Stricker Articles
Stricker Articles
01 August 2010
This nursing journal must be hard up for insightful commentary. Why else would they give Ginger Savely a stump from which to hawk her quackery?
Having been driven out of Texas for her practice of pumping “chronic” Lyme patients full of antibiotics, she’s moved to California to help former penis enlargement expert Ralph Stricker pump antibiotics into people complaining of “chronic” Lyme disease. Since then, they’ve both discovered an online community of psychiatric patients suffering from delusional parasitosis who have renamed their disorder, Morgellons disease. Naturally, a foundation has sprung up to organize these patients, reinforce their delusions, and take their money. Similarly, various quacks have appeared to treat them with expensive antibiotics, insisting that these patients have mysterious infections (probably related to Lyme disease, they claim) and not delusions or the self-inflected wounds of those delusions.
So Nurse Savely’s commentary offers up some intellectual chestnuts from Thomas Khun about paradigm shifts and William Osler about bedside medicine in order to suggest 1) she’s well read, and 2) responsible physicians are intellectually stuck in the mud when it comes to Morgellons disease. Without offering a scrape of evidence in support of her claims she writes:
Delusions of parasitosis should be re-examined as a valid psychiatric phenomenon. Its victims have no prior history of psychiatric disorders, the onset often follows an immune suppressing event, it occurs in children and in entire families, it is more prevalent in certain parts of the country, and its onset is seasonal. Furthermore, it appears to be increasing in incidence. One would suspect an infection rather than a psychosis with this epidemiological picture.
Well, yes, delusion parasitosis is a real disease. A psychiatric disease. Moreover, the suggestion that it is rare is at odds with actual specialists in dermatology and psychiatry. For example:
J Eur Acad Dermatol Venereol. 2007 Apr;21(4):462-5.
Delusional parasitosis in dermatological practice.
Szepietowski JC, Salomon J, H
During the whole working period the majority of dermatologists participating in the survey (84.7%) had seen at least one patient with DP in their practice.
DP is a quite common disorder, however not all dermatologists are sufficiently prepared to treat it. There is an urgent need for training on the dermatological approach to psychodermatoses.
Clin Exp Dermatol. 2010 Mar;35(2):120-5. Epub 2009 Oct 23.
Psychiatric treatments in dermatology: an update.
Sambhi R, Lepping P.
Delusional parasitosis or delusional infestation. This is a psychotic disorder in which the patient has a fixed and false belief that their body and/or their accommodation is infested with parasites, despite there being no objective evidence for this.
[snip]
Patients with delusional parasitosis often lack insight and will not see a psychiatrist, which makes a careful discussion about ways to relieve distress by using antipsychotics paramount. It will often be up to the dermatologist to start and monitor treatment because of the patients' refusal to engage with psychiatric or liaison services. Giving medication to 'relieve distress' can be a way to commence psychotropic medication in an ethical way to a patient who lacks insight.
Dermatitis artefacta. This is a form of factitious disorder, in which the patient presents with self-inflicted cutaneous lesions which the patient typically denies having induced. It is more common in females than males (3 : 1–20 : 1).
So without any obvious training in psychiatry or infectious diseases Savely is merrily providing antibiotics to people in need of far more serious care. According to a website called Morgellons Watch she was charging $500 for treatment. Now in California with access to Stricker’s pool of “chronic” Lyme disease patients (said to number 1,800) she’s probably making a killing. And maybe she’ll eventually kill someone.
Until then, she and Stricker are busy doing some bad research on Morgellons. Presumably to make themselves look like legit investigators and to provide the data (however cooked) to justify their practices.
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Posted by Relative Risk at 13:24 0 comments Links to this post
Labels: Morgellons, Stricker
15 June 2010
Dr. Stricker and I have published a new peer-reviewed article on the flawed IDSA Lyme guidelines development process, the antitrust investigation, and the lack of impartiality in the mandated review process run by the IDSA. (Johnson L, Stricker R. “The Infectious Diseases Society of America Lyme guidelines: A cautionary tale about development of clinical practice guidelines,” Philosophy, Ethics, and Humanities in Medicine….).
