2011 March

Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

The purpose of the study is to establish whether prolonged antibiotic treatment of patients diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO guidelines.

Estimated Enrollment: 270

Study Start Date: September 2010

Estimated Primary Completion Date: September 2013

Additional information, including patient eligibility, is availableClinicalTrials.Gov.

Reduced anxiety-like behavior and central neurochemical change in germ-free mice.

Neufeld, K. M., Kang, N., Bienenstock, J. and Foster, J. A. (2011), Neurogastroenterology & Motility

Background There is increasing interest in the gut-brain axis and the role intestinal microbiota may play in communication between these two systems. Acquisition of intestinal microbiota in the immediate postnatal period has a defining impact on the development and function of the gastrointestinal, immune, neuroendocrine and metabolic systems. For example, the presence of gut microbiota regulates the set point for hypothalamic-pituitary-adrenal (HPA) axis activity.

Methods We investigated basal behavior of adult germ-free (GF), Swiss Webster female mice in the elevated plus maze (EPM) and compared this to conventionally reared specific pathogen free (SPF) mice. Additionally, we measured brain mRNA expression of genes implicated in anxiety and stress-reactivity.

Key Results Germ-free mice, compared to SPF mice, exhibited basal behavior in the EPM that can be interpreted as anxiolytic. Altered GF behavior was accompanied by a decrease in the N-methyl-D-aspartate receptor subunit NR2B mRNA expression in the central amygdala, increased brain-derived neurotrophic factor expression and decreased serotonin receptor 1A (5HT1A) expression in the dentate granule layer of the hippocampus.

Conclusions & Inferences We conclude that the presence or absence of conventional intestinal microbiota influences the development of behavior, and is accompanied by neurochemical changes in the brain.

Click here for more discussion of this mental-microbe state.

Notes from:

The Epidemiology, Prevention, Investigation And Treatment Of Lyme Disease In United Kingdom Patients: A Position Statement.

The British Infection Association

J Infect. 2011 Mar 18.

This article sets out the position of the British Infection Association (BIA) on the investigation, diagnosis, treatment and prevention of Lyme borreliosis (Lyme disease) in United Kingdom patients. It is the intention of the Association to provide assistance to patients and their doctors in an area of infectious diseases that is associated with considerable emotion, media and political interest as well as occasionally unorthodox and non-evidence-based clinical or laboratory practice. This paper draws on the experience of UK infectious diseases physicians and medical microbiologists and has taken full account of extant national and specialist societies’ guidelines and the evidence on which they are based, from the Czech Republic, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovenia, Sweden, Switzerland, and the USA. Account was also taken of the report of a Lyme Disease Review Panel of the Infectious Diseases Society of America (IDSA) and the report of an independent panel commissioned by the Health Protection Agency (HPA), which reviewed the 2004 guidelines of the International Lyme and Associated Diseases Society (ILADS). A number of recently-published peer-reviewed articles have also been included. This paper has been written with the full involvement of the BIA membership through a consultation process.

Tests to be avoided

In the United Kingdom laboratory investigations for Lyme borreliosis should utilise tests which have been properly validated for performance and interpretation and should be undertaken by diagnostic laboratories with a recognised and appropriate accreditation standard. This is particularly important as laboratories offering tests not fulfilling these requirements can provide results that are potentially harmful to patients who are concerned that they may have Lyme disease or a post Lyme syndrome

There is no role for the microscopic examination of blood or other body fluids for Borrelia burgdorferi spirochaetes. CD-57 tests are not useful in the diagnosis of Lyme, and lymphocyte transformation tests single-stage immunoblot tests or immunoblots interpreted using non-standardised criteria are not recommended. Various unvalidated EIA tests (e.g. for “blood-brain barrier antibodies”) are offered by certain commercial ‘Lyme-specialty’ laboratories and these are to be avoided.

Persistent symptoms following treated Lyme borreliosis; “chronic Lyme disease”

The term “chronic Lyme disease” is not consistently defined. It has been applied to patients with presentations of active, previously untreated, infection, such as late neuroborreliosis or ACA, those who have persistent symptoms following treatment for Lyme borreliosis, patients who have had Lyme borreliosis in the past, but whose current illness is unrelated to infection with Borrelia burgdorferi, and patients who have no evidence of current or past borrelial infection. In prospective and retrospective studies many patients labelled as having “chronic Lyme disease” fell into the last category and had received the diagnosis because poorly-specific case definitions and/or unvalidated, poorly-specific laboratory tests had been applied. The IDSA Guidelines Review Panel reiterated the 2006 USA guidelines’ recommendation that, “Whatever definition is eventually adopted, having once had objective clinical or laboratory evidence of B. burgdorferi infection must be a condition sine qua non until a syndrome is formally defined.” The BIA shares the view that only a formally-defined syndrome specific for chronic Lyme disease will obviate the need for previous clinical or laboratory evidence of B. burgdorferi infection. Until such time, a diagnosis of chronic Lyme disease should not be made without this evidence.

Conclusion

Lyme borreliosis is sometimes associated with much anxiety. There has been a great deal written about this disease, not only in academic journals, but also in the lay media and on the internet. These publications are of variable quality, particularly where there has been no peer-review or similar quality assurance process applied. It can be difficult for patients to judge the value of the available articles and websites and thereby detect and avoid unsubstantiated opinion and advice. This paper has been written to help patients and their doctors to make sense of the risks of Lyme disease and its appropriate investigation, prevention and treatment through good medical practice. The BIA hopes that this objective will be achieved.

The Institute of Medicine (IOM) has released a new report on clinical treatment guidelines (“Clinical Practice Guidelines We Can Trust”). The report has prompted LymeNut’s self-appointed wonkette to again beat the dead horse of the reviewed and vindicated IDSA Lyme guidelines.

Quoting from the report, she notes, “Rather than dictating a one-size-fits-all approach to patient care, clinical practice guidelines offer an evaluation of the quality of the relevant scientific literature and an assessment of the likely benefits and harms of a particular treatment. This information enables healthcare providers to proceed accordingly, selecting the best care for a unique patient based on his or her references.”

Pretty much describes the IDSA guidelines and similar guidelines developed by 16 other medical societies and organizations.

The wonkette writes, “The IOM also intends to put some teeth into these concepts by recommending that the National Guidelines Clearinghouse, which distributes most guidelines through its website, follow its recommendations and “discontinue the inclusion of guidelines whose development is not sufficiently documented, and to prominently identify guidelines that reflect the committee’s proposed standards for trustworthiness.”

Well, that’s why the Clearinghouse dropped the ILADS guidelines, and why an independent review of those guidelines concurred.

I assume the same fate would await Joe Burrascano’s famous one-man guidelines if he were so foolish as to hold them up for review. (On the other hand, maybe his disclaimer admits as much: “The information contained in this monograph is meant for informational purposes only. The management of tick-borne illnesses in any given patient must be approached on an individual basis using the practitioner’s best judgment.” So don’t rely on his guidelines either?)

Anyway, as I’ve noted before, if the wonkette and other Lyme activists are going to hold the IDSA guidelines to a particular standard of science, evidence, and flexibility, then they have to hold the guidelines and practices of their own quack doctors to the same standards…which they will not do.

