Just the FAQs, ma'am

"The facts, ma'am. Just the facts."

The word "propaganda" has gotten a bad rap. In our century, it has come to mean unreliable information that is used to manipulate public opinion. (Originally, propaganda referred to the Catholic Church's efforts at "propagating" the faith.)

To a certain degree, the negative connotations are deserved. Those who wish to manipulate public opinion without going through the effort of supporting and legitimizing an argument often take short cuts. References are cherry-picked, poor rhetorical strategies are used, such as ad hominem attacks, and, in the worst cases, facts may be invented, data twisted, and outright lies presented as truth.

The post that appeared yesterday on the CAA website, "CFSAC Responds to Questions Concerning the Contract with the IOM" is not an example of the most disreputable form of propaganda - outright lies designed to inflame the public -  but it does fall into the category of manipulation.

Information or manipulation?

The practice of answering FAQs - frequently asked questions - is one which provides answers to questions of general concern. FAQs enable readers to identify common problems, and quickly find concise answers.

People in the ME/CFS community certainly have questions about the IOM contract. I know I do. In fact, if
someone were to ask me, right now, "What questions do you have?" I would be able to rattle them off in a heartbeat. How will this contract affect me? Will it have an impact on disability claims, medical care, research? Will the IOM "psychologize" the illness, making it even more of a stigma than it is now? Will we end up with "chronic multisymptom illness" as a new name, with a corresponding definition that is even more vague than the current one?

The questions I would not ask are the ones that appeared in the FAQs. Some of these questions were interesting. But it was very clear from their answers - the bulk of which came directly from the IOM website - that the purpose of the questions was not to address the real concerns of the ME/CFS community, but to provide a vehicle for "canned" information, supposedly from a source that is perceived as representing patient interests (CFSAC).

Stakeholders

Are the CAA FAQs propaganda? In the strictest sense, they are. The purpose of these FAQs is not to enlighten, but to persuade, which casts their intent into doubt. If we are not asking these questions, who is? And, who is providing the answers? And, in a more general sense, why is this person, or organization, trying to influence us? How do they benefit?

""Can someone help me out, here? Anyone?"

In this case, the phrasing of these FAQs answers the first two questions.

Whoever in the CAA composed the questions - and most likely their answers as well - is not familiar with government regulations (according to section Federal Acquisition Regulation (FAR) - subpart 49.1, Subsection 49.101 Authorities and
Responsibilities, contracts can be terminated at will), is not interested in taking the time to formulate actual answers (many of which were copied verbatim from the IOM website), and has a penchant for jargon (funds are not "repurposed" - a term Suzanne Vernon uses to excess - they are redirected).

In addition, the person who wrote these FAQs prefers to remain anonymous (the "we" disguises authorship) and, in keeping with the email sent by the CAA asking the signatories of the experts' letter to HHS to revoke their signatures, likes to work "behind the scenes."

As for who benefits from the contract and how - the CAA will benefit from its association with the IOM by renewing its ties to government agencies (in recent years the CAA's funding from government grants has shrunk, making it difficult to maintain six-figure salaries for some of its board members), insurance companies will benefit by not having to pay for expensive treatments once CFS is officially defined as a psychological disorder, and HHS will benefit by making sure the status quo is not challenged.

A short quiz

I have copied the questions - but not the answers - below. Chalk up a point for every question that you don't actually care about or don't understand. Add two points for every question that appears to have a purpose other than addressing a real concern of the ME/CFS community. Add three points if the question is leading. (Hint: There are at least two.) And, if you care to the read the answers, add ten points for every answer that does not satisfy you, or you can't understand, or you suspect isn't quite accurate. The more points you score, the more likely it is that these FAQs were intended to alleviate "concerns" of the proponents of the IOM contract (namely the unpopularity the IOM contract), rather than those of our community. 

Here are the questions. The answers are HERE. 

Who is the target audience for the Institute of Medicine (IOM) study?

Why did the Department of Health and Human Services (HHS) not follow the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommendation to host a workshop in consultation with CFSAC and ME/CFS experts, but instead contracted [sic] with the IOM to do a study?

Can HHS, and all associated agencies, endorse the 2003 Canadian Consensus Criteria based on the recommendation of ME/CFS experts, patients and the International Association of CFS/ME? If not, why not?

What is the standard process that the IOM uses to develop its recommendations?

What criteria does IOM use for selection of committee members?

Does the HHS contract with the IOM specifically require the IOM to use ME/CFS experts as committee members?

Does the contract require the IOM to include a patient as a committee member?

How can patients, family members and other advocates provide input into the IOM study process?

What is the Statement of Task [sic] in this contract with the IOM?

Will the IOM study address treatment for ME/CFS?

What is the total cost of the IOM contract?

If the IOM contract is cancelled, will the contract funds go to ME/CFS research?

What is the difference between the IOM committee charge and the NIH Evidence-based Methodology Workshop for ME/CFS?

Insurance Companies Get Out of Paying Long-Term Disability Benefits to People with ME/CFS

This article (see below) appeared a few days ago on the website Lawyers and Settlements. For those of us who are battling private insurance companies for disability benefits, Christine's case is enlightening.

Why was Christine refused long-term disability by her private insurer? According to the article 

"insurance representatives don’t believe [people with CFS] are disabled. Instead, they are often considered “lazy” and “hypochondriacs,” and capable of work."

To clarify: Insurance claims are not denied based on the private beliefs of insurance representatives. Christine's claim was denied because Cigna has a policy regarding "chronic fatigue syndrome" based on information supplied to them by doctors employed by the company as medical consultants. These doctors, in turn, base their opinions on documents they have read - such as the PACE trials, and other pseudoscientific studies -  that are, in large part, influenced by insurance companies which do not want to pay for long-term disability.

