2011 January

31 JANUARY 2011

Below is a story about an unusual public health measure underway in Swaziland, Africa. In 2009, I was at the grand opening of a new circumcision clinic in Manzini—Swaziland’s biggest city. But given the chance to gown up and observe some of these quickie assembly surgeries, I instead opted for the conference room buffet next door. Swaziland has a horrific AIDS problem—among other things—but like the writer of the article below I’m not sure how helpful this public health “decapitation” campaign will be. In a country with a poor educational system, little public understanding of probability and statistics, and way too much faith in faith, witchcraft and traditional healing, the distinction between “reducing one’s chances of contracting AIDS” and “eliminating one’s chances of contracting AIDS” may be lost on the newly circumcised. What does the Swazi government and the NGOs do and say when large numbers of the circumcised start showing up HIV-positive?

The Swazi King has 14 wives.

The Kindest Cut

Swaziland turns to mass circumcision.

BANELE SHABANGU IS scared because he should be scared. Because a man in a mask is about to stick a needle into the base of his penis. “Are you ready?” the man asks.

“No one could be ready for this.”

“Don’t touch, don’t jump,” says Nurse Justin, the man with the needle. Then he injects Banele with a local anesthetic. Banele shouts. It hurts, but it’s more where it hurts than how much it hurts.

Banele, an 18-year-old in his last year of high school, has come to the clinic in Matsapha, Swaziland, to get circumcised. Like the dozens of teenagers and men packed into the waiting room, he’s doing so because he heard that circumcision offers partial protection against HIV, the virus that is obliterating the future of his country.

But first he needs another injection. “Wait, wait, please,” he says. “I’m sorry for screaming, you’ll forgive me, sir.” He clenches his teeth as the nurse sticks the needle in again.

Just under 20 percent of Swaziland’s 1 million people are HIV positive, an epidemic fueled by poverty, a lack of medical resources, and a male-dominated and promiscuous culture in which polygamy is still common. Look more closely, and the numbers get uglier. Nearly half of women ages 25 to 29 and men 35 to 39 are infected. Since 1998, according to one report, the average life expectancy has dropped from about 61 years to 47. “With the highest prevalence of HIV in a population ever recorded, we have got to do something to intervene,” says Dr. Vusi Magagula, chair of the government’s male- circumcision task force.

Swaziland has been preparing its men for mass circumcision since 2006. The previous year, a randomized controlled trial in South Africa (later confirmed by studies in Uganda and Kenya) found that circumcised men are as much as 60 percent less likely to contract HIV through heterosexual sex. Scientists do not yet know exactly why, but the study was so convincing that it was stopped after 18 months, because preventing the uncircumcised control group from getting the procedure would have been unethical.

Read the rest of the story at The Atlantic.

The Journal of Bone and Joint Surgery. 2011;93:e11.

Commentary on an article by Matthew D. Milewski, MD, et al.: "Lyme Arthritis in Children Presenting with Joint Effusions." R. Mervyn Letts, MD.

The authors of this Level-II study have presented us with the largest review to date in which Lyme disease-induced joint effusions were compared with septic arthritis. However, this contribution is more than just a comparison of two disease entities; it is an in-depth analysis of the effects of the increasing presence of Lyme disease in the endemic areas of North America.

The reason why this analysis is important is that Lyme disease, since itsdiscovery by Steere et al. in 1977, is caused by the spirochete Borrelia burgdorferi and is now the most common tick-borne disease in the United States. As the spirochete can be effectively treated with antibiotic administration, the accurate diagnosis of Lyme disease becomes more important to avoid an unnecessary surgical arthrotomy for the child.

Although the authors tried to definitively distinguish between Lyme disease and septic arthritis with the goal of creating a reliable algorithm in order to enable us all to have a gold standard to differentiate the two, they were unable to do so. In their quest to do so, however, they demonstrated that a diagnosis of septic arthritis is more probable in children presenting with an inability to bear weight, a fever of >101.5°F(>40.6°C), an elevated peripheral white blood cell count of >10.3 x 1000/µL, and a synovial fluid nucleated cell count of >100,000 cells/mm3.However, there is still an overlapping gray zone where the only diagnostic test that will separate the two similar clinical presentations is serologicaltesting of the synovial fluid aspirate for Lyme disease.

Herein lies another important contribution of this paper. In endemic areas in the Northeast, Upper Midwest, and Pacific Northwest of the United States, all children with unexplained, nontraumatic joint effusions should have a joint aspiration followed by serological testing for Lyme disease. Why? Because in these areas, the incidence of Lyme disease has risen 101% over the last fifteen years. Also, once Lyme disease has been diagnosed, antibiotic treatment with use of amoxicillin for patients with an age of less than eight years and with use of doxycycline for those with an age of eight years or more is curative. As synovial involvement is a late manifestation of the disease, morbidity resulting from the involvement of other organs, especially chronic encephalopathy and keratitis, should be ruled out. The authors also reported that 31% of all children who had a joint aspiration were found to have Lyme disease on the basis of serological testing. This high percentage in itself emphasizes the importance of aspirating joint effusions at the time of presentation to the emergency department in endemic areas.

This review also has highlighted a technical deficiency inhibiting our handling of Lyme disease—specifically, the fact that results of serological testing may take up to a week to obtain. We obviously need a quicker Lyme disease test if we are to avoid arthrotomies in children presenting with high synovial cell counts. In this series, 24% of children with Lyme disease and synovial cell counts of >100,000 cells/mm3 underwent an unnecessary arthrotomy simply because one cannot wait for a week for theresults of the Lyme test if septic arthritis is suspected. A corollary to this is that, in an endemic area, the diagnosis of both septic arthritis and Lyme disease must be considered even for children with synovial cell counts of >100,000 cells/mm3. In many studies of septic arthritis, as many as 40% of patients have negative cultures. In endemic areas, undoubtedly some ofthese patients had Lyme disease.

This paper showed no difference between children with Lyme disease and those with septic arthritis with regard to either the erythrocytesedimentation rate or the C-reactive protein level. The data presented by the authors also indicate that we may not be diligent enough in pursuing the diagnosis of Lyme disease as serological testing was performed for only 64% of the patients who underwent joint aspirations in their hospital. Those of us practicing in endemic areas should ensure that our own hospital emergency departments are sending all joint aspirations for serological testing for Lyme disease routinely. An additional interestingfinding was that Lyme disease presents throughout the entire year, and not just when the ticks are biting. Hence, we need to be as diligent in our pursuit of the diagnosis of Lyme disease in January as in July as its onset may be delayed weeks or months after the precipitating tick bite.

Although this was a retrospective study from a single institution, it demonstrates the value of a well-done study concentrating on a specific entity. This well-documented study has increased our awareness of Lyme arthritis and has pointed out to those of us practicing in endemic areas how we can all improve our diagnosis and treatment of children presenting with a swollen joint due to Lyme disease.

Early Antibiotic Use Linked to Asthma and Allergy at Age 6 Years

Medscape, Laurie Barclay, MD.

January 11, 2011 — Early antibiotic use by age 6 months is linked to asthma and allergy at age 6 years, according to the results of a cohort study reported online December 29, 2010, in the American Journal of Epidemiology.

"Early antibiotic exposure, especially to broad-spectrum antibiotics, may suppress the developing immune system and produce a reduced anti-allergic response," said senior author Michael B. Bracken, professor of epidemiology at the Yale School of Public Health in New Haven, Connecticut, in a news release.

[snip]

To evaluate the association between antibiotic use within the first 6 months of life and asthma and allergy at age 6 years, the investigators studied 1401 US children between 2003 and 2007. Children with early antibiotic exposure had an increased risk for asthma, with an adjusted odds ratio (OR) of 1.52 (95% confidence interval [CI], 1.07 - 2.16). In children in whom asthma was first diagnosed after age 3 years, the adjusted OR was 1.66 (95% CI, 0.99 - 2.79). In children who had no history of lower respiratory tract infection before age 1 year, the adjusted OR was 1.66 (95% CI, 1.12 - 3.46).

Children with no family history of asthma had an even stronger association of early antibiotic use with subsequent development of asthma (adjusted OR, 1.89; 95% CI, 1.00 - 3.58; P for interaction = .03). Adjusted OR for a positive blood or skin test result for allergy was 1.59 (95% CI, 1.10 - 2.28).

[snip]

"As noted by the authors, the main study limitation is that both antibiotic use, and data on child asthma and skin prick testing were obtained from maternal report when children were 6 years old," Dr. Kozyrskyj explained. "Of greater concern is the completeness of recall of information on antibiotic use in their infants. Also, mothers were not asked for the specific name of the antibiotic to obtain data on whether the antibiotic was narrow or broad-spectrum. I would imagine that mothers would have had greater difficulty in remembering this level of detail."

On the basis of their findings, the study investigators concluded that early antibiotic use was associated with asthma and allergy at age 6 years and that protopathic bias was unlikely to account for the main findings.

"More judicious prescribing of antibiotics to infants, especially of broad-spectrum antibiotics, is required," Dr. Kozyrskyj said. "This is not a new recommendation. What is worrisome is the revision of clinical practice guidelines for the antibiotic treatment for ear infections in Canada and the US to include more broad-spectrum antibiotics. In Sweden and Norway, basic penicillin remains the antibiotic of choice."

Dr. Kozyrskyj noted that the findings of a greater association between infant antibiotic use and asthma in children without a family history of asthma confirmed her published findings from a Canadian birth cohort of 14,000 children (Chest. 2007;131:1753-1759).

[snip]

Am J Epidemiol. Published online December 29, 2010.

…but you cannot just pick and choose what parts of it to accept. It’s not a la carte or a buffet; it’s all or nothing. And if you don’t know why that is then you don’t know what science is.

Saturday, January 22, 2011

Lyme disease panel hears from experts

RICHMOND -- After the first two meetings of Gov. Bob McDonnell's task force on Lyme disease, the panel's chairman is sure of one thing.

"I think it's pretty clear we need more science," said Michael Farris, the longtime home-schooling advocate and former candidate for lieutenant governor, after presiding over a four-hour meeting Friday. [Unless that science conflicts withthe beliefs of VA’s politicians.]

McDonnell last fall tapped Farris to lead a task force to explore prevention and treatment of a tick-borne disease that is on the rise in Virginia. Farris has a personal interest in the issue. His wife and seven of his 10 children have been diagnosed with Lyme.

[10!? Guess he doesn’t know much about the science of birth control.]

The stuff you find while clicking around the Internet cesspool....

Target: Present this petition to the UN and WHO

Sponsored by: Lyme Bites

We the undersigned, respectfully request that the UN and the WHO hold transparent investigations into media references and allegations that the USA bio-weapons research on Plum Island or elsewhere, lead to the world wide dissemination and the increased virulence of Lyme Disease. If such a connection exists, we also request the UN proceed with "Crimes Against Humanity" charges against those knowledgeable and responsible of perpetrating this crime, and those responsible for the continued concealment of this crime.

I mentioned this in an earlier blog, but it seems appropriate to mention it again in light of the above petition signed by 191 non-institutionalized people:

In an article about physicist Freeman Dyson in the December 2010 issue of The Atlantic, Dyson was asked why he was so bright. The phrasing of the question is wrong, he replied. The question should be: Why is everyone so stupid?

