Name Change Poll Results: ME Wins

In September 2013, the IOM was contracted by HHS to devise a new definition for chronic fatigue syndrome (CFS), the current CDC definition being considered too broad. It was also charged with providing a new name at its discretion.

The IOM made its recommendations on Tuesday, February 10, 2015 in a report entitled, "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.”

One of the recommendations of the report was to eliminate CFS and to replace it, as well as myalgic encephalomyelitis, with "systemic exertion intolerance disease" (SEID).

The overall response to the new name has been negative. Patients don't like it for various reasons, and even Simon Wessely thought SEID might "add to the confusion." In the aftermath of the IOM's announcement, Leonard Jason was contacted by hundreds of outraged patients, which prompted him to write a blog post calling for greater collaboration between patients, ME/CFS physicians and government agencies, so that "all parties are involved in the decision-making process."

The prompt to gather feedback has generated several polls and surveys on the new name, sponsored by Health Rising, Paradigm Change, the ME Association, and ProHealth, among others. 

In all of these surveys and polls, ME has been the name of choice.

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ME Association Poll Results

The ME Association in the UK conducted a poll which had a total of 724 respondents. In answer to the question, "Should CFS and/or ME be renamed Systemic Exertion Intolerance Disease (SEID) as recommended in the U.S. Institute of Medicine Report?" the majority answered with an emphatic "no." This is not surprising given the historical use of ME in the UK.

But while most did not like SEID, there were mixed responses from among the remaining 38%, indicating that a significant number of people are not happy with having two names (ME and CFS) for the disease.

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Cort Johnson/Health Rising Poll Results

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In February, Cort Johnson conducted a poll in which respondents were asked to rank different names for ME/CFS. A total of 550 people took the initial poll.

When asked to rank their favorite names from first to last, ME was the preferred name. SEID was the least preferred.

• Myalgic Encephalomyelitis (ME) – 2564 (26% of total points)

• Ramsay’s Disease – 1942 (20%) 

• Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome – 1932 (20%) 

• Chronic Fatigue Syndrome (CFS) – 1720 (17%) 

• Systemic Exertion Intolerance Disease – 1713 (17%)

In a second survey, Neuroendocrineimmune Disease was added to the list. It proved nearly as popular as ME, but once again SEID came in last. 

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ProHealth Poll Results

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On February 26, 2015, ProHealth conducted a poll on the proposed new name for ME/CFS: “What name would YOU choose for CFS? Take the poll!”

The survey consisted of three questions:

1. Do you have CFS or ME?
2. Do you think CFS should be replaced by a new name?
3. Please choose which name you would prefer.

(Respondents were given a choice of myalgic encephalomyelitis, ME/CFS, Nightingale's Disease, Ramsay's Disease, SEID, Cheney Peterson Disease, Incline Village Disease, and No Preference. In addition, respondents could make suggestions for additional names, and make comments.)

A total of 3059 people filled out the survey, making it the largest survey on the proposed name change. Of those, 2690 respondents reported having either ME or CFS. Of those who did not have either diagnosis, most had a family member with the disease, or had been diagnosed with FM.

The majority of respondents (75%) thought that CFS needed to be replaced. The primary reasons given were that the name was trivializing and did not capture the scope or seriousness of the illness. The 25% of respondents who did not agree that a new name was needed gave familiarity, ease of pronunciation, and accuracy as reasons to keep CFS.

The name which garnered the most support was myalgic encephalomyelitis (781 votes). The reasons given were historical continuity, accuracy, and medical weight. SEID got 309 votes. The reasons given were accuracy, and inevitability ("It's too late now to do anything about it"). 179 people wanted to keep the current name ME/CFS for reasons of accuracy and continuity. Aside from Ramsay's Disease, the remaining names garnered very few votes. Those who commented on the choice of the remaining names mentioned that they did not know who Cheney or Peterson were (or Ramsay) and that they had no awareness of the significance of Incline Village or how Nightingale might be associated with the illness.

