El piruvato es un compuesto orgánico clave en el metabolismo. Es el producto final de la glucólisis, una ruta metabólica universal en la que la glucosa se escinde en dos moléculas de piruvato y se origina energía (2 moléculas de ATP). El ácido pirúvico así formado puede seguir dos caminos: Si hay suficiente suministro de oxígeno, el ácido pirúvico es descarboxilado en la matriz mitocondrial por el complejo enzimático piruvato deshidrogenasa rindiendo CO2 y acetil coenzima A que es el inicio de una serie de reacciones llamada ciclo de Krebs, seguida de la fosforilación oxidativa Si no hay suficiente cantidad de oxígeno disponible, el piruvato sigue una ruta anaeróbica, la fermentación, formándose ácido láctico en animales y seres humanos (fermentación láctica) o etanol en levaduras y algunas bacterias (fermentación alcohólica). En la conversión en lactato interviene la enzima lactato deshidrogenasa y la coenzima NADH; en la fermentación alcohólica el piruvato es convertido primero en acetaldehido y luego en etanol y CO2.
Cabe destacar la importante diferencia entre el Ácido Pirúvico y el Ión Piruvato, que son similares pero no iguales
Kaiser Found Complicit in CT Attorney General Lyme Disease Guideline Investigation
For this month’s newsletter I had intended to write on something other than Lyme disease or Morgellons disease. However, there is some important breaking news that is worthy of comment.
On May 1, 2008, it was announced by the Connecticut Attorney General’s office that a settlement had been reached in the antitrust investigation of the Infectious Diseases Society of America (IDSA) in connection with their restrictive and exclusionary guidelines for the diagnosis and treatment of Lyme disease. The official press release can be found using the following link…
Of particular note are the comments in the last section titled “Additional Findings of Blumenthal’s Investigation.” In the interest of brevity I will quote only one…
“In a step that the British Medical Journal deemed “unusual,” the IDSA included in its Lyme guidelines a statement calling them “voluntary” with “the ultimate determination of their application to be made by the physician in light of each patient’s individual circumstances.” In fact, United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.”
The entire press release by the Connecticut Attorney General is worth reading.
I am glad to see that Kaiser has been officially mentioned as one of the health plans using the IDSA Lyme guidelines exclusively as a means to deny expensive medical treatment.
If you are going to see a Kaiser doctor and are interested in the Lyme disease issue, it would be interesting to note their reaction to a printout of this press release. At Kaiser, Lyme disease has been relegated to infectious diseases specialists.
I would be interested in knowing their responses. With your permission, I would pass these on to appropriate people, including the CT Attorney General. Your name can be blanked out or deleted but it would be helpful to have the name of the doctor to reduce the possible criticism that these comments are fabrications.
On a related note, a documentary film on Lyme disease, “Under Our Skin,” has just been released at the Tribeca Film Festival in New York. I am told that the film has received standing ovations and is a candidate for the best documentary…
Also, an important new book on Lyme disease, “Cure Unknown,” is about to be released. The author, Pamela Weintraub, is a recognized science writer and a victim of Lyme disease as well as her family. She has done years of investigative research for this book. I have not read the book but I am certain that it is a well done, professional and informative work…
I met Pam in the course of her investigation for this book.She is well aware of Kaiser’s negligence in dealing with Lyme disease and told me she would try to have some chapters on West Coast Lyme disease and Kaiser. I gave her my Kaiser medical records and correspondence pertaining to Lyme disease. I know there were some problems with the original length of the book and I don’t know how much she was able to write on the West Coast aspect.
Every library should have this book.
A big thank-you to Attorney General Blumenthal for taking an important step to protect Lyme disease victims.
Por lo que se, hay como 20 personas principales que dominan la informacion de Lyme disease. Y otros 50 personas en su lado. Lo que es muy sospechoso es como estos pocos pueden dominar este enfermedad. Probablemente es con el ayuda del los agencias del gobierno. El CDC y NIH en particular.
Adriana Marques es uno de los 50 personas y trabaja para el NIH. Parece que tambien tiene patentes sobre Lyme disease.
, LCI, NIAID, NIH, Bethesda, MD. Factors that might contribute to the appearance of conflict of interest: Dr. Marquez’s work is based on the theory that Lyme disease is an autoimmune problem. Her employer is NIH. NIH inventors hold the rights, in full, to six patents related to vaccine and diagnostic test development. (See patent chart, above.) NIH has rights to at least 11 additional Lyme-related patents, including those central to the creation of first and second generation vaccines and associated diagnostic tests.
Y tambien estudia Lyme como si fuera una problema "autoimmune." Si admite que Lyme es una problema de infecion chronica, todo el trabajo de Adriana va a la basura.
Subject: [Lyme-E] Las mentiras continuan. Obvian la información que les parece. Malditos sean
1: Infect Dis Clin North Am. 2008 Jun;22(2):341-60. Links Chronic lyme disease: a review. Marques A.
Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 10/11N234 10 Center Drive, Bethesda, MD 20892, USA.
Studies have shown that most patients diagnosed with chronic Lyme disease either have no objective evidence of previous or current infection with Borrelia burgdorferi or are patients who should be classified as having post-Lyme disease syndrome, which is defined as continuing or relapsing nonspecific symptoms (such as fatigue, musculoskeletal pain, and cognitive complaints) in a patient previously treated for Lyme disease. Despite extensive study, there is currently no clear evidence that post-Lyme disease syndrome is caused by persistent infection with B burgdorferi. Four randomized placebo-controlled studies have shown that antibiotic therapy offers no sustained benefit to patients who have post-Lyme disease syndrome. These studies also showed a substantial placebo effect and a significant risk of treatment-related adverse events. Further research to elucidate the mechanisms underlying persistent symptoms after Lyme disease and controlled trials of new approaches to the treatment and management of these patients are needed.
1: Mol Immunol. 2008 Apr 3 [Epub ahead of print] Links Searching for autoimmunity in "antibiotic-refractory" Lyme arthritis. Stricker RB, Johnson L.
International Lyme and Associated Diseases Society, P.O. Box 341461, Bethesda, MD 20827-1461, United States.
In two recent articles published in Molecular Immunology, Steere and colleagues continue their search for an autoimmune mechanism of arthritis in patients who have failed short-course antibiotic therapy for Borrelia burgdorferi, the spirochetal agent of Lyme disease. As in previous attempts, the authors fail to elucidate a molecular mimicry mechanism for the putative autoimmune process, leading to the conclusion that there is no credible scientific evidence for a post-infectious autoimmune mechanism of arthritis in chronic Lyme disease.
PMID: 18395260 [PubMed - as supplied by publisher]
1: J Infect Dis. 2008 May 1;197(9):1352-3. Links Persistent Borrelia burgdorferi Infection after Treatment with Antibiotics and Anti-Tumor Necrosis Factor-alpha. Stricker RB, Johnson L.
International Lyme and Associated Diseases Society, Bethesda, Maryland.
