The American Fibromyalgia Syndrome Association
FIVE YEARS AT A GLANCE
Why was The American Fibromyalgia Syndrome Association, Inc. (AFSA) founded? Certainly, if it hadn’t been for the generosity of thousands of people with fibromyalgia syndrome (FMS) and chronic fatigue syndrome (CFS), AFSA wouldn’t be around today. But there is valid justification for AFSA’s existence. Patients have suffered too long without the benefits of objective disease markers and effective therapies.
When AFSA was founded in 1993, there were no other charitable organizations or government agencies expressing concern about the paucity of research being conducted on FMS. Five million Americans were grappling with FMS and the prevailing attitude among people not affected by this condition was: “Oh well.” This apathetic environment was the very reason that AFSA was founded. No patient group, regardless of their diagnosis or the controversies that surround their illness, should have been so blatantly shunned in the research arena.
In January of 1994, both the State of California and the IRS granted AFSA its tax-exempt, 501(c)3 status as a publicly supported charity. At last, an organization was founded whose primary mission was to fund research directed at the needs of people with FMS, as well as the overlapping condition of CFS.
AFSA’s board of directors and research advisors all serve as volunteers. There are no paid staff members, no salaries or consulting fees. Some might argue for the benefits of having paid staff—that healthy, full-time employees might get more work done. Yet, the goal of AFSA is to function as the conduit that delivers donations from the public (mostly patients at this point in time) into the hands of investigators who propose to perform the most promising research projects with these contributions. Considerable effort goes into this task, no doubt about it. Just remember, though, that when people volunteer for a cause, they have no financial stake in prolonging the suffering of those being served. If it were solely up to AFSA’s volunteers, there would already be a cure for FMS and CFS, and they would be at home enjoying other activities.
AFSA has awarded 15 research projects so far, but it has enough money left in the bank from last year to fund an additional three or four studies. Ideally, this money would have already been spent, but as you will read in the article on page 8, finding physicians who are interested in conducting clinical trials is not a simple matter. We have solicited several people with experience in directing clinical trials in hopes that we can stimulate the testing of more pharmacological interventions in FMS and CFS. We have even sent AFSA’s grant applications to well-known, bilingual scientists in Europe.
Three out of the fifteen projects funded by AFSA are drug trials. A fourth study lays the groundwork for cloning the structure of a naturally produced chemical in the body that is known to produce analgesia and has great potential for minimizing the painful symptoms of FMS and CFS. The remaining eleven projects funded by AFSA deal primarily with uncovering physiological abnormalities in FMS and CFS patients, which should help form a basis for identifying disease markers and better therapies.
A summary of the projects funded by AFSA can be viewed by clicking here. Although the majority of studies funded by AFSA don’t relate to treatments, efforts are being made to stimulate more grant applicants to submit proposals in the area of testing existing pharmacological interventions and jump-starting new drug development. The shift in emphasis from looking at physiological abnormalities to focusing on treatment is intended to help patients now, so that they can more easily ride out the time needed to solve the many mysteries behind FMS and CFS.
In November of 1998, AFSA received a ruling from the IRS stating that it had passed the five-year test confirming AFSA as a public benefit charity as opposed to a private foundation. Further explanation of this ruling is provided below, but it basically means that AFSA has been operating in a manner similar to the estimated projections provided to the IRS in the initial 1993 application. From a tax perspective, the ruling means that all contributions given to AFSA will remain tax-deductible to the fullest extent allowed by law (this is not the case for private foundations).
AFSA’s revenues (from contributions and sales) have grown from roughly $18,000 in its first year of operation which ended in June of 1994, to about $250,000 in the fifth year which ended in June of 1998. Nearly 10,000 caring people have made donations to AFSA during the past five years and we are continuing to grow at a healthy pace. A detailed accounting of AFSA’s fiscal year as well as comparisons to previous years, can be seen by clicking here. The steady growth of AFSA during its first five years is not only gratifying, but it also sends a signal that thousands of people would like to see AFSA fulfill its mission—to fund research on FMS and CFS that will lead to effective treatments now and a cure in the not-so-distant future.
As you read through this five-year report, I hope it will become clear to you that AFSA is working on your behalf and that your contributions are crucial for AFSA to do its job.
Best wishes to all.
Founder and President
IRS APPROVES AFSA FOR THE LONG HAUL
Every charitable organization in the United States lives under the scrutiny of the Internal Revenue Service (IRS) ... as does every citizen! When AFSA applied for tax-exempt, 501(c)3 charitable status in 1993, it submitted an application to the IRS detailing all the activities it might engage in, as well as a 5-year projected financial report. The application to the IRS was nearly an inch thick!
