The Institute of Medicine will be holding a conference entitled Lyme and Other Tick-Borne Diseases: The State of the Science Workshop, October 11-12 2010.
One thing that patients most desperately needs is more research & understanding amongst scientists & doctors worldwide, on the persistent symptoms of Lyme & the terrible consequences of Lyme infection not being treated aggressive enough, to sufficiently eradicate the disease.
Many key authors of the IDSA guidelines 2000 & 2006 have themselves published many research articles on chronic Lyme, persistence of infection AND sero-negativity (download recent Tick Talk article:) Persistence & seronegativity and yet those exact same authors within the past decade are now declaring that Lyme is easy to find & easy to treat. Those experiencing prolonged symptoms must be suffering from something else or perhaps suffering from ‘Medically Unexplained Symptoms’. Yet their own research discusses why the Lyme bacteria can become chronic & they were paid good research grant funding to study this phenomenon.
The Lyme world is therefore very keen to hear in depth discussion of future trials, treatment plans & undergoing studies arising from the State of Science conference – however there is great concern that this will indeed not be so, judging by the speakers who have been asked to present their views. I include below a letter from Tina Garcia, from LEAP Arizona, who explains in very clear terms why the conference may be a concern to many who are suffering from this serious & often prolonged disease.
(Copied with consent from author)
September 16, 2010 (revised Sep 18)
Lyme and Tick-Borne Diseases Committee
Institute of Medicine of The National Academies
c/o Dr. Christine M. Coussens, Study Director
500 5th Street, N.W.
Washington, DC 20001-2721
Re: Lyme and Other Tick-Borne Diseases: The State of the Science
Workshop October 11-12, 2010
Dear Committee Members:
I regret that I will be unable to attend the public comment portion of the above-referenced IOM Workshop. However, in lieu of personal attendance I submit the following:
Re: SURVEILLANCE, SPECTRUM AND BURDEN OF TICK-BORNE DISEASES
Landscape of Lyme Disease: Current Knowledge, Gaps and Research Needs
Presented by Gary P. Wormser, M.D.
Professor of Medicine
Chief, Division of Infectious Diseases
Vice-Chairman, Department of Medicine
New York Medical College
All my comments are in bold:
Gary P. Wormser is a well-known, public figure in the Lyme disease “landscape.” It is no secret that he has received extensive funding for research for many years, continues to make money from studying Lyme disease and spoon feeds the news media by feeding them contradictions and false statements about Lyme and suffering patients. The contradictions of research and false statements made by Dr. Wormser and his cohorts, one of them being Dr. Eugene Shapiro of Yale University, are strongly objected to by the Lyme disease community. (See Tabs 3 and 4)
You have scheduled this man to speak at the Workshop for 25 minutes. So that you may better understand Dr. Wormser’s position as he presents his “recommendations” regarding our current knowledge, gaps in the science and research needs, I submit the following information to you with the expectation that you will use your intelligence, education, analytical skills and powers of discernment to read between the lines of his upcoming presentation.
Through drawing upon all of those abilities, collectively, I would hope that you will be able to “see where he’s coming from” on the issue of Lyme disease. I respectfully request that you determine whether Dr. Wormser’s “recommendations for research” in his upcoming presentation at your Workshop will benefit Lyme disease patients or whether his “recommendations” will benefit Dr. Wormser and New York Medical College.
The following excerpts are from a book entitled “Protect Yourself from Lyme Disease – The New York Medical College Guide to Prevention, Detection and Treatment” written by Diana Benzaia, published in 1989. At the time the book was written, Dr. Wormser was the Director of New York Medical College’s Center for the Study and Treatment of Lyme Disease.
