There’s nothing unexpected in this PUBLISHED guidance. NICE are tied to the flawed process that they use which excludes non-human data. This process needs to be challenged and changed so the petition will continue until they start to listen. (You can look for yourself via the link and/or read some of our assessment which includes a couple of tips that might help you) The premise of any guideline is that it is ‘evidence based’. This document is based on “poor” evidence (NICE’s assessment) and as such NICE have produced poor guidance. “The greatest danger of flawed clinical guidelines is to patients. Recommendations that do not take due account of the evidence can result in suboptimal, ineffective, or harmful practices. Guidelines that are inflexible can harm by leaving insufficient room for clinicians to tailor care to patients’ personal circumstances and medical history. What is best for patients overall, as recommended in guidelines, may be inappropriate for individuals... (BMJ 1999)” Its not possible to conduct randomised controlled trials in many cases with Lyme. 1) Once Lyme is entrenched such that it is no longer recognised by the immune system, you probably wont produce antibodies that most blood tests look for. These people will have disseminated disease, co-infections and opportunistic infections (because their immune system just doesn’t work well enough). Unfortunately it makes these patients too complicated to use in research trials because it will take more than antibiotics for them to recover and the scientists running the studies wont be able to tell which part of the treatment is working best. Also, because there isn’t a test that tells us when the disease has gone and you no longer have an active infection, they can only look at improvement in symptoms. If you have other infections with similar symptoms it can be impossible to tell if one disease has gone or improved. 2) How can you determine whether Lyme is passed from mother to baby without monitoring both after the birth (If the baby survives). There are lots of case studies which forced NICE to acquiesce that transmission is possible, but they’ve said that its rare – because their process wont allow them to use the available data. 3) They haven’t erred on the side of caution at all. Despite there being data to suggest that sexual transmission is possible and that Lyme spirochetes can survive in blood, there is nothing in the published guidance to stop anyone donating blood or organs or having unprotected sex without informing their partner. 4) There is mounting evidence that when Lyme spirochetes come under attack (from antibiotcs etc) they go into a biofilm which keeps them safe until the threat is gone. A recent study of 10 monkeys found active Lyme spirochetes in these monkeys a year after they had been treated with much longer term antibiotics than NICE will now permit. The problem is that the scientists didn’t find the spirochetes in the monkeys blood – they were in their organs and the monkeys were euthanised in order to find them. This study could obviously not be reproduced in humans for ethical reasons but NICE wont accept animal data. It’s a major flaw in their process. Epidemiology NICE have stuck with their original wording in most respects and obviously didn’t come up with any additional data with regards to vectors so: a) Lyme is transmitted by ticks – no mention of Horse-flies or any other insects that non-human studies have suggested can transmit the disease. b) They have stated that prevalence data are incomplete but that infection can occur in “many areas”… which seems vague so please avoid “many areas” in order to avoid getting Lyme Disease. They do also say that in parts of central, eastern and northern Europe (including Scandinavia) and parts of Asia, the US and Canada Lyme may be more prevalent although that also seems a bit vague and unhelpful and certainly wont reduce uncertainty with respect to prevention. Other tick borne disease In the published guideline there is no mention of any of the additional tick borne diseases which we know often co-infect with Lyme. The only part* that mentions "other tick born disease" is in Laboratory Investigations, page 10 where it says: "If the immunoblot test for Lyme disease is negative (regardless of the ELISA result) but symptoms persist...consider alternative diagnoses (both infectious, including other tick-borne diseases, and non-infectious diseases)" For those with clinical symptoms of co-infections and/or opportunistic infections (e.g. Mycoplasma) a) I would be asking for testing for all co-infections and all opportunistic infections - despite the fact that the co-infection tests also have dreadfully low sensitivity and can only detect a couple of species of Bartonella for example. (I’d also be asking how my GP would justify a negative result to those tests.) b) I would be asking whether any of these infections were within my differential diagnosis and I would be demanding a clinical diagnosis based on my symptoms. *Its also included in the research recommendations but who has 10 years + to wait for that? Failure to address co-infections as part of this procedure will undoubtedly negatively affect patient treatment and care. Randomised Controlled Trials and Persisting symptoms Unfortunately, no further data magically appeared. The Stakeholder, ILADS, asked for several clinical studies to be considered and apparently a few were additionally reviewed including those by Fallon but they were not considered to contain adequate evidence regarding longer term antibiotic therapy. So NICE were left with the original pool of low quality data. Only the 26 patients that were followed up to 6 months in the Krupp study could possibly (although highly unlikely) have Chronic Lyme Disease (Defined as systemic entrenched disease with co existing conditions including fatigue and auto-immune deficiency). Worse than that is that those 26 may not have had chronic Lyme at all - its not possible to work it out from the clinical paper because it only says that patients who had some other problem that would stop them studying the fatigue were excluded (so anything that causes fatigue that they could identify would exclude the patient). Its highly likely that there were 0 patients across any of the trials who had actual chronic Lyme. This means that the guidance is based on and represents only one subset of the Lyme patient population. There is a small loophole that might help a few. They have stated on page 10 that the accuracy of the tests can be reduced if a: “person has reduced immunity… which might affect the development of antibodies.” On this basis, it is acceptable to demand testing to determine your immune status. If your immune system is not working well, it is important to point out that the Lyme blood tests are probably therefore compromised and that you will require a clinical diagnosis based upon symptoms. On a positive note, Erythema Migrans rash is now definitively considered diagnosis without necessitating blood tests so IF correctly assessed by the GP around half of cases (those presenting with a rash) should be diagnosed and treated. Dont let them fob with off with Ringworm if you have clinical symptoms of Lyme Disease. Blood testing/delayed diagnosis A number of Lyme sufferers have gone undiagnosed for many years despite presenting with an EM rash or remembering a bite many years prior to illness. NICE has completely failed to address this population’s needs or concerns by refraining from using the term “chronic” etc. In the final version they use the words “ongoing symptoms” which suggests that the cases to which they refer are all patients who have already been diagnosed and had some treatment. What they haven’t discussed or offered guidance on in any detail is this group who weren’t diagnosed for years. These individuals have probably been given multiple other mis-diagnoses and who at the point of true diagnosis undoubtedly have systemic disease complicated by other infections. Research recommendations Nothing reported here that we didn’t already know. They now have 5 years to get the research done before the next review…in 2023 As a former clinical researcher, I can tell you that that is impossible.