Comments from Respondents

Respondents had a great deal to say about the name change. The survey garnered 146 pages of additional comments, the majority of which were critical of both CFS and SEID as appropriate names for the disease. Some of the critical comments of the proposed name SEID are as follows:

"People are going to make jokes about the name systemic exertion intolerance disease." 

"NOT SEID, which is an even worse name than CFS." (7 people made a similar statement.)

"Not SEID. Too much negative stigma." (31 people made a similar statement.) 

"Until they are able to specify exactly what disease people are suffering from, it would be prudent to stick with ME which most people are familiar with." (12 people made a similar statement.) 

"CFS is an appalling name, as is SEID. It is associated with being lazy and nothing could be more untrue. Stick with ME - we all know what this is and can easily identify with the name." (13 people made a similar statement.) 

"I would have great difficulty in remembering what it is that SEID actually stands for. It is so much more than "exercise intolerance."

"I suffer from severe pain all over my body and this is not as a result of "exercise." (7 people made a similar statement.) 

"I don't like the Exertion Intolerance. I think it continues the trivialization of this terrible illness." (13 people made a similar statement.) 

"Exertion intolerance" sounds like people with SEID just don't want to exercise." (37 people made a similar statement.) 

"It still points to a symptom, doesn't capture the broader impact." (14 people made a similar statement.) 

"Changing the name to SEID is just going cause more confusion." (37 people made a similar statement.) 

"Systemic Exertion Intolerance Disease (SEID) sounds like a rubbish name to me. It does not sound as if it relates to the total exhaustion, massive joint instability, massive gut problems, massive migraines and vomiting, massive whole body disturbances. It is altogether too polite and meaningless." 

“Intolerance" in the SEID name is worse than "fatigue" as most people have "intolerances." This word cannot be taken seriously." 

"SEID sounds like we're lazy. It’s an awful name." (16 people made a similar statement.) 

"Exertion intolerance runs risk of being dismissed as work shy or lazy." 

"SEID is a poor choice. ANY of the above would be preferable." 

"Sounds like we're allergic to exercise or would be perfectly well if we handled stress better." 

"SEID is arguably worse than Fukuda (apart from getting rid of the name, CFS), as it leaves out viral symptoms like swollen or tender lymph glands and viral and muscle (peripheral) symptoms. No mention of acute viral onset either. Moving further away from ME and even getting rid of Lake Tahoe type outbreaks, which was additional evidence. I'm concerned that SEID could replace ME. This is yet more political (and insurance industry) interference and attempt to put away links to the original entity." (9 people made a similar statement.) 

"The new name seemed to come randomly out of nowhere. And like the earlier names, it doesn't encapsulate the entire experience of this illness. If they can't do that, then just stick with the names people know. All this name effort might be better invested in understanding the disease and needed treatments." 

"SEID is worse. Way too confusing." (19 people made a similar comment.) 

"My fatigue is NOT just with exertion."

"ME isn't great but at least it sounds serious, and is what the rest of the world calls the disease. The new name is so awkward, no one will ever use it - CFS will continue to be what the disease will be called." 

"I question and suspect Insurance Companies not wanting to cover medical bills as well as disability claims are trying to make the Syndromes even more confusing with less credibility."

Several people made the comment that: "It is a mistake to change the name prior to acquiring enough hard data on its pathophysiology through validated studies."

Some other name suggestions were:

• Myalgic Encephalopathy (20)

• Neuroendocrineimmune Disease (or Dysfunction) (10)

• Ramsay-Gilliam’s Disease (5) Note: Dr. Alexander Gilliam investigated the Los Angeles County outbreak in 1935. Dr. Melvin Ramsay investigated the Royal Free outbreak of myalgic encephalomyelitis in 1955.

• Hillenbrand's Disease

• Get no treatment disease

• The Disease From Hell

• CISCAD : Chronic Immune System Chaos Disease

• The $#!@ 

It is very clear from the 1,244 additional comments that patients with this illness have strong concerns, not just about the name change, but about the lack of funding, the lack of recognition, and the lack of patient care.

