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Re: Evidence For Chronic Lymes Disease

Posted by Phillipa on February 15, 2009, at 20:39:13

In reply to Re: No Evidence For Chronic Lymes Disease » bleauberry, posted by Phillipa on February 15, 2009, at 20:05:24

Last one would like to leave my experience behind. Phillipa

From the LymeLight Newsletter of the Lyme Disease Foundation

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The controversies surrounding Lyme Disease diagnosis and treatment and why it is not uncommon for patients to experience persistent symptoms despite receiving conventional" (short-term) antibiotic therapy for Lyme disease.

"Randomized controlled studies of treatment of patients who remain unwell after standard courses of antibiotic therapy for Lyme disease are in progress. To date, there are no convincing published data that repeated or prolonged courses of either oral or iv antimicrobial therapy are affective for such patients. The consensus of the Infectious Disease Society of America (IDSA) expert-panel members is that there is insufficient evidence to regard "chronic Lyme disease" as a separate diagnostic entity."

So reads the most disturbing statement in the latest Lyme disease diagnostic and treatment protocol, formulated by the Infectious Disease Society of America (IDSA) and published in the September issue of Clinical and Infectious Diseases (2000; 31:1-14). Not surprisingly, the protocol dismisses the existence of chronic Lyme and provides clinicians with a virtual "four weeks cures all" protocol. The LDF expected the contents of the protocol after it discovered internal National Institutes of Health (NIH) documents that confirm the IDSA protocol was coordinated with a CDC-funded protocol to ensure they were identical. Another unsurprising aspect of the protocol is that it does not disclose IDSA committee members' conflicts-of-interest, as some committee members consult for insurance companies and Health Maintenance Organizations.
The IDSA's chronic Lyme disease (LD) statement is especially troubling because it comes during a time when physicians who recognize and aggressively treat late-stage LD are being charged by state licensing boards with overdiagnosis and overtreatment of the disease. For such doctors the protocol adds another "authoritative" document dictating "appropriate management" of a disease in which treatment failure can occur in any stage and no test can definitively diagnose or distinguish active from past infection. Adding further confusion to doctors trying to responsibly help patients is that no consensus has been reached about the clinical spectrum of LD, which the Centers for Disease Prevention and Control (CDC) states is a clinical diagnosis not to be ruled out based on negative tests.

"The implications of the guidelines are chilling," said Kenneth Liegner, M.D., a LD specialist from Armonk, NY, an area hyperendemic for Lyme disease. "They place physicians who treat beyond [IDSA] parameters in an extremely defensive position." Sam Donta, MD a Boston University Hospital infectious disease specialist, has already experienced the impact IDSA's statement is having on other clinicians. "Patients have already told me doctors are telling them there is no such thing as chronic Lyme disease," he said.

Donta, who like Liegner treats late-stage LD patients from around the country with longer-term antibiotic therapy, said he too was stunned that the Society could come to such a conclusion, especially since the National Institutes of Health (NIH) believes in chronic LD enough to study it.

Many physicians and researchers voice displeasure that since Lyme was supposedly "identified" in and around Lyme, Connecticut in 1975 by rheumatologist and IDSA committee member Allen Steere (a medical/insurance consultant), he and a few of his colleagues have become crowned "leading authorities" on LD. They say the approach they and the CDC take studying the disease continues today: minimize medical costs associated with the disease by downplaying its seriousness and defining it in the narrowest terms possible. Such an approach limits patient access to tests, reduces the official number of patients reported to have the disease, and reduces treatment costs, they say.

Initially Steere believed LD was a viral arthritis that affected only children, its symptoms were limited to arthritic conditions, and the disease eventually went away on its own. Southeastern Connecticut shoreline towns were thought to be the only place in the country where one was at-risk for the disease. It was also believed neurological manifestations of LD, common in Europe, did not occur with US strains of the LD bacterium, Borrelia burgdorferi, (Bb).