Well, like all ads, this one is full of crap.
First, it isn’t new. It’s the same rehashed, cut-and-paste whining as the earlier polemics by these two obsessive-compulsive propagandists. I think this is the fourth or fifth version of this nonsense.
Second, no one finds the IDSA guidelines flawed, but Lyme patient wannabes and the quacks who prey on them.
Third, Blumenthal’s anti-trust investigation went nowhere. Which is to say, it never went to court. The IDSA agreed to re-review the guidelines….and re-read the above sentence.
Fourth, there was no impartiality in the review process, which Blumenthal helped set up and which both Stricker and Johnson participated in.
I think that comes to four lies in one sentence written by a lawyer and a liar.
And while we’re on the subject, when did Stricker—barred from receiving federal research funds because he falsified research data and subsequently fired from his university—become an expert on medical ethics?
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Posted by Relative Risk at 22:52 0 comments Links to this post
12 June 2010
Dr. Cheryl Koopman's funded research focuses on people living with serious illness, including breast/gynecological cancer, Lyme disease, and HIV/AIDS. Also, Dr. Koopman is collaborating with experts in Lyme disease and biostatistics to investigate the diverse manifestations of Lyme disease in relation to symptoms, signs, and diagnostic tests.What at first sounds like interesting research and a promising follow-on to the work of Hassett et al. on psychological co-morbidity in Lyme disease patientsturns out to be a junk science project funded by:the Turn the Corner Foundation,the California Lyme Disease Association,and IGeneX, Inc.
Worse, the so-called Lyme experts are fellow ILADS clowns Daniel Cameron and Raphael Stricker, and CALDA advisor, Christine Green.
The same activist funders and the physicians once again are trying to create data to fit a preconceived notion about an infectious disease, and likely using a famous university’s name to legitimize those results and conclusions. Some of their earlier "research" has been discussed here, here, here, here, and here.
So here’s the plan. According to Koopman, “The overall goals of our research project are twofold: (1) To systematically characterize different patterns of manifestations of Lyme Disease: a) in a large sample of patients seen in clinical practice who have been diagnosed with Lyme Disease for who we have retrospective medical record data; and b) in an additional sample of 100 patients diagnosed with Lyme Disease who will be recruited for the prospective phase of this research; and (2) To evaluate and compare the sensitivity of various antibody and PCR assays against patients’ and comparison groups’ clinical diagnosis and symptom and illness patterns. This research is inspired by considerations of the critical need for further research that recognizes the diverse manifestations of Lyme disease.”
Sounds like some of this has already been done. Koopman, et al. have already submitted the below abstract for the November 2010 meeting of the American Public Health Association in Denver.
218837. Lyme Disease: A Complex Illness with Distinct Subgroups
Cheryl Koopman, PhD , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Tyson Holmes, PhD , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Raphael Stricker, MD , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Daniel Cameron, MD/MPh , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Christine Green, MD , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Yvonne Lin, PA-C , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Adelaida Castillo, MA , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Alexandra Aylward, BA , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Jill Whisnant, MA , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
Casey Brodhead, BA , Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA
The diagnosis of Lyme disease merits further study because of the diversity of its manifestations, with infections found in the brain, joints/muscles, and/or heart. Its diagnosis is further complicated by the insensitivity of the two-tier CDC diagnostic criteria requiring positive results on both the ELISA and Western blot. Physicians may rely too heavily on such criteria because of the potentially overwhelming number of symptoms that can accompany Lyme. Therefore, our study aim was to assess if manifestations of Lyme disease could be empirically classified into a small to modest number of symptom constellations. We also sought to identify if medical and demographic characteristics differentiate these clusters. We analyzed medical records of 1059 adult Lyme disease patients from a medical practice specializing in tick-born illnesses. All patients self-reported on the presence or absence of 132 symptoms and provided additional medical and demographic information. Gap statistic analysis identified 10 separable clusters, which differed in symptom frequencies and quantities of patients (3-220). These symptom clusters differed significantly with respect to gender (p ≤ .0005), age (p ≤ .0001), length of time since symptom onset (overall p ≤ .05), and prior use of antibiotic therapy (p ≤ .002). Clusters did not differ significantly with respect to recall of tick bite or bulls-eye rash or to current use of antibiotic therapy. The results of this study may have significant implications for both understanding and treating the complex illness of Lyme disease. Distinct symptom clusters and/or stages of the illness may require different treatment approaches.
