LymeNet Newsletter Volume 7 Issue 12

Volume: 7
Issue: 12
Date: 20-Dec-99

Table of Contents:

I. LYMENET: SmithKline Sued Over Lyme Vaccine II. LYMENET: Scientific Highlights of the 1999 Bard College Lyme Conference III. ARTHRITIS RHEUM: Association of antibiotic treatment-resistant Lyme arthritis with T cell responses to dominant epitopes of outer surface protein A of Borrelia burgdorferi. IV. ABOUT THE LYMENET NEWSLETTER

Newsletter:

*********************************************************************** * The National Lyme Disease Network * * http://www.LymeNet.org/ * * LymeNet Newsletter * ***********************************************************************

Volume 7 / Number 12 / 20-DEC-1999 INDEX

I. LYMENET: SmithKline Sued Over Lyme Vaccine II. LYMENET: Scientific Highlights of the 1999 Bard College Lyme Conference III. ARTHRITIS RHEUM: Association of antibiotic treatment-resistant Lyme arthritis with T cell responses to dominant epitopes of outer surface protein A of Borrelia burgdorferi. IV. ABOUT THE LYMENET NEWSLETTER

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I. LYMENET: SmithKline Sued Over Lyme Vaccine ------------------------------------------------ Date: December 14, 1999

A class action lawsuit filed in Pennsylvania claims the vaccine that prevents Lyme Disease causes an incurable form of autoimmune arthritis and, for some, could produce symptoms far worse than those brought on by the illness.

The complaint, filed in Chester County Court of Common Pleas, alleges SmithKline Beecham, manufacturers of the widely touted LYMErix vaccine, failed to warn doctors and the general public that nearly 30 percent of the population was pre-disposed to a degenerative autoimmune syndrome, which the lawsuit says is triggered by contents of the inoculation.

"Once this autoimmune reaction is triggered, it cannot be cured and can only be treated symptomatically for the remainder of the vaccine recipient's life," the complaint says.

According to the class action, SmithKline used high concentrations of a surface protein called OspA as the foundation for its vaccine. When bitten by a Lyme infected parasite, humans are not exposed to OspA protein. The levels of OspA that enter the bloodstream at any phase of the three-dose LYMErix vaccine, however, place patients classified by genetic type HLA-DR4+ at risk of developing a condition referred to as "treatment-resistant" Lyme Arthritis, the lawsuit says.

Despite this "well documented relationship" between OspA and treatment-resistant Lyme Arthritis, SmithKline neglected to include the information in its widely disseminated promotional literature and insisted LYMErix was safe and generally well tolerated, the class action says.

About one-third of the general population is HLA-DR4+ and risks contracting the arthritic condition when exposed to the vaccine, according to the complaint. The HLA-DR4+ trait is easily detected by a routine blood test; however, SmithKline never recommended that doctors screen for the trait before administering the vaccine, the lawsuit alleges.

The complaint further alleges that patients who are infected with Lyme bacteria when they receive LYMErix -- whether asymptomatic or in the early stages of infection -- could suffer symptoms more progressive and enhanced than if they had not received the vaccine.

SmithKline, the class action says, also neglected to inform doctors and the general public that periodic booster shots beyond the series of three vaccinations would be necessary to maintain immunity to the disease.

The class action includes counts of negligence, unfair trade practices and a bid for medical monitoring of those who are placed at risk of developing autoimmune arthritis but have not yet been diagnosed with the condition.

The class action complaint was filed by Stephen A. Sheller and Albert J. Brooks Jr. of Sheller, Ludwig & Badey in Philadelphia.

Sheller said that in the wake of filing the class action, he expects to file claims on behalf of individuals who received the LYMErix vaccine and are now suffering from the autoimmune arthritis. He is seeking vaccine recipients (both symptomatic and asymptomatic), particularly from New Jersey. For more information, call 800-883-2299.

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II. LYMENET: Scientific Highlights of the 1999 Bard College Lyme Conference ------------------------------------------------------------------ Sender: Nancy Berntsen, RN, BSN <[email protected]> Date: November 22, 1999

This conference shed so much light on Lyme, too much for even the most fastidious note-taker to record. Fortunately, videos and a science-rich syllabus of the event will be available at a later date. Below are some highlights of several of the panelists' presentations.

