ME/CFS Patients Tell the IOM Panel to Resign: Comments from the IOM Public Meeting

I have never been so proud of the ME/CFS advocacy community as I was on January 27 when 14 articulate, intelligent, determined patients and representatives told the IOM panel to go home.

Below are comments by Mindy Kitei, Jeannette Burmeister, Charlotte von Salis, and Maryann Spurgin. I will post a full account of the meeting when videos are available.
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Mindy Kitei

My name is Mindy Kitei, and I’m a journalist. I’ve been reporting on myalgic encephalomyelitis for more than twenty years and started my blog, CFS Central, in honor of my friend Nancy Kaiser, who died of the disease in 2008.

Fifty of the finest ME experts believe that the IOM lacks ME expertise and that the government should adopt the Canadian Consensus Criteria definition immediately.

Patients believe that the IOM will devise a name worse than chronic fatigue syndrome, something like “chronic multi-symptom illness,” the meaningless moniker the government and IOM use for Gulf War Syndrome. On the IOM website, a curious diagram that accompanies an article by Dr. Daniel Clauw, lists several diseases: Gulf War Syndrome, fibromyalgia and CFS, among them, all covered under the big umbrella of somatoform disorders, psychiatric ailments that just LOOK like physical diseases.

Tell that to Nancy Kaiser, who experienced multiple seizures a day. Tell that to Jerry Crum and Leanne Hyneman, both of whom I interviewed in 1994 and have since died from ME. Jerry was in his fifties; Leanne, in her early forties.

Patients believe that the IOM committee will lump real ME patients with the flawed cohort that CDC studies. Dr. Leonard Jason, the premier expert on ME definitions, published that CDC’s cohorts have depression, not ME. Imagine studying HIV—but looking at patients who suffer only from depression, not HIV. It’s insanity.

Not only does CDC study the wrong patients, it conducts the wrong studies. Take its new exercise study. The hallmark of ME is post-exertional crashing.

But Dr. Chris Snell published that exercise-capacity deficits in ME aren't really evident until day TWO of testing. The first day patients resemble deconditioned controls.

So what is CDC doing? A one-day test. Why does CDC want patients to look like couch potatoes? So that the government can write off the ME epidemic of seventeen million souls worldwide, one million in the U.S., the same number with HIV/AIDS.

The best predictor of future behavior is past behavior. In the IOM’s book Gulf War and Health, the IOM Gulf War committee writes about CFS—since the symptoms resemble Gulf War—and recommends graded exercise for CFS, which can lead to crashes that last months, even years. Graded exercise is also recommended by CDC and psychiatrists like Simon Wessely—both of whose work the IOM Gulf War committee endorsed.

Given its clear bias, the IOM must recuse itself. And the government should adopt the Canadian Consensus Criteria and spend that $1 million for real research. Thank you.

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Jeannette Burmeister

Hello. I'm Jeannette Burmeister and I'm an attorney. I've heard some people at HHS are confused about patients' deeply-felt opposition to your project. Let me explain in simple terms why:

HHS hijacked the federal CFSAC recommendation and ignored an unprecedented and impassioned request by 50 international M.E. experts to cease and desist.

The majority on your committee are non-experts.

Insanity!

HHS insured bio-medical research will be not be funded or replicated and yet ordered an evidence-based review. You are hurtling down the psychological rabbit hole, repeating the Gulf War Illness anti-science debacle.

HHS hired an institution without experience or authority to develop case definitions.

An excellent case definition, based on science, already exists and the experts endorsed it.

The IOM has a fatal organizational conflict of interest. I have filed a complaint with the Office of the Inspector General. A formal investigation is under way.

HHS has broken federal law as to FOIA compliance. 2.5 weeks ago, I filed a lawsuit against HHS and NIH in U.S. district court.

To circumvent competition rules, HHS moved from seeking a standalone contract to issuing a task order without a clear scope, violating umbrella contract terms.

HHS issued misleading statements about the nature and terms of, and parties to, the contract.

And finally, hundreds of thousands of patients' lives were ruined or ended by a federal consensus definition in 1994. We have long memories. Patients are furious and alienated by what can only be called state-sponsored bullying.

Given your time frame and the meager "budget-dust" sum provided to you, not even a thoroughliterature review is possible. Do you really expect anyone to consider the definition you produce to be science-based? Everything about this is lose-lose.

You may attempt to serve as oracle of the biased and obstructive NIH/CDC, but your conclusions will be rendered meaningless soon enough. Academic scientists are closing in on the cause of this disease. In due time, your consensus "fairy dust" will be headed for Ripley's "Believe It Or Not"-next to the entries about the earth being flat and the sun revolving around the earth.

My husband, who is an attorney with the world's largest law firm, and I will not hesitate to bring additional lawsuits. We are supported by thousands of patients who are ready to fight you at every step, in federal court and in the court of public opinion.

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Charlotte von Salis, J.D.

Dear Panelists:

You've heard a lot today.

You've heard from three government health agencies, you've heard from IOM-selected stakeholders, you've heard that there is a huge groundswell against this study, and you've heard why that is so.

What can you do?

You can assess this situation as scientists and physicians.

Dr. Nancy Lee is on record stating that Secretary Sebelius told her a case definition is a clinical decision that has to come from the clinical community, not the Federal government.

Yet you have just heard from three representatives of the Federal government. And you have been told to coordinate and work with this study's sponsor, the NIH, through its Pathways to Prevention program.

This is in direct violation of IOM's study process and presents a blatant conflict of interest.

How is this an independent and objective process? How is this about science and medicine?

If you think your task order isn't politically motivated, consider that the CDC has been well-aware of the scientifically sound and expert-driven Canadian Consensus Criteria for over a decade - yet refuses to take down its own diagnostic and treatment guidelines, the harmful and misleading CFS Toolkit.

Your task, to develop clinical diagnostic criteria for ME and CFS, has already been accomplished.

Two primers, specifically aimed at clinicians unfamiliar with the diseases, are already available.

Both are based on criteria developed by disease experts and published in peer-reviewed medical journals. Both are available as easy -to-distribute pamphlets.

I am referring to the Overview of the Canadian Consensus Criteria and the ME-ICC Primer for Medical Practitioners. The latter is an update of the former to reflect scientific developments through 2011.

