Foreward ~ I’m so behind on my own comments, and the deadline for the IDSA Public Comment period is so fast approaching, that multiple posts with relevant or even related content or links are going to published in a rough state, including things like un-formatted and un-annotated lists of links, just to get the information out to those that may be looking. I’ll be cleaning them up, adding to them, and adding relevant Mayday or lymedisease.org links to them as time permits and as applicable.
Understanding (enough of) the History of the Guidelines and Related Background
Deciding where to start in understanding guidelines is a bit daunting. I got my start before my diagnosis after wathcing Under Our Skin for the first time. I’d asked about Lyme a few times during and after Bell’s palsy, since I’d been bit by a tick. But was adamantly told it was not a possibility. I remember watching the film, during a then-ongoing Equal Employment Opportunity (EEO) federal discrimination case (to prove I was able to work), and thinking “Thank God that’s not what I have.” Thinking I was already going through as much as any sick person could take.
It all sounded a bit conspiratorial back then. Credible, but hard to get my head around. I looked up Montana’s guidelines for the treatment of Lyme, curious to see if the logic could really be so poor. And there it all was. I can say now, there were the words that kept me misdiagnosed for over three years, and that have kept me sick for almost five years so far.
The headings for these resources and sections may seem conspiratorial or accusatory to someone not yet familiar with the background, the parties involved, and the issues at play. Which leads to the first few over-view type links.
As more information on the links is added, I may include Comment Period Notes (CP Notes) where applicable. These are as much reminders for me as anything, and doesn’t indicate that the resource is necessary for comments. There are resources to help dig further in specific directions or to find background enough to answer or formulate questions.
If you are looking for resources to support your comments to IDSA’s March 2015 comment period, or seeking specific types of resources, these links in the first list will probably not provide you with new information, (other than the ‘Arguing Chronic Lyme’ post this blog (listed) which includes links t may be of use).
Basic Background (on Problems, Conflicts, History Surrounding Guidelines)
- Under Our Skin Excerpts
- Arguing Chronic Lyme ~ A (Very) Basic Overview & A Few Good Links
- Hub Pages Articles (for now, see Arguing Lyme post, linked above)
- Lymedisease.org Articles (for now, see Arguing Lyme post, linked above)
Background on the Comment Period
- Preliminary info and links (previous post) to the announcement, document, and some resources about commenting so far
- MayDay Project Press Release
*Again, I’d much rather have these organized with more info, but 1) I’m posting in case these links are of use to anyone in the short term (and they fit with specific current questions and discussions), and 2) EVERYONE in the Lyme community needs to pace themselves right now. We’ve got legislative processes rolling in multiple states, planning happening for multiple events and campaigns in May, and the rapidly moving and extremely evolving Lyme Disease Challenge.
Greater Depth ~ To be sorted soon
Video: Background on reviewing guidelines (not specific to this round, but good background) *interesting, states guidelines not meant to “have teeth” but have been used to revoke physician licenses….where did the teeth come from? (branches into a primary question of mine, which is where or whether there are teeth to the comment process or review process)
- Unprecedented Antitrust Investigation into the Lyme Disease Treatment Guidelines Development Process https://www.law.gonzaga.edu/law-review/files/2011/01/Asher.pdf
- Very lengthy and involved, may find similar points in shorter documents such as the Panel’s report
- CP Note: Regardless of the findings of the panel in 2006, there are very valid questions throughout this review and other articles similarly based, that lead to very good questions to consider suggesting to Calderwood for the 2015 panel to be asking and/or that lead to issues to look for and comment on in the Review Plan.
- pp. 140-141 “The 2006 IDSA Guidelines have significantly reduced the Lyme treatment market by denying the existence of chronic Lyme disease and condemning the use of long-term antibiotics.192 Insurance companies have further reduced the Lyme treatment market by citing the 2006 IDSA Guidelines in their coverage plans to deny or limit treatment costs associated with chronic Lyme disease,193 claiming that the costly long-term treatments are “„experimental‟ or „not evidence-based.‟”194 But in reality, “the science underlying both the short-term and the longer-term treatment options is equally uncertain.”195 As such, physicians who treat chronic Lyme sufferers argue that they should be allowed to use long-term antibiotics as treatment because “[e]vidence-based medicine requires only that medicine be practiced in accordance with the evidence that currently exists, not that treatment be withheld pending research.”196 Moreover, in a free marketplace, both viewpoints would be available to patients.”
- CP Note: At least skimming the actual guidelines in advance of other reading, as you get going is a good reminder of you ‘triggers’ for comments, which helps get list going of what to focus on the most as you read the plan. *Very useful in combination with the video link above about guideline review process. I found it useful to let it play in the background as it jogged my memory a bit.
- Problems last time: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901226/table/T1/
- Process integrity issues, due process: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901226
- Statistical issues http://www.mvlymecenter.org/2012/09/07/statistical-review-of-the-lyme-studies-reveals-the-wild-conjecture-behind-the-idsa-guidelines/
Panel report from 2006 review http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/IDSALymeDiseaseFinalReport.pdf *The bar is pretty low….based on what was required under settlement….
Prospective, controlled clinical trials have demonstrated little benefit from prolonged antibiotic therapy. Nearly all primary outcome measures have failed to demonstrate a benefit to prolonged antibiotic therapy. Statistically significant improvements in treatment groups were not demonstrated across studies, were nonspecific, were of unclear clinical importance, and in one case, not sustained at the end of the trial [286, 438, 459, 493, 666].
*MayDay project doc–recommendations pulled from 2006 panel report, added contradictory italicized statements pulled from studies…..