Anthrax report: Medical records point to researcher

Sounds like the FBI is fighting another rear-guard action against the recent NRC reportabout their handling of the anthrax affair back in 2001. (The full report is available here.) Now they’ve employed a right-wing federal judge, with a past history of stalking the Clintons, hunting for Islamic terrorists and bothering stem cell researchers, in order to carry out a damning psychological autopsy of their 2^nd scapegoat, Dr. Bruce Ivins. America’s KGB is nothing if not tenacious when it comes to defending themselves against questions of incompetence.

March 23, 2011.

WASHINGTON — Medical records of Dr. Bruce Ivins, blamed by the FBI for the deadly 2001 anthrax mail attacks, "support the Justice Department's determination that he was responsible," a panel of behavioral experts and psychiatrists contended in a newly released report.

"Dr. Ivins was psychologically disposed to undertake the mailings, his behavioral history demonstrated his potential for carrying them out, and he had the motivation and the means," they said in a report made public Wednesday.

[snip]

Dr. Ivins displayed behavioral problems that should have led his Army employers to look closer at his medical history, the report contended. Such an examination should have prevented him from obtaining the security clearances needed to work with such a dangerous material as anthrax, the panel members said.

Their report was requested in secret by a federal judge, Royce Lamberth of Washington DC, who asked for an examination detailing "the mental health issues of Dr. Bruce Ivins and what lessons can be learned from that analysis that may be useful in preventing future bioterrorism attacks." The findings were filed last fall under seal.

Though many of his co-workers at the bioweapons lab in Maryland have disputed the FBI's findings, the panel found that Ivins "cultivated a persona of benign eccentricity that masked his obsessions and criminal thoughts."

Dr. Gregory Saathoff of the University of Virginia School of Medicine, the panel's chairman, said the medical records "document behavior he claimed he undertook and provide an indication of a strong component of revenge, including graphic plans to engage in violent behavior."

But even though Ivins repeatedly waived confidentiality and gave Army background investigators permission to obtain his medical records, such a step was never taken, panel members said. "Had these records been obtained, they would have shown a longstanding pattern of disturbed thinking in response to stress," the report said.

In one example, in 1987, Ivins placed question marks next to a check list of items on a medical history report that included "memory change, trouble with decisions, hallucinations, improbable beliefs, and anxiety."

A spokesman at the Army lab in Maryland declined to comment, citing privacy laws.

As for his motives, the report says he acted out of a desire for revenge against his critics, "a desperate need for personal validation," and a hope that the response to the attacks would revive the government's efforts to develop an anthrax vaccine — a program on which he was a key researcher.

[snip]

Briefing reporters on their findings, panel members also said they found no reason to question the FBI's findings that Dr. Ivins acted alone in carrying out the anthrax attacks.

The complete article is at MSNBC.

Notes from:

Long-Term Lyme Disease Antibiotic Therapy Beliefs Among New England Residents.

Macauda MM, Erickson P, Miller J, Mann P, Closter L, Krause PJ.

Vector Borne Zoonotic Dis. 2011 Mar 21.

Although several studies have addressed the public perceptions of Lyme disease risk and prevention, few have inquired about beliefs regarding persistent symptoms and prolonged antibiotic therapy. It is thus unclear whether residents in endemic areas believe that prolonged illness caused by chronic infection is common, or whether their concepts of Lyme disease illness and treatment are congruent with standard medical practice.

Accordingly, we sampled the views of people living in Connecticut and Rhode Island, where Lyme disease is highly endemic. Our sampling included questions about prolonged illness and the effectiveness of antibiotics as part of a larger study examining the applicability of the health belief model in predicting Lyme disease prevention behaviors.

Of the 421 subjects who enrolled in our study, 121 were men and 284 were women (16 individuals did not provide gender information) with a mean age of 52 years. Almost half of our sample had a graduate school degree, almost a third had a college degree, and the remainder completed or had some high school. Almost all (93%) of the respondents reported that they lived in either a suburban or a rural area.

Study participants were knowledgeable about the transmission, symptoms, and complications of Lyme disease. Almost all (99%) of the informants knew that Lyme disease could be contracted through the bite of a deer tick. Participants were more aware of the earlier symptoms than the later complications. Most knew that the infection is associated with a rash (94%), joint aches (97%), joint swelling (76%), or

headache (74%). In contrast, less than half were aware of heart palpitations (Connecticut=33%, Block Island=48%), or certain neurologic complications, including cognitive defects (35%), tingling of the hands and feet (21%), or dizziness (28%). Respondents also recognized that Lyme disease has a range of outcomes, as almost all (94%) agreed that ‘‘Lyme disease runs the range of being quite mild to quite severe.’’

Belief in the value of antibiotics for treatment of Lyme disease

During the interviews, some informants expressed doubts as to the effectiveness of antibiotic therapy and many suggested that infection could remain after antibiotic treatment:

‘‘I think it stays with you pretty much forever. From my understanding of it, which isn’t great, I was always under the assumption that you basically always have it. It’s just that you get the symptoms under control and then hopefully you’re ok.’’ —Participant #7, Connecticut female, 30s.

‘‘I believe you can control the symptoms, keep them in line, but I don’t think you can cure’’ —Participant #12, Connecticut male, 50s.

Some participants reported prolonged Lyme symptoms, both in the interviews (‘‘I still have symptoms but I’m not sure if they’re symptoms of Lyme or symptoms of just daily, your run down, or I’m getting older. It’s hard to tell’’—Participant #20, Connecticut female, 30s), and in the survey, where a third of the respondents who reported having Lyme agreed, ‘‘sometimes I wonder if my Lyme disease is really gone.’’

Slightly over half (58%) received ‘‘a lot’’ or ‘‘all’’ of their information from pamphlets and printed material, though in the interviews, few participants could recount specific pamphlets or printed material they had read. Few subjects cited the internet as an important source of information in the interview portion of the study. Lyme support groups were the least common reported source of information for our respondents with only 0.12% of the Connecticut sample and 10% of the Block Island sample reporting they derived ‘‘a lot’’ or ‘‘all’’ their knowledge about Lyme disease in this manner. Less than a quarter of our sample received ‘‘a lot’’ or ‘‘all’’ of their information from television, radio, or veterinarians. More than half of our respondents (63%) who reported that they received ‘‘a lot’’ of information from a doctor also indicated that they received ‘‘a lot’’ of information from others who have had Lyme disease. Thus, sources of information are not mutually exclusive, and the influence of information from a doctor is difficult to separate from other sources.

The majority of our survey respondents believe that the Lyme disease spirochete can persist following antibiotic treatment, that a standard course of treatment for 2 to 4 weeks is often not curative, and that long-term antibiotic therapy of >2 months is sometimes useful. This includes a majority of people who had experienced only a brief period of symptoms associated with Lyme disease. The respondents were generally well educated and had a good understanding of the transmission, symptoms, and acute complications of Lyme disease. Almost all participants reported knowing at least one person who had personally experienced Lyme disease, most of whom reported having a brief illness that was cured following antibiotic treatment. The most common source of information about Lyme disease among our study subjects was from a friend or family member who reported having had Lyme disease.

