For those who missed the IOM workshop yesterday
'A Workshop on the Critical Needs and Gaps in Understanding Prevention, Amelioration, and Resolution of Lyme and Other Tick-borne Diseases: the Short-Term and Long-Term Outcomes '
it can be accessed again not sure how long for here
Having listened to the videocam live there were many things that interested me.
Ben Luft's presentation was the most significant his comments later reminding everyone that Lyme Disease is a Relapsing Borrelia really sums things up.
All the babble from Wormser and Krause is irrelevant just because they haven't recognised this in their research does not prove that it is not the case - listen to the scientists!
The other significance of Luft's presentation was on the Genomic aspects of the 13 strains he looked at. Explaining why some disease is more aggressive and also why there are the problems over testing and the benefits of using this knowledge in the future.
We in the Lyme World know well the discrepancies on the studies presented by Aguero no less the circular reasoning in the Bacon et al ie that a positive blood test was needed to access the study so the study can hardly claim that it thus proves nearly 100% sensitivity in the conclusion.
Because of the lack of Lyme Doctors allowed to present these statements were allowed unchallenged, will the panel use their brains and really listen to what Luft is saying?
Well if the summing up by Walker was anything to go my probably not, he was still babbling about false positives when we in Lymeland know only too well it is false negatives that do the most harm.
Walker couldn't resist in mentioning 'unvalidated or unorthodox' tests sorry my words can't be sure what words he used - this is unrealistic to have mentioned this in summing up when there was no discussion presentation backing up his remark.
Too lump any and every test not done by our Health Authority as being not valuable to the clinical diagnosis when the Health Authority tests Elisa and Western blot clearly are limited in what they can show is irresponsible.
Pam Weintraube gave an excellent presentation as always available on her Facebook here asking for the two medical sides to come together in the interests of patients. It certainly seems that many of the best researchers are already together in a middle ground in recognising that all is not known about this formidable disease and it is too soon to be dictating rigid protocols.
Thanks to Daniel Cameron and Sam Donta for the searching questions they achieved a lot despite not being allowed to present fully.
Thanks also to the patients and Patient advocates for their poignant stories and searching questions.
The Paediatrician sorry not sure his name gave a very powerful presentation reminding the panel that with children we were sentencing them not just to a few years but 60/70 years of chronic illness and also reminding everyone that they are not small adults but that their CNS was not developed as in an adult and their illness therefore does not present in the way of an adult.
Altogether there was much good science that was heard today supporting ILADS views but were the right people listening and will they transcribe that so that science and treating patients can benefit?
Tuesday, 12 October 2010
Sunday, 10 October 2010
STATE OF THE SCIENCE LYME DISEASE AND OTHER TICKBORNE DISEASES
Institute of Medicine Workshop Monday 11th and Tuesday 12th October
The Institute of Medicine Committee on Lyme Disease and Other Tick-borne Diseases: The State of Science is holding a workshop on October 11-12, 2010 on the critical needs and gaps in understanding the prevention, amelioration, and resolution of Lyme and other tick-borne diseases.
Webcast link here
For details over this controversial workshop see CALDA blog here
Despite the clearly biased selection of presenters it is good to see Benjamin Luft will be presenting, especially with his recent work on the Whole Genome Sequences of 13 isolates of Borrelia Burgdorferi here
not forgetting Brian Fallon and Pam Weintraube.
Commissioned papers can be found through the link on the right of this here
The Institute of Medicine Committee on Lyme Disease and Other Tick-borne Diseases: The State of Science is holding a workshop on October 11-12, 2010 on the critical needs and gaps in understanding the prevention, amelioration, and resolution of Lyme and other tick-borne diseases.
Webcast link here
For details over this controversial workshop see CALDA blog here
Despite the clearly biased selection of presenters it is good to see Benjamin Luft will be presenting, especially with his recent work on the Whole Genome Sequences of 13 isolates of Borrelia Burgdorferi here
not forgetting Brian Fallon and Pam Weintraube.
Commissioned papers can be found through the link on the right of this here
Friday, 8 October 2010
WHOLE GENOME SEQUENCES OF THIRTEEN ISOLATES OF BORRELIA BURGDORFERI
UNIVERSITY OF MEDICINE & DENTISTRY OF NEW JERSEY.
Press Release here
Date: 10-08-10
Name: Rob Forman
Phone: 973 972 7276
Email: formanra@umdnj.edu
Researchers Determine the Genetic Blueprint of the Lyme Disease Microbe
Researchers Dr. Steven E. Schutzer of UMDNJ-New Jersey Medical School and Dr. Claire M. Fraser-Liggett of the Institute for Genome Sciences, University of Maryland, and their collaborators have made a major achievement toward better understanding Lyme disease, by determining the complete genetic structures of 13 strains of the bacteria that cause the disease.
These new discoveries may accelerate research efforts to diagnose, prevent and treat the disease, which can affect the nervous system, heart, skin and joints. The occurrence of the disease has grown dramatically over the past ten years in the United States and Europe. The research, which was funded by the National Institutes of Health, has been published online ahead of print in the Journal of Bacteriology.
Journal of Bacteriology
Abstract
Borrelia burgdorferi is a causative agent of Lyme disease in North America and Eurasia. The first complete genome sequence of B. burgdorferi strain 31, available for more than a decade, has assisted research on the pathogenesis of Lyme disease. Because a single genome sequence is not sufficient to understand the relationship between genotypic and geographic variation and disease phenotype, we determined the whole genome sequences of 13 additional B. burgdorferi isolates that span the range of natural variation. These sequences should allow improved
understanding of pathogenesis and provide a foundation for novel detection, diagnosis, and prevention strategies.
Press Release here
Date: 10-08-10
Name: Rob Forman
Phone: 973 972 7276
Email: formanra@umdnj.edu
Researchers Determine the Genetic Blueprint of the Lyme Disease Microbe
Researchers Dr. Steven E. Schutzer of UMDNJ-New Jersey Medical School and Dr. Claire M. Fraser-Liggett of the Institute for Genome Sciences, University of Maryland, and their collaborators have made a major achievement toward better understanding Lyme disease, by determining the complete genetic structures of 13 strains of the bacteria that cause the disease.
These new discoveries may accelerate research efforts to diagnose, prevent and treat the disease, which can affect the nervous system, heart, skin and joints. The occurrence of the disease has grown dramatically over the past ten years in the United States and Europe. The research, which was funded by the National Institutes of Health, has been published online ahead of print in the Journal of Bacteriology.