It's a vicious, and venal, circle.

Once the IOM officially redefines "chronic fatigue syndrome" as a "functional" illness that can be treated with exercise, therapy and antidepressants, it is doubtful that any insurance company will pay long-term disability benefits for ME/CFS.

___________________________________________________

Insurance Company Wrongfully Denies Chronic Fatigue Syndrome Sufferer

By Jane Mundy, November 12, 2013, 10:30:00AM

Detroit, MI: Despite the fact that disability insurance is supposed to protect policyholders in the event they become disabled prior to retirement, some insurance companies still practice bad faith insurance by wrongly denying disability claims for chronic fatigue syndrome. Why was Christine denied benefits by Cigna, her Insurer, yet immediately recognized as disabled by Social Security?

Read the rest of this article HERE.

Burmeister Calls for DHHS Inspector General to Investigate IOM Bias

Yesterday, Jeannette Burmeister called for the Inspector General of the DHHS to investigate conflicts of interest and bias in the IOM. (Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS). 

The accusation of bias is neither far-fetched nor hypothetical. IOM has already stated that CFS is a functional disorder (i.e. psychological), and that treatments should consist of therapy, exercise and antidepressants. The IOM did not cite any credible studies to back their conclusion. Because the IOM has already published its opinion regarding CFS, and because that opinion has not been supported by scientific evidence, IOM is therefore not qualified to devise a definition for ME/CFS.

_____________________________________________________

Daniel R. Levinson, Inspector General

Office of Inspector General, U.S. Department of Health and Human Services

330 Independence Avenue, SW

Washington, DC 20201

Re: Conflict of Interest of the Institute of Medicine With Respect to Its Contract with DHHS Regarding ME/CFS

Dear Mr. Levinson,

I respectfully request your review of a serious conflict of interest in a recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome  (“ME/CFS”).

I am a patient who has suffered from this disease since 2006.

The IOM Contract was announced on September 23, 2013. It was entered into on a rushed and alarmingly secretive basis despite a deafening outcry by the patient community against it. The IOM Contract has so far not been terminated despite the agreement of virtually all U.S. and a fair number of international ME/CFS experts to adopt the 2003 Canadian Consensus Criteria (“CCC”) as the case definition (or diagnostic criteria) for ME/CFS and the opposition to the IOM Contract by these experts (both also on September 23, 2013) and by over 170 representatives of the patient advocacy community (on November 9, 2013). The experts’ consensus negates the need for the IOM Contract and the waste of $1 million in taxpayer money. Nevertheless, Secretary Sebelius has, to this date, not had the courtesy to reply to the experts and advocates. To the contrary, the IOM Contract is being pushed through at an unprecedented speed.

The Federal Acquisition Regulations, an in particular 48 C.F.R. section 9.504, require the [government] contracting officer “to

(1) Identify and evaluate potential organizational conflicts of interests as early in the acquisition process as possible; and

(2) Avoid, neutralize, or mitigate significant potential conflicts of interest before contract award.”

48 C.F.R. section 9.505 sets up the underlying principles in avoiding or mitigating organizational conflicts of interests, including “preventing the existence of conflicting roles that might bias a contractor’s judgment.”

In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).

Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these “treatments” are viewed by most if not all credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients. Exercise is said, in the CMI Report, to have been shown to improve ME/CFS symptoms (page 99) when the potential harm of exercise to ME/CFS patients has been clearly established. At best, if you take into account “research” that has not followed the scientific method, this form of “treatment” is controversial, with most experts agreeing that it is harmful. But it is definitely not a “treatment” recommended by credible ME/CFS experts. This ties directly into the diagnostic criteria for ME/CFS because exercise triggers a post-exertional worsening of symptoms—the hallmark feature of ME/CFS—which is why it is even part of the current woefully inadequate 1994 CDC Fukuda case definition. The CMI Report also opines that there are no biomarkers for ME/CFS (page 203) when the IOM-contract study is to determine whether there are biomarkers and what they are. Furthermore, the CMI Report opines that ME/CFS is not “an organic disease” (page 22).

Throughout the CMI Report, the IOM references ME/CFS and, in particular, its case definition, symptoms and treatment modalities. These are all used as critical building blocks in reaching the IOM’s conclusion regarding treatment of Chronic Multisymptom Illness. The case definition and symptoms and possibly treatments of ME/CFS are at the heart of the IOM Contract. The conflict here is obvious. The IOM is wedded to the CMI Report’s conclusions from just earlier this year that is based in part on its assumptions and conclusions about ME/CFS. That represents a substantial bias in favor of not contradicting its prior assumptions and findings and prejudices the IOM against adopting findings that are inconsistent with the CMI Report.

When you furthermore take into account the tremendous backlash the CMI Report has triggered in the Gulf-War-Illness population, including congressional hearings and serious accusations of the CMI Report being tainted due to an undue influence on the report by the Department of Veterans Affairs, it becomes even more obvious that the IOM cannot afford to backtrack on any of its findings in the CMI Report regarding ME/CFS because the CMI Report rests largely on those.

In a much less significant conflict situation, your office has determined that a conflict of interest exists if a member of an IOM committee under a DHHS/IOM contract has previously stated a position on the issues to be analyzed under the contract (Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health, regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments). In that case, the contract with the IOM was to study the adverse consequences of the Pertussis and Rubella vaccine. The committee member in question had stated his position on this issue in a deposition.

If a position on the contract issues stated in a deposition creates a conflict of interest for an IOM committee member, then surely when the organization itself, the IOM, has publicly stated such a biased position in an official report, the entire organization is unavoidably tainted by a conflict of interest.