It is understandable that people may believe that Lyme disease infection persists, even following standard antibiotic therapy. Some patients do experience prolonged post Lyme disease symptoms, whereas others have prolonged symptoms due to other medical conditions that are misdiagnosed as Lyme disease. It requires fairly sophisticated medical knowledge to know that persistent symptoms following

Lyme disease does not necessarily mean that the infection has persisted, and it is very difficult for a nonmedical person to determine the accuracy of a Lyme diagnosis for themselves, their family, or their friends. In an endemic area, it appears that many people have heard of people with prolonged Lyme disease symptoms, and a few may have experienced this themselves. Because very few patients read the medical literature, or know about autoimmune conditions and other potential noninfectious causes of prolonged symptoms following an infection, the conclusion that Lyme disease can commonly persist as an active infection follows from what they observe in themselves, their friends, and their family.

Although public knowledge of Lyme disease is consistent with that of other major medical conditions in the public consciousness, the widespread belief in chronic Lyme presents challenges for this disease at this point in time. The concept of chronic Lyme disease has entered the public discourse in newspaper articles, the realm of public policy [as several states have passed legislation protecting doctors who provide prolonged antibiotic therapy], and has generated conflict both within academia and with the public at large.

Given the serious harm to patient health that may occur as a result of unnecessary prolonged therapy or the failure to seek appropriate care for symptoms mistakenly diagnosed as Lyme disease, additional work needs to be done to better understand how accurate information about Lyme disease can effectively be transmitted within a community. Our findings suggest that medical doctors need to make certain that they are knowledgeable regarding the cause, clinical course, complications, diagnosis, prevention, and current appropriate therapy guidelines for Lyme disease and other tick-borne diseases and provide that information to all their patients. Medical societies, private foundations, and State and Federal health agencies should increase efforts to educate physicians and the general public on the appropriate diagnosis and treatment of Lyme disease and provide additional funding to determine why some people experience persistent symptoms following this infection.

Gobsmacked by germ theory denialism. Again.

Posted on: March 17, 2011 6:00 AM, by Orac

People believe a lot of wacky things. Some of these things are merely amusingly wacky, while others are dangerously wacky. Among the most dangerously wacky of things that a large number of people believe in is the idea that germ theory is invalid.

Perhaps a better way of putting it is that among the most dangerously wacky of nonsense is germ theory denialism; i.e., the denial that germs are the cause of disease. Few theories in medicine or science are supported as strongly by such a huge amount of evidence from multiple disciplines that converge on the idea that microorganisms cause disease, supporting it with an interwoven web of evidence that bring germ theory about as close to a fact as a scientific theory can be. True, for different diseases it's not always clear what the causative organism is or even if there is a causative organism, but these examples all fit into the general framework of the germ theory of infectious disease.

Read the rest at Respectful Insolence.

How Big Is the Lyme Problem? Using Novel Methods to Estimate the True Number of Lyme Disease Cases in British Columbia Residents from 1997 to 2008.

Henry B, Roth D, Reilly R, Macdougall L, Mak S, Li M, Muhamad M.

Vector Borne Zoonotic Dis. 2011 Mar 17

Difference in incidence between eastern and western North America may arise because I. pacificus is a less competent vector of LD than is I. scapularis. Alternatively, significant under diagnosis and underreporting of LD by physicians, perhaps because of low awareness of disease risk, may be driving these low rates. Although such underreporting has been previously identified in other jurisdictions and is common for passive surveillance systems,Lyme advocacy groups claim that LD incidence rates in BC are actually much higher than reported because physicians are not told of the risk and miss cases, cases are not counted by public health, and laboratory testing is inadequate. They also claim that cases have increased dramatically in the past 10 years.

Over the 12-year period under study (1997–2008), 93 clinically and/or laboratory diagnosed cases of LD were reported to public health authorities in BC. Slightly over half were women and the median age was 46.9 years. The proportion of female cases and median age of our cases is higher than that seen in the 10 high endemic states of the United States (median 7 years; 53% male) but in keeping with the age and percent seen in low endemic states (median 44 years; 49.4% male) (Bacon et al. 2008). One-third of these cases likely acquired their illness while traveling outside of BC, including to Europe and the eastern United States where endemic rates of LD are known to be high (CDC, 2007). The yearly LD incidence in BC is comparable to Washington Stateand California, with all three western jurisdictions having incidence rates of <0.5/100,000 population even when travel-related cases are included; these rates have remained stable in the last 8–12 years.

…analysis revealed that LD is potentially underreported by as much as 40% in this province, although the low sample size means that care must be taken when interpreting this estimate. Underreporting is common for rare diseases when passive reportable disease surveillance systems are used. It is not known whether this underreporting in BC results from clinical cases being treated without testing and not reported or whether the cases are truly not diagnosed. Further investigation is needed into the awareness levels of physicians of the risk, clinical presentation and testing requirements for LD in BC. However, even the maximum incidence estimates using the most conservative CR results are well below those found in highly endemic areas in the eastern United States, confirming the low endemic risk in BC in contrast to claims made by some advocacy groups.

In summary, this study suggests that while important underreporting of LD does exist in BC, the endemic risk remains low. These findings have important public health implications and will help address public concern regarding the true incidence of the disease in BC. There is concern that global warming could lead to expansion of the ecological niche for the vector and a resultant increase in the exposure of the population to infected ticks in BC. Concerns about increasing risk with increasing climate warming further bolster the need for both improved surveillance and strategies to ensure both awareness of LD in treating physicians, as well as increased awareness and use of prevention measures in the population, including those traveling to areas where LD is more highly endemic than in BC.

Notes from:

Clin Microbiol Infect. 2011 Apr;17(4):487-93.

The expanding Lyme Borrelia complex-clinical significance of genomic species?

Stanek G, Reiter M.

Although the B. burgdorferi sensu lato complex now comprises up to 18 Borrelia species, only three of them are clearly pathogenic for humans, namely B. afzelii, B. burgdorferi, and B. garinii (including B. garinii OspA type 4, recently named B. bavariensis).

They can cause localized skin manifestations and disseminated infection by invading various tissues, including the nervous system, the joints, and the skin. B. spielmanii was isolated repeatedly from lesional skin of erythema migrans patients. There are also reports on the isolation or detection of B. bissettii and B. valaisiana from specimens of patients suffering from Lyme borreliosis.

It is, however, unclear what role B. lusitaniae plays, as the described clinical manifestations do not match with the known features of Lyme borreliosis. However, the predominant pathogens in central Europe are B. afzelii and B. garinii (including B. garinii OspA type 4, recently named B. bavariensis). Among nearly 500 skin isolates from patients with erythema migrans in Slovenia, 89% were identified as B. afzelii, 11% as B. garinii, and only 0.4% as B. burgdorferi. According to the detection rates from CSF of patients suffering from Lyme neuroborreliosis in Europe, B. garinii is most often the causative agent, followed by B. afzelii and B. burgdorferi. B. bissettii was isolated only once, and the presence of B. valaisiana was confirmed in three cases.

In a long-term Slovenian study of adults with culture-confirmed Lyme neuroborreliosis, isolates were similarly identified as either B. garinii or B. afzelii. It was found that patients with B. garinii isolated from their CSF had a distinct clinical presentation from that of patients with B. afzelii.

