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Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
There is a core group of university-based Lyme disease researchers and physicians whose opinions carry a great deal of weight. Unfortunately many of them act unscientifically and unethically. They adhere to outdated, self-serving views and attempt to personally discredit those whose opinions differ from their own. They exert strong ethically questionable influence on medical journals, which enables them to publish and promote articles that are badly flawed. They work with government agencies to bias the agenda of consensus meetings, and have worked to exclude from these meetings and scientific seminars those with alternate opinions. They behave this way for reasons of personal or professional gain, and are involved in obvious conflicts of interest.
This group promotes the idea that Lyme is a simple, rare illness that is easy to avoid, difficult to acquire, simple to diagnose, and easily treated and cured with 30 days or less of antibiotics.
The truth is that Lyme is the fastest growing infectious illness in this country after AIDS, with a cost to society measured in the billions of dollars. It can be acquired by anyone who goes outdoors, very often goes undiagnosed for months, years, or forever in some patients, and can render a patient chronically ill and even totally disabled despite what this core group refers to as "adequate" therapy. There have been deaths from Lyme disease.
They feel that when the patient fails to respond to their treatment regimens it is because the patient developed what they named "the post Lyme syndrome". They claim that this is not an infectious problem, but a rheumatologic or arthritic malady due to activation of the immune system.
The fact is, this cannot be related to any consistent abnormality other than persistent infection. As further proof, vaccinated animals whose immune system has been activated by Lyme have never developed this syndrome. On the other hand, there is proof that persistent infection can exist in these patients because the one month treatment did not eradicate the infection.
Indeed, many chronically ill patients, whom these physicians dismissed, have gone on to respond positively and even recover, when additional antibiotics are given.
It is interesting that these individuals who promote this so called "post-Lyme syndrome" as a form of arthritis, depend on funding from arthritis groups and agencies to earn their livelihood. Some of them are known to have received large consulting fees from insurance companies to advise them to curtail coverage for any antibiotic therapy beyond this arbitrary 30 day cutoff, even if the patient will suffer. This is despite the fact that additional therapy may be beneficial, and despite the fact that such practices never occur in treating other diseases.
Following the lead of this group of physicians, a few state health departments have even begun to investigate, in a very threatening way, physicians who have more liberal views on Lyme disease diagnosis and treatment than they do. Indeed, I must confess that I feel that I am taking a large personal risk here today by publicly stating these views, for fear that I may suffer some negative repercussions, despite the fact that many hundreds of physicians and many thousands of patients all over the world agree with what I am saying here. Because of this bias by this inner circle, Lyme disease is both underdiagnosed and undertreated, to the great detriment to many of our citizens. Let me address these points in more detail.
1. Under reporting: The current reporting criteria for Lyme are inadequate and miss an estimated 30 to 50% of patients. Some states curtailed their active surveillance programs and saw an artificial drop in reported cases of nearly 40%, leading the uninformed to believe incorrectly that the number of new cases of Lyme is on the decline. The reporting procedure is often so cumbersome, many physicians never bother to report cases. Some physicians have found themselves the target of state health department investigators. Finally, to many physicians and government agents rely on the notoriously unreliable serologic blood test to confirm the diagnosis.
2. Poor Lyme disease diagnostic testing: It is very well-known that the serologic blood test for Lyme is insensitive, inaccurate, not standardized, and misses up to 40 percent of cases, yet many physicians, including many of those referred to above, and the senior staff at CDC and NIH, insist that if the blood test is negative, then the patient could not possibly have Lyme. This view is not supported by the facts. Lyme is diagnosed clinically, and can exist even when the blood test is negative.