Why indeed? Discounting the 16% of people with IQs less than 85 and the 26.2% of American adults suffering from a diagnosable mental disorder in any given year, we still have a lot of explaining to do.

Clinical Infectious Diseases, Volume 52 suppl 3 February 1, 2011

The Need for a New Lyme Disease Vaccine (Free full text)

Plotkin SA. Correcting a public health fiasco: The need for a new vaccine against Lyme disease. Clin Infect Dis. 2011 Feb;52 Suppl 3:s271-5.

Livey I, O'Rourke M, Traweger A, Savidis-Dacho H, Crowe BA, Barrett PN, Yang X, Dunn JJ, Luft BJ. A new approach to a lyme disease vaccine. Clin Infect Dis. 2011 Feb;52 Suppl 3:s266-70.

Steere AC, Drouin EE, Glickstein LJ. Relationship between immunity to Borrelia burgdorferi outer-surface protein A (OspA) and Lyme arthritis. Clin Infect Dis. 2011 Feb;52 Suppl 3:s259-65.

Poland GA. Vaccines against Lyme disease: What happened and what lessons can we learn? Clin Infect Dis. 2011 Feb;52 Suppl 3:s253-8.

Angela K, Shen AK, Mead PS, Beard CB. The lyme disease vaccine--a public health perspective. Clin Infect Dis. 2011 Feb;52 Suppl 3:s247-52.

CALDA CALLS ON NIH TO STOP TICK FEEDING STUDY ON ETHICAL GROUNDS.

CALDA [Calif. Lyme] has just sent a letter to National Institute of Allergy and Infectious Diseases (NIAID) asking them to pull the plug on an experiment that threatens to harm Lyme patients. The study involves allowing live tick larvae to feed on patients. It is impossible to ensure that ticks are truly sterile and do not carry unidentified pathogens. In addition, tick saliva as well as Borrelia burgdorferi suppress the immune system of patients.

Now there’s a letter for the trashcan: Lyme activists worrying about ethics. First off, this trial has already been approved by an IRB of experts, and not by a two-bit lawyer and some anti-science hypochondriacs. Second, no one is trying to produce “sterile” ticks. Any unidentified pathogens will quickly show up in the SCID mouse model. As for tick saliva being immuno-suppressive, yes, some tick salivary proteins have sometransient suppressive effects on host innate immunity. That does not, however, prevent hosts from mounting neutralizing antibody responses to tick salivary proteins and thereby reducing the tick’s ability to feed and transmit pathogens. Many of these salivary proteins are viable immunogens for future anti-tick vaccines . See:Lyme borreliosis vaccination: the facts, the challenge, the future. Trends in Parasitology, 2011;27(1):40-47. T.J. Schuijt, J.W. Hovius, T. van der Poll, A.P. van Dam, E. Fikrig.

Also, read the study’s objectives and methods, some of which are listed below.

Searching for Persistence of Infection in Lyme Disease

Xenodiagnosis is a way to look for Borrelia bacteria using the animal that usually hosts them, Ixodes scapularis (also known as the deer tick). This method takes advantage of the evolution of the bacteria and the insect that transmits the infection, which can make the insect particularly good at finding the agent. In studies of animals, xenodiagnosis may be more sensitive than current tests for detecting the presence of the Lyme disease bacteria. Researchers are interested in using xenodiagnosis to determine whether uninfected ticks that feed on humans who have been infected with Lyme disease bacteria can detect the continued presence of live bacteria.

In this proposal, the utility of xenodiagnosis for identifying persistence of B. burgdorferi in treated human Lyme disease will be tested in up to 120 subjects with various stages of Lyme disease with 10 healthy adults to serve as controls. Subjects will be followed for approximately 3 months.

In Objective #1, subjects who have the characteristic erythema migrans (EM) rash and have been treated with antibiotics early (within 3 weeks of infection) in the course of Lyme disease will be tested. After completion of antibiotic therapy, 25-30 larval Ixodes ticks will be allowed to feed on the subject and biopsies of the EM site will be performed. Repleted ticks will be collected, allowed to molt to their nymphal stage and then fed on severe combined immunodeficiency (SCID) mice. The repleted nymphal ticks and the immunodeficient mice will be tested for the presence of B. burgdorferi by PCR and culture.

In Objective #2, similar studies will be performed, but enrollment will target subjects with elevated C6 (region 6 of the VlsE surface protein of B. burgdorferi) antibody levels.

In Objective #3, patients with persistent symptoms after antibiotic therapy will be evaluated. As an attempt to increase the chances of a positive xenodiagnosis in humans, patients with EM who are in the first 2 days of antibiotic therapy and patients with untreated Lyme arthritis will also be evaluated.

Evidence that B. burgdorferi can be recovered by xenodiagnosis after antibiotic therapy in subjects with continued symptoms would change the current paradigm for potential mechanisms of disease and provide researchers and clinicians a tool for identifying patients with persistent infection.

In Objective #4 we will assess the safety of the planned xenodiagnostic procedure in humans. All individuals who underwent xenodiagnosis under the study will be assessed for adverse events.

I suspect the real reason CALDA is against this study is because it might further undermine the myth of persistent infection as the cause of so-called ‘chronic’ Lyme disease. Any study that might weaken that belief is going to be attacked for one reason or another. Just as any effort to develop a vaccine for Lyme also will be denounced. Anything that lessens the fear of Lyme disease is bad for LLMDs, ILADS, Lyme specialty labs, and Lyme advocacy groups. Where there is effective prevention or less fear, there is less money and political influence for these groups. It’s all about money and power, and any less of either simply will not do. None of these people want to be put out of business by better science and better medicine. That’s the bottom line.

-

NPR: Curbs On Pathogens Pose Dilemma For Scientists

…Anne Vidaver, a plant pathologist at the University of Nebraska,Lincoln, recently spent a few years researching Rathayibacter toxicus, a bacterium that causes a slime disease in grasses — it makes the grasses toxic to grazing animals, like sheep.

But then the government decided this disease had potential as a bioweapon. So it was added to a special list of pathogens that could potentially be used by terrorists against crops or people. Once it became a so-called "Select Agent," all research had to be carefully controlled — and that meant the end to business as usual for Vidaver's slime disease work.

"Essentially I had to either receive special permission to work with it, or destroy it," Vidaver says, explaining that getting this special permission wouldn't be easy.

Her lab would have to put in place new security measures, like background checks of personnel.

"It would have required an enormous amount of funding and time," she says. So when she was unable to get the necessary funding, she destroyed her cultures.

In this case, she says, there are duplicate cultures in a secure government lab in Fort Detrick, Md. But Vidaver says she knows of colleagues facing similar situations who had to destroy unique samples of dangerous microbes — meaning they were lost to science.

That kind of loss worries Michael Imperiale, a microbiologist at theUniversity of Michigan in Ann Arbor.

"Some of these microbes might be valuable down the line," he says.

Scientists have historically collected different strains of viruses and bacteria because they are useful, he says. For example, large collections of influenza viruses helped researchers understand the pandemic flu strain that emerged a couple of years ago.

But Imperiale says he started to hear about scientists destroying certain microbes in the wake of the attacks of Sept. 11, 2001, and the anthrax attacks that soon followed. That was when the government started imposing its new restrictions on research into pathogens that could be potentially used by terrorists.

To get a sense of how many collections might have been lost in those confusing days, Imperiale and a colleague, Arturo Casadevall of the Albert Einstein College of Medicine, recently sent a survey to microbiologists across the country. It documented 13 episodes of microbial destruction involving viral, bacterial and fungal strains.

But Imperiale says this one survey can't show how widespread the practice was, and it may underestimate the numbers destroyed.

"We don't know how many others there were out there," he says. "We can't say, 'Well, X percent of the strains were destroyed,' or something like that."

In an e-mailed statement, the Centers for Disease Control and Prevention told NPR that the agency does try to help scientists transfer microbes to labs that can legally hold them. It noted that multiple collections have been transferred directly to the CDC — and in many cases, the agency even helped pay for the shipping.

But Casadevall says destruction of microbes is an ongoing problem.

"They're going to say to you that yes, there are mechanisms in place for the transfer of these things," he says. "But what is not recognized is that these mechanisms are complex, they require a lot of energy, and they require the person to put a lot of energy into doing so."

He says if a hospital recovers one of these select agents from a patient, for example, "you have only a few days by which to either send it to a collection or to destroy it."

Even if the hospital can find a collection that actually wants the microbe, Casadevall says, it takes time to arrange for special transportation and fill out all the paperwork.

Most busy doctors and researchers don't have the time, he says — so the easiest way to comply with the law is destruction.

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So S&J are keeping a tally of the opinionated propaganda they’ve been cranking out about Lyme disease and the IDSA.

During 2010, Dr. Stricker and I published nine articles or letters on Lyme disease. Shortly after the New Year, another publication by us came out. This post lists these 10 publications and tells you how to access those that are available without charge.

The world is changing around us and so is medical publication. Publication comes in two stripes these days. There is the old style print publication, which has restricted access. This means you either must be a subscriber to a publication, go to a medical library, or pay to have access to the article of letter. The newer style medical publication is called “open access” and is freely available for anyone to download. Both types are peer-reviewed. Last year, Dr. Stricker and I authored 10 publications that were peer reviewed. Four of the 10 are available open access.

Well, it’s actually not that simple. “Open access” means a number of things. Among them, you pay to publish. It’s an old-fashion vanity press business model that’s been tarted up with some science journals.

Jeffrey Beall at the Auraria Library, University of Colorado in Denver recently wrote about some of these “Predatory” Open-Access Scholarly Publishers. Dove Press, where S&J recently “published” one of their redundant, data-free missives, is described below:

Dove Press- “Charges vary by country. For the U.S. and Canada, the publisher charges $1,527 to $1,679 per article. Fees for newly launched journals are sometimes waived. A 10 percent discount is offered to authors who join the free, “favored author program.” It's clear that Dove Press, like the other publishers we review here, are mere vanity presses.”

Beall concludes: “These publishers are predatory because their mission is not to promote, preserve, and make available scholarship; instead, their mission is to exploit the author-pays, Open-Access model for their own profit. They work by spamming scholarly e-mail lists, with calls for papers and invitations to serve on nominal editorial boards. If you subscribe to any professional e-mail lists, you likely have received some of these solicitations. Also, these publishers typically provide little or no peer-review. In fact, in most cases, their peer review process is a façade. None of these publishers mentions digital preservation. Indeed, any of these publishers could disappear at a moment's notice, resulting in the loss of its content. While we were researching this review, one publisher, Academic Journals, was hacked and the site replaced with radical Islamic propaganda for about a week.” [Actually, the radical Islamic stuff might have been more informative.]

Scientists and physicians are not too enthralled with these open access journals either. A recent ScienceInsider report noted that scientists would rather read the open access articles than publish in them. “…30% [of researchers] cited a lack of high-quality open-access journals in their field. Clearly, “journal quality and impact factor is most important—not [open access]—when deciding where to submit” for the majority of scientists, says Peter Strickland of the International Union of Crystallography….”

Read the entire article, “Quandary: Scientists Prefer Reading Over Publishing 'Open Access' Papers.”