The IOM might argue that their prior position regarding ME/CFS does not represent an organizational conflict of interest because the CMI Report was authored by a committee convened specifically for that report. That argument is not tenable because the CMI Report expressly states that the IOM along with the IOM committee assumes entirely all responsibility for the content of the CMI Report (page vii of the CMI Report).[Italics added] It cannot escape responsibility for statements by an IOM committee that the IOM, as an organization, has fully and unconditionally endorsed.

This bias towards the nature of ME/CFS creates an organizational conflict of interest that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS. The positions on ME/CFS previously stated by the IOM pre-judges any IOM conclusions at the very heart of the IOM Contract.

I specifically request that your office investigate this serious conflict of interest as soon as possible, so that government funds will not be unnecessarily expended on an unavoidably tainted contract.

I would be pleased to respond to any questions you may have.

Sincerely,

Jeannette K. Burmeister

Enclosures:

Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013

Open Letter to Secretary Sebelius by ME/CFS Advocates of November 9, 2013

Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments

cc:

Senator Harry Reid, Majority Leader in the U.S. Senate

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Secretary of Health and Human Services Kathleen Sebelius

Darwin, IOM, and the Dating Game

The controversy surrounding the IOM contract continues unabated. On her blog, Occupy CFS, Jennie Spotila has posted a detailed explanation of the process through which IOM reports are generated. Several steps are involved, including a "statement of task," accepting and approving nominations for the IOM panel, drafting a report, reviewing the report, and, finally, submission of the report for independent review. Conflicts of interest among panel members can lead to their disqualification, as will biases that might affect their judgment.

The entire process sounds carefully planned, well delineated, and comfortingly bureaucratic. There are so many clauses, sub-clauses, stipulations and guarantees, that these steps must surely produce something objective, fair, and in our best interests.

What needs to be kept in mind is that it is possible to appear to meet the letter of the law without in any way conforming to its intent. This is known as rhetoric.

Darwin and the sex lives of organizations

The primary goal of any organization is to perpetuate itself. From a Darwinian perspective, this means that it must live long enough to reproduce. It may sound slightly absurd, but organizations survive in much the same way as any other species: by mating with other similar organizations, and spawning committees with agendas corresponding to those of their parent organizations.

The question is: With which organizations has the IOM mated?

The answer to that question may be found in the IOM's report: Gulf War and Health: Treatment for Chronic Multisymptom Illness ( 2013 ) / 5 Review of Treatments for Comorbid and Related Conditions. (You can read the full text HERE.)

In this report, Chronic Fatigue Syndrome is listed as one of the comorbid conditions of CMI ("chronic multisymptom illness" aka Gulf War Illness). In the chapter entitled, "Chronic Fatigue Syndrome" (page 97), treatments for CFS are described as follows:

"Two specific therapies are recommended for people who have CFS: CBT and graded exercise therapy (GET) (CDC, 1994, Mayo Clinic staff, 2011, National Collaborating Centre for Primary Care, 2007). CBT provides a framework for patients to change how they think and feel about their illness and teaches behaviors that provide patients with a greater sense of control over symptoms (CDC, 1994; National Collaborating Centre for Primary Care, 2007). Exercise has been associated with the body’s natural release of endorphins, natural pain relievers. Both exercise and endorphins have been shown to improve a number of the symptoms of CFS and related syndromes (Cleare, 2003; Harber and Sutton, 1984)."

Ignoring the actual treatment recommendations for a moment and focusing instead on the citations, we see that the origins of the IOM's treatment recommendations are comprised of the CDC, the UK's National Collaborating Centre for Primary Care (originator of the NICE guidelines), and the Mayo Clinic staff - which is simply an iteration of the CDC. (The two research citations serve as filler: the Cleare study - from the Institute of Psychiatry in London - did not investigate exercise as a treatment, and the Harber and Sutton study had nothing to do with either ME or CFS.) 

In the remaining paragraphs of this section, only the CDC and National Collaborating Centre for Primary Care are cited.

Given the paucity of references to actual ME and CFS studies, and no inclusion at all of organizations that specialize in researching ME or CFS (e.g. Simmaron), we can only conclude that the IOM prefers to mate with its own kind, which, in this case, are not medical experts, or even medical researchers, but government agencies. 

What can we expect?

By now, we have a good idea of the sort of report the IOM will produce, because we can read what was recommended for Gulf War veterans. But there is more to this story.

In March 2013, Mr. Anthony Hardie, a Gulf War veteran, testified before the Veterans’ Affairs Subcommittee on Oversight and Investigations alleging subversion of the intent of the IOM report. Mr. Hardie testified that the report was manipulated to form a "treatments" panel that "diverged radically from both the Congressional authorizing language and established science." Mr. Hardie went on to say that "the panel was charged by VA to conduct a literature review rather than to consult with knowledgeable medical practitioners experienced in treating ill Gulf war veterans.  And nearly all of the first presenters focused on "stress-as-cause", psychological, and psychosomatic issues – all debunked years ago."

The literature review, as indicated by the references in the CFS section, was highly selective, obviously cherry-picked to conform to the panel's agenda. In this way, the panel subverted the intent of the law in order to create something that appeared to satisfy Congressional requirements, while simply fulfilling an agenda of its own.

Going over their heads

In spite of having a government that is "by the people, of the people, and for the people" it is clear that the institutional commitments of government agencies are to themselves, rather than to citizens - which is why we have citizens' groups. This is the way it should be. Institutions are given a great deal of power over individuals, and the only way to limit that power is through the watchdog activities of citizens, and through our own insistence on following not just the letter, but the intent of the law.