B. garinii causes what, in Europe, is appreciated as typical early Lyme neuroborreliosis (Garin–Bujadoux–Bannwarth syndrome), whereas the clinical features associated with B. afzelii are much less specific and more difficult to diagnose.

Results from North America, where B. burgdorferi is the only pathogenic agent of Lyme borreliosis, showed that, among the subtypes differentiated by RFLP analysis of the 16S–23S rDNA intergenic spacer region, there was a predominance of genotypes 1 and 2 (70%). Similarly, these were much more likely to cause disseminated infection than genotype 3 isolates.

Correlation of B. burgdorferi subtypes with clinical presentation has been substantiated by others, and might hold the key to explaining the protean manifestations of Lyme borreliosis.

Although many new species have been described, their pathogenic role remains questionable. On a cautionary note, in those exposed to frequent tick bites, exposure to these newer members of the genus might result in seroreactivity that could obscure or complicate clinical diagnosis.

Medical "best practice" often no more than opinion

Mon, Jan 10 2011

By Frederik Joelving

NEW YORK (Reuters Health) - Even when following medical guidelines to the letter, doctors often use treatments that have little or no scientific support, U.S. researchers said Monday.

They found only one in seven treatment recommendations from theInfectious Diseases Society of America (IDSA) -- a society representing healthcare providers and researchers across the country -- were based on high-quality data from clinical trials.

By contrast, more than half the recommendations relied solely on expert opinion or anecdotal evidence.

"Despite tremendous research efforts, there is still a lot of uncertainty as to what is the best patient care," said Dr. Ole Vielemeyer, an expert in infectious diseases at Drexel University College of Medicine in Philadelphia and one of the study's authors.

[snip]

The new analysis, published Monday in the Archives of Internal Medicine, is based on more than 4,200 recommendations made by IDSA between 1994 and 2010.

"These data reinforce that absolute certainty in science or medicine is an illusion," an editorial in the journal notes. "Rather, evaluating evidence is about assessing probability."

[snip]

Doctors across the world look to guidelines when deciding how to treat patients, and insurance companies may use them in coverage decisions.

Because they are drafted by leading experts in the field, they are generally understood to reflect the best medical knowledge available. "People commonly associate guidelines with practicing evidence-based medicine," said Vielemeyer.

But often the relevant clinical studies simply haven't been done. In the absence of evidence, the recommendations end up depending largely on who's on the guideline-drafting panel and any assumptions or opinions they may bring to the process.

[snip]

"We are operating on a lot of bias," acknowledged Dr. Larry Baddour, who chairs the division of infectious diseases at Mayo Clinic College of Medicine in Rochester, Minnesota, and has been on several IDSA panels. He recently published findings similar to those of the current study in the IDSA's journal Clinical Infectious Diseases.

"We struggle with this, even as experts," he said. "We recognize we have bias, but it's impossible to eliminate when there is a dearth of data."

Diana Olson, spokesperson for IDSA, pointed out that all recommendations list the degree of evidence on which they are based. "Clinicians understand when there is really rock-hard evidence behind our recommendations and when there isn't," she told Reuters Health, adding that some guidance is better than none at all. "The public can have absolute confidence in these guidelines," she added. "They remain the best that science and medicine have to offer."

Vielemeyer agreed guidelines offer valuable help to busy doctors. "As long as you understand that they are just guidelines, I don't think they are detrimental to patients," he said. "But if they are considered as dogma, that is when they can become dangerous to patients."

________________________

The analysis of guidelines used in clinical medicine should not come as much of a surprise. Cost, limited patient populations, or ethical considerations often will prevent many treatment recommendations from being based on Level I evidence (i.e., evidence from one or more randomized controlled trials). In the absence of such data many guidelines necessarily fall back on expert opinion (emphasis on “expert”).

In the case of the 2006 IDSA recommendations for Lyme disease, those guidelines were based on a mixture of Level I, II (one or more nonramdonized trials), and III (opinions of respected authorities based on clinical experience, descriptive studies, or reports of expert committees) evidence.

Yet, that seems to irk the Lyme activists. They ignore the three NIH-funded clinical trials, ignore 30 years of laboratory research and clinical practice, ignore the words “expert” and “respected authorities,” and instead focus their wrath about the IDSA and its treatment guidelines on one stand-alone word: opinion. Still, for all the complaining, the guidelines are based on more than mere opinion, and those opinions that are used are based on recognized expertise.

The California Lyme group and their self-styled policy wonk(where’s a good tsunami when you need one?) just blasted off another missive following the Reuter’s report about guidelines and degrees of evidence. It’s the usual denouncement of the IDSA and its guidelines. The Wonk writes, “The lack of evidence in IDSA guidelines is laid out in two separate studies by IDSA members who reviewed the evidence in most of IDSA guidelines.”

No. There’s plenty of evidence from Level I trials, Level II studies, and Level III expert opinion derived from decades of research and practice. The problem here is that activists like the Wonk simply don’t believe in evidence, data, trials, experiments, and observation. It’s not part of their world view. Any reality that conflicts with their personal beliefs and anecdotes is rejected, as are the people who provide such evidence. The situation reminds me of the first encounters between Europeans and the Aborigines. The white explorers and their huge ships were so outside the experiences and world view of the Australian natives that they simply ignored the nearby ships and their sunburned inhabitants….until iron and shot finally got their attention.

So the activists and the Wonk are rejoicing (again) in the alleged absence of evidence without, oddly enough, questioning the quality of evidence supporting the guidelines of their own quack doctors (ILADS).

Examining those guidelines one would find no Level I or II trials. As for “expert opinion” one would have to rely on a couple of psychiatrists, some non-board-certified general practitioners, an elderly pediatrician or two, a few hacks reprimanded by their state licensing boards, an ex-con or two, and at least one hematologist fired from his university and barred from federal research funds. There may be some collective expertise in that mix, but I don’t think any of it has anything to do with infectious diseases.

It’s got quack doctors, non-validated diagnostics, specialty clinics, inappropriate use of antimicrobial agents, ardent patient/activists, politics, alleged conspiracies and paranoia. Yes, the XMRV story is following awell-worn trail left by other imaginary illnesses and syndromes such as chronic Lyme disease, Morgellons, chronic fatigue, Lyme-induced autism, and vaccine-induced autism. Here’s the background from the Chicago Tribune.

Research casts doubt on theory of cause of chronic fatigue. Retroviral link to debilitating illness looking shaky, but critics still bank on anti-HIV drugs.

By Trine Tsouderos

Chicago Tribune, March 17, 2011

[snip]

The Tribune reported last year that the original research on chronic fatigue syndrome and XMRV had led some patients to get tested for the retrovirus and take anti-retroviral drugs intended to treat HIV, which causes AIDS. The situation highlights the danger in putting too much stock in one scientific study, even one in a prestigious journal. Studies need to be replicated, and early research is often proved wrong.

The original study, published in Science in 2009, was led by retroviral immunologist Judy Mikovits of the private Whittemore Peterson Institute for Neuro-Immune Disease in Reno, Nev. The institute plans to open a clinic that in May would begin treating patients diagnosed with chronic fatigue syndrome and other neuro-immune diseases. Despite the newer research, its leaders strongly deny that contamination could account for their findings.

