By the way, it's not THAT long. Print it out and read it:
IE users: select page preview, then print page 2-6.
Happy reading. Maybe.
-------------------- My biofilm film: www.whyamistillsick.com 2004 Mycoplasma Pneumonia 2006 Positive after 2 years of hell 2006-08 Marshall Protocol. Killed many bug species 2009 - Beating candida, doing better Lahey Clinic in Mass: what a racquet! Posts: 830 | From Mass. | Registered: Aug 2006
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Geneal
Frequent Contributor (5K+ posts)
Member # 10375
posted
Evidence based reviews....
I guess it depends on whose evidence and the idiots reviewing it.
Oh wait. I can offer any study that supports my theory.
How?
Major threats to validity. That's how.
From supposedly "random" selection of participants,
To the testing performed to ascertain bb, the accuracy of the testing performed,
Who administered it, who read it, who interpreted it,
Which meds were utilized, etc.
Sheesh.
If anything, the Western Blot should be replaced with an accurate test.
Without this, all studies are potentially flawed and biased.
Especially those who report negative results.
Just my very humble opinion.
Hugs,
Geneal
Posts: 6250 | From Louisiana | Registered: Oct 2006
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Leelee
Frequent Contributor (1K+ posts)
Member # 19112
posted
Thank you for posting, TinCup.
It was a very good article. But, I got scared all over again after reading it. I was having a pretty good day up until then.
Still, I am glad I read it. Tomorrow I hope to be optimistic again.
-------------------- The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy. Martin Luther King,Jr Posts: 1573 | From Maryland | Registered: Feb 2009
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posted
haven't read tincup's above yet, for those not reading the other IDSA running post, just have to make sure you read this one by one of our own, lyme patient/author!
bettyg Honored Contributor (10K+ posts) Member # 6147
Icon 1 posted 26-03-2009 06:09 PM Profile for bettyg Send New Private Message Edit/Delete Post Reply With Quote MUST READ! WELL DONE; THOUGHT OUT!! betty *****************************************************
PJ Langhoff's 3.09 open letter to IDSA Guidelines Panel Members
pj, wow, what an outstanding letter to your to IDSA panel about the 06 guidelines!!
So powerful, that I bolded/unlined certain areas since it was very lengthy so folks caught the highlites of it!
well done pj, my friend; so glad to have you on our lyme/co-infection side!
i'll post this on lymenet.org and mdjunction.com
to others receiving post on your OTHER LYME BOARDS and send to your own lyme list group of friends! really good info below. betty
From: Allegory Press <[email protected]> Subject: Fw: open letter to IDSA Guidelines Panel Members To: "Betty G
Date: Thursday, March 26, 2009, 4:02 PM
This is an open letter that may be shared and reposted, in its entirety.
It went to the IDSA guidelines review panel, along with 10 copies of my new book
The Baker's Dozen & the Lunatic Fringe: Has Junk Science Shifted the Lyme Disease Paradigm?
as well as a 5 page letter including excerpts and references for the panelists to review.
Here is the basic text of the letter. --
PJ Langhoff
***************************
March 25, 2009
Dear Esteemed Guidelines Review Panelists,
I am a Lyme patient, mother of 2 Lyme infected adults, award-winning author, advocate and medical researcher who probably acquired Lyme congenitally.
However after our most recent tick bites, my family was forced to wait 13 years for an accurate diagnosis of Lyme disease despite nearly 100 physician and ER visits.
This unnecessary delay occurred despite the fact that I removed ticks from myself and my then toddlers and we had bull's-eye rashes and other acute Lyme symptoms.
Over time I progressively lost physical ability to the point of being unable to walk, work, drive, think, use the left side of my body, etc.
I suffered intractable pain for years.
My family and I were sick all of our lives because no doctors would touch the words ``Lyme disease''.
One physician told me behind closed doors he was ``not allowed to diagnose'' Lyme patients, or put the words ``Lyme disease'' in patient charts for fear of reprisals.
I spent 10 days at the Mayo clinic in Rochester, MN whereby I was refused Lyme testing despite my symptoms and lengthy medical history.
Repeatedly I heard ``there is no Lyme in Wisconsin'' which was patently ridiculous.
Indeed your panelist Yale's Dr. Paul Duray performed tick surveys on WI military bases around the time my family was most recently bitten (in the 1990s).
Reports indicated that areas of WI were Lyme endemic at that time.
Note I lived just 2 hours from one of those endemic bases.
It is felt that my parents, siblings, and probably children also have Lyme, acquired congenitally.
