Meet the Lyme Disease Experts
Dr. Kenneth Liegner: In The Crucible of Chronic Lyme Disease
Dr. Kenneth B. Liegner has been practicing for over 25 years and has treated patients who come from near and far. “Practicing” is not an inclusive enough term for the battle Dr. Liegner has waged to advance what we know about Lyme and other tick-borne diseases. He recently published an insightful book chronicling his journey down the treacherous path of treating patients with tick-borne disease. The book is a compendium of case histories, scientific studies, and evidence that Lyme disease can persist despite antibiotic treatment. He has been an advocate for many patients, taking on the insurance companies who use dated, incorrect guidelines to deny treatment. And all along, he has called for further scientific work to understand this disease and to formulate a cure. In a Poughkeepsie Journal Op-Ed in 2012, he tellingly said:
If we can put a man on the moon, we can solve the problems posed by Lyme disease and other tick-borne infections. We just need the will.
Full disclosure: Dr. Liegner is my doctor. I’ve been treated by him since 2012, and along with my rheumatologist, I credit him with getting me back on my feet. We switched it up for the interview, which began with a discussion of his recent book: In the Crucible of Chronic Lyme Disease.
Janet: I thought your book was remarkable.
Dr. L: Not everybody can appreciate it.
Janet: Well, it’s personal and clinical, scientific and historical. You cover so much ground. You’ve been doing this for how long - 30 years? That’s why there’s a lot of material there.
Dr. L: I hang on to things, especially things I think are important. So I had documents from 25-plus years. And, I was partly inspired by Rich Horowitz coming out with a book (Why Can’t I Get Better? Solving the Mystery of Lyme and Chronic Disease). It’s not meant to be competitive; I just felt I should get it out there.
Janet What were you trying to do by publishing your book?
Dr. L: It’s so difficult to get information published in high-impact, widely read journals. Some of the most important articles I’ve written were not accepted by the mainstream journals. So, I thought it would be good to pull it all together and publish it and hope it would be of enduring value. It’s documentational in nature.
Janet: It seems like you were chronicling the years in this battle against the naysayers, carefully laying out evidence. The back and forth you had with the people who were chronic-Lyme deniers was fascinating. The arguments were intellectual, well written and hard to refute.
Dr. L: Some of them were with people who aren’t necessarily naysayers, but who did have a hard time coming to terms with chronicity - but honestly so. But then there were the battles with the insurance executives. That was not an intellectual, reasoned exercise; that was against positions you knew you would never change but still you had to try – and also for the record.
Janet: Can you explain what you mean by The Crucible of Chronic Lyme? What emerges from the crucible? Was it that you were slowly distilling the parameters of this disease?
Dr. L: In a sense, the crucible is a trial; those who are in the crucible are subjected to trying circumstances. There were a lot of people who didn’t make it out of the crucible . . . patients and colleagues. I think it’s an accurate description of what I and others have endured through this period of scientific change.
Janet: The diagnosis of Lyme is based on clinical presentation, and then the lab work is supportive or not. Why is it so hard to find Lyme in the body?
Dr. L: We have certain tools. Some of them are antibody tests; some of them are direct-detection methods. The antibody tests depend on the specifics of the person’s immune response, which is very variable. Actually, often you can derive evidence that’s supportive, but then the question is how do you interpret that evidence? Part of the problem with the antibody testing is how the epidemiologic surveillance case definition has been misused to be the sole basis of the diagnosis, and it’s very hard to satisfy the epidemiological criteria.
Janet: Didn’t the Centers for Disease Control and Prevention (CDC) say that these tests were not supposed to be exclusive?
Dr. L: Yes, they’ve said that, but many have ignored that, insurers and many of my colleagues. They’ll say: You know, if you don’t have five bands you don’t have Lyme. You can have four bands but if you don’t have five bands, you don’t have Lyme. You could have three bands. However, if you have three bands, even two bands, then depending what bands they are, while not enough to make a conclusive diagnosis, can be enough to raise the suspicion that Lyme’s involved. So if one is using existing western blot criteria in a fairly broad way, a flexible way, it’s not that difficult to derive some evidence to support a clinical diagnosis. What has made it more difficult is the rigid application of the epidemiologic case definition, and the misapplication of that to make it the sine qua non of a clinical diagnosis.
When it gets to the direct detection method, like PCR, true, it is difficult to detect because the density of the Lyme organism is very low in bodily fluids. There’s a lot of randomness, and in our experience it can’t be more than a 5 to 10 percent yield of DNA detection in bodily fluids. It’s also frustrating to know that there have been more advanced methods of testing that might have been available that haven’t been made available.
