Chronic Fatigue Syndrome Advisory Committee (CFSAC)
Members in Attendance
- Dr. David S. Bell-Chair
- Nancy C. Butler
- Jane C. Fitzpatrick
- Dr. Kenneth J. Friedman
- Dr. Nelson Gantz
- Dr. Anthony L. Komaroff
- Dr. Charles W. Lapp
- Lyle D. Lieberman
- Dr. Nahid Mohagheghpour
- Dr. Roberto Patarca
- Staci R. Stevens
Ex Officio Members
- Dr. Marc Cavaillé-Coll, Division of Special Pathogen and Immunologic Drug Products, Food and Drug Administration
- Dr. Eleanor Hanna, Office of Research on Women’s Health, National Institutes of Health
- Dr. William C. Reeves, National Center for Infectious Diseases, Centers for Disease Control and Prevention
- Dr. William A. Robinson, Center of Quality, Health Resources and Services Administration
- Dr. Larry E. Fields
- Dr. Peter Rowe, Johns Hopkins Children’s Center
- Chelsea Morgan, Florida
- Betty McConnell, New Jersey Chronic Fatigue Syndrome, Inc.
- Dr. Laurence Desi, Sr., Office of Medical Policy, Social Security Administration
A. Call to Order and Request for Roll Call
Dr. Bell called the meeting to order and requested roll call. Dr. Fields conducted roll call.
B. Introductions and Opening Remarks
Last year, the committee discussed CFS in general and came up with broad recommendations. This year, the committee will take a more focused approach, and today’s meeting will concentrate on CFS and pediatrics. The committee will then make recommendations based on topic-specific testimonies from various groups, including advocacy and support groups.
The following meetings will also be topic-specific. To be considered for upcoming meetings, advocacy groups are encouraged to submit their summary of activities via email (firstname.lastname@example.org) or the website (www.hhs.gov/advcomcfs/).
C. Approval of the Minutes of September 27, 2004
Dr. Bell asked for comments on the September 27, 2004 minutes. The following corrections were provided:
- Page 4: “He then asked it was legal” should be “He then asked if it was legal”
- Page 26: “Will working on CFS hurt an academics career” should be “Will working on CFS hurt an academic’s career”
- Page 34: “AMAC” should be “AAMC”
- Ms. Fitzpatrick and Mr. Lieberman were incorrectly listed as being in attendance
- Page 12: “HRSA Data Warehouse” should be “HRSA Geospatial Data Warehouse”
Dr. Gantz motioned to approve the minutes with the corrections, and all members voted to accept the minutes.
II. Executive Secretary
A. Summary of Public Comments
Dr. Fields offered thanks for the public comments received through the CFSAC website. The comments include support for the recommendations, information on activities in various organizations, and requests for explanations (e.g., disabilities). B. Membership Terms, Operational, and Other Matters
Dr. Fields noted that the participation of the members is appreciated. The terms are staggered and are indicated on the website. During this fiscal year, there will be a rotation of some CFSAC members. In terms of operational matters, advocacy organizations are encouraged to submit summary statements, up to three pages in length, using 12-point font and one-inch margins. Once submitted, the statements will be provided to the committee members for their discussion.
III. Invited Speakers
A. Dr. Peter Rowe
Dr. Rowe discussed three main issues: how CFS affects young people; the difficulties in diagnosis and treatment; and steps for HHS to address these issues. He has been working on CFS for 12 years, spending about 60 percent of his time following a large number of adolescents with CFS, and has conducted a number of studies on the pathogenesis of symptoms. Dr. Rowe is the Director of the CFS Clinic at Johns Hopkins Children’s Center. His clinic is one of only a few in the country devoted to CFS. However, it is a barebones operation, and he is the only staff member.
CFS is a heterogeneous illness and how it affects an individual will differ depending on the developmental circumstances of the child and the duration and severity of the illness, which in turn will be dependent on the number of physiologic disturbances that converge to create CFS symptoms. The individual’s response to the illness will be modified by a variety of factors, including the quality of support provided by family, friends, and the medical profession.
To illustrate, Dr. Rowe had a patient who became ill with CFS in 1991. She had been healthy in early childhood and was active in swim, dance, church choir, riding horses, and cycling. She was an A/B student in the sixth grade when she had the abrupt onset of a mono-like illness, characterized by a sore throat, sinusitis, adenopathy, and an enlargement of the liver and spleen. Her symptoms included sleeping excessively, awakening unrefreshed, having to lie down the day after an active day, sore muscles and joints, headaches, and lightheadedness. She had difficulty concentrating and wore dog tags with her name and address on them. She would forget the combination to her locker. She had to reread paragraphs and would slur her speech when she was most tired.
At the onset, she was disoriented and slept up to 20 hours a day on some days. She was on homebound teaching for the remainder of the sixth grade and the entire seventh grade. She managed to attend school in grades eight and nine, though she continued to have reduced stamina and persistent symptoms. In grade ten, she fell off a bleacher, sustaining a closed head trauma, which was followed by increased symptoms, and had to be homebound for the remainder of grade ten.
When she became ill, diagnosis was difficult to come by and many doctors considered the illness as mental. She was sent to the local university, infectious disease specialists, and a pediatric neurologist-all of who were of no help. In 1995, she read a report from Dr. Rowe’s clinic about the abnormalities in the regulation of blood pressure in adolescents with CFS and the potential for improvements in symptoms, when those circulatory abnormalities are treated.
In 1996, she traveled from Georgia to the clinic. Dr. Rowe was impressed by the fact that her fatigue was made notably worse by standing still in line, by shopping, and other forms of low-impact exercise, as well as hot weather and hot showers. She had lightheadedness several times a day and had one episode of fainting. The physical examination was notable for diffuse abdominal wall tenderness, as well as for acrocyanosis.
Dr. Rowe had her stand up for ten minutes and she had a marked provocation of symptoms, including worse fatigue, worse lightheadedness, and difficulty responding to questions. She also had postural tachycardia. Her diagnosis was orthostatic intolerance and she was treated with an increased intake of salt, fluids, and fludrocortisone, and a potassium supplement to replace what fludrocortisone causes the kidney to lose. Soon afterwards, she had a sufficient improvement in symptoms and was able to attend school during grades eleven and twelve. However, she had residual symptoms of fatigue, chest pain, headache, cognitive trouble, lightheadedness, and arthralgias.
In 1999, the patient returned to Dr. Rowe and reported symptoms of early satiety, reflux, and heartburn; she had epigastric tenderness upon examination. All of her symptoms would get worse a few hours after milk protein intake. Her symptoms seemed more consistent with milk protein intolerance, rather than lactose intolerance. These symptoms, as well as her general health, have improved on a rigid milk-free diet. Over the next couple of years, she finished college, but was unable to complete the teacher’s certification examination due to intolerance of prolonged sitting during the test; she cannot sit for more than five minutes without developing cognitive fogginess.
In 2003, she again visited Dr. Rowe and described a daily pelvic discomfort, which was worse at the end of the day. This was initially thought to be due to endometriosis, but she was unresponsive to oral contraceptives. The pelvic pain was associated with lower back pain and urinary frequency. Working with collogues in interventional radiology, Dr. Rowe noted an overlap in symptoms between CFS patients and pelvic congestion syndrome (PCS) patients. At the clinical level, PCS is characterized by pelvic heaviness or pain with long periods of standing, fatigue, and pain with intercourse. This physiology of the disorder is now recognized to be related to varicose ovarian veins. Using interventional radiology techniques that allow the varicosity to be embolized, one report showed that 89 percent of women report about an 80 percent relief after transcatheter embolization.
After the procedure, the patient had resolution of the pelvic pain and her orthostatic tolerance now extended from five to 20 minutes before the onset of symptoms. She also had an immediate improvement in energy and other symptoms after they changed her medication to include midodrine, a vasoconstrictor drug. Her current overall wellness is 85 to 90, out of 100. Her ultimate diagnoses were CFS, orthostatic intolerance, asthma, milk protein allergy, and ovarian varices.
There is a complex interaction between CFS and orthostatic disorders. The pathophysiological variables that contribute to orthostatic intolerance include depression, anxiety, allergies, infection, movement restrictions, direct neural compression, and pelvic vein incompetence. This heterogeneity has consequences clinically. The complex interplay of problems require more time per session than usual, and the current methods of insurance reimbursement for chronic illnesses are not commensurate with the time required.
The heterogeneity also has methodological consequences. First, many studies will be underpowered and much larger studies will be needed to detect the signal of efficacy from all of the background noise caused by the changes in the other comorbid conditions. Second, it will be difficult to control just one variable in a randomized trial. One solution is to conduct randomized trials of withdrawing ostensibly effective therapies. Another solution is to incorporate a run-in period during which as many other influences to symptoms as could be were brought under better control.
Interested and experienced CFS practitioners are overburdened and there is no money left in the clinical care system. To run a two-person clinic, it will cost approximately $141,000 per year. If the estimate billing is $70,000 per year, $45,000 will be paid by the insurers. Subtract the dean’s tax on clinical earnings and the total revenue is $39,500. That leaves a gap of $101,500, which needs to come from grants and private philanthropy. However, obtaining an NIH grant is long and difficult.
The picture is bleak for the care of children with CFS. There are few hospital or university affiliated clinical care centers, no training grants, no university research centers, and an estimated $1 million targeting children with CFS. This is not enough to create critical interest in bringing new people into the field. Additionally, foundation grants are small and most do not provide salary support.
To correct this beyond 2005, NIH should expand its support to be commensurate with the burden and impact of the illness. It would be ideal to establish multiple accredited clinical care centers, multiple university research centers, training grants, salary support awards, clinical investigator awards, science grants, clinical research grants, and a clinical trials network.
Dr. Bell noted that in terms of the incidence of CFS in children, there has been a wide spectrum of figures. Personally, he feels that there is a large number of children and adolescents who may not fulfill a clinical research definition, yet seem to have CFS.
Dr. Rowe agreed with Dr. Bell. As more colleagues and subspecialists get involved, more incidences will be discovered. For example, in cardiology, people have recognized over the past decade that many of the patients with recurring syncope also meet criteria for CFS. Many patients thought to have functional valve disorders also meet the criteria.
Dr. Gantz asked what is the youngest age for diagnosing CFS.
Dr. Rowe responded that in a group of 58 consecutive patients, there was nobody under 10.
