IDSA Lyme Evidence Hearing
A summary of the IDSA Lyme evidence hearing
Blog: Under Our Skin, published by Open Eye Pictures.
Written by: Kris Newby
August 5, 2009
http://underourskin.com/blog/?p=250
On July 30, 2009, a newly formed panel from the Infectious Diseases
Society of America (IDSA) heard 8 hours of testimony from 18 presenters
representing various viewpoints on Lyme disease diagnosis and treatment.
This was the first time the two sides of the Lyme controversy have been
given equal time in front of a conflict-free evidence-review panel. And
it's the first time that a medical guidelines hearing has been broadcast
over the Internet for all the stakeholders to hear, from patients to
researchers to treating physicians.
...
Finally, on a possibly hopeful note, the IDSA just requested from Open Eye Pictures nine copies of
UNDER OUR SKIN which will be given to each of the panelists. In addition, we offered to screen the film
and speak with it at the October IDSA conference in Philadelphia. Though we're skeptical this will happen,
we're happy and humbled that the film is proving its potential to affect policy and people's lives.
Read the complete blog entry and join the conversation:
http://underourskin.com/blog/?p=250
Please see http://underourskin.com/blog/?p=250
for a summary of the IDSA Lyme evidence hearing
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Award Winning Author, PJ Langhoff's letter to the IDSA Guidelines Review Panel Members.
PJ's letter was received by the Review Panel along with 10 copies of her new book,
"The Bakers Dozen and the Lunatic Fringe".
Thank you to everyone who wrote letters to the IDSA Guidelines Review Panel Members to have their voices heard.
March 25, 2009
Dear Esteemed Guidelines Review Panelists,
I am a Lyme patient, mother of 2 Lyme infected adults, award-winning author, advocate and medical researcher who probably acquired Lyme congenitally. However after our most recent tick bites, my family was forced to wait 13 years for an accurate diagnosis of Lyme disease despite nearly 100 physician and ER visits. This unnecessary delay occurred despite the fact that I removed ticks from myself and my then toddlers and we had bull’s-eye rashes and other acute Lyme symptoms. Over time I progressively lost physical ability to the point of being unable to walk, work, drive, think, use the left side of my body, etc. I suffered intractable pain for years. My family and I were sick all of our lives because no doctors would touch the words “Lyme disease”. One physician told me behind closed doors he was “not allowed to diagnose” Lyme patients, or put the words “Lyme disease” in patient charts for fear of reprisals. I spent 10 days at the Mayo clinic in Rochester, MN whereby I was refused Lyme testing despite my symptoms and lengthy medical history. Repeatedly I heard “there is no Lyme in Wisconsin” which was patently ridiculous. Indeed your panelist Yale’s Dr. Paul Duray performed tick surveys on WI military bases around the time my family was most recently bitten (in the 1990s). Reports indicated that areas of WI were Lyme endemic at that time. Note I lived just 2 hours from one of those endemic bases. It is felt that my parents, siblings, and probably children also have Lyme, acquired congenitally. Many of us have been re-bitten and have active Lyme infections and progressing symptoms despite repeated antibiotic treatments.
Later on, as if chronic illness was not enough of an insult to my family, I was forced to fight over 12 years in family court to retain custody of my children post-divorce, yet eventually lost all parental rights in short, simply because I had Lyme disease. That occurred despite expert physician witnesses and laboratory tests clearly showing my family Lyme positive, even by CDC standards. One judge said I didn’t “look sick”. One of my children ended up in a psychiatric ward for observation due to Lyme induced depression. We have lost homes, jobs, reputations, finances; filed bankruptcy, fought disability providers, and insurers just to get medications and treatments that were life-saving, covered; and most were paid out-of-pocket. I have had to endure years of oral antibiotics that do not work, fulminant symptoms, intramuscular and IV therapies, surgical operations, the loss of several organs, and CNS, joint, and brain invasion by organisms that could have been successfully treated at onset if those whom have been holding the purse strings of information censorship had been speaking the truth about spirochetal infections; instead of silencing a growing epidemic in exchange for what has appeared to be profiteering and notoriety.