“…1059 adult Lyme disease patients from a medical practice specializing in tick-born illnesses.” Could that be Stricker’s local San Francisco practice? That’s a lot of patients with Lyme disease. Probably more than the average I.D. doc is going to see in a lifetime. Far more than the whole state of California reports each year.
Where does he find them all? And how does he know all of those patients have Lyme disease? Apparently, despite the alleged insensitivity of diagnostic tests (excluding Igenex, of course) and the endless number of protean symptoms, Ralph and company have no problem identifying patients with Lyme disease. So why the need for research?
Anyway, 1059 patients and a self-reporting checklist of 132 symptoms (quick, name any other disease or infection with 132 symptoms) to slough through. What have they found to date?
“Gap statistic analysis identified 10 separable clusters, which differed in symptom frequencies and quantities of patients (3-220). These symptom clusters differed significantly with respect to gender (p ≤ .0005), age (p ≤ .0001), length of time since symptom onset (overall p ≤ .05), and prior use of antibiotic therapy (p ≤ .002).”
The abstract data is a bit skimpy, but I’m guessing they sorted through 1059 of Ralph’s patients and found 10 statistical groups of people with other illnesses, including perhaps: arthritis, fibromyalgia, chronic fatigue, various autoimmune disorders among female patients and possibly some ALS/MS cases. Maybe one of the smaller clusters actually represented cases of Lyme disease.
“Distinct symptom clusters and/or stages of the illness may require different treatment approaches.”
Yes, especially if those distinct symptom clusters represent diseases other than Lyme Borreliosis.
This sounds like a mess of a study, especially if it leads to further delays in patients receiving a proper diagnosis of illness and appropriate treatment for that illness. Unless Stanford is taking indirect costs for Koopman’s Lyme study, they should cut her lose and tell her this project is her private business and not to be associated with the university. I think they might do that anyway if they knew about Stricker’s past problems with falsifying data, past FDA warningsabout non-standard Lyme tests, and past federal efforts to close down Igenex.
Maybe it’s time to write to Stanford before this nonsense hurts someone.
For general information regarding questions, concerns, or complaints about research, research related injury, or the rights of research participants, please call (650) 723-5244 or toll-free 1-866-680-2906, or write to the Administrative Panel on Human Subjects in Medical Research, Administrative Panels Office, Stanford University, Stanford, CA 94305-5401.
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Posted by Relative Risk at 15:52 0 comments Links to this post
14 May 2010
From the White Coat Underground, PalMD kicks some Stricker and Savely ass over Morgellons and just plain bad, bad science.
Raphael Stricker is a disgraced hematologist who after losing his career to data manipulation took up the chronic Lyme disease banner. He is part of ILADS, which has been demanding that actual experts shut up and get out of the way so they can continue their evidence-free treatment of supposed chronic Lyme disease. Savely has written earlier crappy articles about morgellons. She is a nurse practitioner who "treats" people with "chronic Lyme disease" and morgellons.
[Snip, but check out the photos.]