Dr. Bell asked if there were patients that had symptoms that go back to age five or six.
Dr. Rowe noted that many do, but the age at which symptoms start is a question. Many early symptoms are isolated occurrences and are not necessarily attributable to CFS.
Dr. Lapp noted that Julian Stewart presented data about the redistribution of blood from the thoracic into the splenic circulation. He asked if this fits with the pelvic varices and whether it has been measured.
Dr. Rowe noted that vessels that have a vertical orientation are the most likely to be distended and stretched with upright posture. Since there is not a lot of volume going into those vessels, it must be something else that is elaborated. It may be the pain that leads to the profound symptoms.
Dr. Lapp asked about the cause of fatigue in these children.
Dr. Rowe noted that they initially thought that light-headedness and cognitive dysfunction would fit with a reduction of cerebral blood flow. They conducted a Transcranial Doppler study during tilt testing with CFS patients and were not able to confirm a reduction in brain blood flow.
Dr. Desi noted that a majority of articles in the world literature on CFS and children conclude or imply that CFS in children is psychiatric.
Dr. Rowe responded that he does not believe that CFS in children is psychiatric. However, he emphasized the heterogeneity of the disorder. Depression and anxiety can be a comorbid feature, but the children are not responsible for these conditions any more than they are responsible for their blood pressure.
Dr. Gantz asked if there was a role for tilt table testing in patients with symptoms suggesting of dizziness and lightheadedness.
Dr. Rowe responded that it is helpful to confirm a physiologic abnormality, but not essential.
Dr. Friedman asked about the incidence of CFS in children.
Dr. Rowe responded that he does not know, but the demand for his service is greater than his ability to meet that demand.
B. Chelsea Morgan
Ms. Morgan is 16 years old and lives with her family in Palm City, Florida. Chronic Fatigue Syndrome is a disease that has turned her life into a nightmare and it has had an impact on every member of her family. They have spent the last two and a half years trying to understand what has happened to her.
She experiences horrible headaches and often feels a crushing tiredness. Her throat is sore and at times her muscles and joints ache. However, as sick as she has felt, one of the worst parts has been going to see doctors. When they could not find an easy explanation for her illness, they just became frustrated. Some said, “Just push through it. Everyone gets tired. What would you do if you really got sick?”
She knows that right now there is another child going through exactly what she did. They are sick, overwhelmed, and afraid. They need more than medical tests and lab work can provide. They need a doctor that will admit that they do not have all the answers and will not blame the patient for having a problem that they do not yet know how to fix. Mostly, they need doctors to believe them and tell them they are not alone. She hopes that by telling you what she has been going through, she can somehow make a difference in even one child's life.
It has been a long road to a diagnosis. Since childhood, she has had many ear and throat infections. It seemed as soon as she got over one infection, she would get another. The doctors told her family that she was probably allergic to everything and would outgrow these continuous infections as she got older. By the time she was 11, it looked like they were right. She was feeling better, missing less days of school, and really looking forward to starting middle school.
The next few years were the healthiest and happiest of her life. She met many new friends and school was going great. However, when eighth grade started, she got very sick. Her pediatrician thought her symptoms were the result of a very bad sinus infection. In the past, it had sometimes taken two or three rounds of antibiotics to knock out her infections. This time, nothing was working. She was living on antibiotics and steroids, and she was not improving at all.
She was sent to an allergist who said her sickness was a result of untreated allergies. She began weekly allergy shots and was told it could take years to get her symptoms under control. Her mom purchased special bedding and changed the pillows and rugs in her room. She became a maniac with the vacuum cleaner in the hopes of curing her daughter. While she may have had the cleanest room in South Florida, she certainly did not feel any better.
Next, she was sent to see three different ear, nose, and throat doctors. None of them agreed on her treatment. One wanted to put her on different antibiotics. Another wanted to operate on her sinuses. The third suggested that she did not have a sinus infection at all and should be taken off all medication immediately. He told them that whatever her problem was, it was not in his area. She and her mother left that appointment and sat in the car dumbfounded. What did that mean? If she did not have a sinus infection, why was her head hurting all the time? Why was her throat so sore? Why was she not getting any better? Eighth grade is a blur. She missed a tremendous amount of school and her records indicate that she was absent for 36 days. What those records do not show are all the other times she went to school late or left early. More than once, she was so tired that she fell asleep in the car on the way home.
Her parents met with her teachers and brought home her work. She would try to study, but found she could only work for short periods of time. Her headaches would get out of control if she concentrated for too long. Some teachers understood and were unbelievably kind and helpful. Others made it clear that they did not believe she was sick and were unwilling to help with the work she missed.
A horrible pattern was starting. She would push herself to go to school, struggle through classes for a week or so, and then be home sick in bed for the next week. When she felt better, she would push herself to catch up again, only to have the pattern repeat itself. She was becoming overwhelmed. Additionally, her friends did not understand why she was not coming to school. Some thought she was just lazy.
However, she had a bigger problem than her grades and her friends. In the fall, she would be entering high school. Her guidance counselor explained that no matter how high her grades were, she would be held back if she continued to miss this much school.
During the summer before high school, they spent a lot of time and money traveling to see specialists. It was around this time that she began to notice how bad her neurological problems had become. Often, when someone spoke, she could hear the words but would have trouble understanding what they meant. She began asking people to repeat themselves more slowly. When her mother mentioned these problems to the doctors, they told her she was overreacting and that she was just a typical teenager-she wishes she could be a typical teenager.
When nothing very significant was found during her immunological testing, it was decided that her health might be improved by a sinus operation. The operation was scheduled for the Thanksgiving break of her freshman year. Unfortunately, it took less than two weeks of high school to put her back in bed. The operation was moved up to the beginning of September. When it was done, they got the answer they already knew-her problem was not with her sinuses.
Things became worse and she could not get out of bed at all. Her pediatrician insisted this proved she had school phobia. The pediatrician suggested that she get counseling and be put into an alternative school, a school where they put students who had committed felonies or had been caught with drugs. She knew that she did not belong there and her parents agreed.
She is still not sure who was angrier during the doctor’s visits, her pediatrician or her mother. In the end, her doctor decided that she would no longer treat her for anything having to do with her chronic fatigue, but would refer her to any specialist she chose. She reluctantly agreed to sign papers allowing her to stay out of school for two more weeks. After that, she was to report for alternative education. She was so upset that she wanted to give up. However, her family persisted. The next week, her mother found a well-known rheumatologist. As with the last four doctors, her mother promised that if this appointment turned out badly, she would never have to see another doctor.
This turned out to be the worst appointment of all. This doctor said that she was trying to destroy her family by manipulating them. His solution was antidepressants and a visit to a psychiatrist. This time, no one argued. After they left the building, she and her mother held each other as they cried.
At this point, she had no medical tests that showed that she was sick. Without proof, she was guilty until proven innocent. She knew her family believed her, but it seemed like they were the only ones. She and her mother asked the doctors about the possibility of chronic fatigue syndrome many times. Each time, she was told that she did not have it-and could not have it-because it was not even a real disease.”
Even though her mother had promised no more doctors, she did not give up. She made one more attempt by contacting local support groups for chronic fatigue syndrome. They told her about a doctor who might be able to help. This time was different. This doctor understood her symptoms and explained that she was not alone, in her illness or in the path she had taken to get a diagnosis.
She is still learning what this disease will mean in her life. She is now a sophomore in high school. With help from her new doctor, she has been able to stay out of the school for criminals. Instead, they have set up an education plan that allows her to rest when needed. However, there are still teachers, doctors, and friends who do not understand. Additionally, there are plenty of times when she feels overwhelmed, even though she has people who love and support her.
She is unsure about her future. She would like to become a pediatrician or a medical researcher. On her good days, she knows that she can do it. However, on her bad days, she is not sure she can even make it through high school. She knows that she will have to work harder than most if she is going to make a difference in this world. However, she is determined to find a way to overcome chronic fatigue syndrome. When she does, she will find a way to help other children who are just like her.
Dr. Bell asked Ms. Morgan which group of professionals (e.g., teachers, school nurses, physicians, or psychologists) she would choose to understand this illness. Ms. Morgan replied that physicians or pediatricians would be the better choice. Without a doctor on your side, the school system will not help.
Dr. Gantz asked if Ms. Morgan was on medication for CFS.
Ms. Morgan replied that she only takes medication for allergies.
Dr. Bell asked if she was told that her mother was overbearing and trying to manage her life too much.
Ms. Morgan replied affirmatively.
Dr. Bell added that this is a sad irony, because if a mother does not help a sick child, she is guilty of child abuse. However, if she helps a child with CFS, she is too overbearing. There have been many instances where the mother is taken to court by school officials or pediatricians for Munchausen’s Syndrome by Proxy.
Dr. Friedman noted that Ms. Morgan’s story is similar to his daughter’s history. He added that his daughter has graduated from college, is working fulltime, got married, and is living a relatively normal life.
Ms. Butler asked about the information that Ms. Morgan’s physician provided to the school, in terms of how she should be treated.
Ms. Morgan noted that there is a 504 (b) plan that protects students with illnesses or disabilities. All of the teachers are informed about this and her doctor sent a letter to the school outlining all of her difficulties. There is a hospitalized homebound program and her classes are shortened. However, it took 18 months before the homebound program was approved.
Ms. Morgan’s mother (Mrs. Morgan) added that it is critical to have the support of a sympathetic doctor. Without this support, the schools are unwilling to help. Additionally, their insurance only allowed them to change primary care providers once a month, which further delayed the process.
Dr. Fields asked Mrs. Morgan about what was going on internally to keep moving forward under these difficult conditions.
Mrs. Morgan replied that she was lying when she told her daughter that there would be no more doctors. She was determined to keep persisting until they did everything they could. However, the stress was terrible on her relationship with her daughter and the whole family. She added that she was lucky because she was not working at that time and was able to help her daughter on a fulltime basis. However, single parents could not do this. Dr. Bell asked if they felt that they were abused by the medical profession for 18 months. Mrs. Morgan replied affirmatively. For example, the rheumatologist agreed upfront to sign for a few more weeks of homebound. However, he accused Chelsea of manipulating her family and said that she should someday pay for her abuse to her family.
Dr. Patarca asked how the local support group helped with their situation and what they would recommend to parents just starting the process of seeking help. Mrs. Morgan responded that the support group referred them to a CFS specialist. She noted that parents should try to network with people in similar situations and experiences to find a sympathetic doctor.