The Rocky Mountain Lab of the NIH, which is the country's best government laboratory for Lyme research had developed an excellent diagnostic test for this illness nearly 4 years ago, yet further work on it has been stalled due to lack of funding. Incredibly, if not for private donations of just $5,000 from the non-profit National Lyme Disease Foundation headquartered in Connecticut, then this reaseach would have had to be abandoned. An additional $30,000 was donated by this organization to allow them to continue other valuable projects relating to vaccine development and disease pathogenesis. Yet, many physicians believe that thousands of dollars of grant moneys awarded by the government to other, outside researchers is poorly directed, supporting work of low relevance and low priority to those sick with Lyme. In spite of this, their funding continues, and the Rocky Mountain Lab is still underfunded.
3. The university and Government based Lyme establishment deny the existence of atypical presentations of Lyme and patients in this category are not being diagnosed or treated, and have no place to go for proper care.
RESULTS: Some Lyme patients have had to see, as many as 42 different physicians often over several years, and at tremendous cost, before being properly diagnosed. Unfortunately, the disease was left to progress during that time, and patients were left forever ill, for by that time, their illness was not able to be cured. Even more disturbing, these hard line physicians have tried to dismiss these patients as having "Lyme Hysteria" and tried to claim they all were suffering from psychiatric problems!
1. Because the diagnosis is not being made, for reasons partly outlined above.
2. University based and government endorsed treatment protocols are empiric, insufficient, refer to studies involving inadequate animal models, and are ignorant of basic pharmacology. They are not based on honest systematic studies or on the results of newer information.
3. After short courses of treatment, patients with advanced disease rarely return to normal, yet many can be proven to still be infected and can often respond to further antibiotic therapy. Unfortunately, Lyme patients are being denied such therapy for political reasons and/or because insurance companies refuse to pay for longer treatment, upon the arbitrary and uninformed advice of these physicians, who are on the insurance company's payroll.
4. Long term studies on patients who were untreated or undertreated demonstrated the occurrence of severe illness more than a decade later, reminiscent of the findings of the notorious Tuskeege Study, in which intentionally untreated syphilis patients were allowed to suffer permanent and in some cases fatal sequelae.
5. The Lyme bacterium spreads to areas of the body that render this organism resistant to being killed by the immune system and by antibiotics, such as in the eye, deep within tendons, and within cells. The Lyme bacterium also has a very complex life cycle that renders it resistant to simple treatment strategies. Therefore, to be effective, antibiotics must be given in generous doses over several months, until signs of active infection have cleared. Because relapses have appeared long after seemingly adequate therapy, long term followup, measured in years or decades, is required before any treatment regimen is deemed adequate or curative.
6. When administered by skilled clinicians, the safety of long term antibiotic therapy has been firmly established.
The very existence of hundreds of Lyme support groups in this country, and the tens of thousands of dissatisfied, mistreated and ill patients whom these groups represent, underscores the many problems that exist out in the real world of Lyme disease. I ask and plead with you to hear their voices, listen to their stories, and work in an honest and unbiased way to help and protect the many Americans whose health is at risk from what now has become a political disease.
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
In the summer of 1989 I contracted Lyme disease. I did not realize it at the time, but this disease has had an unusual and profound impact on my life. After enduring a summer's worth of discomfort at the mercy of a bacterium I became interested in microbiology and immunology. This initial interest has culminated in my working on the immune response to Lyme disease for my doctoral thesis in the department of Immunology and Infectious Diseases at the Johns Hopkins School of Hygiene and Public Health.
During that summer, I was residing in Salisbury on the Eastern Shore of Maryland. I was on summer break from the University of Richmond and was living at home with my parents. To earn money for college, I was working two jobs; one as a waitress in a local crab restaurant and the other as a secretary in a doctor's office.
