Vivvo CMS 4.0 http://www.lymedisease.org/news/ ©2007 Spoonlabs d.o.o. http://www.lymedisease.org/news/files.php?file= http://www.lymedisease.org/news/ http://www.lymedisease.org/news/lymepolicywonk/368.html Blog: Lyme Policy Wonk Wed, 10 Mar 2010 14:13:00 -0500 I’ve been getting a lot of email lately about the IDSA. Most of it is about the voting issues, but some of it is about other things they have done to “game the system”. Here’s a list of the top 10 questions patient ask me about the IDSA that begin with the word “why”? As Mark Twain says, “few things are harder to put up with than the annoyance of a good example”—or in this case, ten good examples of why the Lyme community should question the advice to “trust us, we’re the experts” when it comes to the IDSA. Let me know if you think there are any “whys” I left off the list. http://www.lymedisease.org/news/lymepolicywonk/354.html Blog: Lyme Policy Wonk Tue, 16 Feb 2010 05:15:00 -0500 This is a chart of the relative importance of different stakeholders to big Pharma. (Click chart to enlarge.) I was really struck by how little weight patients were given (9%) compared to specialists (47%) and compared to key opinion leaders (21%). So if you take specialists and add key opinion leaders to that, 68% of drug companies thought that key opinion leader who are specialists would have the most influence on their company over the next 2 years. Wow! And, look at the lowly role of the general practitioner http://www.lymedisease.org/news/lymepolicywonk/353.html Blog: Lyme Policy Wonk Tue, 16 Feb 2010 11:05:00 -0500 One of the problems with the IDSA reviewing its own guidelines is that it is not an independent process. The IDSA selected the panel, paid the ethicist, and sets the ground rules. And, now we have the IDSA manipulating the voting process to achieve a goal--protection of the IDSA professional reputation--that conflicts with the goal of providing quality patient care. Think about it. The vote on the lab test requirement for diagnosis was 4 to 4. 4 to 4 means there was NO consensus. Yet the IDSA chalked this up as a victory on its side by ignoring the two step vote requirement and flipping the supermajority vote in its favor. The IDSA is essentially saying 4 to 4 means the IDSA wins on this point. To the fox guarding the chicken coop, this makes perfect sense. Let me drill down into the detail so that what the IDSA did here is clear. http://www.lymedisease.org/news/lymepolicywonk/345.html Blog: Lyme Policy Wonk Thu, 11 Feb 2010 00:53:00 -0500 A recent article in the Greenwich Times addressing the "improper voting procedure” of the IDSA review panel contains a response from IDSA spokesman John Heys that the IDSA is "committed to ensuring the review panel conducts its review to the requirements of that action plan." Sounds a little boiler plate, huh? The next statement by Blumenthal though is more telling. He says that his office has yet to receive a response to the letter. That does not sound like much of a commitment. One has to wonder why it was necessary to write the letter of non-compliance in the first place and why the IDSA's only response to date has been to the press? "We hope there will be a response forthcoming shortly," Blumenthal said. So do we, so do we. . . http://www.lymedisease.org/news/lymepolicywonk/340.html Blog: Lyme Policy Wonk Fri, 05 Feb 2010 08:33:00 -0500 Responding to patient concerns, the President of ILADS, Dr. Robert Bransfield today delivered a letter to the IDSA calling upon the organization to remove barriers to guidelines change. The letter follows patient complaints to ILADS about the IDSA voting process, which were uncovered by the Connecticut Attorney General in the oversight of the IDSA Lyme guidelines review process. According to the Attorney General, the voting process used by the IDSA was in violation of the terms of the antitrust Settlement Agreement. The Attorney General has called upon the IDSA to redo the vote using the proper voting procedures. Text of the ILADS letter follows the jump. http://www.lymedisease.org/news/lymepolicywonk/336.html Blog: Lyme Policy Wonk Wed, 03 Feb 2010 12:49:00 -0500 During an antitrust investigation of the IDSA guidelines development process for the 2006 Lyme disease treatment guidelines, AG Blumenthal http://www.lymedisease.org/news/lymepolicywonk/329.html Blog: Lyme Policy Wonk Sat, 30 Jan 2010 11:07:35 -0500 There is a lot of flurry in the Lyme light about the IDSA recent letter in opposition to the physician protection bill pending in the New Hampshire physician protection legislation. This legislation follows on the heels of legislation already passed in California, Connecticut, and Rhode Island. Like breast cancer patients before them (who passed legislation in 20 states to secure the right to make treatment choices), Lyme patients are appealing to legislators to preserve their right to receive treatment for Lyme disease. The IDSA claims that its guidelines are not mandatory, but to my ears this sounds like double-speak. And, the newly elected President of IDSA, Dr. Whitley essentially admits as much when he complains about lab tests that are not “regulated” by the IDSA guidelines. What makes IDSA think that it has the “right” to regulate lab tests? Who says? How genuine is IDSA when it claims that its guidelines are really just “discretionary”? Come on, guys, one or the other, but you can’t play both sides of this issue with a straight face. Maybe we have to fall back to Lincoln or Bush, take your pick, about how many people you can fool. http://www.lymedisease.org/news/lymepolicywonk/328.html Blog: Lyme Policy Wonk Thu, 28 Jan 2010 12:44:00 -0500 A terrific article by Jerome Groopman, “Health Care: Who Knows Best”, appeared in the New York Times about the healthcare bills. Groopman’s article discusses how healthcare should be implemented in terms of guidelines and notes that there are two choices. The first is through mandates. The second is through “nudging” consumers in the right direction, but leaving the final choice to the consumer. (This approach is advocated by the author of the book Nudge, who is an advisor to Obama.) If this sounds like the Lyme debate, you are catching the drift. As we know, the distinction between mandatory guidelines that do not permit physicians and patients to make choices and guidelines that permit individuals to make their own choices, even if they are unpopular, can determine whether a patient has the opportunity to get well. The question boils down to this: Do the experts know best or do some decisions simply belong to the patient and the treating physician? http://www.lymedisease.org/news/lymepolicywonk/327.html Blog: Lyme Policy Wonk Wed, 27 Jan 2010 09:37:00 -0500 Drs. Janet and Felix Sperling of the University of Alberta published an entomology study on Lyme disease in Canada that is worth a read, especially if you believe that Lyme stops at the US border. Did you know that Lyme has now been recognized in every province in Canada? And that infection rates of ticks are 12.5%? More fast facts after the jump. http://www.lymedisease.org/news/lymepolicywonk/317.html Blog: Lyme Policy Wonk Sun, 17 Jan 2010 11:17:00 -0500 In a press release issued at the end of last year, the IDSA called on the US and European Union to develop 10 new antibiotics by the year 2020. IDSA President Richard Whitley said that “creating a stable research infrastructure for antibiotic development” was essential to provide physicians with the tools necessary to effectively treat patients. That’s good news for the Lyme community because unacceptably high treatment failures occur with all current antibiotics used to treat Lyme disease and the rate of development of new antibiotics has been low. Pharmaceuticals have not been interested in developing new antibiotics because they do not generate the level of profit that drugs that are taken by a broad demographic over the course of a lifetime, like cholesterol medication, do. This is the good news. Now for the bad news. http://www.lymedisease.org/news/lymepolicywonk/316.html Blog: Lyme Policy Wonk Sun, 17 Jan 2010 10:52:00 -0500 You’ve all heard that the latest drum-roll from the rheumatologists at the IDSA hearing was essentially to say that Lyme patients have persistent symptoms and they started off with infection, but now we don’t “believe” in persistence—so what do you call it? How about “medically unexplained symptoms” or MUS for short? All of this seems to regard the real problem with Lyme disease as being what you call it. But patients know the real problem with Lyme disease is how you treat it, how you cure it, how you restore patients to their lives. Disease definitions like MUS are for drug-makers who sell drugs to a market, physicians trying to claim professional turf, and insurers trying to deny treatment reimbursement. They are not for patients. Abraham