Based on the information AFSA provided the IRS and the Secretary of the State of California (the state in which AFSA is incorporated), AFSA was granted an advanced ruling or determination by the IRS stating that it met all the requirements of a 501(c)3 public benefit charity.
The next step for AFSA was to operate during this advanced ruling period (close to five years) in a manner similar to that initially proposed in its application to the IRS. Then during the fall of 1998, AFSA was required to submit operational data and financial reports to the IRS for the duration of its existence. The purpose of all this government paperwork was to prove to the IRS that AFSA had been operating in a fashion similar to its initial proposal to the government and to request that the IRS make a final determination on AFSA’s charitable 501(c)3 status as a public benefit organization. In other words, to confirm that AFSA’s contributions come from the public rather than a handful of individuals or government agencies. If the latter had been found to be the case, AFSA would have been declared a charitable “private foundation,” rather than a public benefit organization.
So what does all this government red tape mean to you, an AFSA contributor? It means that contributions made to AFSA are deemed tax-deductible to the greatest extent allowed by law. Private foundations have additional constraints imposed on them and their contributors.
Contributing $25 or $50 to AFSA may not have any noticeable impact on your tax returns to the IRS. However, we wanted all potential donors to AFSA to know that our organization has undergone the scrutiny of the IRS for a second time and passed with flying colors!
IT'S UP TO YOU!
A popular style in tending to FMS and CFS is to get the patient more involved in the treatment process. First, the physician prescribes a medication that “might” aid in sleep and “hopefully” reduce symptoms. Then it is the patient’s turn to minimize stress (practice relaxation techniques throughout the day), increase exercise to one hour per day (strengthening, stretching and aerobic fitness), modify lifestyle activities that tend to aggravate symptoms, eat nutritionally (perhaps with the help of supplements and additional time spent preparing special meals), stay mentally happy, and don’t worry about the pain or other symptoms that might be seriously impacting your functionality. Oh, and above all else, hang onto your job, your marriage and be a good parent!
If the physician’s prescribed medications don’t adequately restore a patient’s sleep cycle, then the patient should be prepared to spend one hour before bedtime to practice good sleep hygiene. This includes not drinking any caffeine-containing beverages after dinner, not eating chocolate or other delicious-tasting deserts, sitting in a hot tub thinking relaxing thoughts for 20-30 minutes, and then spending 30 minutes reading something boring but not work-related (doing useful work before bedtime is thought to be detrimental to sleep). Good sleep hygiene includes a morning routine as well, such as taking the time to gently stretch out the sore muscles, preparing and eating a healthy, protein-rich breakfast (no coffee and donuts), doing at least a half hour of exercises (it’s best not to do them in the evening), and then taking a shower to further reduce muscle pain.
Wait a minute! You still have to fix your hair, put on your makeup (or shave your face), clean up the kitchen mess, get your kids ready for school, say hello to your spouse, get dressed for work (assuming that you had time to do the laundry last night), prepare a healthy lunch, take your vitamins and other doctor-prescribed medications, stop off at the gas station to tank up your car—all before you arrive at work at 8 a.m. in the morning.
After eight hours of work (taking stress breaks when the boss isn’t looking, of course), you still have to stop off at the physical therapist or massage therapist to ease the muscle pain because the medication the physician prescribed isn’t doing a sufficient job. The therapy is expensive (your doctor is reluctant to write a prescription for it, so insurance won’t cover it), but it seems to be one of the few things you can do that really works. Then you have to “hot-tail” it over to pick up your youngest child from daycare before they close at 6:30 p.m., and then you are homeward bound (assuming that your spouse has stopped off at the grocery store to pick up food for dinner).
Your doctor has advised you to pace yourself, to avoid overdoing it. You understand what the doctor is saying because you have first-hand experience in knowing what it is like when you over-exert yourself—which turns out to be just about every day of the week. Your pain shoots up to intolerable limits, the fatigue becomes unmanageable, your head is throbbing by dinner time and your brain seems scrambled with disconnected thoughts. Of course, you are supposed to make lifestyle adjustments to accommodate your FMS/CFS, but when and how?
The instant you get home with your seven-year old daughter, there is lots of work to be done. Your older child will need help with her algebra homework and the youngest child will need to read out loud to someone for 30-40 minutes. You and your spouse flip a coin to see who helps with which child. Then it’s time to get dinner going—hopefully something easy because it is almost 8 o’clock. You and your spouse work feverishly as a team to get the children fed, bathed and in bed by 9 o’clock.