Many of us have been re-bitten and have active Lyme infections and progressing symptoms despite repeated antibiotic treatments.
Later on, as if chronic illness was not enough of an insult to my family, I was forced to fight over 12 years in family court to retain custody of my children post-divorce, yet eventually lost all parental rights in short, simply because I had Lyme disease.
That occurred despite expert physician witnesses and laboratory tests clearly showing my family Lyme positive, even by CDC standards.
One judge said I didn't ``look sick''.
One of my children ended up in a psychiatric ward for observation due to Lyme induced depression.
We have lost homes, jobs, reputations, finances; filed bankruptcy, fought disability providers, and insurers just to get medications and treatments that were life-saving, covered; and most were paid out-of-pocket.
I have had to endure years of oral antibiotics that do not work, fulminant symptoms, intramuscular and IV therapies, surgical operations, the loss of several organs, and CNS, joint, and brain invasion by organisms that could have been successfully treated at onset if those whom have been holding the purse strings of information censorship had been speaking the truth about spirochetal infections; instead of silencing a growing epidemic in exchange for what has appeared to be profiteering and notoriety.
I have fought hard to defend Lyme treating physicians because of what the medical boards are doing to them (pulling their licenses or other sanctions) because they dare to treat patients outside IDSA ``standards'' of care that are no one's standards -- ``standards'' that are merely recommendations, and which clearly do not work.
This is a tragic situation when our own physicians cannot treat patients in favor of insurance companies or a handful of powerful academicians who dictate medical dogma, the former without a license, the latter without practical clinical experience.
Corporatized medicine serves no one except the profiteers; and certainly not the ill patient populations.
Sadly, our family's tragic situation is not unique.
I contend that if restrictive Lyme disease medical guidelines such as those promulgated unilaterally by the IDSA in 2000 and again in 2006, which deny aspects of this illness and minimize others, are allowed to proliferate, then more families will be facing the kinds of tragic destruction, discrimination and denial that our family has--unnecessarily and unjustly, but for the sake of research dollars and promoting for-profit pipelines.
I urge you to carefully consider the long-term consequences of clinical practice guidelines that are intended to serve as recommendations and not mandate for treating physicians.
The current restrictive IDSA guidelines and processes that allow academicians to patent and profit upon technologies also allow insurance companies to deny patients a right to become healthy and whole.
This is additionally disturbing when we see that some of the academicians who are also guidelines panelists have conflicts of interest including patent holdings, and are paid consultants to pharmaceutical and insurance companies and witnesses in litigation.
That some of these individuals have ongoing vaccine and diagnostic test involvement; as well as a role in the establishment of ``standards'' and information dissemination is intensely troubling when that information denies aspects of illness, as the IDSA guidelines do for Lyme disease.
It is clear that some of these parties well know the severity of this illness but patently refuse to budge on more recent opinion.
Perhaps this is because they and their associates stand to lose much if they admit to the truth about this illness.
How unfortunate for those ill with this disease that power, profit, and reputations appear greater than the welfare of people globally.
You have a chance to change things for Lyme patients for all of history right now, but only if you choose truthfulness over ongoing censorship for profit and private agendas.
In all fairness to patients who are to benefit from current and future guidelines, we request full consensus in writing medical guidelines, even when guidelines are merely recommendations.
This process must include all current research (not just that put forth by a few panelists); everyday experiences of our treating clinicians, and valuable patient input and experience - and I thank you for the opportunity to provide such input at this juncture.
It is my hope that this open public input period is truly meaningful and not just a token conciliatory gesture for patients whereby the end result will be to nevertheless uphold the 2006 IDSA guidelines that patients, physicians, and others clearly do not want nor accept as legitimate.
We do not want or need biased, rubber-stamped, disease dismissing, for-industry guidelines that place profits above human suffering.
And patients will be far more vocal about this the longer it continues to occur--until these practices cease to exist and those held accountable for these practices when they occur.
Illness does not equal powerlessness, and those who are ill, expect and deserve better than what we have been spoon-fed from previous clinical practice guidelines for Lyme disease and some of its panelists.
After all, we are learning the truth about this disease; from study of all available documents, and from personal experience living with these infections.
From our perspective, the guidelines and some of those who have been involved with the Dearborn criteria, the guidelines formation, diagnostic and vaccine technologies, and who also are grant recipients, and patent holders, currently appear far from truthful about this growing epidemic.
The current guidelines are inaccurate and reflect a desire to restrict patient and physician access to life-saving medications and treatment processes.
