TÄRKEÄÄ! IDSA:N HOITOSUOSITUKSET TUOMITTIIN!

[Bb]

Neljätoista Amerikan infektiotautien järjestön, IDSA:n, jäsentä laati v.2006 Borrelioosia ja sen hoitoa käsittelevät hoitosuositukset jotka julkaistiin lääketieteellisessä julkaisussa. Hoitosuositusten laatijoiden toiminnassa on nyt todettu useita laittomuuksia. IDSA:n hoitosuosituksilla on kuitenkin ehtinyt olla jo laajat vaikutukset kroonista borrelioosia sairastavien hoitoon eri puolilla maailmaa.

IDSA:n todettiin syyllistyneen mm. seuraaviin asioihin:
# IDSA ei tuonut lainkaan esille vastakkaisia näkemyksiä kroonista borrelioosia koskevista tutkimuksista. Vastakkaisia näkemyksiä oli runsaasti.
# IDSA:n vuoden 2000 ja 2006 borrelioosipaneelin jäsenet kieltäytyivät hyäksymästä tai ottamasta huomioon tietoa kroonisen borrelioosin puolesta puhuvista tutkimuksista.
# IDSA esti sellaisten tutkijoiden ja lääkäreiden tapaamiset joilla oli IDSA:n kannasta poikkeava näkemys kroonisesta borrelioosista.
# IDSA vaikutti lakien vastaisesti myös toisen lääketieteellisen järjestön Borrelioosin hoitoa pohtivan paneelin hoito-ohjeisiin soluttamalla sinne useita omia jäseniään pyrkien siten edistämään omia näkemyksiään borrelioosista.

Syyttäjän mukaan borrelioosin/kroonisen borrelioosin hoitosuositukset laaditaan uudelleen. Niitä laatimaan muodostetaan uusi puolueeton paneeli.

Allaolevista linkeistä löyttä runsaasti tietoa asiasta. Niistä huomaa että asia on ollut erittäin laajasti esillä Amerikan lehdistössä.


May 1, 2008
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."

CT Ag Press Release

http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284

NY Times 5/2

AP Article

Doctors to reassess antibiotics for 'chronic Lyme' disease

http://www.nytimes.com/aponline/health/ ... ref=slogin



NJ Star Ledger 5/2

Group to reconsider Lyme disease rules

http://www.nj.com/starledger/stories/in ... xml&coll=1



Wall Street Journal 5/3

Lyme Disease Dispute is Settled

SHORT CLIP ? does anyone have access to complete STAFF article?

http://online.wsj.com/article/SB120969421231160733.html



Wall Street Journal Blog

Guidelines for Lyme Disease Treatment to go Back For Review 5/1

http://blogs.wsj.com/health/2008/05/01/ ... od=WSJBlog



Hartford Courant 5/3

http://www.courant.com/news/local/state ... 4350.story



All Headline News article

http://www.allheadlinenews.com/articles/7010836556



Winston Salem Journal 5/3

Lyme Disease Will Get a Second Look

http://www2.journalnow.com/content/2008 ... -2nd-look/



Rochester Democrat and Chronicle 5/2

New hope for sufferers of Lyme disease

May be one of the best articles for specific points!

NOTE: READER SUBMITTED ARTICLE!

Give Anyone Ideas?? (many newspapers have buttons where readers can submit articles incl. pictures)

http://www.democratandchronicle.com/app ... 032/LIVING



Newsday NY 5/1 AP Story

Conn. probe leads to review of Lyme Disease treatment

http://www.newsday.com/news/local/wire/ ... 2680.story



Hartford Courant 5/2

Agreement Is Reached On Lyme Disease

http://www.courant.com/news/health/hc-c ... 5299.story

Hartford Courant 5/1

Lyme Disease Treatment Guidelines To Be Reviewed

http://www.courant.com/news/custom/topn ... 5579.story



Wall St. Journal Blogs 5/1

Guidelines for Lyme Disease Treatment Go Back for Review

http://blogs.wsj.com/health/2008/05/01/ ... od=WSJBlog



The Washington Post 5/2 AP Article

Doctors to reassess antibiotics for 'chronic Lyme' disease

http://www.washingtonpost.com/wp-dyn/co ... tml?sub=AR


Philadelphia Inquirer 5/3 AP Article
Doctors agree to reassess 'chronic Lyme,' treatment
Under prodding, they will review guidelines questioning long-term use of antibiotics.

http://www.philly.com/inquirer/world_us/18543359.html


Philadelphia Inquirer 5/2 AP Article

Doctors to reassess antibiotics for 'chronic Lyme' disease

http://www.philly.com/philly/wires/ap/f ... 99449.html



NECM.com (MA) 5/2

Does Chronic Lyme Exist?

http://www.necn.com/Boston/Health/Does- ... 74818.html



Norwalk Plus News 5/1

Attorney General's investigation reveals flawed Lyme disease guideline process

(rehash of ATTY General?s Press Release)

http://www.norwalkplus.com/nwk/informat ... 1257.shtml



Boston Globe 5/2

Doctors to reassess antibiotics for 'chronic Lyme' disease

http://www.boston.com/news/health/artic ... e_disease/



Boston Globe 5/1

Conn. probe leads to review of Lyme Disease treatment 5/1

http://www.boston.com/news/local/connec ... treatment/



5/2 Yahoo News AP Article

http://news.yahoo.com/s/ap/20080502/ap_ ... me_disease

5/2 UPI Article

http://www.upi.com/NewsTrack/Top_News/2 ... ines/8870/



LDA Press Release

http://www.lymediseaseassociation.org/N ... 61116.html



KDBC Texas 5/2

Doctors to reassess antibiotics for 'chronic Lyme' disease

Associated Press article

http://www.kdbc.com/Global/story.asp?S=8263970

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Lähettäjä: Soijuv Lähetetty: 8.5.2008 8:41

Connecticutin osavaltion asianajaja Blumenthal ja IDSA pääsivät yhteisymmärrykseen siitä, että muodostetaan uusi riippumaton yhteistyöelin laatimaan uudet borrelioosin hoitosusoitukset. Uuteen työryhmään ei oteta edellisen työryhmän jäseniä.

Blumenthalin tutkimuksissa selvisi että edellinen työryhmä oli taloudellisista intresseistä johtuen jättänyt järjestelmällisesti huomioimatta huomattavan osan borrelioositutkimuksia. Lisäksi osa IDSA:n lääkäreistä oli sidoksissa lääketeollisuuteen ja borrelioosirokotteita kehittäviin laitoksiin.


"Agreement is reached on Lyme disease"

Hartford Courant (05/02/08 ) Hilary Waldman

http://www.courant.com/news/health/hc-c ... 5299.story

Connecticut Attorney General Richard Blumenthal and the Infectious
Diseases Society of America have reached an agreement to establish an
independent review of the organization's guidelines for treating Lyme
disease. The Society's treatment standards downplayed a belief by many
that the tick-borne bacteria can remain for years in the bloodstream
and cause debilitating chronic symptoms. The agreement came after
Blumenthal launched an antitrust investigation to look into complaints
that the treatment guidelines were biased. Blumenthal also said his
office found evidence that some members of the Society had personal
and professional financial stakes in companies that make or develop
Lyme disease tests and treatments. "What happened in this process,
what made it so flawed, is it excluded information. The cause of that
excluding of evidence was financial concern," he said. Under the
agreement, the Society will name an independent panel of experts to
review the guidelines. The new board will comprise members who were
not on the original guidelines panel, and they will be approved by an
ombudsman who is an expert in medical ethics. Dr. Donald Poretz, the
Society's president, said he agreed to the settlement in an effort to
clear the air.

To read the agreement between the Connecticut Attorney
General and the Infectious Diseases Society of America, visit
http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf.

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Lähettäjä: jukka61 Lähetetty: 8.5.2008 16:18

Täytyy tunnustaa, että tietty viha-/rakkaussuhde on moneen eri Jenkkilän juttuun - tuskin voisi kuvitella, että meillä tälläista "casea" tulee - sen verran pienet piirit täällä on kytköksissä toisiinsa, laajemmin asia koskee lähes kaikki ns. "kähmintää" ja (poliittisia) lehmänkauppoja.

Toivottavasti tuosta kuitenkin jotain hyötyä on suomalaisille Borrelia-potilaille, joskus ns. virallisen totuuden - mm. käypähoitosuositukset ja muu jankutus vuodesta toiseen - on pakko väistyä "oikean" totuuden tieltä, jotka perustuvat uusiin tutkimuksiin.

Sen jälkeen on mielenkiintoista nähdä, mitä tapahtuu, vai tapahtuuko mitään ja kuinka moni lääkäri/tutkija "kääntää" takkinsa.

[Bb]

Newstimes lehdessä aihetta käsiteltiin seuraavasti:

http://www.newstimes.com/ci_9231161

Useat tieteelliset tutkimukset osoittavat kroonisen borrelioosin olevan todellisuutta. IDSA:n työryhmä ei hyväksynyt tätä näkökulmaa. Siksi työryhmän jäsenenä ollut infektiolääkäri Sam Donta kieltäytyi allekirjoittamasta IDSA:n hoitosuosituksia.

Tutkimuksissa on yleensä tutkittu vain jonkun tietyn antibiootin vaikutuksia borrelioosiin. Mikäli se ei ole auttanut on tehty johtopäätös että antibioottihoidoista ei ole apua. Donta ihmettelee tällaisia johtopäätöksiä ja kysyy: "Mikäli jokin syöpälääke ei tehoa, ei hoitoa silloinkaan lopeteta. Silloin yritetään jotakin muuta syöpähoitoa?" Vakuutusyhtiöt ottivat IDSA:n hoitosuositukset vastaan suurella tyytyväisyydellä sillä suositusten ansiosta ne voivat kieltäytyä maksamasta borrelioosiin sairastuneiden hoitoja.

Vaikka norrelioosin hoidosta on olemassa kaksi toisistaan poikkeavaa näkemystä, on IDSA:n näkemys saanut (taloudellisista seikoista johtuen) enemmän huomiota. Tri Daniel Cameron kertoo ILADS:in lääkäreiden ja tutkijoiden lukeneen samoja tutkimuksia kuin IDSA:n työryhmän lääkäritkin. He olivat kuitenkin tulleet päätelmissään tutkimustuloksista aivan vastakkaisiin tuloksiin. Tri Steven Phillips toivoo, että uuden borrelioosihoitoja käsittelevän työryhmän tulosten jälkeen, kroonista borrelioosia sairastavien hoito paranee.


Lyme disease care under fire
Medical groups differ on courses of treatment
By Robert Miller Staff Writer
Article Last Updated: 05/12/2008 04:14:20 AM EDT

In the battle over how best to treat Lyme disease, a new settlement between Attorney General Richard Blumenthal and a major medical group might seem to offer at least a little hope of expanded treatment for those with the tick-borne disease.

That, however, would involve a change in the lines of debate over the disease, and it's not clear there will be any yielding.

The settlement, reached this month between Blumenthal and the Infectious Diseases Society of America, provides for a review of the IDSA's guidelines for treating Lyme disease -- guidelines that a second group of doctors, the International Lyme and Associated Diseases Society, say are strict and inflexible to the point of harming some patients.

But the IDSA's guidelines will remain unchanged until that review ends. And while the review process will include the participation of an ombudsman, the guarantee that opposing voices will get their say, and hearings that will be broadcast on the Internet, they may not yield a single change, said Dr. Eugene Shapiro, a pediatrician, epidemiologist and professor of investigative medicine with the Yale School of Medicine in New Haven.

Asked last week if the IDSA guidelines could remained unchanged after the review, Shapiro said flatly, "Yes."

"If the scientific data recommends a change, we'll be happy to change," Shapiro said. "But we have 25 years of research on Lyme disease. We feel very comfortable the guidelines will stand up to any scientific scrutiny."

Doctors
Advertisement who are opposed to the IDSA guidelines said they believe there's at least a chance their position -- that infection from the Lyme disease bacteria Borrellia burgdorferi can create a chronic illness that needs long-term treatment with antibiotics -- will gain some credence with the review panel.

"I hope it will lead to an improvement to patient care," said Dr. Steven Phillips of Wilton, who has been one of the doctors opposing the strict guidelines in favor of those in which doctors can tailor treatment to individual patients.

Phillips is a past president of the International Lyme and Associated Diseases Society, which believes there is ample scientific evidence to treat people for chronic Lyme disease.

"We've looked at the same evidence as IDSA and come up with significantly different conclusions," said Dr. Daniel Cameron of Mount Kisco, N.Y., the current president of the group.

This isn't a merely a spat between two opposing medical groups.

In a press release, Blumenthal's office pointed out that insurance companies now use the IDSA guidelines to restrict care for patients and refuse to pay for long-term antibiotic care.

"It's a good way to have people denied insurance," said Maggie Shaw of Newtown, a member of that town's Lyme Disease Task Force. "It also puts the fear factor in doctors.

"Here are two standards of care, but only one gets recognized," Shaw said. "It's because of the stranglehold the IDSA has on this."

The settlement between Blumenthal and the IDSA came after Blumenthal sued the group -- which represents about 8,000 infectious disease specialists in the United States -- in 2006 for antitrust violations.

Blumenthal said his investigation discovered many examples of conflicts of interest among the doctors who wrote the IDSA guidelines. He also said they refused to "accept or meaningfully consider" any evidence concerning chronic Lyme disease in writing the 2006 guidelines and blocked the appointments of scientists and physicians who differed with the IDSA view that all Lyme disease can be treated with two to four weeks of antibiotics and that chronic Lyme disease does not exist.

"Our focus has not been on medicine but the process," Blumenthal said. "There may have been violation of the law and it's my job to enforce the law."

Dr. Sam Donta, a Massachusetts-based infectious disease specialist, was on the panel that drew up the IDSA guidelines. Donta said he refused to sign off on the guidelines when the group refused to acknowledge that chronic Lyme disease is a problem.

--The issue should not be whether there's chronic Lyme disease, but why we're seeing these patients," he said

The review process established in the settlement, Blumenthal said, will be "fair, open and free of conflict." Donta said Friday he hopes to serve on the panel.

But in its own press release on the settlement, the IDSA emphatically denies there was any "significant" conflict of interest on the part of any of the doctors who wrote the 2006 guidelines, or that they excluded conflicting points of view while writing them.

In fact, Shapiro said, having stricter guidelines means doctors who follow the IDSA protocols see patients fewer times and prescribe only short-term regimens of generic antibiotics.

Shapiro said the IDSA agreed to the settlement simply to end any attempt by Blumenthal to take the case to court.

"The alternative was spending a lot of money in an expensive lawsuit," he said.

Shapiro said all the scientific evidence on long-term treatment of Lyme disease, including five double-blind studies in which some patients got antibiotics and others a placebo, show that long-term antibiotics did not cure the symptoms that people include in the diagnoses of Lyme disease.

"It's not that data isn't there. It is," he said, pointing out that 95 percent of all Lyme cases are successfully treated with only two or three weeks of standard antibiotics.

But Cameron said the double-blind studies, all with a small number of patients, only show that Lyme disease is complicated.

"The evidence is quite mixed," he said.

And the trials often look at the effect of just one type of antibiotic on patients, Donta said.

"If one doesn't work, do you say all antibiotics don't work?," he asked. "If one cancer drug stops working, do you not try and find another? There's insufficient information in the guidelines for physicians to make a decision."

Phillips of Wilton said many peer-reviewed articles published in medical and scientific journals make the case that chronic Lyme disease does exist.

What they hope the new review of the IDSA guidelines do, they said, is take all this into account and give doctors a chance to treat each case individually, rather than with a one-size-fits-all approach.

"Let the doctors have some flexibility," Cameron said.

Contact Robert Miller

at bmiller@newstimes.com

or at (203) 731-3345.

LYME DISEASE

The most common tick-borne illness in the United States.

Caused by a bacterial spirochete, Borrelia burgdorferi.

Spread to humans by the bite of the black-legged tick, aka the deer tick.

Can cause fever, headache and muscle ache in early stages.

Often, but not always, is accompanied by a rash spreading from the site of the tick bite.

In most cases is cured by a few weeks of antibiotics.

If untreated or undertreated, Lyme infection can cause arthritic pain and swelling of the knees and joints.

Number of reported U.S, cases in 2006: 19,931.

Number of cases that might actually exist could be up to 10 times the number of reported cases.

There is debate whether chronic Lyme disease -- a long-term infection that can cause fatigue, memory loss, depression, loss of vision and hearing, arthritis and heart ailments -- exists.

[Bb]

Lähettäjä: Soijuv Lähetetty: 20.5.2008 9:41

Amerikan neurologien akatemia kiirehti IDSA:n myötävaikutuksella julkaisemaan omat IDSA:n kantaa myötäilevät hoitosuositukset borrelioosiin. Kolme akatemian jäsenistä edusti IDSA:a. Vastineessaan lääkärit Stricker ja Johnson mainitsevat mm. sen, että vastuullisessa lääketieteessä tunnustetaan mikäli asioista esiintyy vastakkaisia näkemyksiä eikä yritetä kaikin tavoin peitellä vastakkaisia tutkimuksia ja näkemyksiä.


PRACTICE PARAMETER: TREATMENT OF NERVOUS SYSTEM LYME DISEASE (AN EVIDENCE-BASED REVIEW): REPORT OF THE QUALITY STANDARDS SUBCOMMITTEE OF THE AMERICAN ACADEMY OF NEUROLOGY Neurology 2008;70;1719-1720

To the Editor: We wish to point out a serious ethical problem with the recently adopted Lyme disease treatment guidelines of the American Academy of Neurology (AAN).1 These guidelines have been touted as an ?independent corroboration? of the Lyme guidelines published by the Infectious Diseases Society of America (IDSA) in November 2006.2 Nothing could be further from the truth. The IDSA and AAN guidelines committees were clearly not independent in terms of personnel or philosophy. The AAN guidelines were put together by a committee of nine members, three of whom also served on the IDSA Lyme guidelines panel, including the chairman of each committee. The overlapping chairs virtually assured that the form and substance of the AAN guidelines would be like-minded?essentially a repackaging of the IDSA guidelines?by controlling the panel selection and scope of the process. AAN published its guidelines after the Attorney General of Connecticut launched an unprecedented investigation into potential anti-trust violations in the IDSA guidelines formulation.

The AAN guidelines were, not surprisingly, quickly endorsed by IDSA and presented to the medical community as ?independent corroboration? despite the overlapping panels and questions raised by the Connecticut investigation. Thus the timing of the AAN guidelines and the IDSA endorsement compounded the conflict of interest for both organizations. Two medical societies, IDSA and the International Lyme and Associated Diseases Society (ILADS), have published peer-reviewed, evidence based guidelines listed by the government sponsored National Guidelines Clearinghouse and offering divergent treatment approaches for Lyme disease.2,3 Under the IDSA guidelines recapitulated by AAN, patients who fail to respond to the IDSA protocols are denied longer antibiotic treatment. In contrast, the ILADS guidelines consider these patients to have chronic Lyme disease and provide the only viable treatment option for them.

The conflicting guidelines have established two standards of care for Lyme disease.4 Responsible medical societies have an obligation to acknowledge scientific uncertainty and lack of consensus when controversy exists regarding the treatment of medical conditions such as tick-borne diseases.4 It is unacceptable to repackage the beleaguered guidelines of another medical society and allow overlapping panel members with clear conflicts of interest to control the process. To ignore the conflicts of interest in these circumstances represents a serious ethical breach that discredits AAN and misleads the broader medical community, which relies on the ethical accountability of guidelines panels.5

Raphael B. Stricker, Lorraine Johnson, San

Francisco, CA

Disclosure: The authors report no conflicts of interest.



1. Halperin JJ, Shapiro ED, Logigian E, et al. Practice parameter:

treatment of nervous system Lyme disease (an

evidence-based review): Report of the Quality Standards

Subcommittee of the American Academy of Neurology.

Neurology 2007;69:91?102.

2. Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical

assessment, treatment, and prevention of Lyme disease,

human granulocytic anaplasmosis, and babesiosis:

clinical practice guidelines by the Infectious Diseases Society

of America. Clin Infect Dis 2006;41:1089?1134.

3. Cameron D, Gaito A, Harris N, et al, and the ILADS

Working Group. Evidence-based guidelines for the

management of Lyme disease. Expert Rev Anti-Infect

Ther 2004;2(1 suppl):S1?13.

4. Johnson L, Stricker RB. Treatment of Lyme disease: a

medicolegal assessment. Expert Rev Anti-Infect Ther

2004;2:533?557.

5. Steinbrook R. Guidance for guidelines. N Engl J Med

2007;356:331?333.

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Lähettäjä: Soijuv Lähetetty: 26.11.2008 16:51

Marraskuun Science-julkaisussa kerrottiin USA:n kongressin pohtivan IDSA:n hoitosuositusten käyttökelpoisuutta ja pitäisikö borrelioosia sairastaville IDSA:n näkemyksistä huolimatta sallia pitkät antibioottihoidot. Kongressin edustajan Frank Wolfin mukaan infektiotautien yhdistyksen, IDSA:n, antamia hoitosuosituksia ei tulisi käyttää.

Artikkelin lopussa on tri Strickerin tutkimus jossa pidennetyn antibioottihoidon todetaan olevan oikeutettua mikäli sairastuneen oireet jatkuvat ja silloin kun henkilöllä on lisäinfektioita.


http://blogs.sciencemag.org/scienceinsi ... se-ta.html

November 24, 2008
Lyme Disease: Taking Shots at Shots

Congress is wading into the murky question of whether people with Lyme disease should get long-term antibiotics or whether the drugs harm more than help. That issue, which has been a never-ending source of friction among biomedical researchers, will get congressional hearings next year.

If there were a Nobel Prize awarded for disease-that-causes-the-most-controversy, Lyme disease would be a top contender. For years, the tick-borne illness has been the subject of vicious fights between scientists and patient advocates over whether long-term antibiotics can help. Many affected by the disease say yes, citing waning symptoms after treatment; many scientists say no, and several clinical trials back them up.

Now entering the Lyme fray is Representative Frank Wolf (R?VA), who used to oversee funding for the U.S. National Science Foundation and other science agencies as a powerful spending panel chair when Republicans controlled the House of Representatives. In September, he sent a letter to the U.S. Department of Health and Human Services, demanding that it investigate the treatment guidelines of the Infectious Diseases Society of America (IDSA), which shuns long-term antibiotics. He has also requested that a congressional subcommittee hold hearings as soon as possible, and the office of Frank Pallone Jr. (D?NJ), who chairs the House Energy and Commerce panel's Subcommittee on Health, said they will occur next year. ?We want an independent evaluation? of the treatment guidelines, said Wolf in an interview with Science. Patients ?have lost confidence?some people are traveling for miles to get treatment.?

?I don?t believe? the IDSA guidelines should be used, he went on, ?but I?m not a scientist.? IDSA, no stranger to tumult, says it?s happy to cooperate with any hearings but stands by its recommendations. In fact, IDSA recently began assembling an independent panel of eight to 12 people to review its guidelines for Lyme treatment. A spokesperson told ScienceInsider, "We took this extra step to say, 'Okay [if] you don't believe us, let's put this out for review.' "

?Jennifer Couzin

Posted on 24 November 2008 at 04:50 PM | Permalink
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Comments

Please arm yourself with the scientific data, they have/are committing scientific fraud.

http://www.lymecryme.com

Read The Dearborn Conference "How the Test was Spun" to see how and why we are being misdiagnosed with the 41+ year old ELISA (screening neurological chronic Lyme infected people out) testing. They do not want to pay for our long term treatment.

Please read it, for you and your loved ones.

Posted by: Concerned Citizen | November 26, 2008 at 08:10 AM

Counterpoint: long-term antibiotic therapy improves persistent symptoms associated with Lyme disease.
Stricker RB.

International Lyme and Associated Diseases Society, Bethesda, MD, USA. rstricker@usmamed.com

BACKGROUND: Controversy exists regarding the diagnosis and treatment of Lyme disease. Patients with persistent symptoms after standard (2-4-week) antibiotic therapy for this tickborne illness have been denied further antibiotic treatment as a result of the perception that long-term infection with the Lyme spirochete, Borrelia burgdorferi, and associated tickborne pathogens is rare or nonexistent.

METHODS: I review the pathophysiology of B. burgdorferi infection and the peer-reviewed literature on diagnostic Lyme disease testing, standard treatment results, and coinfection with tickborne agents, such as Babesia, Anaplasma, Ehrlichia, and Bartonella species. I also examine uncontrolled and controlled trials of prolonged antibiotic therapy in patients with persistent symptoms of Lyme disease.

