READ CHICAGO TRIBUNE ARTICLE HERE
December 10, 2010
Gerould W. Kern, Editor
435 North Michigan Avenue
Chicago, IL 60611
Re: Chronic Lyme
disease: A Dubious diagnosis
by Patricia Callahan and Trine Tsouderos
Dear Mr. Kern:
I am a chronic Lyme disease patient and advocate who has struggled with Borrelia burgdorferi infection for twelve years, since 1998. The bacteria ravaged my body for six years before I was finally diagnosed and began antibiotic treatment at the end of 2004. At one point I could barely walk and could not effectively communicate due to encephalopathy, neurological and musculoskeletal involvement. I became disabled from the disease and lost my job and my home.
To this day, it has been a devastating journey, and this debilitating chronic infection caused by the bite of a tick in Arizona has profoundly altered my life. I could not find one doctor on my insurance plan who would provide treatment. Therefore, my insurance denied coverage, and my family had to pay for it. We were never able to afford the intravenous antibiotics that were recommended by my Lyme-treating physicians. The delayed diagnosis and denial of treatment extended my suffering, caused disability and has prevented a full recovery thus far. My case is not unique; thousands have reported the same lack of medical care.
I am not shy to state publicly that the main reason for the denial of diagnosis and treatment and terrible suffering that I have experienced was caused directly by the Infectious Diseases Society of America’s Clinical Practice Guidelines for Lyme Disease and the Centers for Disease Control and Prevention’s (CDC) dissemination of those Guidelines on its website.
Another reason for the medical neglect of Lyme patients is the failure of the National Institutes of Health (NIH) to conduct meaningful treatment studies. To date, the efforts of the NIH have been unconscionably weak in this area. Studies should have been conducted a long time ago to determine the efficacy of long-term combinations of antibiotics (months to years, as is provided for tuberculosis and leprosy infections), in search of an effective treatment protocol to alleviate the widespread suffering and loss of productivity experienced by those who have developed chronic Lyme infection, due to lack of timely diagnosis and treatment.
Of particular significance, the NIH study performed by IDSA guideline author, Mark Klempner, M.D. was a study that was analyzed statistically by statistical scientist Alison Delong and found to be flawed.
It would be considered inhumane to bring up the issue of antibiotic resistance when referring to patients receiving long-term treatment for tuberculosis or leprosy, both of which are bacterial infections. Leprosy and Lyme disease share the ability to damage the nervous system.
Why then, does the Chicago Tribune find it acceptable to publish an article that encourages the denial of long-term antibiotic therapy to Borreliosis patients, based upon the premise that such treatment causes antibiotic resistance? Does the Chicago Tribune endorse the practice of sacrificing Lyme disease patients, who are afflicted with neurological damage from embedded infection and resulting persistent inflammation, on the altar of antibiotic resistance, in an effort to save antibiotic use for others?
Professor Garth Nicolson, a microbiologist who has studied Bb, stated that the antibiotic resistance argument is “particularly lame.” He explained that another reason for antibiotic resistance is the INADEQUATE antibiotic treatment of virulent pathogens, such as Borrelia burgdorferi, the bacterium that causes Lyme disease. If you have ever received a prescription for antibiotics from the pharmacy, you may recall that the sticker on the side of the bottle recommends that all the medication be used according to the instructions – that all of it should be taken by the patient. This recommendation is made because UNDERTREATMENT of bacterial infections causes antibiotic resistance.
Therefore, each time a physician adheres to IDSA treatment guidelines for Lyme disease, they are contributing to the antibiotic resistance of Borrelia burgdorferi. Each time a Lyme disease patient is UNDERTREATED, Bb undergoes antigenic variation. In other words, it changes to evade the immune system and antibiotics. This is another way that the pathogen persists in the tissues (not only the blood) of those who are infected.
In addition, there is no definitive test that proves that Bb is eradicated with the recommended treatment set forth by the CDC and IDSA. Numerous tissue samples would need to be collected and tested to determine this, as Bb does not predominantly reside in the blood, at times rendering antibody tests inconclusive. In order to eradicate Bb from the brain, antibiotics must be administered which cross the blood brain barrier to get into the cerebrospinal fluid, and not all antibiotics are able to do this.
