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Recap of the presentations:
The hearing allowed a dynamic pre-selected group of speakers to voice their thoughts and supporting scientific beliefs, either in support of or in dispute of many of the IDSA positions found in the 2006 Guidelines. The patients’ perspective was described by Tina Garcia, Lyme Education Awareness Program, Arizona, who offered facts about her personal experience with Lyme disease and her viewpoint that patients today are informed consumers. Just as cancer patients make treatment choices, Lyme patients deserve the same right. The panel was particularly interested in the frequency of insurance denial as it relates to the IDSA Guidelines.
The IDSA maintains that these Guidelines are not considered mandatory, yet this claim does not ring true since the Guidelines are widely published and disseminated through all medical channels, and are used by many insurers to deny patients medical treatment that does fall within these standards. Presenter Lorraine Johnson, JD, MBA, CALDA Chairman, ILADS, explained how the IDSA Guidelines restrict patients’ access to care, because most physicians follow the Guidelines to the letter. They are considered to be the “Good Housekeeping Seal of Approval” due to the clout of the IDSA. Therefore, few doctors choose to treat outside of this standard, and those who do are often punished by medical boards for treating according to their medical expertise. Lorraine explained that the science is unsettled and incomplete, yet the Guidelines express a widely held position based on medical fact, and she cautions that “expert opinion is not science”, a point that was expounded upon by Daniel Cameron, MD, President ILADS.
Dr. Cameron reviewed 4 NIH funded studies which lay the framework for the IDSA’s widely held positions, even though the small sample size of these studies makes it difficult to extrapolate the findings to the general population. Two of the four studies did show that patients improved in specific measurable areas of fatigue and/or pain after retreatment with antibiotics, a fact that is not referenced in the Guidelines. He explained the process of grading scientific evidence used in support of medical publications and revealed the cost of Lyme disease per patient in real dollars to be $16,199 per year. Projected to the total number of CDC cases (23,673), that equates to an annual cost of $203 million in the USA. Multiplying that figure by 10, as the CDC numbers only reflect an estimated 1/10th of the actual number of cases, the real cost could be as high as $2 Billion. Dr. Cameron expressed the importance of the doctor – patient relationship and espoused the right of patients to have treatment choices.
Phil Baker PhD, ALDF, maintained that Lyme disease is over-treated and over-diagnosed.
He supports the theory that Lyme disease is understood, but chronic Lyme disease is poorly defined and there exists no evidence of persisting infection.
Not so, according to Benjamin Luft, MD, who has studied treatment failures in the animal and human trials. Dr. Luft supports the theory of microbial resistance, which is essential to the survival of the organism. Relapse has been shown by objective measures through xenodiagnosis and PCR. He has identified an efflux pump in the Borrelia organism which effectively pumps antibiotics out of the organism and effectively maintains its viability.
Alison DeLong, MS, The Center for Statistical Sciences, Brown University, challenged two of the IDSA recommendations for the treatment of late neurological disease and PLD (Post Lyme Disease). Alison analyzed the 4 treatment trials including Fallon, 2 Klempner studies and Krupp.
She supported the fact that the Fallon and Krupp studies were well designed and did show statistical significance on the measure of fatigue and pain improvement. She found the Klempner study to be statistically flawed, and the discontinuation of the study was based on too small a sample size and therefore should not be translated into any result, especially one that indicates that the treatment was ineffective. Alison went on to show that if you did correctly analyze the statistics of this study, it did, in fact, indicate a positive treatment effect.
The accuracy of the existing two-tiered tests was the focus of Barbara Johnson, PhD, Centers for Disease Control and Prevention. She explained the MISCONCEPTIONS about the reliability of the tests, stating the ELISA is an excellent sensitive first screening test and the unreliability of the IGG in immunoblot testing for late stage Lyme.
Dr. David Volkman, Professor of Medicine and Pediatrics at SUNY, Stony Brook, stated his concern about the misapplication of CDC surveillance criteria for diagnosis, and further stated that serology does not rule out Lyme disease. Dr. Volkman denounced the one-dose prophylaxis treatment not only because it is ineffective, but also because it blocks EM and seroconversion in 87% of cases. In his practice, he found chronic disease often caused arthritis and CNS infection.
Samuel Donta, MD, Internist, asked the questions: Why not report all the Western blot bands? Why not allow for what we know and what we don’t know? Dr. Donta stated that the two-tier diagnostic is not reliable and shared his clinical experience with various antibiotics. He has found tetracycline to be preferential, which may be because it is an intracellular drug. He expressed concern that ceftriaxone does not have a long lasting effect possibly because it may be working as an anti-neurotoxic agent on the glutamate accumulation from the disease.
Eugene Shapiro, MD, IDSA and Yale University of Medicine, stated that because no evidence exists for persisting infection, no changes to the Guidelines should occur. Although he acknowledged that patients are suffering, and doctors are part of the problem, he reiterated that they are suffering with medically unexplained symptoms.
Brian Fallon, MD, Columbia University Medical Center, addressed the question of whether repeated antibiotic therapy is useful. He explained the positive effect of retreatment in both in the Krupp Study and his study in terms of fatigue and body pain. Dr. Fallon revealed the adverse effects in his study, and the importance of both a complete workup to determine patients who are at risk for adverse events as well as discussing treatment options with patients with full disclosure of treatment risks. One of the most probing questions of the day was: would you retreat a patient with antibiotics for Lyme disease after weighing the risks and benefits? Dr. Fallon expressed that he would do so.
Sunil Sood, MD, Schneider Children’s Hospital, presented his theories on Lyme disease, which are strongly aligned with the IDSA Guidelines and is the subject of his textbook on adult and pediatric Lyme disease. He spent his 20 minutes promoting his book and the Guidelines.