1: Infect Dis Clin North Am. 2008 Jun;22(2):341-60. Links Chronic lyme disease: a review. Marques A.
Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 10/11N234 10 Center Drive, Bethesda, MD 20892, USA.
Studies have shown that most patients diagnosed with chronic Lyme disease either have no objective evidence of previous or current infection with Borrelia burgdorferi or are patients who should be classified as having post-Lyme disease syndrome, which is defined as continuing or relapsing nonspecific symptoms (such as fatigue, musculoskeletal pain, and cognitive complaints) in a patient previously treated for Lyme disease. Despite extensive study, there is currently no clear evidence that post-Lyme disease syndrome is caused by persistent infection with B burgdorferi. Four randomized placebo-controlled studies have shown that antibiotic therapy offers no sustained benefit to patients who have post-Lyme disease syndrome. These studies also showed a substantial placebo effect and a significant risk of treatment-related adverse events. Further research to elucidate the mechanisms underlying persistent symptoms after Lyme disease and controlled trials of new approaches to the treatment and management of these patients are needed.
Emerging Stratton Protocol 4/2008: a new approach to an old set of problems
Reported by Jim K
A number of dilemmas appear in treating Cpni. As we all know here at Cpnhelp, treating with protein-synthase inhibitors alone induces chlamydial persistence-- conversion to the cryptic/persistent form of ‚ "aberrant non-replicating RB‚". Infectious EB‚ still remain in extracellular fluids and tissues to reinfect once antibiotics are withdrawn. The CAPi which addresses all three phases has been the answer to this multi-phase nature of Cpn, but it has problems of it‚" own.
The biggest problem is the tendency to induce strong reactions to treatment which have been attributed to bacterial release of LPSi endotoxini and inflammatory HSP60 endotoxin, and to secondary porphyria. This makes for the additional problem, which is the requirement of a gradual, slow, and long term process of treatment when addressing Cpn infections.
There are more potent anti-chlamydials around, but using them kills the Cpn too fast for the body to tolerate resulting in mass apoptosisi of infected cells and subsequent organ failure or neutropenia.
Existing CAP protocols have been focused on first halting replication, kill a lot of the RB‚" and force the rest into non-metabolizing and non-replicating cryptic/persistent form, with the notion that this will stop the progression of the disease. The cryptic Cpn can then be dealt with at one‚" leisure, gradually over time.
But emerging research has been suggesting that Cryptic Cpn is not benign even if it is not replicating.
Cryptic Cpn is essentially a stressed form of Cpn, and stress causes it to generate of Heat Shock Protein (HSP60). HSP60 is many times more inflammatory than LPS endotoxin. LPS endotoxin is the one that causes the fever and chills and is released mostly when RB‚" are killed and lyse, or when EB‚" are killed. The inflammation of plaques in cardiovascular disease has been associated specifically with Cpn HSP60 and with the persistent (cryptic) form of Cpn. Inflammationi by HSP60 when forcing Cpn into cryptic form may in fact, in Dr. Stratton‚" current view, be the major cause of so-called die-off reactions. ‚"So-called" because HSP60 is induced not by the bacteria dying off, as the release of LPS is, but rather by the Cpn surviving in a stressed, cryptic form.
Additionally, ongoing disease and tissue damage may be occurring as much from the cryptic form, this is apparently so in heart and lung disease,as it is occurring from replication and sub-optimal cell functioning by infected cells. Autoimmune diseases, for example, also exhibit antibodies to HSP.
Some additional observations have collected together to add to this shift in viewpoint. A medical colleague who has treated Cpn through IV treatments using all the agents for all
So this new approach is based on inducing existing persistent/cryptic Cpn to convert back to RB form and limit the conversion into persistent/cryptic form by the threat of antibiotic.
Paul Griffith, a non-medical friend researching this whole area, found that supplementing pyruvate might do the trick. Pyruvate may also have other beneficial effects. Basically, this approach uses 6 grams of calcium pyruvate one hour before taking the antibiotics, and an additional 6 grams if needed later for reactions when the antibiotics exert their effect. In theory the first dose of pyruvate encourages the cryptic/persistent form of Cpn to convert back into RB (replicating) form by supplying it with a ready source for generating cellular energy.
In RB form it is:
a) Susceptible to the regular antibiotics and,
b) Can be killed when it is not in stress‚ so it is not stimulated into producing and releasing so much the highly inflammatory HSP60.
In essence, you are feeding it until it is comfy and sprawling in it‚" chair at the dining table, and then whacking it upside the head before it can spew it‚" hot sauce at you‚ÄîI know, a terrible metaphor, but best I could do. You get the point?
In theory this approach should limit turning Cpn into cryptic form by the treatment and make it more directly susceptible to the protein synthase inhibitors (like doxycycline and azithromycin).
In theory, it should also winnow down the cryptic load one has acquired, along with it‚" inflammatory affects, without needing to kill it directly with flagyl. Flagyl would be used to ‚"clean up" persistent/cryptic forms not gotten to by this approach.
Also in theory, the second dose of pyruvate for reactions to the antibiotics should supply the fundamental cellular energy needed to help lower the generation of porphyrins.
Dr. Stratton outlines below the experimental protocol that they have found, in a small subset of cases, to offer less difficult and faster treatment of Cpn. Please remember that this is experimental, and has not been clinically used with a wide array of Cpn related diseases yet, so should not be engaged in without a knowledgeable clinician to monitor treatment.
From Dr. Charles Stratton, 4/24/08
My thoughts on the current Stratton Protocol is that this is a work in
progress, but given what we know now, it would be the following:
NAC 600 mg one a day to test ‚"Chlamydial Load"
If no reaction, go to 1,200 mg twice a day.
If a severe reaction ("Flu-Like" reaction), use low dose prednisone (5 mg per day) for the first few weeks of therapy.
The next step would be two weeks of a macrolide (clarithromycin preferred because of higher levels obtained, roxithromycin, or azithromycin) with 6 grams of pyruvate given 1 hour prior to the antibiotic dose.
In addition, 400 mg of Ibuprofen should be taken twice a day along with 1,200 mg of NAC twice a day. For those with severe reaction, low dose prednisone 5 mg per day. For those who get a severe reaction with the pyruvate/macrolide, 3-4 days of low dose prednisone could be tried. Also, using additional pyruvate (3-6 grams) for reaction should be tried.
For those that have a major side effect on the pyruvate/macrolide alone, I'd continue to treat with the macrolide alone until the side effects are manageable. For those that don't, I'd add doxycycline 100 mg twice a day with 6 grams of pyruvate 1 hour before. Continue the NAC and Ibuprofen.
After two weeks of doxycycline if all went well, I'd add metronidazole 500mg twice a day with 6 grams of pyruvate before that.
If a reaction is seen to the metronidazole, I'd then pulse it until the reactions were manageable.
If minimal reactions, I'd continue therapy for at least 1 year and then recheck titers. If titers were low, I'd add rifampin or rifabutin (preferably), using the rifamycin with pyruvate taken 1 hour before the rifamycin. If no reactions to this, I'd consider the therapy to be complete.