The good news for me is that I have made significant progress through the use of intermittent antibiotic therapy (oral and intramuscular injections) for the past six years. That’s a lot of antibiotic, but the antibiotics have allowed me to regain function. I am grateful for the progress I have made, and my hope is to get to a point where I can go back to work as a functioning and productive member of society. However, I am now suffering from small vessel disease in my brain and multiple sclerosis-type symptoms which incapacitate me periodically.
I was selected by Connecticut Attorney General Richard Blumenthal and the Infectious Diseases Society of America (IDSA) Lyme Disease Review Panel to testify on behalf of the worldwide Lyme disease patient community at a legal hearing held in Washington, D.C. on July 30, 2009.
As was reported in the Tribune’s article, the hearing was the result of an antitrust investigation of the IDSA and its Lyme Disease Practice Guideline authors, which was conducted by the Connecticut Attorney General.
It was a privilege to speak on behalf of thousands of people suffering from chronic Lyme infection. The outcome of the hearing and the extensive review of submitted medical research, that clearly showed the existence of persistent Lyme infection despite antibiotic treatment, was a rubber stamping of the current IDSA Guidelines, with no immediate changes recommended by the Review Panel. This decision has served the insurance industry by guaranteeing the continuation of diagnosis and treatment denials, as insurance companies base their denials on the IDSA Practice Guidelines for Lyme Disease.
Although the information I am submitting to you is contrary to what was reported in the Chicago Tribune, it is the truth about the medical neglect that Lyme disease patients are experiencing. Lyme disease patients have struggled for more than thirty-five years, due to a complicated web of issues involving inadequate testing methods, ineffective treatment recommendations published by the IDSA and the failure of the NIH and the CDC to perform new and utilize existing patient-centered research.
By definition, screening tests should have at least 95% sensitivity. The ELISA screening test that is recommended by the CDC lacks such sensitivity and falls short in its specificity, thereby missing detection of a significant number of cases. Such a scenario would be unacceptable for HIV, syphilis, hepatitis, tuberculosis, heart disease, diabetes and cancer; it is, therefore, unacceptable for Lyme infection, also.
During the Lymerix vaccine clinical trials, chief Investigator Dr. Allen Steere, did not use the ELISA because of its lack of sensitivity and specificity.
“ELISA’s are commercially available but lack sufficient sensitivity and specificity for use in efficacy trials…The CDC criteria, however, were developed as a surveillance tool, which frequently necessitates a compromise between sensitivity and specificity to reach the optimal surveillance objective….The CDC criteria were therefore deemed to be inadequate for the purpose of conducting a pivotal efficacy trial.”
It is, therefore, obviously inappropriate for the ELISA to be used as a screening test in the clinical setting, for if and only if the ELISA is positive, are patients ”allowed” to progress to the next level of testing -- the Western blot.
“This study confirmed in the reference and research laboratory setting the previously documented problems with accuracy and precision of serodiagnostic tests by using WCS antigens of B. burgdorferi (4-11). The study confirmed that a serious disparity existed between the test results obtained by CDC and those obtained by academic reference centers with the best testing performances. These results guided corrective action and led to the adoption by CDC and ASTPHLD of a two-test approach to serodiagnosis (23), which forms the basis for the future national standardization of Lyme disease serologic testing methods.“
How many hoops must patients jump through to receive diagnosis and treatment? In the case of Lyme disease, half of the patients cannot make it through the first hoop (the ELISA), and therefore, never get the chance to be tested by way of the second (Western blot).
This testing recommendation leaves approximately half of all patients with no diagnosis or treatment -- that is certainly medical neglect. Due to its fallibility, the CDC’s serodiagnostic testing recommendation for use of the ELISA as a screening test for Lyme disease should be reassessed by an unbiased committee not associated with the CDC or individuals involved in creating the Dearborn recommendation (which would include authors of the IDSA Practice Guidelines that were investigated by the Connecticut Attorney General).
