Wednesday, January 29, 2014
To: The Committee for Diagnostic Criteria for ME/CFS
Institute of Medicine of the national Academies
From: Mary M. Schweitzer, Ph.D.
Wisconsin ME/CFS Association, Inc.
Date: January 27, 2014
Thank you for allowing the Wisconsin ME/CFS Association time to speak; Pat Fero is not here but we worked on this presentation together.
We have known about Myalgic Encephalomyelitis since 1934 (when it was called atypical polio); it was classified in neurology by WHO in 1969.
In the mid-1980s, a series of mysterious cluster outbreaks of disease occurred around the nation. At first, because many cases seemed to start with a bout of EBV, they called it “Chronic Epstein-Barr Virus,” or CEBV. That was actually the first name of this organization - the Wisconsin CEBV Association.
But common thinking at the time was that you had an acute case of a virus, and then you were immune to it. Barring something like AIDS, there could be no chronic EBV. NIH decided this had nothing to do with immune systems - therefore not a type of AIDS; and that it had nothing to do with EBV.
NIAID's EBV specialist, Stephen Straus, who had coined the name CFS in 1986, decided that the disease was somatic (the physical expression of a psychiatric problem) - having to do with depression and/or stress. For the next three decades, what little funding NIH allocated went to fatigue studies or studies of stress hormones. As for cluster outbreaks, it was decided they were outbreaks of friendly diagnoses.
Over at CDC, the first demographic efforts came up with a figure of 10-50,000 patients with CFS, all white upper middle class women - yuppies overdoing it trying to have it all. Critics noted that the method CDC used was to ask physicians for information about patients they saw with CFS, which heavily tilted the data set towards those with the means and determination to find someone who could diagnose and treat them.
Nearly 20 years ago, Congress asked CDC to do a study on children and adolescents with this disease. CDC spent the money on another project entirely, and got in trouble with Congress. The money was reinstated, but not the projects. Dr. William Reeves, in charge of CFS at CDC, explained that he didn't think enough school-aged children and teenagers got the disease to be worth a study.
In 1999 Leonard Jason and a team at DePaul estimated that roughly 800,000 American adults probably had the disease, and the disease was equal opportunity - all income groups; all ethnicities. This estimate has been in use ever since – today, the DePaul estimate would put the number of patients closer to 1.3 million.
In 2003, Canada adopted its version of ICD-10, which included CFS, with M.E., in neurology. A committee was convened of clinician experts, including several from the US. The result is called the Canadian Consensus Criteria and does an admirable job of capturing the complexity of this illness.
In 2004, CFSAC recommended to the secretary of HHS that the US adopt the Canadian Consensus Criteria - and that's when we found out about what had happened to the money allocated to CDC to study young people. The recommendation was repeated again two years ago – but HHS’s response was to convene this IOM committee.
The money had been spent on closed annual meetings at a resort. According to Dr. Reeves, they had created a new definition for CFS (the “New International Definition”). Eventually it devolved into a set of questionnaires that Reeves claimed "operationalized" the Fukuda (1994) definition, but they did not. Comparing the Canadian criteria with Reeves' questionnaires, Jason found that Reeves lost the bottom 30% of patients, while inappropriately including patients with primary mood disorders
Researchers never used the Reeves questionnaires. The funds and the time spent were wasted.
I am here to as you not to repeat the errors of the past: Dig Deeper. M.E. experts desperately need funding to replicate and further new research on exercise physiology, immunology, virology, genomics, and intricate metabolic research. Please do not repeat the past – please do not waste money on something that researchers do not want and will not use.
It is ironic that the name CFS replaced CEBV - and the study of "fatigue" and stress replaced the study of viruses and immune systems, because that is where a lot of the research has returned. A study published in PLOS ONE just over a week ago has shown that 3/4 of CFS patients had a deficient EBV-specific B and T-cell response. It appears the dismissal of EBV as having a role in the disease was premature.
Recent research has also shown that 80% or more of CFS patients suffer from chronic infections of CMV, HHV-6, and/or HHV-7. There are new studies on Coxsackie B.
Patients have been found to have abnormal natural killer cell function, the abnormal 37kDa Rnase-L, and abnormal cytokine functions. They have abnormal SPECT scans and CPET tests. Others will talk about the importance of the CPET testing – the most important point in this context is that patients with this disease spend much (if not most) of their time operating in anaerobic metabolism doing the simplest of tasks. When off immune medicine, just walking across a room sends me into anaerobic metabolism. Graded exercise, when the subject is sick with a serious virus and operating in anaerobic metabolism, is dangerous.
With so many ongoing research projects, is it any wonder that 50 experts signed a letter asking HHS not to spend one million on this study? If you create a new, more heterogeneous definition and name - let's say, "Multi-system disorder," will applications for NIH research funds and NDA applications require that the researcher meet the new definition? That would set research back terribly.
These studies are consistent with what I personally have. I have the immune defects and chronic viruses - I even had active HHV-6 and CMV in my spinal fluid. I am only able to stand and talk to you because I am on an experimental immune modulator, and have been for ten of the past fifteen years.