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Below is an interesting little abstract from China describing the denizens of an Internet “chat group” some of whose members believe they have AIDS. They did not, but this illustrates the dangers of turning to the Internet in order to self-diagnosis, or worse, participating in an online forum where one’s fears and ignorance may be amplified and re-enforced by an equally fearful and ignorant group of anonymous individuals. The Internet may be a fine way to communicate, but nothing beats an old-fashioned work-up by a competent physician. Moreover, the retrieval of reliable health and medical information from the digital cesspool that is the Internet is dependent on one’s prior knowledge of the subject being researched.

Zhonghua Liu Xing Bing Xue Za Zhi. 2010 Dec;31(12):1379-1382.

Epidemiologic and clinical characteristics of 59 persons suspecting of being infected by the HIV virus despite having repeated negative laboratory findings. Pei YX, et al. Chinese Field Epidemiology Training Program, Chinese Center for Disease Control and Prevention, Beijing, China.

[A] case was defined as onset of any three of the following self-reported AIDS-like symptoms in a member of relevant "internet chat groups": persistent low grade fever, rash, swollen lymph node, fatigue, diarrhea, weight loss and low CD4(+)T count. We administered an internet-based questionnaire, and invited 59 of the 88 case-persons for voluntary physical examination and laboratory testing.

The 59 case-persons came from 22 provinces; 54 (91.5%) were men; the median age was 34 (range: 22 - 53) years; 84.7% of them had high-risk sexual behaviors before the onset of self-reported symptoms. The median time interval from exposure to onset was 15 d (range: 1 - 365 d). Blood specimens for all the 59 case-persons were tested negative for HIV and syphilis antibodies. There was also no evidence of Xenotropic murine leukemia virus-related virus infection. One case-person was tested positive for hepatitis C virus antibody. The average CD4(+)T lymphocyte count was 707/µl. Of the 59 case-persons, 57 (96.6%) sought medical care from multiple providers; 40 were diagnosed to have no physical disorders.

None of the 59 case-persons had any evidence of infection with HIV or any other infectious agents that could explain their self-reported symptoms.

January 18, 2011

NYT: Vocal Physicians Group Renews Health Law Fight

By BARRY MEIER

A small professional group of doctors involved in the effort to repeal the new health care law has a history of opposing government involvement in medicine, including challenging President Bill Clinton’s attempts to overhaul health care in the 1990s.

The group, the Association of American Physicians and Surgeons, has exerted vocal influence in the country’s health care debate, despite having just 3,000 dues-paying members. Other medical groups assert that the association’s positions are unrepresentative of most of the nation’s 800,000 physicians and that its scientific views often fall outside medicine’s mainstream.

[snip]

The group has been opposed to President Obama’s health care efforts since the beginning. Last year, it filed a lawsuit asking a federal judge to declare the new law unconstitutional; it is still pending. This fall, yet another physician member of the group, Dr. Rand Paul, an ophthalmologist and son of Representative Ron Paul, made opposition to the health care law central to his successful Senate bid in Kentucky.

[snip]

Founded in 1943, the Association of American Physicians and Surgeons opposed the creation of Medicaid and Medicare. A decade ago, it was among groups that unsuccessfully urged the United States Supreme Court to release post-mortem photographs of a former Clinton administration official, Vincent Foster. In its brief, the group argued that an independent inquiry was necessary to confirm that Mr. Foster, whose death was attributed to suicide, was not murdered.

[snip]

The association has promoted some scientific views that other medical experts have characterized as curious.

Its internal periodical has published studies arguing that abortion increases breast cancer risks, a tie rejected by an expert panel of the National Cancer Institute, as well as reports linking child vaccinations to autism, a discredited theory. Another report, “Illegal Aliens and American Medicine,” contended that illegal immigrants not only brought disease into this country but benefited if their babies were born with disabilities.

[snip]

The publication’s longtime editor, Dr. Lawrence R. Huntoon, said its articles were “peer-reviewed” or checked for accuracy by experts, a standard that is used by major medical publications. When asked, he said he could not say that what percentage of those reviewers were members of his own organization.

The National Library of Medicine, a part of the National Institutes of Health, declined requests by the group in 2004 and again in 2008 to index its journal’s articles in the national database of medical reports that the library operates.

[snip]

Within the courtroom, the Association of American Physicians and Surgeons has taken a stance on a variety of issues related to health care or the practice of medicine. For one, it has argued for a ban on late-term abortion and also challenged the oversight procedures of state boards that license doctors, contending that such boards abuse their power to railroad doctors out of practice. The organization has also supported physicians accused of illegally prescribing narcotics, arguing that prosecutors are imposing their views of what constitutes adequate pain treatment. The group holds that health care is not a “right” but a professional service and that doctors should treat patients based on their medical judgment, a role in which government should not interfere.

Read the entire article here.

My God, another letter from these two. Don’t they do anything but crank out pointless, argumentative letters? It’s like a wound that just won’t heal. Here’s part of the latest carping in response to a recently published survey of physicians in Ct.

"Lyme literacy" and physicians in Connecticut.

Stricker RB, Johnson L.

J Pediatr. 2011 Jan 11.

Based on their survey results, Johnson and Feder conclude that half of the primary care physicians in Connecticut do not believe that chronic Lyme disease exists, another 48% are unsure about its existence, and only 2.1% treat chronic tickborne illness. We contend that these conclusions are invalid because….[they conflict with our beliefs.]

In response, the survey authors (Michael Johnson, MD, Henry M. Feder Jr., MD) wrote,

“Lyme-literate physicians argue that a large percentage of primary care physicians in the field commonly diagnose and treat patients with chronic Lyme disease. Our study’s aim was to survey primary care physicians. We found that 2.1% of responding primary care physicians (outliers included) diagnose and treat patients with chronic Lyme disease, and that none (outlier included) prescribe intravenous or oral antibiotic courses for longer than 1 year. We believe our study is accurate and reproducible.”

“We have read the many “letters to the editor” written by Stricker, Johnson, and colleagues, and challenge them to do the research to confirm their many testimonials.”

Others have made similar challenges, but I think those challenges will forever go unanswered. Research is difficult. Bitching is easy.

-

At the request of the Chief Executive of the Health Protection Agency (HPA) an independent working group chaired by Professor Brian Duerden CBE, Inspector of Microbiology and Infection Control, Department of Health, reviewed the International Lyme and Associated Diseases Society’s (ILADS) “Evidence-based guidelines for the management of Lyme disease” (Cameron et al. Exp Rev Anti-infect Ther 2004;2:S1-

13).

The ILADS guidelines are poorly constructed and do not provide a scientifically sound evidence-based approach to the diagnosis and care of patients with Lyme borreliosis.

The ILADS working group does not provide evidence that it used a Cochrane based or similar approach in developing the guidelines. Some references do not provide evidence to support statements for which they were cited in the guidelines. Some good-quality peer-reviewed articles are selectively quoted, using sub-group analyses without regard for the broader findings of the full studies. Some references were published in a n advocacy group-sponsored journal that was not Medline -listed, others are available only as conference/symposium abstracts or are unpublished. Some reference citations are inaccurate, demonstrating poor attention to detail.

The panel recommends that:

the HPA should not include the ILADS guidelines in the list of guidelines and other references recommended by the HPA for help and support in the diagnosis and management of Lyme borreliosis.

the HPA should consider providing a warning against the use of the ILADS guidelines as part of its health protection function, in view of the potential risk to patients from misdiagnosis and inappropriate treatment.

Read the whole bloody massacre here.

The Age-Old Struggle against the Antivaccinationists

Gregory A. Poland, M.D., and Robert M. Jacobson, M.D.

Excerpts from the N Engl J Med 2011; 364:97-99.

Since the introduction of the first vaccine, there has been opposition to vaccination. In the 19th century, despite clear evidence of benefit, routine inoculation with cowpox to protect people against smallpox was hindered by a burgeoning antivaccination movement. The result was ongoing smallpox outbreaks and needless deaths. In 1910, Sir William Osler publicly expressed his frustration with the irrationality of the antivaccinationists by offering to take 10 vaccinated and 10 unvaccinated people with him into the next severe smallpox epidemic, to care for the latter when they inevitably succumbed to the disease, and ultimately to arrange for the funerals of those among them who would die (see the Medical Notes section of the Dec. 22, 1910, issue of the Journal). A century later, smallpox has been eradicated through vaccination, but we are still contending with antivaccinationists.

Little has changed since that time, although now the antivaccinationists' media of choice are typically television and the Internet, including its social media outlets, which are used to sway public opinion and distract attention from scientific evidence.

The H1N1 influenza pandemic of 2009 and 2010 revealed a strong public fear of vaccination, stoked by antivaccinationists. In theUnited States, 70 million doses of vaccine were wasted, although there was no evidence of harm from vaccination. Meanwhile, even though more than a dozen studies have demonstrated an absence of harm from MMR vaccination, Wakefield and his supporters continue to steer the public away from the vaccine.

the reality that none of the antivaccinationists' claims of widespread injury from vaccines have withstood the tests of time and science. We believe that antivaccinationists have done significant harm to the public health. Ultimately, society must recognize that science is not a democracy in which the side with the most votes or the loudest voices gets to decide what is right.

Read the entire commentary here.

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Oh, my. The cranky denizens of LymeLand have discovered an abstract entitled, “Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines,” by Dong Heun Lee and Ole Vielemeyer (Arch Intern Med. 2011;171(1):18-22). Naturally, they have concluded from it that the “IDSA guidelines lack evidence,” and “the [Lyme disease] recommendations end up depending largely on who's on the guideline-drafting panel and any assumptions or opinions they may bring to the process.”

The Lee-Vielemeyer study was mentioned here back on 19 November 2009 so this is old news to many people. I’ll just add a few more notes from the current paper. The authors wrote:

“…in the field of infectious diseases, relatively few large multicenter randomized controlled trials (RCTs) have been conducted, with the notable exception of antiretroviral therapy trials in human immunodeficiency virus (HIV) care. Many infectious diseases occur infrequently, present in a heterogeneous manner, or are difficult to diagnose with certainty. For others, an RCT would be impractical or wasteful or might be deemed unethical. Such examples might include the study of the usefulness of tick bite avoidance through physical distance for the prevention of Lyme disease, the utility of hand hygiene to reduce nosocomial infections, or the use of cesarean delivery over vaginal delivery to reduce the risk of vertical HIV transmission. Also, RCTs are costly, and the lack of resources and funding in the field clearly poses an obstacle to obtaining a level I recommendation for many management decisions.’

“A second reason for the scarcity of level I quality-of evidence recommendations may be the use of the IDSA evidence-grading system. This system was originally proposed to evaluate the effectiveness of preventive health care interventions in Canada. It requires at least 1 supporting RCT for a level I recommendation. Many IDSA recommendations, however, address questions about diagnosis or prognosis (neither of which can be studied using an RCT and, thus, could never receive the highest level recommendation).”

“This study has several limitations. First, we did not include all current IDSA guidelines in the analysis.” “Second, the analysis was purely statistical and descriptive, and the primary cited literature was not evaluated. Third, although several national and international organizations have, likewise, published guidelines pertinent to the field of infectious diseases, we limited this study to guidelines put forth by the IDSA, considered the preeminent organization in the field worldwide.”

“We believe that the current clinical practice guidelines released by the IDSA constitute a great and reliable source of information that should be used.”