I have fought hard to defend Lyme treating physicians because of what the medical boards are doing to them (pulling their licenses or other sanctions) because they dare to treat patients outside IDSA “standards” of care that are no one’s standards — “standards” that are merely recommendations, and which clearly do not work. This is a tragic situation when our own physicians cannot treat patients in favor of insurance companies or a handful of powerful academicians who dictate medical dogma, the former without a license, the latter without practical clinical experience. Corporatized medicine serves no one except the profiteers; and certainly not the ill patient populations.
Sadly, our family’s tragic situation is not unique. I contend that if restrictive Lyme disease medical guidelines such as those promulgated unilaterally by the IDSA in 2000 and again in 2006, which deny aspects of this illness and minimize others, are allowed to proliferate, then more families will be facing the kinds of tragic destruction, discrimination and denial that our family has—unnecessarily and unjustly, but for the sake of research dollars and promoting for-profit pipelines.
I urge you to carefully consider the long-term consequences of clinical practice guidelines that are intended to serve as recommendations and not mandate for treating physicians. The current restrictive IDSA guidelines and processes that allow academicians to patent and profit upon technologies also allow insurance companies to deny patients a right to become healthy and whole. This is additionally disturbing when we see that some of the academicians who are also guidelines panelists have conflicts of interest including patent holdings, and are paid consultants to pharmaceutical and insurance companies and witnesses in litigation. That some of these individuals have ongoing vaccine and diagnostic test involvement; as well as a role in the establishment of “standards” and information dissemination is intensely troubling when that information denies aspects of illness, as the IDSA guidelines do for Lyme disease. It is clear that some of these parties well know the severity of this illness but patently refuse to budge on more recent opinion. Perhaps this is because they and their associates stand to lose much if they admit to the truth about this illness. How unfortunate for those ill with this disease that power, profit, and reputations appear greater than the welfare of people globally. You have a chance to change things for Lyme patients for all of history right now, but only if you choose truthfulness over ongoing censorship for profit and private agendas.
In all fairness to patients who are to benefit from current and future guidelines, we request full consensus in writing medical guidelines, even when guidelines are merely recommendations. This process must include all current research (not just that put forth by a few panelists); everyday experiences of our treating clinicians, and valuable patient input and experience – and I thank you for the opportunity to provide such input at this juncture. It is my hope that this open public input period is truly meaningful and not just a token conciliatory gesture for patients whereby the end result will be to nevertheless uphold the 2006 IDSA guidelines that patients, physicians, and others clearly do not want nor accept as legitimate. We do not want or need biased, rubber-stamped, disease dismissing, for-industry guidelines that place profits above human suffering. And patients will be far more vocal about this the longer it continues to occur—until these practices cease to exist and those held accountable for these practices when they occur. Illness does not equal powerlessness, and those who are ill, expect and deserve better than what we have been spoon-fed from previous clinical practice guidelines for Lyme disease and some of its panelists.
After all, we are learning the truth about this disease; from study of all available documents, and from personal experience living with these infections. From our perspective, the guidelines and some of those who have been involved with the Dearborn criteria, the guidelines formation, diagnostic and vaccine technologies, and who also are grant recipients, and patent holders, currently appear far from truthful about this growing epidemic. The current guidelines are inaccurate and reflect a desire to restrict patient and physician access to life-saving medications and treatment processes. The unfettered censorship of our physicians by academic mandate disguised as “recommendations” is most unwelcome in the patient/doctor relationship, and the toying of our health by insurance companies who whimsically misinterpret the IDSA guidelines is as dangerous to human life as Borrelia burgdorferi is, when left untreated or undertreated.