The keynote speaker was none other than Willy Burdorfer, Ph. D, a brilliant, spry, blue eyed, white-haired man who identified the bacteria that causes Lyme disease in the early 1980's. Using excellent slides to depict the forms of spirochetes, he spoke on the history of spirochetal illness and complexity of vector-borne spirochetes.

Dr. Charles Ray Jones strongly advocated prophylactic treatment of tick bites for children and long term treatment basically two months past cessation of all Lyme symptoms. He spoke favorably of culturing for Lyme bacteria. He presented his recently released video, "The Children of Lyme" that brought tears to the eyes of many viewers.

Michael C. Caldwell, MD, MPH, Commission of Health, Dutchess County Health Department spoke about an increased awareness of Lyme disease in his county where 80% of the ticks carry Lyme bacteria. He attributes more reported cases of Lyme disease to this awareness and showed several local newspapers with headlines regarding prevalence of Lyme disease and ticks in Dutchess county. He and his community participated in vaccine studies and was a "human guinea pig" himself. He was favorable about the SmithKline vaccine thus far, though he said more time is needed to evaluate it fully. He is very interested in means of preventing tick-borne illnesses including means of controlling ticks and hopes to add a full time entomologist to the area in light of West Nile virus, which should in turn help with tbi and tick research in general in his area.

Dr. Kenneth Liegner & his nurse practitioner, Janice Kochevar did a study that strongly indicates other family members of those with Lyme disease should be evaluated for possible infection. They also presented a protocol for the nurse practitioner in accessing for Lyme disease.

Ms. Kochevar along with M. Lynne Canon and Sandra Berenbaum specifically discussed adolescents and neuropsychiatric Lyme disease.

There was a general concern over lack of standardization amongst the labs. Much time was spent explaining ELISA and Western Blot testing and shortcomings too. Dr. L. advises sending bloodwork to 2 or 3 reputable labs as results can vary just from slight temperature changes.

Regarding babesiosis & ehrlichiosis, more than one speaker indicated that these are under-reported and there is concern that they may end up underestimated as Lyme disease is as they are not tested enough. Also, the "southern" type babesiosis is not limited to the south, and babesiosis is spreading by birds to non-coastal areas.

There is some suggestion that as alarm over the West Nile virus increases, ticks will be under more surveillance so this could help in prevention of Lyme disease. There was some discussion about reducing the number of ticks, too.

One doctor said we don't know enough about the tick itself, and that the tick may very well carry a lot of other viruses and infections that are currently unidentified. Several doctors pointed out how harmful the three major tick-borne illnesses are in regard to causing immuno-deficiency and that this was cause for concern over persistent infection, allergies and auto-immunity.

Dr. David Dorward, a co-worker of Dr. Burdorfer of Rocky Mountain Laboratories, spoke on the pathology of Lyme diseases. He continued with projections of excellent visual slides of spirochetes, including an actual microscopic movie of living spirochetes in vitro. He displayed a spirochete with a whitish stain entering a dead lymphocyte and exiting coated with the bright stain of the lymphocyte, inferring it was sheathed and disguised as a lymphocyte. In addition, he had two 3D slides of spirochetes that brought these microbes right in your face! It was truly incredible.

Paul Duray, M.D. of National Institutes of Health, department of pathology early on stated that, regarding Lyme disease, "absence of evidence is not evidence of absence." He spoke very favorably of obtaining biopsies which often show unusual clusters of T & B cells characteristic of Lyme infection. The cost of such is quite reasonable. He disclosed the vast number of body organs and parts that Borrelia burdorferi (Bb) infects. He pointed out that Lyme disease is an inflammatory disease, so we should expect to see inflammation.