Is anyone going to make a similar claim about ILADS and their guidelines cobbled together from trial-and-error, wishful thinking, ouija boards, market projections and legal opinions. And where would you look within ILADS for “expert opinions?” Burrascano. Stricker. Horowitz. Jones. Raxlen. Jemsek. Bransfield. Savely. Maybe they’d have to reach outside the clubhouse to other experts such asShoemaker or Toth or Gubb or Bradford or Ryser or….well it’s a long list and I believe some of them are still in jail.

Well, there’s another paper from theDynamic Duo. This one is comparing Lyme disease to AIDS and regurgitating the usual Lyme Movement lies about the nature of the infection and the Infectious Diseases Society of America (IDSA). As with most pronouncements from Stricker & Johnson one hardly knows where to begin critiquing because there is always so much to criticize.

The first thing I noticed in this awful little paper—mercifully hidden in an obscure Italian journal—was a graph of Lyme disease cases in the USA. It’s the same graph I mentioned here on January 5, and its source is Kris Newby, one of the chief chronic Lyme propagandists and the producer of that nicely photographed but ultimately boring film about an alleged Lyme disease conspiracy, “Under Our Skin.”

The second thing I noticed was what I discussed here on January 11: that is, the effort by S&J to create a body of publications that could be cited subsequently in other publications to suggest actual evidence exists for their opinions. And that is what is in this paper: 19 references from earlier S&J op-eds and letters, and others from their equally opinionated but data-free ILADS colleagues.

Third, there was a chart allegedly showing the poor sensitivity of Lyme disease diagnostics. This is one of the Movement’s favorite claims: that the diagnostics are too poor to reliably detect Lyme disease in patients. (Though this begs the question: if the diagnostics are bad, how does one know they have Lyme disease? Answer: they or their doctor just know. It’s faith. And if you have faith the last thing you need is some pesky test telling you otherwise. Reality must be held at bay.) Anyway, we’ve got another case of “how to lie with charts.” S&J list a couple of papers from before the 1995 standardizing of West Blot interpretations (Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR MMWR Morb Mortal Wkly Rep 1995; 44:590–1.) They misquote from A. Steere’s 2008 review in which he notes, “…the sensitivity of 2-tier testing (ELISA and Western blot) for patients with disseminated or persistent Lyme disease was 100%, and the specificity was 99% [2]. Others have reported similar results [11], and similar results were found with a newer serologic test, the VlsE C6 peptide ELISA [2, 11, 12].” And they don’t bother to mention the role of predictive value in using such tests.

“Although use of these tests in the absence of high pretest probability (i.e. specific symptoms of Lb) has long been discouraged, our study is the first illustrating that the positive predictive value of Borrelia burgdorferi antibody tests, as they are usually applied in everyday praxis, is surprisingly low. Moreover, there is no reason for using such tests in cases of high pre-test probability (i.e. in cases of EM) when the clinical symptom is more specific and sensitive than the serological result could be. Our study suggests that consuming Lyme serological tests in the recent practice results in more harm than benefit. A false-positive Borrelia antibody test results in repeated and unnecessary antibiotic treatments, and additionally, in delayed recognition of the correct diagnosis. Moreover, subsequent complaints will suggest the possibility of Lb ‘‘relapse.’’ Most patients with falsely diagnosed Lb do not heal after repeated courses of antibiotic treatments, or their symptoms will relapse, which augments the false belief of chronic and incurable Lb.”

Lakos A, et al. The positive predictive value of Borrelia burgdorferi serology in the light of symptoms of patients sent to an outpatient service for tick-borne diseases. Inflamm Res. 2010 Nov;59(11):959-64.

It’s not that the diagnostics are bad, it’s that they are used badly by many people.

The fourth thing to note in this cut-and-paste propaganda is that much of it is a retelling of old lies and accusations. For example,

“At least 400 peer-reviewed scientific studies of tick-borne diseases support this [ILADS] viewpoint.” (J&S then cite 6 of their earlier opinions and those of ILADS friends.)

The IDSA guidelines “placed further restrictions on the diagnosis and treatment” of Lyme disease. (Again, please explain howvoluntary ‘guideline’ restrict anything.)

The IDSA ignored “the evidence-based treatment guidelines published by ILADS in 2004…” (Well, so did everyone else.)

A.G. Blumenthal “found significant conflicts of interest and suppression of data in the guidelines development process.” (Blum is a professional politician and conducts his “investigations” by press release and local Ct. news sound bite.” He has never presented a single piece of legal evidence to back up any such claim.)

“…300 peer-reviewed articles and 1,600 pages of evidence that refuted the guidelines recommendations” were presented. (Yes, they threw a lot of paper at the review committee but most of it was: unrelated to the natural history of human Lyme disease, animal models and laboratory phenomena, outdated findings, and individual case reports. The reviewers were not convinced.

“This two-tier test system…was developed by the CDC for surveillance purposes and was never intended to be used for diagnosis of Lyme disease.” (See, Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR MMWR Morb Mortal Wkly Rep 1995; 44:590–1.)

“The IDSA recommendation against treatment…is based on minimal benefit or failure of sequential antibiotic monotherapy in 221 highly selected study subjects who were included in four randomized controlled trials.” (Right. Few subjects because it’s rare to find a lot of people who actually had Lyme disease and still have persisting symptoms that may be related to that infection.)

Speaking of rare, S&J state that “ILADS practitioners…treat 50,000-100,000 patients” (Where do they find them all? A handful of private practice physicians—many of whom have been sued by patients, bared from federal research funding, or disciplined by state medical boards—are treating either three times as many Lyme patients as the CDC reports finding, or nearly a quarter of all the Lyme patients they claim actually exist. Either way it’s a hell of a workload. Of course, since some of these ILADS quackers charge as much as $900 for a visit (never might the costs for antibiotics and diagnostics), that might work out to around $90M.

On the other hand, they also claim “these patients respond to appropriate treatment for Lyme” and “combination antibiotic therapy appears to be effective.” So why are there 50-100K patients walking around with chronic Lyme disease? Either ILADS therapeutic approaches work or they don’t. Have they actually “cured” anyone of “chronic” Lyme disease? There’s a big difference between curing and billing.

Finally, this paper compares Lyme disease to AIDS, which is like comparing apples to elephants. Why would someone compare an antibiotic-responsive, tick-borne, non-fatal, non-contagious bacterial infection of limited geography and seasonality to a genetically unstable, drug-resistant, fatal, contagious, permanent retroviral infection that has spread worldwide and devastated large parts of Africa? It would be more logical to compare B. burgdorferi to M. tuberculosis or C. burnetii or R. rickettsii.

But logic doesn’t play much of a role with ILADS and the Lyme Movement. It doesn’t seem very logical for S&J to bring up AIDS either. Stricker didn’t have much luck in that field and things don’t seem to be working out too well with chronic Lyme either. Oh well, at least we can look forward to some angry letters to the editor from some real AIDS experts.

2010 was a busy year for the propaganda wing of the chronic Lyme disease movement. The chief pamphleteers, Ralph Stricker the LLMD and his lawyer Lorraine Johnson, managed to emit (or is it “emote”?) nine argumentative pieces of commentary and correspondence on behalf of the movement. Though the total output was three times that of 2009 there was little to distinguish this past year’s nonsense from the nonsense of 2009.

There were the usual letters criticizing other people’s work and suggestions that B. burgdorferi might be the etiological agent of various complex illnesses. More nonsense about the IDSA guidelines, which were recently re-examined, re-affirmed, and which remain in effect. And there was an attempt to show pumping people full of antibiotics for weeks or months at a time was not dangerous. (Of course, it wasn’t helpful either, but at least it could be profitable.) Here’s the list from PubMed:

1: Stricker RB, Johnson L. 'Rare' infections mimicking multiple sclerosis: Consider Lyme disease. Clin Neurol Neurosurg. 2010 Dec 17.

2: Stricker RB, Johnson L. The Lyme disease chronicles, continued. Chronic Lyme disease: in defense of the patient enterprise. FASEB J. 2010 Dec;24(12):4632-3;

3: Stricker RB, Johnson L. Lyme disease diagnosis and treatment: lessons from the

AIDS epidemic. Minerva Med. 2010 Dec;101(6):419-25.

4: Johnson L, Stricker RB. Final report of the Lyme disease review panel of the infectious diseases society of america: a pyrrhic victory? Clin Infect Dis. 2010 Nov 1;51(9):1108-9; author reply 1109-1.

5: Stricker RB, Johnson L. Persistent symptoms following treatment of early Lyme

disease: false hope? Am J Med. 2010 Aug;123(8):e25.

6: Stricker RB, Johnson L. Letter to the editor re "Anti-neural antibody reactivity in patients with a history of Lyme borreliosis and persistent symptoms" by Chandra et al. Brain Behav Immun. 2010 Aug;24(6):1025.

7: Stricker RB, Johnson L. Long-term outcomes in patients with early lyme disease: more false hope? Clin Infect Dis. 2010 Jun 15;50(12):1683-4.

8: Johnson L, Stricker RB. The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines. Philos Ethics Humanit Med. 2010 Jun 9;5:9.

9: Stricker RB, Green CL, Savely VR, Chamallas SN, Johnson L. Safety of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease. Minerva Med. 2010 Feb;101(1):1-7.

One observant reader at the forum LymeNet Europe wondered about this steady output of cut-and-paste complaining and proselytizing, noting: They “wrote another article and got it ‘published’ in dovepress. I wonder what the point of all these articles is, because it looks like they are mostly rehashing the same stuff over and over again. Besides that, this article contains some spin on the investigation into potential antitrust violations by IDSA, and a section on biofilms with hard claims like ‘Another mechanism of chronic infection involves the formation of biofilms,’ but without providing solid evidence….”

What is the point of this steady effluent? Probably none of their angry letters and data-free commentaries is intended to immediately sway the scientists and physicians who might read the FASEB Journal or the American Journal of Medicine or CID. Rather the point seems to be to create a body of references that can be cited in subsequent letters and op-eds to suggest a body of published evidence exists to support claims that chronic Lyme disease is a real and persistent infectious disease that must be treated with long-term, expensive antibiotics. It’s (pseudo)intellectual bootstrapping in which references are created and then cited as evidence for one’s claims. It helps that some readers of these Stricker-Johnson diatribes and fictions will not notice that many of the cited references are just letters and op-eds, and not actual research with actual data.

Maybe someday journals will insist that referenced sources be divided into categories of research, case reports, commentaries, letters, and expert opinions. That would give readers a clearer idea of who is talking data and who is blowing smoke.

Stricker and Johnson must be on fire.

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Decline of Western trees swells population of rodents that carry sin nombre virus.

Science News.

SALT LAKE CITY — Recent diebacks of aspen trees in the U.S. West may end up increasing the risk posed by a lethal human pathogen, a new study suggests.

A tree-killing syndrome called sudden aspen decline that has wiped out swaths of trees across the West in the past decade has also changed the kinds, numbers and interactions of creatures living around the trees, researchers have found — including some carriers of human disease. Deer mice at hard-hit sites in 2009 were almost three times as likely to carry sin nombre virus — which can be fatal to humans — compared with mice in less-ravaged aspen stands, Erin Lehmer of Fort Lewis College in Durango, Colo., and her colleagues reported January 4 at the annual meeting of the Society for Integrative and Comparative Biology.

The deer mouse Peromyscus maniculatus looks ironically cute in pictures at meeting presentations, but the Centers for Disease Control and Prevention ranks it as the main rodent reservoir for sin nombre virus. Infected deer mice don’t show many symptoms, but people inhaling virus wafting from mouse urine or saliva can get quite sick withhantavirus pulmonary syndrome.

