts and Researchers and Advocates!!
I’ve posted this elsewhere, but to further play devil’s advocate – What about the federal court case involving CFS that HHS lost earlier this year? 26 April 2013; I.D. v. Secretary of Health and Human Services 0, 04-1593V (Fed. Cl. 2013)
How do we know HHS/SSA isn’t seeking to redefine ME/CFS as a means to prevent future court losses? Just a thought.
Ren, wasn’t this a vaccine case? Cases brought before through the National Vaccine Injury Compensation Program involve a determination of whether the vaccine caused an injury in that specific person bringing the case, not in all cases of that illness. For example, “In the most extreme of these cases, a 2006 petitioner successfully claimed that a hepatitis B vaccine caused her multiple sclerosis despite several studies showing that the vaccine neither causes nor worsens the disease, and despite a conclusion by the Institute of Medicine that evidence favors rejection of a causal relationship.” (from Wikipedia)
That last sentence of Jennie’s comment above makes the case, inadvertently, of another good reason why this contract needs to be stopped: “… despite a conclusion by the Institute of Medicine that evidence favors rejection of a causal relationship.” Imagine a result of the IOM study on ME/CFS similar to that of the Gulf War Illness report (CMSI) – vague, wrong, not based on the science of the disease that exists. The report could be used in court cases to help prove positions in opposition to ME/CFS patients!
Billie
“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.”
I’m guessing this might be a law that applies only to GWS, although it would be good to know.
One can just not help commenting on this after viewing–thank you, Andrew–WHAT a shameful disrespectful DISgusting abonimation of degradation, disregard and DISservice to our veterans–WHAT LIES and cover-ups of MASSIVE proportion. KUDOS to Mr. Anthony Hardie for all of the hard and challenging work he and others are doing!! May the reign of terror imposed upon the Gulf War Veterans AND ME/CFS sufferers soon come to an end.
Jennie, that case was in reference to a vaccine. The below CDC-linked statements about infection made the case seem important to me (but I don’t have a legal background):
In 2012, CDC released a physician-education webinar, “Chronic Fatigue Syndrome: The Challenges in Primary Care.” Within the section, “The Biology of CFS”, Dr. Anthony Komaroff states,
“There’s now solid evidence that CFS can follow a new infection… And finally it’s possible, in CFS, that different infectious agents interact with one another to cause the symptoms… The agents that have been linked potentially to CFS include Epstein-Barr virus, the cause of Q fever – Coxiella burnetii, Ross River virus, the bacterium that causes Lyme disease [borrelia], parvovirus, enteroviruses, possibly Borna virus…and Human herpesvirus 6.” (22.21 / 22.28 / 23.41)
I believe scientific references are provided in the video slides. Also, either in the above webinar or a second, 2013 webinar, Komaroff references a joint 2006 CDC-Australian (I believe) study that determined: the severity of the acute illness (the initial infection) largely predicted the severity of ME (PVFS – aka PIFS – post infectious). I believe Hickie was the psych person involved, and the study found no correlation between mental illness and PVFS/ME. (www.bmj.com/content/333/7568/575)
I suspect it’s very important for some people to “divorce” the term PVFS/PIFS from ME. Enter interloper (honeytrap?) CFS.
I had a .gov link saved for the above webinars, but last time I checked, it no longer worked. If you google the title given, a webmd/medscape (?) functioning link should come up. The second, 2013 webinar should be listed with the 2012 one. I referenced the actual video. There is a transcript as well, but it is not word-for-word.
Also, I have a distinct memory of Komaroff saying something to the effect of CFS was investigated as a psych issue, but that has been disproven and that theory can be put to rest. HOWEVER, when I later went back to pull the exact quote, I couldn’t find it in either video or transcript. It is possible that I remembered incorrectly. A FOIA request has been made asking for a history of edits to the video -but it has not yet been answered.
Also in the webinars, Komaroff says something to the effect of there’s been a lot of new information regarding CFS and also a lot of “misinformation” regarding CFS. This is where I want to say the debunked psych theory was mentioned – but I could very well be wrong. Regardless, the vague term “misinformation” remains. Seems also that I remember a little side note saying something like the video was done in conjunction with CDC but the views contained within might not represent the exact views of the CDC. Would be nice to know what information specifically Komaroff was referring to as misinformation.