I can't go on much longer, because my brain hurts, but one of the most remarkable "findings" is this:
Sixty-four (52.5%) of the subjects had positive Lyme tests by Western blot. Another 44.3% (n = 54) were highly suspect for Lyme disease based on the presence of 5/7 of the defined criteria for a Lyme diagnosis, as outlined in the Materials and methods section. These results imply that 96.8% of the sample may have been infected with B burgdorferi [the organism that causes Lyme disease]
Fascinating. In 2008 there were 74 cases of Lyme disease reported in the entire state of California, and yet somehow, one nurse practitioner in San Francisco managed to find 64 cases in a brief period of time. Remarkable.
This article is so remarkably bad it's almost like they were trying to parody science. Please...don't try any harder.
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Posted by Relative Risk at 17:46 0 comments Links to this post
Labels: Morgellons, Quackery, Stricker
23 March 2010
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."
Posted by Relative Risk at 22:41 0 comments Links to this post
Labels: ILADS, Lyme disease, Stricker
21 March 2010
Oh my, next week in Texas the Morgellonites are meeting to discuss their mysterious fibers (does bellybutton lint count?), scabs and other symptoms. How creepy would it be to sit in a hotel room surround by people with self-inflicted scabs and sores as they compare plastic bags full of fibers they’ve pull off of themselves.Delusional parasitosis in mass. So the deluded will be gathering to be fleeced and lectured to by the following Morgellons experts, some of whom are, oddly enough, also “chronic” Lyme disease experts, or perhaps just as nutty as the patients attending this thing. Here’s the cast of characters to date:Ginger Savely, DNPSan Francisco, CADr. Savely has medically managed over 1000 Lyme and other tick borne disease patients and over 300 Morgellons patients in her practice.“Medically managed’? Not cured? I’m not surprised. If you don’t know what the patient has and you don’t know what you’re doing, the chances of a positive outcome are greatly diminished. So Savely got herself run out of Texas for her practice and now works with the clown below in S.F.Raphael B. Stricker, M.D.San Francisco, CA
Board of Directors ILADS, International Lyme and Associated Diseases Society
Board of Directors CALDA, California Lyme Disease Association. Enough has been said about this opportunistic quack.
Amelia M. Withington, MD
Chester, PA
Attending Psychiatrist at Crozer-Chester Medical Center in Chester, PA.
A psychiatrist. This is probably the only person who could be of any help to the unfortunate patients who come to these gatherings.
Randy S. Wymore, Ph.D.
Tulsa, O K
Director, Center for the Investigation of Morgellons Disease; Associate Professor of Pharmacology & Physiology Oklahoma State University, Center for Health Sciences.
Does OSU know what this guy is doing with their name? It’s bad enough that the University has the word ‘Oklahoma’ in their name, but to throw in a fake center for a fake disease is doubly embarrassing.
Neelam Uppal, M.D.
Pinellas, FL.
Dr. Neelam Uppall maintains a private practice in Infectious Disease in Pinellas, FL. She attended medical school at the Christian Medical College in India. I know this place; it’s in Vellore, just west of Chennai. Shouldn’t she have graduated with a M.B.B.S. instead of a M.D.?
David Gibbs, MS, CDRP
Austin, TX
Social Security Specialist, Disability Claims Professionals of Texas Experienced and successful disability representation for Morgellons and Lyme Disease. I’ll bet this guy gets mobbed for advice. Half the online Lymees seem desperately interested in getting onto the disability rolls and start collecting a check.
In the meantime, the sane world is just going to have to wait for the CDC to conclude their study (forced on them by Congress) of this Internet version of the well-known delusional parasitosis. Not that the CDC conclusions will matter to the Morgellonites.
“Please do not assume that the patient's problem is purely psychological based on this propensity.” From a form letter written by Wymore and intended for patients to hand to their very skeptical primary care physicians.
Posted by Relative Risk at 13:33 0 comments Links to this post
Labels: Morgellons, Stricker
17 March 2010
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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Posted by Relative Risk at 15:05 0 comments Links to this post
Labels: ILADS, Lyme disease, Stricker
01 January 2010
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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Posted by Relative Risk at 12:19 0 comments Links to this post
Labels: ILADS, Quackery, Stricker
28 October 2009
JOURNAL OF WOMEN’S HEALTH
Volume 18, Number 10, 2009
Gary P. Wormser, M.D. and Eugene D. Shapiro, M.D.