RESULTS: The complex "stealth" pathology of B. burgdorferi allows the spirochete to invade diverse tissues, elude the immune response, and establish long-term infection. Commercial testing for Lyme disease is highly specific but relatively insensitive, especially during the later stages of disease. Numerous studies have documented the failure of standard antibiotic therapy in patients with Lyme disease. Previous uncontrolled trials and recent placebo-controlled trials suggest that prolonged antibiotic therapy (duration, >4 weeks) may be beneficial for patients with persistent Lyme disease symptoms. Tickborne coinfections may increase the severity and duration of infection with B. burgdorferi.

CONCLUSIONS: Prolonged antibiotic therapy may be useful and justifiable in patients with persistent symptoms of Lyme disease and coinfection with tickborne agents.

[Bb]

Lähettäjä: Video-Lare Lähetetty: 26.11.2008 23:54

Kiitos "Soijuv:lle" näistä uusista rohkaisevista uutisista USA:sta, että päästään vihdoinkin sielläkin oikein tätä B. asiaa käsittelemään.

Kuinkahan nopeasti nämä uutiset vaikuttavat EU:n hoitosuosituksiin ja sitä kautta varmaan sitten Suomen hoitosuosituksiin.

Toivottavasti pian.

[soijuv]

IDSA:n hoitosuositusten oikeellisuuden tarkistaminen on alkanut. Tarkastuksen arvioidaan kestävän 8 -12 kk.


Conflicts erupted over length of time for using antibiotics and selection process for review panel.

By Susan J. Landers, AMNews staff. Posted March 17.


--------------------------------------------------------------------------------

A review of 2006 guidelines on treating Lyme disease that were drafted by the Infectious Diseases Society of America is now under way.

The review, expected to take eight to 12 months, was required by the Connecticut attorney general after controversy erupted over whether a lengthy course of antibiotics should be included as a treatment option for the tick-borne disease.

The guidelines developed three years ago by IDSA characterize Lyme disease as an acute infection that should be treated with antibiotics for a few weeks at most. This recommendation is similar to that of the Centers for Disease Control and Prevention.

But several patient groups and the International Lyme and Associated Diseases Society, which also has guidelines, say long-term treatment with antibiotics for more than 30 days may be necessary for some patients with persistent and severe joint pain and fever. This presentation of the illness has been called chronic Lyme disease or post-Lyme syndrome.

The warring groups caught the attention of Connecticut Attorney General Richard Blumenthal. He conducted an antitrust investigation of IDSA's guideline development process and ruled in April 2008 that the society must convene an impartial panel to review evidence and determine if its guidelines should be revised. Meanwhile, the group's document as originally drafted remains in effect.

The 10-member panel selected for the review is headed by Carol J. Baker, MD, an infectious diseases specialist and pediatrician with Texas Children's Hospital in Houston. She is a past president of IDSA. Several of the other panelists also come from academic medical centers.

The patient groups have criticized the panel's composition because it "excludes physicians who treat patients with chronic Lyme disease," according to a joint statement from the Lyme Disease Assn., The California Lyme Disease Assn. and Time for Lyme.

"The situation is déjà vu all over again," said Lyme Disease Assn. President Pat Smith. "All Lyme disease-treating physicians who applied for a seat [on the panel] were denied, based on having a 'conflict' if they made over $10,000 treating Lyme disease." Yet these are the physicians who understand what makes patients well, Smith said.

All panel members were screened for potential conflicts of interest and were deemed eligible by medical ethicist Howard Brody, MD, PhD, who directs the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. Dr. Brody was chosen as ombudsman for the panel selection process by Blumenthal and IDSA.

The panel also will hear public testimony at an April 27 hearing in the Washington, D.C., area. Comments are being accepted until April 3 and can be sent to the Lyme Disease Review Panel via e-mail (lyme@idsociety.org). More information about the panel can be found online (www.idsociety.org/lymedisease.htm).

This content was published online only.

Back to top.


--------------------------------------------------------------------------------

Copyright 2009 American Medical Association. All rights reserved.



RELATED CONTENT You may also be interested in:
Summer is the time for Lyme Column July 7, 2008
Lyme treatment accord ends antitrust probe June 9, 2008
Lyme disease debate provokes treatment divide, legal action Dec. 25, 2006
Lyme disease still No. 1 vector-borne illness Aug. 9, 2004
DEET guidelines make for a safe summer June 16, 2003
The complex end of the vaccine for Lyme disease April 22/29, 2002

[soijuv]

IDSA:n laatimalle uudelle työryhmälle voi lähettää näkemyksiä/tutkimuksia borrelioosista huhtikuun 24. päivään mennessä. Työryhmä ottaa kantaa siihen pitäisikö IDSA:n v. 2006 laatimat borrelioosin hoitosuositukset uusia. Julkinen keskustelu asiasta pidetään heinäkuun 30. 2009.

http://www.infectioncontroltoday.com/ho ... -shea.html

IDSA Lyme Disease Review Panel Extends Public Input Period and Sets the Public Hearing Date

04/14/2009
The Infectious Disease Society of America (IDSA) has convened a review panel to examine whether the Society?s Lyme Disease guidelines, published in 2006, should be revised or updated based on a rigorous review of the medical and scientific evidence on the diagnosis and treatment of Lyme Disease.

The Review Panel initiated a 60-day input period to allow the public to submit information to ensure that all points of view are taken into consideration. There will also be an open public hearing to offer a forum for the presentation of relevant information on the diagnosis and treatment of Lyme Disease.

The public input period has been extended to April 24. Submissions must be received by 5 p.m. ET and must include:

-- Name and contact information of the submitter

-- Issue(s)/concern(s) and relevance to 2006 IDSA Lyme Disease guidelines; and/or

-- Issue(s) not covered in the 2006 IDSA Lyme Disease guidelines

-- Reference list of supporting data (if available)

The Review Panel is committed to considering all points of view. The panel requests that comments be succinct and focused into approximately 10 pages; however all written submissions, regardless of length, will be considered. Comments should identify specific recommendations from the 2006 guidelines and evidence that either supports or refutes those recommendations. Submissions should be made to the attention of the ?IDSA Lyme Disease Review Panel? at: lyme@idsociety.org. Submissions may be posted online by the IDSA for public viewing.

The Review Panel will hold an open public hearing July 30, 2009 in Washington, D.C. The hearing, which had been planned for April 27, is being postponed to allow potential presenters more time to prepare and make travel arrangements.

[kuka lie]

Oletkos itse tai tämä järjestö ollut IDSA:n uuden ryhmän kanssa tekemisissä? Ja onko tietoa vielä tässä vaiheessa, että onko mitään muutoksia odotettavissa?

[soijuv]

En ole ollut IDSA:n paneeliin henkilökohtaisesti yhteydessä. Muutama amerikkalainen kollegani tuntee yhden paneelin jäsenistä. Tällä hetkellä näyttää siltä että hän on ainoa paneelin jäsen jonka moraaliin luotetaan ehdoitta. Vaikea sanoa onko mitään muutosta odotettavissa. Uskoisin että IDSA:n hoitosuosituksiin on tulossa pieniä muutoksia. Tällä hetkellä en kuitenkaan vielä usko että he ovat valmiita myöntämään tekemiään virheitä kovin laajasti ja avoimesti. Toivottavasti olen väärässä.

Harmillista on, että amerikkalaisten suosituksilla on laajat vaikutukset kaikkien maiden hoitokäytäntöihin. Saksassa taitaa olla tällä hetkellä parhaimmat mahdollisuudet löytää lääkäreitä jotka toteuttavat paremminkin Kansainvälisen Borrelioosijärjestön, ILADSin, näkemyksiä Borrelioosin hoidosta. Kuulin että osa ruotsalaisista lääkäreistä ottaa vaikeissa Borrelioositapauksissa yhteyttä saksalaiseen lääkäriin (nimi?). Tämä kertoo mitä hoitoja potilaalle tulee antaa ja ruotsalaiset toteuttavat ne. Esim. Yhden henkilön tapauksessa hoitoa jatkettiin 4 vuotta. Hän parani ja on nyt takaisin työelämässä.

[soijuv]

IDSA:n toiminnasta julkaistiin artikkeli toukokuun 2009 Lääketieteen etiikkaa käsittelevässä julkaisussa, J Med Ethics. Artikkelissa käsitellään mm. ongelmia, joita esiintyy yhä enenevässä määrin siitä että lääkärit toimivat erilaisten intressiryhmien - lääketeollisuus, vakuutuslaitokset, rokoteteollisuus jne. - palveluksessa.

J Med Ethics. 2009 May;35(5):283-8. Attorney General forces Infectious Diseases Society of America to redo Lymeguidelines due to flawed development process. Johnson L, Stricker RB.

California Lyme Disease Association, Ukiah, California, USA. Lyme disease is one of the most controversial illnesses in the history ofmedicine. In 2006 the Connecticut Attorney General launched an antitrustinvestigation into the Lyme guidelines development process of the InfectiousDiseases Society of America (IDSA). In a recent settlement with IDSA, theAttorney General noted important commercial conflicts of interest andsuppression of scientific evidence that had tainted the guidelines process. This paper explores two broad ethical themes that influenced the IDSA investigation.The first is the growing problem of conflicts of interest among guidelines developers, and the second is the increasing centralisation of medical decisions by insurance companies, which use treatment guidelines as a means of controllingthe practices of individual doctors and denying treatment for patients. The implications of the first-ever antitrust investigation of medical guidelines and the proposed model to remediate the tainted IDSA guidelines process are also discussed.

PMID: 19407031 [PubMed - in process]

[soijuv]

Borrelioosin hoidosta on maailmalla kahdenlaiset hoitosuositukset; kansainvälisen borrelioosijärjestön ILADS:in ja amerikkalaisten infektiolääkäreiden yhdistyksen IDSA:n laatimat ohjeet. IDSA:n ohjeet on tuomittu puolueellisiksi yms. ja niiden oikeellisuus on parhaillaan uuden tutkijapaneelin pohdittavana.

South Med J. 2009 May 7; [Epub ahead of print]

In the Lymelight: Law and Clinical Practice Guidelines.

Ronn S. Almost

from the beginning, the Ixodes scapularis and I pacificus, adult deerticks, have been a breeding ground not only for Lyme disease, but also forpolitical dissent. Most recently, the battleground moved into the arena ofclinical practice guidelines. Both camps in the "Lyme Wars"-the InfectiousDiseases Society of America (IDSA) and the International Lyme and AssociatedDiseases Society (ILADS)-have published Lyme disease practice guidelines. Theguidelines conflict regarding diagnosis and treatment. The state ofConnecticut's Attorney General's office conducted an investigation, underantitrust laws, into the development and promulgation of IDSA's 2006 guidelines.In an unprecedented move, IDSA and the AG have entered into a legal agreementthat necessitates a rethinking of the guidelines, requiring a new review panelreflecting balanced, conflict-of-interest-free perspectives on Lyme disease. PMID: 19434013 [PubMed - as supplied by publisher]

[soijuv]

Viimeisin hoitosuosituksia käsittelevä artikkeli asiasta (11.5.09): Kansainvälinen Borrelioosijärjestö ILADS on sitä mieltä että borrelioosin diagnostiikka ja hoito on ongelmallista; tauti kroonistuu usein, se ei välttämättä parane helposti, hoito vaatii usein pidempiä antibioottihoitoja eivätkä nykyiset borrelioositestit ole riittävän käyttökelpoisia luotettavuusongelmien vuoksi.

http://www.lymedisease.org/news/lymepolicywonk/123.html

Attorney general challenges controversial Lyme Disease Guidelines

May 11, 2009

By ELLIOTT B. POLLACK and CHRISTINE COLLYER

A generation ago, most physicians would have doubted that antitrust rules and the clinical practice of medicine could intersect. Attorneys were of the same view about their profession until 1975 when the U.S. Supreme Court decided Goldfarb v. Vir­ginia State Bar and threw out minimum fee schedules on restraint of trade grounds.



Now, fast-forward 31 years to November 2006 when Connecticut Attorney General Richard Blumenthal initiated an investigation of the Infectious Diseases Society of America (IDSA). More particularly, the attorney general sought information about the development process of the IDSA?s 2000 and 2006 guidelines on the diagnosis and treatment of Lyme disease.



The investigation did not attack the science behind the guidelines but, rather, sought to determine whether IDSA engaged in exclusionary and monopolistic con­duct during their development. Blumenthal?s inquiry was whether IDSA excluded legitimate but contradictory evidence and opinions on the existence of chronic Lyme disease. This is believed to be the first time a state has relied on antitrust principles to investigate a medical society?s guideline process. However, it is not the first time that antitrust law has been used to chal­lenge a medical entity?s clinical stance.



In 1978, Dr. Chester Wilk and four other chiropractors sued the American Medical Association, among others, alleging Sher­man Act violations because the AMA?s rules prohibited allopathic doctors from referring patients to or even coordinating care with chiropractors. Nine years later, a U.S. District Court found that the AMA had tried to elimi­nate the chiropractic profession; essentially, it had orchestrated a group boycott. The court ordered the AMA to revise its rules. The Su­preme Court upheld its decision.

It is not unusual for a professional medi­cal organization to draft clinical guidelines. These guidelines pack a mighty punch be­cause they are frequently employed to de­fine the relevant standard of care. Doctors apply them in their practice and often base treatment decisions on them. Insurance companies rely on them to determine cov­erage and to deny reimbursement. State reg­ulatory agencies use them in licensure and disciplinary proceedings against doctors.



The IDSA Lyme guidelines have had a sweeping impact on the diagnosis and treat­ment of Lyme disease, especially in Connecti­cut, a highly endemic area for the disease and whose quaint shoreline town gave the disease its name. Insurance companies such as Unit­ed Healthcare, Health Net and others regu­larly rely on them to dispute the existence of chronic Lyme disease and to deny coverage for long-term antibiotic treatment. The Cen­ters for Disease Control and Prevention lists the IDSA guidelines on its website. In three disciplinary proceedings before the Con­necticut Medical Examining Board, the De­partment of Public Health has offered expert witnesses who espouse the IDSA guidelines in its prosecution of physicians who believe in and treat chronic Lyme disease.



Blumenthal?s investigation caused a ma­jor stir in the medical community national­ly. Some, like the Lyme Disease Association, applauded because it believed that IDSA had improperly excluded evidence about the ex­istence of chronic Lyme disease. IDSA sup­porters argued that Blumenthal overstepped his bounds and was improperly interfering in scientific matters.

Two Schools Of Thought

A person unfamiliar with the controversy that surrounds Lyme disease and chronic Lyme disease might not understand the significance of the attorney general?s thrust. Briefly, there are two schools of thought on the diagnosis and treatment of Lyme dis­ease. Physicians adhering to the school re­flected in the IDSA guidelines believe that Lyme disease is easy to diagnose and treat. They contend that short-term antibiotics are the appropriate therapy. They do not believe that chronic Lyme disease exists. They stress the importance of positive laboratory tests to confirm a Lyme disease diagnosis.

Physicians subscribing to the school re­flected in the International Lyme and Asso­ciated Diseases Society?s guidelines believe that the diagnosis and treatment Lyme disease is complex. They maintain chronic Lyme disease is quite prevalent and may require long-term antibiotic treatment, sometimes intravenously. They dispute the accuracy and utility of available testing.

On May 1, 2008, Blumenthal announced that his investigation uncovered ?seri­ous flaws? in IDSA?s guideline process. He stressed that medical groups, such as IDSA, have both a ?legal and moral duty to use ex­acting safeguards and scientific standards.? The panelists who draft the guidelines must be free of conflict, he stated, and should not exclude divergent views unless unsupported by evidence. These were the very concerns of Lyme disease activists who brought ID­SA?s actions to Blumenthal?s attention and who were the catalyst for his investigation.

Some of the serious flaws uncovered by the attorney general?s office were: (1) pan­elists with undisclosed financial interests were not discovered because IDSA failed to conduct a conflict of interest review; (2) panelists refused to consider information concerning the existence of chronic Lyme disease and removed a physician who dis­agreed with the majority opinion; (3) IDSA blocked appointments of scientists and physicians who believed in the existence of chronic Lyme disease by telling them the panel was full even though it was later ex­panded; and (4) IDSA appointed a chair­man who was so biased about the non‑ex­istence of chronic Lyme disease he used his position to appoint like-minded individu­als without oversight committee approval.

Credibility Issues

These flaws called the guidelines? credibility into question. IDSA and the attorney general?s office entered into a settlement agreement under which IDSA agreed to an extensive re­examination of its 2006 guidelines. A review panel will be created to ?scrutinize? the guide­lines to determine whether they should be up­dated or revised. None of the panelists who sat on the 2006 panel are permitted to serve again. IDSA must hold an open application process. All applicants are to be screened for potential conflicts by the ombudsman approved by the Attorney General?s office.


After the new panel is established, it must hold an open scientific hearing, which has yet to be scheduled, to consider information from ?interested parties? approved by the at­torney general?s office and the ombudsman. However, the hearing is not open to the pub­lic ? which has raised some eyebrows in the Lyme disease community. In lieu of a public hearing, IDSA is required to broadcast the hearing on its web site. After the hearing, the reviewers will decide whether the 2006 guidelines are supported by the evidence.


It is too early to tell whether the ?redo? demanded by Blumenthal will produce a different result. Lyme activists have ex­pressed doubt that it will. The most im­portant lesson of the attorney general?s/IDSA settlement is that regulators can no longer be expected to hang back in the face of exclusionary practices by medical clini­cal standard‑setting bodies. The credence given to IDSA?s Lyme disease guidelines by regulatory, reimbursement and profes­sional medical groups, coupled with the hostility showed by IDSA adherents to dif­fering views, was dramatically exposed by the attorney general?s efforts. Legislation is currently pending at the General Assembly addressing the Lyme disease controversy which will be the subject, if enacted, of a future article.

Elliott B. Pollack is a member of Pullman & Comley in Hartford where represents health care providers. Christine Collyer is an associate in the firm?s Hartford office where she handles health care litigation. The authors represent a physician charged by the Department of Public Health with improperly diagnosing and treating Lyme disease.

[soijuv]

Lääketieteen etiikkaa käsittelevässä julkaisussa on käsitelty IDSA:n hoitosuositusten taustalla olevia vaikuttimia. "Hoitosuositusten laatijoilla on yhä useammin taloudellisia kytköksiä esim. lääketeollisuuteen, vakuutusyhtiöihin, rokoteteollisuuteen jne. jonka vuoksi he eivät saisi osallistua hoitosuositusten laatimiseen. Ongelmana on myös vakuutusyhtiöiden pyrkimys vaikuttaa potilaiden hoitoihin." (2009)


http://jme.bmj.com/cgi/content/abstract ... 83?eletter

Journal of Medical Ethics 2009;35:283-288; doi:10.1136/jme.2008.026526
Copyright © 2009 by the BMJ Publishing Group Ltd & Institute of Medical Ethics.

Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process

1 California Lyme Disease Association, Ukiah, California, USA
2 International Lyme and Associated Diseases Society, Bethesda, Maryland, USA

Correspondence to:
Dr R B Stricker, 450 Sutter Street, Suite 1504, San Francisco, California 94108, USA; rstricker@usmamed.com

Lyme disease is one of the most controversial illnesses in the history of medicine. In 2006 the Connecticut Attorney General launched an antitrust investigation into the Lyme guidelines development process of the Infectious Diseases Society of America (IDSA). In a recent settlement with IDSA, the Attorney General noted important commercial conflicts of interest and suppression of scientific evidence that had tainted the guidelines process.
This paper explores two broad ethical themes that influenced the IDSA investigation. The first is the growing problem of conflicts of interest among guidelines developers, and the second is the increasing centralisation of medical decisions by insurance companies, which use treatment guidelines as a means of controlling the practices of individual doctors and denying treatment for patients.

The implications of the first-ever antitrust investigation of medical guidelines and the proposed model to remediate the tainted IDSA guidelines process are also discussed.



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Lyme Article Was Riddled with Inaccuracies--Putting Patients at Risk
Anne Gershon
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IDSA Lyme Guidelines: Response to Dr. Gershon
Raphael B. Stricker, et al.
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[soijuv]

"Hoitosuositustaisto" on nytkähtänyt yhden askeleen eteenpäin.

Tämän kuun lopussa lautakunta kuulee useita kansainvälisen borrelioosijärjestön ILADS:in kantaa edustavia asiantuntijoita, kuten seuraavia lääkäreitä: Daniel Cameron, Ken Liegner, Steven Phillips ja Raphael Stricker, Allison Delong (Brown University) ja tri Donta joka on myös IDSA:n jäsen.

Mielipiteensä borrelioosin hoidosta saavat esittää myös amerikkalaisia infektiolääkäreitä edustavan IDSA:n jäsenet, kuten Eugene Shapiro, Allen Steere, Art Weinstein ja Gary Wormser.

Hhttp://www.lymedisease.org/news/lymepolicywonk/130.html

IDSA announces presenters and order of presentation

The Infectious Diseases Society of America has selected presenters to speak before its Lyme disease guidelines review panel on July 30. (This is part of the guidelines review process mandated by the IDSA?s settlement with the Attorney General of Connecticut.) The speakers representing patient advocates are Tina Garcia, of the Lyme Education and Awareness Program (LEAP) and me. Three researchers that are not affiliated with either ILADS or IDSA will speak: Drs. Brian Fallon from Columbia, Ben Luft from Stony Brook, and David Volkman, previously from the National Institute of Health (NIH). The following members of ILADS will be presenting: Drs. Daniel Cameron, Ken Liegner, Steven Phillips and Raphael Stricker. In addition, Allison Delong, MS, of Brown University, and Dr. Donta, a member of IDSA, will present. Those advocating for the IDSA guidelines include Drs. Phillip Baker (President of the American Lyme Disease Foundation and previously with NIH), Barbara Johnson (Centers for Disease Control), Eugene Shapiro, Sunil Sood, Allen Steere, Art Weinstein and Gary Wormser.

Below is the final order of presenters:

Tina Garcia (patient advocate )
Lorraine Johnson (patient advocate)
Daniel Cameron (physician-scientist)
Phillip Baker (physician-scientist)
Ben Luft (physician-scientist)
Allison Delong (scientist)
Barbara Johnson (physician-scientist)
David Volkman (physician-scientist)
Sam Donta (physician-scientist)
Eugene Shapiro (physician-scientist)
Brian Fallon (physician-scientist)
Sunil Sood (physician-scientist)
Ken Liegner (physician-scientist)
Allen Steere (physician-scientist)
Steven Phillips (physician-scientist)
Art Weinstein (physician-scientist)
Raphael Stricker (physician-scientist)
Gary Wormser (physician-scientist)

[soijuv]

Lääkärien oikeus antaa hoitosuosituksista poikkeavia hoitoja, esim. pitkiä antibioottihoitoja, borrelioosia sairastaville on edennyt Connecticutissa. Viimeksi kuvernööri Rell allekirjoitti lakialoitteen. Lääkärit saisivat lain tullessa voimaan oikeuden käyttää sellaisia hoitoja jotka he ovat kliinisessä työssään ja lääketieteellisen tietonsa perusteella havainneet tehokkaimmiksi - hoitosuosituksista huolimatta.

FOR IMMEDIATE RELEASE CONTACT: Donna Tommelleo, 860-884-8472

June 21, 2009 donna.tommelleo@ct.gov

Governor Rell Signs Bill That Shields

Doctors in Treatment of Lyme Disease



Governor M. Jodi Rell today announced she has signed a bill allowing doctors to prescribe long-term antibiotics in the treatment of persistent Lyme disease ? outside of standard guidelines ? without fear of sanctions from state health regulators if the patient?s clinical diagnosis of the tick-borne disease and treatment have been documented by a licensed physician.



?Doctors in Connecticut ? the absolute epicenter of Lyme disease ? can continue to do what is best for their patients suffering from this complex illness. I think most people know someone who has been infected,? Governor Rell said. ?The bill also recognizes that Lyme disease patients must have the freedom to choose which remedy or regimen best meets their needs.?



The disease gets its name from the shoreline town of Lyme, Connecticut, where in 1975 a cluster of children and adults there experienced uncommon arthritic symptoms Caused by the bacterium Borrelia burgdorferi, Lyme disease is spread through the bite of infected deer ticks. Symptoms include a rash, fatigue, headache, fever, and achy muscles and joints. Later symptoms may include arthritis, neurological problems, and heart problems.