And as one last thought – I only superficially skimmed parts of the document, but a new paper just came out in Sweden regarding diagnostics for Lyme disease (borrelia) in Sweden and some info regarding Post-Lyme disease syndrome. (I think that’s right, PLDS.) Again, I just glanced at one part – but the Swedish authorities suggested that people suffering from PLDS have a mental disorder and they referenced a NIH study that included CFS. I can look for further details. But I remember being very disappointed to see this. My thoughts were that they’re doing the same thing to PLDS as they’ve done to ME/CFS. And I believe this all ties in to the somataform (right word?) psych theories as alluded to on PR recently by justinreilly (? I believe).
Sorry to write so much – but hopefully there’s something useful in there. Also, re Ess’s comment. I too am very ashamed and sad of how veterans have been treated. Perhaps the best honor is to now be part of the solution.
Dear Kate Meck,
thanks for your reply. That’s excellent to see that my communication is in the public record. I would like to include further information for the public record.
The IOM has stated it’s position on ME/CFS in the GWI report this year. I include evidence of this below:
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
The IOM itself is now conflicted and cannot under American law be part of any attempt to re-define ME/CFS. Any IOM involvement would mean conflict of interest, bias (in favour of NICE guidelines, CBT, GET, psychiatry, and IOM’s approval of these), and lack of independence. Furthermore, there is additional bias, as IOM failed to consult the 5,000 research papers into ME/CFS detailing biological abnormalities, dysfunctions and infections in the formation of it’s GWI report. IOM may become guilty of inconsistency and inaccuracy, as it’s stated position on ME/CFS in the GWI report may differ from it’s position in the ME/CFS report. From these scientific and legal facts, and stated position, the IOM cannot be fully trusted to form a panel, as there are questions relating to the IOM’s conflict of interest, bias, consistency, accuracy and independence. The IOM’s definition of ME/CFS (included above) in the GWI report this year, means the IOM will have to remove itself from the attempt to re-redefine ME/CFS. Thus the IOM cannot legally participate in its own study.
There are further aspects to this relating to balance and fairness, and to matters of ‘Public Interest’. There is a memorial section on a web site to those people who have died of ME/CFS and it’s health complications at http://www.ncf-net.org/memorial.htm . The seriousness of an illness can be gauged from the number of people who die of the illness and the many health complications it causes. This issue involves the death of innocent Americans and thus is a matter of vital ‘Public Interest’ and also of national security. One should contrast this level of seriousness with the insulting, degrading and mocking attitudes and views of the wessely school psychiatrists who are behind the failed NICE guidelines in Britain ; the same guidelines which IOM supported in its definition of ME/CFS in the GWI report and has now included in it’s ME/CFS re-definition work. Here is one example of the mentality and motivations of those people who created the NICE guidelines and support psychiatric bias.
” In December of that year, the British Medical Journal continued its campaign of misinformation about ME/CFS in an article co-authored by Michael Sharpe (“What should we say to patients with symptoms unexplained by disease? The ‘number needed to offend’ ”. Jon Stone, Alan Carson, Michael Sharpe et al. BMJ 2002:325:1449-1450). The authors calculated an ‘offence score’ of descriptions pertaining to patients who are deemed to have no disease; those descriptions included ‘putting it on’; being ‘mad’, or ‘imagining symptoms’. The authors noted that the term ‘hysterical’ was the only one on their list that specifically excluded malingering. The conclusion was that many of these labels did not pass the ‘offence’ test, so the best label was ‘functional’ disorders, as this label “provides a rationale for pharmacological, behavioural and psychological treatments aimed at restoring normal functioning”.
The electronic responses to this article included one from Douglas Fraser, a professional violinist unable to work due to ME/CFS: (“The very fact that you are reduced to implementing yet another euphemism should alert readers to the reality that the concept hiding behind it is as ludicrous as it is offensive”); Tom Kindlon from the Irish ME Support Group: (“if the BMJ is going to publish papers like this, it should also publish information about how patients with many currently recognised diseases would have been told in the past that their symptoms were ‘medically unexplained’ or ‘hysterical’, (and) then some doctors might be more willing to say ‘I don’t know what is wrong with this patient’ rather than to conclude ‘this patient’s symptoms are functional / hysterical / all in the mind’ (or whatever euphemism is in fashion at the time”); ”
Source: CORPORATE COLLUSION?, Hooper et al. (2007)
There are many, many examples of insults, abusive comments, lies, and deceptions by wessely school psychiatrists, the same people who drew up the ineffective NICE guidelines. No Federal body, and indeed no American government body should support such outrageous abuse of medicine and science, and abuse of seriously ill patients.
