Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME

Iquitos

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Magical Medicine: How To Make a Disease Disappear - Malcolm Hooper

Background to, consideration of, and quotations from the Manuals for the Medical Research Council’s PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis, together with evidence that such interventions are unlikely to be effective and may even be contra‐indicated

http://www.google.com/url?sa=t&rct=...=t_tb8C5tD1Df5IxdbMcttQ&bvm=bv.56343320,d.dmg
 
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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.
 
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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.
 

Snowdrop

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I'm sincerely sorry if this is not the appropriate thread or if the link below is not remotely on the mark.
I'm not well at the moment and near the end of packing for a move. I came across this:

http://brodyhooked.blogspot.ca/2013/09/how-to-tell-good-from-bad-guidelines.html

and thought that perhaps this person might be a good ally in pursuing justice for an illness group that has been maligned and marginalized.

I have thought like others here that the whole IOM thing is all bad news but I am beginning to think that the IOM has no idea what they have unleashed. By taking this underhanded move they have accomplished something they didn't bargain on. We as an ME community who are extremely exhausted are now MORE angry than exhausted.

They have woken the sleepy giant and now that collective momentum will not be stopped or silenced.
 

justinreilly

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Snowdrop, I don't think this particular author would help us since he says some things we agree with and others we definitely disagree with. He points out the pernicious influence of if financial interests but says the ideal panel would not consist of a majority of subject-matter experts.
 

Snowdrop

Rebel without a biscuit
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Snowdrop, I don't think this particular author would help us since he says some things we agree with and others we definitely disagree with. He points out the pernicious influence of if financial interests but says the ideal panel would not consist of a majority of subject-matter experts.
Thanks for checking it out. It's unfortunate how people in a position to help are stuck in a frame of reference that makes no sense in the real world; re: subject matter experts.
 
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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 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