The unfettered censorship of our physicians by academic mandate disguised as ``recommendations'' is most unwelcome in the patient/doctor relationship, and the toying of our health by insurance companies who whimsically misinterpret the IDSA guidelines is as dangerous to human life as Borrelia burgdorferi is, when left untreated or undertreated.
Clinical trials and controlled studies are necessary aspects of medicine.
However, the practical patient experience has been shifted to the back burner in favor of academic ``expert'' opinion and research funding, including by those who do not see patients, or who occasionally do but who have only a limited patient sampling with one or two symptom presentations.
Adhering to unilateral thought regarding a limited number of patients in favor of controlled, funded studies over time is an unrealistic approach that is woefully out of touch with the clinical experience.
An absence of ``scientific'' proof is not proof of absence.
Physicians who treat thousands of Lyme patients were, and are summarily excluded from the IDSA guidelines process, along with a former panelist who was excused for not agreeing to the ``expert'' opinion of other IDSA panelists.
(Experts who again, do not have practical real time experience treating patients in a clinical setting.)
The patients are crying out loudly for these processes to change, for our welfare, and for the future welfare of all persons yet to be infected with this devastating illness.
To that end, one of my recent books from my Lyme ``It's All In Your Head'' series, was recently released, (titled The Baker's Dozen & the Lunatic Fringe: Has Junk Science Shifted the Lyme Disease Paradigm).
I have included 10 copies, one for each panelist to receive and review during this patient input period.
I have collected significant research sources, including objective peer-reviewed articles, as well as FDA, DoD, NIH, CDC, published books, CME videotapes, and other sources, and compiled them for patients, educators, physicians, panelists, and others to review.
The book illustrates also the research behind this disease as previously published by many of the IDSA panelists.
It clearly shows the IDSA guidelines to be at stark odds with some of the guidelines authors' own earlier published findings.
The fact that earlier claims about the severity and persistence of Lyme disease by some of these parties do not reconcile with their current guidelines recommendations leads us to question the motivations of those who have written them.
That there are tremendous potential conflicts of interest at play does not escape the public.
My book helps to illustrate what some of those important connections and conflicts may be and how they may be influencing the current Lyme paradigm.
It also closely examines the CDC recommendations set forth at the 1994 Dearborn MI conference that was designed to standardize testing; yet apparently simply provided unilateral opinion that appears unsupported by scientific evidence--opinion that led to
a.) the release of what is considered to have been an unsafe vaccine by virtue of OspA sensitivity, chronic treatment resistant arthritis of which certain panelists were aware before the vaccine was released [evidenced by research papers]; and
b.) has also led to the wrongly promoted insensitive diagnostic tests incapable of detecting most patients who have Lyme disease for many reasons examined; which has thus led to
c.) thousands of people like my family being misdiagnosed, undiagnosed, and improperly treated for an organism that could have easily been treated at onset that the IDSA panelists published was persisting and severe; and
d.) the refusal by doctors to continue to treat patients until symptoms are gone due to restrictive guidelines and fear of reprisals through medical board actions; and
e.) the refusal by disability and insurance companies to pay for disability and/or treatments while they conveniently cite IDSA guidelines as mandate and not recommendation in order to control profit margins.
And since the current IDSA guidelines appear written in a manner supportive of this kind of discrimination, thousands have been disabled, killed, or have ended their own lives thanks to intractable pain, severe depression, discrimination and other factors caused by Lyme disease.
If there is no ``illness-for-profit'' paradigm in play, then there is no excuse to continue to defend guidelines that dismiss meaningful research and clinical evidence, and contraindicate access to life-saving treatments.
Lyme disease is a serious epidemic that requires open-ended treatments with combination antibiotics to the benefit of patient wellness as long as, and as frequently as is necessary until symptom resolution.
Treatment benefits are nonexistent under a therapeutic schedule with limited duration that abruptly ends by a predetermined calendar date.
And one which then magically changes all remaining spirochetes into some ``post-Lyme syndrome'', a term that is not only hyperbole and conjecture, but also complete and utter nonsense.
I outline how this is so within my new book which is provided for your review.
That there are those who continue to deny the existence of an organism that has long been studied by the military in collaboration with academic institutions as a bio-weapon; and that some of these parties, after patenting the organisms and processes, now publish contrary to some of their earlier research on these same organisms, is unconscionable in the public opinion of mass majority.
That some of these parties would also be allowed to patent, profit and promote these processes by developing vaccines and insensitive/ineffective diagnostic tools in order to promote a vaccine which failed; while simultaneously holding patents on tests with a greater ability to diagnose Lyme patients but refusing to develop these more accurate processes, is also unthinkable.