Lincoln had it right when he said: “How many legs does a dog have if you call the tail a leg? (Answer) Four. Calling a tail a leg doesn't make it a leg.” I’m not the only one who finds these acronyms aggravating and unhelpful. A post from the internet nails it: http://www.lymedisease.org/news/lymepolicywonk/315.html Blog: Lyme Policy Wonk Sun, 17 Jan 2010 03:22:00 -0500 I had to post this image and encourage anyone interested in biofilms to go visit the website that hosts this interactive introduction to biofilms. Some of you know that biofilms have been implicated in Lyme disease. Drs. McDonald and Sapi recently published on this topic. The gist of the matter is that biofilms may be one of the ways in which bacteria persist in the body. They can provide a protective covering that antibiotics cannot penetrate. It’s a pretty esoteric subject matter, but this website describing how they work is pretty down home. Give it a visit if you get a chance. And, kudos to the University of Montana for making this available to folks like us who just need simple explanations so we know how things work! The link is after the jump. http://www.lymedisease.org/news/lymepolicywonk/311.html Blog: Lyme Policy Wonk Mon, 11 Jan 2010 13:01:00 -0500 Buddha once said “a dog is not considered a good dog because he is a good barker. A man is not considered a good man because he is a good talker.” I would take it a step further and say “a doctor is not considered a good doctor because he is a key opinion leader.” No. The essence of a good dog is loyalty. The essence of a good man is his moral character. And, the essence of a good doctor is his ability to heal the sick and restore health. This can’t be done without holding the patient’s interest paramount. Patients and the concerns of patients are the core element around which medicine is organized. Without patients, there is nothing for medicine to address. Without treatment approaches that restore health, or failing that, improve patient health, medicine becomes a meaningless exercise in capitalism. How do we ensure that patient’s interests come first in treatment guidelines? http://www.lymedisease.org/news/lymepolicywonk/310.html Blog: Lyme Policy Wonk Mon, 11 Jan 2010 12:42:00 -0500 The IDSA hearing results were expected by the year end. Then were delayed—until “after the first of the year”. Perhaps the delay was caused by Dr. Duray’s resignation from the panel due to personal illness. We don’t know because we have not been told the reason for the delay or how long the delay will be. Patients are on tenterhooks awaiting the results and with good cause. Revision of the IDSA Lyme guidelines could make a world of difference for Lyme patients. According to a CALDA survey, 53% of patients with chronic Lyme have been treated according to the IDSA Lyme guidelines and 90% of these were not restored to health under the IDSA protocols. Isn’t the point of treatment guidelines to improve patient outcomes? And, if they don’t, shouldn’t they be revised? http://www.lymedisease.org/news/lymepolicywonk/308.html Blog: Lyme Policy Wonk Sun, 10 Jan 2010 09:07:00 -0500 Antibiotic resistant infections killed more than 65,000 people in the US in 2009. But 70% of antibiotics, which can make animals grow faster, went to cows, chickens and pigs last year. Antibiotics in livestock provide a breeding ground for antibiotic resistant infections that can be passed on to humans. According to a recent AP article, animal fed antibiotics “can develop germs that are immune to the antibiotics. The germs then rub into scratches on farmworkers' arms, causing oozing infections. They blow into neighboring communities in dust clouds, run off into lakes and rivers during heavy rains, and are sliced into roasts, chops and hocks and sent to our dinner tables.” http://www.lymedisease.org/news/lymepolicywonk/302.html Blog: Lyme Policy Wonk Sat, 02 Jan 2010 09:30:00 -0500 This is a little off topic for my blog, but something that is of high interest to patients. Patients ask all the time about the effectiveness and safety of “expired” drugs. A recent article that appeared in the Medical Letter examines the issue in detail. The article notes that generally manufacture expiration dates merely reflect the fact that the drug is “stable” at that point, they do not reflect when the drug becomes unstable. The conclusion of the article indicates that outdated drugs may be effective and safe for at least 5 years after the expiration. Notable exceptions include liquid suspensions and epinephrine in Epipen, which are not stable over time. The article also notes the following: " There are no published reports of human toxicity due to ingestion, injection or topical application of current drug formulations after their expiration date. Renal tubular damage has been reported after use of degraded tetracycline in a formulation that is no longer available (REF 2)." Other sources contain warnings about expired doxycycline, which may (or may not) be based on this outdated tetracycline warning, but patients may want to check with their doctors when using expired doxycycline to be on the safe side. http://www.lymedisease.org/news/lymepolicywonk/299.html Blog: Lyme Policy Wonk Thu, 31 Dec 2009 07:27:00 -0500 I wanted to post a piece of poetry that captured the spirit of the Lyme community to ring in the New Year. I found this great Jack Kerouac poem about people who create change. Then I found out it was not by Jack Kerouac, but actually was an ad for Apple computers. Still, it is a great piece that captures the essence of a community that tirelessly swims against the current trying to change the status quo. And now for that poem. . . http://www.lymedisease.org/news/lymepolicywonk/297.html Blog: Lyme Policy Wonk Tue, 29 Dec 2009 16:33:00 -0500 I was reading a book today about the power of small groups. The book is called Microtrends. It is by Mark Penn. One of the things he said stuck with me: “It only takes 1% of the people making a dedicated choice—contrary to the mainstream—to create a movement that can change the world.” What he is talking about is the increasing fragmentation of America (the world, in fact) brought about by the internet and the collapse of normal distribution channels. Very small groups of people can now connect and be effective through the internet. And, the normal channels of distribution used to control information flow have collapsed. You see this in television where there are no longer three networks to choose from but over 200 channels. That’s fragmentation. http://www.lymedisease.org/news/lymepolicywonk/296.html Blog: Lyme Policy Wonk Mon, 28 Dec 2009 10:50:00 -0500 Have you read the LA Times op-ed that ran on December 16 by Daniel Sarewitz and Samuel Thernstrom? The piece is called “Impure Science”. It is blazingly good. The focus is on the global warming debate and recent suggestions of bias in email exchanges from one side of that controversy that were disclosed to the press. The take-home points though apply to any area, like Lyme, where there is divided science and polemic viewpoints. While the debates are shrouded in science, the real debate is not about science, but stakeholder viewpoints. When science is subject to interpretation by different stakeholder, the question is who controls the mike? http://www.lymedisease.org/news/lymepolicywonk/295.html Blog: Lyme Policy Wonk Mon, 28 Dec 2009 16:42:00 -0500 Have you ever heard the saying “what goes around, comes around”? How about “you scratch my back, I’ll scratch yours”. The revolving door between government and industry is cause for concern. The revolving door between the CDC and the vaccine industry is even greater cause for concern. The most recent revolving door has Dr. Julie Gerberding, the first woman to head the Centers for Disease Control and Prevention, being named president of Merck’s vaccine division. Do you think she knows a thing or two about vaccines and how to get them through the process? Do you think she has connections? Dr. Gerberding comes from an infectious disease background. http://www.lymedisease.org/news/lymepolicywonk/294.html Blog: Lyme Policy Wonk Sun, 27 Dec 2009 12:07:00 -0500 The IDSA panel list has been revised to reflect the fact that Dr. Paul Duray has resigned from the panel. The IDSA does not post this type of information as a stand-alone announcement. Instead, they revise their prior notices. So you have to keep a close watch on their website for changes. What they did was add to his listing the following: Resigned from the Panel on October 7, 2009, due to a family illness. I am sure that everyone’s heart goes out to Dr. Duray and we wish him and his family the best during this trying time. Let’s light a candle for Dr. Duray and his family. http://www.lymedisease.org/news/lymepolicywonk/291.html Blog: Lyme Policy Wonk Tue, 15 Dec 2009 12:07:00 -0500 An important study by