Category:

We Have Been Kept Silent for Too Long

1/20/2014

On January 27, the IOM will hold its only public meeting regarding its contract to develop diagnostic criteria for ME/CFS. The contract has been hotly contested by ME/CFS advocates, and by physicians and researchers who are experts in the illness. The position taken by 50 of the top experts in the field is that non-experts should not have a say in determining the definition of an illness they know little about. They also point out that a clinical definition has already been developed - the Canadian Consensus Criteria.

More than 100 advocates have supported the experts' position. They have also drawn attention to the fact that the previous IOM case definition for Gulf War Illness was a disaster. (The IOM's definition for "chronic multisymptom illness" is currently being challenged by veterans.) In its report on treatments for "CMI," the IOM stated in the Review of Treatments for Comorbid and Related Conditions that "Two specific therapies are recommended for people who have CFS: CBT and Graded Exercise Therapy (GET)." (You can read the report HERE.)

The ramifications of replacing the current CDC case definition with one that is even worse - along with accompanying recommendations for treatments that are either harmful or useless - make the IOM contract one of the most important challenges the ME/CFS community has ever faced.

Do you have something to say?

Seven people have been invited to make short 10-minute presentations at the meeting (see the list HERE). Fifteen more will have a chance to make 3-minute comments. That's a total of 105 minutes.

Do you think that an hour and 45 minutes is long enough to convey the concerns of more than 17 million ME/CFS patients to the IOM?

I certainly don't.

Fortunately, there is a mechanism for making your concerns known to the IOM committee. You can submit written comments via email - and I strongly encourage you to do so.

Send an email to [email protected]

Please focus your comments on the following question:

“What is the most important aspect or information that this committee should consider throughout the course of the study?

Written comments received by January 22, 2014 will be distributed to the committee before the meeting on January 27. After January 27, written comments should be sent to the project email address: [email protected]

Don't miss this opportunity to speak your mind. We have been kept silent for too long.

Federal Lawsuit Filed Against HHS and NIH Over IOM Contract

1/10/2014

This lawsuit is the culmination of Jeannette Burmeister's efforts over the past four months to gain access to documents regarding the IOM contract through the Freedom of Information Act. The FOIA gives citizens the right to access information from the federal government, which includes HHS.

Jeannette Burmeister received her law degree from the Berlin School of Law and her Master of Law degree from the University of San Francisco School of Law. She was a former attorney at Baker & McKenzie, a global law firm employing over 4,100 lawyers in 46 countries.

Reprinted with permission from Jeannette Burmeister and Thoughts About ME.
_____________________________

By Jeannette Burmeister

Today, I filed a lawsuit against HHS and NIH in the U.S. District Court for the Northern District of California for failure to comply with the requirements of the Freedom of Information Act (FOIA) regarding documents I requested relating to the Institute of Medicine (IOM) “study” of diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome. I have asked for my costs and attorney’s fees. The complaint can be found at this link.

I am not claiming that this is the only time a government agency has failed to comply with the FOIA. However, this case seems particularly appalling given its context:

Patients with this disease have been harmed, dismissed, ridiculed, abused, neglected and completely abandoned by the government, and as a result, by the medical profession, insurance companies, friends, family, neighbors, colleagues; in other words, by society at large. This is largely due to the unscientific government-sponsored case definitions, another one of which was ordered from the IOM, which is the issue at the heart of my FOIA request. In light of this crucial reality, it simply boggles the mind that the government would arrogantly ignore their duties under the FOIA.

The IOM “study” is a highly contentious issue and the secrecy game the government is playing at the expense of violating federal law leads many to believe that the government has something to hide. It certainly isn’t worried about giving that impression.

At least two other patients have filed FOIA requests similar to mine.

The documents requested are readily available to the government, as they have been publicly referred to by HHS and quite frankly, it’s callous to force patients to have to go to the effort of filing FOIA requests given the toll that takes on their health.

I followed up on my initial request 3 times and I sent one last letter to the government 5 days ago warning them that my lawsuit is imminent if they don’t comply immediately.