That's right. It's based on science, not politics.

And the combined knowledge of experts who collectively have diagnosed and/or treated more than 50,000 patients with M.E., have more than 500 years of clinical experience, have approximately 500 years of teaching experience, and have authored hundreds of peer-reviewed publications.

You cannot do better. Some of you are new to this disease.

How would you feel if non-experts decided to diagnose heart failure? Or lymphoma? Or Lupus?

If you truly want to fulfill your task, all you need to do is read, share, and distribute these pamphlets. Both are available from the UK charity, Invest in M.E., and can be downloaded from a number of websites.

Both can and should be distributed. Each one of you is a unique position to do just that. Order these guidelines, print them out, or at least share the websites URLs with your networks. Use your positions to get these documents out to primary care physicians.

Tomorrow, tell the IOM to stop this needless study. Defer to the collective judgment of your eminently qualified colleagues and do your part to get the CCC officially adopted.

Resign from this panel.

To do otherwise is to harm patient care and impede research.
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Charlotte von Salis also spoke for a severely ill patient, Maryann Spurgin, founder of the Myalgic Encephalomyelitis Society of America.

Dr. Maryann Spurgin

There are people in this country who spend decades of their lives in silent, darkened rooms, crippled and in excruciating pain.

They have orthostatic intolerance of variegated causes (such as low blood volume, cardiac diastolic dysfunction, and haemotological and RBC pathologies) — they are unable to sit up or to stand.

They suffer hyperacusus — they cannot tolerate any light or sound without becoming severely more ill and without suffering additional pain that does not subside, nor can they summon the strength to speak.

Some are too weak to feed themselves, others paralyzed.

Many cannot even focus on a thought.

A significant group of such patients have died of complications of this disease — some at a young age, others some 20 years earlier than their peers of similar backgrounds and socioeconomic stati, according to a paper by Dr. Leonard Jason.

Known as Myalgic Encephalomyelitis, this disease has a long history. It was recognized by the World Health Organization as a neurological disease in 1969.

These severely ill people, and others with the same or similar yet milder symptoms, have been tossed into a pot with a group of other individuals whose symptoms look strikingly different — persons with depression, some with something so mild as unspecified fatigue, others with pain syndromes like fibromyalgia.

These are not the same diseases as Myalgic Encephalomyelitis.

This pot is what the government calls “Chronic Fatigue Syndrome” — a name that was the government’s 1988 response to an outbreak of M.E in Lake Tahoe in the early 1980′s, the Holmes criteria.

Unfortunately, the Holmes criteria was broadened in 1992 with the Fukuda criteria, and even further with the Reeves criteria.

Some youths with M.E. have died or become worse due to inappropriate treatments (Cognitive Behavioral Therapy and Graded Exercise Therapy) based on these “fatigue” definitions.

M.E was never recognized by the U.S government, but it is not new or fatigue based.

It is scientifically unsound to take people who are sick with M.E. and throw them into a pot with people whose illnesses look very different, and then to conclude that M.E. has no universal biomarkers.

There are more than 500 papers in the medical literature that show measurable physiological abnormalities in the melting pot of “CFS.”

These papers show a pathophysiology for all three of the essential components of the M.E. criteria that Dr. Melvin Ramsey described: circulatory, immune, and muscle impairment.

Articles describing all of these pathophysiologies in M.E patients, although published under the name “CFS,” are available on my website.

Although the cause or causes of M.E. are unknown, the pathophysiology of M.E is not “medically unexplained.” It is available to anyone willing to read the research.

Patients who show these abnormalities should be separated from the “CFS” pot and studied separately as M.E patients.

The Canadian Consensus Criteria (CCC) is a description of these M.E. patients and requires all three of the components that Dr. Ramsey originally described to meet the definition of M.E.

It appropriately identifies milder M.E. patients and those who are homebound and/or bedridden.

“CFS” does not name a specific disease. The study of “fatigue” and the term “CFS” should be abandoned.

We urge that the IOM cease its re-definition effort and recommend that the government adopt the CCC as a clinical and research definition of M.E. until more research can be completed.

Further, unrelated diseases such as fibromyalgia, depression, or unspecified fatigue should not be lumped or studied with M.E.

We further urge that M.E be called by its long-recognized name by the World Health Organization, “Myalgic Encephalomyelitis.”

How "Chronic Fatigue Syndrome" Obscures A Serious Illness

David Tuller 

David Tuller was a reporter and editor for ten years at the San Francisco Chronicle. He served as health editor at Salon.com and frequently writes health stories for the New York Times. He received his masters in public health at Berkeley in 2005.

Reprinted with the kind permission of David Tuller. This article was originally published on BuzzFeed. (Please be sure to "like" the original article on Buzzfeed!)

By David Tuller

Ten years ago, Jeannette Burmeister was working full throttle, logging 80-hour weeks as an attorney specializing in international commercial and employment law at the San Francisco area offices of a major law firm. So when she developed a sinus infection over the Christmas holidays in 2005, she assumed she’d bounce right back.

But she didn’t. The illness persisted; Burmeister then began suffering from profound lapses of energy, crippling problems with concentration and memory, and severe sleep disorders, among other symptoms.

“I went to work for two hours one day, hit a wall, and couldn’t go back the next day,” Burmeister, now 42, said in a recent telephone conversation. “I could not think straight. I had days where I couldn’t spell my name. And such complete exhaustion you can’t describe it, like you just ran a marathon, are hungover, and have the flu, all at once.”

She hadn’t heard of chronic fatigue syndrome until a friend mentioned it; when she looked it up, the symptoms seemed to fit. As with many people who have the illness, a battery of tests found that Burmeister had abnormally high levels of antibodies to a variety of common viruses, including Epstein-Barr virus, human herpesvirus 6, parvovirus, and coxsackievirus. The significance and meaning of such findings are not fully understood; people without the illness can also have elevated viral levels.

Burmeister said the disease — and its trivial-sounding moniker — has isolated her from former friends and

Jeannette Burmeister - Photo by Paul Chinn, The Chronicle

acquaintances. They don’t understand how sick she is, she said, and she recognizes that explaining it to them is often futile. “First of all you’ve got the name,” she said. “And once you’ve put the name out there you’ve already lost most people’s attention, because then they say, ‘Yeah, I have a hard job,’ or, ‘I’m tired too.’”

