Lyme Policy Wonk

  • LYMEPOLICYWONK: Full Disclosure. IDSA Enforces Its “Voluntary” Guidelines

    In 2008, then-Connecticut Attorney General, Richard Blumenthal, criticized the Infectious Disease Society of America (IDSA) guidelines authors for their conflicts-of-interest with vaccines, Lyme test kits and insurance and their failure to disclose these. Since then, their disclosures have been more robust. Apparently, medical journals got that message. Take their disclosure in a recent letter in Lancet by the IDSA gang (link below). Here’s the thing though, most of the conflicts listed involve the IDSA authors testifying against their competitors in medical malpractice testimony and testimony before medical boards. You might recall that when I testified before the IDSA review panel in 2009, the panel seemed shocked when I said that because the IDSA enforced its guidelines, they could hardly be considered voluntary. But if you take a look at the recent disclosures by the IDSA gang, you may wonder that they have time to do anything else, like research, given their aggressive interest in driving out competitive viewpoints. In fact, 6 of the 10 authors of the Lancet letter have testified against competitors. It makes you think these scientists have an anti-competitive ax to grind. It also makes you wonder why Lancet fails to see when scientists have lost the key to the kingdom of science–impartiality.

  • LYMEPOLICYWONK: National Guidelines Clearinghouse–Listen Up

    We are waiting for the final resolution of the National Guidelines Clearinghouse (NGC) determination regarding whether they will pull the outdated IDSA guidelines from their website. Members of both the House of Representatives and the Senate have called for their removal. If you haven’t signed our petition calling for this, please do. We have over 19,000 signatures on it so far. Our understanding is that the IDSA listing on the NGC is now being reviewed by higher ups on the organizational chart, namely the Agency for Healthcare Research and Quality (AHRQ)). Meanwhile, the NGC is calling for public comments on their guideline inclusion policy. We sent off our list today. Here’s the long and short of it.

  • LYMEPOLICYWONK: Patient Centered Research and Lyme—An idea whose time has come?

    A friend forwarded to me the audio link (at the end of this blog) of an interview with Dr. Iain Chalmers of the Cochrane Collaboration—a leading voice in evidence based medicine. Dr. Chalmers, who is interested in the patient perspective in evidence-based medicine, made a number of points that I think you will find of interest. First, he said, research agendas should be driven by patient concerns rather than by researchers’ preferences. There’s an interesting idea. Then he said that physicians have to make a decision today and cannot wait for the research. That sounds right, too. He went on to say that when you are looking at outcomes, the clinical experiences of those who receive the intervention or treatment are the key—these experiences are not the soft data, they are, in fact, the “hard” evidence. Finally, he noted the difficulty of getting “disappointing” results published. Disappointing results can be trials that don’t turn out as planned or that contradict what the researcher expected. His last quote regarding academic researchers in particular stuck with me and should resonate with the Lyme community: “If you have a cherished hypothesis which your career has ridden on for the past 20 years and someone does a really killer experiment which actually shows that you have been wrong all that time, the natural reaction, the human reaction is to say “there must be something wrong with it”—“I can’t have been wrong all these years”. It all sort of takes me back to the Embers monkey study and the complaints of Dr. Baker’s (formerly of the NIH and now the head of the American Lyme Disease Foundation, which many patients believe is a front for the Infectious Diseases Society of America).

  • LYMEPOLICYWONK: Was this important Lyme study hidden for 12 years?

    The recently published monkey study by Embers and colleagues regarding the persistence of Lyme after antibiotic treatment is important for two distinct reasons. The first is because of the scientific results of the study, explained in a 5-part article I posted on this blog last week. (Links follow this post.) The second, more troubling reason, is because publication of this important research was delayed for over a decade. And that delay has seriously harmed Lyme patients.

  • LYMEPOLICYWONK: Embers Monkey Trials Part 5. Of Mice and Men and Monkeys.