I don’t understand why other patients find this kind of mistreatment acceptable and continue to seek a seat at the table when it is clear that the game played at the table is rigged (to borrow Lisa Petrison’s terms). The government feels comfortable violating federal rights of patients for whom they should go above and beyond at this point to atone for their decades of abuse. Yet, the opposite is true. What will it take for people to see that the bureaucrats will not move an inch, unless we make them by suing them or by making them look bad in public? Cooperation clearly hasn’t worked for us because doing the right thing is not a variable that factors into the equation for the government. Remember, the best predictor of future behavior is past behavior, especially when there is a clear indication, as there is here, that somebody, the government, is doubling down on their prior infractions.

Complying with our clear and basic federal rights is about the least respect towards the patients the government should be able to muster. Looking at these facts, one can only guess the level of disgust the government must have for us patients. I have heard from many patients that the feeling is mutual at this point.
_______________________________
Jeannette Burmeister received her law degree at the Berlin School of Law and her Master of Law degree at the University of San Francisco School of Law. She was a former attorney at Baker & McKenzie, a global law firm employing over 4,100 lawyers in 46 countries. Atty Burmeister is licensed to practice law in California and the United States. She was disabled by ME at the age of 34. Atty Burmeister is a dedicated patient advocate and blogs regularly about matters concerning the ME/CFS community on Thoughts About ME.

Behind closed doors

1/6/2014

The following post by Jennie Spotila appeared today on Occupy CFS. It speaks to the secrecy with which the federal government has surrounded all issues pertaining to ME/CFS.

In this instance, the National Institutes of Health (the agency charged with funding nearly all significant medical research in the country) has convened a workshop - essentially a literature review - to provide the material upon which a definition for the illness will be made.

Significantly, the workshop is not open to the public, nor does it include any ME/CFS experts. There can be only one reason for barring input from the people who know the most about the disease: What they intend to say will not be to our benefit.

Click here to contact the P2P program. Ask who the panelists are, what the results of the workshop will be used for, and if there is to be any public input.

Reprinted with permission.
___________________________

By Jennie Spotila

There’s an important meeting happening at NIH today and tomorrow, but you probably know nothing about it. The secrecy of this meeting is intentional, and the implications of decisions made at the meeting are as far-reaching as the Institute of Medicine study. In fact, what I’ve learned about the meeting may strike you as worse than the IOM study process.

Short Version

The P2P Working Group roster has not been made public.

The P2P Working Group will finalize the study questions for the evidence review and workshop.

I can exclusively reveal who was contracted to conduct that evidence review.

I can exclusively reveal the draft study questions.

The P2P panel, which will conduct the Workshop and write its report, will be 100% non-ME/CFS experts.

What Meeting Is This?

January 6-7th is the first meeting of the Working Group for the Pathways to Prevention Workshop on ME/CFS. You may be more familiar with the old name for the meeting, the NIH Evidence-based Methodology Workshop. At the May 2013 CFS Advisory Committee meeting, Dr. Susan Maier clarified the purpose of the Workshop “is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue.” The Workshop itself will not create a research definition for ME/CFS, but Dr. Nancy Lee said that the output of the workshop could be used to inform such a definition. (CFSAC Minutes, May 23, 2013, pp. 6, 48-49)

The Pathways to Prevention Program (P2P) is operated through NIH’s Office of Disease Prevention. Each workshop process takes about a year from start to finish, and its foundation is a technical brief providing “an objective description of the state of the science, a summary of ongoing research, and information on research needs.” This brief is prepared by one of the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (EPC).

At today’s meeting, the Working Group will finalize the study questions that frame the entire workshop process. Obviously, the questions are of critical importance since they form the basis for the evidence review and technical brief, as well as the public workshop itself. But before we get to the questions, don’t you want to know who is on the Working Group?

Who Is On This Working Group?