As science evolved, Steere and his colleagues, most of which continue to receive large government grants to study the disease, were slow to acknowledge Lyme is often a multisystemic disease. As it became apparent that symptoms often did not disappear on their own, they acknowledged antibiotic treatment was sometimes necessary to eradicate the Lyme bacteria. They steadfastly maintain, however, that short-course antibiotic therapy is highly curative, seronegative disease is rare, and patients who remain symptomatic after treatment suffer from misdiagnosis or "post Lyme syndrome", which attributes persisting symptoms to past, not active infection.

While initial conclusions about the disease have been modified, their narrow definition of the disease allows the most conservative conclusions relative to diagnosis and treatment to be made. Patients in late disease with severe neurologic symptoms, which are the most problematic to diagnose and difficult to cure, rarely meet the narrow CDC surveillance criteria (e.g. swollen joint(s) and positive two-tier tests) used as inclusion criteria for research studies. As a result, a large void in Lyme research exists.

Testimony by IDSA committee member/insurance consultant Raymond Dattwyler, MD during a 1994 Food and Drug Administration (FDA) meeting on the Lyme vaccine reveal enough gray areas in scientists' understanding of the disease to suggest standardization of diagnosis and treatment of LD is not yet possible. Nationally-based treatment trials of erythema migrans, Dattwyler said, may suggest regional differences in patients' symptoms and response to antibiotic therapy due to many different strains of Bb found throughout the U.S. Dattwyler also testified that patients who mount a weak immune response to the disease tend to have worse disease and a greater chance of treatment failure than do those who mount a vigorous immune response.

In addition, Dr. Dattwyler echoed the consensus among experts concerning the relationship between the LD bacteria and how it affects humans. "I don't think we have fully delineated all the various clinical manifestations associated with this infection," he said. Several times throughout his testimony Dattwyler repeated that sentiment.

Dr. Liegner has concerns that suggest IDSA bias against the existence of chronic LD. "It's amazing that the Committee ignored piles of published case studies detailing chronic Lyme because they're not double-blinded peer-reviewed studies," he said. Liegner went on to echo the consensus among he and his colleagues: In lieu of the absence of such research and disagreement among experts over the etiology and clinical spectrum of the disease, there are no "evidence-based" experts qualified to determine appropriate standards of care for LD. Therefore, Liegner said, empirical treatment, or treatment based on patient response, should be the standard of care.

Dr. Liegner also expressed concern that out of 99 studies cited in the protocol, only two examines chronic LD. One cited study by Dr. Steere, "Chronic neurologic manifestations of Lyme disease" (N Engl J Med 1990; 323:1438-44) evaluated the outcomes of patients with late neurological LD symptoms when treated with iv ceftriaxone (2 grams daily for two weeks). Of 27 adult patients, 17 (63%) of patients had "uncomplicated improvement." 6 (22%) had improvement and then relapsed and 4 (15%) had no change in their condition. Regardless of this study's 66% "uncomplicated improvement" rate, IDSA recommends treating late neuroborreliosis with 2-4 weeks of ceftriaxone. Guidelines state "response to treatment may be slow and incomplete." Unless relapse is shown by "reliable, objective measures" repeat therapy is not recommended.

An abstract presented by IDSA committee member Dr. Dattwyler at the VII International Congress on Lyme Borreliosis in 1996 revealed similar statistics. That study evaluated the effectiveness of intravenous orintramuscular injections of ceftriaxone, 2 grams daily, for 2 versus 4 weeks. Patients in the study had to have objective evidence of a usculoskeletal, neurologic or dermatologic disorder compatible with the diagnosis of LD and positive ELISA and Western blot tests.

The abstract reported clinical cure rates of 76% for patients treated for 14-days and 70% for those treated with 28-days. While the 28-day group had a lower efficacy rate, patients in this group were "more severely ill" than those treated for two-weeks. (No data concerning patients' specific immune response was included.)

To be eligible for the study, patients must have had an erythema migrans or exposure to an endemic area no less than 3 months prior to enrollment. Therefore it is likely most patients, if not all, were infected less than four months prior to treatment. Doctors such as Liegner and Donta find the hardest patients to treat are those who are likely to have been infected many months or even years before getting diagnosed.

