From IDSA to ILADS: A Journey Toward Reconciliation
by Scott Forsgren
Many patients with chronic Lyme disease have had the experience of meeting doctors who did not believe that our illnesses were real. Many have been told that our conditions are manifestations of our mind. We have been denied adequate care as the result of the IDSA (Infectious Disease Society of America - the most influential organization related to infectious disease in the United States) Guidelines. We often migrate towards doctors that hold a broader perspective, the ILADS (International Lyme and Associated Diseases Society) perspective, on our disease. As a result, over time many of us recover.
Dr. Sam Shor, MD, FACP is an internist in Reston, VA had a practice with a focus on the treatment of Chronic Fatigue Syndrome (CFS). His journey later introduced him to the significant overlap between CFS and chronic Lyme disease and he began to think outside the box, way outside the box in the eyes of many. Dr. Shor's journey is one of hope. It is a journey that requires courage and a willingness to do what is right for suffering patients. It is a journey which we often wish more medical professionals would take. Dr. Shor's journey is a journey from IDSA to
ILADS.
Trained in primary care and internal medicine, Dr. Shor completed his residency in 1985 at George Washington University. He has been in private practice in Virginia since that time. Shortly after he started practicing, he became interested in people with a chronic fatiguing illness of unclear origin which subsequently became known as Chronic Fatigue Syndrome. In the late ‘80s, Dr. Shor referred several of his patients to the National Institutes of Health (NIH). In the '80s and '90s, he took part in a number of NIH symposiums in Bethesda, MD and continued to solidify his interest in the illness. He later became a member of IACFS, the International Association for Chronic Fatigue Syndrome.
Dr. Shor's patients were suffering with a myriad of complex symptoms which included sleep disorders, Fibromyalgia pain, dysautonomias (changes in the autonomic nervous system that result in fatigue, lightheadedness, dizziness, rapid or slow heart rate, and problems with blood pressure), and cognitive impairments. He observed a consistent pattern and was convinced that this complex illness was not only very real but that there had to be a common theme which resulted in patients presenting as they were.
In an attempt to do his due diligence after having been intellectually challenged by the complex presentation of many of his patients, Dr. Shor published an article in 2003 titled "Pathogenesis of Chronic Fatigue Syndrome, A Multisystem Hypothesis" in the Journal of Chronic Fatigue Syndrome. In the article, Dr. Shor attempted to explain the
best understanding of the symptom complex and the process of CFS known at the time.
Soon after the article was published, Dr. Shor became aware of Lyme disease and the potential that Lyme disease could present with a very similar set of symptoms. Prior to that time, Dr. Shor was adhering to the IDSA Guidelines which he notes were fairly strict and remain fairly strict even today. As a generalist, his perspective at that time was that the IDSA doctors were the specialists in infectious disease and he deferred to their guidance when treating conditions such as Lyme disease.
As Dr. Shor learned more about Lyme disease, in an attempt to pursue his due diligence, he went to his first ILADS conference in 2004. He states that he was "struck and dumb-founded" by the similarities of the issues that were presented by the ILADS doctors. He found that there was a significant overlap between what he had been observing for over a decade in the world of Chronic Fatigue Syndrome and what ILADS doctors had been observing in the world of Lyme disease.
At this point, Dr. Shor felt that there had to be a commonality between these two disorders. He was exposed to the difficulty in diagnosing Lyme disease. He also became aware of the adverse impact on the immune system that the Lyme disease infection has.
Dr. Shor and others in the field of Lyme disease recognize that "Lyme disease" is characterized by more than just an infection with Borrelia burgdorferi. He notes that Borrelia burgdorferi is the punitive agent involved in Lyme disease proper but that there are other agents involved such as Babesia, Bartonella, and others.
Dr. Shor learned that Borrelia has the capacity to evade the immune system in many ways. First, it can rapidly change its outer protein coat. It is this outer protein coat which serves as a signal to the immune system to create antibodies. If there is not a sustained stimulus in order to mount an immune response, the body cannot properly generate antibodies. Borrelia can become an immune neutral cyst form when it senses that it is in a toxic environment, such as in the presence of antibiotics. Borrelia adversely impacts the health of the immune system as it has been shown to lower a particular type of NK (natural killer) cell called CD57.
