Sunday, 11 September 2011

TWO TESTIMONIES ON CHRONIC LYME DISEASE

Dr Harold Smith's excellent testimony to the Pennsylvania Public Lyme Hearing August 30 2011


Dr Yost testimony


There are a growing number of doctors who are learning from personal experience or that of a family member about the complexities of Chronic Lyme disease.

When will our Health Authorities really listen to all the evidence about this dreadful disease instead of parroting what the IDSA restrictive and discredited Lyme Disease Guidelines say.

See Lyme Aware Blog for more information here

Saturday, 3 September 2011

INTERPRET SEROLOGIC RESULTS WITH GREAT CAUTION

Large differences between test strategies for the detection of anti-Borrelia antibodies are revealed by comparing eight ELISAs and five immunoblots.

Source

VUMC, Amsterdam, The Netherlands. w.ang@vumc.nl

Abstract

We investigated the influence of assay choice on the results in a two-tier testing algorithm for the detection of anti-Borrelia antibodies. Eighty-nine serum samples from clinically well-defined patients were tested in eight different enzyme-linked immunosorbent assay (ELISA) systems based on whole-cell antigens, whole-cell antigens supplemented with VlsE and assays using exclusively recombinant proteins. A subset of samples was tested in five immunoblots: one whole-cell blot, one whole-cell blot supplemented with VlsE and three recombinant blots. The number of IgM- and/or IgG-positive ELISA results in the group of patients suspected of Borrelia infection ranged from 34 to 59%. The percentage of positives in cross-reactivity controls ranged from 0 to 38%. Comparison of immunoblots yielded large differences in inter-test agreement and showed, at best, a moderate agreement between tests. Remarkably, some immunoblots gave positive results in samples that had been tested negative by all eight ELISAs. The percentage of positive blots following a positive ELISA result depended heavily on the choice of ELISA-immunoblot combination. We conclude that the assays used to detect anti-Borrelia antibodies have widely divergent sensitivity and specificity. The choice of ELISA-immunoblot combination severely influences the number of positive results, making the exchange of test results between laboratories with different methodologies hazardous.

Serologic Tests for Lyme Disease Yield Disparate Results

When serum samples were tested for anti-Borreliaantibodies using eight commercially available ELISAs and five immunoblot assays, intertest agreement was only modest.

Current guidelines for diagnosing Lyme disease include a two-tier testing algorithm: an enzyme-linked immunosorbent assay (ELISA) for detecting anti-Borrelia antibodies, followed by immunoblot confirmation of positive ELISA results. Commercially available tests are based on sonicated whole-cellBorrelia antigens, recombinant antigens, or a mixture of the two.

To compare the performance of these assays, researchers in the Netherlands tested serum samples for anti-Borrelia antibodies using eight commercial ELISAs and five immunoblots (4 commercial, 1 investigator-made). The 89 samples were from 59 patients with suspected Lyme disease, 14 healthy controls, and 16 patients with syphilis or Mycoplasma pneumoniae infection — conditions associated with highly cross-reactive antibodies.

Of the 89 samples, 35 (39%) tested negative — and 16 (18%) tested positive — on all ELISAs. The remaining 38 (43%) tested positive on one to seven ELISAs. The proportion of samples with positive results on any one ELISA ranged from 34% to 59% for patients with suspected Lyme disease and from 0% to 38% for patients with cross-reactive antibodies. Samples from healthy controls almost always had negative ELISA results.

Thirty-one of the samples from patients with suspected Lyme disease were also tested with all immunoblots. Interblot agreement was low (IgG, 30%–84%; IgM, 0%–46%), and it was no higher for recombinant antigens than for whole-cell antigens. Some samples that tested negative on all ELISAs showed blot reactivity; some that tested positive on all ELISAs tested negative on all blots.

Comment: These findings are sobering and, unfortunately, do not facilitate diagnosis of Lyme disease. Clinicians should rely on a precise clinical determination of Lyme disease, interpreting serologic test results with great caution. Clearly, several possible ELISA/blot combinations do not work together very well. Furthermore, there are true Lyme cases with positive ELISA but negative blot results (depending on the test used), and even a few with negative ELISA but positive blot results.

