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Blog: Lyme Policy Wonk

Lorraine Johnson, JD, MBA is an attorney advocate on issues related to the medico-legal andethical aspects of Lyme disease and has published over 30 peer-reviewed articles on this topic. She earned her JD from Loyola University and an MBA from USC. She is the Chief Executive Officer of the LymeDisease.org and is a director and an officer of the International Lyme and Associated Diseases Society. She sits on the steering committee of Consumers United for Evidence-Based Healthcare, a nationwide coalition of consumer groups associated with the Cochrane Collaboration. She is also a member of the international Cochrane Consumer Network and serves as a consumer peer reviewer for Cochrane Collaboration evidence-based protocols and reviews. She has spoken before state legislatures, the CDC, at the Canadian government consensus hearings on Lyme disease, and at the IDSA review panel hearing and before the Cochrane Consumer Network. "Lyme Policy Wonk" focuses on medico-legal ethics and health care policy issues in Lyme disease.

LYMEPOLICYWONK: The IDSA Guidelines And Embers At a Glance Table.

03 May
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I have blogged about the Embers study previously. The Embers study essentially dismantles much of the science that the IDSA relies on in their Lyme guidelines. This post presents a table of the IDSA guideline assumptions and recommendations that the Embers study refutes. This is just one of the many, many reasons the IDSA guidelines should be revised.
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LYMEPOLICYWONK: National Guidelines Clearinghouse–Listen Up

06 Apr
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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the final resolution of the National Guidelines Clearinghouse (NGC) determination regarding whether they will pull the outdated IDSA guidelines from their website.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. Continue reading →

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

29 Feb
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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). Continue reading →

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

22 Feb
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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. Continue reading →

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

16 Feb
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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. Continue reading →

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

15 Feb
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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. Continue reading →

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

15 Feb
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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. Continue reading →

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

14 Feb
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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.) Continue reading →

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

10 Feb
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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. Continue reading →

LYMEPOLICYWONK: Senators Request Removal of IDSA Lyme Guidelines from National Guidelines Clearinghouse

02 Feb
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Today Senators Blumenthal and Gillibrand joined together to ask the National Guidelines Clearinghouse (NGC) to remove the outdated 2006 IDSA Lyme disease guidelines from their website.(Full text of letter below.) We applaud the Senators for speaking up loud and clear. Their letter voices concerns that the guidelines do not satisfy the currency requirement and asks that the NGC remove the guidelines until the IDSA conducts a review that ensures that the guidelines reflect current evidence-based medicine principles. The Senate letter comes on the heels of a letter from Congressman Smith, Wolf, and Gibson expressing similar concerns. New York Assemblyman Richard Gottfried, who chairs the Health Committee also requested that the NGC remove the guidelines pending a review for currency. Approximately 10,000 people have signed a petition launched by LymeDisease.org calling for the removal of the IDSA guidelines from the NGC.
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LYMEPOLICYWONK: And, the Number Is? 5,200 Responses! IDSA Guidelines and Patient Preference Survey

03 Jan
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Let me thank everyone who responded to the Patient Preferences Survey! We have drawn over 5,200 responses, which is just simply fabulous. We will now start the process of reviewing the responses with an eye toward publication of the results. Our last survey was published in Health Policy, a widely respected peer reviewed journal. Those results now help inform the base of knowledge of the access to care problems that Lyme patients face. Our goal with these surveys is to open the space for conversations in the public health arena about what is really going on with Lyme patients from their perspective. We are trying to give voice to the patient community, which is all to often completely ignored in conversations about Lyme disease. Your willingness to participate in these surveys allows us to do that. So hats off to you for being so vocal and letting us know your views. Continue reading →

LYMEPOLICYWONK: Speak Up Now! IDSA Lyme Guidelines And Patient Viewpoints Survey Ends January 1. . .

29 Dec
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Since we launched this survey in early October, we have drawn over 4,800 responses. The survey will end on January 1 so I encourage those of you who have not yet responded to take the time to do so. According to the Institute of Medicine, guideline developers must consider patient values and preferences to be considered trustworthy. This survey aims to find out what you think is important about treatment options, choices, risks and benefits. Respond to the survey and remind the IDSA that patient values are central to treatment guidelines! Continue reading →

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LYMEPOLICYWONK: SIGN THE PETITION TO REMOVE THE IDSA GUIDELINES FROM THE NGC!