Journal of Bacteriology
Abstract
Borrelia burgdorferi is a causative agent of Lyme disease in North America and Eurasia. The first complete genome sequence of B. burgdorferi strain 31, available for more than a decade, has assisted research on the pathogenesis of Lyme disease. Because a single genome sequence is not sufficient to understand the relationship between genotypic and geographic variation and disease phenotype, we determined the whole genome sequences of 13 additional B. burgdorferi isolates that span the range of natural variation. These sequences should allow improved
understanding of pathogenesis and provide a foundation for novel detection, diagnosis, and prevention strategies.
Wednesday, 6 October 2010
MEDICAL ETHICS TUSKEGEE, GUATEMALA AND NOW LYME DISEASE?
Breaking news, nbc exclusive, frankly a stunning disclosure from the federal government about medical experiments. the u.s. conducted on unknowing patients back in the 1940s. today officials at the very highest levels of government will apologize. robert bazzell is nbc's chief science correspondent. good morning.
>> good morning. the officials that will do the apologizing including secretary of state liquiditien and sebelius. from 1946 to 1948, officials with the u.s. public health service injected gonorrhea and syphilis as part every an experiment in people in guatemala without their permission or consent. these people included people in mental institutions, included prostitutes set loose in prison in an attempt to see how the organisms would spread, all part of an effort to learn more about venereal disease. the records were hidden for many years unless a historic at wesleyan found out about them. we'll hear more about t. but a lot of apologizing all the way around.
>> so bob, this professor found out about it, and presumably brought it to the attention of the u.s. government?
>> she brought it to the attention of the u.s. government. she was studying, and has written extensively about the tuesday ka heee expert on syphilis on african-merican men. this raises comparisons with that horrible incident where from 1932 until press reports revealed it was going on in 1972, u.s. government doctors were telling these african-american men that they were treating them for syphilis when in fact they were withholding treatment. this is a very similar event, though it occurred in guatemala. there will be a lot of apologizing to the nation of guatemala and his spain residents of the united states.
>> good the guatemalan government have any suspicion about this?
>> i think at that time they were fully cooperative, chuck. don't forget there was a lot of politics between guatemala and the united states in that time. 1954, the cia engineered a coup in guatemala.
>> they were hiding this as well?
>> they were hiding this as well. a lot of doctors and nurses were involved in this, but it was under the authority of doctors from the u.s. public health service who was in guatemala. the samples, for instance, of the syphilis organism were taken from a lab in staten island and flown from guatemala to be injected in people without their consent. robert bazzell with the breaks news. secretary sebelius will do a public apology today for experiments that happened back in the '40s. the u.s. government intentionally injecting guatemalans.
>> with cooperation from the guatemalan government. you also heard that secretary of state clinton will you issuing an apology.
http://www.msnbc.msn.com/id/21134540/vp/39456613#39456613
LESTER HOLT, anchor: today from President Obama for something that happened more than 60 years ago. The US conducted secret medical experiments that involved the -- intentionally infecting Guatemalan mental patients with sexually transmitted diseases. Tonight Guatemala is calling it a crime against humanity and says it may take the case to an international court. NBC's chief science correspondent Robert Bazell broke the story this morning. He has this late update tonight.
ROBERT BAZELL reporting: The secret experiments took place in Guatemala between 1946 and 1948, financed by the US government and supervised by US government doctors. Susan Reverby, a professor at Wellesley College, who has studied medical malfeasance extensively, found the evidence in US government records.
Dr. SUSAN REVERBY: I thought that -- frankly, that I wouldn't get shocked but I thought this one was pretty horrific. The details of how they did it were pretty graphic. And I was actually quite surprised.
BAZELL: The doctors inoculated almost 700 prostitutes, institutionalized mental patients and prisoners with the germs that cause either syphilis or gonorrhea.
BAZELL: The subjects did not give their permission and were not told what was happening. They were injected in the skin, the genitals, even the spine. Infected female prostitutes were also sent into the prison and mental hospital to infect men.
Dr. REVERBY: They knew that this wasn't appropriate. The surgeon general even said we couldn't do this in the United States.
BAZELL: The experiments were designed to study the effects of penicillin on sexually transmitted disease. Still, as many as a third of the patients were not properly treated. Today, outrage on the streets of Guatemala's capital and in newspapers online, and from Guatemalan-Americans in Los Angeles.
Mr. RAFAEL CASTILLO (Guatemalan Unity Information Agency): Actually, I'm very surprise, upset. It's like a combination of feelings because it's been a long time already, but it's something outrageous, I would call it.
BAZELL: The incident recalls the infamous Tuskegee, Alabama, syphilis experiment.
nidentified Man: What is now called the Tuskegee experiment began here in 1932.
BAZELL: From 1932 until the research was revealed in the press in 1972, government doctors lied to hundreds of African-American men who were infected naturally. The doctors, some also involved in the Guatemala experiment, told the men they were getting treatment, but in fact they were not. Despite numerous apologies, that incident has left many black Americans weary of the medical establishment.
Dr. BILL RELEFORD (Health Educator): It still resonates after generations and generations. And people still talk about it. So this legacy of mistrust in the African-American community still exists.
BAZELL: Even though the Guatemala experiment took place more than 60 years ago, officials today call on the prestigious Institute of Medicine to launch a full investigation and identify steps to prevent further abuses. Another example of the most vulnerable being victimized and of doctors who ignore their pledge to first do no harm. Robert Bazell, NBC News, New York.
http://www.msnbc.msn.com/id/21134540/vp/39466192#39466192
Prof. Susan M. Reverby website
http://www.wellesley.edu/WomenSt/fac_reverby.html
A detailed report by Prof. Susan M. Reverby
http://www.wellesley.edu/WomenSt/Reverby%20Normal%20Exposure.pdf
Prof. Reverby quotes Thomas Rivers the famed Virologist in which he refers to the law winking when medical science is involved.
The ethics of our Health Departments need careful examination when it comes to Lyme Disease and the denial of Chronic Lyme Disease, methinks there has been too much winking going on over the last 30 years and not enough attention to all the available science.
Ken Liegner's letter to the Institute of Medicine likens the problems over Lyme disease to Tuskegee x 10000.
>> good morning. the officials that will do the apologizing including secretary of state liquiditien and sebelius. from 1946 to 1948, officials with the u.s. public health service injected gonorrhea and syphilis as part every an experiment in people in guatemala without their permission or consent. these people included people in mental institutions, included prostitutes set loose in prison in an attempt to see how the organisms would spread, all part of an effort to learn more about venereal disease. the records were hidden for many years unless a historic at wesleyan found out about them. we'll hear more about t. but a lot of apologizing all the way around.
