Reprinted with the kind permission of David Tuller. This article was originally published 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 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.)
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.
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.”
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
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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, 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 intsitute’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.”
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.