Nick Harris, Ph. D., president and CEO of IgeneX presented the controversy of diagnosis using a two step protocol. He provided an excellent discussion of the lab tests for Lyme disease, how they work and their shortcomings. He also discussed the difficulty of culturing from biopsy though he conceded it's value. His presentation was followed by another representative of IgeneX, Jyotsna Shah, Ph. D., director of research and development. The discussion concluded with information about the PCR (polymer chain reaction) test and FISH (fluorescent in-situ hybridization) test.

Carmine Sorbera, director of cardiac electrophysiology. His discussion involved heart problems caused by Lyme disease including myocarditis and autonomic dysfunction, explaining the mechanism of "POTS" which causes a type of shock and lowering of the blood pressure noted by both tachycardia and bradycardia. He discussed use of a tilt table to evaluate for this condition and variations that can affect the results of a tilt test.

Brian Fallon, M.D. presented a most interesting presentation of the psychiatric manifestations of Lyme disease in children and adults. Through the years, he's fine-tuned the art and skill of deciphering intertwined diagnoses of somatic and hypochondriac illnesses with affects caused by Lyme disease. For instance, panic attacks that last only a few minutes are not like those of Lyme disease which can last one to three hours. People with non-Lyme anxiety do not have memory problems. He provided a printout on psychoneurological aspects of Lyme disease in adolescents, noting that ADD, autistic behaviors, PMS, oppositional defiance behavior and numerous other symptoms can be caused or worsened by Lyme disease.

Dr. Marylynn Botsford Barkley, section of Neurology, Physiology & Behavior, Univ. of CA at Davis, Davis, CA. presented some very interesting correlations. Of particular interest to females was a discussion of two studies regarding the menstrual cycle & Lyme disease. One doctor did extensive documentation of her cycle in relation to night sweats & severity of such. They peaked around the first day of her menses for many, many months and only diminished with antibiotic use. This suggested that there is a "immune reaction" phase of the menstrual cycle that corresponds with dropping progesterone levels. The other study regarded a noteworthy increase in Lyme symptoms peaking at the onset of menses.

Louis Magnarelli, Ph. D.. of the Department of Entomology, Connecticut Agricultural Experiment Station discussed reported cases of the three most prevalent tick borne illnesses in Connecticut, stating figures were likely only 20% of the actual cases. He mentioned chipmunks as perhaps more responsible in spreading tbi than mice. He also referred to horses and dogs as carriers. He dispelled a common misconception that HGE and HME are regionalized. He stressed that edges of woods are where risk of tick exposure is greatest in yards. He could not comment whether West Nile Virus can be carried by ticks in the U.S. but that it is in Europe.

Richard I. Horowitz, M.D. emphasized that Lyme disease, babesiosis and ehrlichiosis are all immunosuppressive diseases. He has found that sweats an chills are indicative of co-infection. Fever of 102°F may decrease infection. He discussed medications for these tbi and noted findings of Dr. Brorson of Scandinavia regarding the effects of Flagyl on the cystic form of Borrelia (Lyme) infection, stating that Flagyl prevented cyst formation and degraded and ruptured cysts. He continued in discussion of use of various antibiotics and their effects, eluding to lack of response to Plaquinol being linked to possibly a stealth virus. He recommended heat treatment, vitamins and a yeast free diet in conjunction with aggressive antibiotic measures.

Joseph Burrascano, M.D. of East Hampton, NY was the final speaker. He spoke of untreated and undertreated Lyme disease as cause of permanent neurological damage including paraplegia, dementia, hearing and sight loss. He stated that 1 month of amoxicillin (4-6 grams if needed) for people with Lyme disease less than one year may be adequate but others may find that they are not better six months to a year later. He stated more than once that blood levels of antibiotics should be monitored to make sure they are at therapeutic levels. He also stated that multiple bites either at once or over a long period of time (undetected or untreated) usually require more treatment than a single infectious bite does. He spent the most time of all presenters on treatment protocol, including vitamins and other supplements to boost the immune system and exercise as tolerated. He recommended treatment until the disease is no longer active, stating that rarely patients need open-ended maintenance therapy.