>> so bob, this professor found out about it, and presumably brought it to the attention of the u.s. government?
>> she brought it to the attention of the u.s. government. she was studying, and has written extensively about the tuesday ka heee expert on syphilis on african-merican men. this raises comparisons with that horrible incident where from 1932 until press reports revealed it was going on in 1972, u.s. government doctors were telling these african-american men that they were treating them for syphilis when in fact they were withholding treatment. this is a very similar event, though it occurred in guatemala. there will be a lot of apologizing to the nation of guatemala and his spain residents of the united states.
>> good the guatemalan government have any suspicion about this?
>> i think at that time they were fully cooperative, chuck. don't forget there was a lot of politics between guatemala and the united states in that time. 1954, the cia engineered a coup in guatemala.
>> they were hiding this as well?
>> they were hiding this as well. a lot of doctors and nurses were involved in this, but it was under the authority of doctors from the u.s. public health service who was in guatemala. the samples, for instance, of the syphilis organism were taken from a lab in staten island and flown from guatemala to be injected in people without their consent. robert bazzell with the breaks news. secretary sebelius will do a public apology today for experiments that happened back in the '40s. the u.s. government intentionally injecting guatemalans.
>> with cooperation from the guatemalan government. you also heard that secretary of state clinton will you issuing an apology.
http://www.msnbc.msn.com/id/21134540/vp/39456613#39456613
LESTER HOLT, anchor: today from President Obama for something that happened more than 60 years ago. The US conducted secret medical experiments that involved the -- intentionally infecting Guatemalan mental patients with sexually transmitted diseases. Tonight Guatemala is calling it a crime against humanity and says it may take the case to an international court. NBC's chief science correspondent Robert Bazell broke the story this morning. He has this late update tonight.
ROBERT BAZELL reporting: The secret experiments took place in Guatemala between 1946 and 1948, financed by the US government and supervised by US government doctors. Susan Reverby, a professor at Wellesley College, who has studied medical malfeasance extensively, found the evidence in US government records.
Dr. SUSAN REVERBY: I thought that -- frankly, that I wouldn't get shocked but I thought this one was pretty horrific. The details of how they did it were pretty graphic. And I was actually quite surprised.
BAZELL: The doctors inoculated almost 700 prostitutes, institutionalized mental patients and prisoners with the germs that cause either syphilis or gonorrhea.
BAZELL: The subjects did not give their permission and were not told what was happening. They were injected in the skin, the genitals, even the spine. Infected female prostitutes were also sent into the prison and mental hospital to infect men.
Dr. REVERBY: They knew that this wasn't appropriate. The surgeon general even said we couldn't do this in the United States.
BAZELL: The experiments were designed to study the effects of penicillin on sexually transmitted disease. Still, as many as a third of the patients were not properly treated. Today, outrage on the streets of Guatemala's capital and in newspapers online, and from Guatemalan-Americans in Los Angeles.
Mr. RAFAEL CASTILLO (Guatemalan Unity Information Agency): Actually, I'm very surprise, upset. It's like a combination of feelings because it's been a long time already, but it's something outrageous, I would call it.
BAZELL: The incident recalls the infamous Tuskegee, Alabama, syphilis experiment.
nidentified Man: What is now called the Tuskegee experiment began here in 1932.
BAZELL: From 1932 until the research was revealed in the press in 1972, government doctors lied to hundreds of African-American men who were infected naturally. The doctors, some also involved in the Guatemala experiment, told the men they were getting treatment, but in fact they were not. Despite numerous apologies, that incident has left many black Americans weary of the medical establishment.
Dr. BILL RELEFORD (Health Educator): It still resonates after generations and generations. And people still talk about it. So this legacy of mistrust in the African-American community still exists.
BAZELL: Even though the Guatemala experiment took place more than 60 years ago, officials today call on the prestigious Institute of Medicine to launch a full investigation and identify steps to prevent further abuses. Another example of the most vulnerable being victimized and of doctors who ignore their pledge to first do no harm. Robert Bazell, NBC News, New York.
http://www.msnbc.msn.com/id/21134540/vp/39466192#39466192
Prof. Susan M. Reverby website
http://www.wellesley.edu/WomenSt/fac_reverby.html
A detailed report by Prof. Susan M. Reverby
http://www.wellesley.edu/WomenSt/Reverby%20Normal%20Exposure.pdf
Prof. Reverby quotes Thomas Rivers the famed Virologist in which he refers to the law winking when medical science is involved.
The ethics of our Health Departments need careful examination when it comes to Lyme Disease and the denial of Chronic Lyme Disease, methinks there has been too much winking going on over the last 30 years and not enough attention to all the available science.
Ken Liegner's letter to the Institute of Medicine likens the problems over Lyme disease to Tuskegee x 10000.
An earlier post here
RESEARCH GAPS IN TICKBORNE DISEASES
Congressional Record
111th Congress (2009-2010)
ISSUES REGARDING LYME DISEASE -- (Extensions of Remarks - September 29, 2010)
http://thomas.loc.gov/cgi-bin/query/z?r111:E29SE0-0367:
[Page: E1872] GPO's PDF
---SPEECH OF
HON. CHRISTOPHER H. SMITH
OF NEW JERSEY
IN THE HOUSE OF REPRESENTATIVES
WEDNESDAY, SEPTEMBER 29, 2010
Mr. SMITH of New Jersey. Madam Speaker, as chair of the congressional Lyme Disease Caucus and a person who has been closely involved in Lyme disease issues for over twenty years, I want to bring to your attention extremely troubling issues regarding Lyme disease.
Lyme disease is the most common of all vector-borne infections in the U.S., with approximately 290,000 new cases in 2008. With the increase in Lyme cases, problems due to poor diagnostics and ineffective treatments for Lyme disease have become almost overwhelming--affecting larger numbers of people over longer periods of time.
Many patients are angry because progress in addressing Lyme disease has been impeded by entrenched bias and a lack of accountability in the science of tick borne diseases. It is critical that we identify biases and impediments that are constraining the science on Lyme and to open up the dialogue to honest and transparent debate. The scientists who have long been marginalized, the treating physicians who have felt intimidated and threatened, and most importantly the sick patients and their families need our help.
My main purpose here today is to introduce for inclusion in the Congressional Record the following statement ``The Patient Perspectives on the Research Gaps in Tick Borne Diseases,'' written by three of the Nation's largest Lyme disease advocacy organizations, who represent tens of thousands of patients. I believe that this statement provides important perspectives that need to be heard and taken to heart.