Dr. Stephen Barthold and Dr. Ben Luft was recently published. The title sounds a bit bleak, but don’t let the title fool you: “Ineffectiveness of Tigecycline against Persistent Borrelia burgdorferi”. This study is about how the little guy (Borrelia burgdorferi) always wins and survives despite antibiotic treatment—here tigecycline. To my mind, the findings on persistence are much more important than the finding that tigecycline doesn’t do the job. When one antibiotic doesn’t work, you try another, and if that one doesn’t work, well, you try another or you kick it up a notch and start trying combination antibiotics, like they do with tuberculosis. You don’t fold up the tent and go home because active infection requires antibiotic treatment. And, you won’t ever find out which antibiotic or combinations of antibiotic work, until you try them. So, roll up your sleeves, we have some work to do here. http://www.lymedisease.org/news/lymepolicywonk/290.html Blog: Lyme Policy Wonk Tue, 15 Dec 2009 12:03:00 -0500 Breathe a sigh of relief. No, really. It is not that often in Lyme disease that one reads an unbiased study that speaks truth to power, that values integrity in science over dogma. So, pour a cup of tea and I will pull out the most important findings and conclusions about persistence from the recently published study by Dr. Stephen Barthold and Dr. Ben Luft, “Ineffectiveness of Tigecycline against Persistent Borrelia burgdorferi.” Here they are in a nut-shell for those with neither the time nor the inclination to read the entire study (though I must say it is highly recommended!). http://www.lymedisease.org/news/lymepolicywonk/285.html Blog: Lyme Policy Wonk Wed, 02 Dec 2009 03:47:00 -0500 Someone I know. OK, a young woman whose father called me and who then met me at a support group. OK, a father who called me because my husband played tennis with a co-worker of his. Well, you know how small this world is when you meet someone else with a “rare” (shrug, smile, wink) condition like Lyme. Anyway, this person (drum roll) --Silver Feldman-- who missed a large chunk of high school because of Lyme and who turned 21 this last month took a graphic design class. Guess what her topic was? Don't you just love it when people give back to the community? http://www.lymedisease.org/news/lymepolicywonk/284.html Blog: Lyme Policy Wonk Tue, 01 Dec 2009 07:32:00 -0500 The parallels between breast cancer and Lyme disease are not obvious, are they? I was surprised by them myself. Breast cancer patients have two treatment options (sound familiar?). Mastectomy removes the entire breast, while the newer procedure, a lumpectomy removes only the tumor and immediately surrounding tissue. Consider this: lumpectomies used to be controversial and were opposed by an entrenched medical establishment. It’s hard to imagine, isn’t it? Even harder to imagine is that women had to pass legislation in 20 states to obtain the right to choose between lumpectomy and a radical mastectomy. Physicians were afraid to perform lumpectomies for fear of losing their license. We have passed legislation in 3 states so far protecting physicians who treat Lyme in defiance of the IDSA guidelines from medical board action. But, wait there's more.. http://www.lymedisease.org/news/lymepolicywonk/282.html Blog: Lyme Policy Wonk Sun, 22 Nov 2009 20:34:00 -0500 Have you been following the news lately? So much about health care reform and guidelines revisions that appear to be blatant cost containment issues shrouded in statistical mumbo jumbo. The basis for the revisions to mammograms and cervical cancer screening (is it a coincidence that these are both female specific diseases?) is that it ‘makes sense’ based on a pure statistical analysis of lives saved and costs. Let me tell you something. Statistical lives matter only to those crunching numbers, read insurance companies (close read, ah well that would be the government, sigh). The personal life is everything. I don’t mind losing 1 in a 1,000, but I do mind losing my mother, my daughter, my sister. How about you? So how does this relate to Lyme disease you may be asking? http://www.lymedisease.org/news/lymepolicywonk/280.html Blog: Lyme Policy Wonk Wed, 18 Nov 2009 14:36:00 -0500 Patients think that the IDSA guidelines are harmful to their health because physicians, hospitals, and insurers rely on them to deny patients access to the care they vitally need to restore their health. Patients believe that the IDSA guidelines violate one of the cardinal rules of medicine, “First do no harm.” Depriving seriously ill patients of treatment is an egregious harm. But do the IDSA guidelines violate their own rules? Indeed, they do. http://www.lymedisease.org/news/lymepolicywonk/277.html Blog: Lyme Policy Wonk Wed, 18 Nov 2009 08:54:00 -0500 Now that two studies have shown that IDSA guidelines are generally long on opinion and short on evidence, what should the IDSA guideline panel do? The study by Lee, discussed in yesterday's blog, found that IDSA frequently makes strong recommendations, but that these strong recommendations are supported by strong evidence only 15% of the time. Dr. Maloney found that the majority of recommendations in the IDSA Lyme guidelines were based on the weakest level of evidence--expert opinion. Shouldn't clinical judgment only be suppressed when there is strong evidence? That's what the American Academy of Pediatrics says in its guidelines on making guidelines. http://www.lymedisease.org/news/lymepolicywonk/273.html Blog: Lyme Policy Wonk Sun, 15 Nov 2009 11:46:00 -0500 IDSA guidelines are long on opinion and short on science. This is the stunning conclusion made by an infectious disease specialist at Drexel University, Dong Lee, MD in a poster presentation at the recent IDSA annual conference. Dr. Lee’s analysis is based on a broad review of 30 guidelines published by the IDSA between 1994 and 2009. More than half of the recommendations made by the IDSA in these guidelines were not supported by science. http://www.lymedisease.org/news/lymepolicywonk/272.html Blog: Lyme Policy Wonk Sun, 15 Nov 2009 14:35:00 -0500 Doing a guideline review process correctly and vigilantly is important. It is also a difficult goal to pull off. The 2006 IDSA guideline development process was flawed, as Connecticut Attorney General Richard Blumenthal found in the antitrust investigation. That panel was hand-picked to represent a particular viewpoint on treating Lyme disease and it cherry- picked the evidence or interpreting the evidence in a manner that supported a preconceived viewpoint. When science is unclear or unfolding rather than acknowledging that fact, guidelines sometimes rely on 'expert opinion' to fill the evidence gaps. This is a big problem because evidence based guidelines are presumed to be based on evidence, not opinion. Substituting the 'expert opinion' of someone on a guideline panel is no better, (actually, it is worse) than leaving the matter open and allowing the treating physician to use their own expert opinion. http://www.lymedisease.org/news/lymepolicywonk/270.html Blog: Lyme Policy Wonk Sat, 14 Nov 2009 17:23:00 -0500 50% of the 272 speakers at the October 2009 IDSA annual meeting who disclosed conflicts, had ties to one or more of the five leading vaccine companies: Merck, GlaxoSmithKline, Sanofi Pasteur, Wyeth, and Novartis. Vaccine related financial ties with key members of the IDSA Lyme panel prompted the Connecticut Attorney General antitrust investigation into the development of the IDSA Lyme guidelines. Patients remain concerned about these interests because the IDSA guidelines placed commercial interests of vaccine manufacturers above patient care. http://www.lymedisease.org/news/lymepolicywonk/268.html Blog: Lyme Policy Wonk Fri, 13 Nov 2009 11:26:00 -0500 I have been reviewing the IDSA transcripts and reread Dr. Arthur Weinstein’s testimony. Yesterday, I discussed Weinstein’s argument that chronic Lyme should be considered a somatic disorder in my post and concluded that his assertion is no more than an unproven hypothesis that should have no role in the treatment of patients. Today I tackle the second major assertion in his testimony—namely that one of the problems with diagnosing patients with chronic Lyme is that it delays early diagnosis and treatment for somatic disorder. The big question, of course, is whether the diagnosis of somatic disorder bears any fruit for patients or whether it is instead a dead end road to nowhere. http://www.lymedisease.org/news/lymepolicywonk/264.html Blog: Lyme Policy Wonk Thu, 12 Nov 2009 02:19:00 -0500 I have been reviewing the IDSA transcripts and reread Dr. Arthur Weinstein’s testimony. Weinstein testified in support of the IDSA Lyme guidelines at the IDSA hearing on July 30th. He argued that chronic Lyme disease is a ‘somatic’ disorder involving a “serious amplification of symptoms” and