ILADS Articles

19 September 2010

ILADS Psychiatry

The current president of ILADS, NJ psychiatrist Robert Bransfield, had a brief letter to the editor in one of the Pennsylvania newspapers this morning. It doesn’t really matter what he said—it’s the usual ILADS propaganda about Lyme disease and how the IDSA-insurance-federal cabal is keeping so many hard-working Lyme Literate docs from reaching their full financial potential.

But it reminded me of other nonsensical pieces Bransfield has written about autism and Lyme disease in the free-wheeling journal, Medical Hypotheses.

Even wackier writings can be found in the old newsletters of the Lyme Alliance.

I was particularly interested a 1998 response from a fellow Lyme Literate doc to some of Bransfield’s thoughts. Here’s the letter from James Katzel, MD to the Lyme Alliance (highlighting added).

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

Mon Aug 24 17:18:43 1998

Lyme Alliance Newsletter

May 3, 1998

To Whom it May Concern:

I have been a long-time reader and supporter of your publication, Spotlight on Lyme. I recently finished your April, 1998 edition and found the Bachmann article an interesting personal history and the Rita Stanley, Ph.D. article on hyperbaric oxygen treatment a good update on what's going on. The Tom Grier conclusion article on laboratory testing was excellent, and something that could be used as a model, both for teaching physicians and patients.

Upon reading the article by Robert C. Bransfield, M.D., I was utterly taken back, and the publication of this article has made me reconsider my support for The Lyme Alliance. Part of the title of your name, The Lyme Alliance, Inc., is "Advocates for Truth in Lyme Disease". What truth, if any, is found in this article? The question here is whether Dr. Bransfield is a physician or a pure fascist. The article hints of an ultraconservative agenda of sexism and racism and, although I have never met Dr. Bransfield, my first impression of him is that he is either a truly sick individual or a severely under-educated person.

He has made unacceptable medical innuendoes, which, when printed in a publication such as yours, will be looked upon by many readers as fact, especially since it is written by a person who puts "M.D." after his name. As far as I am concerned, you must publish a retraction of this article immediately. It is totally unacceptable that a medial physician can, at this time, and with the knowledge we have in general medicine, consider Borrelia burgdorferi infection to be a cause of homosexuality. In addition, his use of the phrase "altered patterns of sexual arousal" is beyond interpretation by any rational reader. He goes on to say: "Homosexuality and other variants of sexual arousal do not make sense from an evolutionary perspective. Something causes it."

Dr. Bransfield's implication that Lyme disease, Borrelia burgdorferi or other infectious disease is the cause of what he considers to be a variant of sexual arousal is absurd.

Unless an immediate retraction is printed, I can no longer consider myself a supporter of your publication and, in fact, will lobby aggressively against any type of sexism or fascist writings that you publish. We owe patients with Lyme disease, physicians trying to learn about this disease, and the general public better explanations than what Dr. Bransfield has offered. Some type of review by a professional advisory panel or peer review organization should be done before allowing such an article to be made public. I will eagerly await your retraction and Dr. Bransfield's apology.

Sincerely,

James H. Katzel, MD

Family Practice, Geriatrics

Ukiah Valley Medical Center

University of California, San Francisco

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Labels: ILADS

03 May 2010

The bitching continues….probably forever

Some post-review ranting by ILADS psychiatrist Robert Bransfield, who, in my opinion, needs a sedative and some training in infectious diseases. Here he goes:

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.”

[Actually, it was 3,000 pages of cobbled together anecdotal observations, argumentative letters-to-the-editor, and some peer-reviewed reports of animal models. It was not 3,000 pages of peer-reviewed clinical (i.e., human) studies of treatment. More likely, it was 2,000 pages of letters written by Johnson and Stricker. As for the IDSA’s 45-page document, it also cited 1,025 other publications from which its conclusions and recommendations were drawn.]

“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.” […at the hands of people like Bransfield and his ILADS colleagues.]

“By and large, the people on the IDSA panel who made this decision are ivory tower researchers,” says Bransfield. “They’re not the doctors on the front lines looking into the eyes and faces of these very sick patients, performing exams and then assuming long term responsibility for dealing with patients suffering from chronic Lyme.”

[This is a thoroughly beaten dead horse. As far back as 1998, Bransfield was whining about what makes an expert: “Are the real experts community physicians with the long-term responsibility to treat chronic LD or basic science researchers, administrators, bureaucrats, and insurance company consultants removed from the full human impact of this disease? Barbour's experts are not viewed as true experts in clinical issues by many physicians who have experience treating patients with chronic LD. Physicians need to retain their roots in traditional medicine, obtain a thorough history and perform a careful examination on these patients, and never defer total clinical judgment to dogmatic, ethically suspect guidelines.”

So unless you’re a LLMD making a living by treating and billing people for “chronic” Lyme disease, you’re not an expert on Lyme disease, chronic or otherwise. But in fact, the IDSA review panel members are clinicians seeing patients and working the wards. Part of the reason for the delay of the final IDSA report was due to having some of the panel members on service and seeing patients earlier in the year.]

Bransfield and ILADS point to a number of discrepancies and other concerns about the vote, including:

—68 out of 69 of the original 2006 recommendations under review were OK’d with unanimous votes. “How can there be such a total consensus with any scientific issue?” asked Bransfield. “It’s highly suspect and beyond comprehension.”

[As I mentioned on April 22, “Maybe it’s beyond Bransfield’s comprehension, but there’s plenty of “total consensus” on many scientific issues: everything from the charge of the electron, to the phenomenon of plate tectonics, to the molecular mechanisms of cholera toxin. Bransfield’s problem—among many—is that 1) he’s not a scientist, and 2) he’s not an infectious disease expert. He’s a psychiatrist. Which begs the question: what’s a psychiatrist doing practicing infectious diseases? How would he like it if members of the IDSA started practicing psychiatry? Probably some of them would do a better job.”]

—If Lyme cannot be chronic, then why did the guideline’s authors acquire 200 Lyme disease patents and receive $76 million in Federal funds to study it?

[One might ask the same thing about bubonic plague or influenza. There’s a continuing scientific interest and there’s a continuing market for new diagnostics and vaccines. Not all infections have to be “chronic” to generate interest and funding, and not all “chronic” conditions generate wide-spread interest or funds.]

—The original guidelines are not only controversial, but written back in 2006, are considered old and out of date.

[By whom? Treatment is not high fashion; it doesn’t change from season to season.]

—The CDC has also advised for many years that the disease should be diagnosed on clinical grounds and not by unreliable laboratory tests. The Lyme disease tests are inaccurate 50% of the time.

[More tautologic nonsense. See comment here.]

—The IDSA’s decision reinforces that doctors have little control when it comes to treating diseases such as Lyme. Researchers and insurance companies remain in the driver’s seat of diagnosis and treatment.

[Again, more nonsense from a psychiatrist wanting to practice infectious diseases. The IDSA guidelines are voluntary and they are “guidelines.” Not laws. Not dicta. No papal bulls. Doctors (and quacks) are in control….right up to the point where they kill, injure or rob someone.

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Labels: ILADS, Quackery

02 April 2010

Censoring Nonsense

May Deadline Set for Controversial Journal's Editor

by Martin Enserink on April 1, 2010

ScienceInsider

Time is running out for Bruce Charlton, the medical journal editor who got into hot water for publishing a paper by AIDS "denialist" Peter Duesberg. Charlton says he has received a letter from his publisher, Elsevier, saying that he will be fired on 11 May if he does not agree to an overhaul of procedures at Medical Hypotheses, the journal which he has edited since 2003. Charlton says the move is an attack on academic freedom and amounts to "steamrollering editorial independence."

In response to angry AIDS scientists, Elsevier has already permanently withdrawn the paper, in which Duesberg, a molecular virologist at the University of California, Berkeley, and his co-authors claimed that there is no link between HIV and AIDS and that South-African medical statistics belie the existence of a large AIDS epidemic in that country. The publishing powerhouse had also said it would not renew Charlton's contract at the end of this year.

Now, the company wants Charlton to unconditionally implement five changes at the journal—most importantly, to introduce a form of peer review. Medical Hypotheses has never used reviewers because its founder believed they stifle the introduction of new ideas. The new system would be a little different than at regular journals—reviewers would only judge the "premise, originality, and plausibility" of hypotheses submitted—but that too is unacceptable to Charlton. So is the demand that potentially controversial articles receive especially careful review.

[snip]

[Reviewers as gatekeepers could be bad news for the ILADS crowd. Where are they going to publish their data-free denialism? LymeNet? A neighborhood newsletter? Obscure Italian journals? Yes, by all means, let’s have some reviewers for MH?]

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Labels: ILADS, MISC

23 March 2010

i.v. infusion: Safe? Maybe. Necessary? Who knows?