The IOM should by itself or in referral back to the Secretary of the HHS immediately call for the implementation of the Canadian Criteria 2003 in the USA as advised by the 50 leading ME/CFS medical doctors and researchers. And a retraction of its support for NICE guidelines in defining ME/CFS in it’s GWI report. This would preserve the prestige, integrity and honor of the IOM and enable many Americans to get the diagnostics and treatments they need, and assist the research efforts of scientists in the USA and around the world.
Best Regards,
David Egan.
WELLLL done, DAVID—speak it loud and speak it clear and speak it true. THANK YOU!!! AND, again, thanks to people like Jennie and Jeannette for hosting these most important blogs for us to communicate and move the ME/CFS cause FORWARD!!!
The IOM Plot thickens
Reply from IOM
Dear David,
The Institute of Medicine does not, as an organization, hold positions on the topics that are addressed by committees or other activities. The report that you reference was written by an separate, independent consensus committee for a study that has now ended. The current study on ME/CFS is independent of the Gulf War study.
Best,
Kate Meck
Reply to Kate Meck
Dear Kate,
The National Academy of Sciences and it’s affiliated body the IOM are cited as one of the authors. The report is copyrighted by the National Academy of Sciences ; authors tend to do this. The citations for the report in medical and scientific journals begins with the IOM ; authors tend to do this. The report committee was picked by the IOM and supervised by the IOM, and was to a large under the control or auspices of the IOM. The report was fully approved by the National Academy of Sciences and it’s affiliated body the IOM. There were no reservations. Legally speaking, the report is yours, it belongs to you. And the position taken in the report supports the NICE guidelines and CBT, GET and psychiatric drugs, which so far has proven to be ineffective and indeed harmful ; I refer you to the memorial to those people who have died of ME/CFS and it’s health complications http://www.ncf-net.org/memorial.htm
I think we need to be honest about all of this.
There remain continuing IOM issues of conflicts of interest, bias, consistency and accuracy, independence and the ‘Public Interest’ which need to be resolved.
Best Regards
David Egan.
5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013
I have only included a brief synopsis of each report and links to relevant pages from the report
Gulf War and Health (2013)
Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.
http://books.nap.edu/openbook.php?record_id=13539&page=22
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
http://www.nap.edu/openbook.php?record_id=13539&page=120
Gulf War and Health (2010)
Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=12835&page=210
http://www.nap.edu/openbook.php?record_id=12835&page=211
http://www.nap.edu/openbook.php?record_id=12835&page=212
http://www.nap.edu/openbook.php?record_id=12835&page=213
http://www.nap.edu/openbook.php?record_id=12835&page=214
Gulf War and Health (2008)
Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11922&page=174
http://www.nap.edu/openbook.php?record_id=11922&page=175
http://www.nap.edu/openbook.php?record_id=11922&page=176
http://www.nap.edu/openbook.php?record_id=11922&page=177
http://www.nap.edu/openbook.php?record_id=11922&page=178
Gulf War and Health (2006)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11729&page=161
http://www.nap.edu/openbook.php?record_id=11729&page=1612
http://www.nap.edu/openbook.php?record_id=11729&page=163
http://www.nap.edu/openbook.php?record_id=11729&page=164
http://www.nap.edu/openbook.php?record_id=11729&page=165
Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.
http://www.nap.edu/openbook.php?record_id=9953&page=343
Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”
This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.
http://www.nap.edu/openbook.php?record_id=9953&page=350
http://www.nap.edu/openbook.php?record_id=9953&page=354
http://www.nap.edu/openbook.php?record_id=9953&page=355
The IOM in some difficulty regarding definition of ME/CFS
Kate Meck, IOM
Dear David,
Thank you for your feedback. All IOM reports follow a strict study process and committees are convened in accordance with this conflict of interest policy to ensure reports provide independent, objective advice. If you would like to be added to the listserv to receive updates on the study, such as when the provisional committee is announced, you may sign up for our listserv here: http://iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx.
Best,
Kate Meck
David Egan, ME/CFS advocates and organisations
Dear Kate
Thanks for your reply. I hope we can work together to resolve this issue. There remain issues of conflict of interest, bias, lack of accuracy and consistency, lack of independence, and public interest issues in relation to IOM and its contract to define ME/CFS.
Conflict of interest
IOM itself has a conflict of interest as it is the author and owner of the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. It’s stated position in these 5 reports creates a conflict of interest, as it failed to include vital biological research findings, some 5,000 papers, and had psychiatric bias in all 5 reports. Further details presented below in synopsis of reports and relevant pages from reports.