Unknown to medicine until 1993, hantavirus pulmonary syndrome starts with muscle aches, chills, fever and stomach upset. Later, fluid fills the lungs; more than a third of victims have died. In 2010, the CDC logged 560 cases in 32 states stretching from California to Maine, but mostly in the West.

“Both plant diseases and animal diseases are rapidly emerging globally, and we should be looking for ways that the two might interact,” said Richard Ostfeld of the Cary Institute of Ecosystem Studies in Millbrook, N.Y., who studies Lyme disease transmission.

[snip]

In study sites that had lost at least two-thirds of their aspens, the researchers found fewer species of small mammals. The most abundant of those species was the deer mouse, which isn’t as choosy about its habitat as the vole is. Lehmer speculated that infection might have risen among deer mice as their growing dominance in the landscape let them encounter each other more frequently and get into more mouse fights. Sin nombre spreads readily among rodents through bites.

Results from the aspen study so far seem to parallel the Lyme disease story, Ostfeld says. He and his colleagues have found that as people have fragmented habitat for wild animals, species that make poor hosts for the Lyme pathogen and its tick vector have dwindled in number. In these less diverse landscapes, however, the white-footed mice that carry Lyme disease thrive and readily pass around infections So what’s bad for wild habitat ends up being bad for human health.

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The other day I paraphrased Freeman Dyson’s comments about why people should not ask him why he’s so smart but rather why everyone else is so stupid.

The point was driven home (again) when Bill O’Reilly (i.e., Billo the Clown) of Fox News insisted to one of his unfortunate guests that no one understood the Earth’s tides and therefore that was proof of the existence of God. Tide comes in, tide goes out, pushed by the hand of God, I suppose. Billo is a big guy, but he’s obviously never looked up at night and noticed the Moon. (Maybe he’s afraid of werewolves and stays in at night.) He’s probably never seen a tide chart either even though he’s from Long Island.

Here’s the video clip from the profoundly ignorant Billo. Sadly, his guest could have crucified him on-air, but for the fact that he didn’t seem to know what caused the tides either.

Does anyone go to school in this country? If so, are they learning anything or is it all now just a state-sponsored baby-sitting program for working parents? You have to wonder because here’s another clip of freshly graduated Harvard kids confidently telling an interviewer about why it’s warm in the summer and cold in the winter. All of them are clueless about the mechanism though almost certainly the answer was sitting on a shelf in their schoolrooms from 1stgrade through junior high school.

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Lyme disease a rare cause of death: study

Reuters: Thu, Jan 6 2011

NEW YORK (Reuters Health) - While controversy still brews over the long-term effects of Lyme disease, a new government study concludes that the tick-borne illness is rarely a cause of death in theU.S.

Using death records collected from 45 U.S. states, researchers at the Centers for Disease Control and Prevention (CDC) found that between 1999 and 2003, there were 114 records listing Lyme disease as a cause of death.

But in most cases, Lyme disease was listed as one of multiple health problems contributing to a person's death, and only 23 records showed the disease as the underlying cause.

Of those, the investigators say, just one was consistent with known "clinical manifestations" of Lyme disease. In that case, the person died of respiratory failure that the death record tied to long-term effects on the central nervous system.

The findings, the CDC researchers say, indicate that Lyme disease "is rare as a cause of death in the U.S."

[snip]

Then there are the people who are diagnosed with "chronic" Lyme disease based on non-specific symptoms -- like chronic pain and severe fatigue -- despite having no evidence of a current or past infection with the Lyme-causing bacteria.

This diagnosis is highly controversial because such people could have any of a number of other health problems, like depression or fibromyalgia, and their symptoms are common in the general population.

As for the lethality of Lyme disease, it is plausible that certain documented long-term effects of Lyme disease could contribute to some deaths, according to Dr. Kevin S. Griffith of the CDC'sNational Center for Emerging and Zoonotic Infectious Diseases.

"But the reality is that (Lyme disease) has only rarely been reported to lead to death," Griffith said in an interview. And based on this study, he noted, even death records that do list Lyme disease as a cause often don't stand up to scrutiny.

But Dr. Robert Bransfield, president of the non-profit International Lyme and Associated Diseases Society, took issue with the CDC study methods -- including its reliance on what doctors list on death records.

"There was no attempt to identify deaths from Lyme disease that may have been identified as a death from some other illness," said Bransfield, whose controversial group contends that chronic Lyme disease is a growing problem, and that many people with the infection need longer courses of antibiotics to help prevent it.

"You can't generalize from this to say that deaths from Lyme disease are rare," he said.

Exactly how many deaths might be attributable to Lyme disease is unclear, according to Bransfield. But he argued that the number could be "significant," if the question were looked at in a broader way.

*Bransfield, a psychiatrist, said that suicide may be the major way that Lyme disease can prove fatal. He acknowledged, though, that this belief is based on anecdotal evidence, and there is a lack of hard statistics on Lyme disease and suicide risk.

[snip]

"While anecdotes are compelling, scientific progress must be based on evidence," he [Griffith] said.

*At least suicide is something Bransfield is actually familiar with. “Plaintiff Jeffrey Shectman brought this action against defendant Robert Bransfield, M.D., alleging that defendant deviated from accepted standards of psychiatric care by failing to monitor and supervise his response to certain medications and his deteriorating mental condition, and that defendant's deviations resulted in plaintiff's attempt to commit suicide. The matter was tried to a jury, which returned a verdict for plaintiff awarding $250,000 in damages. Judgment was entered in accordance with the jury's verdict and defendant appeals.”

EFFREY SHECTMAN, Plaintiff-Respondent, v. ROBERT BRANSFIELD, M.D., Defendant-Appellant. No. A-3035-07T2. Superior Court of New Jersey, Appellate Division, Argued October 15, 2008, Decided November 13, 2008.

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Science

7 January 201, Vol. 331 no. 6013 p. 17

Chronic Fatigue Syndrome

Studies Point to Possible Contamination in XMRV Findings

The stormy debate over a potential cause of chronic fatigue syndrome (CFS) is nearing hurricane force. Last month, it prompted headlines suggesting that researchers have reached a dead end, scores of blog posts from disappointed patients, and accusations that scientists had gone beyond their data. The 14-month-old row intensified when four papers appeared in Retrovirology suggesting that reports linking the virus XMRV to CFS were based on false positives.

[snip]

The potential link to CFS has had important consequences: Some CFS patients have begun taking antiviral drugs, which can have side effects. Last month, after being briefed on the original XMRV studies, advisers to the U.S. Food and Drug Administrationrecommended that CFS patients be barred from donating blood.

The Retrovirology papers point to contamination as a possible source of positive results in previous studies. The polymerase chain reaction (PCR) test used to detect XMRV (a mouse retrovirus adapted to infect humans) could actually be picking up minute amounts of mouse DNA or similar mouse viruses.

[snip]

A bigger study is now under way. Funded by the U.S. National Institute of Allergy and Infectious Diseases, virologist W. Ian Lipkin of Columbia University is leading a project that will collect blood from 150 CFS patients and 150 controls from six U.S. clinical sites. The samples will be tested blindly by several labs. Because all the clinicians have agreed on standard methods, the study should help resolve concerns that differences in how CFS patients are selected or how samples are handled could explain clashing conclusions, Lipkin says: “Results will be definitive.”

[snip]

The News Roundup

NYT: Study Linking Vaccine to Autism Was Fraud, Journal Reports

By THE ASSOCIATED PRESS

Published: January 5, 2011

LONDON (AP) — The first study to link a childhood vaccine to autism was based on doctored information about the children involved, according to a new report on the widely discredited research.

The conclusions of the 1998 paper by Andrew Wakefield and colleagues was renounced by 10 of its 13 authors and later retracted by the medical journal Lancet, where it was published. Still, the suggestion the MMR shot was connected to autism spooked parents worldwide and immunization rates for measles, mumps and rubella have never fully recovered.

A new examination found, by comparing the reported diagnoses in the paper to hospital records, that Wakefield and colleagues altered facts about patients in their study.

The analysis, by British journalist Brian Deer, found that despite the claim in Wakefield's paper that the 12 children studied were normal until they had the MMR shot, five had previously documented developmental problems. Deer also found that all the cases were somehow misrepresented when he compared data from medical records and the children's parents.

[snip]

In an accompanying editorial, BMJ editor Fiona Godlee and colleagues called Wakefield's study "an elaborate fraud." They said Wakefield's work in other journals should be examined to see if it should be retracted.

XMRV and Occams Razor

January 3, 2011

Long time readers of ERV know that I do not believe a 'new' retrovirus, XMRV, is the causative agent of any human disease. It does not make sense as a real human pathogen, unless you disregard field basics (or make up new 'rules').

Read the entire blog post here.

It’s on the Internet so it must be true.

Below is part of a USA Today news story about Republican activist/fund-raiser John Wheeler who was founded murdered in Delaware last week.

Wheeler spent his career in and out of government, working as an attorney at the Securities and Exchange Commission in the early 1980s, and helping President Reagan create the Vietnam Veterans Leadership Program. He also founded the Earth Conservation Corps for President George H.W. Bush.

In March 2009, Wheeler was hired as a part-time consultant for The MITRE Corp., a not-for-profit organization that provides systems engineering, research and development and information technology support to the government.

"He was providing part-time support to outreach activities aimed at promoting discussions among government, industry, and academia on cyber defense topics," Jennifer Shearman, a MITRE spokeswoman, said in a statement. "At this time our thoughts are with his family. Due to the ongoing investigation, we feel it is inappropriate to comment further at this time."

Wheeler's connections have spurred a number ofconspiracy theories, including claims that flashed across websites around the globe Wednesday announcing Wheeler was killed to prevent the release of information on American biological and chemical weapons shenanigans that purportedly led to the deaths of blackbird flocks in Arkansas and Louisiana.

Those reports, appearing without a trace of attribution or hard evidence, were tracked back to a European Union Times article claiming that Russian intelligence sources — in a report to Prime Minister Vladimir Putin— linked Wheeler to alleged Defense Department poison gas testing that killed the birds.

The idea took root on television news broadcasts, newspaper websites, conspiracy theory blogs and other web operations where Wheeler's death already had been branded a cover-up of one kind or another.

"This is a good example of when anybody can say anything without any accountability and there are no consequences," said Ralph J. Begleiter, a University of Delaware professor and distinguished journalist in residence who directs the university's Center for Political Communication.

Begleiter said that, across the internet, information can be presented and repeated as news almost instantly, even though "there are no standards, there are no ethics, there are no bylines in most cases."

But there is a gullible, naïve audience for it all.

In an article about physicist Freeman Dyson in the December 2010 issue of The Atlantic, Dyson was asked why he was so bright. The phrasing of the question is wrong, he replied. The question should be: Why is everyone so stupid?

Why indeed. Discounting the 16% of people with IQs less than 85 and the 26.2% of American adults suffering from a diagnosable mental disorder in any given year, we still have a lot of explaining to do.

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This may be the worst manipulation of data I’ve seen in years. I’m reminded of that book, “How To Lie With Charts.”

The point of this post—yes, sometimes there is a point—is to pick through the fantasy-rich graphic below, which purports to show close to half a million cases of Lyme disease in the U.S. during 2009. Wow. How could the CDC miss all those people?