Clinical trials and controlled studies are necessary aspects of medicine. However, the practical patient experience has been shifted to the back burner in favor of academic “expert” opinion and research funding, including by those who do not see patients, or who occasionally do but who have only a limited patient sampling with one or two symptom presentations. Adhering to unilateral thought regarding a limited number of patients in favor of controlled, funded studies over time is an unrealistic approach that is woefully out of touch with the clinical experience. An absence of “scientific” proof is not proof of absence. Physicians who treat thousands of Lyme patients were, and are summarily excluded from the IDSA guidelines process, along with a former panelist who was excused for not agreeing to the “expert” opinion of other IDSA panelists. (Experts who again, do not have practical real time experience treating patients in a clinical setting.) The patients are crying out loudly for these processes to change, for our welfare, and for the future welfare of all persons yet to be infected with this devastating illness.
To that end, one of my recent books from my Lyme “It’s All In Your Head” series, was recently released, (titled The Baker’s Dozen & the Lunatic Fringe: Has Junk Science Shifted the Lyme Disease Paradigm). I have included 10 copies, one for each panelist to receive and review during this patient input period. I have collected significant research sources, including objective peer-reviewed articles, as well as FDA, DoD, NIH, CDC, published books, CME videotapes, and other sources, and compiled them for patients, educators, physicians, panelists, and others to review. The book illustrates also the research behind this disease as previously published by many of the IDSA panelists. It clearly shows the IDSA guidelines to be at stark odds with some of the guidelines authors’ own earlier published findings. The fact that earlier claims about the severity and persistence of Lyme disease by some of these parties do not reconcile with their current guidelines recommendations leads us to question the motivations of those who have written them.
That there are tremendous potential conflicts of interest at play does not escape the public. My book helps to illustrate what some of those important connections and conflicts may be and how they may be influencing the current Lyme paradigm. It also closely examines the CDC recommendations set forth at the 1994 Dearborn MI conference that was designed to standardize testing; yet apparently simply provided unilateral opinion that appears unsupported by scientific evidence—opinion that led to a.) the release of what is considered to have been an unsafe vaccine by virtue of OspA sensitivity, chronic treatment resistant arthritis of which certain panelists were aware before the vaccine was released [evidenced by research papers]; and b.) has also led to the wrongly promoted insensitive diagnostic tests incapable of detecting most patients who have Lyme disease for many reasons examined; which has thus led to c.) thousands of people like my family being misdiagnosed, undiagnosed, and improperly treated for an organism that could have easily been treated at onset that the IDSA panelists published was persisting and severe; and d.) the refusal by doctors to continue to treat patients until symptoms are gone due to restrictive guidelines and fear of reprisals through medical board actions; and e.) the refusal by disability and insurance companies to pay for disability and/or treatments while they conveniently cite IDSA guidelines as mandate and not recommendationin order to control profit margins.
And since the current IDSA guidelines appear written in a manner supportive of this kind of discrimination, thousands have been disabled, killed, or have ended their own lives thanks to intractable pain, severe depression, discrimination and other factors caused by Lyme disease. If there is no “illness-for-profit” paradigm in play, then there is no excuse to continue to defend guidelines that dismiss meaningful research and clinical evidence, and contraindicate access to life-saving treatments. Lyme disease is a serious epidemic that requires open-ended treatments with combination antibiotics to the benefit of patient wellness as long as, and as frequently as is necessary until symptom resolution. Treatment benefits are nonexistent under a therapeutic schedule with limited duration that abruptly ends by a predetermined calendar date. And one which then magically changes all remaining spirochetes into some “post-Lyme syndrome”, a term that is not only hyperbole and conjecture, but also complete and utter nonsense. I outline how this is so within my new book which is provided for your review.
That there are those who continue to deny the existence of an organism that has long been studied by the military in collaboration with academic institutions as a bio-weapon; and that some of these parties, after patenting the organisms and processes, now publish contrary to some of their earlier research on these same organisms, is unconscionable in the public opinion of mass majority. That some of these parties would also be allowed to patent, profit and promote these processes by developing vaccines and insensitive/ineffective diagnostic tools in order to promote a vaccine which failed; while simultaneously holding patents on tests with a greater ability to diagnose Lyme patients but refusing to develop these more accurate processes, is also unthinkable.