Well, Stricker’s paper on i.v. treatments for Lyme disease isn’t much more enlightening than the earlier abstract.As a reminder, the authors of this trial are 1) people who believe in long-term antibiotic use for the persistent symptoms of presumptive Lyme disease, 2) people who are members of an organization (ILADS) dedicated to the use of long-term antibiotics for presumptive Lyme disease, 3) people from a home infusion company who market themselves as a “Lyme literate” pharmacy*, and 4) people who are members of a patient advocacy group dedicated to the belief in chronic antibiotic usage for chronic Lyme disease. Therefore, expect some serious bias.

So Stricker et al. gathered up some data on 200 patients (in 18 states) who had been diagnosed and treated for Lyme disease.

According to the authors, “all patients had significant neuropsychiatric symptoms,” which the authors and the treating physicians apparently attributed solely to Lyme disease. No inclusion criteria for patient selection are provided in the text. There’s no case definition for persistent neurologic Lyme disease. There is only a reference to Fallon’s 2008 clinical trial in which he famously had so much trouble finding well-defined chronic Lyme patients. (After screening 3,368 potential patients, he found 37 with some convincing evidence of Lyme disease. They got treated with 10 weeks of iv ceftriaxone after which Fallon concluded: “10 weeks of iv ceftriaxone…is not an effective strategy.” I wonder why he’s not on this particular study?)

All of the patients also tested positive for B. burgdorferi, but again, they don’t say how they were tested or where. (I’m guessing the various treating physicians in the unnamed 18 states had Igenex do some serology.)

The patients were largely middle-aged (mean 41 years) women (141 women vs. 59 men), plugged into some manner of i.v. device for an average of 118 days. (Interesting sex ratio. According to the CDC surveillance data, men and women contract Lyme in about equal numbers. Then why so many women with “significant neuropsychiatric symptoms”?)

The i.v. devices include PICC lines, peripheral catheters, s.c. ports, c.v. catheters, and midline catheters. The particular device was selected by the various treating physicians, along with the particular antibiotic and dosage. Table 1 in the paper lists 13 different antibiotics used among 200 patients.

So we have 200 people who may or may not have an active borreliosis, enrolled based on vague criteria from an unknown number of primary care physicians using five different i.v. devices and 13 different kinds of antibiotics over a period of time that ranged from 7 to 750 days.

What a mess of variables and unknowns. The stats software must have imploded trying to make sense of this trial. But then some of the virtues of InStat software are 1) that it “does not assume that you are a statistics whiz,” 2) “you don’t have to know the name of the test you need," and 3) “all prompts to the user are in plain English and simple to follow.” Stats for Dummies.

Conclusions?

Table 2 lists complications from the i.v. devices and the medication. There were 24 patients with complications. So that’s 12% of the study population who experienced an adverse event. Is that considered safe? Stricker says so.

Is it effective? Stricker writes, “It remains to be seen whether this length of treatment was able to reduce or eliminate an underlying infection.” (Assuming one ever existed.) Apparently we have to wait for the sequel in the form of another bad paper in an obscure foreign journal. He writes, “The present study…makes no comment about the efficacy of this treatment.”

Was this really ethical? Lining up a bunch of people (with significant neuropsychiatric symptoms) to see if procedure X is not therapeutic but merely safe? Sounds like something you’d do with guinea pigs.

*"The QMedRx Clinical Staff and Medical Advisory Committee have prepared a web based patient outcome questionnaire. Our goal is to help your physician maximize your response to treatment, make data easier for you to document and easier for your physician to retrieve. Some benefits may include the collection and publishing of data to document the positive outcome of IV antibiotic treatment."

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Labels: ILADS, Lyme disease, Stricker

17 March 2010

Don't Believe Everything you Read

Minerva Med. 2010 Feb;101(1):1-7.

Safety of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease.

Stricker RB, Green CL, Savely VR, Chamallas SN, Johnson L.

AIM: Although intravenous antibiotic therapy is recommended for neurologic Lyme disease, safety concerns have been raised about treatment beyond 30 days in patients with persistent neurologic symptoms. The goal of our study was to evaluate the safety of extended intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease.

METHODS: We enrolled 200 consecutive patients with significant neurologic symptoms and positive testing for Borrelia burgdorferi. Patients were treated with intravenous antibiotics using various intravascular devices (IVDs). Standard IVD care was administered to all patients, and monitoring for medication reactions and IVD complications was performed on a weekly basis.

RESULTS: The mean length of intravenous antibiotic treatment was 118 days (range, 7-750 days) representing 23,654 IVD-days. Seven patients (3.5%) experienced allergic reactions to the antibiotic medication, and two patients (1.0%) had gallbladder toxicity. IVD complications occurred in 15 patients (7.5%) representing an incidence of 0.63 per 1,000 IVD-days. The IVD problems occurred an average of 81 days after initiation of treatment (range, 7-240 days). There were six suspected line infections for an incidence of 0.25 per 1,000 IVD-days. Only one of the IVD infections was confirmed, and no resistant organisms were cultured from any patient. None of the IVD complications were fatal.

CONCLUSION: Prolonged intravenous antibiotic therapy is associated with low morbidity and no IVD-related mortality in patients referred for treatment of neurologic Lyme disease. With proper IVD care, the risk of extended antibiotic therapy in these patients appears to be low.

So Stricker finally got around to publishing this defense of LLMD practices: pump the patient full of antibiotics until the wallet is empty. I’m looking forward to picking through the full article—assuming I can lay my hands on this obscure Italian journal.

One thing I have noticed is the published PubMed abstract is different from the original abstract published in J. Invest. Med. 2008;56:190 Meeting Abstr. 261.

The current abstract mentions 200 patients. The original one lists 199. (Maybe one was hiding under the bed.) The current abstract lists 6 “suspected line infections.” The original lists three. Discrepancies aside, if you add up the adverse events you get 15% of the study population. Does that appear to be low risk? Well, like I said, it’ll be interesting to read through the entire work of art.

Couple of other points of interest. The authorship has changed. Lorraine Johnson—a lawyer for the California Lyme advocates group—is now listed as an author. What role could she possibly have played in an alleged clinical trial for chronic Lyme disease? Is she just padding her resume in case she ever goes looking for a job?

Another author is V.R. Savely, a nurse who was run out of Texas for her treatment of Lyme patients and the Internet version of delusional parasitosis, called Morgellons, and who now works for—wait for it--Stricker. Another author is from QMedRx, the “Lyme literate” home infusion company. Presumably, they paid for this study, which only adds to the overall suspicion about the merits and the purpose of this piece of clinical sleight-of-hand.

Finally, I’m eager to find out what antibiotics were pumped into these people for “7-750 days.” And, of course, it should be especially interesting to see what case definition Stricker used to enroll his cohort of 199 or 200 patients. What did he define as “chronic Lyme disease” and did any of his patients recover from it after “7-750 days” on antibiotics.

So at the moment, we have a trial of unknown quality allegedly showing the benefits (or at least safety) of long-term antibiotics for “chronic Lyme disease” conducted by:

people who believe in the routine use of long-term antibiotics for a syndrome called “chronic Lyme disease;” who belong to an organization (ILADS) whose sole purpose to promote such treatments; whose incomes are dependent on such patients and such treatments; and a company whose income is partly dependent on selling such treatments to Lyme patients and LLMDs; all led by a guy who “falsified data” and “selectively suppressed data that did not support his hypothesis, and reported consistently positive data whereas only one of four experiments had produced positive results.”

If the IDSA or some drug company like Pfizer or Merck tried to pass off some research like this, the Lyme activist community would be screaming bloody“conflicts of interest” and speed-dialing Blumenthal, the Lyme-obsessed A.G. in Connecticut. But…strangely…they are not. Why is that?

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Labels: ILADS, Lyme disease, Stricker

25 February 2010

Revising Nonsense

From the ILADS Web site: Although the ILADS guidelines are no longer listed on theNGC, they have not expired. The current guidelines will remain in effect until they are replaced by ILADS revised guidelines, which ILADS is currently in the process of updating.

ILADS expects their next guidelines will continue to meet the NGC criteria to be listed…

I wouldn’t make that assumption. They were posted mistakenly the first time. Why would the NGC make the same mistake twice?

Revised guidelines? Well, I hope they’re not going to do all the terrible things they accused the authors of the IDSA guidelines of doing: ignoring published evidence, ignoring financial conflicts of interest, and ignoring the recommendations of other experts. That kind of hubris could get them sued for anti-trust.

And in a related development….ILADS is going to the U.K. to spread the gospel of Lyme disease quackery.

In conjunction with ILADS, ILADS' Member Sarah Chissell, MD is organizing a one day conference. The goal will be to educate the medical professional on the proper diagnosis and treatment of Lyme disease. It is geared towards medical professionals who have minimal familiarity with the subject matter.