Despite assertions by Dr. Dattwyler that a positive test stands a 98% chance of being a false-positive (1993 WLIW TV interview), the protocol does not explicitly state what constitutes "reliable, objective measures" that would warrant extended therapy when i.v. treatment fails to alleviate symptoms of neroborreliosis. Using direct-detection tests such as PCR, the experience of front-line physicians like Donta and Liegner find such short duration therapy in late stage cases is not likely to eradicate the LD spirochete. They find several months or more of therapy is often required before a patient is symptom-free/relapse free. In some patients, restoration of prior health may not be possible.

Many case reports support the adaptation of a longer-term treatment approach. Liegner has published case studies detailing Bb's ability to evade antibiotic destruction, including "Recurrent erythema migrans despite extended antibiotic treatment with minocycline in a patient with persisting Borrelia burgdorferi infection" (Journal of the American Academy of Dermatology, 1993; 28: 312-314). Numerous full text articles detailing persistence or relapse of LD despite "appropriate" or "conventional" antibiotic therapy have also been published in peer-reviewed journals.

Among the most compelling published evidence of chronic infection despite prolonged antibiotic therapy is the case study "Seronegative Chronic Relapsing Neuroborreliosis," (Eur Neurol 1995; 355: 113-17). It details a patient whose serum was consistently negative for free antibodies for Bb infection, but had laboratory evidence of active infection in the cerebrospinal fluid (CSF). The patient, a previously healthy 58-year-old woman, received four courses of intense antibiotic therapy: 3-weeks of intravenous ceftriaxone followed by 8-weeks of ceftriaxone; 2 weeks of intravenous ceftriaxone followed by 19 weeks of doxycycline; 3-weeks intravenous treatment followed by additional treatment with doxycycline; and 2 weeks of intravenous ceftriaxone.

Evidence of active infection was found each time after intense prolonged antibiotic therapy was administered. Relapse occurred soon after treatment was stopped and Jarish-Herxheimer episodes were experienced each time treatment was initiated. (J-H reactions are symptoms that include fever and nausea and are believed to be cause by the body's initial reaction to toxins from dead Bb.) When the patient was given clarithromycin for 22 months, no new symptoms or deficits occurred.

The report concludes the case is "an unusual case of seronegative Lyme disease" in a patient with "chronic relapsing Bb infection." Renowned neuro-Lyme expert and IDSA committee member Patricia Coyle, MD, SUNY Stony-Brook School of Medicine, co-authored the article. She did not respond to Email requests to discuss the IDSA protocol.

In addition to its rebuttal of chronic Lyme and endorsement of a short-term protocol, the way the Society conducted itself while formulating the guidelines remains a concern to many scientists. Dr. Donta was originally a member of the IDSA while it was drafting the protocol. He says the committee "disbanded" after years without success of trying to agree on anything beyond diagnosis and treatment of early-stage disease. He said during his time on the committee, no statement on chronic LD was included in the protocol's original draft.

When Donta learned the guidelines were going to be published, he said he voiced his desire to make changes to its late-stage section. Rather than consider his suggestions, Dr. Donta said committee member Robert Nadelman, MD, informed him that unanimity was not required for publication, and Donta's name was removed from the protocol without explanation. For reasons that remain unclear, the protocol was taken from committee chair Benjamin Luft, who Donta believes wanted to make changes to its late stage section, and given to Dr. Gary Wormser, an insurance consultant (Aetna) who took over as IDSA chair during the reorganization of the committee. Dr. Donta previously told LymeLight he believed the IDSA meetings "were based on politics, not science" and that when the guidelines were published, they would be "an embarrassment to the Society." Dr. Luft did not return messages to discuss the protocol.

Documents obtained by the LDF support Donta's conclusion. In a October 1995 e-mail, former NIH Lyme Disease Program Officer Edward McSweegan (who was removed from his position), tells new NIH Lyme Disease Program Officer Phil Baker that the American College of Physicians (ACP) and IDSA are currently working on Lyme disease diagnostic and treatment protocols. McSweegan says Dan Rahn, who was in charge of CDC-funded ACP protocol and an IDSA member for the LD protocol, is "supposed to be talking with" IDSA chair Benjamin Luft, MD to "avoid duplication incompatibility." Rather than "copy the wheel," (presumably by writing a third identical protocol), McSweegan suggests NIH find a way "to support the current efforts or provide some kind of endorsement for them."