House Bill 6200, which gained broad bipartisan support in the Legislature, was prompted by an ongoing debate in the medical community. Some health organizations have questioned the existence of chronic Lyme disease and the Infectious Diseases Society of America (IDSA) has cautioned against the long-term use of antibiotics. Some physicians were hesitant to treat patients outside the IDSA guidelines because of potential reprimands from medical boards and insurance companies.


?Doctors will have the right to use treatment guidelines based on their clinical experience and best medical judgment,? Governor Rell said. ?This bill does not, however, shield any physician who provides substandard care.?

[soijuv]

Joidenkin amerikkalaisten lääkärien ja tutkijoiden mukaan ILADS sai päättäjät puolelleen 137 - 0 sillä lakiesitys hyväksyttiin edustajahuoneessa äänin 137 - 0 ja senaatissa 36 - 0. Laki mahdollista pitkät antibioottihoidot borrelioosin hoidossa eivätkä lääkärit joudu vaikeuksiin kirjoittaessaan niitä.


http://blogs.courant.com/capitol_watch/ ... se-bi.html

Gov. Rell Signs Lyme Disease Bill - To Prevent Future Battles

By Christopher Keating
on June 22, 2009 6:47 PM

Gov. M. Jodi Rell has signed a bill that is related to a long-running clash over the treatment of Lyme disease

The bill, which was approved 137 to 0 in the House of Representatives and 36 to 0 in the Senate, allows doctors to prescribe long-term antibiotics as a way to treat patients with Lyme disease. It also prevents the state health department from taking disciplinary action against any physician who prescribes long-term antibiotics to Lyme patients.

The bill concerns a battle within the medical community over the best method of treating those afflicted with Lyme. In a case that received widespread publicity, Dr. Charles Ray Jones, a pediatrician, was disciplined in 2007 after prescribing antibiotics to two out-of-state Lyme patients whom he had never examined or met. That case is still being appealed.

But state health officials say the issue in the Jones case was about prescribing antibiotics to patients without examining them - rather than Lyme. But Lyme patient advocates said the Jones case would have a chilling effect on doctors. In written testimony on the bill, state health commissioner Dr. J. Robert Galvin said his department does not pursue discipline against doctors for simply prescribing antibiotics for Lyme patients.

[Sailairina]

IDSA announces presenters for hearing
IDSA Announces presenters for its July 30, 2009 Hearing of the Lyme Disease Review Panel
Posted June 22, 2009 on the IDSA website

On July 30, 2009 (8:00 AM ? 5:00 PM EASTERN), IDSA will hold an all-day hearing of its Lyme Disease Review Panel to hear testimony from patients, physicians and scientists on its 2006 Lyme Disease Guidelines. Individuals presenting and the order in which they will present follows:


* Tina Garcia, Lyme Education Awareness Program Arizona (L.E.A.P. Arizona, Inc.), Mesa, Arizona
* Lorraine Johnson, California Lyme Disease Association (CALDA), Ukiah, California
* Daniel Cameron, MD, International Lyme and Assoiciated Diseases Society (ILADS), California
* Phillip Baker, PhD, American Lyme Disease Foundation (ALDF), Bethesda, MD
* Ben Luft, MD, The State University of New York, Stony Brook, NY
* Allison Delong, ILADS, Providence, RI
* Barbara Johnson, PhD, Centers for Disease Control and Prevention, Fort Collins, CO
* David Volkman, MD, Nissequogue, NY
* Sam Donta, MD, Falmouth, MA
* Eugene Shapiro, MD, IDSA & Yale University School of Medicine, New Haven CT
* Brian Fallon, MD, Columbia University Medical Center, New York, NY
* Sunil Sood, MD, Schneider Children's Hospital at North Shore, Manhasset, NY
* Ken Liegner, MD, ILADS, Armonk, NY
* Allen Steere, MD, Massachusetts General Hospital & Harvard Medical School, Boston, MA
* Steven Phillips, MD, ILADS, Wilton, CT
* Art Weinstein, MD, Washington Hospital Center, Washington, DC
* Raphael Stricker, MD, ILADS, San Francisco, CA
* Gary Wormser, MD, IDSA & New York Medical College, Valhalla, NY

In-person attendance at the hearing is by invitation only. However, the Hearing will be broadcast live, in real-time via webcast from the IDSA Website (www.idsociety.org/lymedisease.htm) and will be archived on the web for viewing at your convenience. Information on how to attend via webcast will be posted on the IDSA website no later than one week prior to the hearing.

[Sailairina]

Tarvittavat systeemit kuulemisen seuraamiseen voi imuroida tästä: http://www.idsociety.org/WorkArea/showc ... x?id=14974

Kuultavissa noin klo 15 - 23 Suomen aikaa

[soijuv]

Lautakunnan näkemys IDSA:n laatimista hoitosuosituksista julkaistaan vuoden 2009 loppupuolella. Tarkkaa päivämäärää ei ole vielä annettu julkisuuteen. Alla on asiaa käsitteleviä artikkeleita sekä tiivistelmät lautakunnalle esitetyistä kannanotoista.

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Yhteenveto borrelioosin diagnostiikkaa ja hoitoa käsittelevästä kiistasta

http://www.rodale.com/print/1649

"Kaikki borrelioosia käsittelevä tieto tulisi kirjoittaa uudelleen."

Borrelia burgdorferi on ovela ja älykäs bakteeri. Bakteerin aiheuttaman infektion vaarallisuus riippuu kuitenkin pitkälti siitä kenen kanssa aiheesta puhuu, Joidenkin mukaan (IDSA) bakteeri aiheuttaa helppohoitoisen, lyhytaikaisen infektion. Yhä enenevässä määrin tutkijat, lääkärit (ILADS) ja borrelioosiin sairastuneet sanovat bakteerin olevan vaarallisen, tunkeutuvan kaikkialle elimistöön, piiloutuvan laboratoriotesteiltä, aiheuttavan kroonista kipua ja oireita jotka voivat kestää vuosikausia. Aiheen tiimoilta käyty kiista on jatkunut vuosikausia. Connecticutin osavaltion kuvernöörin lainopillinen neuvonantaja, Blumenthal, nosti IDSA:n laatimat hoitosuositukset uuden lautakunnan käsiteltäväksi hoitosuositusten laatimisessa esiintyneiden väärinkäytösten vuoksi. Ongelmana tällä hetkellä on, että lääkärit antavat borrelioosia sairastaville hoidon IDSA:n suositusten pohjalta. Mikäli he eivät tee niin, he ovat vaarassa menettää lääkärinoikeutensa.

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1. Krooninen borrelioosi on todellisuutta. Asia on todettu useissa tutkimuksissa.

Alla on tiivistelmä kuulemiseen osallistuneiden henkilöiden uudelle lautakunnalle esittämistä kannanotoista.

The Evidence Is In: Chronic Lyme Disease Does Exist
Lucy Barnes, July 2009

Not since Chuck Berry sang those famous words, ?Roll Over Beethoven?, introducing rock and roll to a world previously dominated by classical music, has there been such an upset in the status quo. As lights went out following the presentation in Washington, DC, it was clear that an elite few in the medical world had just been rocked from their ivory towers and rolled over by doctors, researchers and patients presenting evidence that chronic Lyme disease does, indeed, exist. It?s a well-documented fact; people can remain ill with Lyme disease even after what was thought to be ?adequate treatment?. The overwhelming scientific evidence proving this well-known fact was finally put on display for the whole world to see on July 30, 2009, thanks to the continuing efforts of volunteers who are fighting to help their families and others who suffer.

Background- On May 1, 2008, an official press release announced that the Infectious Diseases Society of America (IDSA) was found guilty of multiple wrong-doings in regards to the development of its Lyme disease treatment guidelines. As part of a settlement agreement with the CT Attorney General Richard Blumenthal, the organization was required to host a public hearing which would shine a spot light on all of the available scientific research rather than just the limited, biased view point the IDSA has promoted over the years.

To satisfy the mandates set forth in the agreement, the IDSA, after much delay, finally got around to hosting the hearing on July 30, 2009. As the clock ticked away, and everyone waited anxiously for more than a year for the IDSA to organize the event, approximately 350,000 more innocent people were exposed to Lyme disease. Most will not be adequately treated and may become ill with a disease the IDSA claims, even in letters to Congress, does not exist.

Fortunately, the illumination of the previously buried facts at the hearing finally put to rest the IDSA?s theory that chronically ill Lyme patients cannot be sick from persistent infection after receiving a minimal dose of antibiotics. We all know now that is absolutely false and indeed, they can.

Proclamation for a Perfect World- From this day forward, patients shall be treated adequately for their Lyme infections and not be given just a pat on the head and a prescription for anti-depressants, as they are gently shoved out the door. Health care professionals should no longer worry about being subjected to punitive actions for following their oath to ?first, do no harm? when treating chronically ill Lyme disease patients.

This simple Proclamation, should it be put in effect, would save lives and give patients back the right to choose their treatment from available options. It would also allow doctors to use clinical judgment when making important health care decisions that can affect their patients lives.

For now, those suffering from chronic Lyme disease must continue waiting to see if the IDSA Review Panel does the job they were charged with and if they will make sound recommendations based on all the evidence presented in order to change a long-standing diagnostic and treatment protocol that is not working.

The Evidence- Written testimony challenging the IDSA Guidelines was submitted by 150 individuals and organizations to the IDSA Review Panel prior to their April 2009 deadline. One prominent organization?s Working Group, the International Lyme and Associated Diseases Society (ILADS), under the leadership of Lorraine Johnson, submitted close to two thousand pages of scientific evidence, analysis and research studies refuting the recommendations in the IDSA?s Guidelines. The all volunteer, non-profit Lyme Disease Association, representing 35 support groups in 23 states and countless individuals across the country, also submitted multiple challenges.

By Invitation Only- Once applications had been submitted to the IDSA Review Panel, a select few were invited to speak at the open hearing. Technically, it wasn?t an ?open? hearing in the true sense of the word. Patients and the general public, the ones suffering and most concerned, were not allowed to attend. Instead, they were told to watch the event, which was streamed live from the hearing location, on their home computers. According to the IDSA, the final presentations will be posted on the IDSA website (idsasociety.org) and archived for one year.

The Select Few- Two volunteer patient advocates, Lorraine Johnson, JD MBA, and Tina Garcia, were among eighteen speakers selected to present testimony to the Review Panel.

Lorraine Johnson, Chief Executive Officer for the California Lyme Disease Association (CALDA) and a member of the Professional Advisory Boards for both the national Lyme Disease Association (LDA) and the International Lyme and Associated Diseases Society (ILADS), has extensively published on topics such as medical ethics and Lyme disease. Johnson, who has been active for years in creating positive changes in the Lyme community, stated the IDSA Guidelines extend, ?well beyond what is known in science? and ?gaps in research should not prevent treatment of patients?.

According to Johnson, the Guidelines may be promoted as voluntary by the IDSA, but they are often used to deny patients? treatment options and restrict clinicians from using clinical judgment. In addition, Johnson reported, the Guidelines are treated as mandatory by health and disability insurers, medical boards, hospitals, school systems and even by child custody agencies.

Johnson shared results of the 2009 CALDA Patient Survey (3,000 Lyme patients responded), which indicated 73% of the patients had a delayed diagnosis of more than one year. Nearly half the patients (49%) had to see 7 or more doctors before being properly diagnosed. She noted 58% of patients remained ill after being treated by IDSA protocols and 90% found it difficult to find a treating physician.

In addition, more than 60% of chronically ill patients reported improvement with additional courses of antibiotics. Johnson reported 53% had to travel out of state to obtain a proper diagnosis or treatment. Due to their illness, an astounding 88% had to cut down on normal activities, such as work or school, and 50% were unable to attend at all. The survey indicated 41% of the patients responding could not afford to purchase the medications they needed. Her excellent presentation accomplished its goal of representing patient?s circumstances accurately, with the added bonus of bringing an array of scientific facts to the Panel that had not been brought to light previously.

Tina Garcia, founder of the Lyme Education Awareness Program (L.E.A.P) in Arizona, used her personal story as an example of how devastating the recommendations in the IDSA Guidelines can be for patients. She told the audience that it took doctors six years to properly diagnose and treat her illness. In the meantime, she was forced to live with excruciating pain and eventually suffered from dementia, lung infections and paralysis. She lost the ability to drive, to do housework and even to fix herself a meal. Garcia also lost her job and her home before she could was treated with a combination of long term antibiotics. The additional treatment, which is not recommended by the IDSA Guidelines, restored much of her functioning and allowed her to be at the hearing to testify. Her tragic experience is similar to many who have been denied adequate treatment. As patients watched the live broadcast on the Internet, they were pleased she was able to present their collective message with such grace, accuracy and strong conviction.

The Medical Experts-
Dan Cameron, MD MPH, who runs an active clinical practice in Mt. Kiscao, NY, and serves as President of the International Lyme and Associated Disease Society (ILADS), made it clear to the Review Panel, ?patients are being denied treatment based on the IDSA guidelines.? Dr. Cameron headed the sixteen member ILADS Guidelines Working Group, which published evidence-based guidelines in 2004 for the management of Lyme and tick-borne diseases. The ILADS Guidelines provide practitioners with flexible treatment options designed to treat all individuals with Lyme disease, including those with persistent, recurrent and relapsing symptoms of B. burgdorferi [Lyme] infection, something the IDSA Guidelines recommend against. Cameron presented data indicating 34-62% of patients entering clinical trials had continuing Lyme symptoms after their initial IDSA recommended treatment failed and they were still sick an average of 4.7 to 9 years later.

Cameron?s well organized and powerful presentation covered a number of important points, including the cost to society of improperly diagnosed and treated Lyme disease. According to conservative studies, chronic Lyme disease has an average cost of $16,199.00 per year per patient, and an annual economic impact (CDC 10-fold increase) in the US of over $2 billion.

Benjamin Luft, MD from the State University of New York, Stony Brook, has published extensively on Lyme disease, testing methods, effective and non-effective treatment, and related tick borne disease topics since the late 1980?s. His early studies confirmed the fact that even though B. burgdorferi [Lyme] may be sensitive to relatively small concentrations of certain antibiotics such as penicillin and ceftriaxone, the organism is killed slowly, indicating prolonged blood levels of these drugs may be necessary in order to ensure a cure. Research by Luft and others were able to prove two decades ago what the IDSA continues to refuse to acknowledge and what patients and clinicians are experiencing worldwide; chronic Lyme does exist.

Dr. Luft also touched on many critical topics such as Borrelia persistence, patient responses, undefined characteristics and treatment success and failures. He described the early and late phases of the disease state, along with a section describing the objective vs. subjective symptoms and how they responded to various treatments. He explained the significance of the mouse studies and how they correlated with persistence of Lyme in humans. Dr. Luft?s contributions to the scientific community have been invaluable in providing front-line clinicians accurate data.

Allison Delong, MS, from Brown University, Center for Statistical Sciences, Department of Public Health, Division of Biology and Medicine presented two challenges to the Guidelines. Delong concluded the clinical trials relied on by the IDSA to deny the existence of chronic Lyme disease, and which are the foundation of their continuing argument to recommend against treating chronically ill patients, have not, as the IDSA claims, proven re-treatment to be ineffective. In fact, trials indicate the benefits of re-treatment among individuals with worsening fatigue, worsening physical functioning, and those who are in more severe pain. Her conclusions, presented by way of a very impressive and detailed statistical analysis, determined that before IDSA Guideline authors recommend against treatment of patients, more research is needed to support their theories.

David Volkman, a distinguished Ph.D., M.D., Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook who is Board certified in Immunology, Diagnostic Laboratory Immunology, and Internal Medicine spoke on numerous relevant issues. As past Senior Investigator at the National Institute of Allergy and Infectious Diseases (NIAID), he was among the first to isolate and clone human antigen-specific T lymphocytes in retroviral investigations. Dr. Volkman has been involved in both clinical and bench research on Lyme disease since 1985. His presentation on persistent/chronic Borrelia infection, serology-seronegative infection and the IDSA Guidelines flawed prophylaxis recommendation were all supported by solid scientific evidence. The true meaning and use for the CDC?s "surveillance definition? of Lyme disease, along with the optimal diagnostic and therapeutic modalities were covered in his outstanding presentation. Volkman also addressed the ?conflicts of interest policy? in his written testimony, in which he stated, ??committee members should be free of conflicts that may color their treatment recommendations.?

Sam Donta, MD, Infectious Diseases Specialist and Professor of Medicine has published multiple studies on chronic Lyme disease and its treatment over the years. His hands-on experience with treating thousands of Lyme patients has been an invaluable tool for himself and those in the position of having to deal with the growing number of chronically ill patients. Dr. Donta kicked off the afternoon session addressing a list of 'guideline issues'. He spoke to the current problems facing clinicians, what should be done with the post treatment issues and about treatment specifics using Chronic Fatigue Syndrome (CFS), Gulf War Syndrome and Fibromyalgia as models to compare the varied symptoms. He asked revisions be made to the Guidelines and felt more funding was needed for further studies.

Until there are more specific markers of disease activity, Donta stated, we should acknowledge that there are patients who are affected by Lyme disease to varying degrees that range from mildly symptomatic to severely debilitating and who depend on the members of the Infectious Diseases Society of America for diagnosis and treatment. Donta feels we should all move forward with plans to better understand the nature of the illness and develop superior ways to diagnose and treat the disease. His exceptional presentation, based on some of his work in the clinical setting, indicated the IDSA Guidelines protocols fail to diagnose many who are infected and leave many more without adequate treatment for their ongoing infections.

Brian Fallon, MD, MPH, from the Columbia University Medical Center, NY, an Associate Professor of Clinical Psychiatry at the Columbia University College of Physicians and Surgeons, is the Director of the Lyme and Tick-borne Diseases Research Center. Dr. Fallon?s focus has been on neuropsychiatry as it relates to Lyme and other diseases of the brain. He has published over 100 peer-reviewed articles, papers, and book chapters and has served as a reviewer for many journals.

Fallon, stating clearly that he was not a member of the IDSA or ILADS, addressed the IDSA Guidelines statement that claimed antibiotic therapy has not proven useful and is not recommended for patients with chronic subjective Lyme symptoms. Fallon described the results of his extensive research study as it related to cognition, pain, fatigue and adverse events. He then looked more closely at other studies and their outcome measures, including unmasking, and provided a revised statistical analysis. He ended his brilliant scientific presentation with suggestions to reword several areas of the Guidelines.

Kenneth Liegner, MD, Internal and Critical Care Medicine, is a distinguished member of ILADS with an active clinical practice specializing in Lyme Borreliosis & Related Disorders, in Armonk, NY. Dr. Liegner began by presenting some background information describing his research and clinical experiences, followed by the simple, yet compelling statement, ?Walk a mile in my shoes.?

Dr. Liegner, a highly regarded expert in his field, then proceeded to escort the audience on a virtual tour through his well-documented studies and clinical findings, proving beyond a shadow of a doubt the persistence of and serious consequences associated with chronic Lyme disease. Liegner demonstrated evidence of live spirochetes in patients (including biopsy/autopsy photographs) and the subsequent damage caused to organs, including the brain, when patients were not given adequate treatment. The presence of Lyme spirochetes had been confirmed in studies by using various tests from a number of labs and by numerous related clinical findings.

Dr. Liegner presented additional case histories showing treatment improvement in patients and then relapses when treatment was discontinued. Some of these patients (including children) eventually died from chronic persistent Lyme disease and associated complications, including Martin Eisenhardt, whose wife Mary Lou presented testimony to the NY General Assembly in 2001 in an attempt to draw more attention to the severity of Lyme disease.

Dr. Liegner also shared a 2001 video clip of Vicki Logan in the end stages of her battle with chronic Lyme disease. She was thanking Dr. Liegner for his dedication and caring, two qualities for which he is known for throughout the patient community, and also for giving her a better quality life when no one else would. She stated just prior to her death, ?I hope [the story of] what happened to me will benefit others who wind up in the same situation.?

Steven Phillips, MD, Internal Medicine, from Wilton, CT, is the past President of ILADS and a member of the ILADS Guidelines Working Group. He has an active practice in a highly endemic area of the country and has testified as an expert witness in Lyme related hearings across the country. Dr. Phillips presented study after study documenting persistence of Lyme disease after treatment that were not cited by the IDSA during the formulation of their Guidelines. His discussion of independent peer-reviewed literature (both animal and human studies) included some studies by the IDSA guideline authors themselves, indicating persistence of spirochetes and continuing symptoms after treatment and the need for additional treatment.

Phillips concluded his powerful scientific presentation with multiple studies demonstrating re-treatment benefits, leaving no doubt about the need for additional treatment for some patients, something he has demonstrated as beneficial in his own clinical practice. He also proposed new wording for the IDSA Guidelines that reflect the evidence available from 25 studies proving the existence of chronic Lyme disease.

Raphael Stricker, MD, published author and past President of ILADS, from San Francisco, CA, addressed some of the most basic common and damaging myths perpetuated by the IDSA Guidelines. His extensive documentation successfully put to rest several IDSA flawed theories, including some of the most egregious and harmful.

Dr. Stricker provided scientific and clinical studies proving Lyme disease is not ?easy to diagnose? and ?easy to treat? and that persistent infection following a short course of antibiotic therapy is not ?highly implausible?, which are the IDSA?s unsupported theories that have been responsible for destroying many lives. He addressed a common scare tactic often used by the IDSA concerning the alleged and exaggerated ?danger? of prolonged antibiotic therapy for chronically ill patients. Stricker spoke on the limitations of the two-tiered testing system, stealth pathology and treatment considerations relating to early and late stage Lyme disease. Charts, included in his written testimony, brought to light some of the systemic errors and misleading statements in the IDSA Guidelines, including exaggeration, circular reasoning, small sample sizes, data selection exclusion and the author?s reliance on their own so-called expert opinion to the exclusion of all additional evidence.

The IDSA Supporters- Those invited to the hearing in support of the Guidelines (many were the original IDSA Guideline authors) have claimed for years they do not know what causes continuing Lyme symptoms in Lyme patients after their recommended treatment fails, however, they feel it is not caused by active infection and there is no such thing as chronic Lyme disease.

Holding tight to their theory has not helped patients who suffer, but it does please the insurance industry and partially shields the IDSA authors and others from the back lash that would be felt if they were to wavier from their floundering and unsubstantiated position.

Some IDSA?s theories presented to explain why so many people remain ill and become disabled or die after receiving their recommended treatment includes:

a.) People in the community (advocacy groups, media publicity, sympathetic physicians and prominent individuals in society) are able to convince patients they are still sick when they really aren?t (functional somatic syndrome);

b.) Stress can be the cause of remaining physical symptoms after being bitten by ticks;

c.) Secondary gain (patient has hidden motive for wanting to remain ill);

d.) Prior undiagnosed psychiatric disorders (some from as far back as childhood) that don?t appear in individuals until after they have a tick bite;

e.) Even while living in endemic areas, having a tick bite, EM rash, positive lab work and showing improvement on antibiotic therapy- many of the IDSA supporters claim, without examining patients, that they never actually had Lyme disease in the first place so they can?t possibly have chronic Lyme disease;

f.) They feel patients experience improvement due to the placebo effect, so those with continuing symptoms are just easily influenced into believing they are still sick when they aren?t;

g.) If tests don?t support the IDSA?s position, they are being labeled as producing too many false-positives by the IDSA and therefore, the Lyme symptoms remaining must be discounted because the lab tests are inaccurate and the patient can?t have Lyme disease;

h.) Patients that are well-documented, even those house-bound or in the hospital, must have had another tick bite at some point that is causing the continuing symptoms;

i.) A pre-infection emotional state that was never detected or diagnosed is suddenly discovered after getting Lyme disease;

j.) The ?no one else had these symptoms before you did, so you can?t have Lyme? theory;

k.) IDSA feels other doctors are not as versed as they happen to be and are part of the problem because they are telling patients they have Lyme disease and they treat them for it when they don?t actually have it;

l.) Patients often decide on their own they have chronic Lyme disease because they don?t like the stigma attached to having unexplained chronic symptoms after having a tick bite and contracting Lyme disease;

m.) There is not enough research being done on how to explain to patients that they aren?t suffering from Lyme (when they really are) and more research ($$) is needed by the IDSA so they can figure out how to explain that to patients so they believe what they are being told;

n.) Patients have symptoms but they aren?t the same symptoms the IDSA authors have listed in their Guidelines, so it can?t be Lyme disease;

o.) You are a female or you are getting older and the symptoms you have just became noticeable to you since you got Lyme disease;

p.) Your symptoms aren?t bad enough to be Lyme disease, or the opposite, the symptoms are too severe to be Lyme disease;
q.) People in the general population can have those symptoms, so they can?t be Lyme related;

r.) Doctors treating children in endemic areas don?t know the difference between mosquito bites and tick bites and falsely label patients who are experiencing Lyme symptoms with having Lyme;

s.) Anxiety about the illness, derived from reading information on the Internet, causes patients to remain ill and think they have chronic Lyme disease;

t.) The authoritative ?you are not sick because I said so? theory;

u.) Patients develop an unexplained personality disorder, or fibromyalgia, or depression, but only after having a bite from a tick infected with Lyme disease, so it is a coincidence and is unrelated.