Well, the artist responsible for this graphic graph writes: “According to CDC epidemiologists, these reported cases are underestimated 6- to 12-fold in endemic regions due to inherent flaws in its passive reporting system. [2] Consequently, the actual number of new Lyme cases in 2009 could be as high as 461,616.”

Unfortunately, that’s not what was written in the cited MMWR from 2004. This was:

Studies from the early 1990s suggested that LD cases were underreported by six to 12-fold in some areas where LD is endemic; the current degree of underreporting for national data is unknown. In addition, differences in the demographics of reported cases among states with above- and below-average incidence suggest variation in diagnostic and reporting practices among states.

The 1996 studies “suggested” underreporting in “some” endemic areas. Not in all areas and not in all states, and certainly not enough to affect the reporting by one log.

Then it’s off to complaining about the 2008 Revised National Surveillance Case Definition for Lyme disease, which allegedly affects the reporting. She writes:

The Lyme disease surveillance process was changed in 2008, with the goal of reducing the burden of the CDC/CTSE complex mandatory Lyme reporting process on resource-strapped state and local health departments. [4] Unfortunately, the resulting revision, which was held behind closed doors with no provision for public comment, did nothing to address the fundamental flaws in the surveillance criteria….

I don’t know if the reporting is “complex” but it certainly isn’t “mandatory.” It has always been a passive, voluntary system that depends on private practice physicians taking the time to file a report. And as for the “closed doors” business, all she had to do was pay the registration fee at the June 27, 2007 CSTE Conferencein Atlantic City, NJ. Most Lymees, however, chose to stand outside waving lime green protest signs.

And still:

Instead, the CDC/CTSE revision added more complexity and less transparency to the reporting system, creating three categories for Lyme cases – confirmed, probable and suspected.

Actually, the three categories make it easier to report a real or suspect case of Lyme disease to the CDC. Here are the 3 categories:

Confirmed: a) a case of EM with a known exposure, or b) a case of EM with laboratory evidence of infection and without a known exposure or c) a case with at least one late manifestation that has laboratory evidence of infection.

Probable: any other case of physician-diagnosed Lyme disease that has laboratory evidence of infection.

Suspected: a) a case of EM where there is no known exposure and no laboratory evidence of infection, or b) a case with laboratory evidence of infection but no clinical information available (e.g. a laboratory report).

So what was the effect of these changes in categories and reporting? A published report from Lyme-endemic New Jersey, for example, noted that the state “is modifying its LD surveillance system to reduce the surveillance burden (i.e., the cost of conducting LD surveillance in terms of personnel committed and funding required). New Jersey has adopted the revised national LD surveillance case definition, implemented in January 2008, which provides local and state health departments with additional flexibility to classify LD reports as confirmed, probable, or suspect cases. Although the revised national surveillance case definition alone likely will not decrease the LD surveillance burden in New Jersey or other states, it will provide a more complete measure of the surveillance burden and guide development of sustainable surveillance systems that are consistent among states.”

“After New Jersey's introduction of ELR in 2002, the subsequent increase in LD reports referred for investigation likely reflected technological improvements in data acquisition and not an actual increase in the number of laboratory reports received.”

The graph-challenger blogger writes: “The tragedy of this new process is that physicians make diagnostic decisions based on the CDC case numbers, and when cases in their states are underestimated, more Lyme patients will be misdiagnosed. Congress allocates research funding based on the CDC case numbers, too, and by underestimating these numbers by a factor of ten, grants will go to other diseases.

I don’t what kind of quack doctor she visits, but most doctors make diagnostic decisions based on the patient sitting in front of them and their lab reports. I can’t imagine why any doctor would diagnose someone on the basis of last week’s issue of the MMWR. And no, Congress does not allocate funds on the basis of CDC numbers. If that were true we would not be spending billions of dollars on the 13 cases of anthrax reports in the U.S. almost a decade ago, or the occasional case of bubonic plague that may appear in Colorado or Utah; or millions of dollars on dengue research and vaccines for the occasional cross-border case in Florida or Texas; or millions of dollars on smallpox biology and vaccinology for zero cases over the last 25 years. Funding is determined by a number of a factors, including media hype, fear, novelty, geography, communicability, and sometimes politics.

Blatantly trying to overestimate a disease for the purposes of attracting more money doesn’t seem to be any smarter than intentionally underestimating the numbers. In the end, the patient population—big or small—will be evident.

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I heard the other day that ILADS is planning a 2011 meeting in Germany. Good riddance, I thought; let them pedal their pseudoscientific nonsense elsewhere. Still, I wondered why Germany. Then some foolish patient in LymeLand mentioned a LLMD at the Borreliose Centrum Blankenburg, which I took to be some kind of chronic Lyme clinic in Germany. Apparently, it is…or was. According to the website:

The Borreliose Centrum Blankenburg (BCB) in Blankenburg/Harz was unexpectedly closed on 1st December 2010. The operating company, represented by Mr. Kieschke, has canceled all contracts with a short notice, even though the BCB has been working very successfully. As a reason the operating company stated that there were not enough doctors and it was impossible to find more doctors. From spring 2011, the building ("Alte Poliklinik" Blankenburg) will be used as a psychosomatic clinic. The medical head of the BCB, Dr. Hübner, has announced that he would like to continue his successful work as a Lyme Disease doctor as soon as possible. He is searching for a new location at the moment in order to continue his work soon.

Well, it’s interesting that the former chronic Lyme clinic is now going to be a psychosomatic clinic; that way they won’t have to move the patients. More interesting is Dr. Hubner, the “successful” Lyme doctor, who seems to have been cut loose from this one-man clinic. Not enough doctors to bill enough patients to turn a profit? Maybe it’s reassuring that there are not yet enough German LLMDs to staff a clinic.

There also was this announcement on the same web page:

The “BCA [and] the German Borreliosis Society…rely on extensive research by the ILADS and their own experience and knowledge. According to their view Borrelia bacteria are "intelligent", locomotive spirochaetes that know how to escape the body's immune defense and also some antibiotics. You might have heard that Borrelia are "persistent", which means that they can "camouflage" and "hide" themselves. The participating physicians of the German Borreliosis Society and the BCA recommend a long-term antibiotic treatment over several months, possibly with altering antibiotics.”

“Intelligent” bacteria!? Maybe something was lost in translation. In any case, it sounds like the blind leading the blind in the treatment of the gullible.

So the 4-year-old BCA is a Teutonic ILADS, offering a “holistic” approach to chronic Lyme that includes long-term antibiotics and dietary supplements, and even treatments for Morgellons disease. Quacksalberei. Pardon my German. (The BCB, mentioned above, was a 2nd treatment center that opened in Sept. 2009.) The BCA is supported by the German Borreliosis Society, a kind of volk-LDA. (I wonder if they have a Frau Smith equivalent.)

I don’t know anything about Germany’s national social medicine program, but from some of the information on the BCA website it sounds like this chronic Lyme therapy is outside the scope of conventional treatment and payment. Big surprise. Patients appear to be billed directly through a couple of different business entities. (Maybe those are located in Switzerland.) It looks a lot like the cash-and-carry LLMD practices in the USA.

So the usual ILADS suspects (Stricker, Burrascano, Bransfield, for example) are getting together with their German counterparts to…do what exactly? They don’t do any bench or clinical research. What do they talk about? Argumentative letters they’ve written? Trade patient anecdotes? Compare billing and tax strategies?

Well, I hope they have a grand old time in the Fatherland working for “recognition of chronic Lyme disease by health insurance companies and science.” A noble goal from a noble gang.

Auf wiedersehen.

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Saving a buck from insurance costs, only to spend 4 bucks on non-medical costs helps insurers at the expense of society. It really shifts the burden of an illness from the insurer to society. A recent article by Dr. Cameron makes this relationship in Lyme disease clear. The article "Proof that Chronic Lyme Disease Exists" was published as an open access article (meaning you can read it and download it without cost). [Meaning he couldn’t get it published anywhere else.]

We’ve been over this paper before. It’s ILADS’ latest claim that chronic Lyme disease exists. It wasn’t convincing the last time around. Now, for some reason, the LymeWonk has resurrected it from digital obscurity. Perhaps the point of its resurrection is to highlight the alleged costs of this alleged chronic infection. That seems to be the thrust of the latest bit of wonkery. Both the Wonk and Cameron write that, “The mean cost estimate of CLD per patient in the US, of $16,199 per annum in 2002 dollars [8]….”

Well, that’s not what the reference reports. First, the reference (Zhang X, et al. Economic Impact of Lyme Disease, Emerg Inf Dis, 2006;12(4):653-660) is not about “chronic” Lyme disease. It’s about early- and late-stage Lyme disease. Second, Cameron seems just to have picked the biggest dollar figure in the 2006 report and stuck it in his paper.

What the original authors wrote was this: “In year 2000 dollars, the expected mean total cost attributable to LD was $1,965 per patient, and the expected median total cost attributable to LD was estimated at $281 per patient. For LD patients at the clinically defined early stage, the median total cost was ≈$397 (mean $1,310), whereas for patients at the clinically defined late stage, the median cost rose to $923 (mean $16,199). Suspected LD cases, tick bite cases, and other LD-related complaints had median costs of $238 (mean $461), $108 (mean $316), and $256 (mean $714), respectively.”

Related costs are shown in graphics here and here.

Then Cameron climbing farther out on the economic limb when he writes, “In 2002, the annual economic cost of LD in the US, based on the 23,000 cases reported to the CDC that year, was estimated to be $203 million [8]. Considering that the actual number of LD cases is believed to be 10 times higher than the number of cases reported to the CDC, the actual annual cost could be $2 billion [23,24].”

First, Zhang et al. noted there were 23,763 reported cases and they extrapolated that to a national cost of “~$203 million” in 2002 dollars. Second, they noted since cases are believed to be underreported, their national estimate is likely to be low. But not off by 1.8 billion dollars.

The authors wrote:

We found that the average cost per LD case decreased over the study period. In LD-endemic areas, personal protection measures are frequently emphasized and insecticides are widely used. Persons in LD-endemic areas likely visit physicians more frequently whenever they have an exposure or an insect bite, and physicians attending patients from an LD-endemic area likely order serologic testing for possible LD patients and provide prompt treatment. However, our current evidence was limited in that we were only able to find a decrease in per capita cost within diagnosis groups (e.g., clinically defined early- and late-stage LD), but we could not find a shift in the number of cases from late to early stage. Therefore, we don’t know what caused the decrease in average cost per LD case.

This study has certain limitations. …we used clinical case definition (physician determination) instead of surveillance case definition of LD because of limited data. Thus, we may have overestimated the number of LD cases. … because of the large variance between mean and median costs, using mean cost to estimate national impact could be an overestimation. Finally, this study is also limited in that we only had information for indirect medical costs, nonmedical costs, and productivity losses from ≈8% of total patients in the study. Therefore, the results from survey data were extrapolated to represent the whole study population. This method may have biased our results.