More than 1 million Americans suffer from chronic fatigue syndrome, according to the Centers for Disease Control, although many experts believe that the agency’s figures are somewhat inflated. The illness is also known as “myalgic encephalomyelitis,” which means “painful inflammation of the brain and spinal cord,” and many people now refer to it as ME/CFS. Patients are used to having their symptoms belittled as imaginary or dismissed as a manifestation of depression by family, friends, colleagues, and doctors — even though compelling evidence has linked the complex illness to major immunological, neurological, and cognitive dysfunctions. Experts now believe that ME/CFS is likely a cluster of closely related conditions, triggered when an acute infection, or some other physiological insult such as exposure to environmental toxins or mold, kicks the immune system into a prolonged state of hyperactivation.

No drugs have been approved for ME/CFS, but Burmeister has found partial relief in recent years with twice-weekly infusions of the drug Ampligen, an unapproved immunomodulator that she can only obtain through an experimental treatment protocol. She blogs extensively about her illness and in 2012 testified before a Food and Drug Administration panel considering whether to recommend approval for Ampligen. (The panel voted 8-5 against it, citing insufficient safety and efficacy data.)

Jeannette Burmeister addressing the IOM panel on Jan 27

In recent months, her blog has doggedly tracked the creation of a new, federally commissioned panel charged with reviewing and updating the diagnostic criteria for the disease. The Department of Health and Human Services announced in September that it had requested the Institute of Medicine, an independent, highly regarded affiliate of the National Academy of Sciences, to conduct the study. At a public hearing in Washington, D.C., on Monday, Jan. 27, Burmeister plans to tell the members of the panel why she thinks their project stinks.

Few would claim that describing an illness with enough accuracy for clinicians to recognize it and treat it effectively is simple. But for most illnesses, creating diagnostic criteria — known as a clinical case definition — is not the stuff of high drama and conflict. ME/CFS, however, is not most illnesses.

To those who aren’t sufferers, chronic fatigue syndrome often sounds like it’s just stress related or psychosomatic — and ME/CFS has often been framed that way by medical professionals in the past. Now, Burmeister and other patients, clinicians, and researchers fear that the new, 15-member panel could repeat that mistake.

In general, medical experts in a particular illness or condition debate and create clinical case definitions and guidelines. But no single medical specialty claims ME/CFS. Patients often see clinicians in a range of specialties, including infectious diseases, immunology, neurology, rheumatology, and psychiatry. The closest parallel to a traditional medical society is the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, a scientific and advocacy organization of researchers, health care professionals, and others.

Dr. Ellen Clayton, chair
IOM ME/CFS panel

So when the Institute of Medicine announced provisional members of the panel last month, many patients were angry that more than half of the members — whatever their accomplishments in their own fields — were not known to have any professional expertise in ME/CFS. Many clinicians and researchers with experience in the field have already endorsed a set of diagnostic criteria that they say should be used as the starting point for any new case definition.

“I can’t imagine any other field where this would be happening,” said Burmeister, who grew up in East Germany, moved to the U.S. in 1999, and became a citizen in 2012. “You wouldn’t have rocket scientists come up with guidelines for heart surgery. To have a majority of nonexperts on the committee — of course this is crazy.”

The Ripple Effect

A broad or imprecise definition of the illness could have a ripple effect. Patients like Burmeister fear that flawed results will undermine research into organic causes and lead to treatments more appropriate for depression and other psychiatric conditions than for their illness.

Last fall, several dozen top researchers and clinicians in the ME/CFS field signed an unusual letter of protest to Kathleen Sebelius, secretary of the Department of Health and Human Services, strongly urging her to abandon the IOM initiative. Dr. Daniel Peterson, one of the letter-signers and a well-known expert who has treated ME/CFS patients in Incline Village, Nev., for three decades, echoed Burmeister’s concerns about the role of the nonexperts on the IOM panel.

“If I were redefining the criteria for diabetes, I would certainly want 25 diabetologists to render their opinion,” said Peterson. “I wouldn’t want neurosurgeons and psychiatrists and people who have never seen a patient. I can’t imagine being on a committee for some disease I don’t know about.”

In the letter, the experts also criticized the health department’s decision to spend $1 million on the IOM project, given that the National Institutes of Health only spends $5 million annually in research on the disease, far less than it devotes to many less common illnesses.

“Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease,” wrote the experts. “Worse, this effort threatens to move…science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Dharam Ablashi

One letter-signer, Dharam Ablashi, a prominent former researcher at the National Cancer Institute and currently scientific director of the HHV-6 Foundation, chided the federal agency. “Why do you want to spend $1 million to reinvent something?” he said. “The key point is, there are criteria out there that are working — they’re not perfect, but they can be modified.”

The Office on Women’s Health at the Department of Health and Human Services, which is co-sponsoring the IOM project, responded to questions by referring to previously issued department statements, which noted that the institute is an appropriate venue for resolving such thorny issues and that its imprimatur would ensure maximum acceptance and credibility for the findings.

“The IOM has a singular reputation for providing biomedical recommendations on difficult, complex and controversial questions in medicine,” read a FAQ from the department about the project. “The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.”

Two Perspectives: Cooperation vs Resistance

Not all patients and experts oppose the IOM initiative, and the issue of whether it is possible to cooperate with the panel and not be co-opted by it has been vigorously debated on social media. The CFIDS Association of America, a major ME/CFS organization that has frequently been at odds with grassroots patient advocates, has again caused grumbling in some quarters because of its support for the health department’s IOM agreement. Some signers of the experts’ letter have also been invited to join the IOM panel, and have accepted. Moreover, the panel appears to contain more acknowledged ME/CFS experts than many people had expected — seven out of the 15 members, if early reports are accurate.

Carol Head, president and CEO of the CFIDS Association of America, said she understood the concerns of those who oppose the IOM’s involvement but noted that no one medical specialty owns the illness. “It lacks an established medical society as exists in other diseases, so it made sense to us that the IOM would be a place to start with this,” she said.

The panel is expected to deliver its report in a year, and its guidelines are likely to be widely disseminated and accepted by doctors, so the stakes for patients are high. With any disease, accurate case definitions for both research and clinical care are essential. A case definition that is drawn too loosely and thereby includes too many people who do not have the illness in question will skew research findings and lead to unjustified and potentially harmful treatment recommendations. And case definitions that are too narrow end up screening out people with the illness who need treatment but might not be identified because of atypical disease presentation.