Published research has demonstrated that Borrelia burgdorferi uses antigenic variation to evade the host’s immune system, thereby ensuring its survival and causing persistent infection. Bb has the ability to morph into various forms. It is commonly recognized as a corkscrew-shaped spirochete; however, it can change into a cyst form, a cell-wall-deficient form, a granular form and a bleb form and protects itself with a biofilm that sequesters it from attack by the immune system and antibiotics.
Published research indicates that “the interplay between the host and invading spirochetes results in a cascade of signaling events that B. burgdorferi can use to facilitate persistent infection.”
Uncertainty about the existence of chronic Lyme infection is a direct result of misleading information and opinions that have been circulated by the IDSA Guideline authors who were investigated by the Connecticut Attorney General, along with other spokespersons for the CDC. This is a small group of researchers who have, for many years, continually received a large portion of the federal research funds allocated for Lyme disease. Their unfounded statements that chronic Lyme infection does not exist directly contradict the research they have already published in which they did, indeed, demonstrate persistent infection. In fact, there is no uncertainty about chronic infection among patients and the physicians who actually treat patients with chronic Lyme disease.
Please see the research excerpts included at the end of this correspondence.
If patients do not receive diagnosis in the early stage, the disease will develop into a chronic, relapsing/remitting illness that becomes even harder to diagnose and treat. Attempting to clear an embedded infection (one that has persisted for several years), with an early-stage, short-term treatment protocol as has been recommended by the IDSA, is ludicrous. Borrelia burgdorferi colonizes all the organs and tissues of the body, and due to its antigenic variation, its biofilm and its ability to morph into evasive forms, repeated courses of various antibiotics are needed to fight the embedded infection.
In the hurried world of practicing clinicians, it is easy for the line between acute and chronic treatment recommendations to appear nebulous, and those who espouse the CDC/IDSA party line are quite adept at smudging the line that should separate acute from chronic treatment. In fact, the Lyme Medical Cartel has continually used the media to accomplish their despicable dissemination of false medical information. However, if one reads the published literature and makes the crucial distinction between the research on acute and the research on chronic Lyme infection, one will see that there actually is no controversy at all. The controversy has been fabricated by the Lyme Medical Cartel.
Patients are in desperate need for government healthcare agencies, such as the CDC, to utilize research that has already demonstrated persistent infection. You will hear so-called “Lyme experts” make statements that chronic Lyme disease does not exist. You will also hear them reference terms they coined – Post Lyme Syndrome (PLS) and Medically Unexplained Symptoms (MUS). There is no proof of the existence of either PLS or MUS in relation to infection from Borrelia burgdorferi; these are merely opinions passed off as consensus.
Once again, much of the research on persistent infection has been published by the individuals who are now calling persistent infection “Post Lyme Syndrome” and “Medically Unexplained Symptoms “ They are, therefore, contradicting their own research. Their contradictions, published in the IDSA Practice Guidelines, have resulted in the wasteful use of federal research funds, caused insurance denials of treatment and the medical neglect of suffering patients.
In my opinion, the NIH and CDC have continually wasted precious funding allocated by Congress, which should instead be utilized for patient-centered research, not pet projects of individuals investigated for their financial conflicts of interest related to Lyme vaccines, patents for diagnostic tests and consulting arrangements with insurance companies.
The General Accounting Office (GAO) previously investigated the matter of research funds for Lyme disease and determined that the CDC did, in fact, spend appropriated funds on Lyme disease research. This determination, although accurate, did not expose the research monopoly that exists between the CDC and the “most powerful IDSA panelists” who authored the IDSA Practice Guidelines for Lyme Disease. Yes, they funded Lyme research, but the majority of the funds have been granted to members of the Lyme Medical Cartel, who in my opinion, take their marching orders from the CDC.
Connecticut Attorney General Blumenthal revealed the following in his May 1, 2008 Press Release:
"The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.
Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.”