states that he “doesn’t pretend to know the etiology (cause) of the pathophysiology”. He does though assert that the serious amplification of symptoms is associated with patients who have more psychiatric morbidity and is fostered by the labeling the disease “chronic Lyme” by advocacy groups and others that believe in a traditional medical cause for symptoms. This post is part of a twofer. Today, I ask if Weinstein is right that post treatment Lyme disease is a somatic disorder or if this is simply his pet theory. Tomorrow, I ask if the somatic disorder diagnosis provides patients with good patient care. http://www.lymedisease.org/news/lymepolicywonk/259.html Blog: Lyme Policy Wonk Fri, 06 Nov 2009 19:32:00 -0500 Having Lyme means losing your innocence, utterly, in science. It's true. I am remembering the night I explained evidence-based medicine to a friend whose daughter had Lyme. I explained that in Lyme evidence-based medicine was a “tool” for persuasion in a polemic argument. He was stunned. His daughter had Lyme. He believed in science. He had trouble, real trouble, getting his daughter diagnosed and treated. He knew the problems of Lyme from the inside out. But it hadn’t occurred to him that science wasn’t “pure” science. That researchers followed their bias, their pet theories, their commercial interests in designing and interpreting studies. It was an interesting moment with this sharp and concerned father while he tried to understand the depth of the problem in Lyme. It was a moment when innocence is utterly lost for the first time to those who know how the system of science “ought” to work. http://www.lymedisease.org/news/lymepolicywonk/252.html Blog: Lyme Policy Wonk Wed, 28 Oct 2009 11:33:00 -0400 Why do we do what we do? Sometimes we win, but there are many, many (too many) bumps in the road on the way to success. How do we keep our perspective in the face of an adversary that seems unrelenting---vested, no entrenched, in a medical dogma that leaves patients on the side of the road? A medical society that believes that the views of patients are really--(really?) not relevant to the question at hand? I, for one, want to walk the road of other diseases that have been abandoned and forsaken by the medical establishment. But my road (and those of other illnesses), leads to success. And success--is all about the journey. Touching lives one by one until our day in the sun. http://www.lymedisease.org/news/lymepolicywonk/251.html Blog: Lyme Policy Wonk Wed, 28 Oct 2009 18:27:00 -0400 Fresh back from the Columbia/LDA conference and the ILADS conference in Washington, DC. I love going back for these conferences because I see all the people I have talked to over the year and so rarely lay eyes on. I love the energy of the conference. This year, the ILADS conference had break-out sessions on evidence-based medicine and research. These were working groups with a lot of discussion generated—the type of discussion that only occurs when people are together in the same room and real time conversation occurs sparked by ideas. This was energizing to me. http://www.lymedisease.org/news/lymepolicywonk/234.html Blog: Lyme Policy Wonk Fri, 09 Oct 2009 10:56:00 -0400 My recent post on MUS (medically unexplained syndrome) and why that doesn't apply so much to a disease of known etiology drew an interesting comment from a reader. This person says that maybe other (more creative) acronyms are appropriate. Do you have a favorite acronym for Lyme? The post follows. http://www.lymedisease.org/news/lymepolicywonk/238.html Blog: Lyme Policy Wonk Mon, 12 Oct 2009 11:47:00 -0400 Merrill Goozner, a highly regarded medical ethicist, posted a recent commentary on conflicts of interest, "No Light at the End of the Tunnel on Disclosure." The commentary expresses his disappointment at the paltry level of self-disclosure of conflicts even under legal pressure. Those of you following the IDSA antitrust action commenced by Attorney General Richard Blumenthal in Connecticut may recall that the conflict of interest disclosure level of the IDSA panel members increased dramatically AFTER the investigation was launched. It's remarkable how helpful another set of eyes, particularly those of an official, can be when drafting conflict of interest disclosures. My commentary to Merrill's post follows: http://www.lymedisease.org/news/lymepolicywonk/233.html Blog: Lyme Policy Wonk Fri, 09 Oct 2009 09:56:00 -0400 If you don't read medical journals or medical ethics journals, you may have missed a comment made by Dr. Ann Gershon in the Southern Medical Journal. She is responding to an article by Susan Ronn that was published together with an editorial by me and Dr. Stricker. It took me a couple of times reading this, but I think she made a promise based on a dare. She says: "If and when there is credible evidence of the existence of chronic Lyme disease and of the benefits of long-term antibiotic therapy to treat it, IDSA WILL NOT HESITATE TO CHANGE ITS GUIDELINES TO REFLECT THIS EVIDENCE." http://www.lymedisease.org/news/lymepolicywonk/232.html Blog: Lyme Policy Wonk Wed, 07 Oct 2009 15:28:00 -0400 Have you ever noticed how the IDSA says one thing, but really means and does another? For instance, how they say that their guidelines are there to protect patients when in fact they amount to medical abandonment? They are so stringent that sick patients are left completely without treatment options? Or how they say they are all about scientific evidence when in fact their guidelines are based primarily on expert opinion--the expert opinion of researchers with commercial ties to vaccine manufacturers, Lyme tests, and insurers? Or how they say their guidelines are not mandatory, but their members enforce their guidelines by testifying at unprofessional conduct hearings and the IDSA opposes physician protection legislation that would essentially make compliance with their guidelines truly voluntary? Or how they say they are worried about doctors who treat chronic Lyme making money off of sick patients, but they are not concerned about conflict of interest on their guidelines panels? This is called double speak. Saying one thing, doing another. George Orwell described this type of practice "newspeak"--words "deliberately constructed for political purposes: words, that is to say, which not only had in every case a political implication, but were intended to impose a desirable mental attitude upon the person using them." I'd say we could all use a little more plain talk. http://www.lymedisease.org/news/lymepolicywonk/221.html Blog: Lyme Policy Wonk Mon, 28 Sep 2009 07:26:00 -0400 Patients with Lyme disease know how important the definition of an illness can be. We know that the difference between chronic Lyme and Post Lyme Disease Syndrome is the difference between receiving treatment and being medically abandoned. So what’s with all the “new” language at the IDSA hearing about medically unexplained symptoms? MUS for short. No fewer than 3 IDSA speakers use this expression: Drs. Weinstein, Shapiro, and Wormser. It was like they synchronized talking points. First, let me tell you what MUS and PLDS have in common—no antibiotic treatment. Because—guess why? Because the term MUS applies to diseases of unknown etiology— diseases with no identified cause. But wait, you say. Doesn’t Lyme disease have a cause? You might assume that given that the bacteria has been identified, Lyme disease has a cause and isn’t really “unexplained”? http://www.lymedisease.org/news/lymepolicywonk/213.html Blog: Lyme Policy Wonk Tue, 22 Sep 2009 00:16:00 -0400 Talk about exaggeration. No really--at the hearing. Dr. Carol Baker asked Dr. Wormser the $200 question: Why exaggerate if the truth will do? She was talking about the use in the guidelines of words like "vast majority" when the real percentage was 65%. And her question was why not let percentages speak for themselves? If the truth is 65%--why not simply say 65%. Is it just me, or does Wormser sound irritated at the question? His response after a drill down is that he would not use the expression "vast majority" to refer to anything less than say--90%. Excuse me? Did I hear that right? 