Guess what? We don’t know. At the May 2013 CFSAC meeting, Dr. Maier reported that 35-40 potential names were forwarded to the Office of Disease Prevention for possible service on the Working Group. She said that the list included ME/CFS experts, advocates and patients, including some CFSAC members. Despite vigorous objections expressed by Dr. Mary Ann Fletcher, Dr. Maier did not share the list, did not allow CFSAC to provide input, nor did she indicate a timeline for the release of that roster. (CFSAC Minutes, May 23, 2013, pp. 8, 49)

Unfortunately, Dr. Maier also did not provide the roster at the December 2013 CFSAC meeting and, to my dismay, no one on CFSAC asked her about it. Dr. Maier has also refused an individual request for the roster prior to the meeting, citing “standard procedure,” and there is no indication whether or when that information will be made public.

Why is this a big deal? Because the Working Group helps shape the entire workshop process. According to the P2P site, “the Working Group is involved from the beginning to the end of the workshop planning process; it finalizes the questions that frame the workshop, nominates panelists and speakers, and selects the date of the workshop.” Interestingly, the Working Group is made up of “content area experts from the federal government, academia, and clinical practice.” Dr. Maier said the nomination list included advocates and patients, but we have no way of knowing if any were actually appointed to the Working Group.

The Study Questions

Dr. Beth Collins Sharp described the evidence review process in detail at the May 2013 CFSAC meeting. One of the AHRQ EPCs is contracted to conduct a comprehensive evidence review based on study questions. Those study questions were drafted by unknown federal employees, and are finalized with the input of the Working Group, the EPC and federal participants. This is happening today and tomorrow.

As Dr. Collins-Sharp said in May, “You can’t get the right answer if you don’t ask the right questions.” (CFSAC Minutes, May 23, 2013, p. 12) However, Drs. Maier and Collins-Sharp have refused an individual request for the study questions being presented to the Working Group today, and have said only that the final questions will be posted by AHRQ and ODP but provided no timeline for this. Incidentally, they have also refused to disclose which EPC was contracted to perform this review.

However, I can answer both those questions today because I obtained a copy of the EPC task order through FOIA. The “Small Systematic Review for Diagnosis and Treatment of Myalgic Encephalophyelitis/Chronic Fatigue Syndrome (ME/CFS)” will be conducted by the Oregon Health & Science University for $358,211. I will discuss this contract in more detail in a future post. For now, I draw your attention to the draft questions as stated in the Task Order, and presumably being presented to the Working Group today:

I. How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of illnesses or do they encompass the entirety of the population?

II. What tools and measurements will help define the subsets of individuals in the entire spectrum on ME/CFS? Are some of these tools already available and can they reliably detect a subset of illnesses? Is it possible to identify which subset of individuals is not defined by the current tools and measurements? What is unique about the illness quality in those individuals not captured by the tools available?

III. What are the characteristics of the individuals who respond to specific treatments in terms of the spectrum of the disorder? Why do some individuals not respond? What aspect of the disorder is most relieved by specific treatments? For treatments that have been shown to be effective, what are (is) the underlying mechanism(s) of action of that intervention?

IV. What does clinical research on ME/CFS tell us about clinical diagnosis of ME/CFS? Are there hints in the current literature for a consistent defining characteristic? In the clinical realm, what differentiates borderline “cases” into confirmed versus probable? Do co-morbidities help define subsets of the clinical cases?

V. Have previous research findings shaped current clinical practice or are research and clinical practice completely separate with respect to the illness? How much influence does biomedical research help shape [sic] the future of ME/CFS research?

There are so many issues with this list. For starters:

Asking whether ME and CFS differ is critical (I), but this question fails to ask whether the mixed bag of “CFS” is even a valid clinical entity to begin with. It’s also important to note that the remainder of the questions (II-V) revert to lumping ME and CFS back together as one illness.

Question II asks what tools/measurements can be used to identify subsets along the whole spectrum, i.e. NOT whether such a “subset” actually represents a separate illness. It also asks if there is a subset not defined by current tools and measurements. Huh? How could a subset be identified if there are no tools/measurements to identify them?