The IDSA supporters also state there are no studies proving chronic Lyme disease exists, which as we know is completely false. Some believe if patients are to be diagnosed with the condition, they must first have studies on chronic Lyme showing it exists before they can actually have chronic Lyme. This circular logic was actually reported by Phil Baker, who controlled the distribution of NIH Lyme research funding for years and who, after retiring, immediately started working with those supporting the IDSA theories, the same ones who received many lucrative Lyme research grants from the NIH.

One IDSA supporter, a pediatrician on Long Island, stated that the Guidelines should be changed to reflect the theory that ticks need to be attached for 60-72 hours before patients should be given the infamous, cost-effective, one pill of Doxycycline to ?cure? their Lyme disease, instead of the currently recommended tick attachment time of 36 hours. He cited potential problems surrounding the indiscriminate use of antibiotics as the reason to deny patients the one dose of an antibiotic and stated if it takes 60-72 hours to increase the risk of deer being infected from a tick bite in the wild (deer hide that resists briars and limbs), that it must be the same for children (soft skin tissue).

The Big Picture- Other than palliative care, the IDSA Guidelines have recommended against using any and all treatment options (from vitamins to different classes of antibiotics) for chronically ill Lyme patients. This dogma has been spread far and wide, negatively affecting patients across the globe.

The IDSA Guidelines have been responsible for the decline in patient?s health and their advancement into the later, more difficult and costly to treat stages of Lyme disease. The Guidelines have also put a chain around the neck of professionals who desire to treat patients appropriately, but who refuse to do so due to the potential consequences experienced by those who have stepped out of the IDSA ?box? to help the growing number of people who suffer.

The IDSA Guidelines Fate- The IDSA Review Panel (consisting mainly of IDSA members and supporters) will now consider the oral arguments, the mounds of written testimony and the overwhelming scientific evidence presented before making their recommendations on how to improve their highly contested Guidelines. They have the option to discard them, or, if they dare, continue to ignore the scientific evidence and make no changes. The option to keep them ?as is? is not acceptable. Their decision is expected to be released by the end of the year.

Bottom Line- There has never been any convincing evidence presented for supporting the current recommendations in the IDSA Guidelines.

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2. Click here: Lyme Hearing Highlights a Broken System
http://www.rodale.com/print/1649

lyme disease hearing, guidelines, and antibiotics use
Lyme Hearing Highlights a Broken System
Everything we think we know about Lyme needs to be rewritten, one doctor says.
By Leah Zerbe

Protect yourself against Lyme disease; seek early treatment if you think you're infected.

RODALE NEWS, EMMAUS, PA? Borrelia burgdorferi is a sneak. And a smart one at that. Also known as Bb, it?s the organism that?s carried by certain ticks and causes Lyme disease, an infection that affects an estimated 200,000 people a year in the United States. Depending who you talk to, the Lyme bacterium causes a short-term infection that can be cured with a month?s worth of antibiotics or?as a growing number researchers, doctors, and patients say?it?s a serious pathogen that invades different organs, hides from detection by lab tests, and causes chronic pain and symptoms that lasts for months or years. Controversy over guidelines governing how doctors diagnose and treat the disease has been brewing for years, but yesterday the arguments were aired in public as 18 doctors, scientists, and patients testified at a hearing before a new Infectious Disease Society of America (IDSA) Lyme disease review panel in Washington, DC.

THE DETAILS: The hearing was a result of an antitrust settlement brought by the Connecticut attorney general to address alleged flaws (including financial conflicts of interest) regarding IDSA?s 2006 Lyme disease guidelines, which are recommended by the U.S. Centers for Disease Control. The nine-hour hearing featured prominent physicians who stand by the IDSA guidelines, those who treat more aggressively and prescribe longer and stronger doses of antibiotics (as recommended by the International Lyme and Associated Diseases Society, ILADS), and independent Lyme disease researchers.

Here are some of the highlights from the hearing:

?Current guidelines suggest prescribing an immediate single dose of doxycycline if a person finds an attached tick on his or her body; however, one researcher pointed out, that dose won?t effectively block out infection, and it could lead to false-negative blood tests for Lyme. In other words, the practice could keep people who have the infection from being diagnosed correctly and given treatment.

?The blood tests of people who are chronically ill with Lyme disease could also come back negative because of past use of the antibiotic azithromycin. This is problematic because current guidelines rely on those blood tests to confirm Lyme if an infected person doesn?t develop the telltale bull?s-eye rash (which, by the way, fewer than half of Lyme patients get).

?Some Lyme patients report pain levels similar to that of people suffering from congestive heart failure or osteoarthritis.

?There are more than 100 different strains of the bacteria that causes Lyme disease, which could explain why some people with Lyme actually test negative on screening tests, or respond differently to treatment.

?Eugene Shapiro, MD, of IDSA and Yale University School of Medicine in Connecticut, reiterated IDSA?s viewpoint that people who remain sick after being treated with the standard month of antibiotics are not suffering from Lyme, but MUS??medically unexplained symptoms.?

?Perhaps one of the most convincing presentations came from Allison Delong, MS, biostatistician for the Center for Statistical Sciences Program for Public Health at Brown University in Rhode Island. Delong explained major flaws in two studies heavily credited in creating the IDSA guidelines, and ones that are often used to discredit long-term antibiotic therapy. ?She has the ability to lay out the math, and call out other studies as flawed and overrated,? says Daniel Cameron, MD, president of ILADS.

The new IDSA panel will take points from Thursday?s hearing into consideration, revisit peer-reviewed studies, and complete a report regarding guideline revisions by the end of the year.

WHAT IT MEANS:The problem that critics have with the current Lyme guidelines is that they are extremely restrictive, and consequently the testing leaves out many Lyme patients who don?t test positive. Doctors and specialists all across the country adhere to the guidelines; if they don?t, in all but three states (Rhode Island, New York, and Connecticut), they risk losing their licenses. But as the testimonies were laid out by people on different sides of the issue Thursday, it became apparent that the current two-tiered testing system, relying on ELISA and Western Blot blood tests, are not nearly accurate enough. In fact, one presenter, Steven Phillips, MD, former president of ILADS, says current screening tests have a sensitivity between 45 to 55 percent. That leaves out a lot of people who are having trouble receiving treatment because they don?t test positive. And health insurance companies don?t have to pay for treatment if a patient doesn?t test positive. ?Commercial testing for Lyme disease is broken. It needs to be fixed. This panel needs to at least recognize that and revise the guidelines,? says Dr. Phillips.

Lyme disease is complex, but here are some basics to beware of:
We don?t know it all. One of the memorable moments of the long hearing occurred when Ken Liegner, MD, a member of ILADS, said quite plainly, ?A general reassessment of everything that is believed to be true about Lyme disease is necessary.? He added, ?We have to come to terms. This is a formidable pathogen, there?s a still a lot we don?t understand.? Resolving many of the issues will require more scientific research and less rancor between camps. As science writer Pam Weintraub points out in her award-winning book Cure Unknown: Inside the Lyme Epidemic , the fight over Lyme has become politicized and ugly. ?What we really need is more research. If independent people can make this clear, whether the guidelines are changed or not, maybe that?s progress.?

Antibiotics are an important option. One of the biggest controversies in Lyme treatment is the use of antibiotics, particularly long-term use. While this type of treatment can sometimes pose serious side effects, studies have also shown it helps those suffering from chronic Lyme, especially in the fatigue department. If you?re diagnosed with Lyme disease and still don?t feel better after initial treatment, consider seeking a second opinion from a doctor willing to treat Lyme more aggressively. As one presenter put it on Thursday, long-term antibiotic use may not be the answer, but it?s the best thing we?ve got right now.

Prevention is paramount. Of course, the best tactic is to avoid the disease. That may become harder and harder to do as tick populations explode, thanks to warmer winters, large deer populations, and fragmented forests. When you?re outside in wooded areas, wear a hat and light-colored clothing, and tuck your pants into your socks. When you get back, do a vigorous tick check, paying extra attention to darker, moist areas like your groin and armpits, and under your bra line. If you find a tick that?s attached, or even engorged, remove it by using tweezers to pull it off (grasp close to the skin, pull slowly and firmly, don?t twist). Toss the tick in some alcohol and take it with you to your doctor?s office. If you ever find a bull?s-eye-shaped rash, you have Lyme. Go to the doctor right away for treatment. When the disease is caught early, it?s more treatable.

Get tested twice. If you think, or know, you were recently bitten by a tick, and your first ELISA test comes back negative, schedule another one for a few weeks later. Barbara Johnson, PhD, of the CDC, said at the hearing that it is sometimes necessary to take a second sample a few weeks after the first to get an accurate reading.

Know where to turn. If you are diagnosed with Lyme, or suspect you have it (and have ruled other health ailments out), join a Lyme support group to find doctors and tips on dealing with the disease?and how to beat it! Start with LymeNet.org.

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3. Lautakunnan tapahtumista löytyy tiivistelmäraportti myös seuraavalta sivulta:

http://flash.lymenet.org/scripts/ultima ... 001970;p=0

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4. Aihe oli esillä myös Amerikan psykiatrien yhdistyksen julkaisussa 31.7.2009:

From the American Psychiatric Association Headlines July 31:
Rising incidence of Lyme disease seen as reopening debate about treatment.

On its website, ABC News (7/30, Leamy, Gaynor, et al.) rehashed a segment appearing on Good Morning America where it was pointed out that a "rise in the number of ticks this year has infectious disease experts focused on the best way to treat the Lyme disease that the little buggers can spread." Every year, "some 20,000 Americans are infected," a figure that could be higher considering that "countless others go undiagnosed." Some patients exhibit symptoms like "severe headaches, severe joint pain, and even numbness in the hands or feet." There are even "experts [who] believe Lyme disease can rewire the human brain and affect personality."

There is, however, "controversy over almost every aspect of the disease -- how many people have it, how to treat it, even what, exactly, it is," according to The Human Condition blog hosted by Newsweek (7/30, Kalb). The "debate has all the ingredients of a medical sensation: politics, science, ethics, and money." Recently, "the Lyme drama comes to a head with a daylong hearing in Washington, DC, sponsored by the Infectious Diseases Society of America (IDSA)." And, it appeared that "one of the most contentious issues to be aired is the proper use of antibiotics to treat the disease." The meeting was "prompted by an antitrust investigation into IDSA by Connecticut Attorney General Richard Blumenthal." Blumenthal, "after hearing from concerned patients, who said IDSA's 2006 treatment guidelines -- which recommend against long-term antibiotic treatment and which are used by insurance companies to assess coverage -- defined the disease too narrowly and were denying them the care they needed," so he "launched his investigation." Eventually, he "charged that IDSA's guidelines were approved by experts who had conflicts of interest with insurance groups or drug companies."

Therefore, IDSA convened a "new panel of experts to review the current guidelines," WPVI-TV Philadelphia (7/30), an ABC affiliate, reported on its website. Panelists "heard from doctors on both sides of the debate" -- those who "believe the infection is short term and should be treated as such," and "a handful of doctors and patients say it can be long-lasting and requires long-term antibiotics." The "panel is expected to make a decision by the end of the year."

Maryland's The Almanac (7/30, Stern) and Virginia's Centre View (7/30, Albers) also carried articles on the disease in light of a Washington Post (7/30, Gardner) article that noted an uptick in infection rates in the Washington, DC, metropolitan area.

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5. Kaikki 18 kuulemisessa esitettyä kannanottoa löytyy sivulta

http://www.idsociety.org/Content.aspx?id=15026

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Amerikkalainen psykiatrian professori lähetti henkilökohtaisen viestin IDSA:n motiiveista borrelioosin hoitosuosituksia koskevassa asiassa. Hänen mukaansa useiden "IDSA:a edustavien lääkärien motiivit ovat puhtaasti taloudelliset. He haluavat tulla 'miljonääreiksi' (70- ja 80-lukujen tietokonealan ihmisten tavoin) lääketeollisuuden, yliopistojen ja vakuutuslaitosten avustuksella patentoimalla borrelioositestejä ja rokotteita."

IDSA motives are and have long been *exclusively* monetary. They were in this trying to become .com multimillionaires (like the 70's 80's computer born nouveau riche) since the 1970' or 1980's and the money to be realized by leading IDSA members ambitions realized, (in concert with big biopharm, and obviously university complicity, and insurance industry support) via the mechanism of patented diagnostic lab tests, and patented vaccine development.

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Lokakuu 2009. Eurooppalaisten neurologien yhdistys on laatinut borrelioosiin hoitosuosituksensa. Ohjeet ovat aika lailla identtiset IDSA:n suositusten kanssa.

http://www3.interscience.wiley.com/cgi- ... 3/PDFSTART

EFNS GUIDELINES/CME ARTICLE
EFNS guidelines on the diagnosis and management
of European Lyme neuroborreliosis
A°
. Myglanda,b,c, U. Ljøstada, V. Fingerled, T. Rupprechte, E. Schmutzhardf and I. Steinerg
aDepartment of Neurology; bDepartment of Rehabilitation, Sørlandet Sykehus, Kristiansand; cDepartment of Clinical Medicine, University of
Bergen, Bergen, Norway; dBavarian Health and Food Safety Authority, Oberschleißheim; eDepartment of Neurology, Ludwig-Maximilians
University, Munich, Germany; fDepartment of Neurology, Medical University Innsbruck, Innsbruck, Austria; and gNeurological Sciences
Unit, Hadassah University Hospital, Mount Scopus, Jerusalem, Israel

Keywords:
antibiotic therapy,
Bannwarth syndrome,
European, infections,
Lyme neuroborreliosis
Received 7 August 2009
Accepted 2 October 2009

Background: Lyme neuroborreliosis (LNB) is a nervous system infection caused by
Borrelia burgdorferi sensu lato (Bb).

Objectives: To present evidence-based recommendations for diagnosis and treatment.

Methods: Data were analysed according to levels of evidence as suggested by EFNS.

Recommendations: The following three criteria should be fulfilled for definite LNB,
and two of them for possible LNB: (i) neurological symptoms; (ii) cerebrospinal fluid
(CSF) pleocytosis; (iii) Bb-specific antibodies produced intrathecally. PCR and CSF
culture may be corroborative if symptom duration is <6 weeks, when Bb antibodies
may be absent. PCR is otherwise not recommended. There is also not enough evidence
to recommend the following tests for diagnostic purposes: microscope-based assays,
chemokine CXCL13, antigen detection, immune complexes, lymphocyte transformation
test, cyst formation, lymphocyte markers. Adult patients with definite or possible
acute LNB (symptom duration <6 months) should be offered a single 14-day course
of antibiotic treatment. Oral doxycycline (200 mg daily) and intravenous (IV) ceftriaxone
(2 g daily) are equally effective in patients with symptoms confined to the
peripheral nervous system, including meningitis (level A). Patients with CNS manifestations
should be treated with IV ceftriaxone (2 g daily) for 14 days and late LNB
(symptom duration >6 months) for 3 weeks (good practice points). Children should
be treated as adults, except that doxycycline is contraindicated under 8 years of age
(nine in some countries). If symptoms persist for more than 6 months after standard
treatment, the condition is often termed post-Lyme disease syndrome (PLDS).
Antibiotic therapy has no impact on PLDS (level A).

Introduction
Lyme neuroborreliosis (LNB) is an infectious disorder
of the nervous system caused by tick-borne spirochetes
of the Borrelia burgdorferi (Bb) sensu lato complex.
Clinical features of LNB are diverse and differ in
European and American patients ? most probably because
of different bacteria species.
Laboratory confirmation of LNB is hampered by
the low yield of culture and of polymerase chain
reaction (PCR) examination of CSF [1,2]. Presence of
Bb-specific antibodies in the CSF with evidence of
intrathecal production is the traditional diagnostic
gold standard, but has limitations such as low
sensitivity in the very early phase of the disease [3?5]
and persistence for years after eradication of the
infection [6,7]. Several other, more or less validated,
laboratory tests have been developed to improve
diagnosis.

Lyme neuroborreliosis should be treated with antibiotics
to achieve rapid resolution of symptoms and
theoretically to avoid spreading and persistence of
infection. The choice of the best antibiotic, the preferred
mode of administration, and the duration of
treatment are the still debated issues.
The purpose of this guideline is to present evidencebased
recommendations for diagnostic evaluation and
management of European LNB.

Correspondence: A ˚ . Mygland, Department of Neurology, Sørlandet
Sykehus, Serviceboks416, N-4604 Kristiansand S, Norway
(tel.: +47 380 73914; fax: +47 380 73911; e-mail: aase.mygland@
sshf.no).

This is a Continuing Medical Education article, and can be found with
corresponding questions on the Internet at http://www.efns.org/
EFNSContinuing-Medical-Education-online.301.0.html. Certificates for
correctly answering the questions will be issued by the EFNS.

8
2009 The Author(s)
Journal compilation 2009 EFNS

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Hoitosuositusten käsittely viivästyy: http://underourskin.com/blog/

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Kansainvälinen Borrelioosijärjestö, ILADS, on lähettänyt kirjelmän Amerikan kansalliselle infektioyhdistykselle, IDSA:lle, jotta IDSA ei pyrkisi vaikuttamaan takakautta uusien borrelioosin hoitosuositusten tekemiseen. Maailmalla pelätään IDSA:n edelleen pyrkivän vaikuttamaan hoitosuositusten sisältöön niin että niissä ei esim. oteta huomioon taudin yksilöllisyyttä.

Koko kirjelmä:

http://ilads.org/about_ILADS/iladsletter.html

ILADS Calls on IDSA to Remove Barriers to Lyme Guideline Change

Responding to patient concerns, the President of ILADS, Dr. Robert Bransfield delivered a letter to the IDSA calling upon the organization to remove barriers to guidelines change. The letter follows patient complaints to ILADS about the IDSA voting process, which were uncovered by the Connecticut Attorney General in the oversight of the IDSA Lyme guidelines review process. According to the Attorney General, the voting process used by the IDSA was in violation of the terms of the antitrust Settlement Agreement. The Attorney General has called upon the IDSA to redo the vote using the proper voting procedures.

You can read the background on the AG letter to the IDSA by clicking here.
Robert Bransfield, MD
President, ILADS


February 5, 2010

Richard J. Whitley, MD, FIDSA
Infectious Disease Society of America
1300 Wilson Boulevard
Suite 300
Arlington, VA 22209

Dear Dr. Whitley:

Patient organizations have raised new concerns that the IDSA Lyme guidelines review panel might not address the needs of individuals with Lyme disease. These organizations had hoped that their written and oral submissions to the IDSA review panel would lead to changes in the 2006 IDSA Lyme guidelines regarding diagnostic and therapeutic options aimed at benefitting individuals with Lyme disease. Instead, the IDSA panel appears to be ignoring the proper voting procedures, thus making it harder for necessary changes in the guidelines to occur.

ILADS is concerned that the existing IDSA Lyme guidelines do not reflect the best available scientific and medical evidence for many patients with Lyme disease. To date, the limited clinical trials sponsored by the National Institutes of Health have validated the severity of chronic manifestations of Lyme disease 4.7 to 9 years after onset. ILADS has concluded that the current IDSA Lyme guidelines do not offer sufficient diagnostic and treatment options to improve the outcome for these individuals with Lyme disease.

ILADS has raised concerns that physicians experienced in treating Lyme disease based on divergent evidence and dissenting opinions were excluded from the 2006 IDSA Lyme guidelines review panel. IDSA also excluded these physicians from membership on the current guidelines review panel if they reported more than $10,000 income per year treating Lyme disease. The review panel made this decision despite the fact that, as a general rule, practicing clinicians participate in guidelines formulation for other conditions.

ILADS presented the divergent evidence and dissenting opinions about Lyme disease in July 2009 to the review panel, including 300 pages of analysis and over 1,300 pages of relevant peer-reviewed research. ILADS respectfully requests that you ask the review panel to remove any barriers to panel members who might recommend diagnostic and treatment options aimed at improving the outcome for individuals with Lyme disease.

Sincerely,

Robert Bransfield, MD, DLFAPA, President, ILADS

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IDSA näyttää edelleen jatkavan väärinkäytöksiään. Tällä kerralla äänestyskäytännöissä.

Koko artikkeli asiasta:

http://www.lymedisease.org/news/lymepolicywonk/336.html


During an antitrust investigation of the IDSA guidelines development process for the 2006 Lyme disease treatment guidelines, AG Blumenthal?s office uncovered significant procedural deficiencies, including conflicts of interests of the panel members. A settlement was reached, and the IDSA is breaching it. The IDSA is manipulating the voting process to favor no change in the guidelines. The AG has sent the IDSA a letter requesting that they redo the vote in compliance with the agreement.

On Monday, February 1, 2010, the Connecticut Attorney General sent a letter to the IDSA expressing ?concern? over ?improper voting procedures? used by the IDSA in the Lyme guidelines review voting process. The IDSA may soon approve hearing determinations based on this improper voting procedure. The Attorney General requested that the IDSA redo the vote to comply with the Settlement Agreement. The four-page Attorney General letter was released in response to a Freedom of Information Request made on behalf of patient groups for information regarding the IDSA?s compliance with the Settlement Agreement.

What happened? The IDSA used an ?improper voting procedure,? based on a process of its own design, which blatantly violates the Settlement Agreement and undermines the integrity of the voting process. The IDSA consented to the voting procedure in the Settlement Agreement and confirmed its understanding of the required voting procedure in an internal memo from the IDSA to the panel before the panel met. The Attorney General?s letter and the IDSA internal memo to the panel can be downloaded by clicking the link below this post..

What voting process was required and how was it violated? The Settlement Agreement requires a two step voting procedure, with each step requiring a supermajority vote (6 of 8 panelists). The first vote asks the question whether each of the contested guideline recommendations is ?medically/ scientifically justified in light of all of the evidence and information provided.? This vote requires a supermajority of the panel (6 of 8 ) in order for a guideline recommendation to stand. In essence, it asks ?did the panel that adopted the 2006 guidelines get it right?? The second vote, also by supermajority, determines whether the guidelines require no changes, partial revision or complete revision.

The IDSA?s flawed voting procedure combined the two voting steps into one. First, the panel failed to conduct the vote to determine whether the science was sufficient to support the guideline recommendations. Next, the panel substituted its own procedure for the second step in the voting and required a supermajority for any change. This process effectively flipped the supermajority requirement to favor no change to the guidelines.

From the get-go, two significant points stand out:

· The IDSA failed to voluntarily comply with the Settlement Agreement in good faith.

· Absent oversight by the AG pursuant to the Settlement Agreement, the IDSA would have carried out a corrupted process that blatantly violates the agreement?and it might never have been discovered.

Patient groups are appalled that so far the IDSA, which should conduct an honest review and assessment of the evidence supporting the IDSA recommendations, has chosen to manipulate the voting requirement to influence the outcome, in clear violation of the Settlement Agreement and the scientifically based review and voting process which it provides. This turns evidence-based medicine on its head.

Can the process be saved? Patient groups, along with the public at large, expected that the IDSA would comply with the Settlement Agreement in good faith. It is, after all, a settlement agreement with the Attorney General of the State of Connecticut. When the IDSA panel so deliberately violates the voting procedures, as expressly confirmed by the words of the IDSA?s own internal memo, and refuses to comply with the Attorney General?s request, there can be only one conclusion: The ability of the IDSA to run this process with integrity is extremely suspect and any outcome must be viewed critically.

Other examples of abuse by IDSA of settlement process: This is not the first time legitimate questions have been raised regarding the IDSA?s willingness and reliability in performing its obligations with integrity under the settlement process. For instance, the IDSA was charged with selecting the panel and chose to exclude divergent viewpoints (including physicians who treat chronic Lyme disease). One panelist was removed by the panel after patients complained because he had served on another Lyme guidelines? panel− a direct violation of the settlement agreement. Another panelist had also served on a previous Lyme guidelines? panel, but despite patient complaints, was not removed.