Bias
IOM failed to look at the biological research and findings into ME/CFS which amount to approximately 5,000 papers in the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. Yet the IOM quoted the psychiatric papers, some of which had serious scientific and historical flaws and errors. And the IOM recommended psychiatric based treatments. This strongly indicates psychiatric bias in these 5 reports. Further details presented below in synopsis of reports and relevant pages from reports.
Lack of Accuracy and Consistency
The lack of accuracy pertains to the ignoring and omitting of important biological research and findings into ME/CFS which amount to approximately 5,000 papers in the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. The omission of Canadian Criteria 2003, Nightingale Criteria 2007, International Consensus Criteria 2011 point to further lack of accuracy. The “primary research” source in these 5 GWI reports failed to include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. The reluctance and refusal to interview medical doctors who have successfully treated ME/CFS also blocked accuracy in the 5 reports.
As regards consistency, the IOM’s position on ME/CFS may become inconsistent if it examines, analyses and includes biological scientific facts in the new definition which were not included in the 5 GWI reports.
Independence
The IOM selected the committees for these 5 GWI reports below where ME/CFS was extensively mentioned and the position on ME/CFS stated. The IOM oversaw these committees, was in regular communication with them and the IOM had the power to read the final report and recommend amendments or changes in line with scientific and medical facts and public interest issues.
The continued selection of committee members with obvious psychiatric bias in 5 GWI committees producing 5 reports, all of them with psychiatric bias strongly suggests a pre-conceived position and viewpoints, a lack of independence and a lack of independent thinking. The latter being obvious through the omission of biological scientific and medical facts.
The Public Interest
There are matters here of great concern to the health and safety of the American people. This is outlined on the following web site detailing those people who have died of ME/CFS and it’s health complications – http://www.ncf-net.org/memorial.htm The neglect of patients through the use of ineffective, useless and harmful psychological treatments and the stigma and prejudice surrounding this in societies has been a major contributor to these deaths and years of suffering.
5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013
I have only included a brief synopsis of each report and links to relevant pages from the report
Gulf War and Health (2013)
Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.
http://books.nap.edu/openbook.php?record_id=13539&page=22
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
http://www.nap.edu/openbook.php?record_id=13539&page=120
Gulf War and Health (2010)
Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=12835&page=210
http://www.nap.edu/openbook.php?record_id=12835&page=211
http://www.nap.edu/openbook.php?record_id=12835&page=212
http://www.nap.edu/openbook.php?record_id=12835&page=213
http://www.nap.edu/openbook.php?record_id=12835&page=214
Gulf War and Health (2008)
Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11922&page=174
http://www.nap.edu/openbook.php?record_id=11922&page=175
http://www.nap.edu/openbook.php?record_id=11922&page=176
http://www.nap.edu/openbook.php?record_id=11922&page=177
http://www.nap.edu/openbook.php?record_id=11922&page=178
Gulf War and Health (2006)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11729&page=161
http://www.nap.edu/openbook.php?record_id=11729&page=1612
http://www.nap.edu/openbook.php?record_id=11729&page=163
http://www.nap.edu/openbook.php?record_id=11729&page=164
http://www.nap.edu/openbook.php?record_id=11729&page=165
Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.
http://www.nap.edu/openbook.php?record_id=9953&page=343
Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”
This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.
http://www.nap.edu/openbook.php?record_id=9953&page=350
http://www.nap.edu/openbook.php?record_id=9953&page=354
http://www.nap.edu/openbook.php?record_id=9953&page=355
Yours Sincerely
David Egan.
Excellent work David Egan–CONCRETELY laying out the SPECIFICS and ‘grave’ CONCERNS the ME/CFS community has to Ms. Kate Beck (IOM) regarding IOM’s conflict of interest, bias, lack of accuracy and consistency, lack of independence, and public interest issues in relation to IOM’s contract to define ME/CFS.
Thank you so much for speaking LOUD and CLEAR — upfront exposure of the FACTS!
November 18th correspondence with IOM
The IOM’s continued failure to admit serious errors and breaches of it’s own guidelines in relation to ME/CFS from 2000 – 2013
Kate Meck IOM (CC to senior IOM members) November 18 2013
Dear David,
I appreciate you taking the time to express your concerns. The IOM study staff are committed to supporting this committee to develop evidence-based recommendations on diagnostic criteria for ME/CFS. We recognize the historical frustrations of the physician and patient communities in getting ME/CFS to be appropriately acknowledged and understood, and we want the committee’s work to make progress on these efforts, not hold them back. Let me respond to some of your concerns . . .