90%. Really? Ok, let's break it down for him. http://www.lymedisease.org/news/lymepolicywonk/204.html Blog: Lyme Policy Wonk Wed, 16 Sep 2009 19:02:00 -0400 Most of you know the hearing on July 30th before the IDSA hearing panel was about "contested recommendations" in the IDSA 2006 guidelines. These are recommendations and language in the IDSA guidelines that we contest or take issue with. They are important because they provide the road map for what the IDSA hearing panel must review. Contested recommendations must be evaluated by the panel. In order to remain in the guidelines, a supermajority (7 of the 9 panel members) must find that the contested recommendation is supported by the medical/scientific evidence presented at the hearing or otherwise submitted. http://www.lymedisease.org/news/lymepolicywonk/198.html Blog: Lyme Policy Wonk Tue, 08 Sep 2009 16:40:00 -0400 Ask the Lyme community a question, or two or 30 and they answer! When we asked for input before the IDSA Lyme hearing, we had 3,600 completed surveys within 2 months—that’s astounding! I want to thank everyone who participated. The survey results provide very important information for the Lyme community and will be useful to describe the extent of the problem that patients have being timely diagnosed, treated, reimbursed, seriously ill and the devastating effect the guidelines have on patients health. http://www.lymedisease.org/news/lymepolicywonk/190.html Blog: Lyme Policy Wonk Tue, 01 Sep 2009 08:55:00 -0400 There is a fabulous article on the importance of patient choice in universal health care in the Wall Street Journal. The article, "Sorting Fact from Fiction," is by Groopman . I recommend that you take the time to read this important piece, which identifies many of the issues Lyme patients have been raising for some time. I posted a comment to the article drawing the analogies to Lyme disease, which follows. You may want to weigh in on this important topic. http://www.lymedisease.org/news/lymepolicywonk/188.html Blog: Lyme Policy Wonk Sat, 29 Aug 2009 05:42:00 -0400 Those who attended the IDSA guidelines hearing were struck by the even-handed tone of the proceedings established by the Chair, Dr. Carol Baker. It was both unexpected and disarming, and not a small accomplishment given the polarity of the debate. At the same time, there was a feeling of cognitive dissonance—this was not the public face presented by IDSA President, Dr. Ann Gershon—who, in the face of the ILADS submission of over 1,600 pages of scientific evidence contradicting the guideline recommendations, steadfastly maintains there is no evidence of persistence. So what gives? Is this a case of “good cop/bad cop”? Are perceptions deceiving? Is this all a matter of managing public perception? Putting on a public face? http://www.lymedisease.org/news/lymepolicywonk/180.html Blog: Lyme Policy Wonk Mon, 10 Aug 2009 11:33:00 -0400 Ever wonder what is going on with surveillance numbers? How come some states go up, up, up and others go down? If you look at Lyme surveillance in the US from 1990 to 2007 and just consider did cases go up or down, it can get pretty interesting. I don't know what to think when cases go down. Did all the ticks move out of dodge? Did the doctors quit diagnosing? Did people finally get the message and stay in doors with a book? Did the disease definition change? Is there a new department of health head? Did staffing go down? Did certain areas of the US just fall off the books because they were told there was no Lyme south of the Mason Dixie? I don't have answers. This is a list of those states that zigged when others were zagging. Tell me your thoughts. http://www.lymedisease.org/news/lymepolicywonk/179.html Blog: Lyme Policy Wonk Thu, 06 Aug 2009 17:16:00 -0400 Last Thursday, the historic review of the IDSA 2006 Lyme guidelines was held in Washington, D.C. Eighteen people presented arguments for and against the guidelines. We don’t know how the IDSA panel will act in the face of this deluge of previously suppressed information, but we do know that we have grown enormously as a community and that the skill-sets we developed on this project will continue to have a positive effect in the future. I want to share with you a little of the background of the action and acknowledge people who have joined in this massive undertaking over this period. Many others have contributed, and I apologize if I have overlooked anyone’s contribution to this effort. http://www.lymedisease.org/news/lymepolicywonk/177.html Blog: Lyme Policy Wonk Wed, 05 Aug 2009 03:59:00 -0400 The IDSA Lyme disease guidelines review hearing on Thursday was an historic event both in medicine and in the Lyme community. It is the first time an organization has been required to hold hearings and review treatment guidelines that were created by a panel with conflicts of interest. It is also the first time that a broad debate of both sides of the Lyme controversy over diagnosis and treatment with physicians and researchers has been held. http://www.lymedisease.org/news/lymepolicywonk/176.html Blog: Lyme Policy Wonk Sun, 02 Aug 2009 01:44:00 -0400 The IDSA has now posted links to all of the presentation videos. I decided to retape my video outside the hearing so that it will not be subject to the IDSA's decisions about how long to post or keep the archive. The video on the IDSA site includes the Q&A and reflects the proceedings that day. http://www.lymedisease.org/news/lymepolicywonk/167.html Blog: Lyme Policy Wonk Mon, 27 Jul 2009 16:50:00 -0400 CALDA CEO Lorraine Johnson is now in Washington DC, prepared to testify at Thursday's historic hearing before the IDSA Lyme guidelines panel. Included in her report will be results from some 3500 surveys submitted by Lyme patients in recent weeks. From now through Thursday, please refer to our "IDSA Hearing" blog for latest developments. http://www.lymedisease.org/news/lymepolicywonk/164.html Blog: Lyme Policy Wonk Fri, 24 Jul 2009 01:44:00 -0400 The IDSA settlement agreement calls for an open public meeting which must be aired live over the internet. I have serious concerns about the restrictions the IDSA is imposing on people who want to watch the hearings and am discussing these with the Connecticut Attorney General’s office, but meanwhile I want to provide you with information so that if you want to watch you are prepared. http://www.lymedisease.org/news/lymepolicywonk/134.html Blog: Lyme Policy Wonk Tue, 16 Jun 2009 20:09:00 -0400 The Infectious Diseases Society of America’s new Lyme disease guidelines review panel will hold a one day hearing on July 30. This hearing is part of the antitrust settlement that the Connecticut Attorney General negotiated. Of the 18 speakers selected to testify, two are patient advocates, including me. The testimony will be aired live on the internet on July 30 so stay tuned. STAND UP AND BE COUNTED CALDA is conducting a survey of individual Lyme experiences to give you a chance to have input. Results of the survey will be included in my testimony to the IDSA panel. http://www.lymedisease.org/news/lymepolicywonk/162.html Blog: Lyme Policy Wonk Wed, 22 Jul 2009 16:58:00 -0400 It's about going from the abstract to the concrete. Getting out the stop watch and thinking about just how long is 15 minutes. It's enough time to eat lunch or do an errand. But how long is 15 minutes in words? I haven't had to give it much thought until recently. It turns out 15 minutes translates into a number of words. In speeches the pace is generally between 120 and 160 words per minutes. So, if you do a scripted speech for 15 minutes, you have between 1,800 and 2,400 words. Now, if I could only master the art of speed read and teach the panel to speed listen, we'd be off to the races! http://www.lymedisease.org/news/lymepolicywonk/161.html Blog: Lyme Policy Wonk Wed, 22 Jul 2009 09:08:00 -0400 CALDA, the national Lyme Disease Association and Time for Lyme have issued a joint press release regarding the IDSA Lyme review hearing, which is schedule for July 30th in Washington D.C. The release highlights the growing opposition to the IDSA guidelines, the importance of acknowledging the full spectrum of science in Lyme disease, and the importance of permitting clinical judgment and treatment options for patients. Concerns are also raised about the current process, which Attorney Lorraine Johnson points out is not impartial because IDSA controls the process and has selected both the panel members and those who may present before the panel. Of critical importance is that fact that no physicians who treat chronic Lyme disease were selected to sit on the panel. The testimony will be aired live over the internet on July 30th. http://www.lymedisease.org/news/lymepolicywonk/157.html Blog: Lyme Policy Wonk Mon, 20 Jul 2009 01:54:00 -0400 If you have not read the recent editorial by Attorney General Blumenthal published today in “The Day”—you are in for a treat. Despite the IDSA’s protests that the guideline review process is “voluntary”, Blumenthal observes that the IDSA “effectively admitted the flaws by agreeing to a review and reassessment of its 2006 guidelines by a conflicts-free panel”. http://www.lymedisease.org/news/lymepolicywonk/154.html Blog: Lyme Policy Wonk Tue, 14 Jul 2009 11:15:00 -0400 Well, as you can see, I’ve reached the cutting and pasting portion of writing my speech for the IDSA Lyme Guidelines Review Panel—a bit like making a quilt. You start off with yards of different fabrics, cut them into little squares and eventually reassemble them into the quilt, tying