Patient organizations call upon the IDSA to hold an individual vote on whether each of the guidelines? recommendations is medically/scientifically justified in light of all the evidence as requested by the Attorney General. If IDSA fails to do so in good faith, patients continue to rely upon the Attorney General to continue to enforce the Settlement Agreement.



*********************************
An example of the IDSA manipulation of the voting procedure.


The guidelines mandate that Lyme cannot be diagnosed without a confirming diagnostic test.The tests are known to be insensitive and flawed. Requiring a positive test means that many patients with Lyme disease will fail to be diagnosed. One panel vote described in the AG?s letter was whether this recommendation should be revised. Four of the eight panel members voted for change, without the panel first having voted to determine whether the recommendation was supported by the science. As the AG?s letter points out, this clearly means that had the panel voted in accordance with the Settlement Agreement, this recommendation would have failed as not properly supported by the medical/scientific evidence. Why? A vote to uphold this recommendation would have required 6 votes; however, the 4 votes calling for revision (even
though predicated on a flawed procedure) plainly indicates insufficient evidence to support the recommendation. Thus, (a) the IDSA failed to vote to determine whether the science supported the recommendation, (b) substituted its own procedure regarding revision (requiring a supermajority vote to revise), and (c) thereby manipulated the voting requirements to achieve a result in its favor.

You can follow additional comments on Lyme policy at www.lymepolicywonk.org. You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.

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Connecticutin osavaltion kuvernöörin lainopillinen neuvonantaja on huolissaan siitä että uusikaan lautakunta ei noudata heille annettuja ohjeita (10.2.2010) borrelioosin hoitoa koskevien suositusten tarkistamisessa:

AG chides Lyme panel for not following settlement agreement

By Lisa Chamoff, Staff Writer

Published: 09:28 p.m., Wednesday, February 10, 2010

Connecticut's attorney general is concerned that a panel charged with reviewing treatment guidelines for Lyme disease may not be following the proper procedures stipulated in a settlement agreement with his office.

In a Feb. 1 letter to the Arlington, Va.-based Infectious Diseases Society of America, Attorney General Richard Blumenthal said that the organization's special review panel, which is expected to soon recommend whether to change treatment guidelines for Lyme disease, had engaged in "improper voting procedure."

The review by the special panel, which included a July hearing in Washington, D.C., attended by local Lyme disease advocates and doctors, is the result of Blumenthal's antitrust investigation of the organization that found the IDSA panel responsible for the 2006 Lyme disease treatment guidelines had conflicts of interest. The IDSA guidelines don't recommend treating Lyme disease with antibiotics for more than a few weeks.

Many insurance companies look to the IDSA's guidelines when deciding whether to fund a patient's treatment, Blumenthal has said.

In his letter, Blumenthal said that the panel should have voted on whether each of the 2006 treatment recommendations for Lyme disease were medically and scientifically justified in light of the evidence presented at the hearing. Instead, as members of the attorney general's staff found in reviewing records pertaining to the panel's voting, the group only voted on whether each of the guidelines should be revised, rewritten or remain unchanged. The panel has not yet issued a final report.

John Heys, a spokesman for the IDSA, declined to comment on Blumenthal's letter, but said the "IDSA takes its responsibility under the settlement agreement and the action plan very seriously."

"We are committed to ensuring the review panel conducts its review to the requirements of that action plan," Heys said.

Blumenthal said this week that his office has yet to receive a response to the letter. He declined to speculate on how the issue would affect the outcome of the review process.

"We hope there will be a response forthcoming shortly," Blumenthal said.

Representatives from Greenwich-based Time for Lyme, along with the California Lyme Disease Association and other organizations, had submitted a Freedom of Information Act request to Blumenthal's office for documents pertaining to the review process, and became aware of the attorney general's letter.

Debbie Siciliano, co-president of Time for Lyme, which advocates for better research into and treatment of the disease, said if the panel decides not to make any changes to the treatment guidelines "based on faulty process, that's completely an injustice."

"The IDSA has hurt too many people," Siciliano said. "It's hard to trust someone who is playing these kinds of games with people's lives."

Staff Writer Lisa Chamoff can be reached at lisa.chamoff@scni.com or 203-625-4439.

http://www.greenwichtime.com/local/arti ... 360055.php

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Connecticutin osavaltion kuvernöörin lainopillinen neuvonantaja antoi juuri kirjallisen varoituksen IDSA:lle joka ei ole noudattanut sovittuja sääntöjä. Blumenthalin mukaan IDSA ei ole vielä vastannut kirjeeseen.

http://www.acorn-online.com/joomla15/gr ... ement.html



Blumenthal says group not complying with Lyme disease agreement

Written by Ken Borsuk, Staff Reporter
Thursday, 18 February 2010 00:00

Connecticut Attorney General Richard Blumenthal has sent a warning shot across the bow of the Infectious Diseases Society of America (IDSA), saying he is concerned that it is not complying with terms of a settlement reached with his office over an antitrust investigation.

Mr. Blumenthal, a Greenwich resident and a candidate for senate, sent a letter from his office Feb. 1 claiming the Virginia-based organization did not appear to be honoring an agreement to have what he considered to be an impartial, fact-based review of guidelines for Lyme disease practices. The IDSA is an organization of physicians, scientists and health care professionals that specialize in infectious disease and its view that Lyme disease needs only a few weeks of treatment has come under fire from advocates claiming that it?s too narrow and doesn?t acknowledge the true scope of care and treatment needed.

Mr. Blumenthal said the IDSA appears to be violating an agreement made with his office last year after an investigation into the organization?s 2006 clinical practice guidelines for Lyme disease turned up what he called ?significant procedural deficiencies? that raised the question of whether the best scientific and medical evidence were being used in determining those guidelines.

After agreeing to what is known as an ?action plan? with his office, Mr. Blumenthal said the IDSA became obligated to essentially create a new review panel that would determine whether the original panel ?got it right? in making its recommendations and then vote to determine whether simple changes should be made to the 2006 guidelines or if a whole new set of recommendations should be made.

As part of this action plan two levels of voting became required, the first to determine if the original 2006 recommendations were ?medically and scientifically justified in light of all the available evidence collected through an open collection process? and the second then to determine whether revisions or completely new guidelines were made. But Mr. Blumenthal charges that a review of minutes and records of the review panel?s meetings determined that the principle vote on the medical and scientific justification of the original recommendations never took place and that instead the IDSA voted only on whether changes needed to be made to them, effectively skipping the first step to get to the second.

Mr. Blumenthal said that was not part of the agreement and therefore the vote was improperly done. He said there was no way to determine if changes had to be made since no one had studied the guidelines to determine whether they were justified in the first place.

The Greenwich-based Time For Lyme says that it supports Mr. Blumenthal in his efforts. Diane Blanchard, the group?s co-president, told the Post on Tuesday that there is ?major concern? among advocates for Lyme disease that the IDSA isn?t using the best data for its positions and the effect that will have as a result.

?The IDSA is a very influential group not only in America but all over the world and it will affect hundreds of thousands of patients,? Ms. Blanchard said. ?Other countries will follow what they do. This is a real concern.?

Ms. Blanchard said that the IDSA?s attitude toward Lyme disease is ?fairly cavalier? because it says that its easy to diagnose and easy to treat even as data comes in saying just the opposite. Ms. Blanchard and Time For Lyme said that even though Lyme disease starts out as an infectious disease it spreads throughout the body, making it more of a disease that should be treated by general practitioners or a combination of specialists, not just infectious disease specialists.

Additionally, Ms. Blanchard said that IDSA?s stance has curtailed Lyme disease patient?s rights and their access to care and made it easier for insurance companies to deny more extensive care, something she said is ?criminal.?

Mr. Blumenthal told the Post on Tuesday that he has not received a response from the IDSA to his letter. Any further action from his office, he says, will depend entirely on what kind of response is given.

John Heyes a spokesman for the IDSA told he couldn?t speak to any response that would be forthcoming from the organization, but confirmed to the Post that Mr. Blumenthal?s letter has been reviewed.

?IDSA knows its responsibilities under the settlement and the action plan and takes them very seriously,? Mr. Heyes said. ?We are committed to ensuring the review panel does its work according to the requirements of the action plan.?

kborsuk@greenwich-post.com

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Lautakunta antoi päätöksensä 28.4.2010 ja heidän mukaansa hoitosuosituksia ei tarvitse muuttaa. Pitkät hoidot voivat heidän mukaansa olla vaarallisia eikä niiden hyödystä ole lautakunnan mukaan riiittävästi näyttöä. IDSA:n edustajan, puheenjohtaja Richard Whitelyn mukaan aktiiviset potilasjärjestöt ovat johtaneet kuvernöörin lainopillista neuvonantaja, Blumenthalia, harhaan. IDSA sanoo päivittävänsä hoitosuositukset parin vuoden kuluttua. Blumenthal lakimiehineen aikoo perehtyä lautakunnan raporttiin ja selvittää onko väärinkäytöksiä tapahtunut.

http://www.idse.net/index.asp?section_i ... e_id=15057

POSTED: APRIL 28, 2010

Lyme Disease Treatments Fine For Now

Seth Kandel

The Infectious Disease Society of America (IDSA) has ruled that the 2006 guidelines for treating Lyme Disease are satisfactory and need no revision. The IDSA reviewed their guidelines in response to an investigation by the state of Connecticut?s attorney general.

Patients have long been at odds with physicians over the symptoms, classification, and treatment of their condition. Doctors often refuse to classify Lyme Disease as a chronic condition, while patients complain of symptoms and quality-of-life compromises long after antibiotic treatment has rendered their blood tests Lyme-free.

Connecticut Attorney General Richard Blumenthal claimed the IDSA panel that wrote the 2006 guidelines had conflicts of interest and may have overlooked certain key evidence. As a result, the state?ground zero for the original Lyme diagnosis and continually a hotbed for cases?opened an investigation into the 2006 guidelines at the behest of the state?s patients.

?I think the attorney general was misguided by the activists presenting their own opinions,? said Richard Whitely, president of the IDSA. ?We spent an immense amount of time trying to suit his needs and those of his supporters.?

The IDSA review panel concluded that clinical trials for extended antibiotic treatment of Lyme Disease are inconclusive and potentially dangerous. With the absence of study data showing the safety and efficacy of long-term antibiotic use, the panel refused to change its position from 2006.

Mr. Blumenthal said his office plans to review the recent guideline reassessment and determine whether the IDSA did their due diligence. Mr. Whitely stated that the IDSA plans to revisit and update the 2006 guidelines again in about 2 years.

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Mielenkiintoinen tilanne: IDSAn todettiin syyllistyneen useisiin laittomuuksiin laatiessaan borrelioosia koskevat hoitosuositukset v. 2006. Siitä huolimatta uusi lautakunta päätti pitää vanhat suositukset voimassa sellaisenaan.

Kansainvälisen Borrelioosijärjestön ILADSin puheenjohtajan tohtori R. Bransfieldin mukaan tilanne on surullinen sekä koko terveydenhuolloon että borrelioosiin sairastuneiden kannalta. "IDSAn näkemys tarkoittaa käytännössä sitä että borreliatartunnan saaneet saavat jatkossakin virheellisiä diagnooseja ja riittämättömiä, sopimattomia hoitoja."


PANEL RUBBER STAMPS LYME GUIDELINES: WHAT'S NEXT

IDSA_logo.jpg After reviewing 3,000 pages of peer-reviewed evidence challenging advice in its 2006 Lyme disease medical guidelines, eight Infectious Diseases Society of America (IDSA) panelists voted to keep the 45-page document ?as is.? Dr. Robert Bransfield, the president of a group of community-based Lyme specialist physicians (ILADS) issued this statement in response: ?It?s a sad day for the health care system and for everyone who suffers from the Lyme disease epidemic. The IDSA?s flawed positions means patients will continue to suffer with incorrect diagnosis and improper treatment.?

In May 2008, the IDSA agreed to re-evaluate its Lyme disease guidelines as part of a settlement agreement for an antitrust investigation by the Attorney General of Connecticut, Richard Blumenthal. UNDER OUR SKIN covered this investigation as it unfolded, and revealed some of the evidence alluded to in Blumenthal?s investigation, including the significant conflicts of interest among the original IDSA guidelines panelists, suppression of scientific evidence by panelists, and exclusion of panel members with opposing viewpoints.

The Connecticut Attorney General is currently reviewing the IDSA Lyme report to determine whether the IDSA has violated the Settlement Agreement. If you would like to submit your feedback on how the IDSA Lyme disease guidelines have affected you and/or your family, emails can be sent to: 
attorney.general@po.state.ct.us

‣ View the annoucement by the Infectious Disease Society of America

‣ Learn more about the issue and what you can do _____

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Senaattori Blumenthal aikoo saada läpi lakiehdotuksen jonka mukaan Borrelioosin diagnostiikkaa tulee parantaa, tautitapaukset rekisteröidä jne. Tautitapaukset ovat suuresti aliraportoituja.
Pyrkimyksenä on myös saada varoja kroonisen Borrelioosin tutkimukseen vaikka pieni osa lääkäreistä kieltääkin sen olemassaolon.

Krooninen Borrelioosi voi kestää vuosikausia, estää koulunkäynnin, työnteon jne. Hoito voi edellyttää pitkiä antibioottihoitoja. Joidenkin lääkärien mielestä kroonista Borrelioosia ei ole, pitkistä hoidoista voi olla haittaa ja oireiden todellinen syy jäädä huomioimatta.

Blumenthal aloitti v.2006 tutkimuksen IDSA:n hoitosuosituksista koska suosituksia laatineilla lääkäreillä oli taloudellisia kytköksiä lääke- ja testejä kehitteleviin yrityksiin.

Yksi IDSA:ta edustavista lääkäreistä, Shapiro, sanoo ettei kroonista Borrelioosia ole olemassa. Ihmiset vain kuvittelevat että he sairastavat sitä. Hänen mielestään tieteellisen yhteisön, ei poliitikoiden, tulee päättää millaisiin tutkimuksiin varat tullaan kohdentamaan.



Blumenthal takes Lyme disease fight to the Senate

July 18, 2011
By Arielle Levin Becker

NEW HAVEN--As attorney general, Richard Blumenthal won praise from the vocal group of Lyme disease patient advocates who believe the illness can be a chronic condition--and the ire of many doctors--when he challenged a medical society's guidelines for treating the controversial tick-borne ailment.

On Monday, Blumenthal announced that he plans to continue his Lyme disease advocacy in the Senate with a bill aimed at promoting better diagnosis, reporting and research on the disease, which he said is widely underreported.

Blumenthal Lyme press conference 7-18-11

Blumenthal with Time for Lyme co-presidents Debbie Siciliano and Diane Blanchard

The bill would also include funding for research into chronic Lyme disease, a condition that mainstream physicians say does not exist.

Blumenthal described the bill as taking an "open-minded and open-ended approach," without prejudice toward any kind of treatment. But he left little question about his views on the controversial aspects of Lyme. He touted his past work fighting insurance companies and some medical professionals over the existence of chronic Lyme, and was joined at the press conference by Debbie Siliciano and Diane Blanchard, two advocates for recognizing Lyme as a long-term condition.

"Today for me culminates more than a decade of work and probably a decade more, because I've seen firsthand the devastating, absolutely unacceptable damage done by Lyme disease to individual human beings, Connecticut children and residents whose lives have been changed forever as a result of Lyme disease," Blumenthal said.

He added that chronic Lyme disease can last for years and interrupt schooling, work, play and divide families.

While many cases of Lyme disease can be treated with a short course of antibiotics, some patient advocates and physicians say the disease can also exist in a chronic form that can require long-term antibiotics. The mainstream medical community has rejected that view, and some doctors say that patients who think they have chronic Lyme disease could be at risk from both long-term antibiotic treatment and from the failure to diagnose what is really causing their problems.

Blumenthal waded into the Lyme disease controversy in 2006 when he launched an antitrust investigation into guidelines for treating Lyme developed by the Infectious Diseases Society of America. The guidelines, which advised against long-term antibiotic therapy, had been used by insurers to restrict coverage for long-term treatment.

Blumenthal alleged that some members of the panel that developed the guidelines had conflicts of interest, including financial stakes in drug companies or diagnostic tests. The infectious diseases society, which represents physicians, said the panelists wouldn't gain by recommending short-term treatment. But the group agreed to a review of its guidelines by a new panel.


After more than a year of work, that panel decided to continue recommending short-term antibiotic treatment and advising against long-term antibiotic treatment. Its report, released last year, said that "there has yet to be a single high-quality clinical study that demonstrates comparable benefit to prolonging antibiotic therapy beyond one month." But chronic Lyme advocates raised concerns about the review process and the panel itself.

Blumenthal's bill would create a tick-borne disease advisory committee to streamline coordination between federal agencies and private organizations that address tick-borne illnesses. It also calls for the development of more accurate and time-sensitive diagnostic tools to improve surveillance and reporting of tick-borne illnesses to determine their prevalence.

It would create a physician-education program on Lyme-related research that includes "the full spectrum of scientific research," and increase public education through the Centers for Disease Control, and require the secretary of the U.S. Department of Health and Human Services to regularly evaluate guidelines and research on Lyme disease to educate health professionals and to report to Congress.

Blumenthal said it's not yet clear how much the bill would cost, but said the amount would be "relatively small."

Blanchard, the co-president of Time for Lyme, which funds and promotes research and education on Lyme, said public funding for the disease lags behind funding for similar conditions.

"It's time to take Lyme and take Lyme diseases off the back burner, where it has languished for decades, underfunded, misunderstood, and laden with political controversy," she said.

Her co-president, Debbie Siciliano, praised what she called a comprehensive bill, and said the focus on improving diagnostic tools is critical. Chronic Lyme advocates say some patients get false negative results in existing tests.

"Once an accurate test is developed, the controversy goes away," Siciliano said.

But Dr. Eugene Shapiro, a Yale professor of pediatrics and epidemiology who specializes in Lyme disease, called that idea "nonsense." Diagnostic technology can always be improved, but studies don't support the idea that people with longstanding infection get false negative test results, he said, and improving diagnosis won't end the controversy.

Shapiro, who testified in the infectious diseases society's 2009 special review, had not yet seen the bill and did not comment on it directly. He said he fully supports additional funding for looking at both helping control Lyme disease and finding solutions for people who believe they have chronic Lyme disease. That condition does not exist, Shapiro said, but the people who believe they have it do have chronic symptoms and "clearly have something."

He added that it's important that the scientific community, not politicians, determine how research funding is allocated.

Blumenthal said decisions about research would be made by professionals.

He announced the bill at a press conference at the Connecticut Agricultural Experiment Station in New Haven, which has conducted tick research since 1977. While some aspects of Lyme are intensely controversial, others are not, including the importance of prevention and surveillance.

In 2009, there were nearly 30,000 confirmed cases of Lyme, a figure that Blumenthal said represented only a small fraction of the cases that actually occurred.

Dr. Kirby C. Stafford III, head of the department of entomology at the agriculture experiment station, said that some of the physicians least likely to report Lyme are those that see it the most, because of the paperwork involved in reporting. A more active approach to surveillance, in which local health departments follow up with doctors about Lyme cases, could lead to more reported cases.

Stafford, who for the occasion sported a tie with pictures of ticks on it, said it takes time for ticks to infect a person with Lyme, because the bacteria that causes the disease must travel from a tick's gut to its salivary glands, and because the outer surface proteins in the bacteria must change before mammals can be infected. That's why it's important to identify and remove ticks as soon as possible.

The bill is being co-sponsored by Rhode Island senators Jack Reed and Sheldon Whitehouse, and by New York Senator Kirsten Gillibrand, who, like Blumenthal, are Democrats. Blumenthal said that in speaking to his colleagues from the northeast, he found a surprising amount of support, which he attributed to increased awareness of Lyme disease.

"I think there is a level of awareness that makes this bill very, very possible," he said.

Then he added: "If it doesn't pass this session, we'll just keep fighting."

[soijuv]

Senaattori Blumenthal jatkaa taisteluaan Borrelioosihoitojen puolesta Senaatissa. "OLen nähnyt miten vaikea tauti voi olla ja miten suuria ongelmia se voi aiheuttaa ihmisille. Monien elämä muuttuu täydellisesti sairastumisen jälkeen."
IDSA:n jotkut lääkärit eivät ole Blumenthalin aloitteesta mielissään.

CT's Time for Lyme leaders were with Senator Blumenthal today when he made the announcement to continue his fight for us in the Senate. The IDSA doesn't appear happy with his plan to be involved with Lyme disease or his plans to introduce our Senate bill again this session.

"Today for me culminates more than a decade of work and probably a decade more, because I've seen firsthand the devastating, absolutely unacceptable damage done by Lyme disease to individual human beings, Connecticut children and residents whose lives have been changed forever as a result of Lyme disease," Blumenthal said.

(snip)

"Once an accurate test is developed, the controversy goes away," Siciliano said.

But Dr. Eugene Shapiro, a Yale professor of pediatrics and epidemiology who specializes in Lyme disease, called that idea "nonsense." Diagnostic technology can always be improved, but studies don't support the idea that people with longstanding infection get false negative test results, he said, and improving diagnosis won't end the controversy."
Full article:

http://ctmirror.com/story/13311/blument ... ght-senate

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Sairaanhoitajien sivustolla (USA) näyttää olevan laajempi näkemys borrelioosin diagnostiikasta ja hoidosta kuin terveydenhuollon ammattilaisilla yleensä esim. Amerikan infektiotautien yhdistyksellä eli IDSA:lla.

http://rn.modernmedicine.com/rnweb/Mode ... oryId=5796

CDC:n ( =Yhdysvaltojen tartuntatautien valvonta-ja ehkäisykeskus) mukaan "Yksikään nykyinen testi ei pysty luotettavasti toteamaan sairastaako henkilö borrelioosia vai ei." Joka tapauksessa testaaminen tulee tehdä kahdella testillä; ELISA + Western Blot. Näissäkin tapauksissa vääriä negatiivisia tuloksia esiinty usein. Syynä on esim. immuunipuolustuksen heikentyminen jonka seurauksena se ei tunnista taudinaiheuttajia jne. Serologiset testit menettävät myös herkkyyttään ajan kuluessa. Lisäksi erilaiset lisäinfektiot ovat yleisiä borrelioosia sairastavilla. Usein myös latenttina olleet virukset kuten Epstein Barr -virus aktivoituvat borrelioosia sairastavilla. Nämä tekijät tulee ottaa huomioon borrelioosiin sairastuneita hoidettaessa (suom.huom. onko asiaa huomiotu todellisuudessa yhdeltäkään suomalaiselta?).

Sivuilla tunnustetaan myös borrelioosin kroonistuminen. Artikkelin lähteistä löytyy mm. Burrascanon ja Nicholsonin artikkelit.


Originally Posted December 2008

By LYNN SEBOLD, MSN, RN, LORRAINE REISER, PHD, CRNP, and ELIZABETH SCHLENK, PHD, RN

LYNN SEBOLD is a Clinical Instructor of the University of Pittsburgh Medical Center-Shadyside School of Nursing and developed a Lyme disease educational awareness plan for medical offices and school nurses in Pittsburgh. LORRAINE REISER is nurse practitioner and an Associate Professor at the Carlow University School of Nursing in Pittsburgh where she has treated individuals with Lyme disease. ELIZABETH SCHLENK is an Assistant Professor at the University of Pittsburgh, School of Nursing, Pittsburgh, and has a special interest in rheumatic and arthritic diseases such as in late Lyme disease. The authors have no financial relationship to disclose. STAFF EDITOR: MARTHA K. RAYMOND, RN, BSN, BS

Lyme disease is the most common vector-borne disease in the United States, with approximately 20,000 new cases reported each year.1 The incidence rate in 10 endemic states?Connecticut, Delaware, Maryland, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, Rhode Island, and Wisconsin?is more than three times the targeted goal of the U. S. Department of Health and Human Services (HHS) Healthy People 2010 objective, which was set at 9.7 per 100,000.2 The Centers for Disease Control and Prevention (CDC) is particularly keen on tracking Lyme disease in those 10 northeastern states, where the concentration of Lyme disease was 29.2 cases for every 100,000 people from 2003 to 2005.1 The CDC suggests that reports of Lyme disease are 10 times lower than the probable actual number.1 Reasons related to underreporting include delay in or lack of the diagnosis, especially when patients live in nonendemic areas. Recognizing Lyme disease in its early stage is key because prompt treatment is imperative for optimal patient outcomes.