    The guidelines of the Infectious Diseases Society of America (IDSA) deny the existence of persistent infection. “There is no convincing evidence in North America for the persistence of B. burgdorferi in the skin of humans after treatment with antibiotic regimens known to be active against B. burgdorferi in vitro.” The Embers monkey research demonstrates persistence and is consistent with other animal model research. But, humans differ from animals in fundamental ways. So why not go further and demonstrate persistence in humans? The fact is that some experiments cannot be ethically conducted on humans. Hence, animal studies may be the only way research that can demonstrate a point. Such is the case with the Embers monkey trials. Embers demonstrated persistent bacteria notwithstanding 90 days of antibiotic treatment by using invasive tissue sampling that could not be conducted on humans.

  • LYMEPOLICYWONK: Embers Monkey Trials Part 4. Lab Tests Fail to Detect Lyme Disease.

    This is Part 4 of a series on the Embers study of Lyme disease in non-human primates. As described in Part 1 of the series, the Embers monkey research study posed three questions: one regarding treatment of early disseminated Lyme disease, one regarding treatment of late disseminated Lyme disease, and one regarding the ability of the C6 to accurately detect infection. This part of the blog series focuses on the last question, the accuracy of lab tests. Embers evaluated the C6 antibody test to see if its results accurately reflected active infection. It was believed that the C6 might permit researchers to determine whether treatment cleared infection. However, the study concludes: “Reliable procedures to determine that infection has been cleared from Lyme disease patients have not been established.” Moreover, the study demonstrated that the ability of the C6 to detect active infection generally was poor. Although the test detected infection in 100% of the inoculated monkeys at 4 months, after this period it failed to detect active infection in 60% of untreated monkeys in the study and in 100% of infected monkeys that received treatment.

  • LYMEPOLICYWONK: Embers Monkey Study Part 3. IDSA 28 Day Treatment Protocol Fails to Clear Infection.

    This is Part 3 of a series on the Embers study of Lyme disease in non-human primates. As described in Part 1 of the series, the Embers monkey research study posed three questions: one regarding treatment of early disseminated Lyme disease, one regarding treatment of late disseminated Lyme disease, and one regarding the ability of the C6 to accurately detect infection. This part focuses on the first question–the ability of 28 days of antibiotics to eradicate infection in early disseminated Lyme disease. The 28 day treatment with doxycycline was intended to test the treatment recommendation of the Infectious Diseases Society of America (IDSA). The Embers study found that infection persisted in all monkeys treated with this protocol.

  • LYMEPOLICYWONK: Embers Monkey Trials Part 2: Chronic Lyme Disease Treatment and Persistence

    This is Part 2 of a series on the Embers study of Lyme disease in non-human primates. As described in Part 1 of the series, the Embers monkey research study posed three questions: one regarding treatment of early disseminated Lyme disease, one regarding treatment of late disseminated Lyme disease, and one regarding the ability of the C6 to accurately detect infection. This part of my blog series on the Embers study focuses on the second question–the ability of 90 days of antibiotics to eradicate infection in late disseminated Lyme disease. The researchers defined late disseminated Lyme disease as 27 weeks after inoculation. Rhesus macaques were chosen as the animal model because they experience many of the key signs of human Lyme disease, including neuroborreliosis ( an infection of the brain or nervous system.)

  • LYMEPOLICYWONK: Part 1–New Study Shows Lyme Persists in Monkeys

    This is Part 1 of a series of posts I will do on this study. A new study by Drs. Monica Embers, Stephen Barthold and colleagues has found that the bacteria that cause Lyme disease, Borrelia burgdorferi (Bb) persist in monkeys after antibiotic treatment. It is the latest in a number of studies that have demonstrated persistent infection in animal models despite treatment. The issue of persistent infection in Lyme disease is a highly controversial issue. Probably the most controversial issue actually. The authors conclude that their studies “offer proof of the principle that intact spirochetes can persist in an incidental host comparable to humans, following antibiotic therapy.” The study also found that the C6 antibody test gave false negative results in all of those treated with antibiotics and in more than ½ of those untreated. The presence of the bacteria was confirmed by other means. Both the lab tests and evidence of persistence are very important for Lyme patients because they show that Bb may persist after treatment even when antibody tests are negative.

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