For diseases with reliable tests for biomarkers that indicate the presence of an infection or other abnormal physiological phenomenon, a positive result might be all that is needed for an accurate case definition. But for conditions identified through symptoms, like Gulf War Illness and ME/CFS, creating a case definition that includes those with the illness while excluding those without it is far more difficult, especially if some of the symptoms are non-specific and subjective.

In particular, ME/CFS and depression can resemble each another; a loose case definition might end up including people whose primary complaint is depression, not ME/CFS. So it is important but challenging to determine whether depression caused the fatigue and other symptoms or if the patient is depressed because that patient is indeed very sick.

Leonard Jason

Leonard Jason, a professor of psychology at DePaul University in Chicago and a widely respected ME/CFS researcher, said that a good strategy for distinguishing between the illness and depression is to ask patients what they would do if they suddenly recovered. Those suffering from a major depressive disorder, he said, would likely say they didn’t know. “But someone with ME/CFS would probably begin making lists of all the things that they wanted to do,” he said.

A History of Conflict and Condescension

Mistrust and conflict between chronic fatigue syndrome patients and federal health officials has a long history, as Hillary Johnson documented in 1996 in Osler’s Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic, a prodigious feat of investigative reporting. When several outbreaks of a persistent, flu-like illness occurred around the U.S. in the mid-1980s, many suspected Epstein-Barr virus as the culprit. The Centers for Disease Control investigated, identified no causal agent, and ultimately saddled the condition with the unfortunate and condescending name — even though the essentially identical illness known as benign myalgic encephalomyelitis (or just myalgic encephalomyelitis) had been identified many years earlier.

In the late 1990s, the CDC was found to have diverted millions of dollars intended for CFS research into other disease programs, and then to have lied to Congress about it. In the 2000s, the agency further enraged patients when it refused to support a movement to change the name to myalgic encephalomyelitis and instead spent millions on an awareness campaign promoting the name “chronic fatigue syndrome.” Patients have also long complained that the agency has focused more on psychological issues than on possible organic causes. In 2010, for example, the CDC published a study that characterized people with the illness as suffering disproportionately from “maladaptive personality features” — compared with a control group, the ill subjects had higher “scores on neuroticism” and higher rates of “paranoid, schizoid, avoidant, obsessive-compulsive, and depressive personality disorders.”

In fact, two-thirds of patients report that their downward slide started with an acute illness, such as mononucleosis or the flu, that never seemed to resolve. And experts and patients agree that the word “fatigue” causes a great deal of misunderstanding among those unfamiliar with the illness. A cardinal symptom, they say, is not just fatigue per se, but what is called post-exertional malaise or post-exertional relapse — the inability of the body to recover rapidly from even small expenditures of energy. Research in recent years has confirmed the presence of this unusual symptom among people with ME/CFS. Moreover, the exhaustion they report is far more severe than the garden-variety tiredness implied by “fatigue.”

Patients despise the name, said Michael Allen, a psychologist who became ill in the early 1990s. “When I hear that word, it makes me nuts, like waving a red flag in front of a bull,” said Allen, who lives in San Francisco. “Normal fatigue is when you’ve just run five miles and you’re tired and you take a nap and the fatigue is gone. But I have days where I’m lying on the couch for hours and I literally can’t move, like I just had major surgery. Like the mitochondria in the cells of my muscles and brain have just stopped producing energy.”

In a blog post this month at Oxford University Press, Leonard Jason, the DePaul psychology professor, described some possible impacts of the poorly chosen name.

“Chronic fatigue syndrome is an illness as debilitating as Type II diabetes mellitus, congestive heart failure, multiple sclerosis, and end-stage renal disease,” wrote Jason. “Yet 95% of individuals seeking medical treatment for CFS reported feelings of estrangement; 85% of clinicians view CFS as a wholly or partially psychiatric disorder; and hundreds of thousands of patients cannot find a single knowledgeable and sympathetic physician to take care of them. Patients believe that the name CFS has contributed to health care providers as well as the general public having negative attitudes toward them.”

Burmeister concurs with that point wholeheartedly, citing a recent visit to the emergency room after her car was rear-ended. “I was very careful not to mention CFS or ME during check-in, because patients have been known to get abused with that diagnosis in the file,” she said. She knows she is lucky to have a supportive husband who has not questioned the reality of her illness. “He never doubted me, and that’s rare — a lot of patients go through divorces,” she said.

Nonetheless, they live separately, although not because they want to. Only a handful of doctors around the country are willing to submit to the cumbersome protocol requirements for administering Ampligen; one of them is Peterson in Incline Village, which is on Lake Tahoe. Traveling back and forth twice a week to receive her infusions seemed too exhausting, so for the foreseeable future she is living in Incline Village most of the time; her husband Ed, also a lawyer with a major law firm, and 3-1/2-year-old daughter, Aimee, live in Menlo Park, south of San Francisco. Burmeister feels the medication regimen allows her to function at a modest level, although she still must guard against overexerting herself.

Being able to see Aimee only once every couple of weeks is heartbreaking. “I would like to be able to be a real mother, to take her on play dates and to the playground,” she said wistfully. “We Skype and talk on the phone, but that’s not the same as being with her. She’s definitely more attached to my husband, which is hard for any mother. I deal with it mostly by compartmentalizing — otherwise it’s too painful to think about.”

The IOM and the Case Definition for ME/CFS

The recent round of activity involving case definitions began in fall 2012, when the Chronic Fatigue Syndrome Advisory Committee — a body created under the auspices of the Department of Health and Human Services to provide guidance on the issue — recommended that the agency convene a workshop to nail down definitive case definitions for both clinical care and research.

Over the years, researchers and clinicians around the world have created at least half a dozen different case definitions for ME/CFS, based on their understandings at the time. In 1994, the Centers for Disease Control developed what became the most widely used criteria. It required the presence of six months of unexplained fatigue, plus any four of eight symptoms: cognitive problems, sore throat, tender lymph nodes, muscle pain, joint pain, headaches, sleep disorders, and post-exertional malaise.