All of this information made Dr. Shor realize that he was likely dealing with a phenomenon that was "minimally similar to if not actually responsible for“ what he had been characterizing as Chronic Fatigue Syndrome. He further believed that the difficulty in testing for, and making a diagnosis of, Lyme disease perpetuated the problem of characterizing CFS.
CFS by definition is a diagnosis of exclusion. There is no laboratory marker for the syndrome. The diagnosis is characterized by a fatiguing illness of six months or longer with a reduction in functional capacity of 50% or more of one's level of functioning prior to becoming ill. Other causes must be ruled out. In this setting, if Lyme disease is so difficult to diagnose, it is by definition difficult to rule out. The classic presentation of CFS is that a person gets a flu-like illness and has not been well since. In many cases of CFS, there may actually be a viral cause which initiates the process but often, that flu-like illness may very well have been Lyme and related infections. These may serve as the onset of the phenomenon that leaves many patients quite disabled.
Given that Dr. Shor had developed an interest in CFS and that so few people in the medical community have interest or expertise in the illness, he felt obligated personally to learn as much as possible about all ramifications of the symptom complex known as CFS. He became very familiar with the management of dysautonomias and even gets referrals from cardiologists. He became familiar with the management of Fibromyalgia and sleep disorders by the virtue of the fact that he was seeing these issues so commonly and repeatedly. He became an expert in each of these areas to help those that were so disabled. When Dr. Shor, via his association with ILADS, became aware of the potential cause of patients’ suffering, it gave him a whole new perspective from which he could offer patients hope and an improved outcome.
Dr. Shor continued to assimilate all of the information that he was, at that time, just beginning to understand. In 2006, he published an article titled "Lyme Disease presenting as Chronic Fatigue Syndrome". Dr. Shor wanted to further solidify the validity of his approach on a daily basis. He generated a 30 question questionnaire that was a subset of Dr. Joe Burrascano MD's larger Lyme questionnaire. The intent was to extract questions that would give a broad sense of a patient's clinical status and allow the patient to grade how they felt at any point in time. The questionnaire was used over time as the patient was being treated and could be evaluated to determine whether or not outcomes were changing.
Soon after the ILADS meeting, Dr. Shor took select patients from his CFS population and started to investigate their cases with his newfound insight. When there was enough evidence to suggest that the patient may actually have Lyme disease, he began treating them. Dr. Shor needed more supportive evidence himself to substantiate the perceptions that he had at the time. When he started to observe the results, they strongly supported his earlier impressions and moved his work to the next level. He was "flabbergasted not only by the gestalt in clinical improvement" but that the numbers were substantiating his clinical impressions.
One of Dr. Shor's patients was a 42 year-old lawyer that had carried the diagnosis of CFS and was on disability and out of work for over two years. The patient was intent on going back to work but had fatigue, cognitive impairment, and difficulty sleeping along with many other symptoms. He fulfilled the international case definition of CFS but after exploring his case with newfound insight, Dr. Shor felt that he actually had Lyme disease.
Dr. Shor put together an ILADS-approved protocol and started treatment. Recognizing that treatment is a process that takes time, over the next 12-15 months, the patient improved so much that he is today back at
work full-time. Dr. Shor notes that the process was a gradual one and that those patients with chronic Lyme disease generally do not improve overnight. Using the questionnaire that Dr. Shor had created, clear evidence of patient improvement was seen every 4-8 weeks at his regular visits and overall sense of well-being improved. Today, the patient is off all antibiotics and continues to work full-time with an herbal protocol.