off the edges carefully and trying not to prick yourself with the needle on the way. As a patient advocate, I am allotted 15 minutes to make my point and leave the podium. By the way, it is a lot more difficult to write a 15 minute speech than a 45 minutes speech—size matters. It’s like Mark Twain said: “I didn't have time to write a short letter, so I wrote a long one instead.” http://www.lymedisease.org/news/lymepolicywonk/153.html Blog: Lyme Policy Wonk Thu, 09 Jul 2009 12:37:00 -0400 Andy Schlafly of AAPS describes the efforts of AAPS to work with patient groups in health care reform for autism. His comments on how important it it to speak out and for patients and physicians to join together to combat over-zealous medical boards that go after physicians who treat patients is compelling. He points out that the medical board in Texas is in cohoots with insurers behind the scenes and that this has impeded legislative efforts. Take a look at his video. The parallels with Lyme are striking. http://www.lymedisease.org/news/lymepolicywonk/142.html Blog: Lyme Policy Wonk Mon, 29 Jun 2009 19:02:00 -0400 Terrence McNally at KPFK, a local public radio station in Los Angeles interviewed me, Andy Wilson, Mandy, and Dr. Horowitz on June 23rd about the film, Under Our Skin, and about the antitrust settlement. It is a good listen if you have not heard it. The link to the podcast is below. A close friend snapped the picture of me in the booth. http://www.lymedisease.org/news/lymepolicywonk/131.html Blog: Lyme Policy Wonk Sat, 06 Jun 2009 20:44:00 -0400 A couple of weeks ago, I suggested you look the “pistols at dawn” action at the OK Corral between IDSA president, Dr. Ann Gershon, and Dr. Stricker and me on the IDSA guidelines, antitrust law, and Lyme disease. Drum roll. . .The reply by Dr. Sticker and me is now posted on the Journal of Medical Ethics website. This lively debate is a breath of fresh air to the Lyme community. http://www.lymedisease.org/news/lymepolicywonk/130.html Blog: Lyme Policy Wonk Mon, 01 Jun 2009 22:32:00 -0400 The Infectious Diseases Society of America has selected presenters to speak before its Lyme disease guidelines review panel on July 30. (This is part of the guidelines review process mandated by the IDSA’s settlement with the Attorney General of Connecticut.) The speakers representing patient advocates are Tina Garcia, of the Lyme Education and Awareness Program (LEAP) and me. Three researchers that are not affiliated with either ILADS or IDSA will speak: Drs. Brian Fallon from Columbia, Ben Luft from Stony Brook, and David Volkman, previously from the National Institute of Health (NIH). The following members of ILADS will be presenting: Drs. Daniel Cameron, Ken Liegner, Steven Phillips and Raphael Stricker. In addition, Allison Delong, MS, of Brown University, and Dr. Donta, a member of IDSA, will present. Those advocating for the IDSA guidelines include Drs. Phillip Baker (President of the American Lyme Disease Foundation and previously with NIH), Barbara Johnson (Centers for Disease Control), Eugene Shapiro, Sunil Sood, Allen Steere, Art Weinstein and Gary Wormser. http://www.lymedisease.org/news/lymepolicywonk/125.html Blog: Lyme Policy Wonk Fri, 22 May 2009 20:56:00 -0400 You need to take a look at the “pistols at dawn” action at the OK Corral. The article by Dr. Stricker and me on the IDSA guidelines, antitrust law, and Lyme disease has drawn the heat of Dr. Gershon, President of IDSA. This type of exchange is good. It highlights issues. It clears the air. Remember a duel is not a brawl. It is a controlled battle between gentlemen of honor with a certain level of dignity expected of all participants. I don’t know, it still makes me think that I ought to put on a combat helmet before putting put pen to paper. http://www.lymedisease.org/news/lymepolicywonk/126.html Blog: Lyme Policy Wonk Wed, 20 May 2009 20:12:00 -0400 Some more light reading for those late nights when nothing is on the tube and you’re wondering how IDSA got ensnared in antitrust law with its Lyme disease guidelines. Just how flawed was its guidelines development process? Why is it important to democracy that opposing viewpoints be heard before vital freedoms—like your ability to choose among treatment options—are taken away. When do medical societies have an obligation to not suppress legitimate medical controversies? And, what is the drill for the settlement process anyway? If you have comments on the article, send them to me at johnson.lorraineb@gmail.com http://www.lymedisease.org/news/lymepolicywonk/123.html Blog: Lyme Policy Wonk Mon, 11 May 2009 13:35:00 -0400 If you haven't read the article by attorneys Elliott Pollack and Christine Collyer in the Connecticut Law Tribune, "Attorney general challenges controversial Lyme disease guidelines", I suggest you check it out. Those familiar with the Jones case in Connecticut will recognize their names. Early on in the case, I had the pleasure of working with these attorneys and have appreciated the high level of competency and professionalism as well as their dogged pursuit of justice for Dr. Jones. Connecticut is ground zero for Lyme disease--with the Jones case, the Connecticut Attorney General antitrust investigation against IDSA, and the pending state legislation that would provide protection for treating physicians. http://www.lymedisease.org/news/lymepolicywonk/117.html Blog: Lyme Policy Wonk Wed, 29 Apr 2009 02:01:00 -0400 The German Society of Lyme Borreliosis submitted its objections to the IDSA Lyme disease review panel. The society protested the application of the IDSA guidelines in Germany, emphasizing the poor lab test sensitivity, persistence of the organism, and seriousness of the illness. http://www.lymedisease.org/news/lymepolicywonk/116.html Blog: Lyme Policy Wonk Mon, 27 Apr 2009 14:44:00 -0400 Lyme Disease Action (in the UK) filed a submission with the IDSA contesting the IDSA 2006 Lyme disease guidelines. The submission points out that the presentation of Lyme disease in the UK may be different than the presentation in the US, and the application of the guidelines in the UK lead to under-diagnosis and under-treatment of patients with Lyme disease. http://www.lymedisease.org/news/lymepolicywonk/115.html Blog: Lyme Policy Wonk Fri, 24 Apr 2009 15:58:00 -0400 The Association of American Physicians and Surgeons (AAPS), which represents physicians and surgeons in small practices, sets the IDSA Lyme disease guidelines in its cross-hairs. Why? Because the physicians need flexibility and the IDSA guidelines are mandates that restrict the ability of physicians to provide individualized care. The full text of the AAPS letter to the IDSA follows: http://www.lymedisease.org/news/lymepolicywonk/114.html Blog: Lyme Policy Wonk Thu, 23 Apr 2009 18:42:00 -0400 Pop the cork off the Champagne and let the fireworks rip! ILADS made its document submission for the IDSA Lyme disease review panel. And the weight of evidence was staggering-- http://www.lymedisease.org/news/lymepolicywonk/113.html Blog: Lyme Policy Wonk Fri, 24 Apr 2009 07:05:00 -0400 Every now and then you gotta kick up your heels. This year I headed back east for Time for Lyme's GALA. The Young People's Chorus of New York City gave an amazing performance of internationally inspired songs. Actor, Director and Writer Lou Diamond Phillips of Lyme Life gave a compelling speech and a rousing performance singing with the band--including the song LA BAMBA--which had everyone up dancing. The picture is me leaning in to talk with Dr. Luc Montagnier, a Nobel Prize winner for his discovery of HIV, who was honored at the GALA. http://www.lymedisease.org/news/lymepolicywonk/111.html Blog: Lyme Policy Wonk Tue, 21 Apr 2009 10:27:00 -0400 The IDSA trots out bad faith move after bad faith move to ensure that their Lyme disease guidelines are rubberstamped quickly and quietly. IDSA took first things first--which means stacking the panel has been front and center in its cross-hairs for some time. http://www.lymedisease.org/news/lymepolicywonk/110.html Blog: Lyme Policy Wonk Mon, 20 Apr 2009 05:43:00 -0400 Most guidelines panels are heavily populated by academics. Why is that? Take the IDSA guidelines Lyme disease panel in 2006—all academic researchers. Researchers are good at science, but what about medicine? Does good science make good medicine? Not necessarily. http://www.lymedisease.org/news/lymepolicywonk/101.html Blog: Lyme Policy Wonk Mon, 06 Apr 2009 04:42:00 -0400 Applications for the IDSA panel are due April 17th. Time is slipping away. Do not forget this important date. The application for presenting is an electronic application that is available on the IDSA website. The actual panel hearing is scheduled for July 30th. If you have made a submission or are planning on making one, you may wish to refer to that submission in your application so that the