Kenneth Liegner, Internal and Critical Care Physician, ILADS, shared his belief that Borrelia burgdorferi can linger in patients after antibiotic treatment, a point which he supported
with two well-documented case studies that revealed the presence of spirochetes in body fluids after treatment. Dr. Liegner shared a moving video of one of the patients, who eventually succumbed to the illness. He asked the panel to “walk in his shoes” to fully understand the scope of complicated Lyme disease he sees day in and day out.
On the other hand, Alan Steere, MD, Massachusetts General Hospital and Harvard Medical School, claims that this late neurological disease is seen in no more than 1% of cases, which can be defined by diffuse axomal neuropathy and not Lyme arthritis, which is a rarity. Dr. Steere referenced older literature and completely endorsed the Guidelines. This position was quickly refuted by Steve Phillips, MD, Internist, ILADS, who asked the question “How can anyone speak with authority when the book has not been written?”
Dr. Steve Phillips presented a myriad of documentation to support persistent Bb infection, including publications which were excluded from the 2006 Guidelines review, leading to the determination that there is no biologic plausibility of antibiotics for the treatment of Lyme disease. Dr. Phillips highlighted the fact that many of the IDSA 2006 Guideline Panel Members were authors of the publications that disputed their own theory about the borrelia persistence and antibiotic use. He wrapped up his talk by discussing the risk of withholding treatment from patients and told of how patients have been harmed by these Guidelines. He expressed his hope that better antibiotics would be made available because ceftriaxone is not a wonder drug and should not be the basis of treatment trials. The panel was riveted by his presentation and responded with many questions about the various forms of Borrelia and the biologic plausibility of persisting infection.
In response to this, Arthur Weinstein, MD, Washington Hospital Center stated the biological plausibility of persistence is possibly due to relapse, incomplete treatment or a patient being rebitten. He now believes that post Lyme disease is part of a narrow specialty base of syndromes, including fibromyalgia, irritable bowel, TMJ and lupus, which have more in common with somatic disorder. He believes these conditions are associated with a psychiatric co-morbidity including anxiety and depression.
Ray Stricker, MD, ILADS, challenged several Guideline theories including the use of laboratory testing for diagnostic purposes, the duration of treatment for early and late neurologic Lyme disease, the theory that Lyme is “easy to diagnose and treat”, the persistence of infection after treatment and the danger of antibiotic treatment. Dr. Stricker discussed two different studies that show the poor sensitivity of testing in the two-tier method. He spent the remainder of his talk discussing the lack of science to support the IDSA Guidelines, and the need for physicians to provide clinical care.
Gary Wormser, MD, New York Medical College, IDSA, author of the 2006 Guidelines, tried to dispel the theory that the science does not support his Guidelines. He believes the 2006 Guidelines were more accurate than the 2000 Guidelines because among other points, they added a definition of Post Lyme Syndrome for purpose of further study, which includes a review of a patient’s pre-infection emotional state. Dr. Wormser questioned whether a few remaining Borrelia after treatment is enough to cause disease. He offered that the Guidelines should address Babesiosis, but suspected that co-infections are not likely to cause treatment complications. During the question period he alluded to another study that supports the Guidelines.
At the end of the presentations, the hearing panelists asked some additional questions. The first question gave Dr. Steere a chance to redeem himself when asked about the citations about persistence that were attributed to him and presented by Dr. Phillips. He said they were all done more than 25 years ago.
Lorraine Johnson was asked to explain why she believes the Guidelines are used exclusively, when the authors receive no financial gain. Lorraine explained the position of the insurers who use the Guidelines to deny treatment.
Dr. Stricker was asked for any further comments and he took the time to say that Barbara Johnson’s position on testing ignores the fact that “the system of testing is broken and needs to be fixed.” The basic premise that the tests are reliable, coupled with the overreliance of the Guidelines on the tests, leads to erroneous information. The Guidelines are incorrect and need to be revised.
Panel director, Carol Baker, MD, concluded that dialogue is better than mandated legislation. We concur, but the reason we reached this legal settlement was simply because the IDSA refused to enter into discussions with the Lyme treating physicians. Efforts to create state legislation to protect doctors treating Lyme and tick-borne diseases will continue to be necessary if we cannot create an ongoing dialogue and find ways to work together to conquer this medical dilemma.
Many government representatives attended the hearing. Thanks to Pat Smith’s efforts, in attendance was membership from the Office of the Inspector General ; the new NIH Lyme program head, Joseph Breen, MD, who attended the meeting and took copious notes; and Legislative Representative, Tim Lynagh, who works with Congressman Christopher Smith. Senator Christopher Dodd’s office sent a PhD health care representative in response to TFL’s request. We hope to learn the outcome of the hearing later this year, but it is clear that we have the attention of key government decision makers.
For information on how to access the presentations made at the July IDSAHearings, click here. |
The Lyme Disease Review Panel Hearing on July 30, 2009 was an historic day for anyone who has been touched by Lyme disease. It is the day when the management of Lyme disease was carefully scrutinized by a medical team of experts, a day when all the science was finally heard, a day to celebrate the medico-legal system in our country. While the outcome is pending, we can all celebrate the opportunity to finally have the full spectrum of science heard, and the suppressed voices of the patient community resound. This was groundbreaking and should send a message to medical standard setting groups that there is no room for bias in medicine. Our medical system has thrived upon its ability to operate in a free market, where the laws of supply and demand dictate the outcome. As we have all learned, any attempt to unfairly skew a result can raise red flags and create havoc, especially for those afflicted by a medical illness. July 30th represents a day of reckoning, a day where good science met good medicine, a day to give special thanks to the CT Attorney General, for determining the need for this hearing, and for having the determination to bring all the parties together.