Tick bite

Ticks carrying Borrelia burgdorferi spirochetes transmit Lyme disease. The bacteria that cause the disease are transmitted to humans when an infected tick bites and stays attached for one to two days. Brief periods of attachment rarely transmit disease. At first, the bacteria multiply at the site of the tick bite. After three to 32 days, the bacteria migrate from the site of the bite into the surrounding skin, and also spread through the blood and lymphatics to other organs or sites in the skin.

There's a variety of ticks, but the ones most apt to carry Borrelia burgdorferi are the Ixodes genus, which has more than 200 potentially disease-carrying species. Typical vectors include the Ixodes scapularis or deer tick; the Ixodes pacificus, known as the West Coast tick; the Dermacentor variabilis, familiarly the American Dog tick; and the Amblyomma americanum, including the Lone Star tick.3

A tick's two-year life cycle determines the infectious process. The larva, nymph, and adult ticks vary in the ability to pass the Borrelia burgdorferi spirochete to their hosts. The life cycle starts in the spring when eggs develop into larvae toward summer. Larva can become infected with Borrelia burgdorferi if it feeds on a host carrying that specific spirochete. The larva molts in the fall and lies dormant until it becomes active in the spring in the form of a nymph, which is the size of a poppy seed. It's at the nymphal stage that ticks have the most potential to infect their hosts due to their heavily infected salivary glands. In the fall, the nymph develops into an adult tick.3

Tricky assessment

Lyme disease may be difficult to diagnose because symptoms vary from person to person. A differential diagnosis of Lyme disease should be considered even in areas not considered endemic, since every state has reported cases of Borrelia burgdorferi spirochete. The first step in diagnosis is establishing potential risk. Healthcare providers need to ask all individuals presenting with fatigue and joint pain about potential exposure to ticks. For example: Do they camp, hike, hunt, bike, or walk in grassy or wooded areas that may have ticks? Do they have pets? These simple questions are helpful in establishing risk. Once risk is established, reports of clinical symptoms along with a medical history, physical examination, and diagnostic blood test results are key in diagnosing Lyme disease.

The American College of Physicians defines three stages of Lyme disease based on patient symptoms, history, and blood test results.3 Early Lyme disease usually presents with one or more signs and symptoms, including fatigue, chills and fever, headache, muscle and joint pain, swollen lymph nodes, and/or erythema migrans (EM). The erythema migrans rash associated with early Lyme disease infection usually is round or oval with a clearing center, often called a "bull's-eye" rash.4 It may be flat or have raised bumps, and can sometimes itch. More than 50% of Lyme disease patients report having never noticed a rash or bite, perhaps because the bite may have been in an area of the body that is difficult to inspect.5 The fatigue, muscle, and joint pain may be mistakenly attributed to the influenza or cold virus. Healthcare providers should remember that the flu does not usually occur in summer months when tick season is peaking, so this could be a sign to consider a diagnosis of Lyme disease.

Early disseminated Lyme disease?middle stage?is a spirochetal infection that has spread and is affecting other body functions. At this stage, signs and symptoms include numbness and pain in the arms or legs; paralysis of facial muscles, usually on one side of the face; and meningitis with fever, stiff neck, and severe headaches. Additional neurological symptoms include numbness, tingling, and muscle twitching. The heart may exhibit conduction abnormalities that include first-degree heart block and prolonged QT intervals.

Late or chronic Lyme disease develops weeks, months, or years after infection in patients who never received antibiotic treatment for early disease or whose treatment did not eradicate the spirochetal infectious processes. Problems of late Lyme disease include chronic Lyme arthritis, which involves brief bouts of pain and swelling usually in one or more of the large joints, especially the knees. Nervous system problems include memory loss and difficulty concentrating. Patients often complain of chronic muscle pain or disturbed sleep.

Because early symptoms may seem so mild, infected individuals sometimes don't seek treatment. As the disease progresses, symptoms either get worse or lapse into remission. However, left unchecked and untreated, Lyme disease can progress to a multisystem infection. The International Lyme and Associated Diseases Society (ILADS) developed three criteria for chronic cases of late-stage Lyme disease:5 First, the illness is present for at least one year, approximately when immune breakdown attains clinically significant levels. Second, patients have persistent major neurological involvement, such as encephalitis/encephalopathy or meningitis, or present active arthritic manifestations such as active synovitis. Lastly, patients continue to be actively infected with Borrelia burgdorferi, regardless of prior antibiotic therapy.6

Is it Lyme disease?

The CDC reports that no reliable test can diagnose Lyme disease but recommends a two-step testing procedure that first uses serologic testing by an enzyme-linked immunosorbent assay (ELISA) titer.1 This test has a 65% sensitivity value in screening for Lyme disease, whereas typical screening tests have 95% sensitivity.5 blot test, is used if ELISA titer is equivocal or positive. Western blot test has a higher accuracy rate, especially the reading of bands 31 and 34, which are more specific to detecting antibody proteins for Borrelia burgdorferi. However, bands 31 and 34 are not reported in most Lyme tests because the CDC eliminated reading of bands 31 and 34 due to the fact that they were chosen for vaccine development, which is currently unavailable.5 Therefore, the patient may be infected even with a negative Western blot test. False negative results also are due to a damaged immune system, which decreases the immune response. As time passes, the serologic tests become less sensitive, further complicating diagnosis. However, ELISA serology testing with Western blot increases accuracy to 50% to 75%.7 In addition, Western blot can be used six to 12 weeks after infection and is recommended to confirm all positive or ambiguous ELISA results.3

Making matters worse, co-infections also are prevalent among those with Lyme disease.8 The ticks carrying the Borrelia burgdorfi spirochete often have other bacterial infectious agents on board that can infect the host. Some of these co-infection pathogens include Babesia, Bartonella, Ehrlichia, Mycoplasma, and Anaplasma.6 Latent viruses, such as Epstein-Barr, that an individual may already have, also can be reactivated. When co-infections are present, the clinical symptoms exhibited usually are more severe. These factors must be taken into consideration when treating infected patients.

Antibiotic treatment

Guidelines state that treatment early in the course of the infection improves the outcome in eradicating the Borrelia burgdorfi spirochete.4,5,6 Therefore, if a patient is positive for erythema migrans, treatment should begin immediately, and the healthcare provider should not wait for serologic testing results.9 The standard choice of antibiotics varies and may consist of single or multiple types of drugs, according to the prescribing healthcare provider. In the early stages of Lyme disease, both localized and disseminated, first-line treatment is oral doxycycline (Vibramycin, Periostat), amoxicillin (Amoxil, Trimox), or cefuroxime axetil (Ceftin) with accepted alternatives being erythromycin (E-Mycin, Ilosone), clarithromycin (Biaxin), or azithromycin (Zithromax, Zmax).8 If the disease progresses to nervous system involvement, IV medications should be used. IV ceftriaxone (Rocephin) is the drug of choice with penicillin G (Pfizerpen) and doxycycline (Vibramycin, Periostat) being acceptable alternatives. In the late, disseminated stage of the disease, oral amoxicillin (Amoxil, Trimox) and doxycycline (Vibramycin, Periostat) are considered.

In disseminated disease, the patient may develop psychological problems, such as depression, anxiety, and mood disorders. These may be related to waiting for the Lyme disease diagnosis, confusion over the diagnostic serologic tests, and slow improvement.9

Educate to prevent

A thorough treatment plan includes an educational component for disease prevention.10 An infected person can be reinfected by another tick bite.10 The HHS has included Lyme disease prevention as a priority in the Healthy People 2010 program.2 HHS also seeks to decrease the incidence of Lyme disease by 40% by 2010.10 Nurses can be a vital force in the educational process against Lyme disease.11 Patient education should include a description of the symptoms at the different stages, the treatment modalities, and any potential complications of the therapy.12

For example, a patient may develop the Herxheimer reaction, which is a result of the Borrelia burgdorferi dying off with the antimicrobial treatment. The patient's immune system responds to the toxins from the destroyed spirochete. This reaction can be mild to completely debilitating. A Herxheimer reaction can include worsening of present symptoms, recurrence of previous symptoms that may not have been attributed to Lyme disease, rashes, and flu-like symptoms. This adverse reaction can frighten patients if they aren't informed prior to antimicrobial therapy. Supportive therapies are used to ease discomfort. Aspirin, nonsteroidal anti-inflammatory drugs, pain medication, muscle relaxers, and hot baths are treatment modalities that may be prescribed by a practitioner. Other complications include gastrointestinal intolerance with some of the first-choice antibiotics, such as doxycycline (Vibramycin, Periostat), which can be a separate problem and not related to the Herxheimer reaction.

Primary prevention includes:

* Dressing appropriately for the outdoors in tick-laden environments. Light-colored clothing should be worn to make ticks more visible. Tuck pants into socks when going into areas that could harbor ticks.
* Properly using insect repellents containing DEET (N, N-diethyl-m-toluamide). Use caution with children because increased absorption and resultant toxicity is a concern. Do not apply repellents directly to children; instead an adult should apply repellent to his or hands and then put it on the child. Do not apply the repellent near eyes, nose, or mouth, and use sparingly around ears. Do not apply it to the hands of small children. There also are insect repellents that can be applied to clothing; do not apply these to a person's skin. Outdoor areas also may be treated with commercial chemical preparations to reduce the number of landscape ticks, with applications of pesticides done in the spring and early fall seasons.
* Carefully monitoring for ticks. Daily tick checks should be conducted after coming in from the outdoors.
* Properly removing ticks when found. Patient teaching of how to properly remove a tick should be demonstrated so that the entire tick is detached. Using fine-pointed tweezers, grasp the tick by the head or mouthparts, as close to the skin as possible, and pull straight out with a steady movement until the tick releases. The tick's body should not be grasped or squeezed. Apply an antiseptic, such as alcohol, to the bite area. The Lyme Disease Association offers kits for this purpose, and many outdoor recreation stores also carry tick removal kits. Prevention is the best protection.

Other populations to focus on for primary prevention of tick bites and Lyme disease are schools. The Lyme Disease Association has educational information for children in its brochure The ABC's of Lyme Disease, along with information on the schooling of children who are infected with the disease, as they may be too ill to attend regular school classes.13 Furthermore, the public needs to be aware that one can be reinfected with the Borrelia burgdorferi spirochete, even after treatment and recovery from a previous tick bite. Increased Lyme disease education in all areas of healthcare will help prevent and reduce its incidence and meet the Healthy People 2010 goals.
Future directions

Research to develop better diagnostic testing is essential because of the growing prevalence of Lyme disease. Two institutions studying the disease are the NIH Rocky Mountain Laboratory14 and Columbia University15, the latter of which developed a Lyme Disease Research Center. In addition, ongoing monitoring to report the incidence, prevalence, and endemic regions of Lyme disease will heighten awareness of healthcare providers. In turn, these providers could suspect Lyme disease in differential diagnoses leading to earlier identification, which will improve treatment effectiveness. Additionally, research efforts could compare the effectiveness and outcomes of differing treatment guidelines, providing an evidence base for treating patients with Lyme disease.
Holistic care

Late Lyme disease can be costly for society in the form of individuals who no longer can be productive, work, or function independently. They may feel that they alone are enduring the ongoing infection process. Once a diagnosis is made, patients often perceive validation for their illness and symptoms. The patients then feel hopeful about the future and that they will regain their health. Patients with Lyme disease need support from their healthcare providers throughout the course of the disease and treatment.13

A trusting relationship with the patient is imperative. The healthcare provider also can offer information on various resources available to patients. Support groups are available in locations around the United States. The Lyme Disease Association and the CDC's Web sites have valuable information for those who have the disease or know someone who has it.

REFERENCES

1. Centers for Disease Control and Prevention. (2007). Lyme disease?United States 2003-2005. Morbidity & Mortality Weekly Report, 56(23), 573-576.

2. U.S. Department of Health and Human Services. (2000). Healthy people 2010: Understanding and improving health. Washington, DC: Government Printing Office.

3. American College of Physicians. (2003). American College of Physicians: Internal Medicine. Lyme disease: A patient's guide. Retrieved Oct. 30, 2008. http://www.acponline.org/clinical_infor ... index.html.

4. National Guideline Clearinghouse. (Nov. 6, 2007). Evidence-based guidelines for the management of Lyme disease. Retrieved Oct. 30, 2008. http://www.guideline.gov/summary/summar ... tring=lyme

5. National Guideline Clearinghouse. (2007). Infectious Diseases Society of America practice guidelines for clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis. Retrieved Oct. 30, 2008. http://www.guideline.gov/summary/summar ... tring=lyme

6. Burrascano, J.J. (2005). Advanced topics in Lyme disease. Managing Lyme disease. Retrieved Oct. 30, 2008. www.ilads.org/files/burrascano_0905.pdf

7. DePietropaolo, D.L., Powers, J.H., et al. (2005). Diagnosis of Lyme disease. American Family Physician. Retrieved Oct. 30, 2008. www.aafp.org/afp/20050715/297.html

8. Nicolson, G.L. (April 2007). Diagnosis and therapy of chronic systemic co-infections in Lyme disease and other tick-borne infectious diseases. Townsend Letter, 93-98.

9. Wormser, G.P., Dattwyler, R.J., et al. (2006). The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babeosis: Clinical practice guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases, 43(9), 1089-1134.

10. Hayes, E.B., & Piesman, J. (2003). How can we prevent Lyme disease? New England Journal of Medicine, 24(348), 2424-2430

11. Kinsley, J., & Johnson, M. (2004). Lyme disease: Knowledge is the best prevention. The Nurse Practitioner, 29(8 ), 34-43.

12. Lyme Disease Association. (2005). ABCs of Lyme disease. Retrieved Oct. 30, 2008. www.lymediseaseassociation.org/ABCsLYME.pdf

13. Drew, D., & Hewitt, H. (2006). A qualitative approach to understanding patients' diagnosis of Lyme disease. Public Health Nursing, 23(1), 20-26.

14. Gherardini, F. (Feb. 19, 2008). Laboratory of zoonotic pathogens, gene regulation section, Borrelia projects. National Institute of Allergy and Infectious Diseases. Retrieved Oct. 30, 2008. http://www.niaid.nih.gov/labs/aboutlabs ... ionSection

15. Lyme and Tick-Borne Diseases Research Center. (2008). Columbia University Medical Center. Retrieved Nov. 5, 2008, from www.columbia-lyme.org

About the Author
Lynn Sebold, MSN, RN
About Lynn Sebold, MSN, RN
See more articles by Lynn Sebold, MSN, RN
Lorraine Reiser, PhD, CRNP
About Lorraine Reiser, PhD, CRNP
See more articles by Lorraine Reiser, PhD, CRNP
Elizabeth Schlenk, PhD, RN
About Elizabeth Schlenk, PhD, RN
See more articles by Elizabeth Schlenk, PhD, RN

[soijuv]

http://www.cmaj.ca/site/earlyreleases/8 ... ines.xhtml

Hoitosuositusten taustalla olevia myyttejä.

Monien elämäntyönä on kehittää käytännön hoitotyötä ohjaavia hoitosuosituksia. Suosituksista ei kuitenkaan välttämättä seuraa ainoastaan hyvää.

Hoitosuosituksiin liittyy erilaisia myyttejä:

"1. Ei ole olemassa huonoa kliinistä hoitokäytäntöä.
2. Vahva tieteellinen näyttö on aina korkeatasoista.
3. Olet huono lääkäri mikäli et toimi valmiiden hoitosuositusten pohjalta.
4. Asia on totta koska asiantuntija on niin sanonut.
5. Ei tulisi käyttää lääketeollisuuden antamia hoitosuosituksia."

Tosiasia on, että kaikki tieto ei perustu tieteelliseen näyttöön vaan normaaliin järkeen ja kokemukseen. Osa hoitosuosituksista perustuu erittäin vähäiselle näytölle. Ja vaikka tieteellinen näyttö olisikin vahva, ei se tarkoita sitä että ohjeet olisivat sopivat erilaisissa käytännön tilanteissa eivätkä jokaiselle potilaalle.

Valmiit ohjeet antavat käytännön työtä tekevälle lääkärille (suom.huom. ohjeet ovat netissä jokaisen luettavissa) nopeasti tiedon mahdollisista hoidoista mutta ne ovat vain suosituksia eivät kirjaimellisesti toteutettavia ohjeita.

Hoitosuosituksia (Suomessa nimellä "Käypä hoito suositukset") laativilla henkilöillä on usein erilaisia taloudellisia kytköksiä esim. lääketeollisuuteen, sairaalatarvikkeita valmistavaan teollisuuteen tai esim. laboratoriotestejä kehitteleviin yrityksiin. Sen seurauksena puolueettomuus saattaa kärsiä. Asia on syytä tiedostaa. (2011)

NEWS
November 8, 2011
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Busting myths about guidelines

Some information that is considered common sense in family medicine, such as recommended daily salt intake, comes from clinical practice guidelines that may not be grounded in robust evidence, says Dr. Clayton Dyck.

Some information that is considered common sense in family medicine, such as recommended daily salt intake, comes from clinical practice guidelines that may not be grounded in robust evidence, says Dr. Clayton Dyck.

Photo credit: ©2011 Thinkstock

All clinical practice guidelines are not created equal. Actually, some are pretty bad. That was the message delivered on Saturday to a packed room of general practitioners at the Family Medicine Forum 2011 in Montreal, Quebec, during a session called ?Guideline MythBusters: Exploring the limitations, pitfalls, and appropriate application of clinical practice guidelines.?

?There are a lot of people who put their life?s work, with good intentions, into guideline development,? says Jamie Falk, an assistant clinical professor in the pharmacy faculty at the University of Manitoba in Winnipeg, who co-led the session. ?But I think there is just too much blind following of these things and, sometimes, you have to present the bad side.?


During the presentation, Falk and Dr. Clayton Dyck, the associate director of undergraduate education in the family medicine department of the University of Manitoba, discussed five myths about clinical practice guidelines:

There is no such thing as a bad clinical practice guideline

?Strong? evidence is always high-quality

You are a bad physician if you don?t follow clinical practice guidelines

It must be true if an expert said it

You shouldn?t use guidelines sponsored by the pharmaceutical industry

The presenters told the audience that some information from guidelines now considered common sense in family medicine may not be grounded in evidence. Some guidelines are backed by low-quality evidence, while others have little data to back them up. According to Dyck, a popular set of guidelines that doctors often consult on recommended sodium levels references a clinical trial with only 12 participants.


Even if the evidence is strong, that doesn't necessarily mean the guidelines are appropriate for a particular family practice, the presenters suggested. Or they might not be applicable to patients in a certain age range or from a certain demographic.

The presenters recommended that family doctors learn which guidelines are relevant to their practices. They should take note of the medical conditions they most commonly see and search out high-quality guidelines for treating them. They should ensure the guidelines they use are up to date and have clearly stated methodologies. It also wouldn't hurt if they at least skimmed the evidence supporting the guidelines to glean its strengths and weaknesses.

Clinical practice guidelines are important in family medicine because they provide foundational guidance for busy doctors who may not have time to explore the evidence supporting treatments for various ailments in depth, says Dyck. They have little choice but to put a certain amount of trust in the people who do wade through the data. Still, no matter how busy, physicians should critically appraise the guidelines they follow and use them properly. ?They?re guidelines,? says Dyck. ?They?re not rules.?

Other potential problems mentioned during the session include the inescapable creep of opinion into guidelines. The key messages pulled from a set of guidelines, for instance, are decided upon by the authors, and are therefore inherently subjective. Falk also suggested that so much attention is given to a treatment's efficacy in guideline development that patient safety often fails to be properly considered.

Then there are the many conflicts of interest of the people involved in creating guidelines, who often work for or consult for or are otherwise tied to pharmaceutical companies, medical device manufacturers or makers of medical tests. That doesn't mean their recommendations should be automatically discounted, Falk says, as many of the most knowledgeable and trusted people in certain areas of medicine have conflicts of interest. But it is a problem that should be managed, not ignored or accepted as the status quo.

?We have to try to find a better balance,? says Falk. ?There will always be conflicts of interest. Can we have more panel members who don?t have conflicts? Should the lead authors have fewer conflicts? Should we be setting standards on that??

The presentation appeared to resonate with the audience. One physician in attendance, second-year resident Dr. Michelle Bailes, had already been taught about the limitations of guidelines by Falk and Dyck at the University of Manitoba. ?It has helped me to be more skeptical, and to look for the really good guidelines,? says Bailes.

Another audience member agreed that a healthy sense of skepticism is appropriate when appraising a set of guidelines. ?If you get a 183-page document of guidelines, you might not read it all right away, but you look for the key messages. But those key messages might be based on C-level evidence,? says Dr. Tunji Fatoye, an assistant professor in family medicine at the University of Manitoba, referring to the lowest level of evidence cited in clinical practice guidelines. One of the key messages he took from the myth-busting session is that, while guidelines are valuable, physicians must still rely primarily on their brains rather than a document when treating a patient. ?You have to think about what you are doing ? really think about it.?
DOI:10.1503/cmaj.109-4051
? Roger Collier, CMAJ

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[soijuv]

Yleislääketiede
Lääketieteellinen Aikakauskirja Duodecim
2009;125(16):1707
Jukkapekka Jousimaa
Erikoislääkärin uutiset

Hoitosuositukset tukkanuottasilla - lymyääkö Lymen tauti?

Yhdysvalloissa on ajauduttu erikoiseen tilanteeseen kahden järjestön, IDSA:n (Infectious Disease Society of America) ja ILADS:n (International Lyme and Associated Diseases Society) julkaistua omat Lymen tautia koskevat hoitosuosituksensa. Suositusten käsitykset menevät siinä määrin ristiin, että järjestöt ovat ajautuneet ilmiriitaan.

Molemmat ovat yhtä mieltä siitä, että Lymen taudin ensioire on flunssankaltainen sairaus, johon joskus liittyy tyypillinen erythema migrans -ihottuma. Yksimielisyys vallitsee myös siitä, että sairauden myöhemmässä vaiheessa saattaa esiintyä nivel-, sydän- ja neurologisia oireita. Mutta mielipiteet eriävät diagnostiikan ja hoidon osalta.

Suurin kiista vallitsee siitä, voiko Lymen tauti kroonistua alkuhoidon jälkeen. IDSA:n mielestä ei voi, kun taas ILADS on sitä mieltä, että spirokeetta saattaa lymytä elimistössä diagnostiikan ulottumissa ja joskus selvitä asianmukaisesta alkuhoidosta.

Loppu onkin sitten suurta draamaa: molemmat osapuolet kampanjoivat omilla tutkimuksillaan, lehdistötiedotteillaan, kirjeillä, poliitikkoihin vaikuttamisella, oikeudenkäynneillä ja nettisivuilla. Syytteitä on nostettu hoitavia lääkäreitä vastaan, toimivatpa he kumman hyvänsä ohjeen mukaisesti.

Lääkäritkin ovat joutuneet valitsemaan puolensa. Valtaosa noudattaa IDSA:n ohjeita, mutta vähemmistöön jäävä vastapuoli on nimennyt itsensä LLMD:ksi (Lyme-Literate Medical Doctors). Ja Yhdysvalloissa kun ollaan, vakuutusyhtiöt ovat evänneet korvauksia IDSA:n suosituksen vastaisesti hoidetuilta potilailta. Jotkin osavaltiot ovat puuttuneet tähän käytäntöön omalla lainsäädännöllään. (Ronn S South Med J 2009 May 7)



http://www.duodecimlehti.fi/web/guest/a ... usinnumero

[soijuv]

Artikkelin mukaan :"ne IDSA:n jäsenet jotka laativat Borrelioosin hoitoa käsittelevät hoitosuositukset sekä esittivät kantansa kroonisesta Borrelioosista, olivat taloudellisissa kytköksissä lääke- ja testiteollisuuteen ja niiden patentteihin ja/tai vakuutusyhtiöihin. Näiden kaikkien intresseissä on kieltää krooninen Borrelioosi."


Am J Law Med. 2012;38(1):196-224.

Cure unwanted? Exploring the chronic Lyme disease controversy and why
conflicts of interest in practice guidelines may be guiding us down the
wrong path.

Ferguson J.

Source

Boston University School of Law, USA.