panel realizes the importance of your presentation. Priority is going to be given to researchers and physicians. If you have questions regarding this, please contact me at johnson.lorraineb@gmail.com http://www.lymedisease.org/news/lymepolicywonk/100.html Blog: Lyme Policy Wonk Mon, 06 Apr 2009 04:36:00 -0400 The IDSA has set the review panel date for July 30th. None of the other calendar dates have changed. The applications for the panel are due April 17th, document submissions are due April 24th, and selected presenters will be notified by May 15th. If you intend to apply to present or are making a document submission, please let me know and send me a copy of your application or submission at johnson.lorraineb@gmail.com http://www.lymedisease.org/news/lymepolicywonk/98.html Blog: Lyme Policy Wonk Fri, 03 Apr 2009 11:46:00 -0400 JAMA is having a personality conflict with itself. After publishing 3 very strong articles on the ethics in guidelines development, it has asked those who question ethics violations in JAMA’s publications to keep quiet about them. In JAMA’s view, conflict violation in its journal should be discussed only if and when JAMA decides to discuss them. This sounds like a policy designed to silence whistle blowers at a time when we need more whistles and fewer muzzles. Not surprisingly, the Association of Health Care Journals has come out against JAMA on this one. http://www.lymedisease.org/news/lymepolicywonk/95.html Blog: Lyme Policy Wonk Tue, 31 Mar 2009 11:03:00 -0400 Sometimes someone does something so wonderful. Really! Something so wonderful that you have to stop, take a breath, exhale, and look again. In this world, the world of patients with Lyme disease, it happens rarely. And, when it does, we need to acknowledge it, and, more importantly, we need to acknowledge those who do the right thing no matter what. When someone outside this community steps up to bat for us, well, we should just stop what we are doing and give thanks. Here is my thank-you to Dr. David Volkman. (p.s. you can write one too) http://www.lymedisease.org/news/lymepolicywonk/94.html Blog: Lyme Policy Wonk Tue, 31 Mar 2009 05:01:00 -0400 Merrill Goozner continues his insightful beat on conflict of interest articles by JAMA this year. Count them, one, two, three by JAMA--THIS YEAR--SO FAR--AND ITS ONLY MARCH! Does this mark a trend? A turning point for conflicts of interest in Lyme disease? In medicine? Do medical societies have an obligation to hold certain truths to be self evident--that patient concerns come before industry interests and ties? http://www.lymedisease.org/news/lymepolicywonk/89.html Blog: Lyme Policy Wonk Sat, 28 Mar 2009 19:26:00 -0400 When is an open hearing not an open hearing? How do you give the appearance of being open without, well, actually being open? How do you deal with the issue of public accountability in Lyme disease guidelines when you would rather not? I'd say the IDSA open hearing, which excludes the public from participating, but allows them to "view" the proceeds from a safe distance probably fits the bill. And that, my friends, is what the IDSA intends to do. Hold a public hearing that fits the "form" but not the "substance" of a public hearing. In this way--the IDSA does not have to face the patients whose lives it is destroying. This is a one sided communication device--something the patients are quite used to, but something the IDSA should set aside in favor of accountable transparency. If you are going to talk the talk , you ought to walk the walk. Let's call this hearing what it is-- one more way to "silence the sick". http://www.lymedisease.org/news/lymepolicywonk/88.html Blog: Lyme Policy Wonk Fri, 27 Mar 2009 11:12:00 -0400 The IDSA has a new schedule for the Lyme disease guidelines review process—applications are open—submissions of contested recommendations are extended—hearing date is not set. A table of the scheduled events follows. The open public hearing turns out to be, well, not quite so open (no one but presenters can attend?). The IDSA plan here is to air it live over the internet on the IDSA website and hightail it out of town. http://www.lymedisease.org/news/lymepolicywonk/87.html Blog: Lyme Policy Wonk Sat, 28 Mar 2009 07:46:00 -0400 The IDSA has extended the time to apply for the Lyme disease guidelines review panel. The window closes April the 17th so those who are interested are encourage to apply promptly. The application process requires two applications, one on content and the other on conflicts of interest. Both forms need to be submitted by the deadline. Although anyone can apply to present, clinicians and researchers will be given preference. The IDSA panel will advise those who are accepted as presenters by May 15th. The deadline for submitting documents and research has been extended to April 24th. In addtion, any presentation materials must be submitted prior to the hearing. Members of the public will be able to view the hearing live on the IDSA website. A taped archive will be available online after the hearing. http://www.lymedisease.org/news/lymepolicywonk/84.html Blog: Lyme Policy Wonk Fri, 27 Mar 2009 13:41:00 -0400 Yes, we have an extension! Yes, it is official! Yes, Yes, Yes. . . .(don't get me going) http://www.lymedisease.org/news/lymepolicywonk/82.html Blog: Lyme Policy Wonk Thu, 26 Mar 2009 12:10:00 -0400 David Volkman, Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook, and previously Senior Investigator with the National Institute of Allergies and Infectious Diseases, has submitted the attached letter to the IDSA pursuant to its document submission process. He has performed both clinical and bench research in Lyme disease since 1985. Given his impeccable credentials, outlined in the first paragraph of his letter, his submission should carry considerable weight with the panel. Among other things, he points to the suppression of research and stifling of the types of investigative inquiry necessary to begin to address pressing issues for Lyme patients—the need for better testing, the need to acknowledge persistence and start looking for treatment protocols that help patients get better, the need to keep surveillance definitions outside the arena of patient diagnosis, the need to acknowledge the usefulness of PCR testing, and the need to avoid prophylaxis regimens that may promote chronic Lyme. His letter smells a little bit like “courage” to me—a pretty rare commodity these days. http://www.lymedisease.org/news/lymepolicywonk/81.html Blog: Lyme Policy Wonk Thu, 26 Mar 2009 01:58:00 -0400 The IDSA is expected to extend the time period for document submissions to the 24th of April. Jennifer Padberg expects to post a new calendar of events early next week, at which time she also expects the application process for presenters to be opened. The presentation date will likely be pushed until summer. Presenters will be selected by the IDSA, the ombudsman, and the Connecticut Attorney General. ILADS-affiliated speakers will be permitted an equal amount of time for presentations. I will post more news as it becomes available. http://www.lymedisease.org/news/lymepolicywonk/79.html Blog: Lyme Policy Wonk Tue, 24 Mar 2009 09:30:00 -0400 If you have not read the recent article by Brenda Patoine, "Guideline-Making gets tougher: Action by state attorney general over Lyme disease guidelines stirs debate, " I recommend you do. It is a good reminder that reporters can still do the in depth coverage of complex issues and hold their ground on reality based reporting. http://www.lymedisease.org/news/lymepolicywonk/74.html Blog: Lyme Policy Wonk Sat, 21 Mar 2009 10:25:00 -0400 How is it possible for the IDSA to have a public guidelines review on Lyme Disease hearing date set for April 27th when it hasn’t notified speakers that they will be speaking at the hearing? When it hasn’t even selected speakers? When it hasn’t even posted applications for speakers on its website? When it hasn’t reserved a room for the event? You’d think this group had never held a conference before—but wait— it holds annual conferences! So this organization KNOWS how to prepare for and hold a big event that will have a number of speakers; it knows how to reserve a room; and even how to select speakers and give them time to prepare. In fact, it has already worked out all of these details for its own annual meeting in October, which is more than 6 months away. They have a list of speakers, the assigned topics and reserved facilities— the whole nine yards. http://www.lymedisease.org/news/lymepolicywonk/62.html Blog: Lyme Policy Wonk Sat, 28 Feb 2009 19:59:00 -0500 Merrill Goozner at Gooznews cites a recent JAMA article by Tricoci showing that nearly half of the recommendations in treatment guidelines are not based on clinical trials, but rather, are based on no more than the expert opinion of those on the panel. This