  

Mr. Hardie made it clear in his testimony that the manipulation of the IOM report to re-interpret GWI as a psychological ailment should be considered a breach of the law. Among others, he recommended the following actions:

• A provision making it a crime punishable by federal imprisonment for a government employee or contractor to attempt to manipulate an IOM report ordered by a government agency, or for an IOM employee or member to conspire with a government employee or contractor for the purpose of manipulating a report.
• A provision directing VA to immediately terminate the IOM case definition contract [italics added] and contract instead with the DoD Congressionally Directed Medical Research Programs (CDMRP) Gulf War Illness program to develop a case definition that is linked to Gulf War service and excludes mental conditions, and that follows customary case definition practices (including assembling a committee of experts in the illness, who can consult original data sources).

While those of us with ME/CFS are not the responsibility of any institution - unlike veterans, who are supposedly represented by the VA - there is no reason why people with ME/CFS can't make the same demand of HHS. It is a branch of government that we not only pay for, but which is entrusted with our welfare.

The squeaky wheel gets greased

In a recent conversation with a representative from one of our federal departments, I asked the question, "What can I do?" The answer was, "Complain, complain, complain."

The most efficient way to complain is through a group. Unfortunately, we don't have a national organization that represents the interests of ME/CFS patients. (NAAME is a fledgling group that may one day fulfill that role.) We do, however, have local and regional groups that are supposed to represent the interests of ME/CFS patients. 

What we can do:

• Pressure ME/CFS groups to take an official stand against the IOM contract. Some of these groups are non-profits, others are simply ad hoc organizations, but all of them have more clout than a single individual. And all of them respond to input from members and from patients in their regions. These groups can send a letter to HHS - and to their representatives - in the organization's name and post it on their websites. (Go HERE for a list of groups.)
• Sign the three petitions (here, here and here), and send letters to your representatives. (See instructions HERE.) This is easy and quick - and numbers count. 
• Write a letter to the editor of your local newspaper. The "letters to the editor" section of the newspaper is still the one people read first. Now, of course, you can post letters online. Whenever you see an article about CFS, (there was one recently on Jennifer Brea's film, Canary in a Coal Mine), write about the IOM contract. Whenever you see an article about health care, or health conditions, or anything related, write about the IOM contract.
• Complain, complain, complain to the HHS at Kathleen.Sebelius@hhs.gov.
• Last, but not least - TWEET!!! Go HERE to participate in the IOM contract tweet campaign.

In the end, all of our complaints will amount to "public outcry." History has proven that with enough public outcry, even the mightiest institutions will bend.

Making Sense of the IOM Controversy

By Erica Verrillo

Health and Human Services’ (HHS) decision to entrust the new definition of ME and CFS to the Institute of Medicine (IOM) has generated a firestorm of controversy, dividing members of the ME/CFS community into three camps: pro, con and confused.

With the CFIDS Association of America’s endorsement of the IOM contract, (1) and Dr. Bateman's subsequent shift of position, (2) the two opposing camps have become increasingly contentious, while the third is suffering from acronym overload.

Most people with ME/CFS prefer to avoid conflict at all costs, so this division generates, if not an outright headache, something akin to an emotional migraine. Even if we want to be kept informed, after a while the discussion blurs into a dense fog of shifting accusations and counter-accusations that we simply cannot absorb.

There is a strong temptation to simply ignore it all, and let the chips fall where they may. After all, this is not the first time the CFS/ME community has been divided, and it won’t be the last. In any case, a new definition won’t change the realities of the illness ... Or will it?

Why is the case definition important?

As far as research, diagnosis, and treatment are concerned, nothing is more important than a case definition. For researchers, a case definition is used to establish a patient cohort. If a definition is too open-ended, researchers may end up including people who do not have the illness they are studying, thus invalidating their results. For physicians, a case definition is used to diagnose patients, which will then, hopefully, lead to appropriate treatment.

The current case definition of CFS in the United States, the “Fukuda” definition (named for its first author) fails on all of these counts. It was developed in 1994 by a group that included a roster of physicians with highly disparate orientations – from Steven Strauss, Michael Sharpe and Simon Wessely, who believed that the illness they were defining was a psychiatric disorder, to Anthony Komaroff and Dan Peterson, who knew it wasn’t. The diverse backgrounds of these authors, some of whom had no direct clinical experience with the illness, made for a definition that was, like the ungainly camel, “designed by a committee.” By the time this group was ready to publish the new definition, consensus still had not been reached. (3)

In the end, a broad definition of CFS was adopted, leading, as many suspected it would, to problems establishing patient cohorts for research, inaccurate diagnoses, and a widespread belief among the general public and most physicians that the illness could be equated with “tiredness.” Nineteen years later, after pressure from patients and the professional community, as well as the CFSAC, the “Fukuda” definition was finally recognized as inadequate by the federal government.

The development of an accurate case definition

The primary sticking point in the Fukuda case definition is that Post-Exertion Malaise (PEM) is optional, which means patients with major depression - as well as patients with early MS, some forms of leukemia, genetic disorders, incipient heart disease, Hashimoto’s disease, diabetes, and numerous other ailments that a CBC might have missed – may be included. This is a disaster not just for researchers who don’t have a reliable means of establishing a patient cohort (and for patients who end up waiting years for a diagnosis), but for thousands of patients who don’t have CFS. These patients often have illnesses such as early MS (which presents as fatigue), Hashimoto’s disease (which causes profound exhaustion, and does not alter standard lab results until it is advanced), or any one of the myriad other illnesses that begin with fatigue. Because a diagnosis of CFS often produces an admonition to exercise, and perhaps a prescription for antidepressants, for these patients, “CFS” can be fatal.

The numerous shortcomings of the Fukuda definition motivated a group of experienced clinicians and researchers to devise their own. This was the Canadian Consensus Criteria (CCC), which was published in the Journal of Chronic Fatigue Syndrome in 2003. (4) In sharp contrast to the Fukuda definition, the CCC requires PEM, as well as neurological, neurocognitive, neuroendocrine, dysautonomic, circulatory, and immune symptoms.