"This agreement vindicates my
investigation -- finding undisclosed financial interests and forcing a
reassessment of IDSA guidelines," Blumenthal said. "My office uncovered
undisclosed financial interests held by several of the most powerful IDSA
panelists. The IDSA's guideline panel improperly ignored or minimized
consideration of alternative medical opinion and evidence regarding chronic Lyme
disease, potentially raising serious questions about whether the
recommendations reflected all relevant science.”
Blumenthal added, "The IDSA's
2006 Lyme disease guideline panel undercut its credibility by allowing
individuals with financial interests -- in drug companies, Lyme disease
diagnostic tests, patents and consulting arrangements with insurance companies
-- to exclude divergent medical evidence and opinion.
In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.”
Cancer patients are given the choice of chemotherapy with dangerous drugs that not only destroy cancer cells, but cause extensive damage to the rest of the body, as well. Despite the risks associated with cancer chemotherapy, cancer patients are given additional treatment when they relapse, and physicians specializing in cancer therapy are not discouraged from doing so.
Lyme disease patients do not relish using antibiotics for prolonged periods, just as cancer patients do not enjoy undergoing chemotherapy. However, at the present time, antibiotic therapy is the only treatment that provides relief and improvement in symptoms, and the choice of accepting the risks of intravenous infusion of antibiotics should rest with the patient and their treating physician, not the IDSA, which the majority of Lyme patients view as a pseudo-paternalistic medical dictatorship.
For clarification, the majority of Lyme patients do not pursue the dangerous treatments described in the Tribune’s article. It was, therefore, misleading to portray the Lyme patient community as ill-informed consumers. Veteran Lyme patients are quite knowledgeable of the disease they are infected with and most can talk circles around medical doctors who have no experience treating the disease. It is simple reasoning to come to the conclusion that the majority of IDSA member physicians fall into this category, as they deny the existence of the disease.
Therefore, if ID physicians deny the existence of Lyme disease and refuse to treat patients, they don’t have any experience with the disease, correct? So, how can they refer to themselves as Lyme experts? Such a physician would actually be considered a charlatan. The IDSA mantra that chronic Lyme disease does not exist is the blindfold that allows these sheepish IDSA member physicians to fall off the cliff into an abyss of ignorance and arrogance.
Research has demonstrated the remitting and relapsing nature of Lyme disease infection. It is, therefore, inhumane to deny Lyme patients access to long-term antibiotic therapy that is legally prescribed by licensed physicians. If Lyme disease patients are willing to accept the risks of such treatment in lieu of a chronic, debilitating, infectious disease, insurance companies should provide coverage for such treatment and not shirk their responsibility based upon the IDSA Practice Guidelines – Guidelines that were written by those who, at the same time that they publish guidelines for use by the insurance industry, they also serve as insurance consultants and expert witnesses in medical board prosecutions against physicians who actually have experience treating the disease. Now that’s a story your journalists should investigate and publish.
Lyme disease patients expect insurance companies to cover long-term antibiotic therapy, if such therapy is recommended by their treating physicians. In the clinical setting, Lyme disease patients and treating physicians have consistently reported evidence of in utero transmission and suspect sexual transmission, as well. Due to the fact that Borrelia burgdorferi has been found to live in frozen blood for up to eight months, transmission via our nation’s blood supply should also be studied and given serious consideration.
Studies on such modes of transmission have not been adequately pursued. I have strongly urged that such research be funded and performed immediately, as our failure to address these important issues of transmission of Lyme disease, a spirochetal disease that is similar to syphilis, may be jeopardizing public health of and perpetuating the pandemic.
The Lyme patient community has requested assistance from the CDC and the IDSA for many years, but patients have been either ignored or publicly ridiculed, the latter being done by the Chicago Tribune in the Callahan/Tsouderos article. Thus the need for me to write this lengthy essay as a public service.
The Lyme patient community no longer relies upon the CDC or the IDSA to be the guardians of our health, as the research and programs that are funded and performed by them and the clinical practice guidelines that are published and disseminated by them are not “patient-centered.” Nor is the research that demonstrates the existence of persistent infection utilized by the CDC and IDSA for the benefit of patients.