Thomas Gl├╝ck, MD


link here

Thursday, 1 September 2011

DR BRANSFIELD SPEAKS OUT TO PA LYME DISEASE HEARING

Testimony for Public Hearing on Pennsylvania House Bill #272 – Lyme Disease and Related Tick-Borne Disease Education, Prevention(From Dr Robert Bransfield, distinguished psychiatrist, and the President of ILADS:)

Thank you for the opportunity to testify today. I am the President of the International Lyme and Associated Diseases Society, President of the New Jersey Psychiatric Association, a member of the Board of Trustees of the Medical Society of New Jersey, an Associate Professor at RWJ-UMDNJ Medical School, a researcher and a physician who treats patients with Lyme disease, including many from Pennsylvania. I represent the physicians who have the long term responsibility of treating patient with Lyme and associated diseases. I am in strong support of House Bill #272 and reference is made to my August 22, 2010 letter supporting this legislation last year.

In the 1600s Dr Thomas Wynne, William Penn’s physician and the first speaker for the Pennsylvania Assemblies who was also my ancestor treated a smallpox epidemic threatening the early immigrants to Pennsylvania. Today we have a different epidemic—Lyme disease. The recently released CDC Lyme statistics lists Pennsylvania and New Jersey as the two states with the most reported and confirmed new cases of Lyme disease in 2010 (PA: 3805, NJ: 3712 reported & PA: 3298, NJ: 3320 confirmed). The CDC and others recognize the formally reported cases are a small fraction of the actual cases which, according to the CDC, may be 10X the number of reported cases while the research of Boltri demonstrates the actual number of cases may instead be 40X the number of reported cases which would represent over 150,000 new cases of Lyme disease in Pennsylvania in 2010. Clearly prevention has failed. Some will be effectively treated, however a significant that are not adequately treated will progress into chronic illness resulting is a burden of disability, illness and suffering that could have been prevented by earlier diagnosis and treatment. Four National Institutes of Health (NIH) trials documented the severity of chronic Lyme disease symptoms these patients report. One trial described the pain as severe as post surgery patients and fatigue as disabling as seen in multiple sclerosis.

We in mainstream medicine strongly support any program that promotes advancement of public awareness, physician education, research, more accurate diagnosis and adequacy of treatment. As a psychiatrist I often see the failures of our medical system, the most severe late stage symptoms of Lyme and associated diseases are neuropsychiatric and that is why I became involved with Lyme disease. The psychiatric consequences of inadequately tick-borne diseases include a number of severe and disabling mental illnesses, autism, developmental disabilities, dementia and violent behavior. There are some infectious disease physicians and others in the medical community who have minimal training in psychiatry and do not understand that most mental illness is physical injury that impairs brain functioning and many of the so called ―subjective and non-specific∥ symptoms of Lyme disease are objective with adequate testing and are symptoms of sickness syndrome associated with chronic infection. No one on the IDSA guideline panel was knowledgeable about psychiatry and they inappropriately dismissed patient’s symptoms as the –―“aches and pains of daily living”. Refer to the attached list of over 250 peer reviewed medical journal articles supporting this statement.

The National Institute of Health, the CDC and scientists studying the etiology of disease all recognize a growing body of peer reviewed studies published in mainstream scientific journals that demonstrate many common diseases of unknown origin are in fact the result of the presence of slowly acting infections caused by viruses, bacteria or protozoa. Infections are often a cause of many chronic illnesses. Evidence presented during the legally mandated review of the restrictive Lyme guidelines of the Infectious Diseases Society of America (IDSA) has confirmed the potential for persistent infection with the Lyme spirochete, Borrelia burgdorferi, as well as the complicating role of multiple tick-borne coinfections and failure of short-course antibiotic therapy. In addition evidence was submitted that there are mechanisms of persistent infection that allow parasites to evade the immune system and complex interactions between multiple infections. We need to progress forward in medicine and not be hampered by outdated beliefs.