"It is clearly a human infection," Mikovits, the institute's director of research, told an audience at a January presentation hosted by a California alternative medical practice. "It is clearly circulating through the population as is our fear and your fear."

Scientists say there is no evidence to support her statement. "Saying that is just inciting fear," said Columbia University virologist Vincent Racaniello.

Mikovits, who once worked at the National Cancer Institute in Frederick, Md., has made increasingly broad statements about XMRV. At the January talk, she showed a slide connecting XMRV to a list of frustrating medical conditions like ALS, Parkinson's disease, multiple sclerosis and dementia. She also linked it to autism. But no published data exist to support those links.

Mikovits also talked about potential treatments, including the powerful anti-retroviral drugs used to treat people who have HIV. These have not been proved safe or effective for people with chronic fatigue syndrome or any of the other conditions listed.

The WPI's director of clinical services, Dr. Jamie Deckoff-Jones, who has chronic fatigue syndrome and has taken anti-retroviral drugs for a year, is using a personal blog to allege a cover-up by researchers seeking to discredit the XMRV link.

"So is there motivation for the cover-up and baseless attacks against Dr. Mikovits?" she wrote in a posting that has been widely circulated on patient forums. "They cannot attack the data because it is impeccable."

WPI President Annette Whittemore, whose daughter has been diagnosed with chronic fatigue syndrome, said in an interview that she thinks politics are at play.

"I thought we were going to solve my daughter's illness or at least fund more significant treatments," said Whittemore, who founded the institute. "I didn't think we would have such political pushback. That was so naive of me."

Whittemore also defended patients trying anti-retrovirals, saying they are safe if used under an experienced doctor's care.

[snip]

Physicians who work with HIV patients say antiretroviral drugs can cause significant side effects and that efficacy cannot be determined through anecdotes.

The chasm between the WPI and its supporters and many in the scientific community is emblematic of a new, modern-day dynamic in which patients keep close tabs on the work of researchers and feel empowered to challenge that work and form strong opinions about the quality of it.

Early on, many in the online chronic fatigue community threw their support behind WPI, believing strongly that XMRV was the cause of their illness. More than 1,000 people have paid for non-FDA-approved XMRV blood tests from a commercial lab associated with WPI and headed by Whittemore's husband, Harvey, according to state records. The tests range from $249 to $450, according to the lab website.

Patients' ardent support for XMRV as a cause has continued as other research teams have failed to find any evidence that it was true.

[snip]

This month, 4,000 scientists and clinicians gathered in Boston for a retroviral conference that included 10 presentations offering evidence that XMRV is a lab contaminant. Mikovits did not attend.

The Council of State and Territorial Epidemiologists

10-ID-27

Committee: Infectious Disease

Title: Public Health Reporting and National Surveillance forBabesiosis

The purpose of this position statement is to add babesiosis to the CSTE Nationally Notifiable Condition List and to provide a standardized case classification definition for babesiosis.

Currently, individual states’ case classification criteria for babesiosis are variable and do not provide mechanisms for monitoring transfusion-associated babesiosis.

A standardized case classification definition for babesiosis will enable the collection of national surveillance data and enhance the ability of public health authorities to detect, monitor, and prevent babesiosis. Inclusion of transfusion-associated cases and positive donors and co-recipients, even if asymptomatic, will specifically facilitate national surveillance for transfusion-associated babesiosis. We request that babesiosis be added to the CSTE Nationally Notifiable Conditions list.

Suggested case definition:

1. A person who meets at least one of the following:

· Identification of intraerythrocytic Babesia organisms by light microscopy in a Giemsa, Wright, or Wright-Giemsa–stained blood smear

· Detection of Babesia microti DNA in a whole blood specimen by polymerase chain reaction (PCR)

· Detection of Babesia spp. genomic sequences in a whole blood specimen by nucleic acid amplification

· Isolation of Babesia organisms from a whole blood specimen by animal inoculation

· Elevated Babesia microti, Babesia divergens, or Babesia duncani Indirect Fluorescent Antibody (IFA) total immunoglobulin (Ig) or IgG antibody titer

· Demonstration of a Babesia microti Immunoblot IgG positive result

2. A person whose healthcare record contains a diagnosis of babesiosis

3. A person whose death certificate lists babesiosis as a cause of death or a significant

condition contributing to death.

Here’s an odd bit of information from someone who claims to be a “Lyme doctor,” “Board Certified in Family Practice,” and has “over 22 years of experience as a practicing physician.”

From: LymeMD

Lyme and the gallbladder.

This [is] an area of Lyme medicine which deserves more attention. Many Lyme patients end up with removal of the gallbladder. Lyme can infect the wall of the gallbladder and cause chronic inflammation. This appears to happen with increased frequency when there is also evidence of Salmonella infection.

No. The problem is not the infection, but the incompetent application of antibiotic treatment for an infection that may or may not exist at the time. This is an old story that apparently bears repeating. Here’s the abstract:

J Infect Dis. 1995 Feb;171(2):356-61.

Biliary complications in the treatment of unsubstantiated Lyme disease.

Ettestad PJ, Campbell GL, Welbel SF, Genese CA, Spitalny KC, Marchetti CM, Dennis DT. Bacterial Zoonoses Branch, Centers for Disease Control and Prevention (CDC), Fort Collins, Colorado.

Treatment of unsubstantiated Lyme disease has led to serious complications in some cases. Two case-control studies, based on information in clinical records of patients discharged with a diagnosis of Lyme disease during 1990-1992, were conducted at a central New Jersey hospital. Twenty-five patients with biliary disease were identified, and 52 controls were selected from 1352 patients with suspected Lyme disease. Only 3% of 71 evaluatable subjects met the study criteria for disseminated Lyme disease. Patients with biliary disease were more likely than were antibiotic controls to have received ceftriaxone and more likely than ceftriaxone controls to have received a daily ceftriaxone dose > or = 40 mg/kg and to be < or = 18 years old. Fourteen of 25 biliary case-patients underwent cholecystectomy; all had histopathologic evidence of cholecystitis and 12 had gallstones. Thus, treatment of unsubstantiated diagnoses of Lyme disease is associated with biliary complications.

The JID paper was based on an earlier study, “Ceftriaxone-Associated Biliary Complications of Treatment of Suspected Disseminated Lyme Disease -- New Jersey, 1990-1992,” first published in MMWR and available here. The MMWR report notes the following:

This report highlights several important issues related to the diagnosis and management of suspected LD.

• Most patients hospitalized for suspected LD in this study lacked documented objective manifestations of disseminated LD or seropositivity to B. burgdorferi.
• The demographic profile of these patients, mostly preadolescent and adolescent females, differs from that of LD patients reported nationally during the study period.
• The repeated and often prolonged courses of antimicrobials prescribed in these cases suggest that antimicrobial therapy did not achieve satisfactory remission of symptoms and was associated with biliary complications resulting in cholecystectomy in some patients.