leads to the rather obvious conclusion that evidence based medicine is largely bankrupt. Only 11% of recommendations for heart disease were based on multiple randomized trials. http://www.lymedisease.org/news/lymepolicywonk/57.html Blog: Lyme Policy Wonk Tue, 24 Feb 2009 11:08:00 -0500 In response to concerns raised by patient's organizations and physicians about the document submission process--which initially tried to limit submissions to five pages--the IDSA has changed its document submission process. The IDSA is now requesting that submissions be 10 pages or less with an acknowledgment that they will consider all submissions regardless of length. For a submission to be considered by the panel though it must specify what recommendation is being contested. This is because the scope of this panel is simply to consider and weigh the scientific evidence for contested recommendations. http://www.lymedisease.org/news/lymepolicywonk/55.html Blog: Lyme Policy Wonk Thu, 19 Feb 2009 15:28:00 -0500 On February 17, 2009, President Obama signed into law a stimulus program that includes $1.1 billion for comparative effectiveness research. The Partnership to Improve Patient Care, a coalition of patient groups, physicians and pharmaceuticals, warned that the research might be inappropriately used to “limit treatment options for patients.” A health care e-list that I’m on has become an active war zone on this issue. (Full disclosure—I am a combatant.) http://www.lymedisease.org/news/lymepolicywonk/52.html Blog: Lyme Policy Wonk Tue, 17 Feb 2009 07:37:00 -0500 How is it that one week JAMA publishes an article by Sniderman and Furberg, "Why Guidelines Require Reform", on the urgent need to for guideline reform and the next week they publish a piece by Kraemer and Gostin, "Science, Politics and Values", that could have been written by a PR firm for the IDSA, berating the Connecticut Attorney General for trying to accomplish just that? http://www.lymedisease.org/news/lymepolicywonk/56.html Blog: Lyme Policy Wonk Fri, 20 Feb 2009 20:07:00 -0500 A recent article by Sniderman and Furberg, "Why Guideline Making Requires Reform"  is a remarkably comprehensive over-view of the pitfalls of evidence based guidelines.  The http://www.lymedisease.org/news/lymepolicywonk/50.html Blog: Lyme Policy Wonk Sat, 14 Feb 2009 10:42:00 -0500 A recent publication authored by Feder and correspondence to that publication defined the 'Axis of Evil' in this controversy as physicians who treat patients with needlessly prolonged courses of antibiotics, 'specialty laboratories' that perform 'inaccurate' Lyme testing and the internet, which promotes 'Lyme hysteria'. Dr. Stricker and I published a counter article taking on each of the three elements of the "Axis of Evil", one by one (Future Microbiology, Volume 3, Number 6, December 2008 , pp. 621-624(4)). While this version of the article is available on Pub Med, the full version (which contains footnotes) is available for purchase by the publisher Future Science . http://www.lymedisease.org/news/lymepolicywonk/48.html Blog: Lyme Policy Wonk Sun, 08 Feb 2009 23:17:00 -0500 On February 2, 2009, the IDSA announced the opening of the 60-day public input period. The period expires at 5 pm on April 3, 2009. While many issues remain to be sorted out, this posting presents some of the currents Q&A issues that patients are raising. http://www.lymedisease.org/news/lymepolicywonk/47.html Blog: Lyme Policy Wonk Sun, 08 Feb 2009 17:59:00 -0500 In another post, I pointed out problems with the composition of the IDSA panel—namely, that the IDSA panel is biased toward the IDSA perspective because physicians who treat chronic Lyme were entirely excluded and some of the panel members have known biases. A number of patients have contacted me who want to do something. This post will let you know who, what, and where you can write to have the best chance of getting your voice heard. http://www.lymedisease.org/news/lymepolicywonk/46.html Blog: Lyme Policy Wonk Thu, 05 Feb 2009 04:00:00 -0500 Most patients who write me share my concern about the composition of the IDSA panel, and with good cause. Our reasons for concern are two-fold. We are concerned about who was selected for the panel. And, we are concerned about who was rejected from the panel. http://www.lymedisease.org/news/lymepolicywonk/44.html Blog: Lyme Policy Wonk Sun, 08 Feb 2009 07:56:00 -0500 Over the years in the trenches, Dr. Stricker and I have written a number of letters jointly or individual to the New York Times. Not a one has been published. And, we are not the only ones--leading some patients to question what it is the NY Times has against Lyme patients. It's enough to make one wonder about fair and impartial journalism. A number of patients groups have written the NY Times Ombudsman to protest its uniformly one sided view of Lyme disease. Clearly, the topic of Lyme is timely, controversial and newsworthy. Yet only one side seems to merit the cost of ink by the NY Times. http://www.lymedisease.org/news/lymepolicywonk/42.html Blog: Lyme Policy Wonk Thu, 05 Feb 2009 11:11:00 -0500 If you have not read Pam Weintraub's Disappearing a disease: when guidelines are biased, patients suffer I suggest you take a breath and head over to her blog on Psychology Today. Pam Weintraub is the author of "Cure Unknown: Inside the Lyme Epidemic", the seminal book on the politics and science underlying Lyme disease. I recall telling a friend and attorney who simply did not understand why there should be a controversy when so many people were ill--why would any physician, those men in the white coats, deliberately leave patients ill, untreated, and without hope. Since when did medicine become a science of closed doors, double locked against the needs of patients? http://www.lymedisease.org/news/lymepolicywonk/40.html Blog: Lyme Policy Wonk Mon, 02 Feb 2009 10:52:00 -0500 The IDSA review panel has announced that the period for the public to submit information to ensure that all points views are taken into consideration is open. Submissions must be received by April 3 and should not exceed 5 pages. The public hearing date has been set as April 27th in Washington DC area. Information on how to apply to be a presenter will be forthcoming. http://www.lymedisease.org/news/lymepolicywonk/37.html Blog: Lyme Policy Wonk Sun, 01 Feb 2009 10:30:00 -0500 Some of you are aware that the original list of 10 panel members is now 9 because Weinstein was removed. For convenience, I am posting the current list of IDSA panel members with Weinstein removed. http://www.lymedisease.org/news/lymepolicywonk/35.html Blog: Lyme Policy Wonk Fri, 30 Jan 2009 05:36:00 -0500 Antitrust law is concerned with constraints of trade that foreclose consumer choice. Guidelines developed by medical specialty societies that have monopoly power (like the IDSA) can become de facto legal standards for the practice of medicine. When they foreclose treatment options and the exercise of clinical judgment, they constrain consumer choice. Typically, laws are passed in the United States through a democratic process that allows many groups to have a voice in the law before it is passed. Antitrust laws make an exception to guidelines or standards that are developed by groups that have expertise in an area (for instance, computer chips and medicine) so long as they play fair. The reason for this exception is that the level of expertise required in these areas makes it reasonable for "experts" rather than laymen to be setting the rules. http://www.lymedisease.org/news/lymepolicywonk/34.html Blog: Lyme Policy Wonk Fri, 30 Jan 2009 01:54:00 -0500 Gooznews posted an interesting commentary on guidelines, conflicts of interest in guideline development and over reliance on expert panels when there are gaps in evidence. Merrill Goozner is a health care ethicist and this is not the first entry on his blog that has caught my attention. You might want to check it out. His post is premised on the recent article by Sniderman in the Journal of the American Medical Association (recent issue), which does a remarkably job outlining the problems with control in evidence based medicine, how "opinions" of the panel members are recharacterized as "science" in the form of evidence based guidelines. Some of the comments to Goozner's post are interesting. One person responds that "Evidence-based medicine has morphed into pharma-based medicine and HMO-based medicine". I thought Goozner's post was a good opportunity to point out some of the problems with the IDSA guidelines. My comment follows: http://www.lymedisease.org/news/lymepolicywonk/31.html Blog: Lyme Policy Wonk Mon, 26 Jan 2009 08:45:00 -0500 Many people have questions about the IDSA panel, its selection and where we are in the process. This posting I will attempt to answer some of the more common questions. CALDA News, Events & Blogs