Patients are imploring the current panel members to reconsider carefully the input of patients, their treating physicians and the scientific facts that have been formerly ignored during previous IDSA guidelines processes.
The true research evidence is in fact present and easily accessible to all who choose to read same.
Lyme disease is serious, persistent, chronic and debilitating; and even previous IDSA guidelines panelists published these facts -- even if they choose to minimize or flatly ignore their own findings within past and current guidelines and recent publications.
For that reason, I urge you to read fully, or at the very least, glance carefully at the sections in my new book that discuss testing, patenting, grant funding, the guidelines processes, persistence, testing standardization and failures, the IDSA guidelines inadequacies/errors and the earlier research published by the IDSA guidelines authors and their associates.
Likewise, consider carefully all submissions by those outside the IDSA academic ``club'' during this public input period.
Only when you see the truth about Lyme disease, in the form of the published research, the patient and the physician clinical experience, the revelations of conflicts of interests in former panelists, and the extent by which the paradigm is exploited for profit over patient welfare can you objectively, mindfully, and responsibly create guidelines that are clearly in the best interests of the patients they are supposed to serve --
something for and about which, many believe that the former and current IDSA guidelines for Lyme disease have failed miserably.
It is a tragedy that patients have had to endure the kind of prejudice and censorship that we have had over the past several decades -- at times by the very parties who are sworn to ``first do no harm''.
We have trusted unfairly those in the academic world who have had the power to keep us ill in favor of research funding. We are far more educated about our illness now, with full awareness of the political and scientific issues.
Sources like the film Under Our Skin, the CT Attorney General's investigation, and books like mine are helping others to find those truths and bring them into the spotlight.
You merely have to look at them and consider the impact of forcing populations to remain ill by perpetrating ongoing myths that nobody believes or is buying except for the minority, ``Baker's Dozen''.
I urge you to consider your choices carefully.
Patients will no longer stand idly by and accept what we know is not truthful.
With great respect for what you are about to (undertake, but with the personal experience that this disease has long afforded me through decades of dealing with same, my research work and privileges in physician and patient advocacy, I formally request that you read the content of my new book, and put the patients first in your guidelines review process.
Remember to ``first do no harm''.
I include on the following pages some excerpts from my book to facilitate your study--a book with more than 1,060 references.
I collected this over a 4.5 year period, while ill, from publicly accessible sources.
My research was included in the CT Attorney General's anti-trust investigation into the IDSA guidelines, and part of it was shared with producers of the film Under Our Skin.
Of note is that my books are available and selling internationally through popular book sellers.
This information is not being taken lightly by your peers or by patients and physicians the world over.
And in turn we expect and request that in a similar manner, that this information not be taken lightly by the esteemed review panel.
(references, excerpts etc. listed on 2 additional pages)
posted
tincup's link above ... copied here and broken up!
GUIDELINE-MAKING GETS TOUGHER: ACTION BY STATE ATTORNEY GENERAL OVER LYME DISEASE GUIDELINES STIRS DEBATE
Posted on March 24, 2009
by annalsofneurology
Promulgating clinical practice guidelines - already a laborious and often contentious undertaking - has just gotten a bit trickier.
The Lyme disease guidelines developed by the Infectious Disease Society of America (IDSA) are a case in point.
Trouble began almost immediately after they were published in 2006, when IDSA promptly became the target of an antitrust investigation by the attorney general in Connecticut.
The guidelines outraged patient advocacy groups by saying there is ``no convincing biologic evidence'' for chronic Lyme infection and recommending against antibiotic therapy beyond short-term treatment of acute infections.
Three advocacy groups -
the New Jersey-based Lyme Disease Association, Connecticut-based Time for Lyme and the California Lyme Disease Association -
took their concerns to Connecticut Attorney General Richard Blumenthal.
A Surge in the `Lyme Wars'
Blumenthal's action is only the latest salvo in a long-running battle that pits a passionate cadre of patients and the physicians who treat them against much of mainstream academic medicine.
While this ``patients-versus-medical-establishment'' square-off is not unique to Lyme disease, the lines are sharply drawn in the polarized environment of what is now the most common vector-borne disease in the United States.
`Lyme wars' are being fought on the Internet, the media, the courts, and in state and federal legislatures.
Patient groups have fought for legislation, for example, to ensure patients cannot be refused long-term antibiotic treatment.
In Connecticut, they joined with Attorney General Blumenthal to pass such a law, and have made similar - but so far unsuccessful - efforts at the federal level.