In 2003, researchers and clinicians developed a more rigorous case definition widely known as the Canadian Consensus Criteria. In addition to fatigue, this definition requires the presence of all symptoms that experts recognized as hallmarks of the illness: post-exertional malaise, sleep disorders, muscle and joint pain, and evidence of neurological or cognitive problems. The Canadian Consensus Criteria is therefore considered by many to be the most accurate case definition and is now often used by clinicians for diagnosis — although there is general agreement that it needs further updating and refinement.

The 2012 recommendation of the Chronic Fatigue Syndrome Advisory Committee to the Department of Health and Human Services included two key elements: that the workshop to develop the research and clinical case definitions should be for stakeholders in the ME/CFS field, specifically doctors, researchers, and patients, and that it should adopt the Canadian criteria as the starting point for making adjustments.

To advisory committee members who supported the recommendation, the health department’s decision to engage the IOM instead felt like a slap in the face. And rather than designating the Canadian criteria as the basis for modifications, the health department charged the panel with assessing a full range of existing case definitions. (The Department of Health and Human Services also decided to pursue a completely separate process for developing a second case definition appropriate for research and examining other research-related issues.)

Mary Ann Fletcher, a member of the Chronic Fatigue Syndrome Advisory Committee who strongly supported the recommendation for a committee of experts, said she was totally baffled by the health department’s action. “This was not ever our recommendation, so I really can’t explain why they took us there,” said Fletcher, a professor at Nova Southeastern University in Fort Lauderdale and a leader in immunology research related to ME/CFS.

The protest letter from the leading experts to Secretary Sebelius, in addition to registering overall objections to the IOM effort, also identified the Canadian criteria as the appropriate basis for further refinements. In her response to the experts’ letter, Sebelius wrote that the IOM approach “was determined to be the most appropriate response” to the Chronic Fatigue Syndrome Advisory Committee’s recommendation. She also noted that the Canadian criteria would be considered, along with others.

The Department of Health and Human Services referred questions about selection and composition of the panel to the IOM. In an email, a spokeswoman for the institute stated that it had pursued the same strategy for ensuring the selection of disinterested panel members that it always uses for its investigations.

But many people with ME/CFS are especially concerned because of an IOM report produced last year under a contract with the Veterans Administration on treatments for Gulf War Illness — now renamed “chronic multisymptom illness.” By focusing extensively on stress-related factors and recommending cognitive behavior therapy and antidepressants as the key forms of treatment, the report caused controversy and drew complaints from veterans.

Under the Freedom of Information Act, Burmeister has requested documents relating to the IOM project and the institute’s contract with the Department of Health and Human Services, hoping they would shed light on the federal agency’s decisions and intentions. So far she has not received them, which is not unusual; federal agencies often take years before producing actual documents in response to such requests. Undaunted, Burmeister this month filed a lawsuit against the department charging it with violating the Freedom of Information Act.

Whatever the IOM panel decides when it delivers its report, Burmeister believes it is unlikely that she herself will ever recover fully. She misses her past life; she used to exercise five days a week at the gym and loved going out dancing. If she were better, she said, she might start a law firm with her husband to protect the rights of people with disabilities — a cause that she has come to embrace.

As it is, she plans to fight for people with ME/CFS as long as her health allows. “So many friends with this are sicker than I am and can’t do what I’m doing,” she said. “So this is something that’s close to my heart, that has given me a purpose again.”

Diseases can stigmatize

Below is a post which appeared on the OUP blog last week.  Leonard Jason is a professor of psychology at DePaul University in Chicago, Illinois, where he also directs the Center for Community Research.

Since the mid-1990s, Dr. Jason has published more than 60 papers on ME/CFS. Dr. Jason is best known for his epidemiological studies of the disease, for which he has received many honors and awards.



Diseases can stigmatize

By Leonard A. Jason, Oxford University Press Blog, January 21, 2014

Names of diseases have never required scientific accuracy (e.g. malaria means bad air, lyme is a town, and ebola is a river). But some disease names are offensive, victim-blaming, and stigmatizing. Multiple sclerosis was once called hysterical paralysis when people believed that this disease was caused by stress linked with oedipal fixations. AIDS was initially called “Gay Men’s disease” when it was considered a disease only affecting white gay men. Fortunately, when these disease names were changed, those afflicted with Multiple Sclerosis and AIDS experienced less stigma. Inspired patient activists from around the world are currently engaged in another major effort to rename chronic fatigue syndrome (CFS). It is a political struggle to alleviate some of the stigma caused by the language of scientists at the CDC 25 years ago.

Chronic fatigue syndrome is an illness as debilitating as Type II diabetes mellitus, congestive heart failure, multiple sclerosis, and end-stage renal disease. Yet 95% of individuals seeking medical treatment for CFS reported feelings of estrangement; 85% of clinicians view CFS as a wholly or partially psychiatric disorder; and hundreds of thousands of patients cannot find a single knowledgeable and sympathetic physician to take care of them. Patients believe that the name CFS has contributed to health care providers as well as the general public having negative attitudes towards them. They feel that the word “fatigue” trivializes their illness, as fatigue is generally regarded as a common symptom experienced by many otherwise healthy individuals. Activists add, that if bronchitis or emphysema were called chronic cough syndrome, the results would be a trivialization of those illnesses.

Powerful vested forces have opposed changes. In the late 1990s and early 2000s, when I mentioned over the years that patients were stigmatized by the term chronic fatigue syndrome, I was explicitly told it was reckless and irresponsible to change the name. This was despite the fact that patients wanted more medical-sounding name, and our research group had found that a more medical-sounding term like myalgic encephalopathy (ME) was more likely to influence participants to attribute a physiological cause to the illness.

Over the last decade, patient demands for change have grown louder. New names have occurred for several patient organizations (e.g. the Patient Alliance for Neuroendocrineimmune Disorders Organization for Research and Advocacy and the Myalgic Encephalomyelitis Society of America) and research/clinical settings (Whittemore/Peterson Institute for Neuro-Immune Disease). Even the federal government has begun to use the term ME/CFS, and the organization of researchers changed their name to the International Association of CFS/ME. Ultimately, many activist groups want the term myalgic encephalomyelits to replace CFS. Bringing about a name change is a complicated endeavor, and small variations of language can have significant consequences among the stakeholders.