Over the past ten years, researchers who are serious about establishing reliable cohorts have employed the CCC. Clinical ME/CFS specialists also prefer the CCC, finding it to be more accurate for making a diagnosis. (According to a 2011 study led by Leonard Jason, the CDC “Fukuda” criteria only identified 79% of patients with CFS/ME, while the CCC identified 87%). (5) But while the CCC has been used for a decade by serious researchers and clinicians, it is not entirely surprising that the federal government has been slow on the uptake. Federal funding for CFS has been minimal at best, creating minimal interest in the illness on all levels.

The IOM contract – from suspicion to dread

True to form, the federal government decided that rather than adopt a case definition that had been created and successfully used by experts, they would rather reinvent the wheel. On August 28th, HHS announced that it intended to hire the Institute of Medicine (IOM) to formulate a new case definition for CFS. This raised the suspicions of ME/CFS advocates both for the timing of the announcement (right before Labor Day), and for the speed with which HHS intended to assign the contract. (After 19 years, why the sudden rush?)

Suspicions were further confirmed when it was discovered that the IOM not only had little experience in defining illnesses, but that their previous definition of Gulf War Illness as “chronic multi-symptom illness” had met with universal criticism from GWI patients, clinicians and researchers. “Chronic multi-symptom illness,” as GWI advocates correctly pointed out, could describe just about any long-term illness. In effect, Gulf War Illness had been “undefined.” What was more, the IOM’s recommended treatments for “CMI” consisted of antidepressants and cognitive behavioral therapy.(6) There was every indication that CFS was going to suffer the same fate.

Patients and advocates immediately began bombarding HHS Secretary Kathleen Sebelius with letters. It appeared as if the IOM contract had been halted when HHS issued a statement that it was no longer going to pursue its solicitation of the IOM, a statement which was almost immediately revoked when it turned around and hired IOM on September 23rd.

The response was instantaneous. The same day that HHS announced it was going forward with the contract, a letter signed by 35 top ME/CFS physicians both in the US and abroad was sent to Secretary Sebelius requesting that HHS drop the IOM contract, and asking for the immediate adoption of the CCC. Within the month, 16 more experts had signed the letter, bringing the total to 50. (7)

One would think that with such an unequivocal statement from the leading researchers and clinicians in the field that HHS would take notice. More to the point, one would think that the ME/CFS community itself would rally around such an unprecedented move. And, to a large extent it did, with letters of support coming from the National Alliance for ME (NAME), Dr. Lily Chu, and Dr. Eleanor Stein, and no fewer than three petitions. There was, however, one notable exception to this outpouring of approval.

Fifth columnists

The CFIDS Association of America, the largest ME/CFS non-profit in the country, against all apparent logic, decided to endorse the IOM contract. There appeared to be no solid reason for the endorsement other than the hope that the IOM contract would “open federal doors.” In marked contrast to the position taken by nearly all the experts in the field, the CAA came to the conclusion that the IOM contract would be an “opportunity” rather than a debacle.

To bolster what was undoubtedly going to be an unpopular position, the CAA sent an email to all the experts who had signed the letter, asking them (indirectly) to reverse their position. One signatory, Dr. Lucinda Bateman, did so, citing the reasons that had been put forth by the CAA. (Dr. Bateman serves on the CAA’s Research Advisory Council.) One ME/CFS advocacy organization, PANDORA, also published an endorsement of the IOM contract, using much the same language.

Drawing fire

As might be predicted, the reaction to the CAA’s ill-disguised attempt to persuade the experts to rescind their signatures came swiftly. Dr. Mikovits responded with a tart rejoinder:

“I know that the CAA is not and has never in my experience responded to concerns expressed by the patients, nor do they now or have they ever served in the best interests of the patients, as is the only duty of an advocacy organization. This IOM contract is simply a waste of precious resources. I stand by my signature on the letter and my work which is now always has been and will always be in the best interests of the patients.” (8)

Advocates claimed that a conflict of interests might be involved. Suzanne Vernon, scientific director of the CAA, is on the IOM panel that defined Gulf War Illness as “chronic multi-symptom illness.” Critics pointed out that the CAA itself had benefited from its long association with government agencies, and might continue to do so because of its role in the IOM contract. (The CAA earned over $8 million in government grants during 2000-2007. As of 2008, government grants ceased to be a line item on non-profit IRS forms.)

This wave of criticism prompted a response from Suzanne Vernon (originally posted without a signature), in which she attempted to “clear the air.” (9) Her effort at setting the record straight was greeted with skepticism, if not outright derision.

PANDORA’s endorsement of the IOM contract met with much the same reaction. PANDORA's statement that it would “do all [it] can to avoid an IOM definition disaster…" was characterized as delusional. (10) And PANDORA's assurance that the IOM would be open to ME/CFS experts who "have the experience and knowledge to define the disease" and that “any effort to update the definition should start with the 2003 CCC” was judged to be either "naïve or co-opted." *

Shortly after PANDORA issued its statement, a group of 60 patient forum leaders, not-for-profit organization managers, scholars, authors, filmmakers, bloggers and other advocates signed a letter addressed to Secretary Sebelius, voicing their support for experts' letter.

You can’t get there from here

Like the punchline of an old joke, the real question is whether we can get there from here. Can the IOM contract really open doors? Will HHS adopt a precise definition of ME/CFS that requires the hallmark symptom of PEM? Will the experts on the IOM panel be real experts, rather than people who happen to have connections with the IOM? Can the ME/CFS community exert its influence to make sure the IOM definition is conducive to better research, diagnosis and treatment?