The full results of the ProHealth survey were sent to the IOM, HHS Secretary Burwell, and ORWH Deputy Director Susan Maier.

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Lisa Petrison/Paradigm Change/ME Advocacy Survey

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A joint survey conducted by Paradigm Change and ME Advocacy asked a total of 1,147 people about a possible name change for the disease. The results were analyzed in a 526-page report which can be downloaded from Paradigm Change as a PDF file.

As with previous surveys, the preferred name was ME. Neuroendocrineimmune Disease came in second, as it did in Health Rising's second survey.

The Paradigm Change survey broadened its scope by asking for reactions to both the name and the process. The majority of respondents thought that the name SEID was either very bad or pretty bad, and 46% thought the IOM had failed to produce a legitimate name. 72% of respondents said that if the government started using SEID without input from patients, they would find it unacceptable.

In addition to garnering responses to the name, this survey asked respondents about the IOM process itself. More than three-quarters (76%) thought that patients need to have more input ability in the naming process, and that the IOM had not allowed for sufficient input. About half of the participants (51%) said that they felt angry about the naming process.

The survey results were sent to HHS secretary Sylvia Burwell; to the heads of the NIH and CDC; to CFSAC members; to the IOM panel chair; to the NIH P2P committee; and to clinicians and researchers focusing on the disease.

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In sum, it is clear from these surveys that the people whom the new name will most affect - patients, as well as researchers and ME/CFS specialists - have been entirely left out of the process of devising a name for this illness. It is also clear that the preferred name - on both sides of the Atlantic - is myalgic encephalomyelitis. Regardless of the IOM's opinion that brain inflammation is not yet proven be part of the illness, or their belief that pain is "nonspecific," there are historical reasons for choosing ME. 

It is more than likely that the decision to abandon ME was not primarily based on medical reasons - as there are numerous illnesses whose names have been assigned by history - but on politics. 

ME is associated with outbreaks. One of the forces that drives decisions made by HHS, as well as most state health agencies, is downplaying epidemics. AIDS and Lyme are cases in point. Both of these epidemics - one with a human vector, and one transmitted by ticks - were ignored until they became too big to sweep under the rug. Sadly, the agencies that are supposed to be responsible for protecting public health have consistently used the same tactic with ME.

Ultimately, SEID needs to be rejected not only because it is an inadequate name that does a disservice to people who must bear it, but because through inventing yet another name it denies one of the fundamental aspects of the disease, which is its history of outbreaks. 

How Great Britain Fails 250,000 Patients with ME/CFS

Last June, Clare McDermott et al. published a study entitled "What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise" (published in the BMJ, a subsidiary of the British Medical Association).

The study, which was part of McDermott's PhD fellowship, evaluated specialist care for patients with severe ME/CFS in 49 specialist centers in Great Britain via an email survey.

All 49 centers replied, providing an accurate picture of the range of services available to the severely ill ME/CFS population.

(You can read the full paper here.)

Survey results

The results of the survey were disheartening. One-third of specialist ME/CFS centers provided no service at all for housebound patients. A little over half (55%) of the centers treated patients with severe ME/CFS. The remaining centers (12%) offered occasional or minimal support "where funding allowed." There was only one NHS unit providing specialist inpatient ME/CFS care in the entire country.

The authors' final remarks concerning the paucity of care were that "findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group."

Available treatments - The not-so-NICE guidelines

An additional component of this paper was a brief analysis of the type of care provided to patients with ME/CFS. In Great Britain, services for severely ill patients are supposed to follow the NICE guidelines:

• Management of severe CFS/ME is difficult and complex and healthcare professionals should recognise that specialist expertise is needed when planning and providing care for people with severe CFS/ME. [emphasis added] 
• Diagnosis, investigations, management and follow-up care for people with severe CFS/ME should be supervised or supported by a specialist in CFS/ME. 
• When making decisions about prolonged bed rest, healthcare professionals should seek advice from a specialist experienced in the care of people with severe CFS/ME. The significant physical and psychological risks associated with prolonged bed rest should be taken into account. 
• Healthcare professionals working with people with severe CFS/ME who are in bed most (or all) of the time, should explain the associated risks (such as postural hypotension, deep venous thrombosis, osteoporosis, pressure sores and deconditioning) and monitor these.
• People with severe CFS/ME should be offered an individually tailored activity management programme as the core therapeutic strategy, which may be delivered at home, or using telephone or email if appropriate, drawing on the principles of cognitive–behavioural therapy (CBT) and graded exercise therapy (GET). [emphasis added]

(NICE 2007 guidelines on severe chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) extract, page number 305)

While the guidelines state quite clearly that management of severe CFS/ME is "difficult and complex," specialist care, as defined by the guidelines, is quite simple. Core therapeutic strategies consist of CBT and GET, which may or may not be overseen by a physician (telephone calls and emails are considered sufficient).

Although the guidelines state that diagnosis, management and follow-up care should be supervised by a specialist, compliance with this provision is not consistent. For example, some services stated that while they used CBT, they did not have a qualified CBT therapist on the clinical team.

Even when centers reported having a physician on their staff, or other trained professionals, the question remains of whether the treatments and therapies offered by these centers have any real value for the population they are supposed to be serving.

One Size Fits None

Below is a detailed list of the treatment strategies employed by the specialist care services offered by NHS (taken from the McDermott study).

Table 1

Therapeutic approaches used (in combination) by CFS/ME services for severely affected patients

Therapy	Number of services using this approach	Percentage of services using this approach
Activity management	28	93
CBT	25	83
Graded activity	24	80
Mindfulness therapy	22	73
Lifestyle management	22	73
Dietary advice	21	70
Pacing (within graded activity, not adaptive pacing)	17	57
Graded exercise therapy	13	43
Counselling	10	33

CBT = cognitive–behavioral therapy

Anyone who is familiar with ME/CFS - whether they be researchers, experts, or patients - would consider the list of "treatments" employed by these services to be ludicrous. Most, if not all, of these therapies are useless for a population that is bedbound. Exercise therapy, including graded activity as part of GET, is harmful for ME/CFS patients (Twisk and Maes 2009). Given the cardiac abnormalities experienced by ME/CFS patients, exercise could even prove fatal. (Dr. Melvin Ramsay reported that the only ME patients who had died under his care were former athletes who had gone out on the playing field while ill.)

Aside from the far-fetched claim that these therapies are "individually tailored," there is no evidence that these therapies are beneficial treatments for any patient with ME/CFS, regardless of illness severity. For that matter, there is no evidence that the therapies on this list are appropriate treatments for patients suffering from any illness. The dietary advice offered to ME/CFS patients, for example, "Drinking enough fluid, [eating] adequate fruit and vegetables, [and] reducing caffeine intake" is something physicians recommend to everybody, regardless of their state of health.

The advice to exercise is also non-specific, and is a component of the general set of recommendations given by every physician to all patients. In contrast to previous medical advice - now considered antiquated - current medical dogma considers exercise to be a panacea that cures all. (As evidenced by the "harms" associated with bed rest mentioned in the NICE guidelines.) Meditation, counseling and CBT are also currently in fashion. However, neither meditation nor counseling will reverse the course of an illness, or slow its progression. While they may make a patient feel better by reducing anxiety, so will a chat with a caring friend, watching a distracting comedy, or taking anxiolytics.

If a physician in the U.S. limited his or her treatments to those on the NICE guidelines for their cancer or heart disease patients (like ME/CFS, neither has a cure), he/she would have his or her medical license revoked, and possibly face a civil lawsuit.

The McDermott et al. report indicates that severely ill patients are underserved by the NHS, even when there is care. However, the evidence also suggests that none of the patients in the UK with ME/CFS have state-sponsored access to effective treatment (e.g. antivirals, immune modulators, treatment for secondary infections, mitochondrial support, palliation of symptoms, such as insomnia and pain, and so on).