In addition to this effort to rename chronic fatigue syndrome, there is considerable patient activism to change the case definition, which was arrived at by consensus at the CDC rather than through empirical methods. Patients report and surveys confirm that core symptoms of the illness include post-exertional malaise, memory/concentration problems, or unrefreshing sleep. Yet these fundamental symptoms are not required within the current case definition. Patients want the current case definition to be replaced with one that requires these types of fundamental symptoms. If laboratories in different settings identify samples that are not homogenous, then consistent biological markers will not be found, and then many will continue to believe the illness is one of a psychogenic nature, just as once occurred for multiple sclerosis. Clearly, issues concerning reliability of clinical diagnosis are complex and have important research and practical implications. In order to progress the search for biological markers and effective treatments, essential features of this illness need to be empirically identified to increase the probability that individuals included in samples have the same underlying illness.

If progress is to be made on both the name change and an empirical case definition, key gatekeepers including the patients, scientists, clinicians, and government officials will need to work collaboratively and in a transparent way to build a consensus for change. Considerable activity is currently ongoing at the federal level on these critical issues, but only through open communications and the building of trust will there be the possibility of overcoming the past 25 years, which have been marked by feelings of anger and hostility due to being excluded from the decision-making process.

Secrecy, Obfuscation, and Conflict of Interest - Public Comments by Edward Burmeister on the IOM Contract

Below are comments submitted to the IOM by Attorney Edward Burmeister *  for the public meeting to be held on January 27. Please send your own comments to:  mecfsopensession@nas.edu After January 27 you can send comments to: mecfs@nas.edu

And, if you haven't already, you can also sign the petition to cancel the IOM contract and adopt the CCC.

Every email counts. Every signature counts. Every time you speak your mind - it counts. Don't let anybody, or anything, silence you.
___________________________________

Thoughts About ME, January 24, 2014

By Edward Burmeister*

My name is Edward Burmeister.

I am an attorney with the world's largest law firm. My wife, Jeannette Burmeister, is also an attorney who worked at the same firm until she became disabled with ME eight years ago.

I am writing to express, in the strongest terms possible, my objection to the IOM contract to recommend clinical diagnostic criteria for ME/CFS ("IOM Contract").

Moving forward with this IOM Contract is directly against the interests of ME/CFS patients, is in direct opposition to the opinion of 50 ME/CFS experts and is in disregard of the recommendation of the Chronic Fatigue Syndrome Advisory Committee ("CFSAC").

The only reasonable and sensible step to take at this time would be to terminate this ill-advised contract now.

One has to ask the following question:

Why would HHS enter into the IOM Contract for $1 million, 20% of the annual NIH budget for ME/CFS in light of (1) the CFSAC recommendation to convene a stakeholders' meeting of ME/CFS patients, experts and advocates, working in consultation with CFSAC members, to reach a consensus for a case definition for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition, (2) the clearly stated opposition of 50 ME/CFS experts to HHS reaching out to the IOM for developing such criteria and (3) the pitiful lack of any meaningful government funding for ME/CFS?

Moreover, why was this done behind closed doors without consultation with CFSAC, other than notice to its chair?

Add to this question the following:

Why was the IOM Contract entered into quickly and secretly?

To this date, HHS/NIH have refused to release a copy of the IOM Contract and surrounding documentation, despite multiple FOIA requests and an FOIA lawsuit filed by my wife to obtain these documents.

Why the obfuscation by HHS?

In a statement by Dr. Nancy Lee, Designated Federal Officer of HHS to CFSAC, and in FAQs issued by HHS, there is a clear reference to a contract between HHS and the IOM, but in the "National Academics Umbrella Contract Statement of Work/Request for Proposal," released to a patient by HHS, the IOM Contract appears to be a "task order against the NIH umbrella contract" with the National Academies.

Why does this Statement of Work recite that the project to be undertaken by IOM is in support of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), when it runs directly contrary to CFSAC's recommendation?

Why does the proposed IOM committee include a majority of non-ME/CFS experts, as acknowledged by HHS, in a project to develop diagnostic criteria for one of the most complex diseases that exist?

Why is there only one public meeting required under the IOM Contract and why are the IOM recommendations in its final report to NIH to be developed in secret without any opportunity for public or expert comments on the final report?

Why is the IOM the appropriate entity to perform this project given its organizational conflict of interest (the subject of a formal complaint to the HHS Office of Inspector General) presented by its prior ME/CFS findings in its reports on Gulf War Illness and its lack of experience in developing case definitions for diseases, as confirmed by Dr. Kenneth Shine, former president of the IOM.

When one ponders these questions, the answers are quick to suggest themselves.

There are key players within HHS who do not want ME/CFS to be elevated to a serious, physical disease demanding substantially increased funding, approval of research grants, approval of disability claims, approval of Medicare claims, etc.

Once the CFSAC recommendation was made in October 2012, these players set in motion a behind-the-scenes process that resulted in the announcement of the IOM Contract in September 2013, without prior public consideration or comment and, as noted above, in direct opposition to ME/CFS experts and CFSAC.

The process has been structured to (1) minimize public and patient input, (2) insure the ME/CFS experts will be in the minority, (3) ensure the final recommendation will be developed in secret without public comment and (4) ensure NIH control of this process through a secret monthly meeting of the IOM with the NIH Task Leader, contrary to the IOM's normal procedures.

If one is skeptical of my conclusions, I would suggest researching the series of IOM reports on Gulf War Illness, where the VA was in the same role HHS/NIH is in the IOM Contract.

I would commend to your reading the testimony of Mr. Anthony Hardie, a Gulf War veteran, given on March 13, 2013 to the House Veteran's Affairs Committee on Oversight and Investigations.

The IOM Contract cannot be "saved" by tinkering around the edges.

In light of the essential facts - (1) NIH control, (2) organizational conflict of interest, (3) majority of non-experts and several IOM "regulars" as committee members and (4) very little by way of public meetings or review, particularly of the ultimate recommendation - the only appropriate course of action is to terminate this contract or task order now before the inevitable damage to the ME/CFS patient community becomes permanent.

________________________

* Edward Burmeister is listed in Best Lawyers in America, Northern California Super Lawyers and Chambers America’s Leading Lawyers for Business (#1 ranking). In 2011, Mr. Burmeister was recognized as Best Lawyers' San Francisco Employee Benefits Lawyer of the Year.