Excerpts from the 1989 book:
“Lyme disease has now been reported around the world. Virtually every country in western and central Europe is involved, and the range of infection spans the entire Eurasian continent. At international symposia and other scientific gatherings on the disease, reports have come from: Australia, Austria, Canada, China, Czechoslovakia, Denmark, France, Germany, Great Britain, Hungary, Italy, Japan, Netherlands, Sweden, Switzerland, USSR, United States
Although different species of the Ixodes tick carry the Borrelia in different parts of the world—and although it has been called by diverse names as erythema migrans disease, acrodermatitis chronica atrophicans, lymphocytoma of Bäferstedt, and meningopolyneuritis—the illness described in all these reports is clearly Lyme disease.”
So, twenty-one years ago, back in 1989, Dr. Wormser and NYMC knew that the incidence of Lyme disease was worldwide. I feel comfortable in assuming that those involved in Lyme disease research and epidemiology at the Centers for Disease Control and Prevention (CDC) were also aware of this fact.
International symposia and scientific gatherings such as this one at the IOM, do not occur unless there is a significant problem. So obviously, the CDC’s and Dr. Wormser’s “about face” on diagnosis and treatment should be examined to determine its true orgin.
“Symptoms can be highly variable from one person to another and also can vary dramatically over time in one person. Although there is a “classic” pattern of illness in Lyme disease, it is not expressed in nearly half of all patients. This can make spotting the disease extraordinarily difficult and living with it frustrating and painful.”
It is obvious that 21 years ago, Dr. Wormser was well aware of the varying presentations of Borrelia infection. Yet, in recent years in publications and statements to news media and at a legal hearing in 2009, he referenced such demonstrable disease presentations as “Post Lyme Syndrome” (PLS) and “Medically Unexplained Symptoms” (MUS).
Quite frankly, patients are tired of hearing this non-medical and non-scientific gibberish from Wormser, Shapiro and their accomplices!
“If the disease is not treated when the rash or flu symptoms are present, about 80 percent of patients have developed later stages of the disease….Further, even in some patients who are treated in the early stages, the therapy is insufficient. Depending on the dosage of antibiotics used, as many as 15 percent of treated patients develop the same types of complications seen in those who were never treated.
So, weeks or months or years later, neurological disorders, cardiac abnormalities, and widespread arthritis may occur.”
Are you even listening?
Hello? Lyme patients here. The therapy is I-N-S-U-F-F-I-C-I-E-N-T. Can you hear us?
Are you even listening?
“Three Stages of Disease…Many medical scientists find it useful to classify the symptoms of Lyme disease, like its sister disease syphilis, into three stages. First, syphilis starts with a skin or mucous membrane lesion that soon disappears. Second, the individual may be without symptoms for years; during this latency period bacteria remain alive in the body but cause no clinical symptoms. Finally, new symptoms erupt, causing problems in some of the same body systems that are affected by Lyme disease, such as the brain and heart.
When Lyme disease symptoms are classified, the rash and flu-like illness are called Stage 1; neurological and cardiac problems are called Stage 2; finally, arthritic problems are called Stage 3.
However, many physicians do not consider such classifications to be useful for a variety of reasons. The three stages can overlap or occur in inverse order. For example, heart irregularities may be the first symptom noticed. Or, once symptoms appear, they may combine unrelentingly. Further, an extraordinarily wide range of symptoms that are not covered by these stages can occur. Just consider this list of the possible manifestations of Lyme disease:”
See Tab 5 for the list from the book.
“As noted earlier, the severity of the symptoms of Lyme disease vary markedly from person to person and within any individual patient. Some people may get off virtually scot-free with only the rash; others develop recurrent, crippling arthritis; still others are bedridden with fatigue for months. Symptoms can wax and wane for years, flaring up and then calming down, seeming to disappear.”
Lyme disease is like syphilis and relapsing fever. Wormser now claims that fatigue is not a symptom.
“The diversity of experiences is endless, but because the striking similarity to syphilis can’t be missed, doctors worry what might yet be down the road for victims of Lyme disease in the years ahead.”
“All too many people think of Lyme disease as a mild illness: a little rash, some flu-like symptoms, and it’s all over in a week or two. Although that’s what happens to a minority of patients, it’s not the norm.”