Evidence from a variety of sources indicates that the term ‘‘chronic Lyme disease’’ is a misnomer and is often improperly used to diagnose patients who have illnesses completely unrelated to Borrelia burgdorferi infection. Our study found that patients with chronic Lyme disease were significantly more likely to be female than were patients reported to the Centers for Disease Control and Prevention (CDC) with Lyme disease (odds ratio [OR]=2.42, 95% CI 1.98-2.94, p<0.0001) or than were those with ‘‘post-Lyme disease syndrome’’ (OR=2.32, 95% CI 1.62-3.34, p<0.0001). These results suggested the likelihood that nonspecific illnesses with a female predominance, such as fibromyalgia, are being misdiagnosed as chronic Lyme disease. A recent publication by Hassett et al. corroborates both the findings and the conclusions of our report.
[snip]
In their letter, Stricker and Johnson [sorry, but I’m not directing readers to this crap.] hypothesize that the reason for the male predominance in Lyme disease is that the evidence-based interpretative criteria for immunoblot testing recommended by the CDC are in some way biased against women. This is a specious argument for many reasons.
First, a recent study explicitly demonstrated that there is no effect of gender on the results of serological testing for Lyme disease. Moreover, to our knowledge, gender bias in serological testing for infectious diseases is unprecedented.
Second, Stricker and Johnson appear to have overlooked the fact that>70% of Lyme disease cases reported to the CDC are based on the occurrence of erythema migrans (EM) only and, thus, are unrelated to any immunoblot result.
Considering only patients with EM, there is still a male predominance in reported cases (Paul Mead, CDC, personal communication, 2009). A similar male predominance is seen in a wide variety of other tick-borne and mosquito-borne diseases, consistent with an increased risk of exposure to arthropod bites among men.
In addition, in contrast to what Stricker and Johnson state, seropositivity was not in fact a requirement in the Krupp et al. study or in one of the two Klempner et al. trials. Contrary to what Stricker and Johnson assert, evidence convincingly shows that the alternative immunoblot criteria used by Donta to diagnose chronic Lyme disease are insufficiently specific to be useful clinically. Furthermore, the putative relationship of a decrease in CD57 natural killer cells to post-Lyme disease symptoms has been shown to be invalid.
Another day, another correction to the letter-writing antics of Stricker and Johnson.
Posted by Relative Risk at 12:11 0 comments Links to this post
Labels: Lyme disease, Stricker
17 August 2009
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
12 June 2009
Well, this comes as no surprise to anyone familiar with immunology and diagnostics for Lyme disease. I'm sure an angry letter denouncing the study below is already being drafted.
Clin Vaccine Immunol. 2009 Jun 10.
Natural killer cell counts are not different between patients with post-Lyme disease syndrome and controls.
Marques A, Brown MR, Fleisher TA
It has been reported that patients with “chronic Lyme disease” have decreased number of natural killer cells, as defined by the CD57 marker. We performed immunophenotyping in 9 individuals with post-Lyme disease syndrome, 12 who recovered from Lyme disease and 9 healthy volunteers. The number of natural killer cells was not significantly different between the groups.
It has been reported that patients diagnosed with “chronic Lyme disease” have decreased number of natural killer cells, as defined by the CD57 marker, and that the changes in the number of CD57+ cells can be monitored as evidence of response to therapy [Insert Stricker refs here]. CD57 was initially used as a marker for NK cells, but it is not expressed by all NK cells and is also expressed by T cell subpopulations. It is thought that CD57 is a marker of terminally differentiated cells. Currently, the most common approach for identifying NK cells utilizes a combination of CD56 and CD16 surface markers used together with CD3 to exclude T cells expressing NK markers (NK T cells). The CD57 test is being offered in selected clinical laboratories and is being used by some health practitioners [LLMDs] to evaluate and follow patients diagnosed with “chronic Lyme disease”. To further evaluate the utility of NK cell numbers in evaluating and/or monitoring this patient group, we performed immunophenotyping in 9 patients with PLDS, 12 individuals who recovered from Lyme disease and 9 healthy volunteers.