I would continue to monitor titers every several years. If the titers increased, I'd retreat with 6 months of clarithromycin or roxithromycin plus rifabutin plus pyruvate and ibuprofen. I'd continue the NAC for life.
For people on the existing CAP who are being switched:
For those on the current Doxycycline, Azithromycin, Metronidazole, and NAC protocol, my thoughts are that they should first switch from Azithromycin 250 MWF to Clarithromycin 500 mg twice a day (or Roxithromycin) and then add pyruvate
Dr. Stratton adds that Levaquin may be used instead of Clarithromycin for a short period (one month) as it has excellent activity for a short period of time. Clarithromycin = higher levels. Both when combined with pyruvate theoretically will provide better killing.
Severe neutropenia among healthy volunteers given rifabutin in clinical trials
Glen Apseloff, MD, Clinical Pharmacology & Therapeutics, December 2003
This is probably why those ‚"big" studies of 6 months of azithromycin showed not lowering of risk of heart disease, it's not caused by the replicating form of Cpn and the idiots never asked a microbiologist about what might kill cryptic Cpn!
. Heat shock proteini 60 from Chlamydia pneumoniae elicits an unusual set of inflammatory responses via Toll-like receptor 2 and 4 in vivo.
Da Costa CU, Wantia N, Kirschning CJ, Busch DH, Rodriguez N, Wagner H, Miethke T.
Institute of Medical Microbiology, Immunology and Hygiene, Technical University of Munich, Munich, Germany. Eur J Immunol. 2004 Oct;34(10):2874
Effects of Repeated Chlamydia pneumoniae Inoculations on Aortic Lipid Accumulation and Inflammatory Response in C57BL/6J Mice†
Liisa To¨rma ¨kangas,1* et al
INFECTION AND IMMUNITY, Oct. 2005, p. 6458–6466 Vol. 73, No. 10
Worsened MRI Findings During the Early Period of Treatment with Penicillin in a Patient with General Paresis.
Zhang SQ, Wan B, Ma XL, Zheng HM.
J Neuroimaging. 2007 Nov 6
Role of Heat Shock Proteins in Protection from and Pathogenesis of Infectious Diseasesi
Ulrich Zu¨ Gel and Stefan h. e. Kaufmann
Microbiology Reviews, Jan. 1999, p. 19–39 Vol. 12, No. 1
Ethyl pyruvate: a novel anti-inflammatory agent
M. P. Fink
2007 Blackwell Publishing Ltd Journal of Internal Medicine 261; 349–362
Si. Tambien tarda mucho bajar esta pagina web aqui en EEUU. Creo que parte es falta de el pagina web de Kathleen.
Kathleen tiene muchos documentos originales como esta muy cerca de Yale donde estuvo Steere por un tiempo. Creo que Eugene Shapiro tambien esta en Yale.
Su correo ha sido reenviado al Gabinete del Secretario General de Sanidad. Tan pronto como tengamos una respuesta se la haremos llegar.
Oficina de Información y Atención al Ciudadano Ministerio de Sanidad y Consumo Paseo del Prado, nº 18 - 20 28071 - MADRID Tfno: 901400100 www.msc.es oiac@...
De: juancaqd [mailto:juancaqd@...] Enviado el: domingo, 04 de mayo de 2008 0:34 Para: Oficina de Información y Atención al Ciudadano Asunto: dificultades para obtener tratamiento lyme crónico
Me dirijo a ustedes para ponerles de manifiesto la penosa situación
que viven los enfermos de lyme crónico.
El lyme es una enfermedad que se puede contraer en España por
cualquier persona que realice excursiones al campo y se tendría
que tomar más en serio porque si no se trata a tiempo pude hacerse
crónica.
Hace unos años el senador Don Felix Lavilla denunció la situación
de los enfermos de lyme crónico formulando una pregunta al gobierno
sobre las medidas adoptadas.
Han pasado varios años y la situación sigue igual o peor.
En España se utilizan criterios diagnósticos de EEUU a pesar de
tener las variedades Europeas de la bacteria que causa la enfermedad.
En España se deberían usar los criterios serológicos europeos y
no los que se usan actualmente que son muy rígidos y que dan
lugar a muchos falsos negativos y a dejar sin diagnóstico a muchos
enfermos.
Los máximos responsables del estudio de la enfermedad de lyme
en España ocultan la verdad sobre el lyme y llegan al extremo
de recomendar a los hospitales métodos de cultivo que imposibilitan
su cultivo (hay pruebas por escrito en un a tesis publicada) y se ha dado el caso de personas
que han tenido resultados totalmente diferentes casi simultáneamente según
en el hospital que se hayan realizado los análisis.
Muchas personas con los criterios europeos darían positivo pero dan negativo
como resultado de los criterios mas restrictivos que existen en España.
Hay personas que a pesar de tener seroconversiones y pruebas de adn de la
borrelia se les dificulta el tratamiento.
Recientemente las guías de la IDSA que son usadas en España para diagnóstico
y tratamiento se han visto envueltas en una investigación por el Fiscal General de
Connecticut, Richard Blumenthal y su equipo.
Como resultado de esa investigación se ha descubierto el conflicto de intereses
de los firmantes de las guías (empresas farmaceúticas, compañias aseguradoras etc)
y la IDSA tiene que rehacer las guías con otros miembros que no tengan conflictos de
intereses y que incluyan toda la evidencia científica existente sobre el lyme crónico.
Subject: [DCLyme] Behind the Scenes of the Pallone Decision: Message from LDA President Pat Smith
Congressman Frank Pallone Prevents Patients from Receiving Lyme Treatment, Rubber Stamps IDSA, Excludes Patients
Dear Lyme Community,
I apologize in advance for the length of this letter, but you need to understand what is happening to you and why.
Last night, Congressman Christopher Smith, bill sponsor, and a friend and leader to the Lyme community, called me to provide words of encouragement after a very discouraging day. He told me to tell you how sorry he is for everyone suffering out there and for what happened that day and he asked that I tell you that he is “outraged” at this bill decision. He said we must not give up, what we are doing is right and just, and that he will never give up until this bill is passed, a bill which he feels has the ability to go a long way to melding research dollars and policy for Lyme disease. He is a bright light in a world filled with those who lack substance and conscience.
What follows is the reason for his message. In an act reminiscent of the ones IDSA has been rebuked for by Attorney General Blumenthal of Connecticut, Congressman Frank Pallone, House Health Subcommittee Chair, rubber stamped IDSA and its guidelines.
Shocked and saddened are two words that come to mind to describe how I feel about what occurred yesterday in my own state, my own county. The Chair of the very committee in the House of Representatives that is charged with reviewing bills which affect the health of people across this country today took an unprecedented step—he capitulated to the powerful Infectious Diseases Society of America (IDSA). The IDSA was under investigation by the Attorney General of Connecticut for a year and a half, and it has been forced to scrutinize its Lyme guidelines under the oversight of a specialist in conflicts of interest.