Blumenthal's action against IDSA seems to have stemmed largely from complaints lodged by patient groups.
``When the IDSA panel hand-picked research to support their positions and ignored anything that diverged from it, we knew that was inherently wrong, and felt that it was potentially a violation of antitrust,'' said Blanchard of Time for Lyme. ``That's what led us to bring this information to the attorney general.''
Smith of the LDA, said that some of the same information was also presented to attorney generals in other states, but she was unaware that any had acted on it.
Battles rage in the pages of medical journals as well, where recent articles on Lyme treatment have been met with a rash of contradictory letters in response.
The sometimes contentious exchanges provide a snapshot of the scientific issues where disagreement is strongest, including diagnostic test accuracy, prolonged antibiotic therapy in symptomatic patients who had previously been treated for acute Lyme, and the very existence of ``chronic Lyme.''
Us vs. Them
Patient groups, who were represented on the ILADS guidelines-development committee by Pat Smith of the Lyme Disease Association, routinely cite the ILADS guidelines as evidence that prolonged antibiotic treatment for chronic symptoms is a reasonable approach to care in the hands of the right doctor.
Others charge that the ILADS treatment parameters are being used to justify antibiotic therapy for nebulous symptoms that cannot be definitively linked to Lyme infection.
``Reimbursement is high for antibiotic infusion. There are a number of physicians in the country - primarily family physicians - who have made themselves `Lyme disease experts' and treat chronic Lyme with antibiotics,'' said Roos of Indiana University. ``Every patient deserves to be thoroughly evaluated, but they should not be in the hands of these `Lyme clinics.
They should go to academic medical centers and see neuro-infectious disease specialists who have no financial interest in them having Lyme.'' -------------------------------------------------
Lyme researcher David Volkman, an emeritus professor at the State University of New York at Stony Brook, has a unique perspective on the whole Lyme debate: he is solidly in the middle. In fact, he said: ``I think I am despised by both groups.''
He summarized the ongoing battle this way: ``On one side are the `experts,' who dismiss the possibility of persistent infections and discount incontrovertible examples of persistent borreliosis.
On the other side are a large number of ailing people with a myriad of symptoms but no real proof of exposure to B. borrelia, who nonetheless desperately demand IV antibiotics and are supported by almost cult-like advocacy groups.
``What is obviously needed,'' Volkman said, ``are better diagnostic tools and objective science.''
Lyme disease is a politically charged topic in Connecticut, where the pathogenic spirochete bacterium, Borrelia burgdorferi, was first identified in 1981 and the disease is endemic.
Blumenthal is well known for his advocacy on behalf of Lyme patients:
he has held public hearings on Lyme, helped draft a state law assuring patients access to prolonged antibiotic therapy, and has been active in patient groups, including a term on the advisory board of Time for Lyme, according to the organization's co-president, Diane Blanchard.
He launched the civil investigation against IDSA in November 2006, serving subpoenas and written interrogations to the society and to guidelines committee chair Gary P. Wormser, New York Medical College in Valhalla.
AAN Investigated
Meanwhile, an American Academy of Neurology (AAN) committee was developing its own guideline on the treatment of nervous system Lyme disease.
Three members of the AAN panel also served on the IDSA guidelines committee:
chair John Halperin of New York University School of Medicine and Atlantic Health System in Summit, NJ;
Yale's Eugene Shapiro, and Wormser.
The AAN's practice parameter was published online in May 2007.
It too recommended against prolonged courses of antibiotics for what it called ``post-Lyme syndrome,'' and concluded: ``Most available data argue against persistent B. burgdorferi infection in patients who have received what are normally curative courses of antimicrobial therapy.''
Less than a month after the AAN practice parameter was released, Blumenthal subpoenaed the academy for documents related to its development, including panelists' names and correspondence or files related to the IDSA guidelines. Halperin said his computer was subpoenaed and he was instructed not to delete any files for a year. -------------------------
In May 2008, IDSA and the attorney general's office reached a settlement.
A press statement from Blumenthal at the time said there were ``improper links'' between the AAN panel and the IDSA panel, including the overlap of chairmen and development timelines, which he said constituted ``a violation of IDSA's conflicts of interest policy.''
He said the resulting guidelines ``not only reached the same conclusions regarding the non-existence of chronic Lyme disease, [but] their reasoning at times used strikingly similar language.''
In response, AAN General Counsel Murray Sagsveen said:
``The Connecticut attorney general appears to assume that collaboration between professional medical societies is an unacceptable conflict of interest, but he failed to consider that evidence-based collaboration should actually lead to similar diagnosis and treatment of a disease among specialties.''