Patients are imploring the current panel members to reconsider carefully the input of patients, their treating physicians and the scientific facts that have been formerly ignored during previous IDSA guidelines processes. The true research evidence is in fact present and easily accessible to all who choose to read same. Lyme disease is serious, persistent, chronic and debilitating; and even previous IDSA guidelines panelists published these facts — even if they choose to minimize or flatly ignore their own findings within past and current guidelines and recent publications. For that reason, I urge you to read fully, or at the very least, glance carefully at the sections in my new book that discuss testing, patenting, grant funding, the guidelines processes, persistence, testing standardization and failures, the IDSA guidelines inadequacies/errors and the earlier research published by the IDSA guidelines authors and their associates. Likewise, consider carefully all submissions by those outside the IDSA academic “club” during this public input period.
Only when you see the truth about Lyme disease, in the form of the published research, the patient and the physician clinical experience, the revelations of conflicts of interests in former panelists, and the extent by which the paradigm is exploited for profit over patient welfare can you objectively, mindfully, and responsibly create guidelines that are clearly in the best interests of the patients they are supposed to serve — something for and about which, many believe that the former and current IDSA guidelines for Lyme disease have failed miserably.
It is a tragedy that patients have had to endure the kind of prejudice and censorship that we have had over the past several decades — at times by the very parties who are sworn to “first do no harm”. We have trusted unfairly those in the academic world who have had the power to keep us ill in favor of research funding. We are far more educated about our illness now, with full awareness of the political and scientific issues. Sources like the film Under Our Skin, the CT Attorney General’s investigation, and books like mine are helping others to find those truths and bring them into the spotlight. You merely have to look at them and consider the impact of forcing populations to remain ill by perpetrating ongoing myths that nobody believes or is buying except for the minority, “Baker’s Dozen”.
I urge you to consider your choices carefully. Patients will no longer stand idly by and accept what we know is not truthful. With great respect for what you are about to undertake, but with the personal experience that this disease has long afforded me through decades of dealing with same, my research work and privileges in physician and patient advocacy, I formally request that you read the content of my new book, and put the patients first in your guidelines review process. Remember to “first do no harm”. I include on the following pages some excerpts from my book to facilitate your study—a book with more than 1,060 references. I collected this over a 4.5 year period, while ill, from publicly accessible sources. My research was included in the CT Attorney General’s anti-trust investigation into the IDSA guidelines, and part of it was shared with producers of the film Under Our Skin. Of note is that my books are available and selling internationally through popular book sellers. This information is not being taken lightly by your peers or by patients and physicians the world over. And in turn we expect and request that in a similar manner, that this information not be taken lightly by the esteemed review panel.
I ask that you take the time and read every page of this book, which has important information to assist in your evaluation process. At the very least, please read these excerpts from The Baker’s Dozen: Chapter 2: Transmission, pp. 51-66; p. 69: Dr. Andrew Pachner quote re: Bb persistence; Chap. 3: Controversial Conclusions, pp. 75-77; Chap. 5 pp. 84-89; Chap. 6, The CDC Supported IDSA, pp. 98-117; Chap. 7 pp. 119-120; Chap. 8 pp. 132-133 quotes by Dr. Johnson on chronic Lyme disease from 1986; and p. 134 quotes by Dr. Sigal about not being an expert; Dr. Schoen quotes, bottom p. 135, top of p. 136; Chap. 9 (all) pp. 141-181; Chap. 10 pp. 183-206; Chap. 11 pp. 207-220; Chap. 12 p. 223 (Dr. Dattwyler quotes); Chap. 12 pp. 225-249; Chapters 13-15 (all); Chap. 16 pp. 341-347; Chap. 17 p. 353-354 (CDC Grants); Chap. 18 (all); Chap. 19 (all); Chap. 20 p. 398 BSK Medium; Chap. 20 p. 408-420; Chap. 21 (all); Chap. 22 pp. 443-450; Chap. 23 p. A Cure for Lyme Disease: pp. 461-464. References begin on p. 474 to end. All information clearly disputes IDSA guidelines and validity of “current” thinking about Lyme disease, and highlights persistence, chronic nature, and earlier research by IDSA guidelines authors.