Exactly. Can the NIH and CDC not hear what patients have been saying for more than 30 years? It doesn’t go away with a little bit of treatment. It hurts and causes disability. Patients lose their health and ability to function, their careers, their homes, their life savings, their marriages and their families.
Why are Lyme patients denied treatment? Why are the NIH, CDC and IOM not addressing the treatment issue? Such a blatant disregard for the welfare of suffering people is absolutely inexcusable!
“The dreaded complications of Lyme disease are most likely to occur in those who are not diagnosed and treated promptly, but they can strike anyone—sometimes even despite treatment. These complications may occur early in the course of disease or, more likely, may arise months or even years after the original illness. The most common complications—cardiac problems, neurological disorders, and arthritis—may respond rapidly to treatment early or late in the course of disease or prove stubborn to contain and subsequently cause years of misery.”
“Rarely Fatal?“ See Tab 6 for a copy of this page from the book.
“If a blood test is done, neither you nor your physician should be elated by a negative result, especially if it occurs early in the course of the disease at the time of the rash, because these tests spot only 50 percent of cases.”
Only 50% of cases are detected and the testing recommendation set forth by CDC has never reflected the reality and seriousness of Lyme disease. CDC has stated that their epidemiological criteria is not to be used for diagnosis, but they approved their criteria in 1994 knowing all too well that it would be utilized in test kits in labs around the world. And they based their criteria on research performed by Lyme Circus Ringmaster Allen Steere, who used LIPID-FREE, HIGH-PASSAGE STRAINS to create what all Lyme patients have learned to despise — the Dearborn criteria.
“New York Medical College physicians recommend careful evaluation for Lyme disease of any patient in an endemic area who develops facial nerve palsy, aseptic meningitis, radiculopathy in the absence of known intervertebral disk disease, unexplained heart block, or any type of arthritis.
In addition, they advise that a single negative blood test should never be interpreted as excluding Lyme disease when the physician has other reasons to suspect the diagnosis. They recommend that the blood test be repeated, ideally by a second laboratory using a different testing methodology. Also, they point out that in some patients with neurological symptoms, antibodies may be absent from blood but present in cerebrospinal fluid.
In the absence of a firm diagnosis, many physicians familiar with Lyme disease choose to treat patients empirically, assuming that if Lyme disease is the problem, then proper antibiotic therapy will cure them. Wisely, they are unwilling to allow the disease to progress to the point where it may be revealed in a positive antibody test. They review the patient’s history and findings, weigh the risks and benefits of treatment, and often simply go ahead with therapy.”
So, if Dr. Wormser and NYMC previously made such a treatment recommendation, why not ask the good doctors, Wormser, Shapiro and Steere (who consult for insurance companies and testify against Lyme-treating physicians) why doctors who specialize in the treatment of chronic Lyme disease in the clinical setting and treat their Lyme patients so the disease will not progress further, have been targeted for Medical Board prosecution?
But of course, such questions are not within the scope of IOM’s responsibility — such questions would be better answered during a legal deposition and obtained through the discovery process by an attorney representing Lyme disease patients in a lawsuit.
“Government Regulations…what doctors do in clinical practice and what the Centers for Disease Control will accept as a “case,” however may be different. The physician in practice is concerned with the immediate problem of helping patients; government officials are concerned with uniformity of statistics…some researchers have suggested that these overly strict criteria deny the reality of the human experience of Lyme disease and help assure that reported cases are kept low.”
“Where to Turn for Help…Physicians throughout the country need to be better educated about the proper diagnosis and treatment of Lyme disease and to be highly suspicious when they identify in patients any of the dozens of symptoms that can be caused by Lyme disease.”