Dr. Patarca asked why they did not go to the support group earlier.
Mrs. Morgan replied that it was because they did not know what the problem was, partly because many of the doctors were convinced that this was a sinus problem.
Dr. Patarca asked how easy it was to get an appointment with the CFS specialist.
Mrs. Morgan noted that it took six weeks and a lot of begging to meet with the specialist.
Dr. Patarca asked about the insurance situation throughout the process.
Mrs. Morgan noted that they were fortunate in that area, as they had good insurance. However, it still became very expensive.
Dr. Friedman noted that when his daughter got sick, Dr. Komaroff’s office was unable to she her because it was overbooked with patients. As a result, she was referred to another physician who devastated her. They went to a CFS center at the University of Medicine and Dentistry of New Jersey, but were told that she must show symptoms for at least six months before she could be seen at the center. They went to other departments of the university, including rheumatology and allergy and infectious disease, and neither could offer a solution.
C. Betty McConnell, NJCFSA
Ms. McConnell is a member of the New Jersey Chronic Fatigue Syndrome Association (NJCFSA). Having raised a son with CFS, she knew what NJCFSA had to do to improve the lives of children with CFS in New Jersey. It needed to educate the pediatricians, pediatric nurses, school administrators, teachers, school nurses, school counselors, and school psychologists. It identified all of the state and national organizations of these professions to exhibit at their conferences.
In 1998, NJCFSA exhibited at the National Association of School Nurses regional conference in Atlantic City, New Jersey. It was a fulfilling experience. The most repeated statement from the school nurses was, “I had no idea that children got this illness.” They knew of CFS to be a woman’s disease. After reading the handouts, a nurse recognized a student she had in their school system that fit the criteria of CFS and was excited to share the information with the child’s parent when she got home. NJCFSA went to the conference with five boxes of handout articles and left with one box half full.
Later that year, NJCFSA contacted the New Jersey Education Association (NJEA), an affiliate of the National Education Association, and exhibited at its annual convention in Atlantic City, New Jersey. NJEA has 180,000 members, including 115,000 teachers, administrators, school nurses, counselors, and psychologist; 45,000 support personal (e.g., secretary, cafeteria, and janitors); and 20,000 retired members. Fifty-five thousand NJEA members attend its two-day convention each year.
As with the school nurses, NJEA members did not know that children got this illness. They thought NJCFSA was there to educate them about CFS in teachers. One of the best things that came out of exhibiting at the NJEA convention is that they found out about the New Jersey School Nurses Association (NJSNA). They also spoke with school principals, teachers, counselors, and child study team psychologists.
The following year, NJCFSA presented a workshop on CFS at the convention. The medical advisor to the NJCFSA board of trustees, Dr. James M. Oleske, Chief Pediatric Virologist, Professor of Pediatrics, UMDNJ, gave a lecture to school nurses on the diagnosis and treatment of pediatric CFS. Jon Sterling gave a lecture on what accommodations are needed by CFS students, along with a brief description on what NJCFSA does for children with CFS. There was standing room only at the workshop.
NJCFSA regularly exhibits at the NJEA convention. NJEA also invited NJCFSA to write an article on pediatric CFS to be published in the NJEA newsletter, The Review, which will reach all of its 180,000 members. NJCFSA has also exhibited at the following New Jersey organizations’ annual conventions and conferences: New Jersey Pediatric Nurse’s Practitioner’s Association; New Jersey Nurses Association; the N.J. League of Nursing Association; and the New Jersey School Counselors Association.
NJCFSA’s Youth Education Committee participated in the May 12th CFS Awareness Day program with the following projects. The committee put together a pediatric education package full of articles on CFS in children. In 2003, sixty packages were mailed to the Commissioner of Education of New Jersey, Dr. William Librera; the superintendents of schools of each of the 21 counties; the New Jersey State Special Education Advisory Council; and to the five Catholic Dioceses in New Jersey for its schools. NJCFSA received favorable feedback. For example, a superintendent’s office called to ask if they could copy our package and distribute it to each school in their county. They were also contacted by the New Jersey School Counselor’s Association to exhibit at its annual conference. Additionally, they were contacted by a school to give a lecture on pediatric CFS.
For the 2004 CFS Awareness Day, NJCFSA mailed its pediatric education package to 65 members of the American Academy of Pediatrics, New Jersey chapter, targeting the executive council members, the counselors, standing committee members, and members of its task forces. NJCFSA’s medical advisor, Dr. James Oleske, wrote the cover letter introducing NJCFSA and its pediatric education package. As a result of this mailing, they were contacted by many recipients requesting additional packages for their colleagues. NJCFSA has asked the Academy of Pediatrics if it could give a lecture on pediatric CFS at one of their annual conventions or conferences.
NJCFSA helps parents and children with CFS in the following ways. Primarily, it offers moral support to both parents and children with CFS. Through the NJCFSA phone hotline, members of the Youth Education Committee speak with parents to help them with any problems. Parents are sent the pediatric education package free of charge and a current physician referral list is maintained.
The following is an account of different projects and programs that NJCFSA has done that have directly or indirectly helped children with CFS. Through NJCFSA member advocacy, the association wrote legislation asking the state of New Jersey for the funding of medical education and public awareness programs. The legislative bill (A-507) was signed into law by Governor Christine Todd Whitman on April 6, 1999. As a result, New Jersey appropriated $95,000 for the Department of Health and Senior Services (NJDHSS) to create a physician’s manual on the diagnosis, treatment, and management of CFS patients. In 2002, the manual, A Consensus Manual for the Primary Care and Management of Chronic Fatigue Syndrome, was distributed by the Academy of Medicine of New Jersey to 14,000 physicians in New Jersey. The manual includes a chapter on CFS in children and adolescents, which has proven to be a valuable resource for physicians. The manual was included in the pediatric education package that was mailed to physicians in their 2004 Awareness Campaign. It can also be downloaded on the NJCFSA and the NJDHSS websites.
In 1999, NJCFSA established a $1,000 scholarship for New Jersey high school seniors who are continuing their education in a college or technical school. The mailing of the scholarship to every secondary school, both public and private, has proven to be an awareness project in itself, and NJCFSA has received calls from guidance counselors requesting additional information on CFS in adolescents. Since 1999, 70 students have applied for the NJCFSA scholarship.
In 1996, NJCFSA established a lending library of books and tapes, available to its members via mail. The library has the most up-to-date books and videotaped lectures on CFS, as well as many books and lectures on pediatric CFS. NJCFSA also sponsors two medical conferences each year in New Jersey that include CME lectures on pediatric CFS. The conferences are videotaped and available to parents or schools upon request through the NJCFSA lending library. Additionally, NJCFSA has exhibited at the Medical Society of New Jersey and the New Jersey Osteopath’s annual conferences.
NJCFSA has many projects for children. It has:
- Created a pediatric education package;
- Identified pediatric organizations within New Jersey;
- Mailed pediatric education packages to such organizations;
- Exhibited for pediatric organizations at their annual conferences or conventions;
- Given lectures and workshops at pediatric organization conferences or conventions;
- Maintained a phone hot line for NJCFSA members;
- Maintained an up-to-date physician referral list;
- Created a scholarship for New Jersey graduating seniors;
- Maintained an up-to-date lending library;
- Sponsored two medical conferences in New Jersey each year;
- Advocated for legislation for CFS education programs, which funded its physician’s manual;
- Encouraged the governor to proclaim May as CFS Awareness Month in New Jersey.
NJCFSA has two proposed projects for 2005. The first project, designed to increase awareness of CFS in medical schools, is to establish a scholarship for a medical student at the University of Medicine and Dentistry of New Jersey. The second project is a pediatric prevalence study of CFS in children and adolescents in New Jersey. They have taken the first steps on this project by consulting with Professor of Pediatrics, Dr. James Oleske, and Assistant Professor of Pediatrics, Dr. Walter Zahorodny, UMDNJ. Dr. Oleske is an NJCFSA medical advisor and Dr. Zahorodny is currently conducting a prevalence study on autism in children in New Jersey. Also offering advice for the prevalence study is Dr. Rosemary Underhill. Dr. Underhill recently conducted CFS research using NJCFSA members and authored a paper titled, “Prevalence of Chronic Fatigue Syndrome and Chronic Fatigue among Family Members of CFS Patients.” The next step is to discuss this information with the board and seek funding.
All of these programs and projects would not be possible if not for the support of all of the NJCFSA board of trustees members and the financial support of the NJCFSA members.
NJCFSA has many advisors. They support NJCFSA by giving advice, giving lectures on pediatric CFS, writing letters on their behalf, writing articles on pediatric CFS for the media, working on annual updates of the scholarships, and providing directions for future projects. They may also be considered for future testimony before CFSAC.
- Dr. James Oleske;
- Dr. Susan Levine;
- Malcom Schwartz;
- Dr. Edward Hoffman;
- Dr. Rosemary Underhill;
- Dr. Kenneth Friedman;
- Jon Sterling;
- Peggy Walk.
NJCFSA also works with a number of national pediatric organizations. They include:
- U.S. Department of Education;
- National Education Association;
- American Association of School Administrators;
- American School Counselor Association;
- National Association of School Nurses;
- National Association of School Psychologist;
- American Academy of Pediatrics;
- National Association of Pediatric Nurses, Associates, and Practitioners;
- Society of Pediatric Nurses;
- National Institute of Child Health and Human Development.
It is highly recommend that CFSAC educate the above national pediatric organizations by either exhibiting or conducting a workshop at one of their annual conferences. For an example, the American Academy of Pediatrics’ next national conference will be held in Washington, D.C., on October 8–11, 2005. It is recommended that CDC and CFIDS Association of American, through their joint medical education program, contact the American Academy of Pediatrics and offer a workshop or submit an abstract on pediatric CFS for this conference. The deadline for abstract submission is April 15, 2005. This would be a great start to educating pediatricians nationally.
It is recommended that CFSAC consider recommending to the Secretary of HHS the establishment of various grant or other programs to assist state and local CFS/FM organizations in carrying out the parts of their missions that are concurrent with the missions of CDC and HRSA concerning research; disease management and care; and provider, patient, caregiver, and school education. The CDC contract with CAA for provider education is very important, but it should be noted that state and local CFS organizations are the ones that interact most directly with the CFS patient community, especially children, their parents, their schools, and their pediatricians. With increased resources in terms of employees and dollars, much more could be done in New Jersey and elsewhere.