Janet: Such as what?
Dr. L: Such as the Rocky Mountain Lab antigen-capture assay in urine, which was a research tool with good science behind it, but was not supported by the National Institutes of Health (NIH).
Janet: Is it in use?
Dr. L: No. That method detected the blebs shed from the organism as part of the natural biology of Borrelia. The problem is that it was originally designed and developed for use with electron microscopy, which requires very costly equipment and is very labor intensive. However, that method revealed some of the fundamental biology of the organism. At the very least it could have been used as a research tool at the NIH, at the Rocky Mountain Lab, to help us further understand the biology of the infection.
It was licensed by the NIH. The licensee tried to adapt it for a high-throughput method that would be suitable for commercial use (Note: A high-throughput method is one that can test thousands of samples economically so that it is feasible and profitable to a commercial lab.). For about a year or two, the licensee invested quite a bit of funds to try to do that and just wasn’t able to. Then the license reverted back to the NIH and I don’t know what happened to it after that.
In the meantime, importantly, there was a symposium in Washington D.C. involving NIST – the National Institute for Standards and Technology. The people at NIST – I think they were working with John Aucott (Johns Hopkins University School of Medicine) – somewhat randomly came upon a method of refining the outer surface protein membranes associated with Lyme. From what I can understand of that article, what they actually unwittingly did was to develop a high-throughput method that is the correlate of the Rocky Mountain Lab antigen-capture assay in urine. In other words, a very, very sensitive method that is able to detect outer surface protein membranes associated with Lyme.
Janet: Is that in use now?
Dr. L: It’s not, but it was just recently reported. I tried to bring to the attention of Dr. Aucott that this is the correlate of the Rocky Mountain Laboratory antigen-capture assay that tried to adapt to a high-throughput method, and here’s a method I think would be very suitable to a high-throughput methodology - and could even be not only qualitative but maybe even semi-quantitative. I don’t even know if they realize what they’re sitting on – that it could be exploited. I’ve corresponded with Dr. Aucott and sent him copies of the original article from Drs. Garon and Dorward (researchers at the Rocky Mountain Lab), to indicate that this is the correlate.
Janet: It seems like we desperately need accurate tests . . .
Dr. L: . . . that are direct detection, more sensitive, and which don’t rely on antibodies. There’s been a real bias against using those methods – or any direct-detection methods. They’ve all been marginalized – even PCR (polymerase chain reaction).
Janet: How do you explain that? Is it politics?
Dr. L: I think it upsets the paradigm. Use of those (direct detection) methods demonstrates the inadequacy of the standard methods that are promoted and exposes the weakness of the two-tier methodology, which doesn’t make any sense.
Janet: Which tests do you use?
Dr. L: New York State is very stringent and doesn’t allow physicians to use any old test they want to use. They can only use the tests the state has evaluated and found satisfactory. This is not always a bad thing because when you are using them you can say the state has evaluated them and found them satisfactory. So, I’m using PCR, western blotting, and a lot of other tests that, though indirect, give you evidence that something is active or simmering in the body.
Janet: If somebody walks into your office with what you perceive to be chronic Lyme, are you going to test them differently than someone who has a fairly new onset?
Dr. L: If you think someone may have had Lyme for some time, you’re probably going to do a broad assessment. If someone was completely well and then had a tick bite and a rash a week later and now they’re now acutely ill, there’s probably no need to do in-depth testing, unless there’s some reason to think it’s not their first exposure.
Janet: It’s amazing to me that general practitioners will still test for antibodies with someone who’s just had a recent tick bite and wouldn’t have the antibodies yet. Is this some kind of misperception?
Dr. L: I can’t speak for others, but it’s widely understood that very early after a tick bite or even early in the development of erythema migrans – the rash – it’s common for the test to be negative. We’ll sometimes test, but it’s often not because of that recent bite; you want to know if a person has a prior exposure. But it can be a very serious mistake, if somebody comes in with a tick bite or even a rash, and the tests are negative, and incredibly, sometimes it happens that someone says You don’t have Lyme, even though the patient has a rash.
Janet: Right, if the rash is not a bulls-eye it can’t be Lyme.
Dr. L: Even when it is a bulls-eye, I’ve had patients who still didn’t get treated.
Janet:That seems like malpractice.
Dr. L: There’s a lot of work to be done.
Janet: Things have changed in the 25-plus years of your practice. Do you see reason to be optimistic?