Rather than own up to the misconduct of its members, the IDSA is publicly denying culpability in the matter. Rational people must examine why a Society would settle if there were nothing to the AGs allegations as this powerful Society claims. The Attorney General found significant conflicts of interests for the panel member of the guidelines, bias in the selection of participants, suppression of scientific evidence, blocking of divergent viewpoints and foreclosure of treatment options for patients. These are the types of findings that a responsible medical society would take seriously and would launch an internal investigation into the guidelines panel.
Rational people must also examine why Congressman Frank Pallone would chose to endorse IDSA over patients nationwide, patients in NJ, and his own constituents. Mr. Pallone has chosen no treatment for chronic Lyme patients, no alternative treatments and no supplements. This is the IDSA philosophy, the one whose development was investigated, whose development was challenged, whose philosophy development was found by the Attorney General to be riddled with conflicts of interest and exclusionary conduct. Yet yesterday, during the protest outside his Long Branch office, Mr. Pallone issued a press release saying he would not post the Lyme bill until the IDSA convenes its new guidelines’ panel and issues a decision. This panel is part of the settlement which was forced upon the IDSA by process and by threat of legal action by the AG. After the new panel convenes and deliberates, Mr. Pallone has given IDSA carte blanche to make its recommendations to Congress about the Lyme bill, a bill which does not relate directly to treatment but relates to monies for much needed research and a much-needed voice for Lyme patients and treating physicians. What does this mean to patients? He has knowingly placed the fox in charge of the hen house, a fox already caught with chicken feathers dangling from his mouth.
One might also wonder why IDSA was in DC on Friday after the AG settlement with a lobbyist, their CEO, their lawyer and a new man on their team, Dr Phillip Baker. Dr. Baker is the former NIH Lyme Disease Program Officer on whose shift the Klempner study was approved, terminated early, and subsequently touted as the kiss of death for all extended antibiotic treatment for Lyme patients, although the conclusions drawn by the authors were nothing more than a sham attempt to halt treatment for patients. At a meeting I attended related to the Klempner study, Dr. Baker allowed researchers who were anti chronic Lyme to publicly trash treating physicians, researchers and even a patient who was present, all in the name of science. It was so bad, I wrote a letter to him when I arrived home expressing my horror at how unprofessionally this government-sponsored meeting was run.
Industry interests continue to drive government. A primary example of this “revolving door” between industry and government officials is demonstrated by the fact that Dr. Baker is now advocating for the IDSA. Given Baker’s affiliation with the commercial interests of a medical society, it is now clear that there never was anyone involved in that Klempner study that viewed his job as protecting patients or the public health.
How does this relate to what happened in NJ today? What we have here is a cartel of vested interest masquerading under the banner of science. This is not about patients, it is not about the greater good, it is about greed. Patient health has been sacrificed by IDSA to pave the way for those who hold patents, those who have an interest in Lyme testing and vaccines, and those who have a consulting relationship with insurance companies. Dr. Baker’s now public alignment with the commercial interests of the IDSA, and now it would seem, patients’ own elected representative’s alignment, show how powerful commercial interests in medicine can drive healthcare and exclude the interests of patients, entirely.
We understand that the IDSA went to Washington the very day after the Attorney General announced its findings of conflicts of interests, suppression of scientific evidence, and denial of treatment options for patients, and met with Mr. Pallone’s Committee Members. What Mr. Pallone has done is tell Lyme patients that their ability to have research hinges on the decision of a private medical society that has commercial interests in the results and that has been under investigation for allowing its panel of researchers with extensive commercial interests to corrupt its guidelines’ panel. Essentially, he is delegating public policy decision to a medical specialty society whose guidelines are under scrutiny and that has evidenced a profound lack of accountability and responsibility in policing the rampant conflicts of interests of its panel members.
Yesterday, patients in wheel chairs, and IV drips, and mothers whose children are out of school for years peacefully picketed Congressman Pallone’s office and carried signs and did chants at a protest organized by the grass roots Lyme Rights Group. Reporters and radio media attended and many interviews were conducted. Suddenly one reporter on some silent cue left the patients to rush inside to pick up a statement issued by Mr. Pallone’s office. No one else was then allowed to have the statement. I asked the reporter if I could borrow it, and I read to a stunned crowd the news that essentially Pallone supports and endorses the IDSA. I requested from his office a copy of the release. They refused to provide it, telling me it was available online. Obviously I had no access and again requested the document. They told me they were not authorized to give me the document. But you gave it to the reporter I said, well, they replied, that was authorized. I reiterated, so the Congressman issued a public document but would only provide it to a reporter—wouldn’t even provide it to a constituent who was right there. Silence followed.
While this transpired, that constituent of his was trying without success to gain an appointment with Mr. Pallone, a process that began months ago when Congress was on break. They refused then and now to grant her a meeting. She asked what she could do to get this meeting as her nephew is in a wheel chair due to Lyme. They could offer no insights, so I suggested she join the IDSA. It seems that one must be wealthy, powerful, and being investigated to gain the attention of Mr. Pallone.
Most Lyme patients do not fit those categories. However patients have something which IDSA does not have, they have numbers, commitment, no vested interest to get in the way, and they now have a large combined voice which stretches across this great country of ours. It is now obvious to all that this voice must be raised loudly and often in DC, NJ, CA, CT, MN, NY, PA, TX? every state of the union. All of us nationwide need to start in NJ today. We need to be respectful, we need to be angry, we need to be unrelenting in our quest to dismantle this amoral cartel. We start by calling, faxing, visiting, emailing Congressman Pallone’s DC office. We must be relentless. We must let them know that patients are out here. Patients will not tolerate being ignored. Patients will not rest until Mr. Pallone puts their health above moneyed interest. No stone can be left unturned.
If we allow IDSA to manipulate us through its representative in Congress (Mr. Pallone), in a year we will find ourselves in an untenable position. Congress will not only have turned its back on us entirely, but the IDSA will get a bill of its choice, a political plum that they have “earned” in some manner which we have yet to uncover, but we will. Meantime, tens of thousands more people will become sick and tens of thousands of those already sick will be further banished to obscurity as they await their death sentence without treatment.
This message is long, but you need to understand, your plight as a Lyme patient has now been placed in jeopardy again with a casual but deliberate action taken by Mr. Pallone to revoke any rights you may have had to treatment. The time for action is today, tomorrow and all the tomorrows to come until we find out what is really behind this great Lyme cover-up that denies you, the patient, a basic human right?the right to be treated for your disease.