PMID:
22497097
[PubMed - in process]


American journal of law & medicine

Volume 38, Number 1 ? 2012

p.196 Cure Unwanted? Exploring the Chronic Lyme Disease Controversy and Why Conflicts of Interest in Practice Guidelines May Be Guiding Us Down the Wrong Path Johanna Ferguson


"We can't treat conflicts of interest like some family secret no one talks about. We must become more comfortable asking and answering pertinent questions about the sources and substance of industry funding that might influence individuals, institutions, and organizations." (1)

I. INTRODUCTION

In 2006, the Infectious Diseases Society of America (IDSA) published practice guidelines for the assessment, treatment, and prevention of Lyme disease. (2) The guidelines purported to refute the existence of "chronic Lyme disease," (3) a condition that some believe results from persistent Lyme infection even after standard courses of antibiotic treatment. (4) The guidelines, which garnered national attention, (5) were in turn used by physicians and insurers alike as a justification for refusing treatment for chronic Lyme disease. (6) Two years after the IDSA published its guidelines, Richard Blumenthal, the Connecticut Attorney General, ordered an investigation into potential conflicts of interest on the part of the panelists who developed the IDSA's Lyme disease practice guidelines. (7) The findings of the investigation were deeply troubling.

Patients and physicians were startled to learn of the pervasive conflicts of interest that came to play in the promulgation of the IDSA guidelines regarding chronic Lyme disease. As Pamela Weintraub noted in her book, Cure Unknown, the very people who wrote the IDSA guidelines were those who stood to profit from them. (8) The authors of the guidelines not only had significant connections to drug companies, related patents, and Lyme diagnostic tests, several were also being paid by insurance companies to corroborate treatment plans that denied treatment for chronic Lyme disease. (9) With so many players from the IDSA standing to gain from the group's narrow definition of Lyme disease, it might not have been the case that a potential cure for chronic Lyme disease was unknown--it may have been unwanted.

Practice guidelines, such as those developed by the IDSA, are omnipresent in the healthcare industry. Developed by both public and private sector groups, guidelines are used to achieve many goals, such as standardization of practice, reduction of malpractice claims, and cost savings. (10) These guidelines are often created by panels of experts and can have significant effects on healthcare, particularly when used by insurance companies. (11) While practice guidelines can provide benefits to the medical community, the process of developing guidelines can be riddled with problems that detract from the guidelines' potential value. Conflict of interest issues, in particular, have come to the forefront of discussions about practice guidelines.

The healthcare industry comprises many overlapping parts: physicians, research institutions, drug companies, and medical device manufacturers are just a few of the industry's main players. Because of the pervasive connections that exist between all these actors, it can be difficult to achieve independent and unbiased opinions on medical issues. Often, practice guidelines reflect the industry's interwoven relationships rather than the best available medical knowledge. This is an especially problematic reality in the healthcare industry where information asymmetries rule the day. (12) Healthcare is structured around agency relationships, particularly the relationship that exists between healthcare providers and patients. (13) Healthcare providers have highly specialized knowledge that most patients lack. As a result, most patients are ill-equipped to navigate their way through the healthcare system. (14) As a result of this lack of patient knowledge, healthcare providers have most of the control over patients' decisions. (15) While patients may want to believe that healthcare providers always have their best interests at heart, conflicts of interest can make this an unrealistic expectation. Because practice guidelines often take on the force of law and increasingly represent biased and undisclosed relationships in the medical community, rules against conflicts of interest should be put in place to protect healthcare consumers.

Part II of this Note provides an introduction to the chronic Lyme disease controversy. Part III provides general information on practice guidelines. Part IV examines conflicts of interest in practice guidelines generally as well as the conflicts of interest that came to light under the Connecticut Attorney General's investigation into the IDSA's Lyme disease guidelines. Part V examines recent developments in the legal framework in place for managing conflicts of interest in practice guidelines. Finally, Part VI concludes that further reform is needed in order to prevent conflicts of interest from adversely affecting the use of practice guidelines.

II. LYME DISEASE: DISCOVERY AND EARLY DAYS

Transmitted to humans by the bite of an infected blacklegged tick, (16) Lyme disease is one of the fastest growing infectious diseases in the United States. (17) Once infected, patients typically experience a wide range of symptoms, including fever, headache, fatigue, and skin rash. (18) In the event that the infection goes untreated, the disease may spread to the joints, heart, and the nervous system. (19) Certain groups in the healthcare industry, including the Centers for Disease Control (CDC) and the IDSA, believe that Lyme disease can always be effectively treated and eradicated with fourteen to twenty-eight days of antibiotics. (20)

However, other groups believe that this short treatment can be inadequate if the infection is not caught early. These groups believe that if left untreated, Lyme disease can develop into "chronic Lyme disease"--a persistent infection that can cause near-crippling exhaustion, nerve pain, memory loss, confusion, and dementia. (21) In such circumstances, treatment for fourteen to twenty-eight days, as recommended by the IDSA, is simply not long enough to eradicate the disease. (22) Rather, chronic Lyme supporters insist that the infection can require much longer treatment. (23) For their part, the IDSA and the CDC believe that chronic Lyme disease does not exist. These groups contend that any symptoms that remain after treatment are simply remnants of a treated infection that will eventually disperse. (24) Disagreement over chronic Lyme disease and whether it exists has been fierce and contentious.

The battle over chronic Lyme disease had been raging for more than thirty years when the IDSA released its guidelines for treatment in 2006. The origins of the disagreement and, more importantly, the conflicts of interest that are so prevalent in the Lyme community can be traced back to the initial description and definition of the disease in the Northeastern United States by Yale University-affiliated rheumatologist, Allen Steere. (25) In the early 1970s, the Connecticut Department of Health became concerned about the prevalence of what appeared to be junior rheumatoid arthritis (JRA) in a number of young adults living in the same town in Connecticut. (26) JRA, a disease of which clinical prevalence is one to ten per 100,000 people, had been identified in thirty-seven patients, several of whom lived on the same street. (27) At the behest of Connecticut residents and physicians, the Connecticut Department of Health encouraged Steere to look into the matter and identify the problem. (28)

Steere first identified what later became known as Lyme disease in 1977. (29) Although earlier European research had documented a disease with similar characteristics, Steere believed that Lyme disease was the result of a viral infection, unlike its alleged European counterpart, which was bacterial. His reasons for this conclusion were twofold. Steere's own studies had failed to show that all symptoms were eradicated after a very short course of antibiotics, which would have been standard treatment for a bacterial infection. Additionally, due to the fact that several of Lyme's symptoms were not identified in the earlier European research, Steere believed that he was dealing with a different infection entirely. (30) Because Steere believed that the disease was not bacterial, he declined to treat patients with antibiotics and instead offered aspirin and steroids to treat his patients' symptoms. (31) Steere eventually characterized Lyme as an infection that targeted the joints and could result in neurological or cardiac abnormalities. (32)

Steere's hypothesis of Lyme as a viral infection was finally proved false in the 1980s when Willy Burgdorfer discovered the bacteria Borrelia burgdorferi (later named in his honor) responsible for causing Lyme disease. (33) The discovery, of course, meant that Steere's refusal to treat patients with antibiotics no longer made sense. (34) In 1983, Steere released new data in the July issue of the Annals of Internal Medicine recommending a short ten-day course of antibiotic treatment to eradicate any infection. (35)

Upon close examination, Steere's guidelines appeared questionable. Steere had conducted studies in which he had treated patients with one of three antibiotics for ten days to see which antibiotic provided the best curative results. (36) Yet, the data in Steere's study showed that the number of Steere's patients who remained "sick" after a course of antibiotic treatment remained largely consistent with the numbers Steere had seen in previous studies before he had begun treatment with antibiotics. (37) The new results were attributable to a change in methodology; in the fine print of Steere's study, he noted that he had changed the definition of being "cured" of Lyme disease. (38) Instead of encompassing symptoms that were affecting Lyme patients in increasing numbers, the new treatment guidelines limited the symptoms of Lyme disease to joint infections and headaches. Everything else, Steere suggested, was simply an autoimmune reaction to the infection, or, more likely, had nothing to do with Lyme at all. (39) Perhaps unsurprisingly, Steere's research for this new study was funded in part by the Arthritis Foundation, (40) an unlikely organization to fund a study related to bacterial infection.

As Steere developed his own disease pathology for Lyme, physicians across the United States began to see more and more patients suffering from something that looked vaguely like Steere's Lyme disease. However, this new variation of Lyme that physicians saw springing up in their offices differed significantly from Steere's findings. (41) These patients did not fit the narrow definition of a viral infection that targeted the joints, consistent with Steere's findings. Rather these patients appeared to suffer from a multisystemic infection that caused debilitating results. (42) Suffering from symptoms ranging from long-lasting headaches and fatigue to blindness and deafness, these patients were sick and getting sicker, even after they had received Steere's standard ten-day treatment. (43)

Convinced partially by European research that indicated treatment success with antibiotics and otherwise by the responses they saw in their patients, doctors who refused to accept Steere's disease pathology witnessed dramatic results in their patients after extended use of antibiotic treatment. (44) These doctors began to develop their own ideas about the late stages of undiagnosed Lyme disease. (45) The stage was set for a showdown between Steere and those who believed in the existence of chronic Lyme disease.

III. PRACTICE GUIDELINES GENERALLY

Perhaps because of his emblematic role as the scientist who discovered Lyme disease, or perhaps due to his affiliation with Yale, Steere's guidelines were widely accepted. For others, the process of guideline promulgation is not always such a smooth road.

Recommendations for treatment, such as the duration of antibiotic intake, are just one type of practice guideline. Many individuals, groups, and government committees make practice guidelines on an extremely wide range of topics. (46) For this reason, guidelines are widespread in the healthcare industry. Their reach is so great that they affect almost all aspects of healthcare, including marketing of medical services, insurance reimbursements, and treatment practices. (47)

The Institute of Medicine defines practice guidelines as "systemically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances." (48) In particular, guidelines disseminate information from textbooks and peer-review journals (49) by providing standardized methods for physicians and other healthcare providers for use in treating patients. (50) By creating standards for treatment of different clinical conditions, doctors are able to streamline diagnosis and treatment while simultaneously guaranteeing that patients receive the best possible care according to recognized industry norms. (51)

Practice guidelines ideally reflect information that is based on the most current scientific research available. (52) Ensuring that this is the case often requires several rounds of revision and editing of the guidelines by those responsible for them. (53) This process ensures that outside parties will view the practice guidelines as coming from a legitimate source and as likely to achieve desirable outcomes in the treatment of patients. (54) If guidelines are not perceived as unbiased and useful, it is unlikely that they will be followed. (55) In this vein, Kathleen Lohr, an expert in clinical practice guidelines, (56) determined four important attributes of successful practice guidelines: reliability and reproducibility, scientific validity, clinical applicability, and clinical flexibility. (57) Others have stressed that the incentives involved in the development of guidelines matter as a measure of their usefulness. (58) "Routine maintenance" of guidelines, such as scheduled and documented review of existing guidelines, can help to assure outsiders that particular guidelines continue to be relevant and reflective of current scientific information. (59)

Practicing physicians or medical experts typically develop guidelines. (60) Most guidelines are promulgated by panels from a host of public and private sector actors, ranging from the Institute of Medicine and the National Institutes of Health (NIH) to the Harvard Community Health Plan and the RAND Corporation. (61) Guidelines are typically evidence-based, such as those developed by the Cochrane Collaboration, or consensus-based. (62) While many believe that practicing physicians are best suited to develop guidelines because they are "closer" to the practice of medicine in that they treat patients, (63) medical experts may provide insights to which physicians may not be privy. (64) Because the medical field is rapidly changing, physicians are often unable to keep abreast of changes in treatment plans. (65) Therefore, panels comprising both experts and physicians may produce guidelines that most realistically reflect current medical knowledge. (66) Additionally, while conventional wisdom has left patients out of this equation, they may be a useful tool and a source of important information in the promulgation of guidelines. (67) Inasmuch as practice guidelines restrict care to certain practices, patients may find that their values are no longer reflected when a guideline prohibits use of treatment that they find effective. (68)

Through the use of practice guidelines, healthcare providers and insurers seek to achieve several goals. While some guidelines are made for purely quality control reasons or financial gain, others seek to address problems plaguing the healthcare industry, such as high costs, varying quality of services, and the continual stream of malpractice litigation faced by healthcare providers. (69) Because so many different entities promulgate practice guidelines, some guidelines are more successful than others in achieving these goals. (70)

The issue of rising costs is particularly troublesome for the healthcare industry. In 2008 alone, the United States spent $2.3 trillion on healthcare. (71) These costs continue to grow each year. (72) Practice ?

[soijuv]

USA:ssa useat vakuutusyhtiöt kieltäytyvät maksamasta pidempiä antibioottihoitoja. Nyt asetettu komitea alkaa tutkia hoidon esteitä. Komitean mukaan: "Mitä enemmän olemme tutkineet asiaa, sitä enemmän näyttää siltä että siihen täytyy puuttua lakiteitse."

http://www.capecodonline.com/apps/pbcs. ... /206250313

Lyme disease treatment faces scrutiny
By Cynthia Mccormick
cmccormick@capecodonline.com
June 25, 2012

The state Lyme disease commission is exploring obstacles that sufferers face to obtaining insurance coverage for recommended treatments, according to a spokesman for one participant.

Many constituents complain that insurance companies routinely deny antibiotic care, especially long-term care, said Seth Rolbein, senior adviser to state Sen. Dan Wolf, D-Harwich. Wolf serves on a subcommittee that is looking into whether legislation is needed to force insurers to accept physician diagnoses and treatment plans for tick-borne diseases, Rolbein said.

"The more we dive into it the more we realize there needs to be a legislative remedy," he said.

He said Wolf's subcommittee is preparing a draft of recommendations in time for the Massachusetts Lyme Commission's next meeting in mid-July.

The commission was established last year by the state Legislature to explore the reasons behind the under-diagnosis and reported under-treatment of people with Lyme disease.

The driving force behind the creation of the commission was state Rep. David Linsky, D-Natick, whose son had Lyme disease.

Wolf was co-sponsor, Rolbein said.

The 21-member commission's Cape representation also includes Brenda Boleyn, a biologist and retired Cape Cod Community College professor, and Dr. Sam T. Donta, a Boston University infectious disease expert who has an office in Falmouth.

The commission is scheduled to make a full report to the Legislature by April 1.

It is charged with looking into the cost of screening for Lyme, including among schoolchildren, developing educational materials and educating the medical community about acute and chronic cases of Lyme.

The Cape and Islands were ground zero for the Lyme disease epidemic in Massachusetts, but the disease, transmitted by deer ticks, has spread all across the state.

[soijuv]

Yksi Borrelioosihoitosuositusten laatijoista oli tri Linda Bockenstedt. Hän teki jokin aika sitten tutkimuksen jossa totesi antibioottihoidon jälkeen löydettyjen borrelia-bakteerien olleen kuolleita (hiirikoe) eikä siten enää kykeneviä aiheuttamaan oireita - eikä siis kroonisia oireita. Tri MacDonald pyysi Bockenstedtiä lähettämään bakteerinäytteet hänelle jotta hän voisi tutkijaryhmineen tutkia kyseisiä "kuolleita bakteereita". Bockectedt kieltäytyi lähettämästä näytteitä tutkijoille rikkoen näin vakavasti normaaleja tutkijakäytänteitä. Tri MacDonald epäilee Bockenstedtin näytteissä olevien bakteerien olevan osin elossa ja/tai osa borrelia-bakteerien muodostamasta biofilmiyhdyskunnasta. MacDonald kirjoitti Bockenstedtille henkilökohtaisesti ja pyysi tätä tekemään näytteille tietyn yksinkertaisen, halvan värjäystestin jolla pystytään erottelemaan elävät ja kuolleet bakteerit. Bockenstedt kieltäytyi tekemästä testiä eikä antanut MacDonaldinkaan tehdä testiä näytteistä. Hän ei halua muiden tutkijoiden varmentavan ovatko bakteerit elossa vai kuolleita.

Tri MacDonald kirjoitti asiasta artikkelin kliinisiä tutkimuksia käsittelevään julkaisuun (Journal of Clinical Investigation). Artikkeli löytyy sivun loppupuolelta.

http://flash.lymenet.org/scripts/ultima ... 121833;p=0

Lyme borrelia biofilms expert Dr. Alan Macdonald writes to the Journal of Clinical Investigation to protest as...

IDSA Guidelines Author Bockenstedt Contravenes Regulations to Evade Verification of her Findings


by Elena Cook
Background

Dr Linda Bockenstedt is a Yale-based author of the deeply-flawed Lyme Disease guidelines issued by IDSA in 2006. Recently, she published a study purporting to show that signs of persisting Borrelia burgdorferi in antibiotic-treated mice (and, by implication, in humans with chronic Lyme Disease), were nothing more than the remnants of dead bacteria (1). She did not explain why this "debris" should, exceptionally, resist all normal immune mechanisms for clearing dead microbe remnants in a mammalian host.

Images accompanying her publication attracted the attention of Dr Alan B. Macdonald, who is currently researching Biofilms of Borrelia along with Dr Eva Sapi and her team at University of New Haven, Connecticut. This collaboration recently resulted in the first-ever study demonstrating Biofilm formation by Borrelia burgdorferi in vitro. (2).

Biofilms are highly organised structures produced by microbes on both living and non-living surfaces. One of their main functions is protective; they are notorious for shielding bacteria from harmful environmental influences, including the presence of antibiotics.

Dr. Macdonald believes that the bacteria, clearly seen glowing green in Dr. Bockenstedt's images (due to Green Fluorescent Protein DNA recombinantly inserted into the Lyme bacteria's infectivity plasmid Cp26) represents a mixture of live and possibly dead Borrelia biofilm community members in the mouse tissue, as opposed to all completely dead, as she alleges.The term "amorphous globs" used by Dr. Bockenstedt to describe the fluorescent material is unscientific. It has never appeared in any published article in any language describing Borreliosis in any living host.

In her article, Bockenstedt uses arrows to indicate her "amorphous globs" as constituents of "fields or carpets" of Borrelia in the tissues of the mouse, whilst ignoring the fact that spherical (atypical) forms of Borrelia can clearly be seen within!

It is well known that the matrix (non-living structural material of the living biofilm community) is derived from microbes - once living but now dead - which contribute their outer surface glycoprotein "slime layer" and their DNA, (extracellular DNA), possibly also incorporating other microbes within the extracellular matrix. (See image gallery in paper by Sapi et al, referenced below.)

The Borrelia in a biofilm consist of organisms which vary in shape and structure, reflecting the specialisation that takes place within the structure. Spherical forms, such as those visible in the photo published by Bockenstedt, have been shown to be an integral part of a Borrelia biofilm community. Yet Bockenstedt labels this material "amorphous" (ie without shape). That is not what we see when we look carefully at the image material she herself has published (see image included with Dr. Macdonald's letter below).

Because her images so strikingly reproduce the known features of a Borrelia biofilm, Dr. Macdonald wrote to her privately, requesting that she carry out a very simple, dye-based test on the material. The test is inexpensive and easily distinguishes between dead and live micro-organisms. She refused.

Dr. Macdonald then asked her to share some of the mouse tissue from her experiment so that he could perform this test in his own lab.
Once again, Dr. Bockenstedt refused - in flagrant denial of US public health agency regulations, which require taxpayer-funded scientists to make their material available to other researchers for independent verification.

Dr. Bockenstedt's study was funded by the National Institutes for Health (NIH) and the Centre for Disease Control (CDC), but also by the non-profit National Research Fund for Tick-Borne Diseases. Her refusal to share tissue or to perform the simple dye test calls into question her integrity as a scientist.

If Dr. Bockenstedt has nothing to hide,why will she not allow anyone to determine if her "dead" persisting Borrelia are truly "dead"?

Is she afraid that her study will negate the validity of her own recommendations, made in conjunction with the other IDSA Lyme committee members, denying the reality of chronic Lyme Disease? Is she worried that what her own published material shows is actually a biofilm of Borrelia (which now has a precedent in the peer- reviewed literature) and that she may now be obliged to issue a retraction of her manuscript, with its accompanying press releases releases to the national and international media?

Below is the e-letter submitted to the Journal of Clinical Investigation by Dr. Alan Macdonald.

(1)Bockenstedt L. et al Spirochete antigens persist near cartilage after murine Lyme borreliosis therapy DOI 10.1172/JCI 58813
(2)Sapi E. et al. (2012) Characterization of Biofilm Formation by Borrelia burgdorferi In Vitro. PLoS ONE 7(10): e48277. doi:10.1371/journal.pone.0048277
http://www.plosone.org/article/info%3Ad ... ne.0048277

Letter Submitted to Journal of Clinical Invesigations by Dr. Alan B. Macdonald
Oct 2012


Title: Biofilms as a differential diagnosis for "Amorphous Globs of Dr Linda Bockenstedt"
Letter:


Dear Dr Bockenstedt,

I remark with great interest your inclusion of the brief discussion of Biofilms of Borrelia burgdorferi in your Discussion section, in connection with possible etiologies for the GFP-emitting "amorphous blobs" of Borrelia burgdorferi in deep dermal sites closely apposed to the articular cartilage of the murine arthritic Lyme arthritis mice.

Our paper [6] describing for the very first time the entity of in vitro Biofilms of Borrelia burgdorferi, and accepted for publication release on the PLOS ONE website during the week Of October 24, 2012, is the first peer reviewed manuscript on Biofilm formation by borrelia of any species. It is indeed fortuitous that we, and you were working with borrelia burgdorferi.

We and you were curious to understand the implications of possible in vivo Borrelia biofilm formation. At the level of verbal definition to fulfill the requisite (Costerton)[Ref 5] definitions for a biofilm community are the following:

1. Specialization of member microbes within the community which set these specialized forms apart from Planktonic forms of the establishing microbe.

2. Investment of the microbial members of the biofilm community by a self generated Extracellular matrix, usually including structural constituents from once living but now dead members of the biofilm community. The presence of free Extracellular DNA derived from once living now dead members of the biofilm community.

3. The existence of microbe density which exceeds the density of Planktonic microbes on an ordinary bacteriologic solid phase medium.

4. The existence of "plumbing networks" (i.e. water channels and channels for waste product elimination) in the biofilm community. (Ref 4)

5. The Resistance to antibiotic killing among specialized members of the biofilm community. (Ref4)

Now which of items 1-5 above are or might be "in play" in your so called "Amorphous Blobs" of GFP-labeled Borrelia burgdorferi in the Lyme arthritic mice?

1. Specialization:

Morphology of the microbes within the so-called "amorphous globs" differs significantly from the corkscrew-shaped forms (Planktonic forms-motile forms) (Ref 4) of Borrelia burgdorferi, which are nicely demonstrated in your supplementary Videos and in Figures 1-5 (Especially in your figures 5A and 5B). You clearly demonstrate "Round bodies" among the members of the Amorphous blobs.

Round form metamorphosis from pre-existing spiral forms of Borrelia burgdorferi has been elegantly demonstrated in the long list of peer reviewed publications by Drs Oystein Brorson and his cousin Dr. Sverre Henning Brorson (Ref 7) using electron Microscopy and Phase contrast microscopy. Round bodies were embraced by the late Dr. Lynn Margulis.(Ref 8)

You specifically took the time and effort to demonstrate the formation of borrelia Round bodies in your attached supplementary videos in still photographs in Figure 5 (5A and 5B) in your manuscript.Non-spiral borrelia - i.e.round body borrelia are indeed legitimate shape shifted forms of the Borrelia genus, and represent a specialization by the well known spiral MOTILE form of Borreliae (Planktonic from of Borrelia).

Round bodies, granular forms, Cell wall deficient forms, and finally spiral or straightened forms of Borrelia are specialized forms of the Planktonic (spiral form). Thanks to the works of Dr Alban and colleagues (Ref 1) at the University of Rhode Island, these vital round body borreliae demonstrate a diverse protein repertoire which differ from spiral forms in their protein "fingerprint" in two-dimensional SDS PAGE gel electrophoresis.(Ref 1)

2. The overall density of borrelia microbes in your "Amorphous blobs" in the murine deep dermis,exceeds by several orders of magnitude, the density of Planktonic (spiral/motile) forms of Borrelia burgdorferi when these are grown on solid media in the Microbiology laboratory ( Preac-Mursic, V. et al)(Ref 9)

3. The assertion that All of the borrelia microbes in the "Amorphous Blobs in murine deep dermis in laboratory induced Chronic Lyme Arthritis" are ALL DEAD and merely represent "debris"....is just that: an assertion, buttressed by what you say are corroborative mRNA supportive data...( not presented in your paper).

I have suggested to you in a personal private communication that the way to establish Live versus Dead borrelia in your "Amorphous Blobs" is to pour some Dye ( Invitrogen ::Live Dead Assay) (Ref 10)(Red=dead, and Green = alive).
You have steadfastly refused to accommodate this quality control procedure, which is fast, cheap, reliable and easily accomplished.