Mr. Burmeister is past Chairman of the State Bar of California - Taxation Section. He is a member of the Advisory Board of the National Association of Stock Plan Professionals, the Certified Equity Professional Institute (past board member), Santa Clara University, and the Global Equity Organization (past board member).

Mr. Burmeister is a graduate of Stanford University (A.B.) and Stanford Law School (J.D.) where he was Order of the Coif and Managing Editor of the Stanford Law Review. He is admitted to practice in California and before the U.S. Tax Court and Claims Court.

Mr. Burmeister is a veteran of the Vietnam War, having served as a Lieutenant in the U.S. Navy from 1966 through 1970.

We Have Been Kept Silent for Too Long

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 mecfsopensession@nas.edu

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:  mecfs@nas.edu 

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

Note: You can preregister for the webcast HERE.

Cruelty, Revenge and Sadism - How Medical Professionals Have Failed Our Children

In this interview sponsored by the Dutch ME/CFS Association, Dr. Nigel Speight, a British pediatrician, explains how the medical system has failed young people with ME.

Dr. Speight has been involved in 30 cases in which children with ME have either been forcibly removed from their homes, or threatened with sectioning. In all of these cases, the children - or their mothers - were given a psychiatric diagnosis that replaced their diagnosis of ME.

How did this come about?

According to Dr. Speight, "Once someone pulls the trigger to set child protection proceedings in motion it is like a juggernaut ... it is very difficult to reverse. The further the proceedings go the more the professionals dig in. They cannot afford to lose face, or admit they were wrong. There is an almost sadistic element in the worst cases."

Dr. Speight presents horrifying cases in which parents who resist the psychiatric diagnosis have their children taken from them out of "revenge." Once children are placed in a mental ward, parents may be prohibited from visiting them, increasing the despair, and also worsening the physical condition, of these seriously ill children.

While Dr. Speight has defended 30 children with ME, it is important to keep in mind that the practice of removing physically ill children from their homes on a psychiatric pretext is not limited to these cases.

Justina Pelletier a young girl with mitochodrial disease was removed fro her home and placed under psychiatric care in Boston Children's Hospital for nearly a year. Karina Hansen, a young woman with ME, was forcibly removed from her home in Denmark. There are many other cases as well, ones which do not make the news.

The harm that has been done to these children is, in some cases, irreparable. But, as Dr. Speight has pointed out, there is little hope for defending these children until legal action is taken.



The full transcript below has been provided by the Dutch ME/CFS Association. Copyright ME|cvs Vereniging  Wetenschap voor Patiënten (Science to patients)

Interview with Dr. Nigel Speight, Broadcast January 7, 2014

I’m Rob Wijbenga, chair of the ME/cfs association in the Netherlands, and I’m a representative for the project Science to Patients. In that function I’m here to talk to Nigel Speight, paediatrician, who has been willing enough to participate in this project and to give six short talks on different aspects of ME/cfs based on questions from patients.

Welcome doctor Speight and thank you so much for participating. I believe you have been involved in quite a number of cases where children with ME have been threatened with removal from their families by social services. Could you tell us about this area?

Well this is a very painful area. It’s one of the most unpleasant things I witnessed in my entire medical career. It’s something that I’ve seen all over the British Isles, I’ve had cases scattered throughout the map of Great Britain. And they all seem to have similar causes, and a lot of it comes from a simple failure of doctors to protect patients by diagnosing them with ME/cfs. Which then puts them at risk of being persecuted for alternative explanations. I have had about over thirty cases which have all resulted in child protection proceedings with case conferences being held and the threat of removal. Fortunately most of them we have managed to avert by early intervention, giving second opinions. But quite a few have actually, has been a real threat of removal, and one or two children have actually spent time away from their families against their will. Because of court proceedings.

Could you tell us about any particular case, which demonstrates this problem?

Yes, there is one from an area in the Midlands. We’ll call her Tiffany, it’s not her real name for confidentiality. A lovely 13 year old girl, lively, talented, musical and she was in perfect health until she was struck down with quite acute onset ME, at the age of 13. And she was so ill that her mother had to turn to hospital doctors for admission to hospital. She did this openly and trustingly, and once in hospital she was under a paediatrician who believed in ME and everything seemed all right.

But gradually the multi-disciplinary team, including a child psychiatrist, an occupational therapist and a physiotherapist, took over the management of this case. And they set up weekly meetings where the girl was set targets, where she had to reach these targets. And she’d be taken to these meetings in her wheelchair with her head sagging, and have to sit through them and agree to try and achieve the targets next week. She was in hospital for three months, she got steadily worse despite cooperation. The professionals could not tolerate this failure to improve, and they blamed the mother. So the mother’ s visiting was limited till 6 p.m. So the physiotherapist had her all day long. The nurses used to leave her food outside her reach, so she would have to fight to get to it. Whenever her mother came in she found her demoralized and tearful.

Subsequently despite the mothers visiting being limited, the child continued to get worse. The first paediatrician said: “You might as well take her home”, and so the mother took her home. And then the family doctor came and subjected her to 30 minute intense interviews to try to find out what her mental state was and why she was in this state. The girl was reluctant to keep talking to this GP and he reduced her to tears. The family doctor then informed social services that she couldn’t accept responsibility. And social workers came with police and removed this girl from her mother again, and then treated it as a case of Münchausen syndrome by proxy. Mother’s visiting was restricted to when there was a social worker present. And the plan was to remove her to foster care for six months. And this was the aim that she then would get better, because it was her mother who was making her ill.

I was called in by the independent social worker, and met this girl, totally demoralized, resigned going to foster care. And I simply put in the opinion that their management of ME had no evidence to support it, and that it wasn’t the mother’s fault. And fortunately we did manage to get that girl discharged home, after which she made a slow but steady recovery. She has now completed university. So that was a happy ending, but a lot of unnecessary unhappiness on the way. And that was a reasonably typical case that went quite a long way down the line.

That was a nice intervention you could say.

Well that is the virtue of the independent social worker system. How far down the court system goes there is often a chance for second opinions and to try to oppose these sort of proceedings. I’d like to say I have been successful in 28 out of 30 of the cases I have been involved in. But the two that I have lost have been very unpleasant.

That’s marvellous. And do you know of other cases, taken care of by other paediatricians.