I don’t know about you, but by the evening time I feeling like I’m living in a body that is 200 years old. Sure do wish the medications that my doctor prescribes for me could at least make me feel my age, which is 43. I know my doctor keeps reminding me that the successfulness of his treatment plan rests strongly on my shoulders ... yeah, yeah. Right now though, I can’t take on any more burdens. My house is a mess and the laundry is piling up. Everywhere I look, there is work to be done ... I guess that is what weekends are for. Why did I have to develop a help-yourself illness? Why couldn’t I have developed one of those well-established diseases in which doctors just write you a prescription and you are on the mend? This “do-it-yourself” approach doesn’t seem to be of much help for me.
It’s like taking your car to a mechanic for a long overdue engine overhaul. The mechanic intently listens to you explain the operating problems you are experiencing with your car, and then when you stop talking, he hands you a toolbox and says: “Here, why don’t you fix it yourself?” What! If you knew how to fix your car, you certainly would not be visiting a mechanic, would you? Of course not. So why is it that when you visit your doctor about your FMS/CFS symptoms, he or she has a tendency to hone in on what you can do to help yourself?
The answer probably has to do with the limited number of tools or treatments that your physician has in his or her FMS/CFS medical bag. Chances are that your doctor does have a few tricks up his sleeve that he doesn’t think will help you, but that is because there have been no published studies in FMS/CFS to show that the certain medications in question might actually work. To put it another way, there aren’t many tools in the toolbox for fixing bodies that have FMS/CFS.
AFSA hopes that by placing its research focus on funding treatment trials, this situation of a sparsely filled toolbox will soon change. It won’t happen overnight and it rests strongly on the handywork of your donations. Remember, nearly 90% of all contributions sent to AFSA is placed directly into the hands of the researchers commissioned to do the work.
AFSA-FUNDED RESEARCHERS IN THE NEWS!
Two investigators funded by AFSA were asked to provide podium presentations at last November’s American College of Rheumatology meeting in San Diego. This honor is only bestowed on five of the ACR members who submitted a scientific study abstract on FMS (roughly 70 rheumatology researchers).
Laurence Bradley, Ph.D., of the University of Alabama at Birmingham, spoke on: “Acute Pain Produces Abnormal Regional Cerebral Blood Flow (rCBF) in the Anterior Cingulate Cortex (ACC) in Patients with FMS.” A small group of patients and controls were assessed by SPECT (a measure of cerebral blood flow) both before and after an acute pain stimulus was applied. The intent was to show that the brain of FMS patients would respond differently to a painful stimulus than that of healthy controls.
“Our preliminary findings suggest that FMS patients have abnormal rCBF responses to acute pain in the thalamus and the ACC,” says Bradley. These are two important pain processing areas in the brain. Bradley has been funded by AFSA to explore whether this abnormal response phenomenon also holds up when patients and healthy controls are subjected to a sub-acute pain stimulus. He is also going to be comparing his acute pain stimulus findings in FMS and CFS patients, to the data he uncovers in people with major depression. The point is to show that depression is not the same as FMS or CFS.
Roland Staud, M.D., of the University of Florida, spoke on: “Abnormal Temporal Summation of Second Pain (Windup) in Patients with FMS.” The subject of windup is complicated and its a popular topic in the pain literature. Basically, Staud is using a non-invasive apparatus on patients to repeatedly tap the skin in their hands with a small device (thermode) which is at 52°C (about 125°F). Depending upon the patient’s verbal pain ratings of the experience, Dr. Staud believes that he will be able to determine the extent to which the person’s FMS pain is caused by the NMDA receptors in the central nervous system. You can’t get this information from a blood test.
“Our main reason for looking at this effect of windup is that there is a strong relationship with the NMDA receptor,” says Staud. “This gives us an opportunity to study the effect of NMDA receptor stimulators and antagonists, and to determine at what point this pain processing mechanism can be interfered with therapeutically.” Dr. Staud has been funded by AFSA to look at the effects of exercise on windup in patients versus healthy controls. He suspects that exercise may further activate the NMDA receptors, leading to higher levels of pain in patients.