As part of the settlement, IDSA, in exchange for an end to the investigation and without admitting any wrongdoing, agreed to convene a new panel to review the guidelines and determine if revisions are necessary.
IDSA also agreed to expand the review process to include a public hearing, which will be broadcast live on the IDSA Web site.
The parties jointly selected an ombudsman, Howard Brody of the University of Texas Medical Branch, who has written a book on medical conflicts of interest, to screen panel candidates.
Conflicting Claims
In a statement provided to NerveCenter in response to written questions, Blumenthal said his investigation of IDSA had ``exposed a deeply flawed process rife with conflict of interest that improperly excluded alternative views and information.''
In the May statement, Blumenthal said he had found ``undisclosed financial interests held by several of the most powerful IDSA panelists.''
No violation of antitrust laws was noted; however, the statement continued to refer to the action as an ``antitrust investigation.''
Blumenthal declined NerveCenter's request to elaborate on the specific nature of the conflicts, but said:
``Some of the conflicts and significant financial relationships that were not disclosed [at the time the guidelines were published] have been subsequently exposed in other publicly available publications.''
He cited as an example disclosures that were included in a review article critical of chronic Lyme published in the New England Journal of Medicine in October 2007.
The authors included three IDSA panel members (Shapiro, Wormser, and Harvard/Mass General rheumatologist Allen Steere), who disclosed various relationships with insurance companies (e.g., reviewing disability claims related to Lyme disease) and with pharmaceutical or biotech companies.
Shapiro and Wormser also reported serving as expert witnesses or consultants in medical-malpractice cases related to Lyme.
``The more robust disclosure [on the NEJM paper] was due in large part to my investigation, which was ongoing at the time,'' Blumenthal said.
Patient Groups: Guidelines Used as `Hammer'
Patient groups say the guidelines are being used by insurance companies to deny antibiotic treatment to patients and by state medical boards to harass and prosecute physicians who practice outside of the recommendations.
``These guidelines are being used as a hammer and are essentially forcing [physicians] to comply, and if they don't, they stand to be investigated by state medical boards,'' said Blanchard of Time for Lyme.
In a statement at the time of the agreement, IDSA strongly disagreed with the allegations of conflicts:
``Panel members had no financial interests that would have affected, or been affected by, recommendations in the guidelines.''
The society said it was voluntarily agreeing to the one-time special review of the guidelines by an independent panel ``in an effort to clear the air.''
It stood by its guidelines, noting that their scientific validity had not been questioned - a point the attorney general has also underscored - and reiterating that they remain in effect.
A Model for Review and Disclosure?
Importantly, the agreement delineated parameters for what constitutes a conflict of interest among potential members of the new review panel, stipulating that financial or beneficial interests with a combined value of $10,000 or more in the products or concepts addressed in the guidelines ``may be considered to bias a participant's judgment.''
It included a thorough four-page financial disclosure form that applicants for the new panel were required to file.
In the May press statement, Blumenthal said that ``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.''
Sagsveen, the AAN attorney, said he finds this view worrisome: ``I am troubled that a state attorney general is monitoring a medical society's compliance with its own processes and moreover, is forcing a medical society to adopt a disclosure statement that he himself has approved.''
In an editorial comment about the agreement, IDSA President Donald M. Poretz emphasized that ``the expanded review process detailed in our agreement with the Attorney General is pertinent to this unique case only.
The IDSA has not agreed to use it as a model for other IDSA guidelines, nor do we urge other medical organizations and societies to use it.''
In his email, Blumenthal said a new model is needed because of ``growing evidence of improper pharmaceutical influence on medical guideline writing.''
He pointed to Eli Lilly's alleged orchestration of grants and payments to panelists who were developing treatment recommendations for sepsis in order to ensure that its drug Xigris (drotrecogin alfa) was included in the guideline.
``The process my office pioneered provides a powerful check on drug-company attempts to improperly influence guideline writing,'' Blumenthal said.
New Panel Draws Ire
The latest chapter in the case is still unfolding. In late January, IDSA announced the selection of 10 new panelists for the guidelines review and Baylor College of Medicine infectious disease specialist Carol J. Baker as chair.
Almost immediately, the three patient groups released a joint statement calling the new panel ``unbalanced and biased.''
They specifically took issue with the exclusion of physicians who made more than $10,000 treating Lyme disease.
Pat Smith, president of the Lyme Disease Association, said in the statement: ``They have confused helping patients get better with `real' competing conflicts...'' In an interview, she said 18 physicians who treated persistent Lyme applied to the panel and were all excluded.