Yes, I had a case which was similar but different in some ways in which the influence of psychiatry was greater. And this was again a girl of about 13 or 14 in Scotland and she was under the care of a paediatrician who diagnosed ME quite confidently and she was moderate, moderately severe. But then she got more severe and this is one of the risk factors. The severe case of ME is not tolerated by professionals.

The paediatrician lost her nerve and referred her to psychiatry who made the alternative diagnosis, not of Münchhausen syndrome by proxy this time, but of a thing called the ‘Pervasive Refusal Syndrome’. It wasn’t a case of pervasive refusal syndrome. She was cooperating, she was just very ill.

And by the time I was called in to intervene I found her on a psychiatric ward, curled up in a foetal position, being tube fed and very very sensitive to light and sound. And every time the nurses closed the door a shudder went through this girl’s body. But the psychiatrist would not allow her to have ear protectors because that would increase her sense of withdrawal. And the psychiatrist insisted on talking to her in a loud voice and this way they would cure her of her Pervasive Refusal Syndrome. I’d like to say the court order was reversed a week later and she went to a gentle nursing home where she has been allowed to make a slow but steady recovery. But how you can change from having ME to having a purely psychiatric diagnosis just because you have been handed from a paediatrician to a psychiatrist I don’t really understand.

What is your understanding of the factors leading to this state of affairs?

I think it is easy to blame the social workers because when they come in what they do seems to be so cruel but I think we actually have to blame the medical profession first. It is the medical profession’s duty to be able to make a confident clear diagnosis of ME/cfs. And if they do that, this should be protection. But many of the cases I have seen have not even be diagnosed and then care proceedings are started by the education authorities for non-school attendance.

So doctors have to get it right to start with. The social workers will only get it wrong if the doctors don’t protect the child with a diagnosis. I should say, I have seen a lot of real abuse in my life, and I have been involved in protecting a lot of severely abused children. And to now being on the other side and to see innocent families being persecuted by the social workers who should be protecting other children is remarkable. I once saw a 9 year old boy who was threatened with care proceedings and as part of my assessment I asked him his three wishes. Which is one of the things you do to understand a child’s state of mind. And beautifully he said: ‘ I wish there were better judges and social workers in this world who would do better protecting children who need protection and not troubling families like mine’.

And this is a child of nine ???

A child of nine. Out of the mouth of babes and children.

I should say that once someone pulls the trigger to set child protection proceedings in motion it is like an ocean liner. It is like a juggernaut. It is very difficult to reverse. You have a social worker who is trained in child protection. They are used to parents protesting their innocence they have to overpower them and they keep going. And the further the proceedings go, the more the professionals dig in and cannot afford to lose face or to admit that they are wrong. I should say I have had one beautiful experience of a social worker who was completely converted by seeing the film ‘Voices from the shadows’ which touches on this, that she became an advocate for the family, refused the psychiatrist’s diagnosis of child abuse and helped them to withstand further pressure.

So that film did a lot of good there.

Fortunately there are cases like that. There is not much independent thinking in most of the cases, there is a sort of collusion when the whole case conference has met and as one they have voted the same way. They all feel supported by each other.

And you don’t see a development for the better in this country?

I have got three cases going at the moment and that is not good. How can you explain the spectacle of otherwise caring professionals inflicting what you have described as child abuse by professionals? Dr. Leonard Jason as a social psychologist said very perceptively that as a group professionals can commit acts of cruelty that they would not be capable of as individuals. But somehow their kind of self-righteousness of a cut case conference, all agreeing together allows them to proceed down these lines. I keep yearning for there to be a little boy who says ‘the emperor’s got no clothes on’, but there’s a lack of independent thinking in the process. So once the process starts it’s very hard to reverse.

I’m just astonished at how few doctors can confidently diagnose ME/cfs and protect children. I say I’m only seeing the bad cases. Maybe lots of children are being protected. The educationalists have a pressure on them to ensure school attendance. So if children aren’t protected by a diagnosis they will set the motion going. I sometimes think the child-protection social workers who are handling these innocent families are relieved to have such a soft target. Because most of the time their families are very tough to deal with. And if I was a social worker in child-protection I would much prefer to be drinking tea with a respectable innocent family and just taking one or two years of my time over it, than going to a house where my tires were slashed and I was threatened by Alsatians.

But I have to say there is something once the whole process gets going, there is a kind of almost sadistic element to some of the worst cases. They must be able to see the suffering they are causing. And so often as a group the professionals fail to actually speak to the child who is usually quite old enough to tell them their opinion and to put them right. And if you talk to the child it all comes straight.

I sometimes think we should make a dossier of all the cases. I haven’t got round to it but we should take it to people in parliament and colleges and paediatrics and everywhere because it is not getting better at the moment.

So you don’t see any change of attitude at all?

I sometimes feel it is getting worse.

And then you talk about a group of psychology who is at work. Everybody feels supported by the unanimity of the club.

Yes.

So you see independent psychologists who are driven along with this current.

I have seen quite a few cases where the fact that the family have declined the help of a psychiatrist has led to the child protection proceedings. The psychiatrists have felt rejected and have instituted child protection proceedings almost as a revenge. I should say there is another aspect to all this which sometimes comes more from paediatricians, and this is doctors who believe in their therapies. Whether it is graded exercise or cognitive behavioural therapy. And if it is a severe case and they can’t travel, the families are accused of ignoring medical recommendations. Now adults can do that, but parents refusing on behalf of their child instantly makes the paediatrician say they are refusing medical advice, this is child abuse.

So this is more or less a law…?

Yes. Well it is the false believe that they have got effective treatments. So often these treatments, the physiotherapy actually make the children worse. Can you think of anything which will cause, let’s say a new way of thinking? Which tools are available right now to help to effectuate that, if there is any? I have great difficulty thinking of anything at the moment. There is nothing actually happening. Maybe that a cure is found then the doctors will get ME right and the social workers won’t have any referrals. But we need something dramatic to happen. Another possibility is that some families actually take legal proceedings against the professionals and begin to counterattack. But I think most of them are so downtrodden and are so frightened of further action that’s beyond them. So at the moment I am still quite pessimistic.

Thank you so much for participating.

Federal Lawsuit Filed Against HHS and NIH Over IOM Contract

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

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.