An entire generation has gone by since CFS was adopted in 1988. I have friends who first became ill in their teens, who are now in their forties and are still sick. Neither CDC nor NIH has done much to help them. Their parents worry about what will happen as they age. At least I had the opportunity to have a successful career as a scholar, meet and marry the love of my life, have children and grandchildren, and an income of my own. They have not been able to do any of that, although most have a strength of spirit that I deeply admire.
In the meantime, CDC has done little to change the CONTENT of their website in twenty years. During that time, they have left between 850,000 and one million adults with this disease undiagnosed.
How many children and teenagers have been left undiagnosed?
Imagine a 16-year-old girl with the same immune defects and viruses that I have. I was bedridden by these symptoms. The most simple daily tasks were extremely difficult for me. I could not read. I had expressive aphasia, ataxia, confusion, disorientation, partial paralysis, and blackouts. I had constant pain in the back of my neck, back of my eyes, and frequent severe headaches. My muscles hurt all the time.
What do you think that is like for a teenager?
We have no studies into what this disease does to a growing brain and body. We do not know if they are affected the same way. What I do know is I know too many young people who have died of complications from this disease. How many? We don’t know. Why don’t we know? Fortunately, Dr. Jason has recently received funding to find out how many pediatric cases of M.E. or CFS are out there. That is welcome news, but it has taken 30 years to get there, and we are no closer to knowing what the disease does to children. Will a new name and definition delay these studies even more?
Since there is little information out there on children and teenagers with this disease, laypersons turn to CDC. And there they find disinformation.
CDC has a pamphlet on its website that states that children who get CFS have an excellent prognosis and make full recoveries. That is just not true.
On their website, CDC emphasizes the psychiatric treatments and graded exercise therapy (GET) used by psychiatrists in the UK. This also has to come to an end.
We need CDC to come out against efforts to portray this illness as psychosomatic, or a “factitious illness,” or “factitious illness by proxy,” a euphemism for the discredited Munchausen’s Syndrome by Proxy.” We need CDC to stop suggesting exercise programs.
Non-medical laypersons in positions of power over young people use the flawed information on CDC’s website against schoolchildren and their families.
A note from the doctor saying it is okay for you to go to school – but not to participate in exercise – will be deliberately ignored. Students will be urged to try a program of graded exercise and, wanting to be normal, wanting to please, they will. But if you have this disease, you cannot exercise like a normal person.
Students have been harmed by these policies. Students who could walk have ended up in wheelchairs. Students in wheelchairs ended up bedridden. And you are risking killing these children, if not now, then by the long-run effects of forcing exercise on a growing body through anaerobic rather than aerobic metabolism.
We even have had to fight cases where children were taken from their families and placed in foster care just because the family was following the instructions of a licensed physician and known specialist.
Better for CDC to have nothing on its website than promote information that is misleading and dangerous.
These are families with resources. I do not want to imagine the plight of young people who do not have a diagnosis, whose parents do not have access to information, who are completely at the mercy of non-medical professionals. How many kids who are too ill to keep up in school end up in the dropout population? What happens to these motivated kids kicked to the curb?
In 1999, Dr. Leonard Jason showed the world that this was an equal opportunity disease – not a yuppie illness. I think that is still true of CDC's position towards young people - the tip of the iceberg.
What is most frightening is that in attempting to please adults, kids make themselves much worse and put themselves at great risk. One of these was Casey Fero. He tried to be normal. He got a job, applied to college.
But in the early morning hours of July 4, 2005, 23-year-old Casey Fero died of a massive heart attack. The autopsy showed both old and new scarring of his heart. He died of viral myocarditis. Casey had been sick since he was 9, but the only diagnosis he ever had was CFS. He tried so hard to be normal – although he looked like he was having an easy time of it, he was working too hard.
The viruses I have can give you myocarditis. Did Casey have my viruses? That is something his mother, a 30-year patient, would like to know. Casey’s parents are among many who will never have that closure. They will never know why their children died.
If the Holmes committee in 1988 had accepted the recommendations of specialists who said the outbreaks were really M.E., and gone on to connect to existing research, we would never have detoured into the mess that has been CFS.
Now that scientists are again making great breakthroughs, we do not need to descend yet again into a name that implies this is a poorly understood and vague illness having something to do with pain, fatigue, and sleep. We did not need the detour into CFS, and we do not now need a new detour into something like Multi-symptom disorder.
This is a national public health catastrophe.
The government needs to work WITH the experts to find ways to use the biomarkers that have been found, to explain to the world the scientific discoveries that have been made, to fund large studies to confirm or deny the smaller ones. M.E. is NOT a mysterious disease. There is a great deal that is known about it. Listen to the experts.
Perhaps we should try studying this disease in reverse: gather a data set of patients who have immune biomarkers and chronic viruses, and then look at their symptoms. This iterative process could be repeated until we had a good idea of the disease and/or its subtypes.
The public needs doctors able to diagnose this disease, and patients need to be sent to bed to rest. They need to be cared for - and then we need treatment for them. It will take an all-out effort by the professional and government communities, a commitment to the 1.3 million adults and countless youths.
We do not need a new name. We need a sense of urgency. Thank you.