A second patient was a 16 year-old high school student that had been home-schooled because she could no longer tolerate the normal rigors of a student schedule. Initially, she was diagnosed with CFS and Fibromyalgia, but she also fit the paradigm for chronic Lyme disease. Dr. Shor started treating the patient with antibiotics and within three months, she was back to school full-time. In fact, she felt so well that she stopped the antibiotics but she quickly got worse and her symptoms score significantly raised. She was put back on antimicrobials and within three months, she was again back to a state of good health.
The experiences that Dr. Shor was having with his own patients were supportive evidence that what he was doing and what was being recommended by ILADS was in fact "valid and appropriate". Dr. Shor recognized, however, that publishing case reports would not be enough to convince the larger medical community of his findings. He knew that there had to be a more randomized, controlled approach to studying the matter further.
Dr. Shor has written a proposal currently being evaluated by the NIH which would substantiate what he has been seeing in his private practice. He has created a protocol that randomizes patients into either an active or placebo-controlled group of three months of Omnicef and Biaxin. In order to enroll, the patient must have been symptomatic for less than five years, have a negative Lyme ELISA, have criteria for both CFS as well as having supportive evidence through other means, such as IGeneX or low CD57, to suggest that the patient may have Lyme disease.
Different metrics will be used to evaluate clinical changes to see if the patients show a clinically-significant improvement. The study will attempt to show whether or not Lyme disease treatment can improve many of the symptoms that patients with "CFS" experience.
Dr. Shor's patients recently convinced Congressman Frank Wolf to put together an open town meeting on the topic discussed in this article. Dr. Shor was one of three speakers. The other two were from local county health departments. They expected thirty people to attend this event and in fact, over 400 people attended in an indication of the profound interest that the community has on this topic. Members of the audience approached Dr. Shor and asked him to speak at a Congressional hearing with Andy Wilson from Under Our Skin and Pam Weintraub, author of Cure Unknown. The goal was to make Lyme disease a priority for Congress to provide funding for research as well as to deal with the "unfortunate, restrictive approaches that the IDSA is placing on the whole area".
In asking Dr. Shor if he had attempted to become a member of the new IDSA panel tasked with revisiting their current Clinical Practice Guidelines on Lyme disease, Dr. Shor shared that he, like numerous other ILADS members that had applied, was disqualified by the IDSA for "seeing too much Lyme disease". Unfortunately, any practitioner that makes over $10,000 per year from the treatment of Lyme disease was automatically excluded from the new IDSA panel according to Dr. Shor. This excludes clinicians with the most experience in treating the disease.
Dr. Shor suspects that anyone that fits this paradigm sees enough Lyme patients that the IDSA believes the practitioner has a perspective that is inconsistent with its own or if the practitioner is seeing that many patients with Lyme disease, they must have conflicts of interest and likely want to generate their own income by making a frequent diagnosis of Lyme disease.
Dr. Shor points out that the reality is quite the contrary. In his case, the interest evolved because of the need. The word started getting out that there was someone that could help. The end result was a growth in his practice which ultimately became a volume difficult to manage. Dr. Shor notes that his practice is not "churning people out to make money" but rather that he is working with very complex illnesses in people where many are quite disabled.
According to Dr. Shor, to improve the quality of life is the goal of medicine. Fortunately, in its evolution, he has tapped into a multiphasic, multi-system approach that takes the entire person into consideration and has been able to evolve a paradigm that has worked for the majority of the patients that he sees.
Dr. Shor has journeyed from IDSA to ILADS. This is a journey that so many of us with chronic Lyme disease wish that other doctors would be brave enough to take. It is a journey that has helped many people in his practice. However, it is a journey that the larger medical community as a whole must take in order to meet the needs of so many patients that are struggling to find adequate medical care.
When Dr. Shor first started to explore this perspective he noted that he initially had a negative perspective on chronic Lyme disease. The
more that Dr. Shor did his due diligence in an academic and intellectual way, keeping in mind doing no harm but looking for ways to help people, the more confident he became in his belief that chronic Lyme disease is an important area that needs to be "further explored and openly understood".