By the beginning of July I had begun to feel fatigued and suffered from recurrent bouts of malaise and headaches. I ascribed these ailments to a combination of allergies and to "burning the candle at both ends" with my jobs and busy summer social life. I also noticed around this time a large rash on the back of my right knee with a red center and a lighter ring on the outside. It wasn't until much later that I associated the flu-like illness and the tell-tale stigmata of Lyme disease, or erythema migrans, and assumed that the rash was most likely caused by a spider bite. I left work one evening in the end of July because of feeling chilled and because my joints were so painful it was becoming difficult to pick up a pitcher of beer much left serve a whole table. I took some aspirin and went to bed and remained there for a few days too fatigued and sore to even think about moving around. The best description I can think of for the misery of acute Lyme disease is a combination of debilitating mononucleosis and severe arthritis in the knees and elbows. At this time, I noticed more of the strange ring-like rash had appeared on my trunk and lower extremities and decided it was past time to visit the family physician.
Dr. Mary Fleury is our family physician and is an internist practicing; in Salisbury. My symptoms suggested an almost textbook case of Lyme disease although Dr. Fleury was aware of only one other case in the Eastern Shore at that time. I did not remember a tick bite preceding the initial rash but had spent some time earlier that summer on Assateague Island. (A recent study done on Assateague had suggested that the majority of large mammals and Ixodes ticks had contracted the bacteria that causes Lyme disease, Borrelia burgdorferi). During the initial visit, Dr. Fleury suggested that I get tested for Lyme disease and prescribed ten clays of tetracycline. I was tested a week after I had begun antibiotic treatment. Not surprisingly the blood test came back negative, testing procedures tended to be poorly standardized at the time and often gave false negative results especially if done after antibiotic treatment had begun. The diagnosis was then and is now primarily based upon clinical findings.
My condition began to improve with antibiotic treatment and I finished the initial course of antibiotics. However within a few weeks I began to experience malaise, fever, and migratory arthritis again and returned to the doctor s office. She determined that the initial treatment was of insufficient duration and prescribed high levels of tetracycline (one gram per day) for a month. Once again my symptoms began to recede within a few days of treatment and I finished the course with no further relapses.
Thankfully I have not had any further symptoms since the second treatment. However, antibiotic treatment does not always prevent further complications and so I may still be at risk. I am not pleased with the prospect of having to live with chronic Lyme disease and sincerely hope better preventive and curative measures are developed in the near future. As a result of this experience, I have chosen a career in medical science and am currently working on my doctoral thesis at Johns Hopkins studying the immune response to the Lyme disease agent. Such information is essential to the formulation of a vaccine. With continued funding, I hope that this work will move forward and that we will soon have a cure for this perplexing and debilitating disease.
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
In 1985 our only child was born. Unfortunately I had a bug bite and the full range of Lyme disease symptoms while I was pregnant, and soon after Jamie's birth his symptoms started.
During the pregnancy and after the birth I was seriously ill with multiple problems including joint swelling and pain. Shortly after giving birth a doctor told me that my crippling pain was arthritis and a permanent condition, but he expected me to remain on crutches until I required a wheelchair. However, there was this mystery illness called Lyme disease, and the doctors offered me two weeks of antibiotics just in case. If my symptoms went away, then I was cured and I had Lyme disease, if my symptoms remained, I didn't, and I would be wheelchair-bound for the rest of my life. At the same time all five of our beloved pets, three cats and two dogs, became seriously ill and required repeated hospitalizations. As fate would have it, all of us had contracted Lyme disease at the same location and time. Eventually all of our pets were lost due to their Lyme disease.
Jamie was the light of our life, he had blond hair, blue eyes, was always smiling. By the time he was six weeks old, his health was in question. He had repeated vomiting and eye tremors. By six months old, he was showing signs of brain damage, eye problems, possible deafness, and had ceased to grow properly due to malnutrition. I questioned the doctors about whether my son could get Lyme from me during pregnancy, and they guaranteed me, absolutely, no.