Key quotes from the book for your review: (p. 57) “…Before treatment, B. burgdorferi DNA was detected in 88 of 97 patients with Lyme borreliosis…In addition to urine, breast milk from two lactating women with erythema migrans was tested and also found reactive.” (p. 57) “Autopsy and clinical studies have associated gestational Lyme borreliosis with various medical problems including fetal death, hydrocephalus, cardiovascular anomalies, neonatal respiratory distress, hyperbilirubinemia, intrauterine growth retardation, cortical blindness, sudden infant death syndrome, and maternal toxemia of pregnancy.” (p.57) “Transplancental transmission of B. burgdorferi has been documented in a pregnant woman with Lyme disease who did not receive antimicrobial therapy…” (p. 58) reference to Dr. Steere paper from 1986 indicating that Bb has been shown to cause stillbirth. (p. 61) CDC letter “tick-borne pathogens which could possibly be transmitted through blood transfusion” (p. 62) “…untreated individuals may face severe, chronic, multi-systemic involvement, which may in a few cases, terminate in death.” (p. 63) “…the spirochete has also been found in deerflies, horseflies and mosquitoes.” (p. 63) “According to Burrows, relapse strains occur because of the antigenic instability of Borrelia” (p. 64) “a chronic multi-system disease” (p. 66) “urine may be a vehicle for non-tick transmission of the disease” (p. 69) “…highly neurotropic organisms that not only can produce symptomatic neurologic disease but can also exist dormant within the central nervous system (CNS) for long periods.” (p. 74) “previous studies have shown infection rates as high as 40% in certain areas of Wisconsin” and “as evidenced by spirochete infected ticks, infected wildlife, and human cases.” (p.83) 1989 paper “Lyme disease morbidity is increasing…” (p. 84) CSTE recommends for CDC to make Lyme surveillance “a high priority with emphasis on overcoming technical deficiencies” (p. 100) “This surveillance case definition was developed for national reporting of Lyme disease; it is not appropriate for clinical diagnosis” (p. 104) “IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease…” (p. 107) From a US vaccine patent text we read about concerns which focus on “significant socio-economic costs, manifested by reductions in outdoor recreational and social activities due to concerns about tick exposure” (p. 108) chronic Lyme is repeatedly used by Yale colleagues “Borrelia-specific T cell clones have been isolated from peripheral blood, joint and or cerebrospinal fluid from patients with chronic neuroborreliosis and Lyme arthritis…..we are studying the neuropsychological findings of patients suffering from chronic Lyme disease and controls…we are studying the audiological findings in patients with chronic Lyme disease…” (p. 112) “…Though guidelines are based largely on observational data and expert opinion, it is widely believed that adherence to them leads to improved outcomes. Data to support this belief simply does not exist…Practice patterns set up this way may be resistant to change, should new evidence emerge that contradicts certain recommendations….Even if guidelines are entirely appropriate, a ‘one-size-fits-all’ approach is likely to benefit some, but not all. Certain patients may be harmed by adherence to specific guidelines. Guidelines certainly do not encourage clinicians to consider and treat each patient as an individual…They are created by a process that is artificial, laborious and cumbersome. This all but guarantees many guidelines are obsolete by the time they are published. Guidelines are produced with industry support and recommendations often have a major impact on sales of industry products.” (p. 113) “…as many as two-thirds of the people that become infected by this spirochete are unaware of the tick bite…The chronic forms of the disease….may last for months to years and are associated with the persistence of the spirochete…for every symptomatic infection, there is at least one asymptomatic infection…Once infection has occurred, however, the drugs may not purge the host of the spirochete but may only act to control the chronic form of the disease…” (p. 120) “out of 10 authors, only 7 patients had been diagnosed over a period of the previous 5 years time by the panelists” (p. 122) “Dr. Tenenbaum admits that colleagues who serve as expert witnesses often lose objectivity because they are influenced by those who pay them to testify” (p. 129) “4 out of 5 of the speakers had undisclosed ties to drug firms that