Dr. L: I do. I ’m optimistic. It’s been a hard slog, but the data is so compelling and from so many different lines of evidence, that there’s a shifting attitude, not always a welcoming attitude, maybe it’s a reluctant attitude of acknowledgement that it’s more complicated than previously thought. I think things are going in the right direction.
Janet: I recently saw another study had come out from Eva Sapi’s work at the University of New Haven, another study that shows biofilms, so there have been numerous studies showing these colonies.
Dr. L: In vitro, in a test tube. Her recent article, I think, was regarding a patient who had Borrelia lymphocytoma. This was in a living patient and she was able to demonstrate that.
Janet: And that’s very significant?
Dr. L: Very significant because it was from a patient, not in a test tube.
Janet: If you know that these biofilms are forming, how does your treatment of a patient differ?
Dr. L: First of all, I don’t think we have the proven methodologies to necessarily know how to deal with those biofilms, but that certainly may be one of the numerous possible explanations for why there’s chronicity. There are all kinds of things being done that claim to disrupt biofilms. Have there ever been proper studies done to evaluate it? I don’t think so.
Janet: Are all the methods pharmaceutical?
Dr. L: There are all kinds of things that are going on.
Janet: But there are cyst busters . . .
Dr. L: Again, in the test tube there are agents . . . but that’s different than biofilms
Janet: Tell me the difference.
Dr. L: Biofilm is an aggregate of extracellular material within which Borrelia, and maybe other organisms, are protected, and maybe Borrelia is in different stages of its life form. Cysts may or may not exist in biofilms. Cysts are a sub-microscopic form of the Borrelia organism that are tiny, sub-microscopic spheres that require electron microscopy to visualize. There are certain agents, which, in the test tube, are reported to disrupt those cysts.
Janet: And the cysts can change forms?
Dr. L: When conditions become favorable, those cysts can re-aggregate, reconfigure to a classical spirochetal morphology, and so many people incorporate agents that act on cystic phase into their treatment protocols. But also, I’m not aware of any controlled trials to demonstrate that doing that improves the outcome of patients - it might, but like a lot of things with Lyme, it’s all anecdotal. It would certainly be desirable to have some studies that show whether patients fare better or worse when you incorporate those methods.
Janet: Do we know that, when hitting the spirochetes with antibiotics, they change to cystic form?
Dr. L: Eva Sapi has demonstrated that in a test tube. Not so easy to demonstrate in patients. It’s certainly quite possible that it’s happening.
Janet: Does that mean that the Borrelia becomes resistant to the antibiotics?
Dr. L: I’m not sure of the formal definition of resistance. It’s an evasion mechanism. According to Sapi’s work and that of others, the cystic phase is fairly unsusceptible, non-responsive to standard antibiotic treatments. I don’t know if it meets the definition of actual resistance. But it certainly could explain failure to eradicate infection and re-emergence or relapse after treatment.
Janet: There have been questions about how long a tick has to be attached in order to transmit the spirochetes. What do we know at this point?
Dr. L: That’s another controversial area. The official position is that they have to be attached at least 48 to 72 hours. Those are based on some mouse studies done by Joe Piesman, who was at the CDC. But, those are fairly short-term studies in mice where they let the ticks feed on the mice, and then they would do ear-punch studies of the mice about a month later, to see whether they could pick up Borrelia in those samples. So they were fairly short-term studies. Certainly, the longer the tick is attached, the more spirochetes are likely to be transmitted. So with shorter and shorter durations, there will be fewer spirochetes, which might be difficult to detect unless you follow the animals for a very long time. So, I don’t know what the minimal amount of time is required, and nobody knows for sure what the minimal infectious dose is. Could the transmission of one spirochete be enough to cause an infection? Or is that one spirochete eliminated by the host’s defenses? Or, is it that it might take months or years for enough of the organisms to accumulate to cause clinical symptoms?
One of the communications I had with Dave Dennis at CDC was making that point. In Piesman’s study, it would have been interesting to have different durations of attachment and to follow those mice over their natural lifespan – a year or two – and then sacrifice them and look at all the tissues in the mouse. And really search – not just an ear punch. So I don’t really know. I’m very circumspect about the claim that you’re safe if you’ve removed it within 24 or 48 hours. There was a well-documented study of an erythema migrans rash after four hours of duration (Journal of Spirochetal and Tickborne Diseases 1994; 1:77-78. “Disseminated Lyme disease after short-duration tick bite”, Patmas MA, Remorca C). The patient developed Lyme. Those kind of reports you couldn’t get into a mainstream journal.