One can only conclude that when psychiatrists and proponents of the "it's all in their heads" theory hijack medical care, all patients will suffer the consequences of institutionalized neglect.

Time to Deliver Report: How Surveys on CFS and ME Fail to Deliver

Action for ME published two reports during ME Awareness Week (May 11 to 17) 2014. The survey was based on responses from more than 2,000 Action for ME members in 2014.

According to the website:

"Revealing the daily challenges faced by those affected by M.E./CFS in the UK, M.E. Time to Deliver details the impact of M.E./CFS symptoms, highlighting in particular what life is like for those who are more severely affected, including primary and secondary healthcare for people with M.E./CFS, their experience of welfare benefits, social care, employment and education."

You can read the executive summary or read the full M.E. Time to Deliver.

The study did manage to accomplish its goal; it showed how inadequate care is for people with ME in the UK. It was not at all surprising that the majority of participants reported GPs who were uninformed about the illness, poor experiences in clinics, lack of specialty care, no follow-up after medical visits, delayed or reduced welfare benefits, and so on. These experiences are nearly universal.

What was interesting about the survey were the conflicting statistics.

The results of the survey showed that:

• A third of people with M.E./CFS had tried cognitive behaviour therapy; half said they found it helpful or very helpful, while around one in 10 said it made them a bit or much worse.
• Around one in five people with M.E/CFS had tried graded exercise therapy; a third said they found it helpful or very helpful, while nearly half said it made them a bit or much worse.

These positive results would seem to indicate that CBT, and GET are successful therapies for ME/CFS, at least for a subgroup. Of the roughly 700 people who had tried CBT, 350 said it was helpful. Yet, only 200 people were working normal hours. "Helpfulness" does not, in this case, mean a return of function. So, what does it mean? The survey didn't ask, so we can't know

Of the 400 people who had tried GET, 200 said it made them worse, while 133 said it had been helpful. But, once again, what is meant by "worse" and "helpful?" Does "worse" mean lying flat on one's back for long periods of time? Does "helpful" mean a lift of the spirits, even while one remains flat on one's back? To gain any sense of what these terms mean, they need to be clearly defined in terms of function, not feeling.

Self-rated severity of illness also told an interesting story.

• 36% of the survey respondents said they were mildly ill, and less than one in 10 people said they were in full-time paid work, education or training, with only 14% in part-time paid work, education or training.
• Around 90% of people with ME/CFS had either stopped or reduced paid work and social contact, while half had reduced or lost capacity to drive and a quarter were no longer able to leave their home independently.

If one were to compare numbers, roughly 700 people said they were mildly ill, yet fewer than 200 people were still working normal hours. That means that the majority of mildly ill patients had stopped working. If an illness is serious enough to prevent a person from working or attending school, it cannot, by definition, be mild.

When designing a broad survey of this nature, it is important to ask people questions that apply to how they are functioning - rather than how they are feeling -  for the simple reason that most patients who have had ME/CFS for a long time have adjusted to it. If you had been bedridden for years, let's say, but can now drive, do light housework or some shopping, and talk on the phone or visit with friends for an hour or two, you might consider yourself to be mildly ill. Yet, you cannot work, go to school, attend an evening event, stand up and chat at a party, or do anything that might strain your system. Given those restrictions, no healthy person would define that lifestyle as being mildly ill.

Surveys that do not provide for the disparity between how patients interpret the words "mild," "moderate," "severe," "helpful," "worse" and how these words are interpreted by social programs, physicians, and government agencies do not, in the end, serve any practical purpose.

Patient Survey Results for FDA Drug Development Meeting for ME and CFS: 99% of Patients Not Getting Better

Dr. Lily Chu

The results of this survey were presented by Lily Chu at the FDA Drug Development Workshop for CFS and ME on April 25-26, 2013.

Preliminary Results – April 2013 FDA Workshop Survey 

By Lily Chu, Leonard Jason, Madison Sunnquist, Suzanna So

Demographics: 

85% of our subjects were female and almost all subjects were Caucasian. The average age was 51 and the average duration of illness was 18 years. For 50% of our respondents, this survey is the only way they are participating in this workshop. 