These are big questions, and the answer to all of them is "no."

History has shown us that we cannot change HHS "from within." Government institutions have a vested interest in maintaining the status quo for the simple reason that advancement within those institutions is predicated on not rocking the boat. Independent thinking, especially when it contradicts the received wisdom of people higher up in the chain of command, is actively discouraged in government service. In the case of ME/CFS, the status quo is comprised of lack of funding for ME/CFS research, a dismissive attitude towards the illness (couched in kinder, gentler "discussions"), the obstruction of the approval of drugs which might actually be of benefit to the sickest members of our community (Ampligen), and the perpetuation of the myth that the illness is fundamentally psychogenic and can be mitigated through therapy and exercise.

There is a lot at stake here, much more than meets the eye. So, regardless of the “friendly fire,” online arguments, and heated exchanges coming out of this battle, it is absolutely essential that members of the ME/CFS community stay clear and rational.

A redefinition of CFS as “chronic multi-symptom illness,” or any other meaningless concatenation, will not improve upon the current definition, it will not lead to effective treatment, it will not increase funding for research, and it will not lead to acceptance by the medical community. Instead, it will usher in the widespread dismissal of ME/CFS as an organic illness, and cause a halt in meaningful research. As the experts have rightly pointed out, “this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable. ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste.”

In a nutshell

• Hillary Johnson and other knowledgeable advocates have observed that over the past 30 years the government agencies entrusted with our welfare have repeatedly done everything in their power to relegate CFS to the dustbin of psycho-social illness. There is no indication that HHS has made any change in this long-standing policy. Johnson's advice on this matter is: No cooperation, only resistance.
• Fifty of the world’s leading experts in the field of ME/CFS treatment and research have categorically rejected the IOM contract, and have endorsed the CCC as the sole definition for ME/CFS.
• There is at present a world-wide effort to officially, and permanently, categorize ME and CFS as psychological illnesses. The IOM contract is part of that effort.(11)
• The ME/CFS community is not divided on the issue of the IOM contract. Thousands of people have signed the petition to revoke the IOM contract, as well as the thank you petition to our experts, and petition to adopt the CCC. Only two organizations have backed the IOM contract, the CAA and PANDORA. The majority of our ME/CFS organizations have not.
• Government contracts, like any contract, can be canceled. (See: Subpart 49.4—Termination for Default and Section 49.101- Authorities and Responsibilities.)
• Public outcry is the oldest and most effective form of promoting social change.

Further reading: An easy-to-read timeline of events surrounding the IOM controversy can be found HERE.

References:

1. Letter sent by the CAA to the signatories of the experts' letter opposing the IOM contract.
2. Statement from Dr. Lucinda Bateman on the contract between the HHS and the IOM, 9/3/02013 
3. Keiji Fukuda, MD, MPH; Stephen E. Straus, MD; Ian Hickie, MD, FRANZCP; Michael C. Sharpe, MRCP, MRC Psych; James G. Dobbins, PhD; Anthony Komaroff, MD; and the International Chronic Fatigue Syndrome Study Group* “The Chronic Fatigue Syndrome: A Comprehensive Approach to Its Definition and Study.” Ann Intern Med. 1994;121:953-959
4. Bruce M. Carruthers, Anil Kumar, Kenny L. De Meirleir, Daniel L. Peterson, Nancy G. Klimas, A. Martin Lerner, Alison C. Bested, Pierre Flor-Henry, Pradip Joshi, A. C. Peter Powles, Jeffrey A. Sherkey, Marjorie I. van de Sande. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition,Diagnostic and Treatment Protocols.Journal of Chronic Fatigue Syndrome, Vol. 11 (1) 2003, pp. 7-116 
5. Jason, Leonard A. Beth Skendrovic, Jacob Furst, Abigail Brown, Christine Bronikowski, Angela Weng. “Data mining: comparing the empiric CFS to the Canadian ME/CFS case definition.” Journal of Clinical Psychology. Volume 68 Issue 1, pages 41–49, January 2012 
6. Institute of Medicine. Gulf War and Health Volume 9 Treatment for Chronic Multisymptom Illness, January, 2013.
7. An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services, updated with additional signatures, 10/25/2013 
8. Dr. Mikovits' response to the CAA.
9. Vernon, Suzanne. Research 1st. "Clearing the Air." Oct 8, 2013.
10. Burmeister, Jeannette. Thoughts About ME. "Opening Pandora’s Box: PANDORA Cozies up to IOM" Oct 16, 2013
11. Elisabeth Lundsgaard Skovenborg, B.Sc., Andreas Schröder, M.D., Ph.D. Is physical disease missed in patients with medically unexplained symptoms: A long-term follow-up of 120 patients diagnosed with bodily distress syndrome. General Hospital Psychiatry 22 October 2013

* It should be noted that not all members of PANDORA's board support the IOM contract.

This article was first published on ProHealth.

The Domino Effect

Below is "Summary of the HHS IOM Contract Situation" written by Wildaisy Fl. Please feel free to re-post widely.

The CDC, HHS and Kathleen Sebelius have been hiding an epidemic illness that is robbing millions of people of their quality of life - taking away their ability to work and to socialize - and sometimes taking their lives. There is a long ugly history of government mistreatment of people who suffer from this illness.

The illness is Myalgic Encephalomyelitis (M.E.), sometimes incorrectly called "Chronic Fatigue Syndrome (CFS)" and most recently called ME/CFS. This disease afflicts somewhere between 1 and 4 million people in the U.S. and 17 million worldwide (See www.name-us.org/ and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3033815/).

This is a very serious and debilitating illness and the economic cost can be staggering. According to a 2004 CDC study, the illness costs every American with CFS about $20,000 a year in lost earnings and productivity. This means ME costs the United States at least $9.1 billion a year, not counting the cost of health care or disability benefits. This economic cost is in addition to the cost in terms of human lives and misery.