made antiviral drugs” (p. 134) “Tertiary borreliosis is part of the clinical spectrum of late manifestations of the infection” (p. 135) “Most of the increase in cases seem to occur not so much in highly endemic areas but in adjacent geographic regions.” (p. 135) “Several lines of evidence suggest the Lyme disease is very much under-reported.” (from Dr. Schoen 2001 FDA transcript). (p. 136) again Schoen: “A number of factors influence CDC data, but one to keep in mind is this phenomenon of under-reporting, which may therefore underestimate the true health burden in terms of morbidity and cost of Lyme disease.” (p. 137) from A. Pachner book, comment re: three stages of infection and that Bb can “stay alive in human tissue for years” (p. 143) re: OspA protein, “this protein may be ineffective for all strains of Borrelia” (p. 143) “However animal studies indicate that OspA vaccination may not be effective against all strains of Lyme disease Borreliae. OspA is also not useful for immunodiagnosis, due to weak antibody responses to OspA in Lyme disease patients.” (p. 143) “It has been shown that the earliest IgM antibodies formed against antigens of the Bb strain….are directed against….flagellin having a molecular weight of 41kD…but with advancing disease IgG antibodies form against other immunogens…31kD and 34kD.” (arguments for serial diagnostic testing v. one test and accept negative results). (p. 151) “Even using the two-step [testing] approach, the sensitivity and specificity of the combined test results are inadequate…the stage of disease in which the specimen was taken is critical. Many patients with active or recent infections do not have detectable anti-Bb in a single specimen…in summary, serological testing is not useful early in the course of Lyme disease, because of the low sensitivity of tests in early disease. Serologic testing may be more useful in later disease at which time sensitivity and specificity of the test is improved.” (p. 152 & 155) Dr. Steere paper says spirochetes remain alive “throughout the illness” (p. 158) “…a patient can actually have a CDC positive IgG Lyme testing …without actually having any BB genus-specific antibodies present” (p. 160,161) More Studies, Fewer Lyme Patients read re: Steere excluded Lyme patients during studies (p. 162) “The tests showed that the positive cut-off value for the tests was, in their words, ‘inappropriately low’” (p. 164) “Dr. Gubler [CDC] stated that the two-test approach proposed is ‘not the gold standard’…this meant that the CDC did not accept the Dearborn test recommendations as a ‘gold standard’” (p. 166-167) NIH states “there is no test to confirm a diagnosis of chronic Lyme disease” (and repeated references to chronic Lyme by the NIH). (p. 170-173) seronegativity and seroconverstion. (p. 173) MarDx says “their own tests must not be used 4 weeks after onset of Lyme infections. (p. 175) FDA and CLIA certification. (p. 181) IDSA guidelines study #337 discussion that it used flawed research. (p. 197) “Current technology enables correct diagnosis….only after the disease has progressed to a certain maturity…by that time however treatment is more difficult” (p. 199) Dr. Luft “Lyme disease remains difficult to diagnose”…the diagnosis….is based on clinical findings….the dissemination process can occur simultaneously with the EM rash, or within the first 2-4 weeks after its initial presentation…The diagnosis of Lyme disease may not always be clear cut…the presence of or absence of Bb infection should not be based upon serologic test results…antibody levels may not be measurable during the first 3 to 4 weeks of infection….a second serum sample should be tested 4-6 weeks after the first analysis…disseminated disease may cause a variety of chronic manifestations…treatment failures and relapses have been reported…duration of therapy is based on the severity of infection and the patient’s response to treatment…IV therapy may be appropriate for disseminated disease and especially during the first trimester of pregnancy when the fetus is most susceptible to infection….Lyme disease is strictly a clinical diagnosis and not a diagnosis of exclusion….physicians must remain alert to the symptoms of these debilitating and sometimes fatal disease.” (p. 205) References to fibromyalgia, chronic fatigue being caused by Bb by Dr. Allen Steere. (p. 213) [Steere et al] “Bb may occasionally trigger fibromyalgia” (p. 213) “an example of a patient with chronic relapsing Bb infection” [P. Coyle]. (p. 213) A fatal case of neuropsychiatric Lyme disease