For example, there are more than 12,000 pediatricians in New Jersey. NJCFSA cannot afford the costs to contact each pediatrician in New Jersey via mail. If it had grant money, it would have been able hire temporary help and pay for the copy and mailing of its package to every pediatrician in New Jersey.
It is recommended that CFSAC consider requesting that the National Institute of Child Health and Human Development, NIH, publish a booklet on pediatric CFS. The institute has published many informative booklets on many childhood illnesses. However, CFS is not on its list. Additionally, NIH and CDC have published booklets on CFS, but no federal health agency has ever published a booklet specifically on pediatric CFS. This would help the children tremendously.
The final recommendation comes from her experience exhibiting at one of the Medical Society of New Jersey’s conventions. A pediatrician asked her how he was suppose to know how to diagnose CFS in children, since he has not been given any guidelines. He was frustrated by not knowing if there was a diagnostic criterion for pediatric CFS. It is recommended that a case definition be specifically written on pediatric CFS. The Canadian ME/CFS Clinical Working Case Definition includes “Features of ME/CFS in Children.” It would be advantageous to give pediatricians the proper tools to help diagnose CFS in children and adolescents.
NJCFSA judges its success through the communications it has established with pediatric organizations. These organizations are now calling NJCFSA for more information or help. It also judges the success of its programs by the phone calls it no longer receives from parents. Before its pediatric education programs, it used to get frequent calls from parents saying that their child’s school, school nurse, or guidance counselor did not know about CFS and would not cooperate in helping their child receive a proper education. These calls are now rare. In conclusion, everything that has been done for children with CFS in New Jersey can be done nationally.
Dr. Patarca asked how the NJCFSA efforts could be expanded nationwide. He also asked if NJCFSA has attempted to network with other state organizations.
Ms. McConnell replied that CFSAC should contact other state organizations to see what they have done. She added that they have not had success in networking with other organizations.
Dr. Patarca noted that CFSAC has had similarly unsuccessful attempts to network with many professional organizations. He asked if NJCFSA has had other types of interactions with these professional organizations, other than presenting at their meetings.
Ms. McConnell replied that she keeps calling and sending materials, until they give in.
Dr. Patarca asked which organization would be the better target in terms of education.
Ms. McConnell noted that the better option would be the Academy of Pediatrics. Dr. Patarca noted that the Academy of Pediatrics was invited to this meeting, but did not attend.
Ms. McConnell noted that their proposed prevalence study might show that there are more children with CFS than previously documented. This information may help to convince these organizations to get involved and increase their educational efforts. Ms. Fitzpatrick suggested adding the American Physical Therapy Association to the list of organizations to consider.
Ms. McConnell concluded with a story on awareness. In the second year of the scholarship, the award went to a young lady, who was a patient of Dr. Rowe. At the awards ceremony, which was attended by approximately 450 people, the audience started to laugh when it was announced that the next award would go to a student with chronic fatigue syndrome, while other students received applauses. The young lady was horrified and the general perception about CFS is that it is laughable. As a result, the award is announced using “CFS,” rather than “chronic fatigue syndrome.”
IV. Public Comment
A. Dr. Lucinda Bateman
Dr. Bateman noted that she is a general internist in Salt Lake City, Utah. As an internist, she sees many teenagers. In the last four years, she has seen 73 patients in consultation for chronic fatigue. Of those patients, 52 were diagnosed with CFS. Of these patients, 40 are female and 12 are male, and 30 were referred for tilt table testing. Eighty percent of those referred had an abnormal or positive tilt table test.
Of the 52 patients, 37 were interviewed by phone. The average age of onset of CFS was 14-their current average age is 19.8. The average length of illness was 4.9 years, and on average, the illness was serious for 1.1 years, moderate for 2.8 years, and mild for 1 year. Additionally, 13 to 14 percent said that they have recovered from the illness. When asked about the most effective intervention, the most common answer was “nothing.”
In conclusion, CFS is an important health issue in pediatrics. The numbers are large and the patients are quite ill for a long period of time.
B. Erin Floyd
I am Erin Floyd. Thank you for the opportunity to speak to you and present my experiences. My experience with Fibromyalgia (FM) and Chronic Fatigue Syndrome (CFS) has been pretty horrible and has only been made worse by the way I have been treated by those in the medical profession and education, as well as general people.
When I first got FM or first noticed any pain, I was 10 years old and in the fifth grade. I had very sharp pain in my upper left portion of my abdomen that was constant. I could not do anything other than just sit or lay down. I felt lost and did not have any idea what to do. I went to my pediatrician and she was very understanding, but without any real proof that I had something wrong, there was not much she could do to help me. I had to go to the emergency room several times. I had numerous tests and went to gastroenterologists, but nothing abated the pain. Eventually, it lessened and I was able to continue with life pretty much at a basic level. However, I was not able to play sports like I had before or attend school full time.
When we moved to Utah, I am not sure how, but I was able to push through the pain and was able to enroll in public school. However, it was very difficult. I went around as if nothing was wrong; I did not acknowledge the pain. I did not know what was wrong; it was just something weird that I had that had gotten a little better. I started having headaches in sixth grade and was not able to concentrate. I was having difficulty as other symptoms of FMS and CFS were starting to present themselves and I had to drop out of school for the most part. I could not keep up with the class load and could not continue, as I was required to, so I was home schooled.
During the time I was home schooled, some people that we knew that had a daughter with FMS and CFS made us aware of this disease for the first time. We went to a doctor in Provo, Utah, who was some type of specialist. He officially diagnosed me with FM/CFS; I had all of the points, which are used to diagnose the disease. He suggested a lot of strange diets and herbal medications, but none of them helped. Nevertheless, at this point I knew what I had, so I was able to do research online and in books. The information was very confusing, especially at that age. Throughout this experience, I was not able to have much of a life other than trying to figure out where to go and what to do next. It was just a constant search for information. I was not able to keep many of my friends or able to do many social activities. It was a very isolating time for me.
I was made aware of a pain clinic in the University of Utah that specializes in chronic pain. It seemed like it was a good rehab program, but I do not think I was at the stage where I was ready to be rehabilitated. I was still ravaged by the pain. I was also in the program with people who were at least 30 years older than me, many even 40 or 50 years older. It was very uncomfortable and strange, and it ate up a lot of my time.
I eventually heard of that the Primary Children’s Medical Center (PMC) in Salt Lake City was going to start a pain-management program for chronic pain. I went to that and met with a psychologist and a physical therapist who were both very nice and understanding and made me feel better about things. They were open to new ideas and seemed willing to work with me to find answers. Pediatricians and specialists in the past had all seemed to have their ideas about what was wrong with me. Throughout this, even up until now, it seemed that every doctor seemed to think that they knew exactly what needs to be done about FM. The problem arose when my psychologist learned of a pediatric FM study at UCLA. We wanted to go there and see what their program was like and maybe help PMC get something similar. I went there and it was good to have another medical doctor, one with more expertise than the previous one, diagnose me with FM and access the level I was at. However, upon our return, Primary Children’s Medical Center was upset that we had left them.
I eventually left that program and from that point on, we were pretty much on our own. I had not been able to finish a school year since fifth grade. It is hard for anyone to fit in at middle school without having something else weird about you, like taking only a few classes. It was isolating. I did not share in the social experiences that my peers did and I still had no idea what to do other than staying on the medication that was prescribed at UCLA.
I had another pediatrician when I moved to Salt Lake City and she was willing to continue to prescribe the medication, but other than that, she did not know anything about FM. I felt as though I had to teach her about the condition and about what I had read as I was continuing to research online and in books. It was hard to meet with the specialists she suggested. It seems that after a while of doing tests, the doctor seemed to doubt my condition. Though not all of them expressed this to me, I could tell that most of them were just humoring me. It would get so bad sometimes that I would even start to doubt myself. I would think that there was some mental condition that I had, that none of this was real, even though I was feeling extreme pain and I could not control it. I really felt lost throughout this entire experience. I was confused all the time. I never felt like I had control over this. I never felt that this was anything I could ever manage.
My mother was being tested for headaches and migraines, and was told of a physical therapist who was able to help with that. She learned that he also had FM and that he treated patients who had it as well. Going to see him was an amazing experience right from the first visit because he seemed to know what I had been going through, even though we never really discussed it. That helped me a lot, but I still felt that there was something that was not being treated.
As I entered high school, all the bad experiences of middle school were magnified. I had to drop out of school the first few weeks and could not continue in my classes. This was very disappointing to me since academics had been something I had always loved. It was also very hard to miss those first experiences of high school. I was not able to do social activities because nothing had changed. I felt left out of things.
I had heard about other doctors in Salt Lake City who treated only FM and CFS through my physical therapist, but heard that they only treated people over 18. They also had long waiting lists to even get a first appointment. In my junior year of high school, I had to drop out of school again. Throughout that year, I had not been able to eat breakfast. If I did eat something, I would immediately throw it up involuntarily. I had gone to another gastroenterologist and again went through more tests. This would be the third time I had gone to a gastroenterologist for tests. I had to explain constantly that I had not been doing this voluntarily. He thought I was bulimic and I had to convince him that I was not. I could tell that he had just given up. Through this, my pediatrician would no longer prescribe medication for me. I had to go see a psychiatrist. She was convinced that all this was due to depression.
I had allergic reactions to many of the medications that she put me on. I just felt like I was in no control of my emotions. I was not myself and it was a horrible experience. I knew that this was not due to depression. However, it was hard because she would not take me seriously-not many of my doctors ever did. I knew a lot about what was going on and I could tell what was wrong with me. I, more than anyone, knew what I was going through, so eventually the medication she had me on was just barely maintaining me. I could not longer maintain my current activity. I had to drop out of school again and I was just desperate for any sort of solution.
We called Dr. Robinson in Salt Lake City and after explaining that I had this for about seven years and with no relief, she was willing to see me at least once. I felt that I had a real illness. There were medications that she had and there were other patients who had the same thing that I did. It was like I had a normal illness and that I was not making this up. There were really things wrong with me-real measurable things.
C. Karla J. Rogers
Ms. Roger’s testimony was read by Ms. McCleary. Karla J. Rogers, Nevada City, California, is a patient with CFIDS (13 years) and the parent of a young adult with CFIDS (2 years). The objective is to address the issue of educational rights for children with CFIDS and the need for providing a clear and concise “Parent’s Guide to Advocacy” to assist parents with advocating for their children in the public school system.