Adding to the problems of biliary complications and surgical interventions were nosocomial infections: “A review of records of the original cohort also revealed 22 patients with intravenous catheter-associated bloodstream infections; 29 separate episodes of bloodstream infection occurred in these patients. The median duration of catheterization in these patients (measured from insertion to diagnosis of bloodstream infection) was 152.5 days (range: 16-764 days). The blood isolates from these patients included a variety of gram-positive and gram-negative bacteria.”

Cholecystitis, surgery, bloodstream infections. That’s a lot of serious complications arising from the treatment of an infection that may or may not have been present in the first place. Unfortunately, it’s not clear from LymeMD’s online comments that the studies and warnings of 18 years ago have penetrated the alternate universe of the practicing LLMD. Certainly, some of their patients remain equally clueless and dangerously experimental as suggested by one of the LymeNut posters below.

It sounds to me the best rememdy for an infected gall bladder are coffee enemas. The coffee goes into the colon through a portal vein to the liver and back through the gall bladder into the small intestines. If you do enough of these it should help the gall bladder. You might also add baking soda and tinctures to the coffee to kill any infection as the liquid recycle from the colon to gall bladder.

Someone get this idiot a copy of Gray’s Anatomy (the textbook, not the television show), a cup of decaf, and cork to sit on.

Sometimes it’s tough living in California. First, the remnants of a tsunami wash ashore. Then some California Lyme activists announced that…

“Dr. Joseph Burrascano, one of the world's leading experts on Lyme disease, will discuss the newest, most effective methods for treating tick-borne illness in a special northern California appearance. He will be joined by a panel of Lyme-treating physicians at a presentation entitled, "Putting Lyme Behind You: Cutting-edge Ways to Heal from Tick-borne Illness." He will be joined by a panel of other Lyme-treating doctors,” [most of whom are from an alternative medicine clinic that deals with acupuncture, detoxification, herbal medicine, naturopathic medicine, nutritional, therapy, osteopathy, autism and chronic fatigue. It’s one-stop shopping for hypochondriacs.]

So Uncle Joe, voice of the Lyme disease conspiracy and “one of the world’s leading experts on Lyme disease” is coming to Calif. As I’ve noted before, there’s the near pathological use by activists of superlatives to describe the doctors who fleece…I mean treat…them. They are always described as “world- renowned,” “experts,” “noted experts,” a “nationally renowned Lyme disease expert,” a “leading Lyme doctor,” a “renowned Lyme expert and medical researcher,” “a leading authority,” “a renowned physician,” “a nationally renowned expert,” and “the world's leading Lyme pediatric specialist.” Their research--which is seldom published, almost never funded by federal agencies, is occasionally conducted in home basements, and is never reproducible--is described as “pioneering work,” and “pioneering research.”

“One of the world’s leading experts on Lyme disease” has not practiced medicine since 2006, and when he did, it occasionally was under the supervision of another doctor. As Uncle Joe noted in 2002, “ I will be placed on probation with a practice monitor. The original penalty was to have this for 6 months. The appeals board upheld this penalty but did expand the time period of probation to two years, to keep it consistent with other cases.”

What’s he been doing since retirement? Hard to tell. He’s supposed to be the Medical Director of Advanced Research Corporation in Saint Petersburg, FL, but the company doesn’t seem to do much and lacks even a functional website (http://www.arc-cro.com/). The company listing notes: “There is no Board Members Memberships data available. There is no Annual Compensation data available. There is no Stock Options data available. There is no Total Compensation data available.”

There won’t be much Lyme disease data available from Uncle Joe either.

Finally, a California Lyme activist group announced, “After a brief hiatus, Lyme-TAP (Testing Access Program) is back in operation with a new website. Lyme-TAP is a nationwide assistance program helping patients with financial hardship pay for Lyme-related diagnostic testing. It helps pay for diagnostic testing related to Lyme disease, other tick-borne illnesses and CD57 status. The program will provide reimbursement for up to 75% of the patient’s out-of-pocket costs of testing from any CLIA/Medicare-approved laboratory of the patient’s choice. Conditions apply, funds are limited and priority is given to children.”

This is a particularly bizarre announcement coming from Lyme activists because they regularly, almost religiously, denounce all diagnostic testing for Lyme disease, insisting instead, that Lyme is a “clinical diagnosis” (i.e., the holy opinion of the Lyme Literate practitioner). As I said before, “This is one of the [Lyme] Movement’s favorite claims: that the diagnostics are too poor to reliably detect Lyme disease in patients.

Worse, they’re advertising and planning to pay for a test (CD57 white cell count) that has been shown to be worthless for Lyme disease diagnosis. (Why use it, then? Because it was invented by one of those “noted experts,” a “nationally renowned Lyme disease expert,” a “leading Lyme doctor,” a “renowned Lyme expert and medical researcher,” “a leading authority,” “a renowned physician,” Ralph Stricker so it must be a great test.)

Lyme-TAP is being funded by a California Lyme diagnostics company called Igenex. The lab has been the subject of several warnings previously mentioned here, here, andhere. More recent warnings about unvalidated Lyme testing methods have been issued in the U.K., which has its own Lyme activism problems.

So it’s really turning out to be a bad month for California with a triple blow from natural and man-made disasters. Of course, the rest of us are not immune from the latter.

NYT March 10, 2011

Response of W.H.O. To Swine Flu Is Criticized

By DONALD G. McNEIL Jr.

A panel of independent experts has harshly reviewed theWorld Health Organization’s handling of the 2009 epidemic of H1N1 swine flu, though it found no evidence supporting the most outlandish accusation made against the agency: that it exaggerated the alarm to help vaccine companies get rich.

The world is still unprepared to handle a severe pandemic, and if a more dangerous virus emerges, “tens of millions would be at risk of dying,” the panel said in its draft report, which was posted on an obscure corner of the W.H.O.’s Web site on Thursday.

Although millions of doses of vaccine ultimately went unused, the panel found “no evidence of malfeasance.”

[snip]

The panel, which has experts from 24 countries and is led by Dr. Harvey V. Fineberg, president of the Institute of Medicine, criticized the agency’s “needlessly complex” definition of a pandemic, which had six levels of alert, based on the virus’s geographical spread, not its severity. At one point, the agency altered, without explanation, its online pages to remove references to severity. That “invited suspicion,” the panel said.

While the names of the agency’s expert advisers were kept secret for months to shield them from pressure, the tactic “paradoxically fed suspicions that the organization had something to hide,” the panel said.

[snip]

Dr. Fineberg declined to discuss the report’s conclusions, because it is a draft. His panel invited testimony from both critics and the W.H.O. staff, “but everything was voluntary,” he said. “We don’t have subpoena power.”

The report also acknowledges that many problems were beyond the health agency’s control. Vaccine companies use slow 60-year-old technology, diagnostic tests are cumbersome, and virologists know too little about which mutations are the most dangerous.

[snip]

An interesting lab contaminate becomes a less interesting human pathogen. Some comments and conclusions from the Science article are included below.

Science 11 March 2011:

Vol. 331 no. 6022 pp. 1253-1254

More Negative Data for Link Between Mouse Virus and Human Disease.

…two collaborating research teams contend that they have evidence that xenotropic murine leukemia virus–related virus (XMRV) resulted from the chance recombination of pieces of two mouse viruses in lab experiments and that the connections to human disease are spurious.