Dr. Shor holds a hope that we will have reconciliation within the medical community for the betterment of a large segment of the population that "heretofore has gone undiagnosed due to the lack of insight or the direct antagonistic perspective on the topic." He hopes that "the powers that be, who are putting out roadblocks, can ultimately have reconciliation so that we as a society can move forward and benefit from it."
Here's to your health….
Q&A With Dr. Shor
by Scott Forsgren
What percentage of the previously diagnosed CFS patients that you see may actually be dealing with chronic Lyme disease?
Confidently, 50% or more of my CFS patients may have Lyme disease as the underlying cause of their illness.
What is your preferred treatment for Borrelia?
In my study, I am using Omnicef and Biaxin. This was a combination that Dan Cameron, MD had used in a paper to show statistically significant improvement in chronic Lyme disease. I find this combination to be high on my list, though it depends on a number of different issues. I consider whether or not a particular co-infection may need to be addressed. For example, if the patient has Ehrlichia, then I lean more towards Doxycycline.
Which co-infection would you say causes your patients most severe symptoms?
Either Babesia or Bartonella. Both can be very profound. Profound neuropathic pain is identified with Bartonella. Profound fatigue, profuse sweating, and headaches are indications of Babesia.
In terms of difficulty in treating, Bartonella is more difficult. Babesia usually responds to treatment with a macrolide, Mepron, and artemisinin. It may require high doses and require treatment for protracted periods of times. Babesia is easier to track as the majority of people have some sweating and this is an easy symptom to track in patients and adjust treatment. Following Bartonella is more difficult.
What do you find to be the most successful treatment approach for Bartonella?
I use a macrolide and Mycobutin (Rifabutin). Sulfa-drugs can be useful but generally are not nearly as effective. I don't like using quinolones due to problems such as myalgias, arthralgias, and tendonitis which may be experienced with Levaquin. These are generally an independent action of the drug and do not signify a die-off reaction.
With Babesia, when you notice that the sweats are gone and stop treatment, do you believe that the organisms are fully eradicated?
No. I believe that certainly Borrelia and likely Babesia and Bartonella and likely other co-infections cannot be totally eradicated. The goal is to get people to a state of remission. When the diagnosis is made, I tell patients that the goal is to get them to a level of functionality and quality of life that they feel is normal and that does not require antibiotics to sustain. We recognize that the goal represents remission, not cure.
With cure, you do not expect any recurrence of symptoms unless there is a re-exposure. With remission, you can have recurrence even without re-exposure. When a person is in remission, I will then convert the patient to an herbal program for a period of time. Best case, the patient goes off the herbs and the remission is sustained. In some cases, the patient will experience an increase in symptoms when moving from antibiotics to herbal treatment but as the herbs take hold, they normalize. Some people may transition too early and require going back to antibiotic therapy.
What laboratories do you find the most helpful in providing you with information to appropriately diagnose and treat your patients?
I have used a number of labs. I use LabCorp to do the first phase testing. They are the lab that does the CD57. Most of their technology is acceptable though we have to recognize that their Western Blot is far from ideal. Their IgM Western Blot only looks at 2 of 5 Borrelia-specific bands and IgG only 3.
Most insurance companies are more likely to cover testing from LabCorp. If you are able to make a diagnosis from their tests, you can avoid the more expensive testing. If I have clinical suspicion and only partial validation from LabCorp, then I will use IGeneX.
I do preliminary co-infection testing through LabCorp. They are very good at picking up Babesia duncani. I have gotten lots of positives and I am on the East coast. It is definitely found here on the East coast.
If I need more solid grounding on co-infections, I will use IGeneX. Most commonly, I use their IgM and IgG Western Blot for Borrelia. If there is clinical suspicion of a co-infection, such as if a patient has sweats and shortness of breath along with fatigue and headaches, the patient has Babesia until proven otherwise. If a patient has cognitive disturbances, neuropathic pain, and joint pain, Bartonella is likely.
The C6 peptide test can be helpful. When it is positive, it is quite useful, but it is not that sensitive. When it is positive, it is a prognosticator much like CD57 but when it is negative, this does not mean that one can rule out Borrelia as a possible cause of illness. When the test is positive, it is quite helpful, but it is not sensitive enough to rule out the disease when the result is negative.