Question III, the characteristics of patients who do or do not respond to treatment, rests in part on case definition. Will a systematic review dig into the raw data on studies such as the PACE trial or Ampligen trials to identify characteristics of responders and non-responders? Can applicable case definitions in those study cohorts even be assessed retrospectively (e.g. to examine a Fukuda cohort to see how many met the Canadian criteria)? Will the systematic review treat studies with different case definitions as equivalent (e.g. Oxford studies are as valid and relevant as Fukuda studies)?

Question IV strikes me as the question actually being posed in the IOM study. The IOM will be identifying the evidence for various diagnostic criteria, and then develop evidence-based clinical diagnostic criteria. Including the same type of question here seems needlessly duplicative. And what if the two evidence reviews come up with different answers?

Finally, I can answer Question V myself: it’s both. There are a number of key clinician-researchers who maintain a clinical ME/CFS practice and conduct research. For those individuals, their research influences their clinical care and vice versa. But for the rest of the world, we know that clinical care is completely divorced from ME/CFS research. Based on the horror stories we hear from patients, based on the dramatic under-diagnosis of the disease and simultaneous use of CFS as a wastebasket diagnosis, I think it is abundantly clear that research and clinical practice is separated by a great wall for most patients.

The Working Group’s planning appears to be closed to the public, and we have no input onto the final questions. We wouldn’t even have this draft list if I had not managed to file a successful FOIA request. The anonymous Working Group will finalize the questions, and these will be posted publicly – although we have no timeline for that.

Non-Experts By Design

Supposedly, the Working Group is made up of ME/CFS experts. That’s the impression Dr. Maier gave at the May 2013 meeting, and by the P2P website. But the P2P Panel is a completely different story.

The P2P Panelists perform several functions: review the evidence report produced by the AHRQ review; attend a pre-Workshop webinar to discuss the evidence report and additional materials; attend the Workshop and ask questions of the presenters; prepare a draft panel report; and review and incorporate public comments to finalize the report.

Panelists can be nominated by members of the Working Group BUT there are significant restrictions on their expertise. Specifically, the panelists:

May be knowledgeable about the general topic under consideration, but must not have published on or have a publicly-stated opinion on the topic.

Must not have intellectual conflicts, such as participation in statements by professional societies or participation in advocacy groups on the topic.

Must not hold financial or career (research) interests in the workshop topic.

Let’s be very clear about what this means. If someone has ever published on or made a public statement about the diagnosis and treatment of ME/CFS, he/she is disqualified. If someone has participated in statements from professional societies or participated in advocacy groups, he/she is disqualified. If someone has a financial or research interest in the diagnosis and treatment of ME/CFS, he/she is disqualified. Furthermore, there is no public comment period on the panel roster like there was for the IOM panel. In fact, it’s not even clear to me how far in advance we will know who has been appointed to the panel.

If the IOM process makes you mad, then this process should make you furious. There will be no ME/CFS experts on the panel that writes the Workshop report identifying methodological and scientific weakness in ME/CFS, suggesting research needs, and providing “an unbiased, evidence-based assessment of a complex public health issue.” The only involvement of experts will be through the Working Group and through the presentations made at the Workshop. I only see one upside to this arrangement: anyone who has been associated with the psychogenic model of ME/CFS will also be excluded.

This process may work very well for the “generally noncontroversial topics” that P2P is designed to address. For example, I can easily imagine the benefit of non-experts examining the state of research for a rare genetic disease. Only one other disease has been examined through P2P: polycystic ovary syndrome. The P2P workshop examined the current diagnostic criteria, causes and risk factors, and prevention and treatment strategies. There were only four panel members: an obstetrician-gynecologist, a cardiologist, the executive director of the American College of Nurse-Midwives, and the Executive Dean for Research at the Mayo Clinic. No patients or advocates spoke at this Workshop. It is not clear to me how well received the panel’s recommendations were in the PCOS patient community.