My name is Karla Rogers. It is indeed a privilege to present my concerns before this distinguished committee. When it was announced that today’s meeting was to convene with an emphasis on pediatrics, my heart was deeply touched and stirred. It is a subject that strikes at the very core of our family.
In reviewing the transcripts of the March 2003 CFSAC meeting, it was encouraging to read Dr. Bell’s comment that the education of children affected by CFS is an important issue and recommended that the Education Subcommittee not focus solely on medical education, but also address the educational needs of these children. I could not agree more; it is the reason I am testifying here today.
CFIDS has deeply touched and rewritten the script of my life, as well as the lives of each member of my family. Having been diagnosed and legally disable in 1991, one can certainly imagine the utter horror my husband and I experienced when our only child was also stricken and diagnosed with CFIDS in 2003. Recognizing that each of you are intimately acquainted with the devastation this illness creates, I will forgo the details of our personal story except to say that I, and now my son, are blessed to be under the care of one of the pioneering and foremost CFIDS researchers/clinicians in the world.
Oscar Wilde once wrote, “Experience is the name everyone gives to their mistakes.” What I wish to present today is the result of the experience I had and mistakes I made while intervening for my son in the public school system. As I waded through the maze of teachers, school officials, and guidance counselors, the lack of available materials to assist in this journey became painfully evident.
My proposal today is the creation of a “Parent’s Guide to Advocacy” brochure that clearly and concisely explains the federally mandated rights, privileges, and options available. It should be a guide that any parent can easily comprehend. Hopefully, this would be readily accessible in an understandable format for anyone who desires it. Perhaps it could be similar to the current “Pocket Resource Guide to CFS,” made available for practitioners (by the CFIDS Association under contract to the CDC).
Recognizing that medical practitioners have tremendous responsibilities simply dealing with the medical issues of such children, it would seems unfair to expect them to also be aware of all the current mandates regarding educational rights. These guides could be distributed to parents upon diagnosis, through physicians, local SELPA (Special Education Local Plan) offices, school nurses, guidance counselors, and when they become a reality, the Centers of Excellence. Although familiar with resources such as the CFIDS Association of America, AACFS, and various books on CFIDS, I found very little information available regarding the “nuts and bolts” of working with the school system.
Please consider that only a small percentage of newly diagnosed children will have parents who are also afflicted with CFIDS. A much larger population of parents will be dealing with understanding and learning to accept the CFIDS diagnosis, in conjunction with figuring out how to best advocate for their child’s educational rights. Most, if not all, parents will be in a “crisis mode.”
Ideally, these brochures will clearly state and include information on the 504 Accommodation and Modification Plan, an IEP (Individualized Education Plan), special education, home/hospital placements, home schooling options, provision of tutors, a description of SEPAC (Special Education Parent Advocacy Council), and any other available resources. Recognizing that the needs of students with CFIDS diagnosis differ greatly from that of other students that fall under the category “Other Health Impaired,” I witnessed first hand the confusion as to how to best address their unique physical and educational needs. At the onset of our journey, the following questions were raised: When does an illness become a disability? At what point do these students qualify for Special Education? When is a 504 appropriate or is an IEP a better provision?
Home/hospital is an available option, yet confusion often arises because students with CFIDS are not facing an acute situation, such as recovery from surgery, an injury, or a short-term illness, but rather are faced with a long-term illness with variable symptoms and severity. These issues pose difficult challenges for school officials.
With the increased accuracy with which children are now being diagnosed with CFIDS, the magnitude of the need for disseminating this type of information will greatly expand. More and more parents will find themselves in that “crisis mode,” seeking assistance and answers, yet finding little help readily available. How my heart aches for those parents. If our own struggles could but save one family from the painful process we faced, it will be worth our struggles and efforts.
Diogenes Laertis said, “The foundation of every state is the education of its youth.” This proposal builds upon the very foundation of our great nation by providing relief and assistance to those families who will be faced with the challenge of assuring that their child’s right to an appropriate and meaningful education not be diminished. Remember, children are one our nation’s most precious assets, our hope for a better tomorrow, and for parents, they are truly our most treasured joy.
D. Joshia Huggins, Jr.
Mr. Huggins has spent 20 years coming to grips with CFIDS. At the time of the onset of the illness, his wife was nurse. To learn more about CFIDS, he read and went to NIH for a protocol in 1997. At that time, they did not have the information to be helpful, and all he knew was that this was a disease that white females had. As a black male, he did not realize that he had CFS. As a motivational speaker and a management consultant, it has been challenging to be self-employed because of the demands of deadlines, projects, and travel. There may be many African Americans who are afflicted with CFS. His mother was recently diagnosed with FM; she had always been struggling with something. Additionally, his 18-year-old daughter is beginning to show signs of CFS. In conclusion, CFS does not have a color, age, or gender.
Dr. Lapp noted that it was not until the CDC studies, which did show a higher frequency of CFS in African American populations, that doctors began seeing more African Americans for care. He asked why there is a mismatch between those who are ill and those who are seeking care.
Mr. Huggins responded that not everyone has the resources to fight what the issues are. Many do not have a voice, the presence of mind, access to medical care, or the knowledge. If Chelsea Morgan was black, she would have been sent to the school for criminals. Additionally, the African American community is afraid to go against doctors.
Dr. Patarca noted that in all chronic illnesses, there are stereotypes based on sex, age, and ethnicity. It is important to advocate and break down these stereotypes. He asked what would be the best way to educate the medical community regarding this problem.
Mr. Huggins responded that protocols and clinical trials should be more open and better promoted. Another venue is the support group. Additionally, technology allows for the message to be disseminated via multiple venues. In conclusion, the message has improved over the last 10 years and is getting louder.
V. Ex Officio Member Updates
A. Dr. William Reeves, CDC
Dr. Reeves presented an outline of the CDC CFS Research Program activities for FY05. Throughout the year, they will be conducting microarrays for gene expression data. They have finished all testing from the Wichita Clinical Study and is now in the analysis phase. They are doing testing on the post-infectious fatigue model, which is a psycho-neural immunology model of physical stress, brain activity, and gene expression. Another activity is the surface enhance laser desorption ionization, which is a method to quantify the presence of every protein in serum. They are in the process of using this method for the Wichita Clinical Study and have entered into a materials transfer agreement with a company called Ciphergen.
The next activity is a DNA project, which will study the genetics behind CFS. They are interested in DNA methylation patterns-the genome can be modified and the genes can be turned off. They are currently using the Wichita data for this study. For fieldwork, they are in the first year of their study of CFS in metropolitan, urban, and rural Georgia. They have about 30 percent more people identified with illness than previously thought possible. They will be initiating some pilot studies to start a registry of CFS patients. This will initially occur in select areas in Georgia and then expand to the entire state, the region, and, in a few years, the nation. Another activity is the GCRC project, which is a three-day inpatient study using functional magnetic resonance imaging at Emory University.
They are currently doing a study of sequelae and infection following West Nile virus. People with West Nile can get a flu-like, meningitis-like, or encephalitis-like illness. The post-infectious fatigue study, which is in Australia, is in its last year. They are also in their last year for the interfere on alpha model study at Emory University. The education activities continue and they are begining a public awareness campaign this year. They also plan to begin in FY06 a fatigue clinic of excellence with Emory University.
Following an outbreak, CFS was first defined in 1988 by CDC. This case definition brought an increasing attention to CFS. In 1990, another case definition was published in Australia, and in 1999, the United Kingdom published its own case definition. In 1994, CDC convened international experts and published the current internationally accepted research case definition for CFS. In 2004, CDC published identifications of ambiguities and recommendations as to how the case definition should be applied. Currently, the Brighton Collaboration is in its penultimate phases of publishing a case definition for surveillance and clinical purposes.
CFS is defined by symptoms and disability. There are at present no confirmatory physical signs or laboratory abnormalities. In part, the etiology and pathophysiology remain unknown. The case definition, as published in the Annals of Internal Medicine, states that:
Fatigue is persistent or relapsing for at least six months;
Fatigue is not alleviated by rest;
Fatigue results in substantial reduction in activities;
There are no explanatory medical or psychiatric causes;
Fatigue is accompanied by at least four of eight symptoms (impaired memory or concentration, post-exertional fatigue, unrefreshing sleep, headaches, muscle pain, multi-joint pain, sore throat, and tender lymph nodes).
The limitations of this case definition include:
It focuses almost entirely on fatigue;
It was developed by consensus, not empirically;
It was based on clinical experience, not population-based (the people who have this illness and the people who are represented by doctors are different people);
The sensitivity and specificity of the case definition are not defined (the specific pathophysiologic process associated with CFS has not been identified).
The issue of symptoms has been addressed in the past. In the Wichita Study, participants reported a variety of symptoms lasting at least six months, and 13 percent of those with CFS reported having four of more CFS symptoms. Determining which symptoms define CFS can be achieved through a mathematical technique known as factor analysis, which attempts to see what goes together. The analysis showed that unexplained chronic fatigue of at least 6-month duration has three different components: musculoskeletal, inflammation-infection, and cognition-mood-sleep. The leading symptoms in each component are those symptoms that are in the case definition.
Using population data in the United States, the construct of CFS looks good. Using international data and factor analysis, the key constructs are mood, musculoskeletal, inflammation-infection, cognition, and sleep, which are consistent with the U.S. construct. This construct also applies across cultures.
Unlike the constructed definition, an empiric definition would be based on population-based clinical data. Patients from the Wichita Study that showed signs of CFS were brought in for a 2-day inpatient clinical study. Of the 604 people evaluated: 70 had CFS diagnosed over the four-year follow-up; 41 had CFS, accompanied by major depressive disorder with melancholic features, diagnosed; 70 had insufficient symptoms or fatigue (ISF) to be called CFS; and 39 had ISF to be called CFS, accompanied by major depressive disorder with melancholic features. They also had a 70-member, non-fatigued control selected from the general population, matched with the CFS patients on age, race, sex, and body mass index. To create the clinically empiric case definition, all of the patients had a standard medical and psychiatric evaluation. The next step was to measure the effects of the illness (disability) by an acceptable, internationally validated scale that measures disability or function and well being. All of the subjects completed the SF-36, which is the standard, international instrument for measuring disability. It has eight 1–10 scales: physical function, social function, role physical, role emotional, bodily pain, mental health, vitality, and general health.
