What those know-it-alls need, I thought with an admittedly un-Christian attitude, is a real good case of Lyme.
And so the idea for this novel was born. It would take another seven years before I was ready to write it.
In Over the Edge the background information about Lyme disease and the Lyme wars is straight out of my research. To this day many Lyme patients have to fight for diagnosis and treatment. But beyond that, this book is a work of fiction. The characters are in no way real. Brock McNeil does not represent any one doctor. Rather, he arose from my own imagination as a combination of researchers who still deny the existence of chronic Lyme as an active infection. In placing him at the Stanford School of Medicine I'm casting no aspersions on that respected institution. It simply provided a setting for my story. One other fictional point to note: In Over the Edge Jannie's test results from the Lyme lab were available within about six hours. I wrote it that way to keep my story moving. In reality, results could not be ready that quickly.
Now, fiction aside, let's talk about the realities of Lyme.
The Lyme wars go back a number of decades. It's a complex war with complex arguments, but simplified it comes down to these two sides: Lyme-literate doctors—working in the trenches with very sick patients—who believe long-term antibiotic treatment is effective, vs. doctors aligned with such powerful entities as the Centers for Disease Control (CDC) and the Infectious Diseases Society of America (IDSA), who deny the existence of chronic Lyme as an active infection. This latter group of doctors instead insist that long-term patients suffer from a post-Lyme treatment syndrome—some form of autoimmune disease as yet unknown and undefined. This "syndrome" should only be treated symptomatically, they say, and not with antibiotics.
As Over the Edge depicts, the Lyme wars arise from these four factors, which form a vicious circle:
First, Ineffective testing. The CDC criteria for administering and interpreting tests have been controversial since they were approved in 1994. First the CDC insists on a two-tier form of testing, starting with the ELISA test, then proceeding to the Western blot only when the ELISA is positive. Unfortunately all too often a negative ELISA is a false negative because of the test's poor sensitivity. (Although the CDC insists the test is sensitive.) So many patients are lost right there.
Those who do test positive move on to the Western blot, which looks for antibodies to Borrelia burgdorferi in the blood that reveal themselves in the form of stripes or "bands." Each band refers to a certain type of antibody and is indicated on the test results by a given number. Even when the test for Lyme was first developed many doctors protested the inclusion and exclusion of certain bands. One of the biggest arguments was over band 31—an antibody to a protein on Borrelia's outer surface called OspA that is exclusive to Lyme. Yet this band was not included as a positive indicator on the test, while other bands that were less important were included. In order to test positive for Lyme, a patient must see a certain number of the included bands indicate positive. Many patients fall short of that required number of positive bands, often due to the fact that Lyme-specific bands that should have been included as significant were not. Overall, as a result of these controversial criteria, patients can see "negative" false results as much as thirty to forty percent of the time.
To counteract the CDC's ineffective criteria for testing, labs such as IGeneX in Palo Alto, California, have designed their own criteria that include the Lyme-specific bands that the CDC's criteria do not. IGeneX tests also search for more than one strain of Borrelia, while the most common test kit in other labs looks for only one strain—B31, the original strain found on Long Island. Lyme-literate doctors often send blood to labs such as IGeneX. Meanwhile the CDC and medical community at large do not recognize results from such labs as legitimate. Like Jannie McNeil, in 2009 my results from IGeneX were positive for Lyme according to IGeneX criteria, but negative according to CDC criteria. As sick as I was with Lyme, if I'd relied on standard diagnostic criteria, I would have remained undiagnosed and untreated. That unfortunate scenario happens again and again for Lyme sufferers.
Second, Lack of education among doctors. Lyme-literate docs are few and far between. The rest simply don't know enough about the disease, relying on outdated information as to where Lyme is found and what its symptoms are. For example, to this day many doctors still believe the old axiom that a patient must present the erythema migrans or "bull's-eye" rash in order to have Lyme. While the E.M. rash is a strong indication of Lyme when it occurs, many patients never have it. I didn't. The CDC itself looked at 119,965 Lyme patients between the years of 1992 and 2004, finding that only 68 percent of them had the rash. Other research indicates the rash, when present, resembles the infamous "bull's-eye" only 9 percent of the time. In addition you'll still hear docs in many states swear that Lyme is never found there—even when they'll admit it occurs in nearby states. Amazing. I wonder how those ticks know to stop at the state borders.