Confirmed speakers for this event include: Robert Bransfield, MD; Sarah Chissell, MBChB MRCOG; Richard Horowitz, MD; David Martz, MD; Carsten Nicolaus, MD; Prof. Perronne; Leo J. Shea, III, PhD; Raphael Stricker, MD.

Well, at least half of them have not been hauled before medical licensing boards or been found guilty of scientific misconduct. As far as I know.

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Labels: ILADS

22 February 2010

Bye Bye Guidelines

“ILADS...guidelines are evidence-based and peer-reviewed.”

Well, they were posted on the AHRQ website and published in Expert Review of Anti-Infective Therapy. But the AHRQ disclaimer says they can’t vouch for anything on their website, and the publisher explicitly states :

“In this instance the guidelines represent a consensus document produced by a working group consisting of members of the International Lyme and Associated Disease Society (ILADS). As such, the document was not subject to our standard review procedures as applied to individual articles and the guidelines reflect the collective opinion of the ILADS working group, as set out in the introduction.”

And now they don’t have to. The ILADS Guidelines (such as they were) are gone. TheNational Guideline Clearinghous finally took them down.

I’m sure ILADS will want to post them again for purposes of propaganda, but first they’ll have to update them. How, I wonder, are they going to go about the process of updating their guidelines? Will it be an honest and open process, looking at other sets of guidelines and other “expert” opinions? If not, I hope someone doesn’t file an anti-trust suit against them. Anyone have Blumenthal’s number handy?

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Labels: ILADS

01 January 2010

The Dynamic Duo

Sounds like the dynamic writing team of Stricker andJohnson are busy photocopying their last polemic—which somehow got published in the Journal of Medical Ethics—for the pages of the Journal of Clinical Ethics. This will probably be a duplicate publication with a couple of the previous lies in JME re-arranged for JCE. It’s legal, but not necessarily ethical to crank out essentially identical papers just to produce another publication for the ol’ resume.Of course, most of what they write are just letters to the editor and the occasional long-winded and redundant opinion piece. There’s never any data—just denunciations of other people’s data. There are no facts—just distortions of other people’s facts. It’s scientific debate by slight-of-hand, cherry-picking, distortion, propaganda, and lies. What I can’t figure out is why Stricker needs a lawyer (Johnson) as a co-author. True, he was banned from receiving federal funds for scientific misconduct and later fired from his university. He eventually found salvation (financial, I guess) in a penis enlarging clinic, and later in treating people who thought they had “chronic” Lyme disease or Morgellons. So I guess Johnson serves some kind of legal ass-covering role.

Certainly, as an unemployed lawyer with no scientific or medical training, she could not be expected to make any credible contributions to a topic on anti-tumor necrosis factor or "antibiotic-refractory" Lyme arthritis, for example. (But to be fair, I’m not sure Stricker can either.)

Maybe she’s just a good typist.

Anyway, look for some more redundant bitching from the dynamic dudes of Lymeland in the new year.

1: Stricker RB, Johnson L. Gender bias in chronic lyme disease. J Womens Health (Larchmt). 2009 Oct;18(10):1717-8; author reply 1719-20.

2: Stricker RB, Johnson L. The Infectious Diseases Society of America Lyme Guidelines: Poster Child for Guidelines Reform. South Med J. 2009 May 7.

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

4: Stricker RB, Johnson L. Chronic Lyme disease and the 'Axis of Evil'. Future

Microbiol. 2008 Dec;3(6):621-4. Review.

5: Stricker RB, Johnson L. Re: Prolonged Lyme disease treatment: enough is enough. Neurology. 2008 Oct 21;71(17):1380; author reply 1380-1.

6: Stricker RB, Johnson L. Serologic tests for lyme disease: more smoke and mirrors. Clin Infect Dis. 2008 Oct 15;47(8):1111-2; author reply 1112-3.

7: Stricker RB, Johnson L. Re: 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 May 6;70(19):1719; author reply 1719-20.

8: Stricker RB, Johnson L. Persistent Borrelia burgdorferi infection after treatment with antibiotics and anti-tumor necrosis factor-alpha. J Infect Dis. 2008 May 1;197(9):1352-3.

9: Stricker RB, Johnson L. Searching for autoimmunity in "antibiotic-refractory" Lyme arthritis. Mol Immunol. 2008 Jun;45(11):3023-4. Epub 2008 Apr 18.

10: Stricker RB, Corson AF, Johnson L. Reinfection versus relapse in patients with lyme disease: not enough evidence. Clin Infect Dis. 2008 Mar 15;46(6):950; author reply 950-1.

11: Stricker RB, Johnson L. Lyme wars: let's tackle the testing. BMJ. 2007 Nov 17;335(7628):1008.

12: Stricker RB, Johnson L. Lyme disease: a turning point. Expert Rev Anti Infect Ther. 2007 Oct;5(5):759-62.

13: Stricker RB, Brewer JH, Burrascano JJ, Horowitz R, Johnson L, Phillips SE, Savely VR, Sherr VT. Possible role of tick-borne infection in "cat-scratch disease": comment on the article by Giladi et al. Arthritis Rheum. 2006 Jul;54(7):2347-8.

14: Stricker RB, Burrascano JJ, Harris NS, Horowitz R, Johnson L, Smith PV, Phillips SE. Coinfection with Borrelia burgdorferi and Babesia microti: bad or worse? J Infect Dis. 2006 Mar 15;193(6):901-2; author reply 902. PubMed PMID:

16479529.

15: Phillips SE, Burrascano JJ, Harris NS, Horowitz R, Johnson L, Smith PV, Stricker RB. Rash decisions about southern tick-associated rash illness and Lyme disease. Clin Infect Dis. 2006 Jan 15;42(2):306-7; author reply 307-8.

16: Phillips SE, Burrascano JJ, Harris NS, Johnson L, Smith PV, Stricker RB. Chronic infection in 'post-Lyme borreliosis syndrome'. Int J Epidemiol. 2005 Dec;34(6):1439-40; author reply 1440-3. Epub 2005 Nov 30.

17: Phillips SE, Harris NS, Horowitz R, Johnson L, Stricker RB. Lyme disease: scratching the surface. Lancet. 2005 Nov 19;366(9499):1771.

18: Stricker RB, Johnson L, Harris N, Burrascano JJ. Inaccurate information about lyme disease on the internet. Pediatr Infect Dis J. 2005 Jun;24(6):577-8; author reply 578-9.

19: Johnson L, Stricker RB. Treatment of Lyme disease: a medicolegal assessment. Expert Rev Anti Infect Ther. 2004 Aug;2(4):533-57. Review.

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Labels: ILADS, Quackery, Stricker

14 December 2009

16 to 1 (well, actually, 16 to 0)

Recommendations for diagnosis and treatment of Lyme borreliosis: guidelines and consensus papers from specialist societies and expert groups in Europe and North America

The European Union Concerted Action on Lyme Borreliosis (EUCALB) initiative, funded initially by the EU, continues to promote research and evidence-based clinical practice through European multi-disciplinary collaboration and a highly-regarded and frequently updated website. Its clinical case definitions for Lyme borreliosis were published in 1997 and an updated version is to be published shortly. EUCALB’s current work programme includes a review of currently recommended treatments in Europe and the evidence on which they are based.

Since the publication of the Infectious Diseases Society of North America’s updated guidelines for Lyme borreliosis in 2006 there has been considerable public dispute in the USA and elsewhere regarding choice of antibiotic agents and duration of antibiotic treatment for Lyme borreliosis, particularly for patients who have persistent symptoms following standard treatment. Some patient support groups and a minority of physicians have been very active in promoting prolonged or multiple repeated courses of antibiotics for patients with persistent symptoms in North America and in Europe.

There has also been criticism about the use of the IDSA guidelines for patients in Europe, prompting the evaluation of European guidelines and recommendations and a comparison with American recommendations.

No evidence-based European or North American guideline recommends prolonged or multiple courses of antibiotics for persistent symptoms following previously treated Lyme disease.

"Evidence-based." That's why the score is 16-0.

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Labels: IDSA, ILADS

19 November 2009

Evidence for Guidelines: Good to Excellent

Infectious Disease Treatment Guidelines Weakened By Paucity of Scientific Evidence

Daniel M. Keller, PhD

November 13, 2009 (Philadelphia, Pennsylvania)

One piece of news out of the recent IDSA meeting in Philly has the denizens of Lymeland outraged. Though to be fair, they’re easily outraged and prone to daily fits of sputtering. The recent episode of sputtering was initiated by the following report about clinical guidelines produced by the IDSA:

Two separate analyses presented here at the Infectious Diseases Society of America (IDSA) 47th Annual Meeting revealed that most of the society's treatment guidelines are based on expert opinion, nonrandomized trials, and case studies. Only about 15% of the guidelines are supported by randomized controlled trials (RCTs), considered the highest level of evidence.