Janet: Because it’s anecdotal? It’s only one patient?
Dr. L: Because it upsets the dogma. People want to be reassured, i.e.: I got the tick off within 24 hours, I’m good. Are they? It’s very troubling; it’s very problematic.
What really needs to happen is a re-education of the rank and file physicians so you don’t have to go to a specialist. You shouldn’t have to travel two hours or four hours or across the country to see somebody who understands tick-borne disease. Unfortunately, so much of the information that is being fed to family physicians and internists is incorrect, and that’s coming from on high (the CDC and IDSA). I don’t totally blame the physicians in the trenches, because most of them are not experts and they’re listening to the authorities. The problem is that so much of the information is wrong. How much is their responsibility and how much is the responsibility of the medical education system, the CDC, and the IDSA?
Janet: It’s like you’re bucking the whole system: Medical Education, CDC, NIH . . .
Dr. L: . . . and the insurance industry, which
Janet: . . . which has a vested interest in keeping you from revealing these things
Dr. L: Right. And so-called practice guidelines that insist that you have this very narrow focus and you are potentially sanctioned if you behave in a way that doesn’t conform. There’s tremendous pressure to conform.
Janet: You had said something in your book: Lyme doctors treat at risk to themselves. Is that still true?
Dr. L: It’s still true.
Janet: Has the climate in New York State improved?
Dr. L: Yes, since the law was passed. But there are many other venues where it remains highly dangerous for the practitioners and there’s tremendous peer pressure not to treat - in this country, in Canada, in Australia, it’s really a big problem.
Janet: It seems like in England now, there’s a rising tide of voices, patients who are saying: I have Lyme. How can you tell me I don’t have Lyme? Hopefully it will shift.
Dr. L: Well, it’s really necessary for the patients to be vociferous and active, and do whatever they can personally and through the legislative process.
Janet: So, how can patients advocate for themselves? Do they need to get involved with the legislative processes? Or, even on a very basic level: if I go to a doctor who is not Lyme literate – do I have to have all the facts? Do I expect to change anyone’s mind? Or do I give up and try to find a Lyme-literate doctor?
Dr. L: It depends what you’re looking for. If you’re looking for general medical care, unfortunately, often the best you can hope for is someone who will provide your general medical care and be non-oppositional. But the chances of finding someone who really has a deep understanding of Lyme – there’s not that many around. It does require a lot of effort and application to gain that understanding. People engaged in a general medical practice don’t really have the time or the motivation to devote themselves to understanding tick-borne disease, and also, I think many people are aware of the risks of going in that direction, so they’d just rather not.
Janet: But, we’re in a Lyme endemic area and I’m sure the GPs see so many patients with Lyme. How could you ignore that?
Dr. L: There needs to be a change in medical education. In my book I include the 42-page letter I wrote to Chris Gibson. Every four years, in order to get your medical license, you have to take an online infection control course. Has nothing to do with Lyme, but rather with hand-washing, duodenoscopes, difference between infection and decontamination – it’s a bit of a bother, but not bad. To me, what greater need is there than to have a segment on tick-borne diseases for every physician in the state? That would be a way in which every physician in the state would have to think about it. Even if there were two points of view presented, as least they would be presented. That’s doable - if there is a will to do it. However, the risk is that the process will get captured by people who will try to promote the same wrong information that has already been disseminated. The medical society in the state of New York, of which I am a member, has not been my friend concerning Lyme. There are certain things that we share in common but I have never gotten a sense of support from them. So, to try to put in place a module on tick-borne diseases that would need to be updated every four years – that would be a huge battle. And then, even if you got it, my fear, given the power relationships, is that it would become co-opted.
But, in terms of how to educate people in a proper way, without getting hijacked, that could be strategic. Will it happen? I don’t know.
Janet: You first called attention to the link between multiple sclerosis (MS) and Lyme in 1990. Have you learned more since then about autoimmune diseases and Lyme? Does Borrelia or tick-borne disease trigger the development of autoimmune disorders? Or is it deterioration of the body due to the infection that triggers the autoimmune process?
Dr. L: I am quite convinced that Borrelia infection can trigger autoimmune reactivity in people who are genetically susceptible. I’ve seen that many times. I can’t claim that Lyme equals MS, but I’ve seen many cases where Lyme disease resulted in an MS-like illness that was often antibiotic responsive. I’m not looking at the universe of MS to know that all cases are due to Borrelia. I can’t say that.