First, the Institute of Medicine does not, as an organization, hold positions on the topics that are addressed by committees or other activities. Previous reports do not constitute a conflict of interest for the organization because IOM reports are authored by independent committees of experts. The IOM’s role is to assemble a committee with appropriate knowledge, with minimized and balanced intellectual biases, and without conflicts of interest. The Committee on Diagnostic Criteria for ME/CFS will be screened for intellectual biases and conflicts of interest. You (and the rest of the public) will have the opportunity to formally comment on the provisional committee slate if you feel that the committee composition is unbalanced with regard to intellectual biases.
I understand your concerns about the accuracy of the discussion of ME/CFS in the reports listed below. ME/CFS was not the focus of any of those reports, but it is the ONLY topic to be addressed by the Committee on Diagnostic Criteria for ME/CFS. This committee has been specifically tasked to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients. We will be conducting an extensive literature search to identify published materials for the committee to review and we will hold at least one public meeting to hear directly from the physician and patient communities. You (and the rest of the public) have the opportunity to send or recommend specific articles for the committee to review. The IOM staff will work closely with the committee to ensure that the report accurately reflects the evidence base, including biological/medical research.
I hope that I have addressed some of your concerns. If you would like to be notified when the provisional committee slate is posted, please sign up for the project listserv. If you would like to send materials for the committee to review, you can send them to mecfs@nas.edu. Please note that all written materials provided to the committee will be placed in a Public Access File. If you have additional questions about IOM processes, you can contact Molly Galvin (cced here).
Best,
Kate Meck
Reply from David Egan ME/CFS patient and advocate and representing ME/CFS organisations
Dear Kate,
thanks for your assistance in this matter. You state “committee to develop evidence-based recommendations on diagnostic criteria for ME/CFS.” , “he IOM’s role is to assemble a committee with appropriate knowledge, with minimized and balanced intellectual biases, and without conflicts of interest.”
Yet in the 5 GWI reports your “independent” committees of “experts” recommended totally ineffective, inaccurate and harmful diagnostics and treatments for ME/CFS, specifically GWI soldiers with ME/CFS. They showed clear psychiatric bias and ommitted important and vital biological scientific research and medical findings. That’s 5 reports by “independent” committees of “experts”. Neither independence or expertise were shown by these individuals. This was a key failing of the IOM. The credibility and reputation of the IOM has been affected by this lack of scientific and medical thoroughness.
How could the IOM make the same mistake 5 times, and elect the same type of “independent” committees of “experts” with the same mistakes and ommissions ? The IOM had ample opportunity to amend these 5 reports in line with scientific and medical accuracy and the protection of the public interest, but did not do so. The IOM owns the process which created these reports, selected the committees and owns the reports themselves, so it is not independent of the reports.
We are not holding the IOM back, its far better to get the outstanding matters resolved than engage in another rushed job at IOM and have another meaningless and ineffective psychiatric based definition and more years and decades of suffering and premature deaths for ME/CFS patients in the USA and elsewhere. We are dealing with life and death issues here, as exemplified here at this link http://www.ncf-net.org/memorial.htm
IOM is holding itself back by failing admit to it’s past errors, mistakes and ommissions and breaches of its own guidelines. The IOM could decide to step aside until these matters are fully resolved and recommend the current best international practises in diagnostics for ME/CFS ; these being
Myalgic encephalomyelitis: International Consensus Criteria, 2011.This supercedes ‘Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols (2003)’ listed below.
ME Primer for Healthcare Professionals: based on Myalgic encephalomyelitis: International Consensus Criteria, 2012
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols, 2003
For Medical Doctors – Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Diagnostic and Treatment Protocols, 2003
Yours Sincerely,
David Egan.