I know a twenty-year-old who was once healthy and outgoing. Now she lies bedridden, unable to walk or even hold a phone to her ear. She knows of receiving four tick bites, three of which caused the definitive bull's-eye rash. Even so her doctor insisted there was no reason to test for Lyme. "We don't have Lyme in this state," she was told. If she had been treated early on, she probably would be well today. But instead she went years without a diagnosis or treatment. All the while the spirochetes within her body reproduced and spread throughout all her systems.
I'm also left to wonder about the upcoming ranks of doctors and nurses. A couple years ago a nursing student in Washington state was telling me about her class on diseases. When they came to Lyme, the instructor said, "No need to bother with learning about that one. It's pretty rare, and we don't have it in this state." Wrong and wrong. I know people in Washington who are fighting Lyme. It's frightening to think that the health-care providers of tomorrow are being taught the old, incorrect axioms.
As one Lyme-literate doctor explained to me, at the heart of many doctors' inability to recognize Lyme is the incorrect application of the CDC surveillance criteria for Lyme. The role of the CDC is surveillance of disease in the U.S. Therefore the criteria the CDC establishes to determine if someone has a particular disease is very stringent. In surveilling cases of Lyme nationwide the organization wants to make very sure every person it counts as a Lyme patient indeed has Lyme. But these stringent criteria—which include presentation of only a few certain symptoms and a positive test result according to CDC criteria, among other things—are being misused as diagnostic criteria in doctors' examining rooms. The CDC web site itself says its "surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis." Yet from doctor's office to doctor's office, the criteria are being used to diagnose, no matter how strongly a patient might present other known symptoms of Lyme.
Third, Doctors' fear of treating chronic Lyme. Many of the doctors who treat Lyme with long-term antibiotics are taking a great risk. Some Lyme-literate docs have had their licenses pulled. They've been sued by insurance companies, who didn't want to cover the expensive drugs. Even a reputable doctor who recognizes a case of Lyme may refuse to admit it because he simply does not want to get caught in the Lyme war crossfire.
I remember talking on the phone with one desperate man in Oregon who was very sick. "I've had three tests for Lyme," he told me. "All three were positive. Plus I have many obvious Lyme symptoms. But after every test my doctor insists it's a false positive and still refuses to treat me."
Fourth, Misdiagnosis. Since the patients are really sick and Lyme is ruled out through misuse of the CDC criteria and poor testing—well, they must have something. That "something" often is misdiagnosed as Chronic Fatigue Syndrome, Fibromyalgia, Multiple Sclerosis, Parkinson's, Rheumatoid Arthritis, and other diseases. Either that or the symptoms are just "all in their head." (Which some doctors have been know
n to claim.) The problem with misdiagnosis isn't just the lack of right treatment, but the introduction of wrong treatment. For example, CFS patients are often given steroids to combat their swollen, painful joints. The problem is, steroids suppress the immune system and therefore are never given when a doctor knows a patient has an active infection of any kind. Bacteria are left to thrive in an immune-suppressed body. The Lyme patient gets worse.
Such is the unfortunate story of the twenty-year-old mentioned above. Since she "couldn't have Lyme" in the state in which she lived, she was diagnosed with CFS and put on steroids for months. She became much worse. Her Lyme was allowed to run rampant for years until someone finally pointed her to a Lyme-literate doctor for testing. But by then she was bedridden.
In the last few years Lyme proponents have seen some breakthroughs regarding the medical community's resistance to treating chronic Lyme. On July 1, 2009 a bill in Connecticut took effect that allows licensed physicians to administer long-term treatment to diagnosed Lyme patients and prohibits the Department of Public Health and the Connecticut Medical Examining Board from taking disciplinary action against doctors for such treatment. (Dr. Carol Johannis spoke of this legislation with Jannie.) A victory for Lyme patients, to be sure—albeit too late for some Lyme-treating doctors. Still, how amazing that it took until 2009 for this to happen in Connecticut—considered the ground zero state for Lyme and home to the town for which the disease is named.