Nonetheless, more than 40% of the guidelines' recommendations were classified as class A, the strongest level of treatment recommendation, according to Dong Lee, MD, and colleagues from the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine in Philadelphia, Pennsylvania.

Between 1994 and April 2009, IDSA issued 68 guidelines on 52 different topics (there have been 2 more since April). Most were published in Clinical Infectious Diseases.

Of the 52 current guidelines, Dr. Lee's team analyzed the 30 that followed IDSA's standard grading system to evaluate the class of clinical recommendations and the strength of the supporting evidence underlying them.

"Our analysis revealed that more than half were based on expert opinion or not supported by properly controlled trials," Dr. Lee announced.

In an oral presentation, he reported that the 30 guidelines he analyzed contained a mean of 47 recommendations (range, 14 to 150).

Recommendations ranged from class A (should always be offered) to class C (optional).

The quality of evidence ranged from level I, consisting of 1 or more properly conducted RCTs, to level III, the opinion of respected authorities, based on clinical experience.

Level II evidence is derived from 1 or more properly controlled trials without randomization.

The guidelines revealed a total of 589 class A recommendations. "Ideally, all should be [supported by] level I evidence," Dr. Lee said.

Well, that’s the key word: “Ideally.” It’s expensive to do randomized, controlled studies. It’s difficult to find funding for such things, not too mention finding appropriate patient populations. For better or worse, much of science, medicine, and technology is guided by expert opinion because there is nothing else available.

Guidelines for common conditions were often based on fairly strong evidence.

So even in the absence of ideal trials there is high confidence that expert-derived guidelines offer fairly reliable advice about treating patients.

He explained the lack of RCTs for some conditions, saying that certain infections occur rarely or present in heterogeneous forms, making it difficult to design a study.

Furthermore, in some cases it might be unethical to conduct such a trial, and at times certain knowledge based on sound clinical judgment will never be tested in RCTs. Finally, funding to do trials might be lacking.

"Although a randomized controlled trial is referred to as level I evidence, not all RCTs are created equal," he warned. "Some choose surrogate markers, others choose patient-centered outcomes.

Well-designed nonrandomized trials may provide more information than certain randomized controlled trials, but I do think that a randomized controlled trial minimizes bias and does deserve the high levels of evidence."

Lee also reminded attendees at his presentation that guidelines are just that: guidelines. Not law. Not regulation. Not written in stone. It’s a word and a concept that some lawyers and most Lyme activists repeatedly fail to comprehend.

Physicians and trainees should not just look at guidelines, but should also examine the strength of the evidence on which they are based, he advised. “. . . Clinicians should remain cautious when using current guidelines as the sole source for guiding patient care."

Richard Whitley, MD, professor of pediatrics, microbiology, medicine, and neurosurgery at the University of Alabama at Birmingham and president of IDSA, “noted that sometimes expert opinion or small uncontrolled studies have to suffice if there are not enough patients to conduct better trials.”

That, of course, has been a frequent problem in treatment trials for Lyme disease. There are few patients with objective signs of infection.

Nonetheless, the Lyme activists have taken the Lee analysis as evidence that the 2006 IDSA guidelines for the treatment of Lyme disease are deeply flawed and should be abandoned. Curiously, there’s no clamor to abandon the boot-strapped guidelines promulgated by that renegade group calling itself the “International Lyme and Associated Diseases Society (ILADS).

Those guidelines were cobbled together by a handful of private practice physicians (almost all of whom lack training in infectious diseases) looking to justify their own expensive but ineffective treatments of patients who believe they have a persistent Lyme infection. Their own guidelines remain unsupported by RCTs, other trials, or expert opinion. Instead they seem to be based on belief, anecdote, a touch of quackery, and good old-fashioned greed.

In the end, any activists’ accusations aimed at the IDSA also must be directed at the practices of their own doctors, the LLMDs of ILADS.

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Posted by Relative Risk at 08:26 0 comments Links to this post

Labels: IDSA, ILADS

08 November 2009

Conference Wrap-up

Below are a couple of comments from a Maryland-based family practice physician who went to the recent ILADS conference. (I’m not linking to his blog because it appears to be nothing more than an ad for people who think they have Lyme disease.) Sounds like even he was groping for something positive and informative to pass on.

Eva Sapi's research: very revealing. Lyme in the test tube quickly convert to cyst form when doxycyline is added to the cultures.

Wow! An antibiotic causes bacteria to curl up and die in a test tube. That’s amazing! I won’t have expected this kind of ground-breaking research from the University of New Haven’s lone Lyme “expert.”

The ILADS' conference was great this year. Presentations were scientific and evidenced based.

So in previous years the presentations were not scientific or evidence-based?

Dr. Burasanno and Dr. Horowitz were animated and informative. "There is no one right way to treat Lyme."---Dr. Burascanno.

Yes, but what did they have to say that was scientific and evidence-based? And there’s no right way to treat Lyme? How about that evidence-based approach?

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Posted by Relative Risk at 09:40 0 comments Links to this post

Labels: ILADS

30 September 2009

Buying Participants?

Are these Lyme activists getting desperate? Now they’re paying people to attend their meetings?

Here’s a recent note from one such organization:

Reimbursement for ILADS and LDA conference attendance up to $500 total.

CALDA will reimburse up to $500.00 out-of-pocket expenses for any actively practicing MD, DO, ND, NP or PA in any state to attend the annual conferences put on by the International Lyme and Associated Diseases Society (ILADS) and the Lyme Disease Association (LDA). CALDA grants are limited and are only available to those qualifying professionals who are attending the conferences for the first time.

Most professional society meetings have some travel money for grad students, postdocs, and fellows who are presenting talks and posters. But this sounds like CALDA or LDA or ILADS--well, actually they’re all the same people--are trying to rope in some naïve practitioners who don’t know much about Lyme disease or about Lyme disease activists. It could turn out to be more like an indoctrination than an education for the unlucky recipients of these conference grants.

Personally, I think it would take a lot more than $500 to make the average professional sit through lectures by the likes of Stricker, Johnson, Pat Smith, Joe Burrascano, and the 80-year-old Jones. What could one possible learn from such people? How to get through a licensing board hearing? How to threaten someone with legal action? How to manipulate and intimidate local politicians? How to survive a federal funding bar? How to hide cash payments?

I’m sure on one level it would be entertaining, but $500 isn’t enough money to drag me in.

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Posted by Relative Risk at 01:51 0 comments Links to this post

Labels: ILADS, LDA

23 September 2009

ILADS Baloney from Maloney

Well, it’s only been a few days since some ILADS priest has issued a polemic denouncing evidence-based medicine in general and the Infectious Diseases Society of America in particular.

This time ILADS quack, Elizabeth Maloney, has written “The Need for Clinical Judgment in the Diagnosis and Treatment of Lyme Disease” in the house organ of a right-wing medical group, the AAPS.

It’s the same old crap thinly disguised as reasoned analysis and argument.

First off, she attacks the insensitivity of serology in early stage Lyme disease. Well, yes, you need time to make antibody before you can measure antibody. Don’t blame diagnostics or the IDSA; blame Mother Nature. That’s just how the world--and immunology--works.

Then she’s on to the alleged insensitivity and specificity of current diagnostics in late stage Lyme, citing a couple of 15-year-old papers about Lyme testing. No mention of the diagnostic changes following the 1994 Dearborn Conference or the multitude of papers on serology and assays that followed. (Centers for Disease Control and Prevention. 1995. Recommendation for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR. 44:590-591.)

Next up, some arguments and citations suggesting long-term antibiotics and i.v. antibiotics are safe. But again, no mention of the cases of antibiotic-associated biliary complications among people with suspected Lyme disease or the horrific death of one individual at the hands of some clumsy, incompetent “Lyme Literate” doc (refs below).

Ceftriaxone-Associated Biliary Complications of Treatment of Suspected Disseminated Lyme Disease -- New Jersey, 1990-1992.

January 22, 1993. MMWR. 42(02);39-42

Clin Infect Dis. 2000 Oct;31(4):1107-9.

Death from inappropriate therapy for Lyme disease.

Patel, R et al.

No mention either of the 142,000 annual ER visits due to antibiotic adverse events, or the 20,000 annual community-acquired C. difficile infections caused by overuse or improper use of antibiotics.

Her best excuse for pumping antibiotics into people who think they have Lyme disease: “there is no test of cure.” Well, I’m hard pressed to think of a ‘test of cure’ for anything. Why not keep cancer patients on chemo indefinitely? Why not irradiate people indefinitely? Why not pump INH and rifampicin into TB patients for years and years beyond the standard 6-9 month timeframe? After all, there’s no definitive test to show that they’re free of every single cancer cell or mycobacterium.