A new approach to IOM
Email to Mr. Daniel Levinson, Inspector General of DHHS
Subject: Conflicts of Interest, Bias and Fraud which require Investigation by the Inspector General
Dear Mr. Daniel Levinson,
I would like to draw your attention to serious and continuing matters involving conflicts of interest and bias in relation to the IOM contract to redefine the illness “ME/CFS” which contravene US laws and regulations and the policies of the Department of Health and Human Services and the IOM. This was briefly outlined in a letter sent to you by ME/CFS patient (and lawyer) Jeannette K. Burmeister on November 11th 2013. There is further corroborating evidence of this involving five separate reports by the IOM into ME/CFS between 2000 and 2013, which show clear signs of bias, lack of accuracy and integrity, and misrepresentation and which now create a conflict of interest for the IOM itself in the recent awarding of a contract to it by the HHS. I have detailed this below in correspondence I had with senior IOM personnel recently. (See Correspondence with IOM at end of letter)
In addition to the above, there has been a massive fraud committed against the American people, the American taxpayers and the Department of Health and Human Services in relation to the diagnosis and treatments for ME/CFS or “Chronic Fatigue Syndrome” for several years . This fraud has consisted of denial of proper scientifically and medically verified diagnostics and treatments and best international practises for ME/CFS for many years and the use of inadequate, ineffective and medically unsound treatments which have cost the American government and economy many billions of dollars every year and in addition has cost the lives of many Americans. The financial and economic losses are approximated here at http://www.me-ireland.com/why.htm#100 while the cost in human lives is catalogued here at http://www.ncf-net.org/memorial.htm
To put all of this in context, there was an uncovering of substantial fraud concerning Federal monies designated for ME/CFS research in the 1990’s. From fiscal 1995 through fiscal 1997, some $5.8 million that the CDC told Congress had been spent on CFS research actually went to other activities. Certain members in the CDC tried to cover this up at the time. There were no criminal prosecutions and court cases at the time, and no one was fired or resigned, which was unusual when one considers the seriousness of the crimes and the fact that Americans were dying of the illness. A trend has emerged and it has continued, a trend of fraud, abuse, denigration, neglect and mistreatment of seriously ill patients.
I think it’s important to emphasise here that serious transmissible diseases within ME/CFS patient cohorts are being neglected and ignored and this is having devastating consequences for patients themselves, their partners and for the unsuspecting wider American public, and will continue to do so. The sheer scale of the problem means that swift and decisive actions are required at Federal level and State levels to resolve this ongoing issue. It will require a very thorough investigation by your office, possibly in liaison with other Federal investigative bodies including the FBI, NSA and Homeland Security as there are issues here which affect the lives and security of millions of Americans. The seriousness of the situation would merit Federal court cases and Congressional or Senate investigations to uncover the nature and extent of the frauds committed, the conflicts of interest and bias, the breaking of regulations and laws, the lies and deceptions, the lack of independence, accuracy and integrity in scientific papers, the wilful neglect of patients, the endangerment of lives, and the reckless and irresponsible behaviour of some persons in authority. People need to be brought to account and made answerable to the American people and government for this.
In the interim, while this is being investigated, I would ask that the US government authorities (i) stop the IOM contract and (ii) heed the top ME/CFCS medical doctors and scientific researchers and immediately implement medically and scientifically sound diagnostics and treatments for the illness, using best international practises across the USA. These have been widely used and been found to be very effective. Links to the doctor’s letter and to their recommended Diagnostics and Treatments is included below:
Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013
Myalgic encephalomyelitis: International Consensus Criteria, 2011.This supercedes ‘Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols (2003)’ listed below.
ME Primer for Healthcare Professionals: based on Myalgic encephalomyelitis: International Consensus Criteria, 2012
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols, 2003
For Medical Doctors – Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Diagnostic and Treatment Protocols, 2003
Using these new medical protocols, certain private medical clinics, some of them catalogued here at http://www.me-ireland.com/diag-treat.htm continue to lead the way in medical treatments and recoveries from the illness and in significant improvements in most cases. Following from this, the scientific research is focussing much effort on identifying the chronic immune dysfunctions and deficiencies and the chronic infections and opportunistic infections which continue to pose health risks to the patients themselves and their families and to the American population in general.
I would ask that your office investigate the matters mentioned above and carry out actions necessary to safeguard the health and well being of these seriously ill patients and the wider American public at your earliest possible convenience.
Yours Sincerely,
David Egan
Correspondence with IOM and Kate Meck attached
David Egan–you have done an AMAZING job with this e-mail to the Inspector General of the DHHS. We thank you so much for identifying clearly these atrocities of Conflicts of Interest, Bias and Fraud; articulation of the past, current and ongoing historical debacle ‘engulfing’ and imposed upon pw ME/CFS.
Over to the Inspector General for investigation . . . I hope your e-mail as above reaches far and wide exposing the truth of this ‘open dialogue’ as recently expressed by the Honorable Kathleen Zebelius.
Thanks, I am glad to help out. I am determined that justice will be done.