There’s actually quite a bit of literature about spirochetes and multiple sclerosis. Again, the mainstream seems to be unwilling to look at that, which is puzzling, because it is actually a pretty good fit.
Initially, there was all this effort aimed at finding a viral cause of MS, and there are some viruses that result in a nervous system that could be MS-like. But the whole idea of a primary viral cause for MS has never been substantiated. So right now it’s viewed as some kind of immune derangement, and as a result, different kinds of immune modulating treatments are being developed and applied. All the way from steroids – high-dose steroids are being used for certain things like optic neuritis - and Copaxone, interferons, and some newer agents that I’m not that familiar with. They’re all aimed at immune modulation. A lot of these newly developed agents are very costly, so they’re blockbuster drugs for Big Pharma. Whereas, antibiotics are not blockbuster drugs. In fact, just the opposite, a lot of them are off patent.
Janet: Although, the cost of doxycycline went up quite a bit.
Dr. L: That’s true. There’s a lot of exploitation. There’s no reason doxycycline should be exorbitant – or tetracycline. These drugs are as old as the year dot. We shouldn’t be running out of standard drugs. Recently there was a back order on cefotaxime, which is the second most commonly used intravenous agent after ceftriaxone. For some people, its advantageous, and we just can’t get it. It’s kind of crazy. There’s no reason for it. When there’s a shortage, they can increase the price.
Janet: I saw that the National Guidelines Clearing House pulled the old IDSA (Infectious Disease Society of America) guidelines – do you want to comment on that?
Dr. L: Long overdue. Hallelujah. I didn’t understand why they didn’t come off in 2011.
Janet: Did they put up ILADS guidelines?
Dr. L: The ILADS guidelines are up there. Does the CDC link to these guidelines? I don’t know. They should, if they’re the only Lyme guidelines on the National Guidelines Clearing House, so you would think they would, but given the past history, I’d be surprised if they were. The very fact the IDSA guidelines stayed up after they expired is questionable. My understanding is that the lame excuse was: Well, there was that 2009 Lyme Disease Review Panel in Washington D.C. Actually, the IDSA didn’t do anything to review or modify. They got challenged by us (ILADS), and somehow that was used as a pretext for keeping the guidelines up when they hadn’t been revised. They’re supposed to be up for five years. They were put up in 2006 and should have come down in 2011, but here they are, only coming down in 2016.
Janet: That says something right there.
Dr. L: The insurance companies use these to support non-treatment.
Janet: It’s still a discouraging picture.
Dr. L: The fight is not over.
Janet: How long do you intend to keep fighting? You have many other interests - photography, music. You invented something too!
Dr. L: I have four patents, which haven’t made me a dime. I don’t have any plans to retire. I’m just going to keep doing what I do. There are a lot of patients who need help and not a lot of places where they can get help. I intend to continue.
Janet: Where do you get to play music?
Dr. L: I’m a member of the Berkshire Stompers, which is a nice group in Millerton. And also, the Dutchess Community College has a jazz ensemble; that’s a nice group too. You remember when you tried to learn the multiplication tables, how hard it was until you finally figured it out and it came together? In a way, learning to improvise jazz is like that but a lot more challenging. You have to learn the language. You have to learn the basics and then acquire facility with the language.
Janet: How long have you been playing?
Dr. L: I’ve been playing on and off since my internship. I was interested in jazz from the very beginning. It’s one thing to play a jazz tune, it’s another to have some facility to improvise. I’m what I’d call an intermediate player. But it’s fun. Music is transformative.
And we’re so lucky to leave in such a beautiful area. We have the affliction of tick-borne disease, but this is a gorgeous part of the country to be in.
Janet: I’m glad to hear you say that because sometimes I want to flee. You know, because of ticks and Lyme.
Dr. L: Where are you going to run to?
Janet: I don’t know. It’s everywhere, right?
Dr. L: Exactly. Stay and fight. Adapt.
Janet: Do you have anything else you might want to say?
Dr. L: This is a sociological and historical process that’s going to work its way out over time. But, that doesn’t mean both physicians and patients shouldn’t do everything one can reasonably do to move it forward. Advocate for yourself. Don’t be passive.
Janet: It’s hard for very sick people. They just don’t have it together physically or mentally to do that.
Dr. L: But there’s also growing patient advocacy - even militancy or stridency - and I think that’s necessary.
Janet: I agree with you. Thank you so much for your time.
Kenneth B. Liegner, M.D., is a board certified internist with additional training in pathology and critical care medicine. He is a member of ILADS and has served as a director. His practice in Pawling, New York, focuses on tick-borne disease.