PATIENT PERSPECTIVES ON THE RESEARCH GAPS IN TICK BORNE DISEASES
(Submitted by Time for Lyme, the national Lyme Disease Association, and the California Lyme Disease Association on behalf of our patients across the United States)
In December 2009, Labor HHS 2010 appropriations language, signed into law by President Obama, encouraged the National Institutes of Health (NIH) to ``sponsor a scientific conference on Lyme and tick-borne diseases ..... the conference should represent the broad spectrum of scientific views ..... and should provide a forum for public participation and input from individuals with Lyme disease.'' The language also requires NIH to identify research gaps to understand the ``mechanisms of persistent infection.'' The passage of this language represents a significant opportunity to summarize and solidify the issues that prevent scientific progress for a disease recognized here for 35 years, if, and only if, this process occurs without bias. Progress can be accomplished if the stewards commit to the elimination of predisposition by key decision makers.
It is not clear why the NIH elected to subcontract this issue to the Institute of Medicine (IOM), given that the existing NIH conference structure contains the best process to address the appropriations language requirements. According to the NIH Consensus Development Program, which explains the two relevant types of conferences offered by NIH, ``when the available evidence is weak or contradictory, or when a common practice is not supported by high-quality evidence, the State-of-the-Science label is chosen.'' This conference format would appropriately address the research gaps that exist for Lyme and tick-borne diseases as it provides a ``snapshot in time'' of the state of knowledge on the conference rather than a policy statement of the NIH or the Federal Government.
In Lyme disease, there are two distinct disease paradigms, each providing science to support its claims. One paradigm views the disease as ``hard to catch and easy to cure'' and denies the existence of chronic Lyme disease--persistent infection with Borrelia burgdorferi, the spirochete that causes the disease. Under this paradigm, the state of the science for patients with chronic Lyme disease is closed. Any treatment is considered too risky because practitioners are unable to determine the cause or extent of patient symptoms, or they view the symptoms
[Page: E1873] GPO's PDFas insignificant and write off the patients' complaints as psychiatric in nature. This leaves seriously ill patients without any viable therapeutic avenues. It also shuts the door on future research necessary to get patients to a state of wellness.
The alternative paradigm says that the science is too unsettled to be definitive and there can be one or more causes of persistent symptoms after initial treatment in an individual who has been infected with the agent of Lyme disease. These causes include the possibility of persistent infection, or a post-infectious process, or a combination of both, with the Lyme bacterium itself driving the autoimmune process. This paradigm allows doctors the ability to exercise their clinical judgment and provide therapies that are helping their patients.
Patients with Lyme disease need a research agenda that reflects outcomes that matter to patients, namely effective diagnostic tools and effective treatments that restore them to health. The reason there are two disease paradigms in Lyme disease is because central pieces of the puzzle are missing or are inadequate. The first area of concern involves testing.
There are no reliable biomarkers of the disease.\1\ Current diagnostic tests commonly used do not detect the spirochete that causes Lyme disease, rather, they detect only whether the patient has developed antibodies to the pathogen. Antibody production, if it registers on the tests at all, takes weeks to appear, thus rendering the current tests ineffective in the earlier and more easily addressed stage. Additionally, the Lyme antibody has been shown to form a ``complex'' with the bacterium itself--and tests cannot detect ``complex'' antibodies. Once triggered, antibody reactions may remain long after an infection has been treated, also clouding the diagnostic and treatment picture.
The two-tier testing system endorsed by the Centers for Disease Control and Prevention (CDC) is very specific for Lyme disease (99%), so it gives few false positives. But the tests have a uniformly low sensitivity (56%)--missing 88 of every 200 patients with Lyme disease. By comparison, AIDS tests have a sensitivity of 99.5%--missing only one of every 200 infected patients.\2\ Sensitive AIDS tests were developed less than 10 years into the disease, while archaic Lyme tests remain unreliable 35 years later. There is a critical need for research exploring newer technologies such as polymerase chain reaction (PCR), which is used with many other diseases, and cutting-edge proteomics. Strain variations and co-infections with other organisms, often transmitted by the same tick bite, obscure the diagnostic picture further.
A vast number of strains of Borrelia burgdorferi have been identified. Variation in strain may cause differing symptoms or severity of symptoms as well as determine the appropriate antibiotics and duration of treatment needed to clear the infection.\3\ Different strains may also express different proteins. Preliminary research shows that proteins need to be examined to find the ones most often expressed, then using microarray technology, doctors may be able to diagnose patients using a chip which contains the proteins.
Research is needed concerning the role of mutation on persistence. Some research indicates that bacteria can exchange genetic material, probably contributing to its ability to invade different systems in the body--some may have a proclivity for the heart muscle, others for the brain, and some for muscles and joints. By exchanging genetic material, bacteria may be able to form a symbiotic relationship to avoid detection by the immune response or to further invade the body.
To date, every NIH-funded treatment research study has been designed using the inaccurate diagnostic test results as part of the entry criteria. The entry criterion in these studies excluded the vast majority of Lyme patients and created sample sizes too small (less than 220 patients to date) to detect clinically important treatment effects or generalize to the clinical population. Moreover, Lyme has not attracted industry funding for treatment approaches, which places the disease at a considerable research disadvantage. To detect clinically relevant treatment effects requires much larger treatment trials with sample populations that reflect those seen in clinical practice.\4\
One thing that past research has demonstrated is that patients with Lyme are a heterogeneous population. Hence, the course of illness and responsiveness to treatment may vary depending on the duration of onset of the disease to its diagnosis and treatment, the presence of co-infections, comorbid factors, other genetic characteristics of the patients, and the virulence of the strain(s) with which the patient is infected. Research sample populations must reflect those seen in clinical practice to yield clinically relevant results.
As advised by the Appropriations language, research on the pathophysiology of Lyme disease is necessary. Research projects need to be designed which determine the course of the disease from inception, and which utilize treatments that effectively interfere with the mechanisms that allow the infection to persist. Little to no government sponsored science has been dedicated to the effects on persistence of the different forms of the Lyme bacterium (cyst vs. flagellar), the role, if any, of biofilms, sequestration of the organism from the immune system, the exchange and mutation of genetic material of the spirochete, and the role that components of the bacterial genome may play in protecting it from eradication by the immune system or antibiotics. Understanding the pathology of the organism can greatly enhance targeted diagnostics and treatment modalities.