“That nails it,” said retrovirologist Nathaniel Landau of New York University. “Everyone working on this thing has this virus contaminating their stuff. It's been a tremendous waste of time and money.”

Vinay Pathak, a retrovirologist who works at the HIV Drug Resistance Program run by the U.S. National Cancer Institute (NCI) in Frederick, Maryland, explained how kepticism has steadily built about the link between XMRV and these diseases as several labs examined patient samples and could not find the virus or antibodies to it….

Hammering the nail in further, Oya Cingöz in Coffin's lab [atTufts University] looked for XMRV in dozens of inbred and wild mice and reported that she found no evidence that the virus naturally exists.

…[John] Coffin has changed his thinking. “It's all contamination,” he says. At this point, Coffin questions whether any human has been infected with the virus. “It remains a distant possibility,” he says.

“I don't think XMRV is a human pathogen,” S. Hue [of University College London] says. “It's as simple as that.” Like Coffin, he doubts that XMRV has even infected a human but adds that “one can never say that something doesn't exist.”

“The evidence coming out at this meeting is incredibly impressive, and the weight of evidence is indicating that this is not a major human virus in terms of pathogenesis,” says Michael Busch, who heads the Blood Systems Research Institute in San Francisco, California

Lyme activism never rests. There’s always some protest to attend, letter-writing campaign to start, meetings to organize, online messages to post, or quack doctors to bail out. Over at Open Eye Pictures they’re busy launching phase II of an ongoing Lyme disease propaganda campaign.

We are now gearing up for the next phase–the Uncover the Epidemic national outreach campaign, which we’re launching in conjunction with our theatrical and educational DVD release this summer. In addition to getting the film before mainstream audiences, we’ll be partnering with national organizations to bring Lyme awareness into current debates on health care and the environment. We will also be working to get the film into classrooms, medical schools and libraries, so that the truth about Lyme disease (and the system that has kept it hidden) can no longer be ignored.

Wouldn’t it make more sense to call this political action, “Uncover the Conspiracy?” After all, it’s kind of hard to hide an epidemic, but by definition, conspiracies are always hidden. Epidemics, on the other hand, are usually obvious. Here’s why: “Epidemic is defined as the occurrence in a community or region of a group of illnesses of similar nature, clearly in excess of normal expectancy, and derived from a common or from a propagated sources.” [Epidemiology by Leon Gordis, 2004]

So these paranoid, self-appointed detectives are looking for truth and the people who have hidden that truth. Sounds like a terribly familiar quest. Parents’ basements and mental health clinics are full of such seekers. Maybe they should rename their film company Wild-Eyed Pictures.

Names aside, it looks like they have a ways to go with that propaganda war chest. Hope they’re keeping good records of all those donations. You never know when someone may start looking through their public IRS 990s to see where all the money is going.

Well, good luck. Looking forward to learning more about this vast conspiracy. Grab those magnifying glasses and don your tinfoil hats, the game’s afoot.

More from the imaginations of Andy Wilson and Chris Newby, the folks who brought you the celluloid version of the Lyme disease conspiracy. Reviews of this anti-science film have been posted here, here, here, here, here, here and here.

From the UNDER OUR SKIN blog:

On June 26, 2007, we, the producers of the documentary, “Under Our Skin,” submitted a Freedom of Information Act (FOIA) request to investigate possible conflicts-of-interest of three Centers for Disease Control (CDC) employees who control public health policy for Lyme disease. Almost four years later, we’re still waiting for this information, and we’ve just learned that our request is among the ten oldest unfulfilled requests awaiting action at the CDC’s parent agency, the Department of Health and Human Services (HHS).

[I can’t imagine who these three might be. Please tell us. I know everyone at CDC and I can’t think who there—or anywhere—is controlling “public health policy for Lyme disease.” Is there such a policy and what exactly might it be? There is plenty of research going on, and recommendations based on research and epidemiology, but I don’t think anyone would call that body of work and data a formal federal policy.]

[snip]

For the purposes of our documentary, this FOIA request is essential in answering some of the most puzzling questions surrounding Lyme disease — why has the CDC been endorsing an outdated symptom list and unreliable testing protocol on their website? Why has the CDC been underreporting Lyme cases for the last decade? Are these CDC employees really working in the interest of the tax-paying public or are they being influenced by hidden commercial influences?

[Well, because it’s not outdated and the testing—done properly—is very reliable. As for under-reporting, the CDC can only report what it receives form the community of private practice physicians. “Hidden commercial influences?” Sounds like a conspiracy. Though as market experts point out, there’s not much money to be made in treating Lyme disease, never mind not treating it.]

Communicating the government’s point-of-view in our film was a top priority, but lack of cooperation and transparency by the organizations in charge of setting Lyme disease policy in the U.S. made this virtually impossible. At a 2005 infectious disease conference, the director of the CDC Lyme disease group, Lyle Petersen, MD, MPH, refused to speak with us on or off camera. “Talk to media relations,” he said angrily.

[It’s clear from the comments of UOS people that they are not interested in objective information and informed debate. They have an agenda and a fixed set of beliefs that are not going to be altered by any discussion with anyone. So why talk to them. Read more about both of the film’s creators here.]

[snip]

Undaunted, we flew a crew to the Montana home of retired NIH Lyme disease expert, Willy Burgdorfer, Ph.D., M.D., the discoverer of the Lyme bacterium. While setting up the cameras, an NIH representative showed up uninvited, and said, “I’ve been told that I need to supervise this interview. This comes from the highest levels. There are things that Willy can’t talk about.”

[Never happened. I know the guy—one of Willy’s colleagues—who showed up. If it did happen as alleged, where’s the tape, the film, the recordings? Two such suspicious people as Newby and Wilson surely who have had some recording equipment running. It would have been perfect for their conspiracy film. Maybe next time they can get some help fromGOP prankster James O’Keefe.]

That left a FOIA request as the next logical step in trying to understand the government’s reluctance to talk about Lyme disease.

[snip]

Initially we were told that our request for three resumes and some email records would cost $27,515 out-of-pocket, because whomever handled our request mistakenly decided that our educational film production company was a “for-profit commercial interest” that “does not publish current news of current interest to the general public.” It didn’t matter that our appeal showed that we were granted status as a non-profit 501 (c) (3) documentary producer in 2005, or that we had a website that proved that we had produced a number of educational medical films on AIDS, cancer, and dystonia.

[I have no idea what the non-profit status of UOS really is, but it’s clear from Andy Wilson’s own words that he’s not terribly interested in public education.

“…our film has brought unprecedented attention to the issue of Lyme disease. But we have more work to do. We are now gearing up for the next phase--the Uncover the Epidemic national outreach campaign, which we're launching in conjunction with our theatrical and educational DVD release this summer. We need to raise $100,000 in the next two and half months to continue our vital outreach work, including our awareness tour, advertising, PR and promotional materials. Never before has the Lyme community had a media tool like UNDER OUR SKIN. It is imperative we don't pass up this opportunity to create lasting mainstream awareness and change.”

This isn’t education; it’s propaganda. And apparently profitable propaganda, given all those DVD sales to deluded Lyme activists and patients.]