You have refused me tissue from your "amorphous Globs" dermal tissue from murine subjects, so that I might perform this simple quality control step in my own laboratory. Refusal to provide tissue to an outside scientist, is in violation of the guidelines of the NIH and other Federal funding agencies.

Your Research activities were accomplished with the use of public funds. You have an incumbent obligation to provide tissue to outside scientists upon request,to verify your experimental findings.


4. A review of all previously published manuscripts since the 1982 NEJM articles announcing the Spirochetal (Borrelial) etiology of Lyme Disease, performed by me and by pathology colleagues (Ref3) interested in the published peer-reviewed Borrelia pathology manuscripts , which specifically demonstrate with figure illustrations Borrelia burgdorferi in diseased tissues-- Such a comprehensive 30-year literature review by Board Certified Anatomic and Clinical Pathologists--reveals that there has NEVER been published a manuscript which contains images of Borrelia burgdorferi - either Living Borrelia or Dead Borrelia - which are present in mammalian tissue in the densities which were illustrated in your figures 5A and 5B. (Ref 3)

By Density criteria ALONE, these "Amorphous globs" are Biofilm communities in murine tissue, UNTIL PROVEN OTHERWISE.(Ref 4)

I therefore challenge you to voluntarily participate in Quality Control microscopic exercise -- to establish with the LIVE DEAD Invitrogen Kit that ALL of the Borrelia inside of your "Amorphous Blobs" stain Red(=Dead) and that none of the borrelia within your "Amorphous Globs" stains Green in the Invitrogen Live Dead assay.(Ref 10) If you are correct, there is nothing to lose in this quality control exercise.

Respectfully,
Alan B.MacDonald MD, FCAP, FASCP

References:

1. Microbiology. 2000 Jan: 146 ( Pt1):119-27. Serum-starvation-induced changes in protein synthesis and morphology of Borrelia burgdorferi. Alban PS, Johnson PW, Nelson DR. Source Department of Biochemistry, Microbiology, and Molecular Genetics, University of Rhode Island, Kingston R.I. 02881, USA
2.Burgdorfer, W,., Barbour, A.G., Hayes,S.F., Benach, J.L. et al, "Lyme Disease - A Tick borne
Spirochetosis" , Science, 1982:216: 1317-9
3. Duray, Paul Harrison, MD, Complete Bibliography, Pub Med.
4. Montana State University, Center for Biofilm Studies: http://www.biofilm.montana.edu
5. Costerton, William , J. , Complete bibliography ( 600 peer reviewed Biofilm manuscripts), Pub
Med.
6. Sapi, Eva, J, et al, PONE-D-12-11352R2 Characterization of biofilm formation by Borrelia
burgdorferi in vitro :PLOS ONE , 2012, In Press, To be released on the Internet PLOS ONE website in the week of October 24, 2012.
7. Brorson, Oystein and Brorson, Sverre Henning, Complete bibliography, PubMED
8. Brorson, O,... Margulis, Lynn, et al, "Destruction of spirochete Borrelia burgdorferi round-body propagules (RBs) by the antibiotic Tigecycline ", Oystein Brorson, Sverre-Henning Brorson, John Scythes, James MacAllister, Andrew Wiere, and Lynn Margulis
http://www.pnas.org/cgi/content/full/0908236106
9. Preac-Mursic V, Wilske B, Reinhardt S. Eur J Clin Microbiol. Infect Dis. 1991 Dec;10 (12):1076-9.
“Culture of Borrelia burgdorferi on six solid media.-, Source Max von Pettenkofer Institut, Ludwig-Maximillian-Universitat, Munich, Germany.
10. Invitrogen Inc-
http://www.invitrogen.com/site/us/en/ho ... wcytometry‐ protocol/cell‐viability/live‐dead‐fixable‐dead‐cell‐stain‐kits.html
11. Eisendle K, Grabner T, Zelger B.Focus floating microscopy: "Gold standard" for cutaneous borreliosis?, Am J Clin Pathol. 2007 Feb;127(2):213-22.

(Note: Use of boldface, extra spacing and other minor formatting changes mine -EC)

Above: Set of images included by Dr. Macdonald in his letter to Dr. Bockenstedt, sent to JCI, showing the striking resemblance between what she dismissed as shapeless globs and a known Borrelia biofilm. As some resolution may have been lost in transferring this image, interested readers can view the original published by Bockenstedt at http://www.jci.org/articles/view/58813/figure/5. There many round forms can clearly be distinguished in the so-called "glob" labelled "A". (All the green in her image is Borrelia, genetically altered to fluoresce for easy identification.)
Below: The same known Borrelia biofilm reproduced below showing more detail. The use of spectral imaging has clearly brought out the shapes of the Borrelia organisms in photo "A", which appear in red. A few spiral, very many round forms are distinguished from the extracellular matrix (here coloured green) which envelopes them.


IMAGES

A supplementary atlas of Biofilms of Borrelia and related information are available on Dr. Macdonald's two websites at the following URL's:

http://www.alzheimerborreliosis.net


http://www.molecularalzheimer.org

The articles by Elena Cook on this website may be distributed as long as they are reproduced without changes, attributing the author, and the link to the original URL is included.

Disclaimer: Material on this website is intended for informational purposes only. It is not intended as medical advice. For all questions relating to your own health, please consult a qualified medical professional.The site owner is not responsible for the content of external sites.

An attempt has been made to render this website accessible to people with a variety of disabilities. If you are having difficulty using this site, or have suggestions for improving the site's accessibility, please contact me.
Copyright © 2012-2013Elena Cook
http://www.elenacook.org/macdonaldjci2012.html

[soijuv]

By ELIZABETH MALONEY

Last update: April 22, 2010 -

The April 12 article about the resolution passed by the Minnesota Board of Medical Practice ("Activists and doctors divided over Lyme disease treatment") brought many questions to mind, including: "When did the Star Tribune morph into Fox News?" The article used buzzwords and themes known to inflame physicians, and it misled readers regarding the professional credentials and capabilities of physicians who recognize that persistent/chronic Lyme exists.

I am a family physician who has spent the last several years researching and developing educational materials and programs on Lyme disease; my current course for primary care physicians is accredited for six continuing medical education credits by the American Academy of Family Physicians.

Lyme disease is a relatively new illness. Our scientific understanding of it continues to evolve, yet basic questions remain unanswered. For example, we lack reliable diagnostic tests and tests of cures. Until we can separate the infected from the noninfected and the cured from the uncured, arguments over diagnostic and treatment approaches will continue.

This is especially true when it comes to the medical management of patients who remain ill after receiving commonly prescribed courses of antibiotics. Persistent infection has been demonstrated in multiple animal models and human case reports, and two schools of thought have developed.

The Infectious Diseases Society of America (IDSA) takes a narrow view, offering limited treatment options. The International Lyme and Associated Diseases Society takes a broad view, believing that doctors can best determine who should be treated and in what manner.


http://www.startribune.com/opinion/comm ... _Yyc:aUUsZ

[soijuv]

"ILADS:in jäsenet esittivät yli 1000 tutkimusta joissa todettiin borrelioosin kroonistuvan. IDSA ei välitä kyseisistä tutkimuksista."


http://www.newstimes.com/news/article/N ... 459159.php


National Panel Concludes Lyme Disease Doesn't Exist

by Robert Miller, Staff Writer

The national medical association that sets guidelines for treatment of infectious diseases Thursday unanimously confirmed the policy it established in 2006 -- that the condition known as chronic Lyme disease doesn't exist.

"The Review Panel finds that the 2006 Lyme Guidelines were based on the highest-quality medical/scientific evidence available at the time and are supported by evidence that has been published in more recent years,'' the Infectious Disease Society of American concluded in a report issued Thursday.

"In addition to the review by this Panel, the recommendations in the 2006 Lyme Guidelines are further corroborated by guidelines and statements by other independent bodies in the United States and Europe," the report stated.

Dr. Steven Phillips of Wilton, who has been a strong proponent of the existence of chronic Lyme disease as a condition that should be treated by a long-term course of antibiotics, pointed out Thursday that the IDSA chose the members on the review panel -- analogous, he said, to the accused in a trial getting to pick all the members of a jury.

"I shouldn't be surprised but I still am,'' he said.

Phillips said that in the hearings that led up to Thursday's report, physicians who are members of a second group -- the International Lyme and Associated Diseases -- presented more that 400 pages of testimony, citing more than 1,000 reports in scientific journals, all pointing to chronic Lyme infection.

Phillips said he's never seen a scientific panel reach a unanimous finding, which, he said, raises the question of whether the panel was interested in science, or "simply the rubber-stamping on an intransigent ideology.''

The IDSA represents the majority of physicians in the United States who treat infectious disease and its policies are influential. The national Centers for Disease Control and Prevention carry the association's guidelines for Lyme treatment on its website.

Those guidelines, published in 2006, call for a three-week course of antibiotics for most early cases of Lyme disease and a four-week course for people suffering from arthritis caused by Lyme infection.

But the guidelines conclude that "to date, there is no convincing biologic evidence for the existence'' of chronic Lyme infection after three to four weeks of antibiotics.

And, it said, "antibiotic therapy has not proven to be useful and is not recommended for patients with chronic subjective symptoms after recommended treatment regimens for Lyme disease.''

These guidelines were immediately criticized by doctors and patients who believe chronic Lyme infection exists and that long-term antibiotic treatment can treat it successfully.

They were joined in their fight by Attorney General Richard Blumenthal, who claimed that the doctors who wrote those 2006 guidelines had conflicts of interest because they served as consultants to insurance companies.

In a 2008 settlement with Blumenthal, the IDSA agreed to hold a complete review of those guidelines, which took place in July 2009. Both proponents of the IDSA guidelines and the doctors and patients who opposed them got to submit testimony.

On Thursday, the IDSA unanimously endorsed the 2006 findings, saying that opposing testimony involved scientific study that was "uncontrolled and highly subject to selection and reporting biases.''

Blumenthal said Thursday his office was reviewing the IDSA findings.

Contact Robert Miller

at bmiller@newstimes.com

or 203-731-3345.

[soijuv]

Johnson and Stricker
Philosophy, Ethics, and Humanities in Medicine 2010 5:9
2010,

Article by Ray Stricker and Lorraine Johnson on IDSA Guidelines

http://www.peh-med.com/content/pdf/1747-5341-5-9.pdf

http://www.peh-med.com/content/5/1/9

Open Access RESEARCH
© 2010 Johnson and Stricker; licensee BioMed Central Ltd. This is
an Open Access article distributed under the terms of the Creative

Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Research
The Infectious Diseases Society of America Lyme
guidelines: a cautionary tale about the
development of clinical practice guidelines
Lorraine Johnson
1,2
and Raphael B Stricker*
1,2
Abstract
Flawed clinical practice guid
elines may compromise patient care. Commercial
conflicts of interest on panels that write
treatment guidelines are particularly problematic, becaus
e panelists may have conflict
ing agendas that influence
guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels.
However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into
the development of Lyme disease treatment guidelines by one
of the largest medical societies in the United States, the
Infectious Diseases Society of America (IDSA). Although the
investigation found significant
flaws in the IDSA guidelines
development process, the subsequent review of the guidel
ines mandated by the settlement was compromised by a
lack of impartiality at various stages of the IDSA review
process. This article will ex
amine the interplay between the
recent calls for guidelines reform, the
ethical canons of medicine, and due proc
ess considerations under antitrust laws
as they apply to the formulation of the IDSA Lyme disease tr
eatment guidelines. The article wi
ll also discuss pitfalls in
the implementation of the IDSA antitrust settlement that should be avoided in the future.

[soijuv]

Allolevan artikkelin mukaan IDSA:n jäsenet myönsivät kroonnisen borrelioosin olevan todellisuutta v 2000 ja 2006 muutamissa artikkeli ja patenttihakemuksissa.

IDSA tietää, että krooninen Lyme on olemassa


http://sci.tech-archive.net/Archive/sci ... 00078.html

IDSA on tietoinen kroonisesta Lymestä. Tiedämme tämän, koska
vuosien 2000 ja 2006 Lyme - taudin ohjepaneelien jäsenet kirjoittivat
tutkimusartikkeleista ja patenteista, että krooninen Lyme on olemassa.

Todisteet kroonisesta Lyme-borrelioosista ovat lisääntyneet
vuoden 2006 LD-ohjeiden julkaisemisen jälkeen.

Kalifornian tutkijat ilmoittivat äskettäin, että Bb ei voi vain pysyä
hiirissä keftriaksonihoidosta huolimatta, mutta Borrelia voi myös
tartuttaa muita punkkeja ja hiiriä. (1) Tämä tutkimus tukee edellistä
tutkimukset, jotka osoittivat, että Borrelia voi jatkua hiirillä (2, 3), koirilla (4,
5, 6) ja ponit (7).

Tutkimukset ovat myös osoittaneet, että Bb voi jatkua antibiooteista huolimatta ihmisen soluissa, kudoksissa, elimissä ja kehon nesteissä:

* Fibroblastit (8; Mark Klempner, IDSA LD: n ohjepaneelin jäsen vuonna
2006, on tämän tutkimuksen kirjoittaja)

* Iiris (9)

* Synovium ja nivelneste (10, 11, 12, 13)

* Nivelsiteet (14)

* Perna (15)

* Virtsarakko / virtsa (16)

* Iho (17, 18, 19, 20)

* Veri ja aivo-selkäydinneste (21)

Allen Steere on myös julkaissut tutkimuksia, joissa kuvataan potilaita, joilla on
jatkuva Bb-infektio antibioottihoidon jälkeen.
Artikkelissa hän kuvasi 67-vuotiasta naista, jolla oli serologiset testit
todisti, että hänellä oli äskettäin alkanut Borrelia burgdorferi-infektio, aine, joka aiheuttaa Lymen taudin. Kahden kuukauden
sairauden aikana hänen tilansa pysyi vaikeana, hoitona
antibiootit, salisylaatit ja steroidit. Viime kädessä kehittyi kohtalokas hengitysvaikeusoireyhtymä; tämän uskottiin olevan
toissijainen Lyme-tautiin.? (22)

Toisessa tutkimuksessa Steere havaitsi, että 10 potilasta 38:sta eli 26,3%
uusiutui vuoden kuluessa Lyme-taudin antibioottihoidon jälkeen.
Potilas 12 kuoli ja hänen aivoissaan oli spirokeettoja ruumiinavauksen yhteydessä. (23, 24)

Muut tiivistelmät ja tutkimukset kuvaavat myös Borrelian pysyvyyttä
burgdorferi potilailla, joita hoidetaan antibiooteilla (25, 26, 27, 28,
esimerkki).

Steere ja Klempner eivät ole ainoat IDSA: n ohjeiden tekijät, jotka tietävät
että Bb voi jatkua antibioottihoidosta huolimatta. Raymond Dattwyler,
sekä ennen IDSA:n LD-suuntaviivoja että niiden jälkeen myönnetyissä patenteissa
julkaistiin vuonna 2006, kirjoitti, että Lymen tauti voi esiintyä kroonisessa muodossa
antibioottihoidon jälkeen.

Helmikuussa 2007 Yhdysvallat myönsi tohtori Dattwylerille patentin
, johon hän kirjoitti seuraavat:

Tällä hetkellä Lymen tautia hoidetaan useilla antibiooteilla, esim.
tetrasykliinit, penisilliini ja kefalosporiinit. Kuitenkin tällainen hoito
ei aina onnistu puhdistamaan infektiota. Hoito on usein
viivästynyt väärän diagnoosin takia ja
infektio etenee krooniseen tilaan, jossa
antibiootit eivät ole usein hyödyllisiä. Yksi tekijöistä, jotka vaikuttavat
viivästyneeseen hoitoon on tehokkaiden diagnostisten välineiden puute ? (29)

Dattwylerin lausunnot ovat ristiriidassa IDSA: n kroonisen kannan kanssa
Lymen tautia ei ole olemassa antibioottihoidon jälkeen, ja että nykyiset
testit ovat tehokkaita Lymen taudin diagnosoinnissa.



IDSA knows that chronic Lyme exists


http://sci.tech-archive.net/Archive/sci ... 00078.html

IDSA knows that chronic Lyme exists

The IDSA is aware that chronic Lyme exists. We know this because
members of the 2000 and 2006 Lyme disease guideline panels wrote, in
research articles and patents, that chronic Lyme exists.

Evidence about the existence of chronic Lyme borreliosis has increased
since the 2006 LD guidelines were published.

Scientists in California recently reported that not only can Bb persist
in mice despite treatment with ceftriaxone, but the Borrelia can also
infect other ticks and mice. (1) This study buttresses previous
studies that showed that Borrelia can persist in mice (2, 3), dogs (4,
5, 6), and ponies (7).

Studies have also shown that Bb can persist despite antibiotic
treatment in the following human cells, tissues, organs, and body
fluids:

* Fibroblasts (8; Mark Klempner, an IDSA LD guideline panel member in
2006, is an author of this study)

* Iris (9)

* Synovium and synovial fluid (10, 11, 12, 13)

* Ligaments (14)

* Spleen (15)

* Bladder/urine (16)

* Skin (17, 18, 19, 20)

* Blood and cerebrospinal fluid (21)

Allen Steere has also published studies that describe patients with
persistent Bb infection following antibiotic treatment. In a JAMA
article, he described a 67-year-old woman who had serologic tests that
?proved that she had an infection of recent onset with Borrelia
burgdorferi, the agent that causes Lyme disease. During a two-month
course of illness, her condition remained refractory to treatment with
antibiotics, salicylates, and steroids. Ultimately, fatal adult
respiratory distress syndrome developed; this was believed to be
secondary to Lyme disease.? (22)

In another study, Steere found that 10 out of 38 patients, or 26.3%,
relapsed within 1 year after antibiotic treatments for Lyme disease.
Patient 12 died and had spirochetes in her brain at autopsy. (23, 24)

Other abstracts and studies also describe the persistence of Borrelia
burgdorferi in patients treated with antibiotics (25, 26, 27, 28, for
example).

Steere and Klempner aren?t the only IDSA guideline authors who know
that Bb can persist despite antibiotic treatment. Raymond Dattwyler,
in patents awarded both before and after the IDSA?s LD guidelines were
published in 2006, wrote that Lyme disease can exist in a chronic form
following antibiotic treatment.

In February 2007, Dr. Dattwyler was awarded a patent by the U.S.
government in which he wrote the following:

?Currently, Lyme Disease is treated with a range of antibiotics, e.g.,
tetracyclines, penicillin and cephalosporins. However, such treatment
is not always successful in clearing the infection. Treatment is often
delayed due to improper diagnosis with the deleterious effect that the
infection proceeds to a chronic condition, where treatment with
antibiotics is often not useful. One of the factors contributing to
delayed treatment is the lack of effective diagnostic tools.? (29)

Dattwyler?s statements contradict the IDSA?s positions that chronic
Lyme does not exist following antibiotic treatment, and that current
tests are effective in diagnosing Lyme disease.

Dattwyler has also published research that contradicts the IDSA?s
position that denies the existence of seronegative, chronic Lyme
disease. (30) Studies by other medical researchers buttress his
findings. (31, 32)

Still other research studies cast doubt on the IDSA guideline authors?
contention--repeated in last fall?s NEJM article--that Bb does not
develop resistance to antibiotics. One study, published last year,
found that not only could Bb develop resistance to some types of
antibiotics, but it also could transfer the resistance genes to other
species of bacteria, including Bacillus subtilis and Enterococcus
faecalis. (33)

Another study found that Bb has an outer membrane protein, BesC, that
is part of an efflux apparatus and is involved in antibiotic
resistance. (34)

Yet another study, by Yale researchers, asserted that ?calprotectin may
modify the clearance of spirochetes at sites of inflammation.? In
particular, calprotectin prevents the eradication of Bb by therapeutic
doses of penicillin G. (35)

A different study has described a mechanism by which Borrelia can evade
beta-lactam antibiotics through pleomorphism into spheroplasts without
cell walls. (36)

Other studies have shown that not only can Bb change into spheroplast L-
forms (37, 38, 39, 40), including after exposure to penicillin (41, 42,
43), but the Borrelia can also revert back into motile forms. (44, 45,
46)

Stephen Malawista, a former colleague of Allen Steere at Yale, has also
recently published a study showing that Bb can move ?upward of two
orders of magnitude above the speed of a human neutrophil, the fastest
cell in the body. This alacrity and its interpretation, in an organism
with bidirectional motor capacity, may well contribute to difficulties
in spirochete clearance by the host.? (47)

Researchers from New York Medical College have also found that the
extracellular matrix can provide a protective niche for Bb that allows
the bacteria to evade robust host immune responses. (48)

ILADS has an online slide presentation that shows how the IDSA
guideline authors? statements are contradicted by their own research
studies. (49)

A CytoViva video of Borrelia also shows that the IDSA guideline
authors? denial of the intracellularity of Borrelia is a pile of bull
squeeze. (50)

Bottom line: there is considerable and growing evidence that Lyme
borreliosis can become chronic, despite antibiotic treatment. Even the
IDSA?s Lyme disease ?experts? know so.

-----------------------------------------------------

1 http://www.ncbi.nlm.nih.gov/pubmed/18316520

2 http://www.ncbi.nlm.nih.gov/pubmed/17436229

3 http://www.ncbi.nlm.nih.gov/pubmed/8913478

4 http://www.ncbi.nlm.nih.gov/pubmed/8968890

5 http://www.ncbi.nlm.nih.gov/pubmed/10834975

6 http://www.ncbi.nlm.nih.gov/pubmed/10720533

7 http://www.ncbi.nlm.nih.gov/pubmed/15863289

8 http://www.ncbi.nlm.nih.gov/pubmed/1634816

9 http://www.ncbi.nlm.nih.gov/pubmed/8106639

10 http://www.ncbi.nlm.nih.gov/pubmed/9613343

11 http://www.ncbi.nlm.nih.gov/pubmed/8242938

12 http://www.ncbi.nlm.nih.gov/pubmed/10467661

13 http://www.ncbi.nlm.nih.gov/pubmed/8892586

14 http://www.ncbi.nlm.nih.gov/pubmed/8240439

15 http://www.ncbi.nlm.nih.gov/pubmed/2910019

16 http://www.ncbi.nlm.nih.gov/pubmed/8923044

17 http://www.ncbi.nlm.nih.gov/pubmed/15793100

18 http://www.ncbi.nlm.nih.gov/pubmed/16530006

19 http://www.ncbi.nlm.nih.gov/pubmed/11251580

20 http://www.ncbi.nlm.nih.gov/pubmed/8436647

21 http://www.ncbi.nlm.nih.gov/pubmed/10442678

22 http://www.ncbi.nlm.nih.gov/pubmed/3357244

23 http://www.annals.org/cgi/content/full/121/8/560

24 http://www.ncbi.nlm.nih.gov/pubmed/8085687

25 http://www.ncbi.nlm.nih.gov/pubmed/2613324

26 http://www.ncbi.nlm.nih.gov/pubmed/11233667

27 http://www.ncbi.nlm.nih.gov/pubmed/8852456

28 http://www.ncbi.nlm.nih.gov/pubmed/7625800

29 http://tinyurl.com/2uefov

30 http://www.ncbi.nlm.nih.gov/pubmed/3054554

31 http://www.ncbi.nlm.nih.gov/pubmed/8004045

32 http://www.ncbi.nlm.nih.gov/pubmed/2613324

33 http://www.ncbi.nlm.nih.gov/pubmed/17905571

34 http://www.ncbi.nlm.nih.gov/pubmed/18389081

35 http://www.ncbi.nlm.nih.gov/pubmed/16552081

36 http://www.ncbi.nlm.nih.gov/pubmed/8811359

37 http://www.ncbi.nlm.nih.gov/pubmed/12194230

38 http://www.ncbi.nlm.nih.gov/pubmed/11081332

39 http://www.ncbi.nlm.nih.gov/pubmed/15859564

40 http://www.ncbi.nlm.nih.gov/pubmed/14560706

41 http://www.ncbi.nlm.nih.gov/pubmed/7103461

42 http://www.ncbi.nlm.nih.gov/pubmed/7698837

43 http://www.ncbi.nlm.nih.gov/pubmed/7625800

44 http://www.ncbi.nlm.nih.gov/pubmed/9646104

45 http://www.ncbi.nlm.nih.gov/pubmed/11478686

46 http://www.ncbi.nlm.nih.gov/pubmed/12422604

47 http://www.ncbi.nlm.nih.gov/pubmed/18286190

48 http://www.ncbi.nlm.nih.gov/pubmed/17600717

49 http://www.ilads.org/Presentation_ChronicLyme.html

50 http://www.cytoviva.com/gallery_flash.htm

.

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