There are obvious problems with trying to apply this process in ME/CFS. First, there is no single body system to focus upon. While the PCOS Workshop could draw on endocrinologists, gynecologists and women’s health experts, what is the specialty pool for ME/CFS? Second, it is well known, and I believe generally accepted, that doctors and researchers without ME/CFS expertise will still have preconceptions about the disease. We need look no further than FDA for an example. It wasn’t until after the four-hour active listening session in April 2013 that FDA representatives, by their own admission, began to understand the seriousness of the disease, and this was a group of people who were familiar with ME/CFS to some extent. If the P2P panel is comprised of people with little ME/CFS knowledge and possibly negative preconceptions, and the Workshop does not include significant participation from ME/CFS patients and advocates, it seems unlikely that the best results will be achieved. Based on our decades of experience with misinformed scientists, clinicians, and policy makers, it is very hard to trust in such a process.

Bottom Line

Almost the entire process of this Workshop is being conducted behind closed doors. The Working Group roster has not been released. The Working Group meeting is not open to the public. The draft questions were obtained only through a FOIA. There is no information about when the final questions will be posted. We have no idea who will be on the Panel, or even who will make that decision. And the only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear.

So if you are worried about the lack of ME/CFS experts on the IOM panel, or if you think that the public will not have a sufficient opportunity to participate in the IOM process, pay attention! The NIH P2P process looks even worse. We cannot lose sight of the forest for the trees, and IOM is not the only moving piece on this chessboard.

What can we do? I believe that advocates must demand more information about the P2P Workshop, and must demand meaningful opportunities to participate. The planning and execution of the Workshop should be transparent if it is to have any legitimacy in the advocacy community. I urge you to participate in both the IOM and P2P processes at every opportunity – ask questions, provide input, and present a united front based on the truths we know about ME/CFS. We cannot wait until the end of the P2P process to make our voices heard, especially since this process will provide input into the IOM study.

New Advocates’ Letter to Secretary Sebelius Re IOM Contract Open for Signatures

12/18/2013

Below is a letter written by Lisa Petrison and Jeannette Burmeister. I signed the first advocates' letter, and have signed this one. It is quite unlikely, given their previous definition of Gulf War Illness as "chronic multi-symptom illness," that the IOM will come up with anything less heinous for us.

_________________________________________________________________

Following is a letter regarding the IOM contract that will be sent to HHS Secretary Kathleen Sebelius and other government officials this coming weekend.

We hope that everyone who signed the first advocates’ letter to Secretary Sebelius will choose to sign this one (and that we pick up some additional signatures as well!).

Due to time limitations, we are asking that those wishing to sign send notice of this by Friday, December 20, to our email address at:

[email protected]

You also can help out by letting others know about this letter and encouraging them to sign it.

Note that as in the past, this letter is open only to people acting as advocates for the disease (in a volunteer or professional capacity), rather than to all patients or to the public at large.

However, especially since the limitations of this illness make it difficult for many patients to do very much work, we are defining the word “advocates” broadly.

If you have provided information about this disease to others, or answered questions from newly diagnosed patients on a forum, or shared your views or experiences publicly, or discussed with other patients strategies about how to make the world a better place for people with this disease, or helped out in other
ways — then you count as an advocate. Please join us!

The basic format for signatures is as follows:

Name

Degree, School

Former Job (age or year disabled)

Advocacy Position (or “Patient Advocate”)

Website or Email Address (if desired)

Here is the link related to the discussion in the letter of the IOM committee advising the government about the disease formerly known as Gulf War Illness: http://bit.ly/1fBJ8sF

Here is the link related to the budget disparities between ME/CFS and other diseases with similar prevalence and severity: http://report.nih.gov/categorical_spending.aspx

Thanks much to everyone for participating.

Lisa Petrison

Jeannette Burmeister

*****
An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services

December 22, 2013

Dear Secretary Sebelius,

We are writing as researchers, physicians, authors, filmmakers, patient forum leaders, not-for-profit organization managers, bloggers and other advocates working on behalf of individuals with Myalgic Encephalomyelitis (ME), a disease that the U.S. government has historically referred to by the misleading name of Chronic Fatigue Syndrome (CFS) and more recently has called ME/CFS.