Subject: [Lyme-E] RE: demandar acciones al congreso y al ministerio de sanidad
las guias idsa se siguen en españa? el ultimo articulo que me dio el internista era de un hospital pediatrico americano que decia que el lyme cronico es una obsesion con manifestacion somatica, que burrascano es un criminal con causas pendientes en euu, y bueno, que que no se trata con antibioticos, ese es su criterio personal, no de idsa
--- En lyme_y_otras_zoonosis_cronicas_espanol@yahoogroups.com, "juancaqd" <juancaqd@...> escribió: > > Con la información de que las guías de la IDSA que se siguen en > España son el producto de unos corruptos sin escrúpulos > debeíamos ejercer nuestro derecho constitucional de petición. > Yo ya he expuesto el problema a la comision de sanidad y consumo > en el congreso y he presentado queja al ministerio de sanidad via e- mail. > Por lo menos hay que intentarlo, que hagan su trabajo . > A ver si no soy el único que les escribe > > Saludos. >
Dear Friends, Probably, it will be interesting to you to read it:
Jury awards $1.7 million to Cecil teen
By Carl Hamilton, Whig Staff Writer (Maryland, USA)
ELKTON - A civil jury awarded more than $1.7 million Monday to a Port Deposit teen who suffers long-term health problems because local physicians failed to diagnose his Lyme disease. This is believed to be the highest award of damages in Cecil County history, according to veteran lawyers and court officials.
Lyme disease is the most prevalent tick-borne disease in the United States, costing about $1 billion a year due to inappropriate medical care, lost productivity, and legal fees associated with misdiagnosis. The latest research on the diagnosis and treatment of the crippling disease will be presented during the second largest Lyme disease conference in the United States, "Understanding and Treating Lyme Disease: Choices and Challenges" on May 17, 2008 at the University of New Haven (UNH), Dodds Theater. The conference is open to the general public with a registration fee of $65. The event includes an evening networking reception for Lyme disease patients.
Eva Sapi, Ph.D., associate professor of Biology and Environmental Sciences at UNH and organizer of the annual conference, says that topics addressed at the conference include the latest developments in the treatment of chronic Lyme disease, using traditional and alternative methods. Topics will include how the Lyme disease bacteria can escape therapy by forming protective layers around itself and how an alternative imaging method can help researchers better understand the biology of Lyme bacteria. Discussion topics will also include the neuropsychological effect of Lyme disease especially in children, and what parents and educators need to know about it, and new testing for Lyme and tick-borne diseases.
The "Understanding and Treating Lyme Disease: Choices and Challenges" conference is sponsored by the UNH College of Arts and Sciences, the Department of Biology and Environmental Sciences, and the Cellular and Molecular Biology Graduate Program.
las guias idsa se siguen en españa? el ultimo articulo que me dio el
internista era de un hospital pediatrico americano que decia que el
lyme cronico es una obsesion con manifestacion somatica, que
burrascano es un criminal con causas pendientes en euu, y bueno, que
que no se trata con antibioticos, ese es su criterio personal, no de
idsa
--- En
lyme_y_otras_zoonosis_cronicas_espanol@yahoogroups.com, "juancaqd"
<juancaqd@...> escribió:
>
> Con la información de que las guías de la IDSA que se siguen en
> España son el producto de unos corruptos sin escrúpulos
> debeíamos ejercer nuestro derecho constitucional de petición.
> Yo ya he expuesto el problema a la comision de sanidad y consumo
> en el congreso y he presentado queja al ministerio de sanidad via e-
mail.
> Por lo menos hay que intentarlo, que hagan su trabajo .
> A ver si no soy el único que les escribe
>
> Saludos.
>
No tengo contestaciones para tus preguntas. Espero que el "review" resulta en revision de los guidelines de IDSA.
Se que Blumenthal tiene muchos informaciones sobre el corrupcion en Lyme. No se si guarda esto en reserva para usar contra el Lyme club de IDSA si continuan con sus mentiras. Creo que estos informaciones se pueden usar en otro modo.
Por el momento, no olvides que puedes votar en el articulo de IDSA. El peor que puedes dar es "1." Aqui hay un link que trabaja...
Agreement Ends Lyme Disease Investigation By Connecticut Attorney General
Medical Validity of IDSA Guidelines Not Challenged
The Infectious Diseases Society of America (IDSA) has entered into an agreement with the Attorney General of Connecticut ending his investigation of the Society’s Lyme disease guidelines. Under the agreement, the guidelines remain in effect; but in an effort to clear the air, IDSA is voluntarily agreeing to an extra step: a one-time special review of the Lyme disease guidelines.
The agreement ends the investigation of IDSA and its volunteer guideline panel members without the filing of a complaint or the entry by a court of factual or legal findings, without IDSA paying any fines or penalties, and without imposing on IDSA any restrictions on its right to promulgate guidelines for Lyme disease or any other disease or condition in the manner it believes best serves public health.
“IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” said IDSA President Donald Poretz, MD. “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by the Society, and we look forward to the opportunity to put to rest any questions about them.”
The IDSA Lyme disease guidelines recommend against long-term antibiotic therapy, an unproven and potentially dangerous treatment. A small group of physicians outside the medical mainstream and their patients endorse such long-term treatment, despite the compelling medical evidence that it is ineffective and can have serious, life-threatening complications—and, furthermore, is extremely expensive. This agreement does not change the medical advice to patients: The 2006 Lyme disease guidelines remain in place.
Under the terms of the agreement announced today, IDSA will convene a review panel to conduct a comprehensive review of the Lyme-related literature to determine whether the 2006 guidelines should be revised or updated. While IDSA periodically reviews all of its treatment guidelines in order to keep them current, the agreement allows for an expanded process that includes an opportunity for public presentation and submission of information to ensure that all points of view are presented to and considered by the review panel.
IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines. This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.
The main actions of the agreement include:
Complete resolution of the Attorney General’s investigations, issues, and potential claims and causes of action against IDSA and its volunteer panel members.
The current Lyme disease guidelines remain in effect. The medical and scientific basis of the 2006 guidelines remains in place and unchallenged.
IDSA will convene a review panel to determine whether the 2006 Lyme disease guidelines should be revised or updated. Howard Brody, MD, PhD, who has been jointly selected by the Office of the Attorney General and IDSA, will serve as an ombudsman who will have a limited role that will focus on screening potential conflicts of interest. The ombudsman will not be involved in the operation of the review panel. Any proposed changes to the guidelines would require a supermajority vote of 75 percent of the panel.
IDSA strongly disagrees with the Attorney General’s assertion that panel members had significant conflicts of interest. Panel members had no financial interests that would have affected, or been affected by, recommendations in the guidelines. The guidelines recommend generic drugs and generic diagnostic tests. Panel members do not stand to profit from any recommendation in the guidelines. In fact, the panel members denied themselves and their colleagues an opportunity to generate a significant amount of revenue when they recommendedagainstexpensive, repeated, long-term antibiotic therapy.
IDSA also strongly disagrees with the Attorney General’s allegation that the Lyme disease guideline panel excluded competing viewpoints. In fact, the panel offered an opportunity for other organizations and individuals to submit additional evidence and carefully considered all information provided. In 2000, a single member of the panel voluntarily stopped participating. He was not removed from the panel, as the Attorney General has alleged. Furthermore, all IDSA guidelines are subjected to a rigorous, multi-level review and approval process before they are published, which allows other clinicians who did not serve on the panel that developed the guidelines to ensure that the guidelines are relevant, accurate, useable, and balanced.