Symptoms:

The 5 most significant symptoms were fatigue, post-exertional malaise, pain, sleep, and cognitive problems. Symptoms that haven’t been studied as much such as multiple chemical sensitivities, gastrointestinal symptoms, and orthostatic intolerance were also deemed to be significant by over 50% of our subjects. 99% felt that their illness was not improving over time, citing worsening of existing symptoms and appearance of new symptoms.

Out of five objective tests we asked about, 66% had at least one abnormal result. For natural killer cell activity, for example, 70% noted an abnormal result. Tests like these could be used as study inclusion criteria, as outcome measures, and as a way to select subgroups for analysis. We believe that studying subgroups may help yield more effective treatments given the heterogenous nature of CFS.

Impact on Daily Life:

Using a standardized measure of physical functioning, we found our respondents to be more disabled than 95% of the general US population. Only 13% were employed, with almost all citing ME and or CFS as the reason for why they could not work. For even basic personal care, 89% needed assistance or had to change their pre-illness routine. On their worst days, 60% were bedridden. On their best days, 75% could only do some light housework or less.

Five example tests to consider in CFS:

Test	Number who got tested	Normal	Abnormal	Not sure if tested/result
NK cell activity	172	7%	70%	23%
Repeated CPET	173	31	63	5
Brain Imaging	216	49	46	6
Neuropsych test	172	31	53	16
Tilt Table	132	16	80	5

For each test, between 40%-60% of respondents answering the question had never had the test before due partly to cost, insurance coverage, and physician resistance to ordering a test; they're excluded from the above table. Results above are those who had the test, think they might have had it but are not sure, or did not remember the result but had the test.

Perspectives on Current Treatment:

75% of people felt current treatments were not helpful or only slightly helpful but not enough to improve their day-to-day function. Patients  repeatedly wrote about the need for disease-modifying treatments and not only for treatments that helped control symptoms.

We asked about how well currently recommended treatments worked for the illness overall and for three common symptoms: sleep, pain, and cognitive problems. 

These treatments were cited as helpful by more than 50% of subjects:

• for the overall illness - balancing rest with activity, restricting or modifying physical/ mental activities
• for sleep – CPAP, over-the-counter medicines, zolpidem, eszoplicone, TCAs, trazodone, benzodiazepines
• for pain – short/ long-acting opioids, flexeril, ibuprofen

Some alternative/ complementary/ non-drug treatments also made the cut. Helpful prescription drugs cited in patient comments included gamma-hydroxybutyric acid for sleep, lisdexamfetamine for thinking, tizanadine/ baclofen for pain, and midodrine/ florinef/ beta-blockers for orthostatic intolerance.  In contrast, exercise programs, administered by a professional and part of the current standard of care, were noted by 62% as worsening their health. 

The main reasons cited for stopping a medicine were side effects followed by decrease in effectiveness over time, especially with sleep medications. For effective non-drug treatments, cost and insurance coverage were major reasons for discontinuation. Respondents were also concerned about being more sensitive to drugs and the dependency potential of some medications.

Limitations:

The overwhelming majority of respondents to our survey self-identified as Caucasian. This is likely a result of adequate access to care to obtain an accurate diagnosis, Internet access, and membership in support groups rather than an accurate reflection of the epidemiology of ME or CFS. In fact, multiple community-based studies suggest a higher prevalence and more severe morbidity in minority populations. 

We did ask about antibiotics, antivirals, and immunomodulators but 1) answers were rather mixed (side effects, not enough time on medicine due to physician/ cost, etc.) 2) sample sizes were too small to come to concrete conclusions. Also, to date, no blockbuster drug has been noted in open patient comments to be very successful by more than a handful of respondents. In addition given the relatively short length/ nature of the survey, we weren't able to subgroup respondents and ask how they did on various treatments, which I think is key to finding effective treatments.

For more information, contact Lily Chu (lilyxchu@gmail.com)