Dr. Amiram Katz indicated a concern that researchers are not investigating auto-immune symptoms that may be caused by Lyme disease (not infection itself), i.e., demylenation of nerve tissue. His presentation focused on Borrelia and it's effect on the central and peripheral nervous systems. He outlined specific symptoms resultant of such infection, diagnostic testing and then touched upon treatment protocol, stating that in some cases, use of high dose steroids are useful in conjunction with antibiotic treatment. He expressed concern over lack of standardization for SPECT scan exposure and interpretation.

About the author: Nancy Berntsen, RN, BSN, Columbia, Connecticut. Nancy was diagnosed with Lyme disease in 1994 having had symptoms since childhood. She is a wife and mother of four boys, a home educator, and coordinator of Tick-borne Illnesses Self-Help Alliance, Eastern Connecticut, www.oikourgos.com/trisha , [email protected] , [email protected]

Obtaining videos or a syllabus of the Conference: The cost of a syllabus will be $20 or $25 dollars (depending on the total amount printed), including shipping and handling (slightly more, if being mailed outside the US.) This will probably not be available for several months, but for those interested, please place your order soon. Contact Sandy, [email protected]. The video tapes can be purchased for $25/set from the Lyme Disease Association of NJ, PO Box 1438 Jackson, NJ 08527. However they will not be available for several months. This is a subsidized price by the LDA-NJ to make it affordable for everyone.

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III. ARTHRITIS RHEUM: Association of antibiotic treatment-resistant Lyme arthritis with T cell responses to dominant epitopes of outer surface protein A of Borrelia burgdorferi. --------------------------------------------------------------------- AUTHORS: Chen J, Field JA, Glickstein L, Molloy PJ, Huber BT, Steere AC ORGANIZATION: Tufts University School of Medicine, Boston, Massachusetts, USA. REFERENCE: Arthritis Rheum 1999 Sep;42(9):1813-22 ABSTRACT:

OBJECTIVE: To explore further the association of antibiotic treatment- resistant Lyme arthritis and T cell reactivity with outer surface protein A (OspA) of Borrelia burgdorferi, including the identification of T cell epitopes associated with this treatment- resistant course. METHODS: The responses of peripheral blood and, if available, synovial fluid lymphocytes to B burgdorferi proteins, fragments, and synthetic peptides, as determined by proliferation assay and interferon-gamma production, were compared in 16 patients with treatment-responsive and 16 with treatment-resistant Lyme arthritis. RESULTS: The maximum severity of joint swelling correlated directly with the response to OspA. Moreover, the only significant difference between patients with treatment-resistant and treatment-responsive arthritis was in reactivity with N-terminal and C-terminal fragments of OspA, OspA1 (amino acids [aa] 16-106), and OspA3 (aa 168-273). Epitope mapping showed that 14 of the 16 patients with treatment- resistant arthritis had responses to OspA peptides (usually 4 or
5 epitopes), whereas only 5 of the 16 patients with treatment- responsive arthritis had reactivity with these peptides (usually 1 or 2 epitopes) (P = 0.003). Patients with HLA-DRB1 alleles associated with treatment-resistant arthritis were more likely to react with peptide 15 (aa 154-173) and, to a lesser degree, with peptide 21 (aa 214-233) than patients with other alleles, whereas the responses to other epitopes were similar in both groups. CONCLUSION: The maximum severity of joint swelling and the duration of Lyme arthritis after antibiotic treatment are associated with T cell responses to specific epitopes of OspA.

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IV. ABOUT THE LYMENET NEWSLETTER ----------------------------------------------------------------------- For the most current information on LymeNet subscriptions, contributions, and other sources of information on Lyme disease, please refer to: http://newsletter.lymenet.org----------------------------------------------------------------------- To unsubscribe from the LymeNet newsletter, send a message to: [email protected] On the first line of the message, write: unsub lymenet-l ----------------------------------------------------------------------- LymeNet - The Internet Lyme Disease Information Source ----------------------------------------------------------------------- Editor-in-Chief: Marc C. Gabriel <[email protected]> FAX (for contributions ONLY): 908-789-0028 Contributing Editors: Carl Brenner <[email protected]> John Setel O'Donnell <[email protected]> Frank Demarest <[email protected]>
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