IDSA’s guidelines—like all medical societies’ guidelines—are voluntary. They are for the benefit of physicians seeking the best possible advice from experts in the field. Medical societies do not have the authority or the desire to dictate to physicians how to practice medicine. Nor do they have the ability to dictate to insurance companies how to reimburse for services. No ties exist between IDSA and any insurance company.
The physicians who wrote IDSA’s 2006 guidelines concluded that, for nearly all patients, a short course of antibiotics is an effective treatment for Lyme disease. Studies have proven that long-term antibiotic treatment, which is usually given through a needle and a catheter, is ineffective, expensive, and potentially harmful. The overuse of antibiotics also contributes to an important public health threat: the development of drug-resistant infections that are difficult if not impossible to treat.
“We recognize that medicine is always evolving, and we welcome the opportunity that the review panel provides to examine any new evidence and vet our earlier findings,” said Dr. Poretz. “We are pleased that under this agreement, the proper diagnosis and treatment for Lyme disease will be decided in a medical forum, not a courtroom. We hope this special review of the guidelines will help quell the unfortunate controversy surrounding the treatment of Lyme disease and ensure that patients receive advice and treatment based on the best available scientific and medical evidence.”
###
IDSA is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has more than 8,000 members, was founded in 1963 and is based in Arlington, VA.For more information, visitwww.idsociety.org.
"People think of the spirochete as the spiral form, corkscrew shaped form, and that is what you'll read about if you look in a biology or medical textbook. You'll see that spirochetes are different from other bacteria because they are long and curly. They expect to see that when they look in tissue.
Unfortunately, spirochetes have more diverse forms than just the corkscrew, or spiral form. One of the functions of my website is to call attention to the other forms that exist that are just as legitimate as the spiral form. If you took the spiral and you reduce it to dashes and dots, those little dots contain DNA, and those are smaller units of the spirochete. There are also rounded balloon-like form called the cystic form. Spirochetes in certain circumstances will round up and make a round balloon-like structure, which has its DNA, and that is a second form. And then there are a number of very easily distorted forms called L-forms, which are sort of like soap bubbles that can stretch out and contain various boundaries, and are not as easy to identify as spirochetes, but they are also a part of the mixture of forms that the spirochete can have.
One of the functions of my website is to call attention to the fact that not only is this true for the Borrelia spirochete, but it's true for the syphilis spirochete, its related morphology, or shape changes are common to the two.
If you're looking for evidence of an infection in tissue you want to see the bug. And if you're looking for the bug and you only look for spiral forms, you may miss the other forms, forms that are granular or rounded cyst forms or L-forms."
Research yields discovery of Borrelia biofilms
"One of the most exciting things we've come across in the last six months is the idea that, in addition to all these forms, there are groupings of spirochetes, or colonies, that are biofilms. Biofilms are one of the things that bacteria use to promote their survival in adverse conditions.
We've shown, in our preliminary work, Dr. Eva Sapi and I, that Borrelia biofilms are part of the biology of Borrelia. And that these biofilms are ways or strategies for spirochetes to survive in hostile or adverse conditions.
In the biofilm unit, which is a colony of spirochetes, the spiral form is often lost and is replaced by cystic forms, granular dot forms, or L-forms. So that makes all of the previous biological discussion that I've just reviewed very relevant, and very meaningful. It helps to understand that a group of spirochetes with the DNA and the potential to cause disease can exist without having a single spiral form at all, but they have other diverse forms as they unite into a colony to survive under adverse conditions.
Biofilms are very resistant to antibiotic treatment, and they are resistant to killing, and we've found biofilms in cases of European Lyme Borreliosis, which is the skin manifestation: Acrodermatitis chronica atrophicans (ACA).
Studies that have been done in Europe have shown that colonies of Borrelia spirochetes are present in the skin, and people have had a condition called acrodermatitis chronica atrophicans (ACA), a condition where the skin gets very thin and very fragile, and it persists for many years, and is one of the late manifestations of Lyme disease in the skin. It occurs about thirty years after you've been infected. It's associated with the European form. It isn't very common over here. At least people don't think it is.
ACA contains groupings or colonies of Borrelia, and we have shown that those groupings or colonies are actually Borrelia biofilms. Biofilms are one of the ways that bugs survive in a hostile environment for long periods of time in nature, or in the human body, or in niches where they want to establish themselves."
In your view, why is the recurrence of Lyme infection controversial?
"We live in an arena where there are political, as well as scientific and medical discussions. And I think that scientific and medical discussions are important, and political discussions sometimes prevent us from getting very far with our science and our medicine. As long as people enter an opportunity for discussion and dialog with preconceived notions about what they will and will not embrace as an idea, you have a political weight that is dragging down the level of the opportunity to learn from discussion or from listening to patients.
If people decide that there is no such thing as maternal fetal transmission in Lyme disease, then they can't learn very much when they read my paper, because my paper does show that there is tissue evidence of the infection in newborns that were stillborn, or fetuses that didn't make it to full term.
And there are opportunities to read other papers and not understand how dormant conditions can exist for twenty or thirty years, such as the ACA model in Europe. If you enter the discussion with a preconceived notion of what you will or will not take away from the discussion, you can't learn. So politics is an unfortunate mindset, where the mind is closed before the discussion begins. And that's where a lot of, I think, the politics of discord come from in discussing this, or any other infection.
You know, in the early days of HIV infection, there was a certain reluctance to see it as a public health problem that we know now HIV infections are, in a worldwide basis. But back in the early eighties, when I was beginning my practice, there wasn't a lot of open mindedness about the need to treat HIV as a medical problem. It was a political problem for people who came from Haiti, or for people who lived in San Francisco who happened to be gay. It was a political problem.
Now, we have gotten past that and we see that HIV is a chronic infection. It's a medical issue, not a political issue anymore. Sometimes it takes a long time for politics to exit, and for medicine and science to get back on an even keel."
Agreement Ends Lyme Disease Investigation By Connecticut Attorney General
Medical Validity of IDSA Guidelines Not Challenged
The Infectious Diseases Society of America (IDSA) has entered into an agreement with the Attorney General of Connecticut ending his investigation of the Society’s Lyme disease guidelines. Under the agreement, the guidelines remain in effect; but in an effort to clear the air, IDSA is voluntarily agreeing to an extra step: a one-time special review of the Lyme disease guidelines.
The agreement ends the investigation of IDSA and its volunteer guideline panel members without the filing of a complaint or the entry by a court of factual or legal findings, without IDSA paying any fines or penalties, and without imposing on IDSA any restrictions on its right to promulgate guidelines for Lyme disease or any other disease or condition in the manner it believes best serves public health.
“IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” said IDSA President Donald Poretz, MD. “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by the Society, and we look forward to the opportunity to put to rest any questions about them.”
The IDSA Lyme disease guidelines recommend against long-term antibiotic therapy, an unproven and potentially dangerous treatment. A small group of physicians outside the medical mainstream and their patients endorse such long-term treatment, despite the compelling medical evidence that it is ineffective and can have serious, life-threatening complications—and, furthermore, is extremely expensive. This agreement does not change the medical advice to patients: The 2006 Lyme disease guidelines remain in place.