In 2006, five years after that 2001 article I read in my doctor's waiting room, IDSA published its updated Clinical Practice Guidelines for Lyme. These guidelines further narrowed the parameters of the disease, thereby further limiting ability to treat. The IDSA guidelines are no small thing. Insurance companies cite them as reason not to pay for treatment, and medical boards quote them as proof chronic Lyme doesn't exist—that is, the bacteria causing Lyme are completely eradicated from the body after the recommended two to four weeks of antibiotics. As a result of the IDSA guidelines doctors would remain wrongly educated about the disease and refuse treatment.
Incensed they'd been had once again, Lyme patients rallied—literally. In time the attorney general of Connecticut launched an antitrust investigation into IDSA and the guidelines. From the looks of it, too many of the doctors on the IDSA panel had reputations and money at stake, apparently causing them to ignore dissenting views and research findings about Lyme. In May 2008 the Connecticut attorney general announced that his investigation had indeed uncovered serious flaws in the IDSA guideline-writing process, including conflicts of money interests, quashing of research that pointed to the existence of chronic Lyme, a biased chairman who handpicked doctors who believed as he did, and more. As a result a new review panel, consisting of doctors with reportedly no conflicting interests, would be created—again under the auspices of IDSA—to relook at the guidelines.
In 2009 a national hearing was held, during which physicians and scientists on both sides of the debate presented their research data regarding Lyme to the review panel. Some of the presentations arguing against the IDSA guidelines included:
1. Dr. Benjamin Luft, from SUNY Stony Brook, who presented evidence that Lyme bacteria can indeed persist in the body beyond the IDSA-recommended two to four weeks of antibiotic treatment.
2. A dissection of the four peer-reviewed IDSA studies, which showed that two of them were based on serious flaws, while the other two showed that patients did improve after six weeks of IV antibiotics. Since the four studies were based on only 207 patients in total and administering only one antibiotic, presenters argued that much more study was needed.
3. Dr. Ray Stricker and others, who presented studies that showed the two-tier standardized Lyme test lacks the sensitivity required to be accurate, missing eighty-eight out of every two hundred Lyme patients. The CDC spokesperson, Barbara Johnson, stood by the tests, although it was shown her endorsement was based on a ten-year-old study of a mere twenty-six patients.
After the hearing everyone waited for the pronouncement of the review panel. The panel said it would have findings by December of 2009, but 2010 rolled around with no announcement. The Lyme community remained skeptical. After all, the chair of the panel was a past president of IDSA. In April of 2010 the review panel finally announced its findings: bottom line, the current IDSA guidelines would stand. Specifically, the panel declared:
1. "There is no convincing biologic evidence for the existence of symptomatic chronic B. Burgdorferi infections among patients after receipt of recommended treatment regimens for Lyme disease."
2. "Antibiotic therapy has not proved to be useful and is not recommended for patients with chronic (>6 months) subjective symptoms after recommended treatment regimens." Controlled clinic trials for extended antibiotic treatment demonstrated "considerable risk of harm," and "little benefit." Therefore the risk/benefit ratio "strongly discourages" prolonged antibiotics.
3. The case reports of "perceived clinical improvement" during prolonged antibiotic treatment, including those presented at the 2009 hearings, were "intrinsically incapable of hypothesis-testing." These reports were pronounced tainted for various reasons, one being that many participating patients' diagnoses of Lyme was questionable because they weren't tested under current CDC standards.
That's right—the very testing criteria that are inaccurate to begin with. Such a declaration from the review panel is one example of the cyclical reasoning that has arisen ever since the narrowly-defined Lyme symptoms and testing criteria were established in 1994. Often the cyclical reasoning goes something like this: only the CDC criteria are correct . . . therefore studies should include only patients meeting the CDC criteria . . . therefore results of said studies prove the CDC criteria are correct.