So, Dr. Wormser, his accomplices, the IDSA and the CDC are actively engaged in educating physicians that the subjective misery that Lyme disease patients “believe” they are experiencing are not attributable to this “easy to diagnose and easy to cure” disease at all. Physicians are being taught to ignore Lyme patients, to deny treatment to Lyme patients and to remain ignorant about an epidemic that is sweeping the nation, because Dr. Wormser and his accomplices have “determined” that what patients are really experiencing are the fabrications of his imagination that he is attempting to pawn off as “science” – “Medically Unexplained Symptoms” and “Post Lyme Syndrome.”
In their 2009 published paper, Implications of Gender in Chronic Lyme Disease (Tab 3), Drs. Wormser and Shapiro made the following FALSE STATEMENT:
“A small number of practitioners (often self-designated as Lyme-literate physicians) have introduced the term “chronic Lyme disease” to describe patients with similar kinds of subjective symptoms, with or without credible evidence (either clinical or from the laboratory) of a preceding or current infection with B. burgdorferi.”
“Chronic Lyme disease” is NOT a term introduced by Lyme-treating physicians and patients.
“Chronic Lyme disease” is NOT a term introduced by Lyme-treating physicians and patients. It is a term that has been used in published research by Wormser and his accomplices for many years. Along with stating that chronic Lyme disease does not exist, this is a prime example of the FALSE STATEMENTS being made in published research and to the news media by Drs. Wormser and Shapiro.
Dr. Wormser, in his debunked 2001 published paper, Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease (Tab 2), along with accomplices Mark Klempner and Arthur Weinstein, referred to “chronic Lyme disease” three times:
“The primary goals of these studies in patients with symptoms that persist after recommended antibiotic treatment for Lyme disease were to characterize the impairment in health-related quality of life among such patients and to determine the efficacy of prolonged treatment with antibiotics. The effect of chronic Lyme disease on the health-related quality of life was substantial in both seropositive and seronegative patients. The deficits in physical health status as measured by the SF-36 were equivalent to those observed in patients with congestive heart failure or osteoarthritis and were more than 0.5 SD greater than the impairment observed in patients with type 2 diabetes or a recent myocardial infarction.7,8 Chronic pain was an important contributor to the impairment of physical health and was similar to that reported by patients with osteoarthritis.7,8 The impairment of mental health status was similar to that observed in patients with subthreshold lifetime depression (a depressive disorder that does not meet all of the criteria for major depression of the Diagnostic and Statistical Manual of Mental Disorders, third edition).7,8,26 The study patients also had some impairment in cognitive functioning. Their base-line FIQ scores reflected the impairments in health status that were evident in the SF-36 scores and were similar to those in previous studies of patients with fibromyalgia or those with chronic Lyme disease after treatment.8-13″
So once again, we see that according to Dr. Wormser’s esteemed medical and scientific standards, his use of the term “chronic Lyme disease” is justified, but when Lyme-treating physicians and patients use the term, it is merely a term that we “invented.”
It’s time for Dr. Wormser to retire his imaginative fairy tales and begin to respect the medical and scientific community that he claims he belongs to.
See Tab 1 for Research that Demonstrates Persistent Infection
In conclusion, I am well aware that my opinions and language are quite harsh on this issue; however, I encourage you to interpret my strongly-worded opinion and language as the wave of frustration and emotion that has driven the Lyme patient community to the following point — it is the point of saying to all of you, “We’ve experienced more than our share of medical negligence, we don’t want to hear any more statements that Chronic Lyme disease doesn’t exist, stop denying medical treatment as was done during the infamous Tuskegee Study of Syphilis, and we expect the NIH, the CDC and the IOM to conduct MEANINGFUL research on and provide us with effective combination treatment protocols!
Patients and physicians have had enough sidetracking and derailing for more than 30 years! We expect that Gary Wormser’s fairy-tale science and any such sales spiels that request that valuable funding be used for Lyme disease gimmicks not be tolerated.
Tina J. Garcia
Lyme Disease Patient for nearly 12 Years
Lyme Disease Advocate for More than 5 Years