The purpose of this letter is to inform you that our previously expressed position regarding the government’s plan to redefine this disease through the Institute of Medicine (IOM) remains unchanged.

Since the September announcement of the contract with the IOM, concerned stakeholders have conveyed to you their opposition to the involvement of the IOM in the re-definition of the disease in a number of ways (including an experts’ group letter, an advocates’ group letter, multiple petitions and many individual emails).

IOM has now released a slate of proposed committee members, asking for comments. This proposed list is unacceptable for a number of reasons. The majority of the named individuals are not experts in ME/CFS; the committee chair appears to have no ME/CFS experience at all; and several of the proposed members have backgrounds focusing on mental health issues.

These problems reinforce the concerns generated by the initial report from the IOM committee charged with providing guidance to the government on Gulf War Illness, released earlier this year. That committee gave the disease an inappropriate new name; mentioned that it has symptoms overlapping with those of “Chronic Fatigue Syndrome”; and discussed the effectiveness or need for study only of treatments that are appropriate for depression but have been shown to be ineffective or harmful for ME/CFS patients (including antidepressants, cognitive behavioral therapy and aerobic exercise). Considering that this IOM panel also was dominated by non-experts in the disease being discussed and included a number of members with backgrounds in mental health, our concerns about the likely outcome of the IOM effort to redefine ME/CFS remain very high.

We again request that the IOM contract be cancelled and that the government adopt the Canadian Consensus Criteria as the definition for this disease.

In addition, we request that the government increase the budget for biomedical research into this disease to become more equitable with the budgets for other diseases with a similar level of prevalence and severity. For instance, NIH spends more than 600 times as much on HIV/AIDS as it does on ME/CFS (with a 2014 budget of $3.1 billion for HIV/AIDS vs. a trivial $5 million for ME/CFS). Considering that the number of U.S. patients living with ME/CFS (1 million) is roughly the same as the number of people in this country living with HIV, and considering that the level of suffering endured by many ME/CFS patients is equal to that experienced by untreated AIDS patients prior to their deaths, ME/CFS is woefully underfunded. This needs to be rectified immediately.

Finally, we request that the government consistently refer to this disease by its proper name, Myalgic Encephalomyelitis (ME).

Thank you for your attention to this matter.

Sincerely,

(Signatures)

Cc:

Barack Obama, President of the United States of America

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

Danile R. Levinson, Inspector General, U.S. Department of Health and Human Services

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

Dr. Harvey Fineberg, President, Institute of Medicine

Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human Services

Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health, Department of Health and Human Services

Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality

Dr. Thomas Frieden,Director, Centers for Disease Control and Prevention

Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services

Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration

Dr. Mary Wakefield, Administrator, Health Resources and Services Administration

Dr. Francis Collins, Director, National Institutes of Health

Dr. Harold Varmus, Director of the National Cancer Institute

Dr. Anthony Fauci , Director of the National Institute for Allergy and Infectious Diseases

Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

Sloppy Medicine, Silly Syntax, and CFS "Subgroups" - HHS Continues to Sink Our Ship

11/28/2013

This post by Mary Dimmock appeared today on Occupy CFS. Mary raises some valuable points that have profound implications not just for people with ME, but for those with GWI, cancer, thyroid conditions, MS, and a host of other diseases. If ME is to be subsumed into a vague general category of "fatiguing illnesses" what's to prevent the IOM from "undefining" other diseases as well? (The IOM has already "undefined" GWI.) Will IBS, Interstitial Cystitis, and chronic Lyme follow suite? Will the remedies for these problems consist of a talk and a walk?

This scenario is not as far-fetched as it seems. Sloppy medicine breeds sloppy science (and vice versa). In this case, sloppy medicine could lead to a Pandora's Box of repercussions.
________________________________________

Which Disease Is HHS Studying?

By Mary Dimmock

HHS recently issued an FAQ about the IOM contract. As Jennie Spotila, Erica Verrillo, Lois Ventura and Jeannette Burmeister pointed out, the FAQ falls far short of providing useful answers, is misleading and leaves critical questions unanswered.