There are two opposing standards of care regarding Lyme disease which are supported by two opposing views and two opposing sets of guidelines—ILADS and IDSA. ILADS, the International Lyme and Associated Diseases Society, is evidence based and defines Lyme disease in a broader and more comprehensive manner and recognizes the limitations of current testing and the complexity of treatment while the IDSA definition is restrictive and places greater confidence in current testing and short courses of antibiotic treatment and a recent review by Lee and Vielemeyer ―found a relative paucity of good quality evidence behind current IDSA guidelines. We academicians, researchers and clinicians within ILADS and those following our guidelines that bear the responsibility to treat these patients recognize the limitations of current testing the complexity, chronicity and seriousness of these problems. The average physician inappropriately uses the CDC surveillance case definition as diagnostic criteria. The CDC website clearly states ―This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis. The Lyme ELISA has only a 46-56% accuracy rate and the Chair of the recent Virginia Task Force on Lyme Disease and Other Tick-Borne Diseases recently stated: "Doctors here in Virginia are committing malpractice by saying the ELISA test is sufficient. Their report is submitted with my testimony. There are multiple other problems with lab testing that I can expand upon. Evidence based medicine recognizes all treatment decisions are a risk vs. benefit clinical assessment that is made using the best scientific evidence available, clinical judgment and patient considerations. There is evidence some patients clearly benefit from longer courses of antibiotics and inadequate treatment of infectious diseases encourages antibiotic resistance. Although all medical treatments have risks, there is considerable evidence that inadequate treatment has been linked with autism, serious neurological, psychiatric, and other disease and death. Acne is treated for years with some of the same antibiotics used for Lyme disease. What gives distant third parties the right to oppose medically necessary treatments for Lyme disease?

We have a serious problem that cannot be ignored. It is puzzling why there is opposition to a bill that establishes a task force to investigate Lyme disease and other tick borne infections, to develop a program of public and professional education and to allow adequacy of treatment and insurance coverage. An increasing number of physicians are successfully treating patients with chronic Lyme and associated tick-borne disease with treatments that are effective and beneficial – allowing patients to have a better quality of life. As physicians we took an oath to protect our patients from harm. Laws, governmental policy and insurance mandates should complement our oath and not oppose it. Texas recently passed Lyme disease legislation because Senator Harris required 17 months of treatment and the previously restrictive IDSA based regulatory policy only allowed one month. As a senator he was able to circumvent regulations by receiving his antibiotics from 17 different physicians, but the average working person lacks this capability. This issue is best summarized by Dr. Benjamin Rush, signer of the Declaration of Independence and personal physician to George Washington who stated—―Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship to restrict the art of healing to one class of men and deny equal privileges to others: The Constitution of this Republic should make a special privilege for medical freedom as well as religious freedom. Although it has been stated politicians should not meddle in medical matters, government has a responsibility to protect basic freedoms including the freedom to access to medically necessary care.

Sincerely,

Robert C Bransfield, MD, DLFAPA

President International Lyme and Associated Diseases Society

President New Jersey Psychiatric Association

Board of Trustees Medical Society of New Jersey

Clinical Associate Professor Robert Wood Johnson UMDNJ Medical School

Associate Director Psychiatry Riverview Medical Center

Chair of Psychiatric Quality Assurance Riverview Medical Center

Board Certified American Psychiatry and Neurology in Psychiatry

Certified in Psychopharmacology by American Society of Clinical Psychopharmacology

Distinguished Life Fellow American Psychiatric Association

MEDICAL FREEDOM - THE RIGHT FOR DOCTORS TO TREAT CHRONIC LYME DISEASE PATIENTS






Dr Bransfield speaks out at Lyme Hearing in Pennsylvannia

PA Public Hearing Lyme Bill HR272 Recap

“House Bill 272 directs the Department of Health to establish a task force to address the issues surrounding Lyme disease. This task force will make and implement recommendations regarding the gaps in education, prevention and surveillance of Lyme and other tick borne diseases in Pennsylvania. The bill will also ensure that Physicians can apply the two different standards of care that exist today for the diagnosis and treatment of Lyme disease. Insurance companies have “cherry picked” which standards of care they will approve – effectively “practicing medicine” instead of doctors. With this bill, physicians will be able to apply longer-term therapies to treat Lyme disease that does not respond to shorter courses. Research has long demonstrated persistence of these infections which are related to syphilis. Lastly the bill ensures that insurance companies will pay for the treatment the physician prescribes, putting medical decisions back in the hands of physicians and patients where they should be made.”

click here for a link