Neuroscientist Alice Larson, Ph.D., of the University of Minnesota, published an excellent article about how the phenomenon of windup can lead to a spreading of pain throughout the central nervous system, causing a state of central sensitization. The title of the study, “Windup leads to characteristics of central sensitization,” appeared in the journal PAIN 79:75-82, 1999. Dr. Larson was funded last year by AFSA to temporarily “mimic” in rats the abnormally elevated spinal fluid levels of substance P and nerve growth factor that have been found in FMS patients. She will attempt to determine how this alteration in neurotransmitters might be linked to the development of FMS-like symptoms.
With so little money available for doing studies on FMS and related chronic pain syndromes, one would think that AFSA shouldn’t have any difficulties finding researchers to test pharmacological therapies. AFSA received thirty grant applications last March, but only one of them addressed AFSA’s primary research objective of looking at pharmacological interventions. John Stewart, Ph.D., of The University of Colorado in Boulder, provided AFSA with a grant proposal to clone a small, naturally produced peptide in the body that is known to have a pain-fighting role. In fact, if this substance can be manufactured into an FDA-approved drug, then it may actually work to counteract the problems of high levels of substance P in the spinal fluid of people with FMS.
Dr. Stewart’s project has therapeutic potential, but the development stage will take several years. Still, it’s an exciting study because the end result will hopefully produce a safe, analgesic medication that is neither an opioid or a nonsteroidal anti-inflammatory drug. Time will tell if this new class of potentially potent pain-fighters will provide effective pain relief for people with FMS and CFS.
What about the meantime? Shouldn’t drugs that are already developed and FDA-approved be put to the fibromyalgia pain test? For example, opioids have been available for decades. Their high degree of safety (e.g., no organ destruction) and side effects (e.g., primarily constipation), have been well documented. Even the weakest of opioids, Ultram, has been tested in FMS patients and found to be effective in reducing the painful symptoms by about 50% in a subgroup of patients. But what if you are not one of the lucky patients in which Ultram does a sufficient job? Shouldn’t more potent opioids be tried? This actually was the recommendation of Robert M. Bennett, M.D., when he spoke last November at the rheumatology conference. Unfortunately for patients, the majority of the audience of physicians did not share Dr. Bennett’s opinion.
If Ultram does not adequately control a person’s pain, what next? Does the treating physician simply write a prescription for a more potent pain reliever, such as an opioid (e.g., oxycodone, hydrocodone or morphine-based medications)? Chances are, this won’t be the case for an FMS or CFS patient who battles persistently severe pain. Based on theory alone, opioids should be beneficial to a subgroup of FMS/CFS patients but there are no drug trials to prove this notion.
Currently available opioids aren’t the only medications that deserve to be tested in FMS/CFS. Sleep medications, novel pain relievers that will soon hit the market and other drugs that may lesson the symptoms of FMS/CFS ought to be considered as well. Despite the abundance of medications that could be tested for people with FMS/CFS, there appears to be a lack of interest from the research community to do so—or at least to conduct preliminary studies.
Dr. Bennett is in the midst of testing the effectiveness of adding dextromethorphan to Ultram to determine if the combination will provide more symptom relief for FMS/CFS patients. Robert McMurray, M.D., of Jackson, MS, is in the process of analyzing his data from a dual study of melatonin and bromocriptine (a drug that acts like dopamine in the body). In January of this year, Don L. Goldenberg, M.D., was awarded a grant by AFSA to look into the beneficial effects of using low nighttime doses of clonazepam (perhaps better known by its brand name of Klonopin). Clonazepam is a benzodiazepine that has anti-seizure type properties. It’s known for its effectiveness in treating two common sleep disorders in FMS: restless leg syndrome (RLS) and periodic limb movements during sleep (PLMS). Yet, a large percentage of physicians will not prescribe clonazepam because they view all drugs in the benzodiazepine class as bad, habituating medications.
Drs. Stewart, Bennett, McMurray and Goldenberg are all to be commended for their desire to improve the well-being of FMS/CFS patients as soon as possible. While the physiological-type studies awarded by AFSA are extremely crucial for advancing our understanding of FMS/CFS so that therapies directly targeting FMS/CFS can be developed and a cure eventually found, the need today for tested therapies is substantial. How else can patients be expected to maintain function if their physicians don’t have available to them a variety of proven-effective treatment options?
While patients wait for the convenience of this slowly evolving field of science to develop a cure, AFSA’s commitment is to fund promising drug trials today. We have opened our grant award opportunities to every investigator who is fluent in English. All it will take to accomplish our goal to fund drug trials is just a few dedicated researchers!
AFSA, Inc., 6380 E. Tanque Verde, Suite D, Tucson, AZ 85715
Copyright © 1998 - American Fibromyalgia Syndrome Association, Inc.