Patients also need studies that explore a range of treatment options. The ideal antibiotics, route of administration, and duration of treatment for any stage of Lyme disease are not established. No single antibiotic or combination of antibiotics appears to be capable of completely eradicating the infection in all patients, and treatment failures or relapses are reported with all current regimens, although they are less common with early aggressive treatment.\5\ Treatment failure rates suggest the need to re-examine the effectiveness of the currently recommended monotherapy as a treatment approach. Studies need to explore combination treatments and longer term treatment regimens, which have been critical to the successful treatment of AIDS and tuberculosis.
Patients need the type of outcomes research advocated by the IOM to examine how well treatments are working in actual clinical practice.\6\ While not all patients with chronic Lyme disease have returned to a state of wellness, many have, and we need to find out how and why. This information can then be applied to other patients and used to establish a research agenda for treatment that has a likelihood of success, rather than abandoning patients based on limited treatment trials.
The IOM process does not allow these research ideas to be heard in an unbiased and transparent fashion with balanced divergent viewpoints. While the NIH process precludes bias on the part of panel members, the IOM does not. Four of the six members of the IOM panel that have been selected belong to IDSA, a medical society that has a known bias against chronic Lyme disease diagnosis and treatment. Rather than providing curative treatments that restore health, the IDSA would provide costly and long term palliative treatments, presumably for life. While the NIH requires participation by major stakeholders (including patients and treating physicians), the IOM does not.
The summary of the IOM proceedings will reflect this pervasive lack of objectivity, undermining its integrity and credibility. Additionally, much IOM deliberation is done behind closed doors and an anonymous panel will be permitted to comment on the written record. Because of such flaws in the IOM proceedings, the three largest patient interest groups who were offered a brief opportunity to speak (TFL) at the IOM October 2010 meeting and an opportunity to provide a commissioned paper--CALDA, the LDA and TFL--pulled out of the conference in protest.
From a research perspective, strongly held paradigms can create a closed loop, and experiments may be designed, implemented and interpreted to support a particular viewpoint.\7\ The antidote to bias is to balance scientific perspectives and to ensure that all scientific viewpoints are being heard and explored. Given the extraordinary stream of federal funding granted to researchers who support the closed paradigm which was created and is supported by the Infectious Diseases Society of America (IDSA) and their vested interest in maintaining the status quo, it is not reasonable to expect this group of researchers to serve as neutral arbiters of scientific debates over competing scientific paradigms. For example, Lyme related panels dominated by IDSA have time and time again excluded opposing viewpoints from participating or controlled the review process to ensure outcomes that reinforce the IDSA paradigm. If past is prologue, it is obvious what the future holds for panels dominated by one group.
Worse, the small treatment trials that have been conducted have been given an undue amount of weight by IDSA researchers and in its guidelines and used to apply a degree of certainty on the science that far exceeds the limitations of the small sample sizes of the studies. Further, they claim that the state of the science is sufficient to determine with certainty that chronic Lyme disease does not exist, is not treatable with antibiotics, and that no further research on this topic is needed. Sample size affects the strength of the conclusions that may be drawn from them: ``Providing definitive answers in the face of low event rates and small-to-moderate treatment effects necessitates sample sizes in the thousands or tens of thousands. ..... Funding for such mega-trials is very limited, and is often restricted to industry sources.'' \8\
For that reason, the Connecticut Attorney General antitrust investigation into the development process of IDSA Lyme guidelines found exclusionary practices and suppression of divergent viewpoints on the part of IDSA panels that crafted IDSA 2000 and the 2006 Lyme disease guidelines. Although IDSA settled the investigation with the Attorney General by agreeing to review its guidelines with a panel without conflicts of interest, the control of the process was in the hands of IDSA, which again selected a panel consisting almost exclusively of IDSA members and excluding treating physicians who held divergent viewpoints.
It was patients who pressed for the language in the Appropriations bill that called for a review of the state of the science of Lyme disease. However, patients need that process to occur in a transparent manner, without bias, and with the participation of all stakeholders. Albert Einstein defined insanity as ``doing the same thing over and over again and expecting different results.''
[Page: E1874] GPO's PDFThis process is a perfect example of that insanity.
Patients want research which will restore their health. Their voice and the voice of the clinicians must be given the necessary weight to legitimize the research agenda and the research process. Truth in science can be achieved through open debate in an independent process free from bias and conflicts of interest. The scientific process fails when one side of a debate controls the arena and sets the rules to ensure that its viewpoint prevails.
Lorraine Johnson, JD, MBA, Chief Executive Officer, California Lyme Disease Association.
Patricia V. Smith, President, Lyme Disease Association, Inc.
Diane Blanchard/Deb Siciliano, Co-Presidents, Time for Lyme, Inc. ENDNOTES
\1\ Steiner I. Treating post Lyme disease: trying to solve one equation with too many unknowns. Neurology 2003; 60:1888-9.
\2\ Stricker RB, Johnson L. Lyme wars: let's tackle the testing. BMJ 2007; 335:1008.
\3\ Weintraub P. What we don't know about Lyme. Experience Life Magazine June 2009.
\4\ Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med, 2008; 5:e4.
\5\ Hunfeld KP, Ruzic-Sabljic E, Norris DE, Kraiczy P, Strle F. In vitro susceptibility testing of Borrelia burgdorferi sensu lato isolates cultured from patients with erythema migrans before and after antimicrobial chemotherapy. Antimicrobial agents and chemotherapy 2005; 49:1294-301.
\6\ Institute of Medicine (Committee on Quality of Health Care in America). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press, 2001.
\7\ Ernst E, Canter PH. Investigator bias and false positive findings in medical research. Trends Pharmacol. Sci. 24(5), 219-221 (2003).
\8\ Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med, 2008; 5:e4.
***************************************************
111th Congress (2009-2010)
ISSUES REGARDING LYME DISEASE -- (Extensions of Remarks - September 29, 2010)
http://thomas.loc.gov/cgi-bin/query/z?r111:E29SE0-0367:
[Page: E1872] GPO's PDF
---SPEECH OF
HON. CHRISTOPHER H. SMITH
OF NEW JERSEY
IN THE HOUSE OF REPRESENTATIVES
WEDNESDAY, SEPTEMBER 29, 2010
Mr. SMITH of New Jersey. Madam Speaker, as chair of the congressional Lyme Disease Caucus and a person who has been closely involved in Lyme disease issues for over twenty years, I want to bring to your attention extremely troubling issues regarding Lyme disease.