The whole point of this paper--and every other op-ed, letter, commentary, and piece of fiction from ILADS and their patient supporters--is to again make the demand that “physicians should be free to act without interference….” Well, I’d like that right too. And I’m sure the police would too. And the FBI. And oil executives. And politicians. And Wall St. financiers….Oh, wait. They had that right, but it didn’t turn out too well for anyone but them.

Given their track record of patient lawsuits, federal sanctions, criminal charges, and license suspensions, I’m sure all these “Lyme Literate” quacks would like to be free of all legal, professional, financial and moral modes of interference. But that’s not going to happen. Ever.

Maloney laments the shortcomings of medical guidelines in general and the IDSA guidelines for Lyme disease in particular. So why is she a member of a group that bootstrapped their own treatment guidelines for Lyme disease? Better yet, why isn’t she advocating those ILADS guidelines instead of complaining about the IDSA guidelines? Why not try to promote the alternative guidelines? Is it because those guidelines are little more than a fig leaf for physicians to “act without interference?”

Maloney signs off noting she’s a physician from a “Lyme disease endemic area in Minnesota.” She can’t be very busy. According to last week’s MMWR there have been 67 cases of Lyme reported in Minnesota to date. In all of 2008, there were 330. Did she happen to treat all 330 last year or has she just neglected to report all her cases to the CDC like a good doc should?

Posted by Relative Risk at 11:27 0 comments Links to this post

Labels: diagnostics, ILADS, Lyme disease, Politics

14 September 2009

The Bizzaro Version of a Scientific Conference

Below is a list of conference “faculty” for an upcoming meeting of the ILADS, a group of like-minded quacks preying on people who think they have a chronic, incurable bacteria infection otherwise know to the saner world as Lyme disease.

If the roof of the conference room was to fall in, it would put an end to a large amount of quackery in the U.S., save many people from financial ruin, and lessen the workload of numerous state medical licensing boards.

Quite a few of these so-called “Lyme Literate” doctors have been sued by former patients or dragged before state licensing boards for their unorthodox practices; and not because they’re treating Lyme disease, but because they’re just bad doctors. Some of them aren’t even doctors.

What’s particularly interesting about the below list is the large number of people with training in psychiatry or psychology. Now Lyme disease is a common bacterial infection, normally treated by internists, rheumatologists and infectious diseases specialists. That a number of head doctors are involved with chronic Lyme patients suggests they at least recognize the common psychiatric co-morbidity among people who think they have a chronic Lyme infection and are taking advantage of that professional recognition. Regrettably, they are probably taking financial advantage of the situation. (Note: the exception is Joseph J. Trunzo, PhD at Bryant University in Rhode Island who is trying to conduct a legitimate study of these unfortunate people. No doubt this will be his last ILADS meeting....unless he starts up a study of doctors who believe in chronic Lyme disease or make a living off of chronic Lyme disease patients.)

What’s surprising about these annual self-stroking sessions is that they have anything to talk about. They don’t do research. They don’t pay attention to actual infectious disease research or the professional literature because they despise the people who do that work. More to the point, they actually don’t believe in research in the modern sense or what most scientists recognize as evidence. So what do they talk about year after year? Bill padding? How to hide cash payments? Property values in the Caribbean? How to get your patients to pay your legal fees through Internet-solicited defense funds? I don’t know. It might be interesting to attend some of this conference, but I’m afraid my head would explode.

Finally, quite a few of these quacks seem to have gone though something called ILADS/TTCF training. I’m not sure what it involves, but it probably makes a bad doctor worse, or perhaps less aware of his or her inadequacies by masking them within a group of equally bad or unaware graduates of medical schools now masquerading as healthcare providers. Certainly, it doesn’t help patients. The Internet is choke-full of middle-aged, white women sitting online at home convinced they have an incurable infection that robs them of the ability to do anything but sit at home online complaining about their incurable infection and the vast conspiracy of insurance companies and academic researchers who are keeping them from appropriate treatment.

Wayne Anderson, ND, ILADS member, is a naturopathic doctor

Paul V. Beals, MD, is an integrative medicine specialist and ILADS member

Sandra Berenbaum, LCSW, is an ILADS member with a private practice

David Berg, MS, is lab director at Arizona Coagulation Consultants

Steven J. Bock, MD, ILADS member

Marilyn Boehm, MD, graduate ILADS/TTCF training program, private practice

Robert C. Bransfield, MD, President-Elect ILADS, private psychiatry practice

Joseph J. Burrascano, Jr., MD, Board member ILADEF

Daniel J. Cameron, MD, MPH, President ILADS, private practice

Sarah Chissell, MD, graduate ILADS/TTCF training program, OB-GYN

Ann Corson, MD, graduate ILADS/TTCF training program, now a training physician

Jonathan Forester, MD, MS, FAAOA, ILADS member, private practice

Andrea Gaito, MD, Past President ILADS, rheumatologist

Eric Gordon, MD, ILADS member, private practitioner in specializing in alternative medicine

Christine Green, MD, ILADS training physician; private practitioner

Steven Harris, MD, ILADS/TTCF training physician; private practitioner

Richard I. Horowitz, MD, President of ILADEF, ILADS/TTCF training physician; private practice

Joseph G. Jemsek, MD, ILADS Treasurer and ILADS/TTCF training physician. Private practice

Lorraine B. Johnson, JD, ILADS Secretary, Executive Director, California Lyme Disease Association

Charles Ray Jones, MD, ILADS member, ILADS/TTCF training physician

Ahmed Kilani, PhD, is lab director of Clongen Laboratories

Cheryl Koopman, PhD is associate research professor of psychiatry

Judith G. Leventhal, PhD is membership chair, ILADS and is in private psychological practice

Kenneth Liegner, MD, ILADS/TTCF training physician who is in private practice

Elizabeth Maloney, MD is a prolific advocate on behalf of Lyme patients. She is a member of ILADS.

David C. Martz, MD, is an ILADS Board member and advocate for Lyme patients

Maureen McShane, MD is a graduate of the ILADS/TTCF training program. She is in private practice

V. Anne Mears, BSN, is a member of ILADS and Lyme advocate

Shawn Naylor, DO, is a graduate of the ILADS/TTCF training program with a special interest in alternative medicine

Carsten Nicolaus, MD, PhD is a member of ILADS.

Steven E. Phillips, MD is past president of ILADS. He is in private practice

Bernard D. Raxlen, MD, is a ILADS/TTCF training physician in private psychiatry practice

Virginia Savely, RN, FNP-C, ILADS member and graduate of the ILADS/TTCF training program

Armin Schwartzbach, MD, PhD is an ILADS member. He is specialist in laboratory medicine

Leo J. Shea, III, PhD is a Board member of ILADS. He is in private clinical psychology practice

Virginia T. Sherr, MD is in private psychiatric practice. She is a former Board member of ILADS.

Samuel M. Shor, MD, is an ILADS member and internal medicine specialist

Sheila M. Statlender, PhD is an ILADS member in private clinical psychology practice

Raphael B. Stricker, MD, is past president of ILADS. He is in private practice

Aparna N. Taylor, ND is a graduate of the ILADS/TTCF training program and member of ILADS. She is in private practice

Keri B. Topouzian, DO, is a graduate of the ILADS/TTCF training program in practice

Joseph J. Trunzo, PhD is associate professor, Department of Applied Psychology at Bryant University.

Diane Wilcox, PhD is an ILADS member.

David S. Younger, MD is an ILADS member who has a private clinical practice

Leila H. Zackrison, MD is a former ILADS Board member and active in clinical practice

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Posted by Relative Risk at 11:44 0 comments Links to this post

Labels: Cameron, ILADS

17 August 2009

Panel hears conflicting views on Lyme disease treatment

The board of eight physicians and a veterinarian is charged with deciding if one society's guidelines should be revised.

By Susan J. Landers

AMNews, Posted Aug. 17, 2009.

Washington -- The debate over whether chronic Lyme disease exists and how it should be treated has become increasingly contentious in the past few years, even prompting antitrust charges by one state attorney general over treatment guidelines.

A day-long hearing was held July 30 as part of a voluntary agreement between the Infectious Diseases Society of America and the Connecticut attorney general for a review of the society's guidelines. Those guidelines characterize Lyme disease as an acute infection best treated with antibiotics for a few weeks at most.

In contrast, the International Lyme and Associated Diseases Society recommends long-term treatment with antibiotics for patients with what is called chronic Lyme disease, or post-Lyme disease syndrome, characterized by persistent and severe joint pain, fever and fatigue.

Scientists and physicians have to do a better job of reminding reporters that ILADS isn’t a real medical society, but rather a small collection of like-minded private practice physicians—many of whom have been censured by state medical boards, sued by their own patients, or barred from federal granting agencies—with little or no research experience or infectious disease training, and whose headquarters is a mail drop in Bethesda, Maryland. Their own treatment guidelines are a non-peer-reviewed, anecdote-based collection of self-justifications for expensive quackery.