Under the terms of the agreement announced today, IDSA will convene a review panel to conduct a comprehensive review of the Lyme-related literature to determine whether the 2006 guidelines should be revised or updated. While IDSA periodically reviews all of its treatment guidelines in order to keep them current, the agreement allows for an expanded process that includes an opportunity for public presentation and submission of information to ensure that all points of view are presented to and considered by the review panel.
IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines. This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.
The main actions of the agreement include:
Complete resolution of the Attorney General’s investigations, issues, and potential claims and causes of action against IDSA and its volunteer panel members.
The current Lyme disease guidelines remain in effect. The medical and scientific basis of the 2006 guidelines remains in place and unchallenged.
IDSA will convene a review panel to determine whether the 2006 Lyme disease guidelines should be revised or updated. Howard Brody, MD, PhD, who has been jointly selected by the Office of the Attorney General and IDSA, will serve as an ombudsman who will have a limited role that will focus on screening potential conflicts of interest. The ombudsman will not be involved in the operation of the review panel. Any proposed changes to the guidelines would require a supermajority vote of 75 percent of the panel.
IDSA strongly disagrees with the Attorney General’s assertion that panel members had significant conflicts of interest. Panel members had no financial interests that would have affected, or been affected by, recommendations in the guidelines. The guidelines recommend generic drugs and generic diagnostic tests. Panel members do not stand to profit from any recommendation in the guidelines. In fact, the panel members denied themselves and their colleagues an opportunity to generate a significant amount of revenue when they recommendedagainstexpensive, repeated, long-term antibiotic therapy.
IDSA also strongly disagrees with the Attorney General’s allegation that the Lyme disease guideline panel excluded competing viewpoints. In fact, the panel offered an opportunity for other organizations and individuals to submit additional evidence and carefully considered all information provided. In 2000, a single member of the panel voluntarily stopped participating. He was not removed from the panel, as the Attorney General has alleged. Furthermore, all IDSA guidelines are subjected to a rigorous, multi-level review and approval process before they are published, which allows other clinicians who did not serve on the panel that developed the guidelines to ensure that the guidelines are relevant, accurate, useable, and balanced.
IDSA’s guidelines—like all medical societies’ guidelines—are voluntary. They are for the benefit of physicians seeking the best possible advice from experts in the field. Medical societies do not have the authority or the desire to dictate to physicians how to practice medicine. Nor do they have the ability to dictate to insurance companies how to reimburse for services. No ties exist between IDSA and any insurance company.
The physicians who wrote IDSA’s 2006 guidelines concluded that, for nearly all patients, a short course of antibiotics is an effective treatment for Lyme disease. Studies have proven that long-term antibiotic treatment, which is usually given through a needle and a catheter, is ineffective, expensive, and potentially harmful. The overuse of antibiotics also contributes to an important public health threat: the development of drug-resistant infections that are difficult if not impossible to treat.
“We recognize that medicine is always evolving, and we welcome the opportunity that the review panel provides to examine any new evidence and vet our earlier findings,” said Dr. Poretz. “We are pleased that under this agreement, the proper diagnosis and treatment for Lyme disease will be decided in a medical forum, not a courtroom. We hope this special review of the guidelines will help quell the unfortunate controversy surrounding the treatment of Lyme disease and ensure that patients receive advice and treatment based on the best available scientific and medical evidence.”
###
IDSA is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has more than 8,000 members, was founded in 1963 and is based in Arlington, VA.For more information, visitwww.idsociety.org.
estaba mirando indices de coagulacion que muestren hipercoagulabilidad por infeccion, y sirva para ver el progreso, he visto que la borrelia usa el factor de Willebrand que se activa con daño endotelial, para unirse a la matriz extracelular, sin adhesion no infecta, dicen en los articulos lo ha adquirido evolutivamente y les resulta extraño es el mismo que el de los piroplasmidos, y es distinto a los factores empleados por treponema, que si mantiene sus ancestrales; este factor willebrand es un indicador de daño endotelial que puede salir positivo a pesar de que aparentemente no haya marcadores de hipercoagulabilidad, lo hacen en hemex.com
Agreement Ends Lyme Disease Investigation By Connecticut Attorney General
Medical Validity of IDSA Guidelines Not Challenged
The Infectious Diseases Society of America (IDSA) has entered into an agreement with the Attorney General of Connecticut ending his investigation of the Society’s Lyme disease guidelines. Under the agreement, the guidelines remain in effect; but in an effort to clear the air, IDSA is voluntarily agreeing to an extra step: a one-time special review of the Lyme disease guidelines.
The agreement ends the investigation of IDSA and its volunteer guideline panel members without the filing of a complaint or the entry by a court of factual or legal findings, without IDSA paying any fines or penalties, and without imposing on IDSA any restrictions on its right to promulgate guidelines for Lyme disease or any other disease or condition in the manner it believes best serves public health.
“IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” said IDSA President Donald Poretz, MD. “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by the Society, and we look forward to the opportunity to put to rest any questions about them.”
The IDSA Lyme disease guidelines recommend against long-term antibiotic therapy, an unproven and potentially dangerous treatment. A small group of physicians outside the medical mainstream and their patients endorse such long-term treatment, despite the compelling medical evidence that it is ineffective and can have serious, life-threatening complications—and, furthermore, is extremely expensive. This agreement does not change the medical advice to patients: The 2006 Lyme disease guidelines remain in place.
Under the terms of the agreement announced today, IDSA will convene a review panel to conduct a comprehensive review of the Lyme-related literature to determine whether the 2006 guidelines should be revised or updated. While IDSA periodically reviews all of its treatment guidelines in order to keep them current, the agreement allows for an expanded process that includes an opportunity for public presentation and submission of information to ensure that all points of view are presented to and considered by the review panel.
IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines. This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.
The main actions of the agreement include:
Complete resolution of the Attorney General’s investigations, issues, and potential claims and causes of action against IDSA and its volunteer panel members.
The current Lyme disease guidelines remain in effect. The medical and scientific basis of the 2006 guidelines remains in place and unchallenged.
IDSA will convene a review panel to determine whether the 2006 Lyme disease guidelines should be revised or updated. Howard Brody, MD, PhD, who has been jointly selected by the Office of the Attorney General and IDSA, will serve as an ombudsman who will have a limited role that will focus on screening potential conflicts of interest. The ombudsman will not be involved in the operation of the review panel. Any proposed changes to the guidelines would require a supermajority vote of 75 percent of the panel.
IDSA strongly disagrees with the Attorney General’s assertion that panel members had significant conflicts of interest. Panel members had no financial interests that would have affected, or been affected by, recommendations in the guidelines. The guidelines recommend generic drugs and generic diagnostic tests. Panel members do not stand to profit from any recommendation in the guidelines. In fact, the panel members denied themselves and their colleagues an opportunity to generate a significant amount of revenue when they recommendedagainstexpensive, repeated, long-term antibiotic therapy.