Lyme disease is the most common of all vector-borne infections in the U.S., with approximately 290,000 new cases in 2008. With the increase in Lyme cases, problems due to poor diagnostics and ineffective treatments for Lyme disease have become almost overwhelming--affecting larger numbers of people over longer periods of time.
Many patients are angry because progress in addressing Lyme disease has been impeded by entrenched bias and a lack of accountability in the science of tick borne diseases. It is critical that we identify biases and impediments that are constraining the science on Lyme and to open up the dialogue to honest and transparent debate. The scientists who have long been marginalized, the treating physicians who have felt intimidated and threatened, and most importantly the sick patients and their families need our help.
My main purpose here today is to introduce for inclusion in the Congressional Record the following statement ``The Patient Perspectives on the Research Gaps in Tick Borne Diseases,'' written by three of the Nation's largest Lyme disease advocacy organizations, who represent tens of thousands of patients. I believe that this statement provides important perspectives that need to be heard and taken to heart.
PATIENT PERSPECTIVES ON THE RESEARCH GAPS IN TICK BORNE DISEASES
(Submitted by Time for Lyme, the national Lyme Disease Association, and the California Lyme Disease Association on behalf of our patients across the United States)
In December 2009, Labor HHS 2010 appropriations language, signed into law by President Obama, encouraged the National Institutes of Health (NIH) to ``sponsor a scientific conference on Lyme and tick-borne diseases ..... the conference should represent the broad spectrum of scientific views ..... and should provide a forum for public participation and input from individuals with Lyme disease.'' The language also requires NIH to identify research gaps to understand the ``mechanisms of persistent infection.'' The passage of this language represents a significant opportunity to summarize and solidify the issues that prevent scientific progress for a disease recognized here for 35 years, if, and only if, this process occurs without bias. Progress can be accomplished if the stewards commit to the elimination of predisposition by key decision makers.
It is not clear why the NIH elected to subcontract this issue to the Institute of Medicine (IOM), given that the existing NIH conference structure contains the best process to address the appropriations language requirements. According to the NIH Consensus Development Program, which explains the two relevant types of conferences offered by NIH, ``when the available evidence is weak or contradictory, or when a common practice is not supported by high-quality evidence, the State-of-the-Science label is chosen.'' This conference format would appropriately address the research gaps that exist for Lyme and tick-borne diseases as it provides a ``snapshot in time'' of the state of knowledge on the conference rather than a policy statement of the NIH or the Federal Government.
In Lyme disease, there are two distinct disease paradigms, each providing science to support its claims. One paradigm views the disease as ``hard to catch and easy to cure'' and denies the existence of chronic Lyme disease--persistent infection with Borrelia burgdorferi, the spirochete that causes the disease. Under this paradigm, the state of the science for patients with chronic Lyme disease is closed. Any treatment is considered too risky because practitioners are unable to determine the cause or extent of patient symptoms, or they view the symptoms
[Page: E1873] GPO's PDFas insignificant and write off the patients' complaints as psychiatric in nature. This leaves seriously ill patients without any viable therapeutic avenues. It also shuts the door on future research necessary to get patients to a state of wellness.
The alternative paradigm says that the science is too unsettled to be definitive and there can be one or more causes of persistent symptoms after initial treatment in an individual who has been infected with the agent of Lyme disease. These causes include the possibility of persistent infection, or a post-infectious process, or a combination of both, with the Lyme bacterium itself driving the autoimmune process. This paradigm allows doctors the ability to exercise their clinical judgment and provide therapies that are helping their patients.
Patients with Lyme disease need a research agenda that reflects outcomes that matter to patients, namely effective diagnostic tools and effective treatments that restore them to health. The reason there are two disease paradigms in Lyme disease is because central pieces of the puzzle are missing or are inadequate. The first area of concern involves testing.
There are no reliable biomarkers of the disease.\1\ Current diagnostic tests commonly used do not detect the spirochete that causes Lyme disease, rather, they detect only whether the patient has developed antibodies to the pathogen. Antibody production, if it registers on the tests at all, takes weeks to appear, thus rendering the current tests ineffective in the earlier and more easily addressed stage. Additionally, the Lyme antibody has been shown to form a ``complex'' with the bacterium itself--and tests cannot detect ``complex'' antibodies. Once triggered, antibody reactions may remain long after an infection has been treated, also clouding the diagnostic and treatment picture.
The two-tier testing system endorsed by the Centers for Disease Control and Prevention (CDC) is very specific for Lyme disease (99%), so it gives few false positives. But the tests have a uniformly low sensitivity (56%)--missing 88 of every 200 patients with Lyme disease. By comparison, AIDS tests have a sensitivity of 99.5%--missing only one of every 200 infected patients.\2\ Sensitive AIDS tests were developed less than 10 years into the disease, while archaic Lyme tests remain unreliable 35 years later. There is a critical need for research exploring newer technologies such as polymerase chain reaction (PCR), which is used with many other diseases, and cutting-edge proteomics. Strain variations and co-infections with other organisms, often transmitted by the same tick bite, obscure the diagnostic picture further.
A vast number of strains of Borrelia burgdorferi have been identified. Variation in strain may cause differing symptoms or severity of symptoms as well as determine the appropriate antibiotics and duration of treatment needed to clear the infection.\3\ Different strains may also express different proteins. Preliminary research shows that proteins need to be examined to find the ones most often expressed, then using microarray technology, doctors may be able to diagnose patients using a chip which contains the proteins.
Research is needed concerning the role of mutation on persistence. Some research indicates that bacteria can exchange genetic material, probably contributing to its ability to invade different systems in the body--some may have a proclivity for the heart muscle, others for the brain, and some for muscles and joints. By exchanging genetic material, bacteria may be able to form a symbiotic relationship to avoid detection by the immune response or to further invade the body.
To date, every NIH-funded treatment research study has been designed using the inaccurate diagnostic test results as part of the entry criteria. The entry criterion in these studies excluded the vast majority of Lyme patients and created sample sizes too small (less than 220 patients to date) to detect clinically important treatment effects or generalize to the clinical population. Moreover, Lyme has not attracted industry funding for treatment approaches, which places the disease at a considerable research disadvantage. To detect clinically relevant treatment effects requires much larger treatment trials with sample populations that reflect those seen in clinical practice.\4\
One thing that past research has demonstrated is that patients with Lyme are a heterogeneous population. Hence, the course of illness and responsiveness to treatment may vary depending on the duration of onset of the disease to its diagnosis and treatment, the presence of co-infections, comorbid factors, other genetic characteristics of the patients, and the virulence of the strain(s) with which the patient is infected. Research sample populations must reflect those seen in clinical practice to yield clinically relevant results.