So where did Cameron get his wild-ass $2B estimate for that undefined condition called “chronic” Lyme disease? He lists two references for it, but the first one (23) has nothing to do with costs or Lyme disease. The second one (24) is from one of Dick Blumenthal’s many hearings on Lyme disease. This one was the “Verbatim proceedings of a Public Hearing of the State of Connecticut, Department of Public Health, In Re: Lyme Disease, held January 29, 2004, at the Legislative Office Building, 300 Capitol Avenue, Hartford, Connecticut. . .” And the only reference to a billion anything in the transcript that I could find was this from Dr. Stephen Sinatra:

“Thank you, Dr. Galvin, Dr. Blumenthal. First of all, I want to relate to you that I'm not a Lyme specialist. I don't treat Lyme Disease on a day-to-day basis. I'm a cardiologist and a nutritionist. And my experience with Lyme Disease is that it was placed in my path. I have it personally. My dogs have it. And I'm treating myself and my dogs. First of all, I want to say that in relation to this disease, it's worldwide. It's epidemic. It's in six continents. And a lot of researchers believe that a billion people are infected. It's a worldwide epidemic. And as much as 15 percent of the population right now is infected with Lyme Disease.”

A billion people? Two billion dollars? Gibberish. Great reference though. And some real insights into infectious diseases and epidemiology from a guy who is treating himself and his dogs for something none of them likely have. I wonder if they all use the same flea powder.

The Wonk should have left this garbage buried where not even PubMed could have found it.

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Oh, my. The cranky denizens of LymeLand have discovered an abstract entitled, “Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines,” by Dong Heun Lee and Ole Vielemeyer (Arch Intern Med. 2011;171(1):18-22). Naturally, they have concluded from it that the “IDSA guidelines lack evidence,” and “the [Lyme disease] recommendations end up depending largely on who's on the guideline-drafting panel and any assumptions or opinions they may bring to the process.”

The Lee-Vielemeyer study was mentioned here back on 19 November 2009 so this is old news to many people. I’ll just add a few more notes from the current paper. The authors wrote:

“…in the field of infectious diseases, relatively few large multicenter randomized controlled trials (RCTs) have been conducted, with the notable exception of antiretroviral therapy trials in human immunodeficiency virus (HIV) care. Many infectious diseases occur infrequently, present in a heterogeneous manner, or are difficult to diagnose with certainty. For others, an RCT would be impractical or wasteful or might be deemed unethical. Such examples might include the study of the usefulness of tick bite avoidance through physical distance for the prevention of Lyme disease, the utility of hand hygiene to reduce nosocomial infections, or the use of cesarean delivery over vaginal delivery to reduce the risk of vertical HIV transmission. Also, RCTs are costly, and the lack of resources and funding in the field clearly poses an obstacle to obtaining a level I recommendation for many management decisions.’

“A second reason for the scarcity of level I quality-of evidence recommendations may be the use of the IDSA evidence-grading system. This system was originally proposed to evaluate the effectiveness of preventive health care interventions in Canada. It requires at least 1 supporting RCT for a level I recommendation. Many IDSA recommendations, however, address questions about diagnosis or prognosis (neither of which can be studied using an RCT and, thus, could never receive the highest level recommendation).”

“This study has several limitations. First, we did not include all current IDSA guidelines in the analysis.” “Second, the analysis was purely statistical and descriptive, and the primary cited literature was not evaluated. Third, although several national and international organizations have, likewise, published guidelines pertinent to the field of infectious diseases, we limited this study to guidelines put forth by the IDSA, considered the preeminent organization in the field worldwide.”

“We believe that the current clinical practice guidelines released by the IDSA constitute a great and reliable source of information that should be used.”

Is anyone going to make a similar claim about ILADS and their guidelines cobbled together from trial-and-error, wishful thinking, ouija boards, market projections and legal opinions. And where would you look within ILADS for “expert opinions?” Burrascano. Stricker.Horowitz. Jones. Raxlen. Jemsek. Bransfield. Savely. Maybe they’d have to reach outside the clubhouse to other experts such asShoemaker or Toth or Gubb or Bradford or Ryser or….well it’s a long list and I believe some of them are still in jail.

Posted by Relative Risk at 06:30 0 comments Links to this post

Well, there’s another paper from the Dynamic Duo. This one is comparing Lyme disease to AIDS and regurgitating the usual Lyme Movement lies about the nature of the infection and the Infectious Diseases Society of America (IDSA). As with most pronouncements from Stricker & Johnson one hardly knows where to begin critiquing because there is always so much to criticize.

The first thing I noticed in this awful little paper—mercifully hidden in an obscure Italian journal—was agraph of Lyme disease cases in the USA. It’s the same graph I mentioned here on January 5, and its source is Kris Newby, one of the chief chronic Lyme propagandists and the producer of that nicely photographed but ultimately boring film about an alleged Lyme disease conspiracy, “Under Our Skin.”

The second thing I noticed was what I discussed here on January 11: that is, the effort by S&J to create a body of publications that could be cited subsequently in other publications to suggest actual evidence exists for their opinions. And that is what is in this paper: 19 references from earlier S&J op-eds and letters, and others from their equally opinionated but data-free ILADScolleagues.

Third, there was a chart allegedly showing the poor sensitivity of Lyme disease diagnostics. This is one of the Movement’s favorite claims: that the diagnostics are too poor to reliably detect Lyme disease in patients. (Though this begs the question: if the diagnostics are bad, how does one know they have Lyme disease? Answer: they or their doctor just know. It’s faith. And if you have faith the last thing you need is some pesky test telling you otherwise. Reality must be held at bay.) Anyway, we’ve got another case of “how to lie with charts.” S&J list a couple of papers from before the 1995 standardizing of West Blot interpretations (Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR MMWR Morb Mortal Wkly Rep 1995; 44:590–1.) They misquote from A. Steere’s 2008 review in which he notes, “…the sensitivity of 2-tier testing (ELISA and Western blot) for patients with disseminated or persistent Lyme disease was 100%, and the specificity was 99% [2]. Others have reported similar results [11], and similar results were found with a newer serologic test, the VlsE C6 peptide ELISA [2, 11, 12].” And they don’t bother to mention the role of predictive value in using such tests.

“Although use of these tests in the absence of high pretest probability (i.e. specific symptoms of Lb) has long been discouraged, our study is the first illustrating that the positive predictive value of Borrelia burgdorferi antibody tests, as they are usually applied in everyday praxis, is surprisingly low. Moreover, there is no reason for using such tests in cases of high pre-test probability (i.e. in cases of EM) when the clinical symptom is more specific and sensitive than the serological result could be. Our study suggests that consuming Lyme serological tests in the recent practice results in more harm than benefit. A false-positive Borrelia antibody test results in repeated and unnecessary antibiotic treatments, and additionally, in delayed recognition of the correct diagnosis. Moreover, subsequent complaints will suggest the possibility of Lb ‘‘relapse.’’ Most patients with falsely diagnosed Lb do not heal after repeated courses of antibiotic treatments, or their symptoms will relapse, which augments the false belief of chronic and incurable Lb.”

Lakos A, et al. The positive predictive value of Borrelia burgdorferi serology in the light of symptoms of patients sent to an outpatient service for tick-borne diseases. Inflamm Res. 2010 Nov;59(11):959-64.

It’s not that the diagnostics are bad, it’s that they are used badly by many people.

The fourth thing to note in this cut-and-paste propaganda is that much of it is a retelling of old lies and accusations. For example,

“At least 400 peer-reviewed scientific studies of tick-borne diseases support this [ILADS] viewpoint.” (J&S then cite 6 of their earlier opinions and those of ILADS friends.)

The IDSA guidelines “placed further restrictions on the diagnosis and treatment” of Lyme disease. (Again, please explain how voluntary ‘guideline’ restrict anything.)

The IDSA ignored “the evidence-based treatment guidelines published by ILADS in 2004…” (Well, so did everyone else.)

A.G. Blumenthal “found significant conflicts of interest and suppression of data in the guidelines development process.” (Blum is a professional politician and conducts his “investigations” by press release and local Ct. news sound bite.” He has never presented a single piece of legal evidence to back up any such claim.)

“…300 peer-reviewed articles and 1,600 pages of evidence that refuted the guidelines recommendations” were presented. (Yes, they threw a lot of paper at the review committee but most of it was: unrelated to the natural history of human Lyme disease, animal models and laboratory phenomena, outdated findings, and individual case reports. The reviewers were not convinced.

“This two-tier test system…was developed by the CDC for surveillance purposes and was never intended to be used for diagnosis of Lyme disease.” (See, Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR MMWR Morb Mortal Wkly Rep 1995; 44:590–1.)

“The IDSA recommendation against treatment…is based on minimal benefit or failure of sequential antibiotic monotherapy in 221 highly selected study subjects who were included in four randomized controlled trials.” (Right. Few subjects because it’s rare to find a lot of people who actually had Lyme disease and still have persisting symptoms that may be related to that infection.)

Speaking of rare, S&J state that “ILADS practitioners…treat 50,000-100,000 patients” (Where do they find them all? A handful of private practice physicians—many of whom have been sued by patients, bared from federal research funding, or disciplined by state medical boards—are treating either three times as many Lyme patients as the CDC reports finding, or nearly a quarter of all the Lyme patients they claim actually exist. Either way it’s a hell of a workload. Of course, since some of these ILADS quackers charge as much as $900 for a visit (never might the costs for antibiotics and diagnostics), that might work out to around $90M.

On the other hand, they also claim “these patients respond to appropriate treatment for Lyme” and “combination antibiotic therapy appears to be effective.” So why are there 50-100K patients walking around with chronic Lyme disease? Either ILADS therapeutic approaches work or they don’t. Have they actually “cured” anyone of “chronic” Lyme disease? There’s a big difference between curing and billing.

Finally, this paper compares Lyme disease to AIDS, which is like comparing apples to elephants. Why would someone compare an antibiotic-responsive, tick-borne, non-fatal, non-contagious bacterial infection of limited geography and seasonality to a genetically unstable, drug-resistant, fatal, contagious, permanent retroviral infection that has spread worldwide and devastated large parts of Africa? It would be more logical to compare B. burgdorferi to M. tuberculosis or C. burnetii or R. rickettsii.

But logic doesn’t play much of a role with ILADS and the Lyme Movement. It doesn’t seem very logical for S&J to bring up AIDS either. Stricker didn’t have much luck in that field and things don’t seem to be working out too well with chronic Lyme either. Oh well, at least we can look forward to some angry letters to the editor from some real AIDS experts.

Posted by Relative Risk at 13:56 0 comments Links to this post

Labels: ILADS, Stricker

11 January 2011

2010 was a busy year for the propaganda wing of the chronic Lyme disease movement. The chief pamphleteers, Ralph Stricker the LLMD and his lawyer Lorraine Johnson, managed to emit (or is it “emote”?) nine argumentative pieces of commentary and correspondence on behalf of the movement. Though the total output was three times that of 2009 there was little to distinguish this past year’s nonsense from the nonsense of 2009.

There were the usual letters criticizing other people’s work and suggestions thatB. burgdorferi might be the etiological agent of various complex illnesses. More nonsense about the IDSA guidelines, which were recently re-examined, re-affirmed, and which remain in effect. And there was an attempt to show pumping people full of antibiotics for weeks or months at a time was not dangerous. (Of course, it wasn’t helpful either, but at least it could be profitable.) Here’s the list from PubMed:

1: Stricker RB, Johnson L. 'Rare' infections mimicking multiple sclerosis: Consider Lyme disease. Clin Neurol Neurosurg. 2010 Dec 17.