Instead, the research is contradicted, or simply ignored, in favor of personal agenda-promoting opinions and manufactured disease parameters. As revealed formerly in the CT Attorney General’s Press Release, these financial conflicts of interest were exposed during the antitrust investigation of the IDSA and its 2006 Lyme Disease Practice Guideline authors. Unfortunately, the Attorney General was not able to extend his investigation into the bowels of the monopoly -- the CDC and its Division of Vector-Borne Infectious Diseases, and possibly, the United States Public Health Service, which if you recall, led the Tuskegee Study of Syphilis from 1932 to 1972.
Despite extensive funding for Lyme disease research, the healthcare needs of Lyme disease patients have been neglected for too long. Precious funds are wasted by those who place their own interests in developing a Lyme vaccine and marketable test kits above the health needs of patients. Clinical practice guidelines are being written and published to serve the personal agendas of the authors and those who have a stake in the guidelines, barring the most important stakeholders – the patients.
The irresponsible behavior of the IDSA prior to, during and following the investigation and review process of the IDSA Practice Guidelines for Lyme disease, in the form of fraudulent public statements that chronic Lyme infection does not exist and their continued dissemination of other false information, such as,
“no convincing biologic evidence for a Lyme infection that persists”
has caused the majority of their infectious disease member physicians to deny diagnosis and treatment to chronic Lyme disease patients.
The CDC plays a leading role on the world stage of health. The CDC provides a link to the IDSA Practice Guidelines for Lyme disease on its website, and this action has resulted in diagnosis and treatment denial to chronic Lyme disease patients in the U.S. and in other endemic countries around the globe.
At the recent October Institute of Medicine forum on the state of the science of Lyme disease, the patient community suggested that funding be given to other researchers not involved in the Lyme Medical Cartel research monopoly. This monopoly is the one that Willy Burgdorfer, Ph.D., discoverer of the Lyme disease bacterium, referred to when he made the following statement in the film “Under Our Skin”:
“The controversy in Lyme disease research is a shameful affair. And I say that because the whole thing is politically tainted. Money goes to people who have, for the past 30 years, produced the same thing—nothing. Serology has to be started from scratch with people who don’t know beforehand the results of their research.”
With regard to the other article in the Chicago Tribune entitled “Behind the curtain on our investigation into dubious medicine,” Trine Tsouderos stated the following:
“Working at a newspaper devoted to digging deep on behalf of our readers, we believe it is our mission to develop well-researched stories as an antidote to all the unfiltered and unreliable information on the Internet. We do that by investing time and resources into stories like these."
Allowing the current Tribune article, with its many flaws, to stand as a factual reference and an example of a well-researched story, is irresponsible journalism that continues the damaging medical neglect of thousands of patients who have been diagnosed with Lyme disease in North, Central and South America, Europe, Asia and Australia. This is an infectious disease pandemic that is disabling people worldwide. A more knowledgeable reflection of the journalists would be cast, if Ms. Callahan and Ms. Tsouderos would cease parroting the following Lyme Medical Cartel misinformation –
“infected ticks live mostly in Minnesota, Wisconsin and the Northeast.”
Therefore, on behalf of suffering patients, I request that the Chicago Tribune and its investigative journalists, Patricia Callahan and Trine Tsouderos, publish a follow-up article that incorporates the information I have provided in this correspondence. Such a follow-up article would demonstrate to the public that the Chicago Tribune should not be held accountable, through its complicity with the Lyme Medical Cartel, of perpetuating the inhumane medical neglect of Lyme disease patients that has occurred for more than thirty years.
If you read the Tuskegee Timeline on the CDC website, you may be surprised at the similarities between the Tuskegee Study of Syphilis that was inhumanely carried out by the United States Public Health Service / condoned by the CDC and the denial of diagnosis and treatment for those infected with Borrelia (a cousin to syphilis). There’s another story for you, if your investigative journalists have the courage to tackle it.