The bracketed notes are mine. Curious about the phrase, "selected clinical laboratories," I searched the Internet for the the words, "CD57 test." One of the first things to pop up was a link to Carol Ryser of Health Centers of America. According to CourtHouse News, she's being sued for diagnosing and treating non-existent Lyme disease.
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Posted by Relative Risk at 12:09 0 comments Links to this post
Labels: diagnostics, Lyme disease, Stricker
12 May 2009
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
15 April 2009
Sadly, a group of delusional patients got together recently to re-enforce their delusions of a mysterious infection (Morgellons) and allow themselves to be preyed upon by a couple of quacks who believe enough money and antibiotics can cure anything.
The Texas-based Oak Hill Gazette reported on the meeting (I’m not providing a link to the meeting or the foundation that sponsored it.) Some excerpts from the paper’s story are below.
Casey, like many others at the conference, credits Ginger Savely, DNP, a nurse practitioner famous for treating the controversial Morgellons and Chronic Lyme diseases, for finally showing her respect and compassion, and for giving her treatment that she says has reduced the number of lesions and the severity of her pain and itching.
Savely, who has a PHD in nursing, is practically worshipped in Morgellons and Lyme circles. She gave two lectures at the conference, one in which she described case studies of various Morgellons patients she has treated, and another discussing treatment options for the disease.
Not only is Chronic Lyme real, Savely maintains, but it has a strong association with Morgellons. She discovered the connection while treating Chronic Lyme patients in her practice in Austin. She found that approximately 10 percent of her chronic Lyme patients had the fibers, lesions and skin-crawling sensations characteristic of Morgellons. As news of the Morgellons phenomenon spread over the Internet, she started hearing from more patients who came to her for Morgellons treatment. She says overall, about 95 percent of Morgellons patients she has treated are co-infected with Lyme disease.
Where’s the data for any of those comments and conclusions? Should we expect to see it published in any peer-reviewed journals in the near future?
And this is what really upsets many in the mainstream medical community. They criticize her for prescribing heavy doses of a variety of medications for extended periods, outside the normal medical guidelines, when she doesn't even know what she is attacking or which of her treatments will work.
She was forced to leave the state of Texas when the medical board put pressure on her sponsoring physician and she could find no other Austin physician to work with. She now practices in San Francisco, California where the laws governing medical treatment are more liberal.
But other researchers are also looking into the cause. One such researcher who spoke at the conference is Dr. Raphael Stricker, MD, a clinician who, like Savely, treats Chronic Lyme and Morgellons patients in California. Morgellons skeptics dismiss Stricker's research because he was fired from the University of California in 1990 for allegedly suppressing data in a 1985 research paper on AIDS that would have contradicted his hypothesis.
[Note: Stricker and Savely, along with a couple of other Lyme Quacks serve on the board of the Morgellons Research Foundation where they no doubt troll for more deluded patients.]
Stricker presented research he conducted along with Savely and Vitaly Citovsky, Ph.D of the State University of New York at Stony Brook, in which they tested lesions from seven Morgellons patients as well as biopsied skin samples from a healthy control population. They found agrobacterium in all seven Morgellons patients and none was found in the control group.
Unless you’re a potted plant—and I’m guessing many of these Morgellons patients are—there’s little chance of being bothered by common agrobacteria. Some species of Argobacterium have caused rare catheter-related bacteremias among geriatric and oncologic patients, but nothing like the self-exacerbated lesions seen among otherwise healthy patients suffering from delusional parasitosis.
Posted by Relative Risk at 16:20 0 comments Links to this post
Labels: Morgellons, Stricker