Like the fundamental question: “What disease is HHS developing definitions for – ME or the diverse conditions that meet the overly broad “CFS” criteria?

I recently asked that question of both IOM’s Kate Meck and HHS’ Dr. Nancy Lee. From their answers, which I summarized below, the only possible conclusion is that the IOM study is intended to establish diagnostic criteria for the diverse conditions that meet the overly broad “CFS” criteria and that ME will be treated as a subgroup.

All of us, patients, advocates and experts alike, must reject this as completely unacceptable. We must call on HHS to acknowledge that ME is not part of the overly broad CFS. We must continue to call on HHS to adopt the Canadian Consensus Criteria.

We all know the problem. ME, the neurological disease characterized by post-exertional malaise, cognitive issues and immunological dysfunction has been buried inside of “CFS”, a diverse collection of medically unexplained fatiguing conditions. Numerous authors, especially Dr. Jason of DePaul, have reported extensively on the serious research and clinical problems caused by these overly broad CFS definitions, definitions that lump biologically unrelated conditions together. Dr. Bruce Carruthers summed it up simply, “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome.”

Having rejected the Canadian Consensus Criteria as unacceptable, HHS is conducting three separate initiatives to develop its own criteria. But what does HHS intend to do about the “web of confusion” that has been created by “CFS”? What disease will these new criteria describe?

The ME/CFS IOM Statement of Work is ambiguous on this point as it uses the same jumbled, non-specific disease labels that have gotten us into this mess to begin with. The SOW states:

"the Committee will consider the various existing definitions and recommend consensus clinical diagnostic criteria for this disorder [ME/CFS]. . .

The Committee will also distinguish between disease subgroups . . .

For the purposes of this document, ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness."

I asked both Kate Meck at the IOM and Dr. Lee, the designated federal official for the CFS Advisory Committee (CFSAC) to clarify what “scope of disease” had been specified in the IOM contract. Has the IOM been contracted to develop clinical criteria specifically for ME? Or has IOM been contracted to develop clinical criteria for the range of unrelated fatiguing conditions that meet the “CFS” criteria? I asked Dr. Maier of NIH and Dr. Beth Collins-Sharp of AHRQ a similar question on the NIH Evidence Based Methodology Workshop process and am waiting on a promised response.

Here’s a summary of the responses I received from Dr. Lee of HHS and Kate Meck of the IOM:

Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point and that this will need to be defined as the process goes forward.
Dr. Lee indicated that the panel itself would need to resolve this issue and that possible outcomes could be ME as a subgroup of the broader CFS, ME as part of a spectrum that includes these other conditions, or ME as a separately defined disease. Ms. Meck indicated that HHS would be asked to clarify what scope of disease was intended at the first meeting. I raised the concern with Ms. Meck that the scope of disease directly affects panel selection and evidence base selection but she felt that the panel and process would be able to adjust as needed.
In a follow-up email, Dr. Lee confirmed the above statements but also reiterated an earlier point she had made that the IOM task list specifies that the “committee will also distinguish between disease subgroups”. She also said that in order for the target audience – defined as the primary care physicians – to effectively use the resultant guidance, “it is important to start a bit broad and then have criteria which distinguishes between subgroups.”

These answers are profoundly disturbing.

First, the statement that the scope of disease has not yet been defined is frankly hard to believe. This is a million dollar contract and panel selection is due to be announced soon. How can such a critical issue as the scope of disease to be covered by the new criteria be undecided at this point? If it really is undecided, who will decide and how? What criteria have been used to select the panel? And will that panel still be the appropriate one once a decision is reached on what disease or diseases the new criteria will cover?

But the statements about subgroups and spectrum of illnesses are much more disturbing.

Yes, ME is a complex disease that needs to be broken down into legitimate subgroups in order to better understand the disease and the treatment options. Perhaps those subgroups are based on whether onset is sudden or not, the level of severity of the disease or the nature of the immune profile and viral load. But let’s be realistic. What is the likelihood that the panel selected for the IOM study is going to be able to identify proper subgroups of ME itself when our experts are still working through that? Or when the evidence base lacks the ME specific studies – studies done with proper ME definitions – that would be needed to substantiate ME subgroups?