Medical treatment guidelines are tremendously important in determining your treatment options. All important treatment guidelines are listed by the National Guidelines Clearinghouse (NGC), which is part of the US Department of Health and Human Services. It’s the government’s way of providing updated information about different diseases to health care professionals. NGC’s own rules require that listed guidelines be updated every 5 years. The Infectious Diseases Society of America has not revised its controversial Lyme disease guidelines for more than 5 years. Nevertheless, the NGC recently permitted the IDSA to continue listing the Lyme guidelines without updating them. Continue reading →

LYMEPOLICYWONK: CBS Lyme Story, A Tale of Conflicts of Interest & Bias

18 Dec
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A CBS news story on Lyme disease has patients concerned about the misinformation that it promotes. On top of that, the story does not have the level of journalistic integrity that serious topics should have. For one thing, there is the title: “Lies and Truths”. Lies are statements that are known to be false that are told to intentionally deceive another person. Lies are not issues that are matters of scientific debate. When a science article title uses the word “Lies”, it tells the reader that it is not about science. Second, the article is a single source article. This means unlike most journalism and particularly good science journalism, there is no attempt to present different sides of the issue. One side, in fact, one person’s opinion is put forth as uncontested “truth” with no counterpoint. Third, the piece is edited by the Orly Avitzur, M.D., M.B.A., Editor-in-Chief of the American Academy of Neurology (AAN). You may recall that the AAN was part of the antitrust investigation by the Connecticut Attorney General into the Lyme guideline development process by the Infectious Diseases Society of America. The reason? Continue reading →

LYMEPOLICYWONK: NIH Tick Feeding Study Safety Risk Update

20 Nov
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We recently received a response from the NIH regarding our concerns about the NIH tick feeding study and the risk of tickborne infections from the larval ticks that researchers intend to place on patients to feed. We have written the NIH about this several times. Our latest letter focused on the newly identified pathogen, Borrelia miyamotoi, which can be transmitted to larval ticks through the mother's eggs. We asked the NIH to tell us what bacteria they test for in the larval ticks to ensure that patients in the study are not at risk. According to the NIH, the following pathogens are screened for: Borrelia burgdorferi, Babesia microti, Anaplasma phagocytophilum, Borrelia miyamotoi, Bartonella spp, Rickettsia sp., deer tick viruses and orbiviruses. We are glad to see that these pathogens are being screened for but remain concerned that unidentified pathogens nevertheless place patients at risk in the study. Continue reading →

LYMEPOLICYWONK: Perception is Everything—Is it Black or White: Who decides?

17 Nov
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When science is uncertain, who decides what to do? Do patients get treated or are they abandoned and told to wait for research that, in the case of Lyme disease, may never come? I attended a conference in Spain this year at the Cochrane Collaboration. One of the speakers, Dr. Mary Docherty, pointed out that recommendations to deny care based solely on “insufficient evidence” could be inappropriate and harmful to patients. To illustrate the point, she used the example of an upper GI (gastro-intestinal) bleed. Suppose there are two treatment options, but there is insufficient evidence to support either one? Still, the patient with an upper GI bleed must be treated. To do otherwise, might risk death or serious disability for the patient. Such is the case with Lyme disease. Continue reading →

LYMEPOLICYWONK: Patient Viewpoints Survey Update. 2,000 Responses! We Are On Our Way.

07 Oct
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The Lyme disease Patient Preferences Survey initially posted on October 5 has drawn over 2,000 responses to date! We want to thank everyone who responded and encourage you to distribute the survey to others you know who have Lyme disease. We received many comments on the survey as well with suggestions for future surveys. The two competing guidelines for diagnosing and treating Lyme disease (those of the International Lyme Disease Association and those of the Infectious Diseases Society of America) are both over 5 years old. Because of this, we assume they are in the process of revision. We have contacted the IDSA and asked about their timetable for guideline revision and requested that patient viewpoints be included in any development process. We will keep you posted. Continue reading →

LYMEPOLICYWONK: Newly Discovered Tick Pathogen, Borrelia miyamotoi, May Increase Safety Risks for Patients in NIH Tick Feeding Study

22 Sep
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Researchers recently discovered that Borrelia miyamotoi, a species of corkscrew-shaped bacteria found in Asia, Europe and North America and previously thought to be non-pathogenic, causes human illness similar to Lyme disease. In a parallel study, it was shown that tick larvae carry B. miyamotoi and that ticks can transmit the bacteria via the ovaries to newly hatched larvae. This discovery highlights the risk to patients in a current NIH study from exposure to unidentified pathogens in tick larvae that may not have been detected by the researchers. The study allows live tick larvae to feed directly on patients. Researchers generally attempt to reduce the risk of transmitting illness to research subjects by using newly-hatched laboratory-raised larval ticks that don't carry known pathogens. Because it was not known that B. miyamotoi was pathogenic, larval ticks used in the study may not have been screened for this disease. Last January we asked the NIH to pull the plug on the study because of the risk that unidentified pathogens in tick larvae posed for patients enrolled in the study, and we filed a Freedom of Information Act request for the study approval documents. The NIH responded by acknowledging the risk of unidentified pathogen transmission to study participants and said the issues were considered during the study approval review. However, the study documentation does not show that the issue was either carefully considered or that adequate precautions were taken. Although the NIH study consent form advises patients of the risk of acquiring an unidentified illness, we do not believe that disclosure is sufficient. So, again, today, we take pen in hand and ask the NIH to demonstrate that the study is safe or pull the study entirely. Continue reading →