I generally will treat people in cases where clinical symptoms point to one of the common infections regardless of lab results. Lab testing is expensive and insurance is not covering many of the tests that are done. With the economy in its current state, doctors have to be critical as to which tests are ordered. You have to really know that you will use the data. I ask myself the question, "Am I going to change the decision that I make based on the lab result? If the result is negative, am I going to treat anyway?" If the answer is yes, then I don't order the test.
Do you find the CD57 test to be of value in gauging treatment progress or progression of disease?
Yes, with a major qualifier. I do feel that CD57 is a useful marker in the majority of patients. If CD57 is below 40, then that is a good indicator of the activity of the disease. One can then use this information to help direct the decision making process with respect to intervention or treatment. I generally use the concept that Joe Burrascano, MD has defined. If CD57 has been shown to be low and you can get it back above 120, generally this is associated with an improved sense of well-being, improved health, and decreased risk for recurrence of symptoms.
This is not an absolute, however, and the major qualifier is that in those people who clinically have Lyme but CD57 is well within the normal range or even high, these patients generally have co-infections and most often, Babesia. In some cases, treatment of co-infections will result in a drop in CD57. It may be the case that when you are treating one co-infection which may have somehow been suppressing the activity of the Borrelia, Borrelia may then move into a more active state and CD57 may drop. This can be difficult to sift through. If CD57 is elevated and the patient is presenting with many of the symptoms, they likely have co-infections such as Babesia or Bartonella.
Do you believe that autoimmunity plays a significant role in the persistence of symptoms? If so, how do you treat patients when their own bodies begin to turn on themselves?
Autoimmunity in my view is only a secondary phenomenon. We know that autoimmune markers are very often elevated, though in low levels and in a non-specific presentation. ANA markers may be elevated but the majority of people have a normal SED rate which indicates that there is not a profound systemic inflammatory process underway.
With the insights that I have, my view is that it is a combination of several things. First, the fact that Borrelia, and possibly other co-infections, bore into cells of many different types and in the process, there is a remnant destruction of cells which provides an antigenic stimulus for the body to respond to itself. It is the body's own cells that are being destroyed on a microscopic level. Thus the body's attempt to clear what it now perceives as foreign is the autoimmune response. It is an immune response to self that is being generated by the infection that is exposing the body to cells or chemicals that would otherwise not be present.
We know that in the majority of Western Blots, it is more commonly the IgM that is positive in people with chronic Lyme disease, not IgG as in most other infections. Generally, IgM is the antibody response seen in an acute phase of an infection that goes away and is later followed with IgG response which occurs after the IgM response and is sustained in order to impart immunity to whatever it is that the body is responding to.
In Borrelia, this is not what happens. The immune system struggles to clear the Lyme infection. It only intermittently perceives its presence due to a number of mechanisms that Borrelia has acquired which allow it to hide from the immune system. If enough of the infectious agent is present and the immune system is exposed to enough of the protein coat of the organism and the immune system is healthy enough to perceive its presence, the body generates the acute or IgM response. The organism has evolved mechanisms to hide and thus the immune system perceives that the infection has been cleared when it in actuality has not.
There is a cyclic pattern where the body perceives and later does not perceive the presence of the infection. This cyclic recognition causes the immune system to remain in a hyperactive state in attempt to clear the infection. Many markers which represent this "revved up" immune system are often found in patients with Chronic Fatigue Syndrome. If you extrapolate my perception that the majority of CFS cases are actually Lyme disease, this would fit the paradigm that the body is constantly trying to clear this infection.
Unfortunately, since the immune system is in a "revved up" state, it is generating antibodies to things that it should not be and thus it is not uncommon to see autoimmunity develop.
Do you specifically treat the autoimmune component of the illness?