[snip]

Raphael Stricker, MD, past president of the ILADS, which advocates long-term use of antibiotics for patients with the chronic form of the disease, testified that he would like to see the IDSA guidelines rewritten.

I’m sure he would. He could probably use the money from all those foolish patient/fan/activists.

Dr. Stricker is hopeful that such a revision is possible. "The panel members seemed genuinely moved by the evidence, and I can only hope that will translate into something that is productive rather than something that is political," he said.

I think he means “something that is financial.” Activists and their enabling quacks have always claimed Lyme disease is a “political” disease, but it’s not: it’s a financial disease, in which a few practitioners, diagnostic labs, and home infusion companies hope to continue to make millions of dollars pumping expensive antibiotics (or more likely cheap saline) into gullible hypochondriacs.

[snip]

Phillip Baker, PhD, who served as program officer for the Lyme Disease Research Program at the National Institute of Allergy and Infectious Diseases, supported the IDSA guidelines.

"A major criticism raised by those who oppose the IDSA guidelines is that they fail to provide evidence to support legitimate opposing views, namely that extended antibiotic therapy is beneficial for the treatment of chronic Lyme disease," Dr. Baker said. "That is not a deliberate omission. The simple fact of the matter is that there is no published evidence -- derived from a well-designed placebo-controlled clinical trial -- to show that such therapy is both beneficial and safe."

Phil’s right of course. Scientists and clinicians are all from Missouri where the motto is, “Show us the evidence!” There’s nothing more compelling than hard data…except maybe cold, hard cash.

[snip]

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Posted by Relative Risk at 11:12 0 comments Links to this post

Labels: IDSA, ILADS, Lyme disease, Politics, Stricker

13 July 2009

ILADS: Home Sweet Home?

I had always assumed the ILADS Bethesda address was just a mail drop. Turns out it’s a house.

On a recent trip to the once small town of Bethesda, Maryland, I had some time to drive through the leafy, deer-infested wilds of Bethesda. And up on Dellwood Place—a narrow neighborhood street of single-family homes—was the apparent headquarters of ILADS.(It’ll show up on Google Maps.)

Seems like an odd place to have a society headquarters. Its locale reminded me of the frequent Mexican lament: “So far from heaven, so close to the U.S.” Of course, in the case of ILADS that refrain might be: “So far from credibility, so close to the NIH.”

Posted by Relative Risk at 20:39 0 comments Links to this post

Labels: ILADS

12 May 2009

A Medicolegal Broken Record

I finally got around to reading“Treatment of Lyme disease: a medicolegal assessment,” by the dynamic duo, Lorraine Johnson, JD and Ralph Stricker, MD. The assessment was published in 2004, and five years later they’re still dribbling out the same argumentative mis- and dis-information. But they get points for staying on message.I’m not going to review the entire paper: it’s 24 pages long and we’ve heard it all before. But just for fun—and because it’s important to call out dishonest people—let’s pick through some of the nonsense, starting at the back of this tedious justification for practicing bad medicine and bad law.

First, there are an impressive number of references (221). But many of them are worthless, being from well-known quacks, non-peer-reviewed presentations and abstracts, public testimony, and the websites of Lyme activist organizations. Hardly reliable, objective sources of data. Which is why we can ignore the stated claim of 21 “documented deaths associated with Lyme disease.” (Curious use of “associated.” Why not just say “caused,” “from,” or “due to”? Anyway, it’s pretty hard to die just from Lyme disease, and there are no references in this paper to the handful of cases of Lyme disease in AIDS patients or the successful treatment of those patients.)

Three sentences into this long-winded argument, they’re insisting Lyme disease is a polymicrobial infection, a notion Stricker first tried out in the pages of ASM News (nowMicrobe), and which has since evolved into ubiquitous “co-infections.” Whatever you call it—mixed, co- or polymicrobial infections—it remains the exception not the rule in Lyme disease.

Further down in that same paragraph, they suggest tick-borne Lyme disease might be communicable and a STI. Five years later, this effort to turn a vector-borne infection in a dead-end host into a contagious infection or STI is going strong because quack doctors can then justify treating whole families for Lyme disease. I believe at one point, the Lyme specialty lab, Igenex, was offering a family or group discount for Lyme testing.

Next up, the problem with current diagnostics. They write, “Recent studies…came to the conclusion that the currently available ELISA tests do not have adequate sensitivity to meet the two-tiered approach recommended by the CDC….” Sounds reasonable, but then you have to check the reference paper to discover “recent” actually began in 1991 and led to a 1992-1994 study of lab proficiency testing in Wisconsin, which was finally published in 1997. In 1994, the CDC, NIH, and numerous academic scientists and lab directors—aware of testing problems—met in Dearborn, Michigan to revise recommendations about Lyme disease diagnostic criteria (MMWR, 1995;44:590-1).

They continue beating the dead horse of bad diagnostics and finally write, “The current state of diagnostic testing cannot demonstrate the eradication of B. burgdorferi.” No kidding. No test does or can….for any infection. So having insisted no tests can detect the presence or absence of the bug, they insist treating physicians become economists and “assume an infection.” That’s fine…sometimes. It’s called treating empirically, but at some point you run into the problem of having to define treatment endpoints. And in the absence of an original infection treatment apparently becomes open-ended….at least until the patient’s money runs out.

Next Stricker and Johnson bring up the old claim that Lyme is an intracellular infection, and “intracellular pathogens are notoriously difficult to treat and cure.” Apparently both the MD and the JD need a refresher in basic microbiology and pharmacology, and I happily refer them to Paul Tulken’s online presentation of intracellular pathogens and antibiotics.

“No single antibiotic or combination of antibiotics appears to be capable of completely eradicating the infection…” Right. For 30 years, thousands of people each summer have contracted a common bacterial infection that cannot be treated. Do they actually believe this crap?! And, of course, it begs the question of why then would these Lyme quacks bother to pump their patients full of antibiotics for weeks or months on end. Oh, right. The money.

“Physicians who advocate longer-term antibiotic treatment use an empirical approach based on the clinical evidence of active infection to determine treatment duration. Evidence of ongoing infection is determined by examining all clinical data, including persistence of symptoms, serologic testing…MRI scans, SPECT imaging, neurocognitive testing….” Suddenly serology has some value? None of this stuff is actually going to tell you about the presence or absence of an infection, especially infection by one particular pathogen. These things might say something about pathology but not about etiology.

Then there’s this: “There are no reliable microbiologic or immunologic criteria to document active infection in Lyme disease.” Which is followed by this: “The persistence of B. burgdorferi despite presumptively adequate antibiotic treatment has been repeatedly demonstrated by post-treatment isolations of the bacteria.” Well, which is it: you can determine infection by isolation or you can’t? Ignoring the issue of re-infection in this nonsense, let’s look at the cited reference about post-treatment isolation of bacteria. It’s Orv. Hetil. 2002;143(21):1195-8. The article is actually about in vitro antibiotic sensitivity, not chronic infection, and states, “…treatment failures may be interpreted by serum and tissue levels of the antibiotic [being] too low for an effective killing…. However, prolonged treatment regimens applying higher dosages of antibiotics…may be linked to aggravated side effects.” I guess they don’t read all of the papers they cite.

Still trying to justify the open-ended use and cost of antibiotics, they cite other examples of infections that require long-term antibiotics. These include TB, leprosy, endocarditis, leptospirosis and syphilis. First, there is always evidence of an actual infectious agent in these cases. Second, treatment typically consists of one or two drugs given orally. TB, for example is treated with 6-9 months of oral antibiotics.

Even a chronic, insidious infection like leprosy will typically require three oral meds for 6-12 months. Whereas many Lyme quacks have put their victims on powerful i.v. antibiotics for weeks or months at a time. Lyme is not leprosy.

Yet, “Fallon notes that for over 3400 patients screened for the Columbia persistent Lyme disease study, the mean duration of intravenous treatment was 2.3 months and the mean duration of oral antibiotic therapy was 7.5 months.”

Lyme is not leprosy. The tragedy (or crime) here is that of the cited 3400 Lyme patients, so few actually had any evidence of current or past Lyme disease the study was endanger of termination for lack of patients with objective evidence of Lyme disease. Thirty-seven people were eventually enrolled and the study was forced to conclude:

“Treatment resulted in no sustained benefit. The authors concluded: ‘10 weeks of IV ceftriaxone followed by 14 weeks of no antibiotic is not an effective strategy.’ More than one quarter of antibiotic-treated patients had significant adverse effects necessitating treatment termination.” (Neurology. 2008 Mar 25;70(13):986-7)

“ILADS is an interdisciplinary group of physicians….” Yes, many of whom have been disciplined by state medical boards, banned from receiving federal funds, lack training or board certification in infectious diseases, have been indicted and jailed for fraud and other crimes, conduct cash-only practices, have ties to i.v. drug and nutritional supplement companies, and troll for patients at Lyme activist meetings.