As advised by the Appropriations language, research on the pathophysiology of Lyme disease is necessary. Research projects need to be designed which determine the course of the disease from inception, and which utilize treatments that effectively interfere with the mechanisms that allow the infection to persist. Little to no government sponsored science has been dedicated to the effects on persistence of the different forms of the Lyme bacterium (cyst vs. flagellar), the role, if any, of biofilms, sequestration of the organism from the immune system, the exchange and mutation of genetic material of the spirochete, and the role that components of the bacterial genome may play in protecting it from eradication by the immune system or antibiotics. Understanding the pathology of the organism can greatly enhance targeted diagnostics and treatment modalities.
Patients also need studies that explore a range of treatment options. The ideal antibiotics, route of administration, and duration of treatment for any stage of Lyme disease are not established. No single antibiotic or combination of antibiotics appears to be capable of completely eradicating the infection in all patients, and treatment failures or relapses are reported with all current regimens, although they are less common with early aggressive treatment.\5\ Treatment failure rates suggest the need to re-examine the effectiveness of the currently recommended monotherapy as a treatment approach. Studies need to explore combination treatments and longer term treatment regimens, which have been critical to the successful treatment of AIDS and tuberculosis.
Patients need the type of outcomes research advocated by the IOM to examine how well treatments are working in actual clinical practice.\6\ While not all patients with chronic Lyme disease have returned to a state of wellness, many have, and we need to find out how and why. This information can then be applied to other patients and used to establish a research agenda for treatment that has a likelihood of success, rather than abandoning patients based on limited treatment trials.
The IOM process does not allow these research ideas to be heard in an unbiased and transparent fashion with balanced divergent viewpoints. While the NIH process precludes bias on the part of panel members, the IOM does not. Four of the six members of the IOM panel that have been selected belong to IDSA, a medical society that has a known bias against chronic Lyme disease diagnosis and treatment. Rather than providing curative treatments that restore health, the IDSA would provide costly and long term palliative treatments, presumably for life. While the NIH requires participation by major stakeholders (including patients and treating physicians), the IOM does not.
The summary of the IOM proceedings will reflect this pervasive lack of objectivity, undermining its integrity and credibility. Additionally, much IOM deliberation is done behind closed doors and an anonymous panel will be permitted to comment on the written record. Because of such flaws in the IOM proceedings, the three largest patient interest groups who were offered a brief opportunity to speak (TFL) at the IOM October 2010 meeting and an opportunity to provide a commissioned paper--CALDA, the LDA and TFL--pulled out of the conference in protest.
From a research perspective, strongly held paradigms can create a closed loop, and experiments may be designed, implemented and interpreted to support a particular viewpoint.\7\ The antidote to bias is to balance scientific perspectives and to ensure that all scientific viewpoints are being heard and explored. Given the extraordinary stream of federal funding granted to researchers who support the closed paradigm which was created and is supported by the Infectious Diseases Society of America (IDSA) and their vested interest in maintaining the status quo, it is not reasonable to expect this group of researchers to serve as neutral arbiters of scientific debates over competing scientific paradigms. For example, Lyme related panels dominated by IDSA have time and time again excluded opposing viewpoints from participating or controlled the review process to ensure outcomes that reinforce the IDSA paradigm. If past is prologue, it is obvious what the future holds for panels dominated by one group.
Worse, the small treatment trials that have been conducted have been given an undue amount of weight by IDSA researchers and in its guidelines and used to apply a degree of certainty on the science that far exceeds the limitations of the small sample sizes of the studies. Further, they claim that the state of the science is sufficient to determine with certainty that chronic Lyme disease does not exist, is not treatable with antibiotics, and that no further research on this topic is needed. Sample size affects the strength of the conclusions that may be drawn from them: ``Providing definitive answers in the face of low event rates and small-to-moderate treatment effects necessitates sample sizes in the thousands or tens of thousands. ..... Funding for such mega-trials is very limited, and is often restricted to industry sources.'' \8\
For that reason, the Connecticut Attorney General antitrust investigation into the development process of IDSA Lyme guidelines found exclusionary practices and suppression of divergent viewpoints on the part of IDSA panels that crafted IDSA 2000 and the 2006 Lyme disease guidelines. Although IDSA settled the investigation with the Attorney General by agreeing to review its guidelines with a panel without conflicts of interest, the control of the process was in the hands of IDSA, which again selected a panel consisting almost exclusively of IDSA members and excluding treating physicians who held divergent viewpoints.
It was patients who pressed for the language in the Appropriations bill that called for a review of the state of the science of Lyme disease. However, patients need that process to occur in a transparent manner, without bias, and with the participation of all stakeholders. Albert Einstein defined insanity as ``doing the same thing over and over again and expecting different results.''
[Page: E1874] GPO's PDFThis process is a perfect example of that insanity.
Patients want research which will restore their health. Their voice and the voice of the clinicians must be given the necessary weight to legitimize the research agenda and the research process. Truth in science can be achieved through open debate in an independent process free from bias and conflicts of interest. The scientific process fails when one side of a debate controls the arena and sets the rules to ensure that its viewpoint prevails.
Lorraine Johnson, JD, MBA, Chief Executive Officer, California Lyme Disease Association.
Patricia V. Smith, President, Lyme Disease Association, Inc.
Diane Blanchard/Deb Siciliano, Co-Presidents, Time for Lyme, Inc. ENDNOTES
\1\ Steiner I. Treating post Lyme disease: trying to solve one equation with too many unknowns. Neurology 2003; 60:1888-9.
\2\ Stricker RB, Johnson L. Lyme wars: let's tackle the testing. BMJ 2007; 335:1008.
\3\ Weintraub P. What we don't know about Lyme. Experience Life Magazine June 2009.
\4\ Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med, 2008; 5:e4.
\5\ Hunfeld KP, Ruzic-Sabljic E, Norris DE, Kraiczy P, Strle F. In vitro susceptibility testing of Borrelia burgdorferi sensu lato isolates cultured from patients with erythema migrans before and after antimicrobial chemotherapy. Antimicrobial agents and chemotherapy 2005; 49:1294-301.
\6\ Institute of Medicine (Committee on Quality of Health Care in America). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press, 2001.
\7\ Ernst E, Canter PH. Investigator bias and false positive findings in medical research. Trends Pharmacol. Sci. 24(5), 219-221 (2003).
\8\ Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med, 2008; 5:e4.
***************************************************
For detailed information leading to the above Speech see CALDA blog at Lyme Policy Wonk
Monday, 4 October 2010
TIPPING POINT IN THE SCIENCE SURROUNDING LYME DISEASE?