NIH reports spending $5 million to $6 million annually on ME/CFS research. This compares with $115-$137 million annually it spends on Multiple Sclerosis, an equally devastating disease. See: http://report.nih.gov/categorical_spending.aspx

Now, in this time of government austerity, when the government has been shut down due to budget constraints, HHS Secretary Kathleen Sebelius' agency has signed a contract estimated to cost at least one million dollars to the Institute of Medicine (IOM) to redefine ME/CFS. This is being done in spite of the fact that 50 (originally 35) well-respected researchers and clinicians, experts in ME/CFS wrote an Open Letter asking Secretary Sebelius not to sign this contract but to use a consensus definition by experts and unanimously recommended by the 50 ME/CFS experts (See: http://www.mecfsforums.com/wiki/Open_Letter_from_ME/CFS_Advocates_to_the_Honorable_Kathleen_Sebelius,_U.S._Secretary_of_Health_and_Human_Services_10/28/2013 )

Ms. Sebelius is choosing to ignore the opinions of experts in order to spend a million dollars to have strangers to this illness define its symptoms. This defies logic. HHS is spending a million dollars for the IOM to do something which has already been done by experts over a period of 20+ years, at no cost to the government!

ME/CFS patients are protesting this spending. Please sign the Petition: https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME/)

Generally, the US government works very slowly, but this time they are moving at lightening speed, even though the government has been shut down.

This decision will affect every M.E. patient, regardless of where they live. If the USA adopts a "garbage" definition for M.E. like the IOM definition for "Chronic Multisymptom Illness," formerly called "Gulf War Illness," that will start the use of a psychological definition for M.E. which will spread to other countries and have a "domino effect" on the diagnosis and treatment of M.E. all over the world.

The time to stop this is now! Everyone can help to stop this IOM contract!

You can see more detailed information here:

http://www.mecfsforums.com/wiki/2013_Contract_between_HHS_and_IOM

Magnesium: An Essential Supplement for ME/CFS

This article was originally published on ProHealth.

By Erica Verrillo

Found abundantly in leafy greens, fish, nuts, seeds,and dried fruits, magnesium is the unsung hero of nearly all our body's metabolic processes. It is a cofactor in over 300 enzyme systems, and performs vital roles in regulating blood glucose levels, protein synthesis, blood pressure, and muscle and nerve function. Along with potassium, calcium and sodium, it is classed as one of the seven minerals essential for the functioning of the human body. Without it, we would die. 

According to the USDA, fully 68% of Americans do not consume the daily recommended intake for magnesium^.1 Independent researchers place this figure even higher, at 75% - 80%. ²  (Keep in mind that the daily recommended intake is not the optimal amount a person needs to consume in order to maintain a healthy, fully functioning body, but the minimal amount one needs in order to avoid illness.)

Because magnesium is essential for relaying nervous system impulses and for the metabolism of calcium

and for the metabolism of calcium and potassium,the effects of magnesium deficiency run the gamut, from growth retardation to heart failure, from anorexia to learning disabilities and personality changes, from weakness to muscle pain, and, of course, fatigue. Even at the daily recommended intake, symptoms of deficiency can appear. In 1990, Kubena et al. listed the effects of chronic marginal intakes of magnesium, including “abnormalities in reproduction, growth, and development and disorders of neuromuscular, cardiovascular, renal, and immune function." 9 Considering the fact that roughly three-quarters of Americans are functionally deficient in magnesium, we would expect to see at least mild deficiency symptoms in the majority of our population. 

Given both its widespread systemic effects as well as its under-consumption by most of the population, it is not surprising that magnesium has been used as a treatment for such diverse conditions as diabetes, cardiac disorders, migraines, asthma, and major depression. ^3-7

Magnesium Deficiency in ME/CFS

In early 1991, I.M. Cox, M.J. Campbell, and D. Dowson published a preliminary study on magnesium levels in CFS/ME patients. All 22 patients studied had reduced levels of serum magnesium. ¹⁰ (A reduced level of serum magnesium is cause for alarm, given that the vast majority of magnesium is found in tissue, not blood.) The researchers followed up their findings with a randomized clinical study in which 15 of the patients received intramuscular injections of magnesium sulfate every week for six weeks and 17 received a placebo. Of the 15 patients receiving magnesium, 12 reported improvement in symptoms. 

A subsequent article by Dr. Mildred Seelig observed an overlap with ME/CFS and many of the symptoms of latent tetany syndrome, a medical condition resulting from magnesium deficiency leading to sleep abnormalities, vertigo, mitral valve prolapse, headaches, and anxiety. She proposed that ME/CFS patients would improve with the treatment used for LTS, namely magnesium.⁸ Dr. Seelig concluded that “The evidence that Mg deficiency causes a variety of both humoral and cellular defense disturbances, among which are several that have been identified in CFS and FM, is a reason to suspect that either Mg deficiency or its abnormal utilization might be a pathogenic factor in CFS.” 

Dr. Martin Pall's work supports Dr. Seelig's conclusion. Dr. Pall speculated that, given the likelihood that people with CFS/ME are marginally deficient in magnesium before falling ill, magnesium deficiency may actually contribute to the pathogenesis of the illness. In his book,Explaining “Unexplained Illnesses,” Dr. Martin Pall presents a compelling argument implicating oxidative stress in the etiology of CFS/ME. ¹¹ An important part of the cycle of oxidative stress typical of multisystem illnesses like CFS/ME, FM and Gulf War Syndrome is the chronic excitability of NMDA receptors. This over-excitability results in a hyperactive nervous system – along with cell damage, inflammation, and lowered production of ATP. Magnesium is one of the principal inhibitors of NMDA activity, which makes it a valuable treatment for any illness involving chronic oxidative stress.