“ILADS….guidelines are evidence-based and peer-reviewed.” Well, they were posted on the AHRQ website and published in Expert Review of Anti-Infective Therapy. But theAHRQ disclaimer says they can’t vouch for anything on their website, and the publisher explicitly states : “In this instance the guidelines represent a consensus document produced by a working group consisting of members of the International Lyme and Associated Disease Society (ILADS). As such, the document was not subject to our standard review procedures as applied to individual articles and the guidelines reflect thecollective opinion of the ILADS working group, as set out in the introduction.”

No, the guidelines are not peer-reviewed. Nor are they based on solid clinical and experimental medicine. The ILADS quacks deny the results of four expensive human clinical trials, and instead point to some mouse-based laboratory studies and anecdotes, which are euphemistically referred to as “clinical judgments.”

Having defined and defended their guidelines, the authors go on to disparage guidelines and the people who write them.

“Recent reviews of practice guidelines have shown that most fail to meet quality standards, and that guidelines produced by specialist societies are generally of poor quality.” “Between 72 and 90% of physicians writing clinical practice guidelines have undisclosed conflicts of interest.”

Well, in the latter case, ILADS certainly fits the bill. (“…the committee that created the ILADS guidelines included the president of a company that manufactures an alternative Lyme disease diagnostic test and multiple physicians whose practices are listed with a CLD advocacy group’s patient referral service—but ILADS did not disclose the conflicts in its guideline document.” JAMA, February 11, 2009—301;6:665-7.)

And if they were thinking of the IDSA’s 2000 guidelines for Lyme disease in the former, then they missed the mark again. The authors of the cited study on guidelines didn’t look at the IDSA guidelines—or any infectious disease guidelines for that matter. They wrote,“we decided to concentrate on specific scientific societies and we excluded the myriad of small groups that were captured by the [Medline] search.”

So I guess we can conclude that the ILADS guidelines for Lyme disease are not evidence-based, not peer-reviewed, do not meet quality standards, and are plagued by conflicts of interest.

Now it’s 2009 and Stricker, Johnson and their equally obsessive colleagues are staying on message, oblivious to new data and new studies, and to the everyday reality that Lyme disease is a common bacterial infection that is non-communicable, non-fatal, antibiotic responsive, and geographically and seasonally limited.

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Posted by Relative Risk at 22:27 0 comments Links to this post

Labels: diagnostics, ILADS, Lyme disease, Stricker

04 May 2009

Lies, Distortions, and Wishful Thinking

Earlier this year, two respected law professors at the O’Neill Institute for National and Global Health Law at Georgetown University wrote an article entitled, Science, Politics, and Values: The Politicization of Professional Practice Guidelines (JAMA, 2009;301(6):665-667.) The article reviewed the 2006 legal assault on the Infectious Diseases Society of America’s guidelines for the treatment of Lyme disease by Connecticut’s A.G. Richard Blumenthal.The Georgetown professors noted, “The case exemplifies the politicization of health policy, with elected officials advocating for health policies against the weight of scientific evidence.” They went on to point out that Blumenthal’s absurd use of anti-trust law against a medical society’s voluntary, consensus-based guidelines already had been undermined by a prior federal court’s claim that professional guidelines are a “medical not a legal question.”

The authors concluded, “When political leaders using the force of law sued IDSA for its appropriate scientific conclusions that differed with the results they desired, they abused the public good.”

Apparently, not everyone agrees with those conclusions.

Lorraine Johnson, a self-described Lyme disease activist with a law degree, and Ralph Stricker, a self-described Lyme disease expert with a medical degree, have published the Bizarro World’s version of the above legal analysis in the Journal of Medical Ethics. They are an odd duo to be writing about such a thing in such a journal.

Stricker has previously been barred from receiving federal research grants after he“falsified data for a manuscript,” and later found employment in a penis-enlargement clinic. Now, as a scientific advisor, he pedals long-term antibiotic treatments to the deluded denizens of the California Lyme Disease Association, the Lyme Disease Association, and the Morgellons Foundation. Johnson, who doesn’t appear to practice law, spends her time with Stricker co-authoring angry, argumentative letters to medical journal editors. Their latest polemic is, Attorney General forces Infectious Disease Society of America to redo Lyme guidelines due to flawed development process. The very title is a lie.

The IDSA voluntarily entered into a mutual settlement with Blumenthal in which the guidelines would be reviewed again. “Under the agreement, the guidelines remain in effect; but in an effort to clear the air, IDSA is voluntarily agreeing to an extra step: a one-time special review of the Lyme disease guidelines.” “IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines. This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.”

From the flawed title, the article rapidly degenerates into a series of accusations, distortions, and an evident unwillingness to comprehend common English words. For example, the IDSA is described as having “monopoly power,” though this alleged power did not prevent an alternate group of doctors (ILADS) from promulgating their own set of Lyme disease treatment guidelines. Nor are the IDSA guidelines “mandatory.” They are “guidelines” (check the dictionary). They are voluntary. They are not enforceable because the private IDSA lacks an army or even a police force. The guidelines are not “extremely restrictive” and do not deny “the use of clinical judgment.” Again, how could they? Nor do they demand that doctors “sit on their hands and let the patients experience a disability…” I’ve read the guidelines. I don’t recall any such words or demands. I do, however, recall reading that treatment of a particular infection should be preceded by a diagnosis of that particular infection.

Stricker and Johnson repeat the often made claim that the original review panel ignored “divergent viewpoints.” Again, this isn’t about personal views or opinions, it’s about science: observable, reproducible data and demonstrative causality. No one cares what you think, only what you can proof.

The dynamic duo goes on to write, “There is tremendous financial gain in Lyme disease through vaccines, diagnostic tests and consulting with insurance companies.” Really? I thought there were big bucks in treating it and using specialty labs to diagnosis it. For example, there’s Lyme doc Raxlen who charges $900 for the first appointment and $500 for the second, and Lyme doc Jemsek who charges $750 for new patients, and a diagnosis from the preferred lab of LLMDs and chronic Lyme patients, Igenex, is going to cost $410 for the initial Lyme Panel, $475 for the complete Lyme Panel, and $400 for follow-up Lyme testing (2008 price list).

Actually, this is the heart of the claims by Blumenthal and his co-conspirators in LymeLand: that there are financial conflicts among the IDSA panelists that colored their pronouncements about diagnosis and treatment. Johnson and Stricker list the alleged financial conflicts of five of the IDSA panel members, but fail to suggest how most of them would constitute a real conflict. For example, they list the NIH grants of one panel member, but mysteriously neglect to mention the NIH support of three others. Nor do they explain how having a federal grant is a conflict. Another panelist is listed as having been associated with a now defunct company that has “no products or services.” This is a financial conflict?! Some of the panelists are listed as having stocks in various drug companies, but then most antibiotics used to treat Lyme are available as generics so, again, where’s the conflict? Finally, several panelists are accused of having been associated with the Lyme vaccine (Lymerix) or having patents for various vaccine platform technologies and a “wildlife vaccine.” Well, Lymerix was pulled from the market in 2001 after poor sales, so where’s the conflict in having worked on a vaccine that hasn’t existed in 8 years?

It’s all smoke-and-mirrors to hide the real financial conflicts among activists and their doctors, and which is touched on in the earlier JAMA paper by Kraemer and Gostin. “IDSA did disclose its panel members’ potential conflicts of interest in its published guidelines; even though there is no evidence that any conflicts altered the guidelines’ content. Meanwhile, the committee that created the ILADS guidelines included the president of a company that manufactures an alternative Lyme disease diagnostic test and multiple physicians whose practices are listed with a CLD advocacy group’s patient referral service—but ILADS did not disclose the conflicts in its guideline document.” And while we’re at it, let’s not forget to mention Blumenthal’s own conflicts of interest and his use of a public office and funds to pursue his personal obsession with Lyme disease.

(Ironically, the renewed scrutiny of potential conflicts of interest during the upcoming IDSA review is keeping off the new panel the very people activists wanted on the panel: namely, their LLMDs. The amount of money they make treating Lyme patients constitutes a financial conflict, therefore they cannot be on the panel.)

Stricker and Johnson close out this libelous assault on reality with high praise for Blumenthal. “[He] has demonstrated that he is a man of courage, resolve and persistence—a man who intends to enforce the terms of the settlement agreement and expects the IDSA to comply with its terms.”

No, I think Blum has demonstrated that he’s just another crooked pol in a state where mayors, judges and even a governor have been indicted and jailed in recent years. He’s a media-addicted clown who will temporarily pursue any cause for a few minutes of television time. He’s a bad politician and a bad lawyer. Even the hapless Glen Beck of FoxNews managed to beat him up on air after Blum tried to incite a made-for-TV-news riot in the Greenwich neighborhood of some AIG executives. No wonder this guy avoids the courtroom. If Glen Beck can kick his ass in a cross-examination, what chance would he have against real lawyers and a real judge?!