There are two aspects of the case definition that involve fatigue: persistent and relapsing fatigue not alleviated by rest and post-exertional fatigue. They used the multidimensional fatigue inventory (MFI), an internationally validated and culturally independent instrument that measures the dimensions of fatigue, to measure five constructs of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.
There are several accompanying symptoms of CFS, and over the last 15 years, they have using the CDC symptom inventory (CDC-SI). The construct of CDC-SI has been validated and is being used for the study. CDC-SI contains 19 items. It measures the eight defining symptoms of CFS and other symptoms that are not in the case definition, but may or may not accompany CFS. It has three components. First, does the symptom occur? If it occurs, how often does it occur (frequency)? If it occurs, how intense is it? Frequency and intensity are multiplied, resulting in a SI score.
Using the SF-36, MFI, and CDC-SI instruments, CFS can be empirically defined. They used four of the eight SF-36 scales that best approximate the characteristics of the case definition. They used population norms as the cutoff, so that if patients had physical function less than 70 (75th percentile) or social function less than 75 or role physical less than 50 or role emotional less than 67, they met impairment criteria. Additionally, if they had an MFI score in general fatigue greater than 13 or reduced activity greater 10, and at least three CDC-SI symptoms with a CDC-SI score greater than 24, they met criteria. If they met none of these, they were defined as non-fatigued. Those that met some, but not all, were defined as insufficient symptoms of fatigue. In the study, CFS patients scored significantly worse in every scale.
Currently, they have a manuscript submitted on the symptom inventory. They are in the final stages of clearance to submit the manuscript on the above data. They are going to submit for publication the international study, and they are now in the process of looking at the Wichita data for:
Autonomic nervous system;
The next level of analysis will look at how neuroendocrine function and gene activity go along with polysomnography and the case definition.
In response to a question concerning autonomic nervous system, Dr. Reeves noted that all those with CFS and the appropriate control were subjected to a standup, 10-minute screening for orthostatic instability, including orthostatic intolerance. Those who were not on medications and were not over 55 were subjected to a formal head-up tilt table test. It is important to note that this is a study of patients representative of CFS in the population, and not those referred. Unfortunately, there is no evidence that there is a difference in orthostatic instability between those with CFS and those without CFS. Additionally, there was no one that was abnormal in the standup test.
Dr. Reeves noted that for polysomnography, they are looking for sleep apnea, alpha/delta sleep abnormality, and parasomnia-like conditions. They have a collaboration with the sleep people in the Division of Neurology at Emory University. They rented part of a hospital and used state-of-the-art sleep equipment. Each subject had two overnight sleep studies and four multiple sleep latency studies. They were looking for primary sleep disorders that could be diagnosed and the results of multiple sleep latency studies. They are now in the process of looking at alpha/delta intrusion.
Dr. Reeves added that cognitive function is memory and processing of information, while psychometrics is comorbid psychiatric conditions and reactions to stress. Dr. Reeves noted that the prevalence of children with CFS from the Wichita Study is low because the actual numbers are low. CFS in adolescents is a much more devastating problem with much longer effects than it is in adults. However, the risk is very low. For adults, the overall risk in people over 20 for CFS is 300/100,000. For a population study, the risk (or prevalence) of having CFS in people between 12 and 18 is extremely low. As a result, it becomes difficult to study risk factors in a population study for that group.
In the Georgia study, they assumed that they would bring 1,000 people into the clinic for evaluation using random digit dialing. They are a quarter way through the process and have 950 who have met clinical eligibility. There are a number of reasons why the number is so large. One explanation could be that this is the first intensive examination of large numbers of black and Hispanic populations. If these racial/ethnic groups have different risks, that could be driving up the numbers. However, the data for children is still unknown, but they are included in the survey and the registry.
Dr. Komaroff asked how the analysis would be conducted with respect to the two case definitions.
Dr. Reeves responded that they would focus only on the new definition. The problem with the previous definition is that it is applied in different ways by different people, making it irreproducible. However, using the new standard instruments, applications are now reproducible.
Dr. Patarca asked if a person could fluctuate between CFS and ISF. Dr. Reeves responded that he does not know, but suspect that a person could fluctuate between CFS and ISF.
Dr. Bell asked if the Center of Excellence at Emory University was a result of the CFSAC recommendations.
Dr. Reeves noted that the Center of Excellence at Emory University is a scaled-down version of the recommendation.
Dr. Friedman noted that the types of healthcare practitioners that are being used by the subjects could be added to the study.
Dr. Reeves responded that the Georgia study has a major component to look at the direct and indirect cost of CFS, which is tied to access to and utilization of healthcare. Dr. Bell noted that there is a misunderstanding of the CDC role in the overall population of patients with CFS. What CDC is trying to do is develop a case definition that would allow the study of the most clean group of CFS patients, without the extras seen in clinical practice. As a result, it is not necessary for a 100 percent of people who say they have CFS to meet the new case definition. The new CDC case definition may not include all patients with CFS, though that is not its intention.
Dr. Reeves responded that that is correct. The new definition is for research purposes. The goal is to find markers that would identify CFS. Those subjects that do not completely meet the new definition then become a comparison group for the study. He added that the SF-36 instrument might produce enough information that could readdress the issues of disability for Social Security and HMOs in a more precise way.
Dr. Patarca asked how the effects of medication on markers are being looked at. Dr. Reeves noted that this was a problem with the Wichita Study. However, the Georgia Study will begin with those that are medication free.
Dr. Cavaillé-Coll asked if the new definition should be used in clinical studies for evaluating therapeutic measures.
Dr. Reeves replied affirmatively, because it is completely reproducible. He added that the new definition measures the same construct of the 1994 definition in a reproducible way.
Dr. Patarca asked if the CDC CFS Program budget has increased and if the CFSAC recommendations had an impact on the way the program is approaching education.
Dr. Reeves noted the CDC is awaiting its budgets, but the legislative mandate is to continue the same level of effort. He added that the recommendations have had an impact on the program.
B. Dr. Eleanor Hanna, NIH
Dr. Hanna noted that the institutes are unable to provide funding for Dr. Reeves’ study because they do not know if they will have the funds for programs to which they have already committed-NIH cannot commit funds until FY08. However, the study did increase the interest in creating centers, which could be modeled after the recommended Centers of Excellence (COE) to include training, treatment, and research.
Dr. Patarca noted that the paradox of the situation is that CFSAC came up with recommendations that cannot be implemented because there is not enough money.
Dr. Hanna noted that the recommendations helped to push the agencies to support what NIH is doing in terms of CFS. Though there may not be all of the necessary funds, there are other ways to move the process forward. She added that NIH is funding approximately 20 percent of the CFS grants, which is slightly higher than other diseases. Seven of the grants that were reviewed in council have been encumbered-funds have been promised by the institutes for FY04, but may not have yet been awarded. For FY05, there are 27 applications slated for review, 18 of which are for January council and nine for the May council.
Dr. Reeves noted that many of the CFSAC recommendations are now under consideration or in the process of being developed. He recommended that CFSAC should turn its attention to new areas and issues, such as childhood CFS and disabilities pertaining to Social Security and third-party providers.
Dr. Patarca commented that a progress report on the recommendations could be provided on the website.
Dr. Bell asked about the funding process after the recommendations are sent to the Secretary of HHS.
Dr. Fields responded that the agencies are the action component of the process. In terms of the funding process, after the recommendations are made, there are internal discussions on the recommendations. The recommendations also help to fuel progress at the agency level.
Dr. Fields asked Dr. Reeves how subjects with core morbidities, such as obesity, are being tracked.
Dr. Reeves responded that the study recruits its subjects using random digit dialing of the populations. It then gives a questionnaire. Those who meet criteria are asked to come to a clinic, at which time they are tracked, regardless of what they may have.
C. Dr. William Robinson, HRSA
Dr. Robinson commented that he had invited the director of the Division of Medicine and Dentistry and the Internal Child Health Bureau to this meeting. Unfortunately, neither could attend. However, he will be talking with them via phone to discuss adolescents and CFS. He encouraged CFSAC to develop recommendations concerning CFS and adolescents.
Some agencies have resources dedicated to CFS. However, HRSA has no dedicated funds for CFS because its budget lines are much more general. As a result, it is difficult to generate funding support for a specific disease, especially when it is not part of the legislative mandate. He added that the CFSAC recommendations help to support his advocacy efforts.
D. Dr. Marc Cavaillé-Coll, FDA
Dr. Cavaillé-Coll mentioned that FDA is reorganizing its Center for Drug Evaluation and Research, and consolidating all of its centers into a new campus at White Oak. The Office of New Drugs is also being reorganized, and the details are available on the FDA website. With the consolidation of the centers, there could be closer collaboration between different divisions.
VI. Subcommittee Updates
Dr. Roberto Patarca, Chair
The Education Subcommittee will reconvene to discuss the feedback from the agencies and work on specifics with the new directive. They continue to receive materials from different groups. For this year, the subcommittee will continue to focus on specific areas, such as schools and healthcare professionals, and continue to work with CDC, NIH, and HRSA. However, they have been unsuccessful in getting the interest of professional societies.
VII. New and Other CFS-Related Matters
Dr. Bell asked if the committee should continue the topic-specific format and, if so, what the next topic should be.
Dr. Komaroff commented that this was a good format, but had hoped to get an academic and professional perspective.
Dr. Lapp added that the next topic could be on disability.
Dr. Gantz noted that the criteria, process, and obstacles pertaining to disability would be a good topic.
Dr. Bell suggested that someone should arrange the speakers for the next meeting to ensure diversity in the specific presenters. Dr. Lapp responded that the Disability Subcommittee would take on the role of inviting speakers.
Dr. Bell commented that there would be three slots that would be paid for by HHS that would include an advocacy group and two professionals. The meeting should focus on issues in which CFSAC would have a role in making recommendations. He asked that the training of the adjudicators be addressed at the next meeting.
Ms. Fitzpatrick asked if the committee should also discuss third party payers.
Dr. Lapp commented that a discussion on third party payers might require an entire meeting. Additionally, CFSAC has no control over the insurance industry and may not be able to come up with recommendations on this subject.
Ms. Fitzpatrick noted that if Medicare revised its guidelines, insurance companies might follow.
Dr. Gantz commented that insurance and Medicare would be a good topic for another meeting.