No. Treating the underlying infectious process generally normalizes the autoimmune process. If you use ANA elevation as a marker for autoimmunity in a given patient, you generally observe improvement if not normalization of the presence of the autoimmune marker - it goes away. I do not use any immune-suppressing agents. In fact, you want to avoid most rheumatologic drugs such as steroids or strong cytokine inhibitor such as Enbrel, Humira, and other similar medications as they can suppress portions of the immune system that are required to clear the underlying infectious process. Patients that have been on steroids have a far more difficult course because the infectious process has become more deep-seated.
Do you employ any non-antibiotic treatment options in dealing with Lyme disease?
I am a Western-trained, traditionally-trained clinician. However, in keeping with the recognition that we are dealing with phenomenon that are often poorly understood, involve multiple systems in the body and are difficult to treat, my whole approach to dealing with these illnesses is to keep an open mind and think outside the box.
Since the time that I started treating CFS in the eighties, I have opened my willingness to explore complementary medicine which I believe is absolutely crucial in dealing with these illnesses. Exploring complementary medicine has to be a part of the approach for many patients or they simply may not get well.
With respect to the treatment of Lyme disease, I had to do my due diligence in evolving my treatment approaches in the complementary medicine arena, always keeping in mind that we must first do no harm.
One approach that I utilize is the NutraMedix products. I was particularly interested in the herb Samento which is a purified form of Cat's Claw. Some reports in the literature suggest benefits in treating Lyme disease. I later learned of the Cowden Protocol and have conferred with Dr. Cowden to understand his perspective. I was looking for options that might help some of my patients to get better.
What I found was that three agents from the Cowden protocol are particularly helpful for their antimicrobial effects, namely Samento, Cumanda, and Quina. These have been a benefit in some patients. Some patients have profound responses with just one drop of Samento. I aggressively use Burbur and Parsley to help patients who may experience a Herxheimer reaction. In some cases, I use ½ to 1 dropperful of Burbur as frequently as every ten minutes for a few hours to reduce die-off reactions so that the patient can continue taking their prescribed protocol.
I use Chlorella which has been shown to bind to the byproducts of the immune response that may be part of an inflammatory response involving cytokines and other chemicals.
I use the Researched Nutritionals product line. I like that the company has made an aggressive effort to have evidence-based recommendations. Many of their products are in keeping with recommendations in other areas in complementary medicine. I have had a number of their products for which a fairly substantial number of patients have experienced an improved sense of well-being, particularly NT Factor Energy™ and Energy Multi-Plex™.
If a patient has not responded to treatment after 2-3 months, I may do a DMSA challenge with MetaMetrix and if heavy metals are an issue, I may use CheleX from Xymogen and trace minerals. In these cases, I recommend avoiding tap water and using water filtration to avoid further heavy metal exposure.
I am hoping that in using these agents it will allow me to sustain a patient's remission.
Can you provide a breakdown of your patient outcomes?
Of 100 patients with chronic Lyme disease that I aggressively treat with formal antimicrobials, at least 80-85% improve. Of the 100, at least 50% go back to normal. There are some residual symptoms in a subset even once you get off antibiotics. Of the 100, there are 10-15% of people that I throw the kitchen sink at and they just don't seem to improve. I refer them to other ILADS doctors such as Joseph Jemsek, MD.
Of the 85% that improve, I have been able to get 100% of these off of antibiotics. I do not have any patients that are on antibiotics now that I expect to require them for the rest of their life. Using alternative
approaches, we can generally get away from life-long antibiotic treatment being required.
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About Dr. Shor
Dr. Sam Shor, MD, FACP practices Internal Medicine in Reston, VA. His practice provides care for patients dealing with CFS, Fibromyalgia, and chronic Lyme disease. Dr. Shor is an Associate Clinical Professor at George Washington University.
Dr. Shor is a member of ILADS which can be found on the internet at http://www.ilads.org. For patients interested in working with Dr. Shor, his office can be reached at 703.709.1119 or via his web site at
http://www.intmednova.com.
For additional information on Lyme disease medical policy issues, visit the Lyme Policy Wonk at:
http://tinyurl.com/lymepolicywonk