that was exhibited in a patient by progressive frontal lobe dementia, “and pathologically by severe subcortical degeneration” [1995]. (p. 220) “the greater significance of these agents may be as immunosuppressants” (p. 223) [Dattwyler] “It’s a bigger problem than, I think, people realize.” (p. 227) [Steere et al] “important to treat patients prophylactically, because untreated…many patients went on to develop sequelae that was cardiac, neurologic, or arthritic in origin…antibiotics were not as effective in patients if they waited to treat until their symptoms were more debilitating.” (p. 229) “some patients continue to have symptoms after treatment…Lyme disease spirochete may sometimes persist in the nervous system for many years…” (p. 229-230) “Lyme arthritis is virtually always caused by either persistent infection or the antigenic waste that is left behind” [Malawista] “patients will be free of arthritis when….the last Bb has shown itself to the immune system and been killed, and its antigens have been biodegraded.” (p. 230) “the most logical explanation for relapse…was failure to eradicate the spirochetes…this is reminiscent of far advanced neurosyphilis.” (p. 231) Klempner study flaws. (p. 233) [CDC reports] “not all patients with Lyme disease will develop the characteristic bull’s eye rash” (p. 235) Behavioral symptoms quotes throughout the page in relation to LD. (p. 239) References to inaccuracy of the tests. (p. 240) “passing Lyme disease to unborn infants through the placenta was documented in a pregnant woman who had Lyme left untreated” (p. 243) “The guidelines authors repeatedly recognize the lack of published evidence…yet make generalized conclusions of their own while lacking supportive references…” (p. 244) Comments on IDSA guidelines saying no documented indigenous cases of LD south of VA or MD—but book references prove otherwise. (p. 246-248) prominent guidelines inconsistencies discussed. (p. 255) [antibiotic resistance] “There is no known resistance that has developed in this organism…[it] is not under pressure because it is a zoonosis, so there is no human pressure out there….there are whole classes of antimicrobials that this organism is not sensitive to.” (p. 256) “once infection has occurred….the drugs may not purge the host of the spirochete but may only act to control the chronic forms of the disease” (p. 257) “…such treatment is not always successful in clearing the infection. Treatment is often delayed due to improper diagnosis with the deleterious effect that the infection proceeds to a chronic condition, where treatment with antibiotics is often not useful…one of the factors contributing to delayed treatment is the lack of effective diagnostic tools.”(p. 259-260) comments on guidelines inappropriate recommendations regarding testing and exclusion. (p. 260) “keep in mind that the Wampole PreVue Bb antibody detection assay is intended to presumptively detect antibodies to Bb and not to diagnose Lyme disease.” (p. 273) discussion on MarDx test kits which were already under contract during Dearborn criteria standardization that would rely on these tests. (p. 273) “negative results (either first- or second step) should not be used to exclude Lyme disease” (p. 274) IDSA guidelines suggest diagnostic tests are required for confirmation of extracutaneous Lyme disease, HGA and babesiosis. All research shows otherwise. Read discussion. (p. 278) Vaccine rep acknowledges chronic Lyme, and need for long-term antibiotics (read discussion). (p. 284) “infrequently, Lyme disease morbidity may be severe, chronic, and disabling”[SmithKline document].(p. 289) referencing Steere paper “from months to years later, after long periods of latent infection, that chronic neurological manifestations might develop…the organism invades and persists in affected tissues, throughout the illness.” (p. 291) “Dr. Hansen says that Western blotting should not be considered to be a confirmatory test for Lyme borreliosis….no universally effective antibiotic treatment for Lyme disease.” (p. 297) [Steere re: testing] “crude extracts that are used…no serological test distinguishes between active and past infection, and tests that identify the spirochete itself are greatly needed…some patients continue to have symptoms after treatment. This is particularly troublesome since recent research has shown that the Lyme disease spirochete may sometimes persist in the nervous system for many years.” (p. 298) “My major message is don’t pull back, more is needed, push ahead boldly. The current research