Gridlock on Capitol Hill - Part II

There were six witnesses who testified at the hearing. In part II of my Lyme disease hearing coverage I’ll share summaries of what the first three witnesses listed below testified. Yes, this is turning into a three part post. The digital age has broadened our horizons in almost every aspect of life, while also shortening our attention spans. I do not want to present an epic post that would cause your lovely eyes to glaze over and lose interest in my quest to arm you with Lyme-knowledge.

Witnesses:

• Patricia Smith, President of the Lyme Disease Association
• Stephen W. Barthold, Ph.D., Distinguished Professor of the Dept. of Pathology, Microbiology and Immunology Center of Comparative Medicine, School of Veterinary Medicine at the Univ. of California
• Raphael Stricker, M.D., Vice President of the International Lyme and Associated Diseases Society
• Mark Eshoo, Ph.D. Director, New Technology Development, Abbott Laboratories
• Evan White, Lyme disease Patient
• Ms. Stella Huyshe-Shires, Chair, Lyme Disease Action

Patricia Smith

Patricia Smith has traveled the country for the past 20 years listening to patients, scientists, doctors and government officials discuss Lyme disease. Her testimony was full of jaw-dropping information, and is available here in written form. It is two pages long and worth the read as it shows the effect that the controversy surrounding Lyme disease has on patients and their families. 

Patricia Smith referred to Lyme disease as a medical and political debacle. She stated that many doctors refuse to diagnose outside certain limited federal criteria and subsequently insurance companies can refuse to pay for care. She also lamented the fact that thirty-seven years after Lyme was recognized, sick patients cannot get diagnosed and not be treated because of antiquated, unsubstantiated tests which may pick up 50 percent of cases.

Stephen W. Barthold

Dr. Barthold has been researching Lyme disease for 25 years in animal model systems, with funding provided by NIH. One of the things that has intrigued him the most is the fact that Borrelia persists in its immunologically competent hosts as the rule, not the norm, thus proving that persistence is part of its biological behavior. This has been shown in 100 percent of mice, rats, hamsters, guinea pigs, gerbils, dogs, and nonhuman primates--two different species of nonhuman primates. He explained that when you have an organism that is a professional at persisting and evading host immune clearance, you have a problem when you approach it with antibiotics. The antibiotics are likely to fail under some circumstances, if not many circumstances.  By stating these facts gathered through his research, Dr. Barthold finds himself in a rather unique spot. He started in the mainstream of Lyme disease research and is now considered somewhat of a pariah, in terms of the established medical opinion.

Dr. Barthold’s studies in animal models have found that early treatment during the pre-immune phase of the infection can cure the animals. But during persistent infection, (advanced Lyme disease)100 percent of the animals remain persistently infected after antibiotic treatment. This has been described in a number of different laboratories: One in Finland, one in New York, one in Louisiana, and one in Connecticut. It has been described in mice, in dogs, in nonhuman primates. It has been described with a number of different antibiotics, including ceftriaxone, doxycycline, tigecycline, amoxicillin, azithromycin. In his written testimony, Dr. Barthold included some unpublished data, which will hopefully will get published in the next year or so, that shows after a 12 month Lyme disease treatment of mice they saw a resurgence of spirochetes in very large numbers, equivalent to numbers of wild-type infection in which the animals had not been treated with antibiotics. “The significance of continued infection indeed needs to be better understood, it is time to recognize that Lyme disease is not a simple bacterial infection”. He also mentioned that researchers follow the money and that if enough incentives were given, there would be more research done. He underscored that people on both sides of the issue are “good” people but that they just look at the issue from a different perspective

Raphael Stricker

The International Lyme and Associated Diseases Society (ILADS) point of view was represented by Dr. Stricker. He emphasized the fact that the Infectious Diseases Society of America (IDSA) clinical guidelines only address the immediate bite. [Julie’s Commentary: For people like me who never saw a tick on their being, let alone knew they were bitten, these guidelines are useless]. He also stressed the need for national protection for doctors who treat chronic Lyme disease and better diagnostics from NIH. He urged the group to look at the evidence of persistence infection from Borrelia burgdorferi (Bb).

Dr. Stricker is a practicing physician in San Francisco with a specialty in internal medicine and he currently has 2,000 Lyme disease patients. He treats patients from Canada to Costa Rica, from Great Britain to Brunei, and from Germany to Japan. Many of these patients have been ill for years and have been unable to find a medical provider who can diagnose and treat them for Lyme disease. Dr. Stricker stated that in spite of the fact that the disease is so common, medical providers are often ignorant about how to diagnose and treat Lyme disease. There are a number of reasons for this ignorance:

• The telltale bullseye rash that is a classic sign of Lyme disease may be absent in more than half of Lyme disease patients
• Patients are often unaware of a tick bite, in many parts of the world the black legged tick that transmit Lyme disease may be no larger than a poppy seed
• Lyme disease has a wide range of symptoms, and physicians are often unaware of the various manifestations of the disease
• Testing for Lyme disease remains problematic. Most laboratories around the world use tests that are unstandardized and insensitive; these tests give negative results in about half the cases of Lyme disease
• Treatment for Lyme disease has evolved in a haphazard fashion; the “standard of care” put forth by specialty medical organizations such as the IDSA only address acute infection immediately following a tick bite. The IDSA standard ignores the more common and severe chronic form of Lyme disease.

To Be Continued...

Gridlock on Capitol Hill

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”.

Old Man Winter is Kicking My Ass

It is not writer's block that has kept me from delivering the next installment of my Lyme disease journey, it’s exhaustion mixed with increased achiness and a side of grumpiness. It turns out that cold, damp weather exacerbates my symptoms. The roller coaster winter we are experiencing is zapping me of my energy. It is also making the rusty feeling in my joints worse. If you live near me there is no need to tune into the weather channel, contact me and based on the intensity of my joint and muscular pain, I will provide you with the most accurate forecast in town! 

I love winter. In fact I am usually annoyed by the lack of snow in the DC area. Right now I am thankful for the fact that the big blizzard forecast for this weekend is way north of us. I probably wouldn't be able to get out of bed if that storm hit here. Speaking of getting out of bed, I have written a haiku that I hope captures the grace of my morning ritual when it is cold and damp outside. 

Thump

Slide to side of bed, 
cascading over the edge.

Wow, the floor is hard.