[snip]

Along the way, we’ve been told that the delays are due to understaffing, year-end financial deadlines, and people taking vacation. We’ve been told that our calls remain unanswered because there’s a phone “dead zone” in the new CDC FOIA office in Atlanta. Several times we’ve been told that we’re at the top of the FOIA queue, and that our request is on the verge of being handled. When we had the president of a D.C. Lyme disease foundation ask a visiting CDC representative, Ben Beard, Chief of Bacteriology and the Lyme disease program, about our FOIA request, he said, “It is our policy not to respond to such letters. We consider the accusations in that FOIA to be slanderous.”

[Could be true. I think everything these activists have ever said about NIH and CDC staff, and Lyme researchers has been wrong, false, or slanderous. Often they can’t even get people’s names or titles correct. So again, why talk to them.]

This week — 3 years and 8 months after our original FOIA filing — we received the first glimmer of hope in the FOIA process. The good news: HHS assures us that there will be a ruling on our appeal and fee waiver within the next six weeks. The bad news: HHS has no idea how long it will take the CDC to send us the requested files once our FOIA request leaves the appeals desk.

In the meantime, Lyme disease continues to grow at an alarming rate, doubling in the last five years. The CDC remains mum on the controversies surrounding Lyme disease, venturing out of their Ft. Collins, Colorado enclave to speak to patient groups only once or twice a year. Their website content is tightly aligned with the Lyme disease doctrine endorsed by the quasi-commercial medical society, the Infectious Diseases Society of America, and it’s unclear what personal or commercial interests ties exist between the CDC and the authors of the controversial IDSA Lyme disease guidelines, until our FOIA request is answered.

[They venture out of their enclave—and it’s a very nice enclave, except for the summertime rattlesnakes—only once or twice a year because it’s not part of their job. They are there to do research and occasionally take some time out for public education efforts. But again, there’s only so much time you can devote to talking to people who simply will not listen. As for the “quasi-commercial” IDSA, part of the society is apublic charity (just like UOS claims to be); the rest is aprofessional society for ID physicians. Finally, the CDC’s website content is not so much aligned with the IDSA as the IDSA’s recommendations are informed by the research of CDC and NIH.]

We hope someday to be able to provide answers to these questions on the “Under Our Skin” website. But until then, we continue to wait.

[Try to wait quietly please. Some of us are trying to work.]

Below is a recent Time’s article about chronic fatigue, but what’s interesting about this particular article is the emphasis on the concept of a case definition. I’m posting part of it here as a reminder that the chronic Lyme folks and their quack doctors have yet to produce a case definition of what “chronic Lyme disease” is supposed to be. Without a solid case definition, it’s hard to know who has a particular condition and how they should be treated, among other things. But maybe that’s exactly why there is no case definition for chronic Lyme; that way it can be whatever the doctor says it is and whatever the patient wants to believe it is. It’s an undefined win-win.

New York Times, March 4, 2011

Troubles of Chronic Fatigue Syndrome Start With Defining It

By DAVID TULLER

When reports emerged 30 years ago that young gay men were suffering from rare forms of pneumonia and cancer, public health investigators scrambled to understand what appeared to be a deadly immune disorder: What were the symptoms? Who was most susceptible? What kinds of infections were markers of the disease?

They were seeking the epidemiologist’s most essential tool — an accurate case definition, a set of criteria that simultaneously include people with the illness and exclude those without it. With AIDS, investigators soon recognized that injection-drug users, hemophiliacs and other demographic groups were also at risk, and the case definition evolved over time to incorporate lab evidence of immune dysfunction and other refinements based on scientific advances.

“If you recognize something is happening, you need a case definition so you can count it,” said Andrew Moss, an emeritus professor of epidemiology at the University of California, San Francisco, and an early AIDS investigator. “You need to know whether the numbers are going up or down, or whether treatment and prevention work. And if you have a bad case definition, then it’s very difficult to figure out what’s going on.”

Once a disease can be diagnosed reliably through lab tests, creating an accurate case definition becomes easier. But when an ailment has no known cause and its symptoms are subjective — as with chronic fatigue syndrome, fibromyalgia and other diseases whose characteristics and even existence have been contested — competing case definitions are almost inevitable.

Now a new study of chronic fatigue syndrome has highlighted how competing case definitions can lead to an epidemiologic “Rashomon” — what you see depends on who’s doing the looking — and has stoked a fierce debate among researchers and patient advocates on both sides of the Atlantic.

[snip]

No case definition is perfect; every disease has outliers. But whether a definition is broadly or narrowly drawn can profoundly affect the statistics vital for public health planning.

[snip]

“You have to really define the characteristics, and everybody has to use the same criteria, because otherwise you’re calling something an apple and someone else is really looking at a peach and calling it an apple,” said Dr. Anita Belman, a neurologist at Stony Brook University who conducts research on pediatric multiple sclerosis.

I missed this story back in October, but it’s posted here as a reminder of a pending CDC report on an old illness (delusional parasitosis) that has found new life on the Internet as a new disease (Morgellons), which has attracted some bad scientists to explain it and treat it.

Whatever Happened To ... the mysterious disease known as Morgellons

The Washington Post

By Brigid Schulte

Sunday, October 31, 2010

In 2004, Sue Laws began to itch. She found tiny red fibers all over her back. Within weeks, her skin broke out in lesions. She felt bugs crawling under her skin, and one day, she said, she pulled a worm out of her eyeball and coughed up a springtail fly. "That's when I thought, 'I'm really going to kill myself,'" the Gaithersburg resident told The Washington Post Magazine in 2008 in a story about a strange medical condition she thought was Morgellons.

Laws's doctors thought she was delusional. But she found a host of other sufferers on the Internet and joined the Morgellons Research Foundation and the lobbying effort that prompted a number of lawmakers, including then-Sen. Barack Obama, to write the Centers for Disease Control and Prevention demanding an investigation.

Now, nearly three years later, the CDC has completed its investigation of Morgellons, or what it calls unexplained dermopathy, evaluating patients in Northern California and sending tissue samples to the Armed Forces Institute of Pathology for analysis. CDC experts are preparing the final draft of their report, which they hope to submit for publication in a peer-reviewed scientific journal sometime in early 2011.

So, is Morgellons real? Or is it a delusion?

The CDC won't say right now, for fear that releasing information might jeopardize the study's publication. Mark Eberhard, director of the CDC's division of parasitic diseases, said, "We were very clear from the outset that no one study, not even this one, would likely provide the whole answer."

[snip]

Sue Laws received a diagnosis of small-cell lung cancer in 2008. As she underwent chemotherapy, she wrote on an Internet discussion board that when her hair fell out, out, too, came "millions of red, blue, black and clear-white fibers and springtails, spiders, ants, dog scabies, human or dog lice." [Wow, cancer and completely nuts. The hospital staff must have had a time cleaning up all those fibers, insects and arachnids.]

By October 2009, the cancer had spread to her brain. She refused further treatment. She died Dec. 13.

Her last wish was that her body be donated to science to help find a cure for Morgellons. But her family couldn't find a researcher who wanted it. Her husband plans to spread her ashes in St. Croix in the spring.

[Stay tuned for the forthcoming CDC report on “unexplained dermopathy.”]