In short, all findings from the hearing that proved Borrelia burgdorferi exist after the IDSA-recommended two to four weeks of antibiotics were completely discounted.
In Over the Edge, Jannie reads an abstract of research that proves Borrelia continue to exist in mice after the recommended four weeks of treatment. This was taken from the article "Persistence of Borrelia burgdorferi following Antibiotic Treatment in Mice" by Emir Hodzic, Sunlian Feng, Kevin Holden, Kimberly J. Freet, and Stephen W. Barthold. from the University of California at Davis. The full paper can be found online at: http://aac.asm.org/cgi/content/abstract/52/5/1728.
In 2009 the film crew of the award-winning Lyme documentary Under Our Skin interviewed Dr. Willy Burgdorfer, the scientist who discovered the spirochete that causes Lyme—which was named after the doctor. Dr. Burgdorfer had been retired since 1986.
When asked what he thought about the current Lyme wars, he responded, "The controversy in Lyme disease research is a shameful affair . . . The whole thing is politically tainted. Money goes to people who have, for the past thirty years, produced the same thing—nothing. Serology has to be started from scratch with people who don't know beforehand the results of their research. There are lots of physicians around who wouldn't touch a Lyme disease patient. So [this] shame includes [them.]" His biggest regret in the aftermath of his discovery of Borrelia burdoferi is "that the technology used to diagnose and treat Lyme Disease wasn't worked all the way through. It [was based on] only a few results, then published. And later on, people [wanted] to take them back."
But even years later, at least as of the writing of this novel, they haven't been taken back. And so, for chronic Lyme sufferers, the fight goes on.
I wrote Over the Edge to tell a good suspense story. But beyond mere entertainment, I wanted to help shed light on the difficult struggles of thousands of Lyme patients in this country. I hope the novel helps individuals out there. Perhaps you. Perhaps someone you love.
If you are experiencing muscle weakness, joint pain, confused thinking, or other symptoms mentioned in this story, you owe it to yourself to be properly tested for Lyme. Don't allow doctors in your area to dissuade you from tests by claiming it doesn
't exist in your state. And to ensure results are as accurate as possible, have your blood sent to a lab dedicated to testing for Lyme. There are numerous organizations and online sites that can help with information. I list a few of them here.
1. Lyme Disease Association. "Readiness through prevention, education, research, and patient support." This is an all-volunteer national nonprofit organization. (http://www.lymediseaseassociation.org)
2. International Lyme and Associated Diseases Society. A nonprofit organization. (www.ilads.org)
3. Lyme Disease Network. "A nonprofit foundation dedicated to public education of the prevention and treatment of Lyme disease and other tick-borne illnesses." The Lyme Disease Network offers local support groups, online forums for questions and answers, a newsletter, and much more. (http://lyme.net)
4. The Lyme Disease Foundation, "the premier nonprofit dedicated to finding solutions for tick-borne disorders." LDF was cofounded by Karen Vanderhoof-Forschner and Thomas E. Forschner, whose young son, Jamie, died in 1991 during a relapse of Lyme disease. (http://www.lyme.org/front.htm)
5. Canadian Lyme Disease Foundation. "A federally registered charitable organization dedicated to promoting research, education, diagnosis, and treatment of Lyme and associated diseases since 2003." (www.canlyme.com)
6. California Lyme Disease Association. "The California Lyme Disease Association (CALDA) is a non-profit corporation acting as the central voice for all tick-borne disease issues in California and a supporting voice for national issues." CALDA publishes the Lyme Times; was instrumental in establishing the Lyme Disease Advisory Committee (LDAC), which advises the California Department of Public Health on matters concerning Lyme disease; and is active in legislation regarding Lyme. (http://www.lymedisease.org)
7. Lyme Disease Research Database. Covering "Lyme disease symptoms, treatment, diagnosis, prevention, and research." Members receive access to the large database of LDRD resources. (http://www.lyme-disease-research-database.com)
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