``They've done it again,'' said Blanchard. ``They've managed to eliminate a very important voice in this process, that of Lyme-treating physicians.''
Internet blogs for Lyme disease patients reacted quickly as well. A January 30 news item on an online support forum for patients said Lyme awareness groups were ``alarmed'' at Baker's appointment as chair.
In a blog post on the site, Lynn Shepler, a vocal patient advocate who says she has been disabled by persistent symptoms from a Lyme infection 13 years ago, raised concerns that Baker's expertise in vaccine research and development would bias the panel ``in favor of any party interested in commercializing Lyme vaccines.''
IDSA spokesman Steve Baragona defended the agreement's conflict-of-interest provisions:
``IDSA and the attorney general agreed that anybody making substantial amounts of money treating people with long-term antibiotics has a clear conflict of interest in the outcome of this board's deliberation.''
Such physicians were ``screened off the panel'' by ombudsman Brody, Baragona said, and the panel selection was okayed by the attorney general.
Brody declined to comment on advocates' concerns.
Baragona added: ``There is a risk of this panel's work being pre-judged by people with a vested interest in the outcome.
Let's give [the panelists] a chance to look at the evidence before concluding that they're biased.''
A Need for Reform?
The challenge to IDSA's guidelines comes at a time of increasing scrutiny on treatment standards and practice parameters.
In a recent commentary in JAMA, Allan Sniderman and Curt Furberg argued the need for reform in the guideline-making process, especially in light of the fact that guidelines have become ``the final arbiters of care'' for many clinicians.
IDSA was not mentioned in the article; the example used was cholesterol guidelines.
The authors made several specific recommendations for ensuring integrity in guidelines development, which included fully disclosing financial interests of panelists, excluding from the process panelists who have collaborated on related guidelines, and providing a forum for alternate interpretations and viewpoints to be aired.
In an interview, Sniderman - a cardiologist at McGill who was not familiar with the chronic Lyme controversy - said, ``Guidelines represent a best attempt to cover complex material in a very short period of time. They should not be conflated into Bible.''
He took particular issue with the notion that unanimity is essential among guidelines committee members.
Instead, he suggested an approach more like that of the Supreme Court, which issues dissenting opinions in cases. ``That would be a powerful way to avoid situations in which people feel their views have been illegitimately disenfranchised or not acknowledged.''
On the issue of financial disclosures, he said: ``We simply have to disclose much more fully than has been the habit. It is not enough to say `less than $10,000′ or `more than $10,000′ - there is a big difference between $10,000 and $100,000.''
He added that future relationships need to also be considered, particularly in the case of guidelines development.
``Many pharmaceutical companies market their products by enlisting key opinion leaders.
In cardiology, for example, if you are a prominent participant in developing a guideline, in the subsequent year or two the pharmaceutical companies will want to have you out all over the map,'' Sniderman said.
Room for Dissent?
Halperin, the chair of the AAN practice parameter committee, said that some of the major concerns raised by Sniderman and Furberg ``simply are not an issue with IDSA and AAN Lyme guidelines.''
Clearly, he said, ``All guidelines committees are obligated to consider all evidence on all sides of the question,'' but he rejected the idea that a greater acknowledgement of divergent views is applicable to the IDSA guidelines.
``This is not a debate based on conflicting scientific evidence,'' he said. ``The scientific issues are actually quite clear; all well-performed studies have produced internally consistent results.''
One group that vehemently disagrees with that view is the International Lyme and Associated Diseases Society (ILADS), a physician's group established in 1999 and closely allied with patient advocates.
In 2004, ILADS published its own Lyme treatment recommendations recognizing chronic Lyme and endorsing long-term treatment with antibiotics.
In the introduction to its guidelines, ILADS says its goal is ``to present practitioners with practical and defensible guidelines for treating all individuals with Lyme disease, including those with persistent, recurrent and relapsing symptoms of B. burgdorferi infection.''
(ILADS president and chief author of the guidelines, Daniel Cameron, did not respond to an interview request.)
Collateral Damage
Professional societies that publish treatment standards are paying close attention to the IDSA case, as medical and legal scholars.
Antitrust attorney Judith Harris of the Washington, D.C. law firm of Reed Smith, discussed the legal implications of the case on Mondaq.com:
``[This] matter should serve to reinforce how carefully associations must tread when their actions might adversely impact competition and thus, might implicate antitrust laws.''