2: Stricker RB, Johnson L. The Lyme disease chronicles, continued. Chronic Lyme disease: in defense of the patient enterprise. FASEB J. 2010 Dec;24(12):4632-3;

3: Stricker RB, Johnson L. Lyme disease diagnosis and treatment: lessons from the

AIDS epidemic. Minerva Med. 2010 Dec;101(6):419-25.

4: Johnson L, Stricker RB. Final report of the Lyme disease review panel of the infectious diseases society of america: a pyrrhic victory? Clin Infect Dis. 2010 Nov 1;51(9):1108-9; author reply 1109-1.

5: Stricker RB, Johnson L. Persistent symptoms following treatment of early Lyme

disease: false hope? Am J Med. 2010 Aug;123(8):e25.

6: Stricker RB, Johnson L. Letter to the editor re "Anti-neural antibody reactivity in patients with a history of Lyme borreliosis and persistent symptoms" by Chandra et al. Brain Behav Immun. 2010 Aug;24(6):1025.

7: Stricker RB, Johnson L. Long-term outcomes in patients with early lyme disease: more false hope? Clin Infect Dis. 2010 Jun 15;50(12):1683-4.

8: Johnson L, Stricker RB. The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines. Philos Ethics Humanit Med. 2010 Jun 9;5:9.

9: Stricker RB, Green CL, Savely VR, Chamallas SN, Johnson L. Safety of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease. Minerva Med. 2010 Feb;101(1):1-7.

One observant reader at the forum LymeNet Europe wondered about this steady output of cut-and-paste complaining and proselytizing, noting: They “wrote another article and got it ‘published’ in dovepress. I wonder what the point of all these articles is, because it looks like they are mostly rehashing the same stuff over and over again. Besides that, this article contains some spin on the investigation into potential antitrust violations by IDSA, and a section on biofilms with hard claims like ‘Another mechanism of chronic infection involves the formation of biofilms,’ but without providing solid evidence….”

What is the point of this steady effluent? Probably none of their angry letters and data-free commentaries is intended to immediately sway the scientists and physicians who might read the FASEB Journal or the American Journal of Medicine or CID. Rather the point seems to be to create a body of references that can be cited in subsequent letters and op-eds to suggest a body of published evidence exists to support claims that chronic Lyme disease is a real and persistent infectious disease that must be treated with long-term, expensive antibiotics. It’s (pseudo)intellectual bootstrapping in which references are created and then cited as evidence for one’s claims. It helps that some readers of these Stricker-Johnson diatribes and fictions will not notice that many of the cited references are just letters and op-eds, and not actual research with actual data.

Maybe someday journals will insist that referenced sources be divided into categories of research, case reports, commentaries, letters, and expert opinions. That would give readers a clearer idea of who is talking data and who is blowing smoke.

Stricker and Johnson must be on fire.

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Posted by Relative Risk at 13:16 1 comments Links to this post

Labels: Quackery, Stricker

09 January 2011

Decline of Western trees swells population of rodents that carry sin nombre virus.

Science News.

SALT LAKE CITY — Recent diebacks of aspen trees in the U.S. West may end up increasing the risk posed by a lethal human pathogen, a new study suggests.

A tree-killing syndrome called sudden aspen decline that has wiped out swaths of trees across the West in the past decade has also changed the kinds, numbers and interactions of creatures living around the trees, researchers have found — including some carriers of human disease. Deer mice at hard-hit sites in 2009 were almost three times as likely to carry sin nombre virus — which can be fatal to humans — compared with mice in less-ravaged aspen stands, Erin Lehmer of Fort Lewis College in Durango, Colo., and her colleagues reported January 4 at the annual meeting of the Society for Integrative and Comparative Biology.

The deer mouse Peromyscus maniculatus looks ironically cute in pictures at meeting presentations, but the Centers for Disease Control and Prevention ranks it as the main rodent reservoir for sin nombre virus. Infected deer mice don’t show many symptoms, but people inhaling virus wafting from mouse urine or saliva can get quite sick with hantavirus pulmonary syndrome.

Unknown to medicine until 1993, hantavirus pulmonary syndrome starts with muscle aches, chills, fever and stomach upset. Later, fluid fills the lungs; more than a third of victims have died. In 2010, the CDC logged 560 cases in 32 states stretching from California to Maine, but mostly in the West.

“Both plant diseases and animal diseases are rapidly emerging globally, and we should be looking for ways that the two might interact,” said Richard Ostfeld of the Cary Institute of Ecosystem Studies in Millbrook, N.Y., who studies Lyme disease transmission.

[snip]

In study sites that had lost at least two-thirds of their aspens, the researchers found fewer species of small mammals. The most abundant of those species was the deer mouse, which isn’t as choosy about its habitat as the vole is. Lehmer speculated that infection might have risen among deer mice as their growing dominance in the landscape let them encounter each other more frequently and get into more mouse fights. Sin nombre spreads readily among rodents through bites.

Results from the aspen study so far seem to parallel the Lyme disease story, Ostfeld says. He and his colleagues have found that as people have fragmented habitat for wild animals, species that make poor hosts for the Lyme pathogen and its tick vector have dwindled in number. In these less diverse landscapes, however, the white-footed mice that carry Lyme disease thrive and readily pass around infections So what’s bad for wild habitat ends up being bad for human health.

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Posted by Relative Risk at 11:41 0 comments Links to this post

Labels: Emerging Infections

08 January 2011

The other day I paraphrased Freeman Dyson’s comments about why people should not ask him why he’s so smart but rather why everyone else is so stupid.

The point was driven home (again) when Bill O’Reilly (i.e., Billo the Clown) of Fox News insisted to one of his unfortunate guests that no one understood the Earth’s tides and therefore that was proof of the existence of God. Tide comes in, tide goes out, pushed by the hand of God, I suppose. Billo is a big guy, but he’s obviously never looked up at night and noticed the Moon. (Maybe he’s afraid of werewolves and stays in at night.) He’s probably never seen a tide chart either even though he’s from Long Island.

Here’s the video clip from the profoundly ignorant Billo. Sadly, his guest could have crucified him on-air, but for the fact that he didn’t seem to know what caused the tides either.

Does anyone go to school in this country? If so, are they learning anything or is it all now just a state-sponsored baby-sitting program for working parents? You have to wonder because here’s another clip of freshly graduated Harvard kids confidently telling an interviewer about why it’s warm in the summer and cold in the winter. All of them are clueless about the mechanism though almost certainly the answer was sitting on a shelf in their schoolrooms from 1st grade through junior high school.

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Posted by Relative Risk at 09:00 0 comments Links to this post

Labels: MISC

07 January 2011

Lyme disease a rare cause of death: study

Reuters: Thu, Jan 6 2011

NEW YORK (Reuters Health) - While controversy still brews over the long-term effects of Lyme disease, a new government study concludes that the tick-borne illness is rarely a cause of death in the U.S.

Using death records collected from 45 U.S. states, researchers at the Centers for Disease Control and Prevention (CDC) found that between 1999 and 2003, there were 114 records listing Lyme disease as a cause of death.

But in most cases, Lyme disease was listed as one of multiple health problems contributing to a person's death, and only 23 records showed the disease as the underlying cause.

Of those, the investigators say, just one was consistent with known "clinical manifestations" of Lyme disease. In that case, the person died of respiratory failure that the death record tied to long-term effects on the central nervous system.

The findings, the CDC researchers say, indicate that Lyme disease "is rare as a cause of death in the U.S."

[snip]

Then there are the people who are diagnosed with "chronic" Lyme disease based on non-specific symptoms -- like chronic pain and severe fatigue -- despite having no evidence of a current or past infection with the Lyme-causing bacteria.

This diagnosis is highly controversial because such people could have any of a number of other health problems, like depression or fibromyalgia, and their symptoms are common in the general population.

As for the lethality of Lyme disease, it is plausible that certain documented long-term effects of Lyme disease could contribute to some deaths, according to Dr. Kevin S. Griffith of the CDC's National Center for Emerging and Zoonotic Infectious Diseases.

"But the reality is that (Lyme disease) has only rarely been reported to lead to death," Griffith said in an interview. And based on this study, he noted, even death records that do list Lyme disease as a cause often don't stand up to scrutiny.

But Dr. Robert Bransfield, president of the non-profit International Lyme and Associated Diseases Society, took issue with the CDC study methods -- including its reliance on what doctors list on death records.

"There was no attempt to identify deaths from Lyme disease that may have been identified as a death from some other illness," said Bransfield, whose controversial group contends that chronic Lyme disease is a growing problem, and that many people with the infection need longer courses of antibiotics to help prevent it.

"You can't generalize from this to say that deaths from Lyme disease are rare," he said.

Exactly how many deaths might be attributable to Lyme disease is unclear, according to Bransfield. But he argued that the number could be "significant," if the question were looked at in a broader way.

*Bransfield, a psychiatrist, said that suicide may be the major way that Lyme disease can prove fatal. He acknowledged, though, that this belief is based on anecdotal evidence, and there is a lack of hard statistics on Lyme disease and suicide risk.

[snip]

"While anecdotes are compelling, scientific progress must be based on evidence," he [Griffith] said.

*At least suicide is something Bransfield is actually familiar with. “Plaintiff Jeffrey Shectman brought this action against defendant Robert Bransfield, M.D., alleging that defendant deviated from accepted standards of psychiatric care by failing to monitor and supervise his response to certain medications and his deteriorating mental condition, and that defendant's deviations resulted in plaintiff's attempt to commit suicide. The matter was tried to a jury, which returned a verdict for plaintiff awarding $250,000 in damages. Judgment was entered in accordance with the jury's verdict and defendant appeals.”

EFFREY SHECTMAN, Plaintiff-Respondent, v. ROBERT BRANSFIELD, M.D., Defendant-Appellant. No. A-3035-07T2. Superior Court of New Jersey, Appellate Division, Argued October 15, 2008, Decided November 13, 2008.

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Science

7 January 201, Vol. 331 no. 6013 p. 17

Chronic Fatigue Syndrome

Studies Point to Possible Contamination in XMRV Findings

The stormy debate over a potential cause of chronic fatigue syndrome (CFS) is nearing hurricane force. Last month, it prompted headlines suggesting that researchers have reached a dead end, scores of blog posts from disappointed patients, and accusations that scientists had gone beyond their data. The 14-month-old row intensified when four papers appeared in Retrovirologysuggesting that reports linking the virus XMRV to CFS were based on false positives.

[snip]

The potential link to CFS has had important consequences: Some CFS patients have begun taking antiviral drugs, which can have side effects. Last month, after being briefed on the original XMRV studies, advisers to the U.S. Food and Drug Administration recommended that CFS patients be barred from donating blood.

The Retrovirology papers point to contamination as a possible source of positive results in previous studies. The polymerase chain reaction (PCR) test used to detect XMRV (a mouse retrovirus adapted to infect humans) could actually be picking up minute amounts of mouse DNA or similar mouse viruses.

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A bigger study is now under way. Funded by the U.S. National Institute of Allergy and Infectious Diseases, virologist W. Ian Lipkin of Columbia Universityis leading a project that will collect blood from 150 CFS patients and 150 controls from six U.S. clinical sites. The samples will be tested blindly by several labs. Because all the clinicians have agreed on standard methods, the study should help resolve concerns that differences in how CFS patients are selected or how samples are handled could explain clashing conclusions, Lipkin says: “Results will be definitive.”

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