On July 17, 2012 Lyme experts testified at the first-ever Congressional Hearing on the global challenges of Lyme disease. The vast majority of committee hearings are open to the public, so I took advantage of the fact that I live in Washington, DC and attended the hearing. This was the first time Congress had looked at the global implications of Lyme disease and chronic Lyme disease with a focus on science and putting patients first. Witnesses gave testimony about how policies and actions by government agencies such as CDC, NIH and the Infectious Diseases Society of America (IDSA) have hindered research on chronic Lyme disease in turn hindering patient diagnosis and treatment. Solid science was presented for the record showing persistence of Lyme disease in animal studies, and cutting-edge testing for Lyme was examined. Viewpoints from a treating physician, advocate and patient were finally able to become part of public record.
Sounds pretty cool huh?
“As I have met scores of patients suffering the devastating effects of Chronic Lyme—who only got well after aggressive treatment by a Lyme-literate physician—I have been dismayed and angered by the unwillingness of some to take a fresh, comprehensive look at this insidious disease,” said Chris Smith, who co-chairs the House Lyme Disease Caucus. “It will be necessary for the physicians, scientists, government leaders, and media to be discerning – to evaluate the evidence to see if it is based on the best science and to scrutinize the studies and the critiques of those studies to determine whether they are of high quality. We need scientists to speak out in an unfettered way. We need government agencies to show leadership and to forcefully say what we know and what we don’t know based on the best available evidence.”
The hearing turned out to be an eye opening experience. I went home that evening realizing that the chronic Lyme disease diagnosis I had received thrust me into the middle of a controversy that is hindering forward progress on diagnosis and treatment, which of course is the opposite of what anybody who is currently being treated for chronic Lyme disease wants to hear.
Congressman Chris Smith of NJ, Chairman of the House congressional panel that oversees international global health issues ran the hearing. On May 5, 1998 he introduced a comprehensive, bipartisan Lyme Disease bill, H.R. 3795 Lyme Disease Initiative Act of 1998, which had at its core, the establishment of a task force—an advisory committee—to comprehensively investigate Lyme with at least four things in mind; detection, improved surveillance and reporting, accurate diagnosis and physician knowledge. He reintroduced the bill again in 1999, 2001, 2004, 2005, 2007, 2009 and 2011. The following comment he made during his opening remarks really stuck with me, and summarizes a huge issue with Lyme disease research and treatment: "In 1998 I also introduced a comprehensive law to combat Autism. Despite significant opposition in Congress and at NIH and CDC that paralleled the Lyme bill struggle, it became law in 2000. Last year I authored the Combating Autism Reauthorization Act of 2011 which was signed into law in the fall, with the support of NIH and CDC. If only we had done the same with Lyme disease legislation in the late 90s, a missed decade on Lyme”.
A Summary of the Opening Remarks
In Europe, Lyme disease syndromes were described as early as 1883, and by the mid-1930s neurologic manifestations and the association with Ixodes ticks were recognized and known as tick-borne meningoencephalitis. In the United States, Lyme disease was not recognized until the early 1970s, when a statistically improbable cluster of pediatric arthritis occurred in the region around Lyme, Connecticut. In 1981, Dr. Willy Burgdorfer, an NIH researcher at the Rocky Mountain Laboratories, identified the spiral-shaped bacteria (or spirochetes) causing Lyme disease and made the connection to the deer or black-legged tick, Ixodes scapularis.
Lyme disease is the most common vector-borne illness in the U.S. and is also endemic in parts of Europe and Asia, and recently has been confirmed to be endemic in the Amazon region of Brazil. In Europe, the highest rates are in Eastern and Central Europe. Recent surveillance studies have described growing problems in Australia and Canada. In the US, Lyme disease has been reported in 49 states and is most common in the northeastern and north central states, and in Northern California into Oregon. Over 30,000 confirmed cases were reported to the Centers for Disease Control and Prevention (CDC) in 2010, making it the 6th most common reportable disease in the US and the 2nd most reportable in the northeast. CDC has estimated that actual new cases may be 10 times more than the reported number, indicating roughly 300,000 new cases in 2010 alone.
The “Lyme Wars”
Few diseases have aroused such a high level of emotion and controversy among the public, physicians, and researchers than Lyme disease. There are two distinct views of Lyme disease; each citing scientific evidence to support its claims, while outcomes research is limited and conflicting.
- View 1: Promoted by the Infectious Diseases Society of America (IDSA), is that the disease is “hard to catch and easy to cure” and denies the existence of chronic Lyme disease or persistent infection with the Lyme bacteria. Any treatment other than a short course of antibiotics is considered too risky. Patients’ who do not fit the paradigm may have few options outside of psychiatric evaluation.
- View 2: Promoted by the International Lyme and Associated Diseases Society (ILADS) and also by numerous academic researchers in the US and around the globe, is that the science is too unsettled to be definitive and there can be one or more causes of persistent symptoms after initial treatment in an individual who has been infected with the agent of Lyme disease. These causes include the possibility of persistent infection, or a post-infectious process, or a combination of both.
Three areas central to the controversy are: the quality of diagnostics, post-treatment persistence of Borrelia, and available treatment options in light of clinical guidelines.
DIAGNOSTICS
Current diagnostic tests commonly used do not detect the spirochete that causes Lyme disease, rather, they detect whether the patient has developed antibodies to the pathogen (serological testing). CDC recommends two-tier serological testing, but cautions that the 2-tier system should be used only for surveillance purposes and not for diagnosis. Part of the difficulty in clinically managing suspected Lyme disease is that the CDC protocol is frequently not only used, but required for diagnosis.
PERSISTENCE
IDSA has repeatedly stated that there is no “convincing” evidence that the Lyme Borrelia persists after standard antibiotic treatment. However, there are numerous documented case studies of persistence in humans after antibiotic treatment. Studies have been conducted of the mechanisms by which Borrelia may evade the immune system and antibiotics. Studies have suggested that resistance to antibiotics might be due to formation of different morphological forms of B. burgdorferi, including cell wall deficient forms and biofilm-like colonies. Research also indicates that Borrelia can exchange genetic material, possibly contributing to its ability to avoid detection by the immune system.
TREATMENT GUIDELINES
The final major area of controversy is the significance of the IDSA’s treatment guidelines which directly impact patients and their ability to get treatment. Guidelines should be developed based on the best science, and there has been extreme controversy regarding the restrictive nature of the IDSA guidelines. The guidelines do not allow for the possibility of chronic infection and severely limit physician discretion on treating the disease. Supporters of the IDSA guidelines point to dangers of the prolonged use of antibiotics and the possibility of treating when an infection has not been established. IDSA and supporters place heavy weight on certain clinical trials of Lyme treatments supported by NIH. There has been much controversy of the quality of those trials and their generalizability to broad populations of patients. It is disturbing to the lay bystander that the controversy has ensued for so long without resolution. Certainly there are numerous unknowns about the bacteria and the disease; however, the public questions why the “experts” can’t even agree on whether these small numbers of clinical trials are well designed, well executed, and of sufficient power (whether they have a large enough number of patients), and the degree to which they can be generalized to other patient populations.
Congressman Smith ended his opening remarks by announcing the following: “I am looking forward to hearing the valuable perspectives that each of our witnesses brings to this hearing. I regret that, today, we will not be hearing from NIH, CDC, or a representative from the IDSA. They all were invited, but declined, the IDSA expressing that their potential witness had a scheduling conflict. I will reissue an invitation to them, and expect they will testify before our subcommittee”.
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