In an opinion essay on the attorney general's action, Jerome O. Klein worried about the possibility that the IDSA case ``sets a precedent for politicians representing the views of aggrieved constituents to challenge the recommendations and guidelines of professional societies.''
He called for close monitoring of the situation to ``assure that the process and the science are not subverted by advocacy groups or their political representatives.''
At the AAN, Sagsveen echoed this concern:
``This raises the possibility that any state attorney general may challenge a clinical practice guideline that is disfavored by the politician's constituents.
If special-interest organizations can influence clinical practice guidelines to reflect their political objectives rather than accepted, peer-reviewed literature, medical and public confidence in guidelines may be irreparably damaged.
Such a threat could `chill' the guideline development process and discourage members from volunteering to author guidelines.''
Karen Roos, Indiana University CNS infections specialist, is currently heading two AAN practice parameter committees, and she is feeling the chill. ``It's disturbing that the attorney general is meddling in evidence-based medicine,'' she said.
One of the guidelines she is working on ``very, very carefully'' is childhood immunizations, also a political hot-button issue that is almost certain to stir controversy.
``I may have to go into the witness protection program when that one comes out,'' she said wryly. AN
Brenda Patoine
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STIRS DEBATE''
1. Lorraine Johnson, on March 25th, 2009 at 4:42 am Said:
if you have not read the recent article by Brenda Patoine, ``Guideline-Making gets tougher: Action by state attorney general over Lyme disease guidelines stirs debate, '' I recommend you do.
It is a good reminder that reporters can still do the in depth coverage of complex issues and hold their ground on reality based reporting.
I am so utterly impressed with this article by Brenda. It is obvious that she put her all and more into doing a lot of investigative work, not just listening and propagating one particular players opinion.,
This article was the most comprehensive and balanced work I have read to date.
There's some old quote about how society is doomed when judges and police forces are corrupt.
I think that journalists have an even more powerful role in law and order.
WE citizens desparatly need fair and balanced reporting, otherwise we are brainwashed drones, without the capacity to make better decisions.
It is so refreshing to see this level of reporting around such an incredibly complex topic.
I've studied the history of the disease and how it has played out medically and politically, and I was truly amazed at the caliber of this coverage.
I have read some snide, sarcastic and one sided articles about this ``war'' in some well respected publications, and again, it was so surprisingly refreshing to read this piece.
Thank you Brenda!!!
A few other thoughts... I am very puzzled by the review panel forbidding the participation of those who treat the disease the most - Lyme physicians who treat patients on the ground.
The reasoning was that they have conflicts of interest because they make more than $10,000 a year in treating Lyme patients. Huh?
Isn't that like forbidding neurologists who treat patients a place on a guideline panel because they make their living treating patients with neurological diseases?
It seems to me that there is a huge difference between `real' conflicts of interests such as huge amounts of money paid by insurance companies or vaccine and patent owner to those who are the authors of treattment guidelines, and those whose profession it is to treat patients.
I think an anology can be made with the White House and the Iraq war.
Politicians and generals who are not on the battleground can make horrendous decisions with the loss of thousands of soldiers on the ground, when they are not constantly getting UNBIASED feedback and opinions from those carrying out orders on the battle ground.
It is when politicians and the major power players care more about their reputation and sphere of power that tragedy and ignorance occur.
Truly, reading about the ``Lyme Wars'' is more interesting than a Michael Crichton novel.
Try reading Pamela Weintraub's book ``Cure Unknown'' about the disease. In parts, it is mouth dropping, unmitigated rage producing, with many tragedies interlaced.
I highly recommend it as entertainment regardless of the horror of the disease itself.
The sad thing is that the term ``Lyme War''. is given to capture the subject of the disease. In a better world, the term would be something like ``The Lyme Project''.
I think the one thiing both sides can agree on is that the direction of this debate will be transformed when scientists are able to come up with a 100% effective lyme test. I'm hoping and praying for that day to come sooner than later. Theresa
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METALLlC BLUE
Frequent Contributor (1K+ posts)
Member # 6628
posted
Some of these people have the market covered on behaving unprofessionally as well as being pompous towards ill patients, their families and anyone advocating on their behalf.
Using euphemisms and snide back-handed statements in the media isn't going to help. Then again, we are at war and while some may dismiss the seriousness of such a statement, it's a fact.
When your way of life -- your very existence -- depends on receiving a therapy that someone else is trying to take from you and those you love, they have to be prepared to be attacked, whether physicially, politically, legally, etc.
I don't condone violence, but I sure do understand why people are calling this a war.
-------------------- I am not a physician, so do your own research to confirm any ideas given and then speak with a health care provider you trust.
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