Dr. Fields added that the committee should begin to think now about topics for future meeting themes.
Dr. Bell asked for other topic ideas. He suggested research issues, public perception, and education.
Dr. Lapp added the topic of non-government grants and funding sources.
Dr. Bell noted that the next meeting, April 4, 2005, would be on disability issues.
Dr. Friedman asked if the committee should consider primary screeners for CFS. Patients are having difficulties in being diagnosed with CFS, especially in rural areas because of the lack of referral physicians.
Dr. Bell responded that rural physicians are less dependent on specialty referrals than urban physicians, and are getting used to the concept of CFS. The emphasis should be on primary care physicians, rather than on secondary specialists.
Dr. Friedman commented that he was referring to non-primary care physicians as screeners, such as dentists, neurologists, and gynecologists. He added that there needs to be more outreach to educate people in rural areas.
Dr. Gantz does not believe dentists should conduct screenings.
Ms. Stevens commented that the dentists have agreed to consider screening and that CFSAC should not hold them back.
Ms Butler added that dentists could just be the first step in the process and not the diagnosticians.
Dr. Friedman noted that dentists are familiar with dealing with pain and should be inquiring about the general health of their patients.
Dr. Komaroff asked what would happen after the dentist concludes that a patients meets the screening criteria.
Dr. Friedman responded that a screener education package should include a mandated procedure that includes a referral to a CFS specialist.
Dr. Gantz commented that the committee’s resources would be better used on other avenues, rather than on dentists as primary screeners.
Dr. Friedman added that dentists would not be the sole focus, which could include nurse practitioners.
Ms. Fitzpatrick asked about having ex officio members from Veterans Affairs and the Department of Education.
Dr. Fields noted that this is being evaluated.
Dr. Robinson commented that increasing the number of screeners would increase the number of referrals. He asked if there were enough resources to handle the increase in demand.
Dr. Reeves noted that the CDC education efforts focus on primary healthcare providers. The focus should not be on the referral process, but on primary care. The focus should also be on those groups that finance primary care, such as HMOs and insurance providers.
Dr. Mohagheghpour asked if CDC is planning to update the physician’s diagnostic manual.
Dr. Reeves replied that the manual would be updated after the articles have been reviewed and published.
Ms. Stevens asked what the committee should do about the pediatric issues.
Dr. Bell commented that the committee could develop recommendations for the next meeting or wait until more topics are discussed.
Dr. Komaroff recommended that the committee spend some time at the next meeting to discuss concrete proposals regarding pediatric CFS.
Ms. Butler asked ex officio members if the recommendations should be submitted right away or at the end of the fiscal year.
Dr. Robinson responded that the recommendations should be sent as soon as possible to take advantage of any initiatives on childhood health at the agencies.
Dr. Hanna agreed with Dr. Robinson.
Dr. Reeves commented that it might be better to send out a collection of recommendations at the end of a specified time period. This would ensure that the recommendations are well thought out and linked together. For example, childhood health is not in a vacuum, and has other related problems, such as disability. If the childhood recommendations are sent out before the discussions on disability, it could be a missed opportunity to develop recommendations that are more comprehensive. He added that the minutes and deliberations of the committee also act as good advocacy tools for the ex officio members.
Dr. Fields noted that the committee could submit recommendations at any time. Submitting recommendations as a collection provides for the opportunity to prioritize and address multidisciplinary issues. However, there may be times when a recommendation will need to be submitted sooner to address time-sensitive matters.
Dr. Bell commented that he agrees that recommendations should be sent as a collection. He asked for an outline on what CDC is doing in CFS and adolescents for the next meeting.
Dr. Fields noted that the recommendations were provided to the Secretary of HHS, as well as policy-making and legislative entities, other departments and agencies, and advocacy groups. As a result, the recommendations have initiated discussions and actions at multiple levels.
Ms. McCleary added that advocacy groups use the recommendations to facilitate discussions with legislators.
Dr. Robinson commented that not everyone reads the minutes and that waiting to submit recommendations on adolescents could result in missed opportunities.
Dr. Fields responded that the work of the subcommittees could alleviate this potential problem by engaging the different agencies between meetings.
Dr. Hanna noted that committee deliberations, rather than recommendations alone, can create discussions and actions.
Dr. Lapp suggested that the committee send topic-specific recommendations as they are approved and an end-of-the-year summary recommendations. He added that this might be a better process for adolescents, which has no subcommittee.
Dr. Reeves commented that there should be a subcommittee on adolescents.
Dr. Fields offered that an alternative is to have each of the existing subcommittees take on this issue, as it pertains to their theme.
Dr. Bell asked if there should be a subcommittee on adolescents.
Ms. Fitzpatrick commented that the Education Subcommittee could take up the issue of adolescents.
Ms. Butler responded that adolescents are a part of every subcommittee.Dr. Bell suggested that the matter be discussed over email. Ms. Fitzpatrick asked for the most current figures on CFS disability from the Social Security Administration for the next meeting, as well as a comparison with gulf war syndrome disability cases. She is also interested in learning if the Veterans Hospital has patients with CFS.
Dr. Bell asked the Disability Committee to communicate this request to Dr. Desi.
VIII. Public Comment
A. Beverly Bugos
Ms. Bugos’ testimony was read by Dr. Fields.
Thank you for letting me submit my testimony here today. For purposes of this testimony, I am using the term ME/CFS, as the vast majority of the patient community and much of the medical and professional community worldwide would prefer to have a name that reflects the serious nature of the disease.
First, I would like to comment on the need for a continuous source of patient representation at these meetings. Jill McLaughlin has been representing patients for a long time and is familiar with all of the issues and their history. I strongly recommend that the committee bring Jill on as a consultant, to provide the kind of long-term background, commitment, and continuity to our issues that we need on this committee. I very strongly feel that we need an individual that really represents the patients and I believe that Jill McLaughlin is the best patient representative to do that.
Then I would like to turn to the issue of the desperate need for a name change. The word fatigue is so very damaging to both the patient and to the researcher trying to get funds to study the debilitating disease. (See recent study by Dr. Leonard Jason, etc.) It is even more critical for children with ME/CFS. These poor, defenseless children have not been able to even experience the normal joys of childhood and they will not be able to enjoy being teenagers either. They are being robbed of their childhood. And, they are literally being punished for being sick. The situation for them will remain bleak until such time as the scientists are given funds to study ME/ CFS in pediatrics.
Research has shown that there is a definite stigma associated with the name Chronic Fatigue Syndrome or Disease. This committee cannot possibly being to understand the negative impact that “CFS” has, or the name would have changed a long time ago. As I have said in the past, this disease is much too serious and debilitating to be named by a single symptom, fatigue, which many other diseases also have. Not only do names matter, in this case, the name has become critical. Patients should not have to wait decades until the cause and illness is conclusively resolved before they can get proper medical care. ME/CFS patients cannot get proper medical care under this current system. In fact, the care that they can get might harm them.
Myalgic Encephalomyelitis (ME) predates CFS by some 50 years. It has been documented in the medical literature since 1934 in both epidemic and sporadic forms and has been formally classified by the World Health Organization (WHO) as a neurological disorder since 1969. I truly cannot understand what brought the United States to change the name to CFS. Many countries are looking at this issue with an open mind and are finding the 2003 Canadian Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Clinical Working Case Definition, Diagnostic, and Treatment Protocols, to be welcomed internationally as superior to other existing definitions. In divisive contrast to the DVS Fukuda criteria, it is compulsory that in order to be diagnosed with ME/CFS, a patient must become symptomatically ill after exertion and must also have neurological, neurocognitive, neuroendocrine, dysautonomic, and immune manifestations. We need to fund studies today that look at this defined group of patients. CBT and GET is definitely not a cure for them and can be damaging. We need to find medical help for these patients and the first step there is to change the name.
The Name Change Working Group (NCW) studied the issue for three years. It was a federally appointed group of professionals and patient advocates. Dr. Lapp, an esteemed member of CFSAC and NCW, and a board member of AACFS, has issued a statement on the need for a name change. He stated that the name CFS should be changed, that ME is the preferred term, and that there could be an over arching term such as Neuroendocrineimmune Dysfunction Syndrome (NDS), which is part of what the NCW recommended. It certainly seems much more accurate than the current CFS terminology. A task force in Australia recently released its comprehensive Clinical Guidelines for ME/CFS 2004 for the diagnosis and management of CFS, based largely on the Canadian case definition.
The United States is being left behind, hanging on to a definition that for some reason seemed useful to some (e.g., psychiatrists) in 1988. We need a more useful name, not this stale damaging term that was thrust upon the patient community. In my email yesterday there was news of a possible genetic basis for this illness. Dr. Jonathan Kerr, Imperial College, London, has identified a genetic abnormality in a group of patients with CFS, and that abnormality is present in no fewer than 15 genes involved in the proper functioning of the nerves and the “batteries” that provide energy for cells. Such studies are encouraging to patients. We just wish we would hear more about ones being done here in the United States. Patients need the medical community to see the damage that is being done to them in the search for the perfect name. We need a name that is not damaging, as CFS has been. We need it now. Please hear us and help us.
B. Jill McLaughlin
I have worked with patient organizations for six years. I am here today on behalf of two of my daughters who have ME/CFS and to ask for help on their behalf. Hearing all of the statements from those who spoke today and from our own personal experience, the stories are all the same. The fact remains that there has been no real progress that has directly benefited patients in terms of diagnosis, treatment, or basic recognition of the illness.
For children, this is a crisis and the committee should act quickly on formulating recommendations in this area. I understand the need to prioritize, but this needs to be a priority, and this committee could be a catalyst for change. What patients, parents, and the patient community can do is very limited and inadequate. These children are truly being left behind.
However, it is entirely possible to make recommendations to rectify the problems and injustices. The most important would be:
Establish a pediatric case definition. Children may present differently and not meet the case definition currently in use. Also, children often have a gradual onset, which is more difficult to recognize.
Include pediatric ME/CFS in any COE or research networks.
Issue an RFA focusing on pediatric ME/CFS to stimulate research.
For physician education:
Establish medical and educational guidelines, with specific training for educators.
Publish a summary or overview of pediatric ME/CFS in a mainstream, peer-reviewed medical journal.
Establish management advice specifically aimed at healthcare professionals working in primary care. There also needs to be advice relating to the difficulties that occur when children fail to recover from a viral illness, remain ill, and a firm diagnosis of ME/CFS cannot be established.