To understand this disease and what it did to our family I would like to tell you what it did to our son's brain. The bacteria attacked the part of his brain that controlled his eye movements, causing his eyes to swing rapidly back and forth, to turn inward at times and outward at other times; and he became light sensitive. This caused double vision, motion sickness, inability to open his eyes outside, and blindness. Jamie's facial and tongue muscles were also involved, causing his face to be partially paralyzed and droop, which is like a Bell's Palsy, resulting in excessive drooling, loss of speech, loss of the ability to eat or swallow, and allowed food or saliva to go directly into his lungs instead of into his stomach.
Children and adults started staring at him. The loss of speech frightened him. Feeding him by mouth became life-threatening, as repeated lung infections set in, and eventually a partially collapsed lung resulted in multiple hospital stays. Jamie could not tell us that he was scared, that he had a headache, that he was hungry, or that he needed to go to the bathroom. Jamie became mute, malnourished, and frustrated. His hearing was affected causing the hearing test to show - another blow to us - that he was profoundly deaf. It was only then when his speech started that we realized that the test was wrong and had been influenced by the damage done by the Lyme disease bacteria. He indeed wasn't deaf.
Jamie's stomach was involved, causing repeated vomiting, and since he was too weak to lift his head, we had to worry that he was going to drown. Jamie's nerve conduction was affected, which delayed the innervation to the muscles. This caused him to lose muscle tone and he became floppy. This meant that he couldn't sit, crawl, or hold his head up, and he certainly couldn't feed himself. The devastating state of involvements that are known to be Lyme disease involvements made Jamie 100% dependent for life. Tests, probes, biopsies, all could not pinpoint the problem. When Jamie was one and one half, he had surgery to realign his stomach in an attempt to stop the life-threatening vomiting. The surgery didn't work, and our son had a permanent hole cut in his stomach so that he could feed through a feed tube. Indeed, we only really needed antibiotics.
Tom's company, a CPA firm, declared that Tom no longer had that little zip that they expected for partners-to-be, and let him go. Today the family leave bill would have protected him and given him time to set his home life more in place.
As Jamie approached his second birthday, we found ourselves unable to provide the medical care needed, and were told to institutionalize him, or put him up for adoption, as there are families who are set up to handle multiple handicapped children. I turned into our son's advocate, no longer listened to what the doc said, and started searching the medical literature, and I realized Jamie had Lyme disease, I had Lyme disease, our pets had Lyme diqease, and trans-placental transmission had already been published. We fell through somebody's crack.
Then a doctor saw permanent damage in our son's eyes, damage caused by a congenital infection, one just like Lyme disease. We tested positive, we were told we would be cured, we got some treatment, and my life was good.
Unfortunately it wasn't quite true, and our son relapsed. The meningitis in his brain had caused his head to enlarge to the size of a fourteen-year-old, his clothes no longer fit, we had to get specially adapted clothing. As a little boy, the head still has room to grow larger when it's a lot of pressure, and the only time we had to worry is when his head stopped having that ability to enlarge. When his relapses were in process, his throat would collapse, and he would spend time on life support. Indeed, our lives were a mess.
Media people saw this child as a great example for some sort of TV little blurb in sound bites. Indeed, I think that what we saw was a child that was courageous and might indeed help other people learn a little bit about this disease, and maybe, God forbid, yeah, maybe he might be able to get some funding from the government, so there would be answers before he would die. Indeed, when I saw what was happening, when Dan Rather had him on television and showed the story, not of what I saw was a courageous story, like the courageous stories here, but all of a sudden a story of what was termed "every parent's worst nightmare".
Indeed, he wasn't the worst nightmare, and we hadn't gone through the worst nightmare yet. Those words will always haunt me. And then the nightmare began. Indeed, he was on life support many times, and when he received treatment he would recover, his vision returned, his speech started, he started to feed by mouth, the vomiting stopped, he gained weight, his lips could kiss, and his arms could hug, but despite the dramatic and documented improvements, over the years local doctors and health officials would interfere repeatedly with our son's re-treatment. Indeed, it was an obsession to make sure that our little boy didn't get treated, because it was curable, and
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