What is particularly telling about his attack on the IDSA is that none of the other 49 state AG’s felt compelled to join him. Nor has Blumenthal bothered to investigate the guidelines of any other medical or professional societies. Apparently, Lyme disease is the only thing that concerns him. Why is that, I wonder?

Kraemer and Gostin wrote, “Medical science, and the health of patients who depend on it, are too important to be subjected to political ideologies.”

“While it is unlikely IDSA’s guidelines will change due to the investigation, the daunting potential for litigation by those unhappy with the outcomes of treatment guidelines may well chill the willingness of medical associations to make appropriate scientific evaluations of controversial topics—a development that would significantly threaten patient care and increase medical costs.”

Blumenthal, Johnson, Stricker, and the other cultists and demagogues of LymeLand have always been their own worst enemies. Now it would seem they are on the threshold of becoming everyone’s worst enemies.

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Posted by Relative Risk at 18:11 0 comments Links to this post

Labels: Blumenthal, IDSA, ILADS, Politics

14 April 2009

Dr. Jones Speaks

I’ve been reading through last fall’s transcripts from the medical board’s investigation ofCharles Jones, Connecticut Lyme Doc to the foolish, the gullible, and the desperate. It’s hard to understand why this elderly man is still in active practice and why people would bring their children to him. Reading through the proceedings, I’m left with the impression of a man who doesn’t seem to know much about medicine in general or infectious diseases in particular. At times, Jones seems baffled by the investigation and the examiners’ questions. He gives the impression of having a hearing problem and of being confused—sometimes about his own notes and professional background. Sometimes I feel sorry for the old man that emerges from the pages of this inquiry. One of his most frequent answers to a question is, “I’m sorry?” He says that 33 times through 276 pages of testimony.

STATE OF CONNECTICUT

DEPARTMENT OF PUBLIC HEALTH

PETITION NOS. 2006-0111-001-010

RE: CHARLES JONES, M.D.

2006-0411-001-069

2006-0407-001-068

SEPTEMBER 12, 2008

CONNECTICUT MEDICAL EXAMINING BOARD

BEFORE: RICHARD BRIDBURG, M.D., CHAIRPERSON

ANNE C. DOREMUS, PUBLIC MEMBER

EDWARD OSSWALT, PUBLIC MEMBER

FOR THE BOARD: TANYA DeMATTIA, ASSISTANT ATTORNEY GENERAL

Here he is introducing himself and outlining his professional background.

My name is Charles R. Jones, M.D. I’m a physician not in Hamden but in New Haven as the Statement of Charges reflect me as being in Hamden. I’m in New Haven. I practice pediatric adolescent medicine, but they -- most of the children I see and adolescents I see having Lyme as well as other tick-borne diseases.

Q Dr. Jones, can you hear me satisfactorily? Doc, can you hear me satisfactorily?

A I’m sorry?

Q Can you hear me?

A Yes.

Q Good. Can you tell the Panel something about your educational background, please?

A Yes, I was -- graduated from New York Medical College in 2000 -- in 2000 -- in 1962. I was resident -- well, first of all, I served as intern in pediatrics at St. Luke’s Hospital in New York City for one year and then residency in pediatrics and adolescent medicine at St. Luke’s and at Memorial Sloane Kettering. The --

Q Any further training, sir, fellowships or anything of that sort?

A Fellowships, yeah, as a rheumatoid arthritis fellow when I was a medical student which enabled me to do -- do basic science research as well as clinical research while I was in -- while I was a medical student, excuse me, while I was a medical student and at the same time while I was an intern and resident at St. Luke’s Hospital. And I was also -- while I was a medical student at New York Medical College, I was an Assistant in the Department of Biochemistry all through the time I was a medical student and did research and some teaching. That was essential because my wife and I weren’t totally independent and I had to have as much income -- we had to have as much income as possible. And she taught and I went to medical school and did research as well as taught.

Q When did you enter clinical practice, doctor?

A I’m sorry?

Q When did you enter clinical practice?

A If I remember -- 1965.

Q And where?

A In New York City, 111, not 111 in --

CHAIRPERSON BRIDBURG: Excuse me. I’m a little confused. Didn’t he say --

A -- in Madison -- just off Madison Avenue. That’s off -- that’s on the east side.

MR. POLLACK: One second, I’m sorry.

CHAIRPERSON BRIDBURG: I thought he said he graduated 1962, is that right?

MR. POLLACK: Correct.

Q But when did you enter clinical practice, do you --

A I haven’t figured that one out. I would have -- ’66 or ’67.

Q And what was your practice initially?

A The practice initially was -- consisted of pediatric adolescent medicine and pediatric oncology.

Q And how long did you practice in those areas?

A In -- until 1969 we moved from New York City to Hamden, Connecticut to -- it was very difficult practicing in New York City. We started having a family. It was difficult raising children in New York City so we decided to move to New Haven, Connecticut, the New Haven area. It was in Hamden. And have a regular pediatric practice and not do cancer and leukemia any longer.

Q When did you begin to focus on tick-born[e], diagnosing and treating tick-born diseases and Lyme disease doctor?

A To focus on?

Q Yes.

A Not just begin seeing it? Begin seeing it?

Q Begin and then focus.

A Okay. Shortly after arriving in New Haven or in Hamden, I started, I’d say in the late sixties and early seventies, started seeing children come into the practice who had -- they were coming in clusters. They had a juvenile rheumatoid arthritis-like picture.

And juvenile rheumatoid arthritis is not supposed to cluster and these children came in in clusters, three or four in the same community, also some from the same family. Some of them -- I wasn’t the only one seeing this. I mean other people in the area were too.

This was at the beginning of the Lyme awareness, where some of the children came in with strep infections and they were put on antibiotics and got better pretty rapidly. And we started treating all the people with the juvenile rheumatoid arthritis-like picture with antibiotics.

snip

Q Going back to the question I asked a moment ago, can you tell the Panel of just the one or two, perhaps, distinctions or awards or honors you’ve received in connection with your pediatric Lyme practice, Dr. Jones?

A Well, one was an award given through a group in California. We’ve got a new group in California but it’s a Lyme organization that publishes Lyme Time. And that was concerned with my being the outstanding physician in Lyme disease and especially -- with reference to pediatric and adolescent medicine in 2000.

I’ve received many awards over the years in the form of plaques denoting outstanding achievement in treating children with Lyme disease from various organizations.

Q Doctor, any connection with Columbia University Medical School?

A Well, that’s a different issue. Not a different issue, it’s one -- it’s a related issue. At Columbia University in the medical school, there’s a -- there’s a fellowship in my name, the Charles Ray Jones Endowment -- endowed fellowship that enables students who completed the first year of medical school -- medical school schooling, to be able to apply for a fellowship in my name. It’s in my name, Charles Ray Jones Endowed Fellowship involving with learning more about the treating of tick-born disease -- diseases.

Q And what’s the nature of that fellowship, please?

A The fellowship enables the recipients to be able to go to offices of physicians who practice and treat Lyme and tick-born diseases or to be with basic science researchers at Columbia or elsewhere to learn more about tick-born diseases. It’s a -- it’s a -- it’s sort of thrilling to have the students come in who are fresh and are not -- who just completed their first year of medical -- medical school and who are interested very much in learning more about clinical medicine. They’ll come in and stay for a week or a month or two months and do a program of -- of awareness. And when they are -- and the people who come to my office, I’ve had about eight or nine -- eight or nine over the years, the people who come to my office have -- I’ve enabled them to participate in the -- in the questioning and also the evaluation of the children who have Lyme disease. It’s a hands-on experience.

A lot of the people who do it have decided that they want to go into a field of medicine that -- that treats infectious diseases, and not just Lyme, but infectious diseases.

Q So these students actually come from the medical school to your office, is that so?

A Yes.

Q And does the medical school send them to you and select them?

A There -- there’s a rather rigorous selection process that Dr. Brian Fallon is involved in where students can apply and then go through a rather -- rather horrendous application and interview situation. But then they are selected or rejected. I don’t know how many are rejected, but a good many are. I think they select two to four a year now. It used to be one. The endowment -- I don’t know what the endowed monies consist of now, but.

Q One last question, when was that fellowship program inaugurated, doctor, if you can recall?

A Maybe -- maybe ’98.

Except as a bad example or a “what not to do,” what could this guy possibly teach new medical students?! I’d love to know what these med students thought of their experiences with Jones. Someone should track them down and find out.

Posted by Relative Risk at 17:16 0 comments Links to this post

Labels: ILADS, Jones, Lyme disease

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