and public health efforts in Lyme disease are threatened…it would be a tragedy if this highly successful research and public health effort were allowed to fall apart because of funding cutbacks…” (p. 302) “potential agents of bioterrorism or organisms that cause emerging diseases such as SARS, West Nile Virus, and Lyme Disease.” (p. 326) “two stages of the disease, acute and chronic…if left untreated, the patient may acquire chronic Lyme borreliosis…most assays used in laboratories are unreliable.” (p. 327) in a flagellin patent held by Yale, “stage three, or late infection, is defined as persistent infection, and can be severely disabling. Chronic arthritis, and syndromes of the central and peripheral nervous system appear during this stage, as a result of ongoing infection and perhaps a resulting auto-immune disease.” (p. 331 & 337) [Wormser] “A practical limitation of using doxycycline is that the drug is not available over-the-counter; an antibiotic prescription is required and the medication must be obtained within 72 hours of tick removal for the treatment to be effective.” (p. 342) [IDSA Dr. Blaser] “…fewer antibiotic products are in the drug pipeline to treat serious and life-threatening infections and fewer companies continue to invest in antibiotic research in favor of drugs for chronic diseases, which provide greater profit potential.” (p. 344) [Rib-X/Yale/Pfizer collaborators] “…grown a pipeline of clinical stage programs and an antibiotic drug discovery process to sustain the continual pipeline build.” (p. 349) “in the country of the blind, the one-eyed man is king” (p. 353) [CDC Grant to:] “increase the number of healthcare settings that comply with evidence-based guidelines for disease identification and management.” (p. 356) [Wormser grant] “In June 2003...authorities from [CDC] suggested that single-dose doxycycline be considered as an option for the prevention of Lyme disease” [and unscientific claims] “In addition, doxycycline is only recommended for patients bitten by I. scapularis ticks that are engorged with blood, an assessment that requires skill and can only be done if the tick has been saved and is relatively intact.” (p. 369) “current serological assays lack specificity and sensitivity.” (p. 372) “untreated, the disease can progress to more chronic neurologic and rheumatologic manifestations and therefore, effective management of Lyme disease is dependent on early diagnosis.” (p. 375) [Dr. Dunn] “Zoonotic pathogens including those transmitted by insect vectors are some of the most deadly of all infectious diseases known to mankind…pose serious threats…a number of these agents have been further weaponized…the most significant biothreats…we plan to use Borrelia burgdorferi…as our principal test agents…it is easy to grow…we have extensive experience in working with it” (p. 376) [Tulane grant] “preliminary studies thus far indicate that doxycycline has little effect on the spirochete enzymes.” (p. 381) “a novel biodefense anti-infection therapeutic represents a substantial market opportunity and public health need” (p. 387) “Government agencies responsible for the funding of peer-reviewed research on vector-borne diseases must be given increased resources to accomplish this goal.” (p. 387) [Dr. Fish] “…Lyme disease…these are not trivial conditions; they include Borrelia burgdorferi (the cause of Lyme disease)…Bartonella (the cause of cat scratch disease).” (p. 397) “the authors then suggested that ‘most cases’ of STARI ‘do not appear to be caused by any known borrelia species’” (read comments). (p. 398) “caution must be exercised when interpreting gene expression studies that grow Bb in this culture medium” [BSK]. (p. 407) “the CDC has stated repeatedly that the surveillance case definition is not a substitute for sound clinical judgement.” (p. 441) “We are alarmed and disappointed that Clinical Infectious Diseases has chosen to publish an article that clearly violates principles of scientific integrity.” (p. 444) [IDSA Blaser] “the CDC is suffering severe fiscal constraints and ongoing reductions at a time when vaccine needs are growing due to the licensing of several new vaccines…” (p. 462) “recent research has shown that human neutrophil elastase can kill the causative agent of Lyme disease, Borrelia burgdorferi…neutrophil elastase is also known to target outer membrane proteins.”
Thank you for your kind consideration and review of all of the materials prior to your final decision during this evaluation period.
Respectfully,
PJ Langhoff
pj@allegorypress.com