Any medical curriculum needs to include pediatric ME/CFS and must include concrete information and known features of the disease, such as orthostatic intolerance.
For educational issues:
The critical features are those of ME, mainly that activity beyond the level that a child can tolerate will result in a significant worsening of symptoms.
Problems such as cognitive dysfunction, photophobia, visual disturbances, and sleep disorders significantly impact the child’s education and need to be recognized.
Special education currently operates on a model of inclusion. However, for these children, distance learning or home tutoring often achieves the greatest academic success and aids in recovery more effectively.
Establish a collaborative care management model, such as those in the United Kingdom. A multidisciplinary team of professionals may include the child’s GP, pediatrician, physical therapists, teachers, and educational consultants.
Children should not have to act as advocates-they should be protected. Sick children usually elicit the utmost sympathy and concern. Yet, I can think of no other instance where there is such a complete lack of support, compassion, or caring. It is clear that the federal government needs to take an active leadership role and publicly acknowledge this illness. These children deserve appropriate medical care and a suitable education. Pediatric issues warrant serious attention from all those who are in a position to and responsible for providing medical care and education.
Dr. Lapp added that adults do not have to work, but children are required to go to school by law, which puts extra pressure on them.
C. Shanon McQuown
I introduce myself as Anthony’s mom because he is why I am here. I have been a professional for several years in special education, working with children with mild or moderate mental retardation, autism, learning disabilities, and emotional disturbances. I am the core leader of the accessibility ministry at our church for all disabilities. I am trained as a special education coach, which empowers parents to advocate for their own children. I am a member of Partners in Policymaking and I am on the Special Education Advisory Committee for our school system.
I am an expert in “Anthonyology.” As adults, we know how difficult it is when we are not capable of going to work because we are sick. However, our children are expected to do their job despite debilitating and devastating effects of CFS. Children are subjected to judgment, ridicule, and humiliation by uninformed educational staff or those who have just enough information to make an incorrect assumption, such as the child is not showing any effort or they are just depressed. These are the people who are responsible for the evaluations and observations that determine a child’s eligibility to access services from the school system.
Parents must navigate the medical kingdom and must also vigorously battle through the special education maze. No Child Left Behind includes our children with CFS, but they are being left behind. Educators are unsure how to apply special education criteria to a child with CFS. Since CFS covers such a vast spectrum of symptoms, educators become overwhelmed when trying to construct educational plans. They fail to realize that just because something has never been done, it does not mean that it cannot be done. For example, homebound for more than five hours per week is possible and electives on foreign languages can be taught on homebound. School systems expect physicians to make recommendations for the child’s educational plans. However, physicians are not always aware of the most up-to-date strategies or related services, such as occupational therapy, physical therapy, speech language pathology, or visual aids that are available to the school systems.
After working for several years in special education, I was surprised to learn that I would one day have to apply the strategies that I had learned to my own son. I thought that it would go smoothly once my son was diagnosed. However, the process did not go smoothly. I was involved in a two-year battle that included the Virginia Department of Education. I knew what documentation to keep and I knew how to fight the system, because I was trained by that system. What happens to the other children?
I was distressed that there were not a lot of modifications available in relation to pediatric CFS. As a result, I developed an educational plan specific to my son’s need and I was vigilant over exemplimentation. I am happy to report that my son’s lowest cumulative grade as a senior is 3.75. Seeing that success, I developed a workshop for educators to help other children. The last half hour of the workshop is devoted to brainstorming in groups over case studies and presenting recommendations. These recommendations are given to the parents, who in turn can present them to the child committee.
I have seen these children realize educational success. I want the same available to all of our children with CFS. I have driven people crazy at my son’s school and other schools by asking “what if” and “why not.” If the answer was no, I would ask for it in writing. This approach gets results.
Some of my suggestions would be that educational workshops should focus more broadly on the entire school staff (including bus drivers, school psychologists, school nurses, librarians, and special education supervisors), with hands-on application of learned materials. The second recommendation is to inform parents and the Department of Education about CFS in children, their educational needs, how to level the academic playing field. The third recommendation is to develop an outline for parents on how the IDIEA applies to children with CFS.
D. Marly McKibben, P.A.N.D.O.R.A.
I am here once again representing P.A.N.D.O.R.A., Inc (Patient Alliance for Neuroendocrineimmune Disorders Organization for Research and Advocacy). I am the founder of P.A.N.D.O.R.A. We are a 501c3 charitable organization whose mission is to raise awareness to the many issues affecting folks who have CFS, FMS, GWS, and Multiple Chemical Sensitivities. We aim to find a cure for these conditions. Since hurdles are at times enormous, we have made part of our mission to address issues of quality of life, such as short and long term disability, access to qualified medical care, and access to medical insurance. We have also placed a high level of priority and importance in educating the community in South Florida about the myths and misconceptions, and present an accurate picture of what a person suffering from any of these debilitating chronic illnesses has to endure.
I am also representing the following empowerment/support groups from our area:
The CFS/FMS Empowerment Group at Temple Sholom, Pompano Beach, Florida;
The CFS/FMS Empowerment Group at Memorial Hospital West, Pembroke Pines, Florida;
The Miami CFIDS Support Group at the University of Miami-VA Hospital, Miami, Florida;
The Non-Group from the Plantation/Weston, Florida.
I am very pleased to be here today. It gives me a chance to thank you personally for your hard work and dedication to the issues affecting CFS patients and their families. It also means I am not homebound, nor bed bound. I suppose I could say it is a personal accomplishment on my part. As we all know, CFS is an unpredictable illness. It takes a certain amount of courage to travel to Washington, D.C. in the winter season. However, being here is such a meaningful opportunity to speak on the issues, which are dear to P.A.N.D.O.R.A. and the neuroendocrineimmune community in Florida.
However, the reality is that this personal accomplishment will have been in vain if the CFSAC recommendations given to Dr. Christina Beato in a letter dated August 23, 2004, containing a set of 11 important recommendations is not implemented soon.
I am here to:
To let you know I will do everything possible as a citizen and as a person with CFS representing P.A.N.D.O.R.A. to work with you and to work with our government to ensure all of your recommendations are put in place.
I will ask you today to follow up with a letter to HHS asking them to immediately begin working on the following issues:
The implementation of the recommended five Centers of Excellence, “with funding in the range of 1.5 million per center per year for five years.”
The development of an international Network of Collaborators.
The CDC and NIH, as you recommended, “accelerate focused workshops in specific areas of CFS and to invite investigators not currently working on CFS.” CFS research needs to be, for lack of better word, advertised as being rewarded and exciting.
Regional, national, and international CFS education for healthcare providers should be a top priority through conferences sponsored by CDC and NIH.
The classification of CFS as a nervous system disease as specified in the ICD-10 G93.3.
The CFSAC recommendations above, if quickly put in place, will also provide us with enough scientific material, research, and interest to fully address the issue of the name change as well.
In order to provide you with the right support so that these recommendations are implemented as soon as possible, I would kindly ask you to share with us who are here today how we can help as a citizen. We want to make sure it will happen. We need to ensure unity in action. We need to collaborate more.
Tomorrow, I am meeting with South Florida congressmen to address these issues in great detail. However, my personal experience has been that this is not enough. Perhaps a liaison person within the committee could be assigned to specifically address the task of collaboration. More needs to be done. CFSAC is composed of great experts in the areas needed to ensure a national policy for CFS and neuroendocrineimmune disorders is implemented. I welcome a closer dialogue with the members of your committee and I put myself at your service as well.
Finally, P.A.N.D.O.R.A. will be working very hard to establish a Center of Excellence at the University of Miami/VA Hospital in Miami, Florida. Fund raising activities have started, as the our main goal in 2005 is to upgrade the current CFS Center in Miami and to place it in a highly competitive level to guarantee its establishment as one of the five recommended Centers of Excellence. This issue will be discussed in detail when I visit Capitol Hill tomorrow.
I would like to add one more recommendation. I heard you all discussing about physician education. There are several clinical centers being established in this country, such as Dallas, Houston, Atlantic, and Austin, where they are calling themselves fatigue and FM clinics. They are taking care of many people. Some of these facilities do not accept insurance. Maybe you should invite some of these folks to make a presentation on how they are treating their patients, because they are the foot soldiers in the trenches taking care of CFS patients. It is very difficult to find a referral to a doctor, even in South Florida. This may also provide insights as to how to expand the education program.
E. Elsie Owings
Dr. Fields read Ms. Owings’ testimony.
I had the privilege of attending the September 27 meeting, at which the committee presented its 11-point plan to the Secretary of HHS. Maria has distributed to you a letter I wrote, which was signed by several other patient advocates, in support of your plan and your right to implement that plan.
Today’s topic is pediatric CFS, a field in which there is an enormous need for informed doctors to actively dispel false medical assumptions. Currently, Medscape CME courses are teaching that children with CFS perpetuate their own illness through abnormal illness beliefs and deconditioning. Patient advocates are portrayed as having the same abnormal beliefs, so we cannot fight these practices alone. The promoters of these psychosocial models have financial motives and will not give up easily.
We need your help, not only to provide the medical profession with accurate information, but also to oppose the falsehoods and to exert pressure on the medical journals to publish the truth.
F. Additional Public Comments
Dr. Shafer discussed two patients that have testified before CFSAC. One of the patients had become too ill to go to school. Her friends took her to a school fair. The next day, the friends were told by the school department that they were truant. This involved lawyers and Munchausen’s Syndrome by Proxy was raised. The other patient went back to school with the doctor’s proviso that she must not be in physical education. However, the new physical education teacher made her participate. As a result, she ended up in a wheelchair and was sick for a long time. The urgency for adolescents is worse than for adults, because the abuse that they are receiving at the hands of people who do not know what they are doing is frightening. This is happening at the individual level. To involve the Department of Education, these issues have to be considered urgent. She suggested that the learning disability community could help.
Dr. Bateman provided additional comments on behalf of the Floyd family. She asked the committee to read the last page of Erin’s testimony, which describes the more positive aspects of her experiences. Once she received supportive medical care, she was able to start functioning better, got a motorized wheelchair, and is now attending college and getting very good grades.
Dr. Bell noted that he has seen a number of adolescents who have become extraordinary, whether they have recovered from their illness or not. This is a tribute to the human spirit.
There was a motion and a second to adjourn. All voted in favor and Dr. Bell adjourned the meeting.