The journalist who broke the story of the Tuskegee Study in the 1970’s helped bring closure to that inhumane medical “study” that resulted in a public apology from President Clinton and a financial settlement with the victims and their families.
Thank you in advance for your consideration of the important issues and information I have provided, and I anxiously await your response.
Tina J. Garcia
Cc: Deborah Shelton,
Patricia Callahan, Investigative Journalist
Trine Tsouderos, Investigative Journalist
Excerpts from Research Published by IDSA Lyme Disease Guideline Authors
With regard to the 2006 14-member IDSA panel and the review of research by those IDSA guideline authors, it is evident that they did indeed deem some Lyme-related research as not meeting “rigorous scientific standards.” It is astounding that some of the research the IDSA panel members chose to ignore was their very own. The IDSA Review Panel also ignored the guideline authors’ research and more than 1600 pages of research and analyses submitted by the International Lyme and Tick-Borne Diseases Society (ILADS).
Here are but a few examples of the 2006 IDSA Guideline Authors’ research:
This is an abstract from a published article co-written by Allen C. Steere, one of the authors of the 2000 and 2006 IDSA Treatment Guidelines, in the New England Journal of Medicine, Nov 22; 323(21):1438-44, which refers to a study of Borrelia burgdorferi:
“These chronic neurologic abnormalities began months to years after the onset of infection, sometimes after long periods of latency, as in neurosyphilis…The typical response of our patients to antibiotic therapy supports the role of spirochetal infection in the pathogenesis of each of the syndromes described here…The likely reason for relapse is failure to eradicate the spirochete…This last article is one of many studies that show continuing symptoms are most likely due to persistence of the spirochete.”
The following is from another published article by Dr. Allen C. Steere:
Steere, AC., 1995, Musculoskeletal manifestations of Lyme disease. American Journal of Medicine, 1995, 88:4A-44S-51S.
“…a 1-month course of oral antibiotics may not always eradicate viable spirochetes.”
Also from Steere:
Steere, AC., et al., 1994, The long-term clinical outcomes of lyme disease. A population-based retrospective cohort study. Annals of Internal medicine, 121(8)560-7.
“Ten of the 38 patients with Lyme disease reported relapses within 1 year of treatment…and had had repeated antibiotic treatment (5 patients with intravenous ceftriaxone). …Patient 4, in addition, had had second degree atrioventricular block with acute Lyme disease that resolved with penicillin treatment. Her irregular rhythm recurred 2 years later, resolved temporarily with ceftriaxone treatment, but progressed to complete heart block requiring a pacemaker. …Patient 12…was treated with 2 weeks of parenteral penicillin. She later developed a progressive speech disorder, bradykinesia, and abnormal ocular motor function. Magnetic resonance imaging of the brain showed scattered white matter lesions in the hemispheres and pons…she was re-treated with 2 weeks of parenteral ceftriaxone in 1989 that had no effect on her neurologic symptoms. During the time of observation, this patient died. At autopsy…[using] Dieterle silver stain, a spirochete was present in the cortex and another was exterior to a leptomeningeal vessel.”
From Raymond J. Dattwyler, another author of the 2000 and 2006 IDSA Treatment Guidelines:
Dattwyler, RJ., et al., 1988, Seronegative Lyme disease. Dissociation of specific T-and B-lymphocyte responses to Borrelia burgdorferi. New England Journal of Medicine, 1988, 319(22):1441-6.
“We studied 17 patients who had presented with acute Lyme disease and received prompt treatment with oral antibiotics, but in whom chronic Lyme disease subsequently developed.”
This scientific published research by Drs. Steere, Dattwyler and Klempner, members of the IDSA panels, for some odd reason does not meet the IDSA’s “rigorous scientific standards” and does not support the IDSA hypothesis that chronic Lyme disease does not exist.
The IDSA Guideline authors demonstrated that chronic Lyme disease is caused from persistent bacterial infection. So, they not only ignored a worldwide body of published research, but they ignored their very own research in the formulation of the 2000 and 2006 IDSA Guidelines for the treatment of Lyme disease.
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