Evolution and Distribution of the ospC Gene, a Transferable Serotype Determinant of Borrelia burgdorferi
Alan G. Barbour and Bridgit Travinsky
http://mbio.asm.org/content/1/4/e00153-10
The full article is available through the above link and something I felt was highly important was
'Nevertheless, we doubt that the observed antigenic diversity of OspC is merely epiphenomenal to functional differences between proteins. The range of pairwise sequence distances among family of surface proteins of the relapsing fever agent ospC alleles nearly matches that of the highly polymorphic Borrelia hermsii immunity (4). Possibly, both immune and niche selective forces are in play, but their relative contributions remain to be determined.'
I was alerted to this through the comments from
Microbe World
Lyme Disease Bacterium Collaborates with Accomplices to Evade Immune System
submitted by Merry Buckley on September 29, 2010
http://www.microbeworld.org/index.php?option=com_jlibrary&view=article&id=4903
Warning: the bacterium behind Lyme disease is collaborating with its accomplices to construct a gene that can defeat your immune defenses.
Although this work supports much that Ben Luft has been studying for some years and has been found by other researchers over the last 20 years, the significance as I see it is that Barbour an IDSA doctor has long since supported the IDSA Guideline Authors stance and this very clearly is a move towards what ILADS doctors have been saying for years.
Are we at last at that long awaited tipping point in the science surrounding this emerging disease?
I previously posted the Tom Grier lectures, links in my side bar an extract from lecture number 4 below shows that Pachner had already published on similar findings.
PACHNER MOUSE BRAIN MODEL
1) Normal uninfected mice are inoculated with Borrelia burgdorferi in the tail vein.
2) One month later, blood is isolated from the tail of the same mouse, and the bacteria are isolated for tests.
3) The bacteria are also isolated from the brain of the same mouse, and kept completely separate for testing.
4) The antibodies from the mouse’s blood recognize and attack the bacteria that were isolated from the blood of the mouse.
5) The same antibodies fail completely to recognize the bacteria that were isolated from the same mouse’s brain; it is as if these bacteria were completely invisible to the mouse’s immune system.
What has happened to the bacteria in the mouse brain?
Once the bacteria were isolated within the brain, it was then cut off from the peripheral immune system.
This allowed the bacteria to change with each new bacterial division, and without the mouse’s immune system recognizing the changes; it is just like a criminal getting a face-lift and wearing a disguise.
The immune system kept up with the bacteria trapped in the blood, but could not make antibodies to the Lyme bacteria trapped within the brain.
The antibodies that were being produced no longer recognized the bacteria because it was still looking for the original strain, and what were now in the mouse’s brain were several generations away from the strain that Dr. Andrew Pachner started with.
Basically in crude terms, the Lyme bacteria that became isolated within the brain, mutated.
The Lyme spirochete we started with that was originally injected into the tail, is no longer the same isolate that Dr. Andrew Pachner found in the brain of the same mouse.
You now begin to see how current Lyme tests that are created using a laboratory strain of bacteria; a strain not even found in nature, can hardly be expected to keep up with the over 200,000 possible variations that Borrelia are capable of producing.
Alan G. Barbour and Bridgit Travinsky
http://mbio.asm.org/content/1/4/e00153-10
The full article is available through the above link and something I felt was highly important was
'Nevertheless, we doubt that the observed antigenic diversity of OspC is merely epiphenomenal to functional differences between proteins. The range of pairwise sequence distances among family of surface proteins of the relapsing fever agent ospC alleles nearly matches that of the highly polymorphic Borrelia hermsii immunity (4). Possibly, both immune and niche selective forces are in play, but their relative contributions remain to be determined.'
I was alerted to this through the comments from
Microbe World
Lyme Disease Bacterium Collaborates with Accomplices to Evade Immune System
submitted by Merry Buckley on September 29, 2010
http://www.microbeworld.org/index.php?option=com_jlibrary&view=article&id=4903
Warning: the bacterium behind Lyme disease is collaborating with its accomplices to construct a gene that can defeat your immune defenses.
Although this work supports much that Ben Luft has been studying for some years and has been found by other researchers over the last 20 years, the significance as I see it is that Barbour an IDSA doctor has long since supported the IDSA Guideline Authors stance and this very clearly is a move towards what ILADS doctors have been saying for years.
Are we at last at that long awaited tipping point in the science surrounding this emerging disease?
I previously posted the Tom Grier lectures, links in my side bar an extract from lecture number 4 below shows that Pachner had already published on similar findings.
PACHNER MOUSE BRAIN MODEL
1) Normal uninfected mice are inoculated with Borrelia burgdorferi in the tail vein.
2) One month later, blood is isolated from the tail of the same mouse, and the bacteria are isolated for tests.
3) The bacteria are also isolated from the brain of the same mouse, and kept completely separate for testing.
4) The antibodies from the mouse’s blood recognize and attack the bacteria that were isolated from the blood of the mouse.
5) The same antibodies fail completely to recognize the bacteria that were isolated from the same mouse’s brain; it is as if these bacteria were completely invisible to the mouse’s immune system.
What has happened to the bacteria in the mouse brain?
Once the bacteria were isolated within the brain, it was then cut off from the peripheral immune system.
This allowed the bacteria to change with each new bacterial division, and without the mouse’s immune system recognizing the changes; it is just like a criminal getting a face-lift and wearing a disguise.
The immune system kept up with the bacteria trapped in the blood, but could not make antibodies to the Lyme bacteria trapped within the brain.
The antibodies that were being produced no longer recognized the bacteria because it was still looking for the original strain, and what were now in the mouse’s brain were several generations away from the strain that Dr. Andrew Pachner started with.
Basically in crude terms, the Lyme bacteria that became isolated within the brain, mutated.
The Lyme spirochete we started with that was originally injected into the tail, is no longer the same isolate that Dr. Andrew Pachner found in the brain of the same mouse.
You now begin to see how current Lyme tests that are created using a laboratory strain of bacteria; a strain not even found in nature, can hardly be expected to keep up with the over 200,000 possible variations that Borrelia are capable of producing.
These findings give reasons for:-
the problems with seronegativity,
the problems in finding effective vaccines
the reasons why the immune system and antibiotics combined have difficulty eradicating the infection especially the longer it is allowed to get established.
Public awareness and Doctor awareness is an immediate concern to prevent others un-necessarily being infected and allowed to progress into a chronic health problem for which there is no known definitive treatment cure.
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