I became interested in Lyme disease in 1982, when the first cases were being presented at Mt. Sinai Hospital in New York City, where I did my internal medicine residency. This was the first infectious disease which had clearly been shown to trigger autoimmune disorders. The concept of autoimmunity, however, would seem to be counterintuitive to those who subscribe to the theory of evolution. Why would an organism allow for its body to reject parts of itself as if they were foreign invaders?
It was then that the study of Lyme disease became fascinating to me. I attended the first conference on this disorder in 1984 and began to read whatever material became available on the subject. After moving to New Jersey and establishing a private practice in 1988, I started looking deeper into cases of lupus, chronic fatigue, fibromyalgia and arthritis, and wondered if some of them really exhibited the long-term manifestations of Lyme disease. Some patients clearly had Lyme disease, others did not, and some patients seemed to fall somewhere in between. Over the years, I presented my findings at the annual international conferences hosted by the Lyme Disease Foundation. In 2003, I co-chaired a conference with Dr. Brian Fallon, Professor of Clinical Psychiatry, Columbia University College of Physicians and Surgeons.
In the early 1990's, as a physician who diagnosed and treated many Lyme disease patients, I became a target of investigation and intimidation by insurance companies. This did not sit well with me since I knew that many of the sickest patients responded very slowly to treatment and often required far more treatment than insurance companies were allowing.
The situation became very contentious in 1993 through 1995 when I was asked to sit on a panel of experts discussing criteria for the diagnosis and treatment of Lyme disease intended for use by insurance companies. There were heated debates. I was one of the physicians vocally opposed to establishing overly restrictive criteria which would be used by insurance companies to deny coverage. When the majority leader of the New Jersey Senate at that time saw the level of disagreement, he invited a group of us to meet with him to discuss legislation. The intent of the legislation was to mandate insurance coverage for at least 12 weeks of intravenous antibiotics as treatment for Lyme disease. It came as a shock that not only did we have opposition from specific academics, but also from radical patient groups who opposed the concept of any limits to therapy. We tried twice to get this legislation passed, but failed both times to get it through both the Senate and the Assembly.
Interestingly, the Lyme vaccine trials were beginning at about this time, and the CDC surveillance criteria were being discussed. The definitive criteria for the diagnosis of Lyme disease resulted directly from the need to objectively define the disease in order to perform the vaccine studies. How could you decide if a vaccine is preventing a disease, if you have no accurate definition of the disease itself?
Thus began a dark era where patient welfare took a backseat to more market-driven concerns. Test kits were patented based upon specific strains of Lyme bacteria which were designed to differentiate vaccine recipients from natural cases. While this approach was useful for vaccine testing purposes, it was not appropriate to use these kits and these criteria to screen the general population for Lyme disease. To this day, the current CDC criteria do not include tests for the most common antigenic variants seen in the general population. Before the human clinical vaccine trials, we also knew that animal studies suggested possible adverse reactions to the product if there was existing infection, and human studies had confirmed that Lyme could trigger autoimmune disease in genetically predisposed individuals. How then could anyone conduct studies on the general population without screening for these risk factors?
Around the same time, the researchers conducting these studies were solicited by insurance companies to write guidelines for the diagnosis and treatment of Lyme disease. These guidelines imposed stringent restrictions on diagnosis and treatment and ensured that many patients being treated for Lyme disease would not be covered by their insurance companies. Concurrently, physicians who used the knowledge they gained from attending conferences and reading the wealth of studies from both the United States and Europe realized that this illness could become chronic and progressive. They understood that some patients would need months to years of treatment before a successful clinical outcome was ensured. These physicians' perspectives were clearly at odds with the dogma perpetuated by insurance companies. Many of these insurance company experts lectured at academic medical centers and presented the position that those who treat Lyme disease as a chronic illness were “quacks” and “mavericks” and should be put out of business.
I was one of the many physicians put in the uncomfortable position of deciding whether we should follow our hearts, our clinical judgment, and the Hippocratic Oath or to play it safe. Should we insist on treating this disease as aggressively as possible to avoid the devastating consequences of permanent arthritis, multiple sclerosis, and a host of other sequelae of incomplete treatment? Or, should we play it safe and follow the artificially devised, restrictive guidelines, and avoid inquiries, investigations and complaints by insurance companies and state medical boards?
It is not in my nature to allow anything to compromise my ethics, so I chose the tougher route. I have faced harassment by insurance companies, threats by local hospitals, and threats to revoke my license, but I am firmly convinced that I am doing the right thing. I have seen Lyme disease transform brilliant minds into confusion, dementia, and profound depression. I have seen athletes develop crippling pain, weakness, and confinement to wheelchairs. I have also seen that with enough treatment, nutritional therapy, and exercise regimens, these same people can return to normal.
This is not a debate about the science. This is a brutal attack launched by a few influential physicians who have aligned themselves with insurance and pharmaceutical companies against individuals who threaten to expose their misconceptions and deceptions, and who have the courage to continue to treat patients correctly despite threats and intimidation tactics.
This book represents patients who are seen on a daily basis by physicians like myself who treat Lyme disease. Physicians who courageously treat these incredibly sick patients deserve the highest respect from the medical profession, rather than the condescending and scathing criticism to which they are subjected almost daily. There is a silver lining: a growing group of legislators and lawmakers are recognizing this injustice and forging the way for change.
I want to thank the authors for this moving and brilliantly written book, and I am honored that they have chosen me to write this foreword. I also urge all of you physicians who are treating this disease to continue to fight for your patients because the tide is turning.
Lesley Ann Fein, M.D., MPH
West Caldwell, New Jersey
September, 2005