Adding further suspicion of collusion to establish one specific protocol for LD diagnosis and treatment is a portion of the book "Lyme Disease" authored by IDSA-committee membr Dan Rahn,M.D., M.P.H., and Yale physician Janine Evans, M.D., and the American College of Physicians. Page 199 of the book states: "Nationwide, efforts are well underway to limit practice variation, reduce unnecessary health care expenditures, and measure and improve patient outcomes." Not only might this pertain to avoiding "duplication incompatibility" on authoritative LD protocols, but also one must wonder its relevance to the nationwide harassment of physicians by state health departments against doctors who deviate from "authoritative" protocols such as the IDSA's and treat beyond their recommendations.

Reached at his office at the Medical College of Georgia (MCG), Dr. Rahn, Chair of the MCG-Blue Cross/Blue Shield Center of Health Care Improvement, said no effort was made to coordinate protocols and that the paragraph in question simply pertains to analyzing if Lyme patients are receiving "the known best practice by leading authorities" for diagnosing and treating LD. As an example, Rahn cited "Quality of Medical Care Delivered to Medicare Beneficiaries" a study in the October issue of Journal of American Medical Society (JAMA 2000;284:1670-1676). The study analyzes quality of care Medicare recipients receive for primary prevention, secondary prevention and/or treatment of 6 medical conditions (e.g. stroke) for which there is "strong scientific evidence and consensus that the process of care either directly improves outcomes or is a necessary step in a chain of care that does so." In light of polarized medical and scientific communities over the diagnosis/treatment and clinical spectrum of LD and ongoing NIH studies examining the issue of chronic LD, it seems such a study for Lyme cannot be done on a scientific basis.

Likewise, efforts to "standardize" diagnosis and treatment protocols would be, at best, premature. Though Rahn cited the JAMA study as an example what his book referred to, he offered no specifics as to what similar studies may have been "well underway" when the book was published in 1997.

It is such suggestions as Dr. Rahn's that make many Lyme doctors such as New Jersey physician Anthony Lionetti irate. "Right now, it is impossible to formulate any protocol for Lyme that goes beyond early stage disease," Lionetti said. "Thousands of treated patients experience persisting symptoms despite 28-days of treatment. How can we standardize their treatment when there is not one double-blinded, controlled study that examines how they respond to additional antibiotic therapy." Lionetti estimates he has treated over 1,000 late-stage Lyme patients. For the majority of those, he prescribes a maximum of eight weeks of intravenous antibiotic therapy and estimates the success rate by treating with such duration is "about eighty to ninety percent."

New York State Office of Professional Medical Conduct's trial against East Hampton doctor Joeseph Burrascano, Jr., on charges of overdiagnosis/treatment of LD and its revocation of Long Neck Lyme specialist Perry Orens, MD, last year exemplifies the "chilling" impact Liegner and others believe the protocol will have on Lyme docs who aggressively treat late-stage LD. After leaving Burrascano's case open for over six years, OPMC informed him just weeks after the protocol was first released in late August that they will proceed with their case against him. The opening date of his trial took place October 26. LDF chair Karen Vanderhoof-Forschner anticipates the IDSA protocol will be among the primary evidence used against Burrascano.

Though Burrascano cannot reveal the specific charges against him, media reports state the charges include overdiagnosis and overtreatment of LD. The case represents a pivotal chapter in the Lyme disease controversy, as Burrascano is perhaps the most vocal, respected and influential physician who recognizes and aggressively treats LD. With his Lyme disease diagnosis and treatment protocol published in Conn's Current Therapy (Rakel, 1997), many Lyme-literate doctors rely on his guidelines to diagnose and treat LD.

Should Burrascano lose his case, the ever-shrinking list of doctors willing to aggressively treat patients who remain symptomatic after "conventional" short-term therapy because of unscientific protocols such as the IDSA's is sure to become even shorter.

And the implications of that go far beyond chilling.

 

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