IDSA also strongly disagrees with the Attorney General’s allegation that the Lyme disease guideline panel excluded competing viewpoints. In fact, the panel offered an opportunity for other organizations and individuals to submit additional evidence and carefully considered all information provided. In 2000, a single member of the panel voluntarily stopped participating. He was not removed from the panel, as the Attorney General has alleged. Furthermore, all IDSA guidelines are subjected to a rigorous, multi-level review and approval process before they are published, which allows other clinicians who did not serve on the panel that developed the guidelines to ensure that the guidelines are relevant, accurate, useable, and balanced.
IDSA’s guidelines—like all medical societies’ guidelines—are voluntary. They are for the benefit of physicians seeking the best possible advice from experts in the field. Medical societies do not have the authority or the desire to dictate to physicians how to practice medicine. Nor do they have the ability to dictate to insurance companies how to reimburse for services. No ties exist between IDSA and any insurance company.
The physicians who wrote IDSA’s 2006 guidelines concluded that, for nearly all patients, a short course of antibiotics is an effective treatment for Lyme disease. Studies have proven that long-term antibiotic treatment, which is usually given through a needle and a catheter, is ineffective, expensive, and potentially harmful. The overuse of antibiotics also contributes to an important public health threat: the development of drug-resistant infections that are difficult if not impossible to treat.
“We recognize that medicine is always evolving, and we welcome the opportunity that the review panel provides to examine any new evidence and vet our earlier findings,” said Dr. Poretz. “We are pleased that under this agreement, the proper diagnosis and treatment for Lyme disease will be decided in a medical forum, not a courtroom. We hope this special review of the guidelines will help quell the unfortunate controversy surrounding the treatment of Lyme disease and ensure that patients receive advice and treatment based on the best available scientific and medical evidence.”
###
IDSA is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has more than 8,000 members, was founded in 1963 and is based in Arlington, VA.For more information, visitwww.idsociety.org.
Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines and the IDSA has agreed to reassess them with the assistance of an outside arbiter.
The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.
Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.
"This agreement vindicates my investigation -- finding undisclosed financial interests and forcing a reassessment of IDSA guidelines," Blumenthal said. "My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.
"The IDSA's Lyme guideline process lacked important procedural safeguards requiring complete reevaluation of the 2006 Lyme disease guidelines -- in effect a comprehensive reassessment through a new panel. The new panel will accept and analyze all evidence, including divergent opinion. An independent neutral ombudsman -- expert in medical ethics and conflicts of interest, selected by both the IDSA and my office -- will assess the new panel for conflicts of interests and ensure its integrity."
Blumenthal's findings include the following:
The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;
Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;
The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee;
The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";
The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;
The IDSA portrayed another medical association's Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.
IDSA has reached an agreement with Blumenthal's office calling for creation of a review panel to thoroughly scrutinize the 2006 Lyme disease guidelines and update or revise them if necessary. The panel -- comprised of individuals without conflicts of interest -- will comprehensively review medical and scientific evidence and hold a scientific hearing to provide a forum for additional evidence. It will then determine whether each recommendation in the 2006 Lyme disease guidelines is justified by the evidence or needs revision or updating.
Blumenthal added, "The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.
"Our investigation was always about the IDSA's guidelines process -- not the science. IDSA should be recognized for its cooperation and agreement to address the serious concerns raised by my office. Our agreement with IDSA ensures that a new, conflicts-free panel will collect and review all pertinent information, reassess each recommendation and make necessary changes.
"This Action Plan -- incorporating a conflicts screen by an independent neutral expert and a public hearing to receive additional evidence -- can serve as a model for all medical organizations and societies that publish medical guidelines. This review should strengthen the public's confidence in such critical standards."
THE GUIDELINE REVIEW PROCESS
Under its agreement with the Attorney General's Office, the IDSA will create a review panel of eight to 12 members, none of whom served on the 2006 IDSA guideline panel. The IDSA must conduct an open application process and consider all applicants.
The agreement calls for the ombudsman selected by Blumenthal's office and the IDSA to ensure that the review panel and its chairperson are free of conflicts of interest.
Blumenthal and IDSA agreed to appoint Dr. Howard A. Brody as the ombudsman. Dr. Brody is a recognized expert and author on medical ethics and conflicts of interest and the director of the Institute for Medical Humanities at the University of Texas Medical Branch. Brody authored the book, "Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry."
To assure that the review panel obtains divergent information, the panel will conduct an open scientific hearing at which it will hear scientific and medical presentations from interested parties. The agreement requires the hearing to be broadcast live to the public on the Internet via the IDSA's website. The Attorney General's Office, Dr. Brody and the review panel will together finalize the list of presenters at the hearing.
Once it has collected information from its review and open hearing, the panel will assess the information and determine whether the data and evidence supports each of the recommendations in the 2006 Lyme disease guidelines.
The panel will then vote on each recommendation in the IDSA's 2006 Lyme disease guidelines on whether it is supported by the scientific evidence. At least 75 percent of panel members must vote to sustain each recommendation or it will be revised.
Once the panel has acted on each recommendation, it will have three options: make no changes, modify the guidelines in part or replace them entirely.
The panel's final report will be published on the IDSA's website.
ADDITIONAL FINDINGS OF BLUMENTHAL'S INVESTIGATION
IDSA convened panels in 2000 and 2006 to research and publish guidelines for the diagnosis and treatment of Lyme disease. Blumenthal's office found that the IDSA disregarded a 2000 panel member who argued that chronic and persistent Lyme disease exists. The 2000 panel pressured the panelist to conform to the group consensus and removed him as an author when he refused.
IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings. In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines a the same time -- a violation of IDSA's conflicts of interest policy.
The resulting IDSA and AAN guidelines not only reached the same conclusions regarding the non-existence of chronic Lyme disease, their reasoning at times used strikingly similar language. Both entities, for example, dubbed symptoms persisting after treatment "Post-Lyme Syndrome" and defined it the same way.
When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to "strengthen" its guidelines' impact. The AAN panel -- particularly members who also served on the IDSA panel -- worked equally hard to win AAN's backing of IDSA's conclusions.
The two entities sought to portray each other's guidelines as separate and independent when the facts call into question that contention.
The IDSA subsequently cited AAN's supposed independent corroboration of its findings as part of its attempts to defeat federal legislation to create a Lyme disease advisory committee and state legislation supporting antibiotic therapy for chronic Lyme disease.
In a step that the British Medical Journal deemed "unusual," the IDSA included in its Lyme guidelines a statement calling them "voluntary" with "the ultimate determination of their application to be made by the physician in light of each patient's individual circumstances." In fact, United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.
Blumenthal thanked members his office who worked on the investigation -- Assistant Attorney General Thomas Ryan, former Assistant Attorney General Steven Rutstein and Paralegal Lorraine Measer under the direction of Assistant Attorney General Michael Cole, Chief of the Attorney General's Antitrust Department.
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