At the same time, we have an agency with a long-term commitment to studying medically unexplained chronic fatigue as the single clinical entity, “CFS”. We have an agency that has taken the position that Oxford, Fukuda and the Canadian criteria all describe the same set of patients for whom one set of clinical guidance is appropriate. We have an agency that questions the scientific evidence surrounding even post-exertional malaise and its measurement while simultaneously rejecting the Canadian Consensus Criteria because it does “not account for scientific evidence developed since 2003.” We have the CDC’s Dr. Unger, rhetorically asking at the May 2013 CFSAC “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?” And we have the IOM adopting the same overly broad view of CFS as HHS in recent IOM publications on Gulf War Illness.

Now we have Dr. Lee stating that the target audience of the new criteria is the primary care physicians and that they need criteria that start broader and then distinguish between subgroups. What about the patients who desperately need criteria that accurately reflect their disease?

What are we to conclude from all this? HHS has not committed to criteria specific to ME. HHS is not talking about the proper subgroups of ME that we all envision. HHS intends the IOM study to define criteria for the broader set of CFS conditions, with ME characterized as a subgroup. Or worse, ME becomes a subgroup of the even broader chronic multisymptom illness (CMI).

Either way, this will be a disaster that will degrade ME research and worsen the abysmal clinical care and stigma that ME patients receive today. This is the nightmare scenario that we all fear.

If HHS truly wants to reverse the chaos and the grievous harm to patients caused by years of sloppy definitions, it will first and foremost declare that ME, the disease described by the Canadian Consensus Criteria, is not the same disease as the overly broad “CFS” and should not be considered as either a subgroup of CFS or part of a spectrum of CFS diseases.

And if HHS cares not only about primary care physicians but also about the ME patients that they treat, it will acknowledge the harm done to patients by its clinical guidelines as reported at a recent Mount Sinai conference. CDC will immediately highlight PEM as a hallmark symptom of ME, will provide “black box warnings” about the adverse effects of exercise on ME patients and will point clinicians to the Canadian Consensus Criteria and the IACFS/ME primer.

Beyond that, HHS needs to immediately require that the Canadian Consensus Criteria be used in every study funded by NIH, even if it is used in parallel with Fukuda as an interim step.

Patients, advocates and experts alike must demand and accept no less, especially in the context of the IOM study and the NIH Evidence Based Methodology process.

Actions Speak Louder Than Words - David Egan Challenges the IOM

11/20/2013

David Egan, Irish ME advocate and signatory of the Advocates' letter to HHS Secretary Sebelius, has been conducting a correspondence with the IOM concerning conflict of interest and bias in their evaluation of ME/CFS.

As written responses from the IOM, or any government agency are rare, I am printing it below. Not surprisingly, it consists entirely of a statement of expertise, and a challenge to offer our input. (It should be pointed out that the IOM is under no legal obligation to accept any of our input.)

Scroll down to read David Egan's reply, in which he challenges the IOM, not based on its statement of purpose, but on no less than five of its own reports, in which IOM's

"'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 omitted important and vital biological scientific research and medical findings."

If this were a trial, a recusal would be in order.

(You can read all of David Egan's letters to the IOM HERE.)
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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 [email protected]. 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

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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, "The 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 omitted 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 omissions?

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, it's 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.

IOM is holding itself back by failing to admit to its past errors, mistakes and omissions 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

Just the FAQs, ma'am

11/17/2013

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?

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

Whoever composed the questions - and their answers - is not knowledgeable about contract law (contracts, as any lawyer can tell you, can always be canceled), or interested in taking the time to formulate lucid answers (many of which were copied verbatim from the IOM website), or verbally adept (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 general form "we" disguises authorship) and, like the email sent by the CAA asking the signatories of the experts' letter to HHS to revoke their signatures, works "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 their funding from government grants has shrunk), 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 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 address "concerns" of the proponents of 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 [sic], 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?