In addition to its contribution to oxidative stress, Dr. Myhill believes that low magnesium levels in CFS/ME patients is a symptom of mitochondrial failure. When mitochondria fail, calcium leaks into cells and magnesium leaks out. According to Dr. Myhill, this leakage explains why it is useless to test serum levels of magnesium. As she puts it, “Serum levels are maintained at the expense of intracellular levels. If serum levels change this causes heart irregularities and so the body maintains serum levels at all cost. It will drain magnesium from inside cells and indeed from bone in order to achieve this.” ¹² Dr. Myhill's explanation not only accounts for why serum levels of magnesium are inconsistent in CFS/ME, but why magnesium supplementation is so effective.

Treating ME/CFS With Magnesium

Although nearly every CFS/ME physician includes either injectable or oral magnesium as part of their protocol, there are relatively few studies measuring the overall effects of magnesium supplementation. The paucity of studies may be due to the fact that body stores of magnesium cannot be measured via a blood test. However, one of the few formal studies (Manuel y Keenoy et al.) found that supplementation with magnesium led to an improvement in magnesium body stores, as well as serum vitamin E levels in ME/CFS patients.¹³ The results of that study indicate that magnesium supplementation not only leads to increased body stores, but may reduce oxidative stress (as indicated by the increase in vitamin E levels). 

What Form to Take?

Because oral magnesium is difficult to absorb, the forms most frequently recommended are magnesium citrate and magnesium glycinate. Magnesium citrate dissolves in water, which makes it more bioavailable than most other forms of magnesium (such as sulfate or oxide, both of which are inorganic and poorly absorbed ¹⁴).
Dr. Paul Cheney has observed that magnesium glycinate causes the least intestinal upset and is the most easily absorbed.¹⁵ The usual recommended dosage is 200 to 400 mg/day taken with food, although CFS/ME patients are cautioned to start with a smaller dose and increase it gradually. Intramuscular injections of 1 cc of magnesium sulfate (50%) or magnesium chloride can be administered once or twice a week. Because of magnesium's effect on heart function, the first injection should be performed in a physician's office. The main drawback of injected magnesium is that the injections are painful. The simultaneous administration of vitamin B12 or lidocaine helps relieve the pain of the injection. Because magnesium is a cathartic, high doses can cause diarrhea. In patients prone to gastrointestinal upset, a low dose is normally recommended.

Benefits

Most people with ME/CFS who take magnesium, whether oral or injected, report increased stamina and energy. Many include better sleep as an additional benefit (most likely due to magnesium's muscle-relaxing effects). 

MAGNESIUM IN A NUTSHELL

PROS:

• Increases energy
• Decreases pain
• Helps insomnia
• Reduces oxidative stress
• Anti-inflammatory
• Immune system regulator
• Inexpensive
• Oral forms are effective

CONS:

• A high dose may cause diarrhea

FURTHER READING

Excellent summary of magnesium's effects on the body from the Linus Pauling Institute. 
USDA statistics on nutrient consumption by state and nationally.

References

1. USDA Agricultural Research Service, “Percentage of individuals meeting DRI - Magnesium - 32 per cent”  
2. Ford ES, Mokdad AH. Dietary magnesium intake in a national sample of U.S. adults. J Nutr 2003;133: 2879-2882. 
3. Rude RK. Magnesium deficiency and diabetes mellitus: Causes and effects. Postgrad Med 1992; 92: 222-4. 
4. Iseri LT, Freed J, Bures AR. Magnesium deficiency and cardiac disorders. Am J Med 1975;58:837-46. 
5. Mauskop A, Altura BM.  Role of magnesium in the pathogenesis and treatment of migraines. Clin Neurosci. 1998;5(1):24-7. 
6. Marcela Davalos Bichara and Ran D. Goldman, MD. Magnesium for treatment of asthma in children. Canadian Family Physician. September 2009 vol. 55no. 9 887-889.
7. George A. Eby , Karen L. Eby. Rapid recovery from major depression using magnesium treatment. Medical Hypotheses(2006)
8. Seelig, Mildred MD, MPH. “Review and Hypothesis: Might Patients with the Chronic Fatigue Syndrome Have Latent Tetany of Magnesium Deficiency.” Journal of Chronic Fatigue Syndrome, Vol. 4(2) 1998
9. Kubena KS, Durlach J. “Historical review of the effects of marginal intake of magnesium in chronic experimental magnesium deficiency.” Magnes Res.1990 Sep;3(3):219-26. 
10. Cox IM, Campbell MJ, Dowson D. “Red blood cell magnesium and chronic fatigue syndrome.” Lancet. 1991 Mar 30;337(8744):757-60. 
11. Pall, Martin. Explaining “Unexplained Illnesses.” CRC Press, 2007.
12. Dr. Myhill discusses magnesium deficiency and treatment in CFS/ME patients. DrMyhill.co. 
13. Manuel y Keenoy, B, Moorkens, G, Vertommen, J, Noe, M, Neve, J, and De Leeuw, I. “Magnesium status and parameters of the oxidant-antioxidant balance in patients with chronic fatigue: effects of supplementation with magnesium.” J Am Coll Nutr. 2000 Jun;19(3):374-82.
14. Lindberg JS, Zobitz MM, Poindexter JR, Pak CY. “Magnesium bioavailability from magnesium citrate and magnesium oxide.” J Am Coll Nutr. 1990 Feb;9(1):48-55. 
15. Carol Sieverling "Dr. Cheney's Basic Treatment Plan for Chronic Fatigue Syndrome.” ProHealth, 10/19/01.