The Baker's Dozen & the Lunatic Fringe: Has Junk Science Shifted the Lyme Disease Paradigm?
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 recommendation in 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.
PJ Langhoff, Hustisford, WI
This book, The Baker's Dozen & the Lunatic Fringe: Has Junk Science Shifted the Lyme Disease Paradigm? is available from Amazon.com.