LymeNet Newsletter Volume 2 Issue 04

Volume: 2
Issue: 04
Date: 21-Mar-94

Table of Contents:

I. ANALYSIS: Dr. Lloyd Miller on the PCR Study by Nocton et al II. ANNOUNCEMENT: LDF Medical Advisor Seeks Patient Input III. NIH RFA: Intravenous Antibiotics for Rheumatoid Arthritis IV. Q&A: Roxithromycin and Lyme (A) V. Q&A: Neuroreport article on Alzheimer's and LD (Q) VI. Q&A: Roxithromycin and Lyme (A) VII. Q&A: Pulse Therapy (Q) VIII. Q&A: Alternative Treatments? (Q) IX. How to Subscribe, Contribute, and Get Back Issues

Newsletter:

*********************************************************************** * The National Lyme Disease Network * * LymeNet Newsletter * ***********************************************************************

IDX# Volume 2 - Number 04 - 3/21/94 IDX# INDEX IDX# IDX# I. ANALYSIS: Dr. Lloyd Miller on the PCR Study by Nocton et al IDX# II. ANNOUNCEMENT: LDF Medical Advisor Seeks Patient Input IDX# III. NIH RFA: Intravenous Antibiotics for Rheumatoid Arthritis IDX# IV. Q&A: Roxithromycin and Lyme (A) IDX# V. Q&A: Neuroreport article on Alzheimer's and LD (Q) IDX# VI. Q&A: Roxithromycin and Lyme (A) IDX# VII. Q&A: Pulse Therapy (Q) IDX# VIII. Q&A: Alternative Treatments? (Q) IDX# IX. How to Subscribe, Contribute, and Get Back Issues IDX#

QUOTE OF THE WEEK:

"The main concern at this time is to see why there is a group of individuals who are going after the doctors who aggressively treat Lyme disease. Why is there a strong influence to investigate the doctors and suspend their licenses? Finally, why has there been an effort to publish incomplete or misleading patient data to illustrate that Lyme has been over-diagnosed and over-treated?"

-- Dr. Craig Cleveland (see section II)

INTRODUCTION:

From the first issue, LymeNet Newsletter has always given editorial priority to reader contributions. This week, that policy is put to the test as we publish the longest issue of the Newsletter ever. Despite the high volume of information, I hope each reader will take the time to examine each article and respond when appropriate.

Many who read the recent Nocton retrospective study on PCR analysis were puzzled by the conclusions announced by the researchers. Some felt the conclusions did not match the data, and the mass media were fed misinformation. In this issue, Dr. Lloyd Miller provides us with his perspective on the study.

Next, Dr. Craig Cleveland asks patients to send him information regarding their treatments and experiences. He is seeking to compile this information for analysis by a panel of physicians at the Lyme Disease Foundation Conference next month.

Subsequently, we learn the NIH is interested in the effects of IV antibiotics on RA patients. We have heard many rumors about this impending Request for Applications in the past few months, so we felt it necessary to publish the information as soon as possible.

The remaining features are Questions and Answers. Once again, your contributions are important. Send them via e-mail to [email protected] or by FAX to 908-789-0028.

-Marc.

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I. ANALYSIS: Dr. Lloyd Miller on the PCR Study by Nocton et al. ------------------------------------------------------------------ Sender: Lloyd E. Miller, DVM <[email protected]>

COMMENTS BY LLOYD E. MILLER CONCERNING: Nocton JJ, Dressler F, Rutledge BJ, Rys PN, Persing DH, Steere AC: Detection of Borrelia burgdorferi DNA By Polymerase Chain Reaction In Synovial Fluid From Patients With Lyme Arthritis. N Engl J Med 1994;330:229-34.

This article points out how important a research tool PCR testing can be in investigating Lyme disease. At the same time it shows that negative PCR tests can not be used to completely rule out a diagnosis of Lyme arthritis. In their PCR testing it took four primer-probe sets to detect Bb DNA in 75 (85%) of 88 patients. Based on the authors' assumptions, there should have been no false positive test results since all patients (by their criteria) had Lyme arthritis. The authors show that great care was taken to avoid contamination of samples and false positives test results. Interestingly, 13 (15%) of the tests were then falsely negative in that they didn't detect Bb DNA by any of the primer-probe sets. Had the authors not used four primer-probe sets the most they would have detected using the best results of set 3 was 75% (25% false negative results).

Using the worst results of primer-probe set 4 (not detecting OspA DNA) there would have been 52% false negative results. Primer-probe sets 2 and 3 looked for the same OspA gene segments using different probes. Results show that probes used also influence test outcomes. There were 11 more positive tests with set 3 than set 2. Put another way, set 2 resulted in 11 more false negative results than set 3. Apparently certain substances in synovial fluid can inhibit the PCR and when present in synovial fluid can result in false negative tests. In 2 of the 15 negative samples PCR inhibitors were detected. What substance inhibited these samples is not speculated. Their data also demonstrate interlaboratory variability. Results between two laboratories using the same primer-probe sets had 22% of their results discordant.

It appears that the PCR test is well suited for investigational studies of Lyme disease if one takes into account all the possible variables. False positive tests are certainly possible in laboratories not paying attention to strict laboratory procedure. It is obvious from the data presented that the false negative rate even under the best of conditions can be high (15%). It is also clear that the choice of primer sets and probes is important in development of accurate PCR tests. One of the drawbacks I see with the PCR test is that Bb DNA can not be found in the same tissue or fluid in every patient. Unless the Bb containing fluid or tissue is tested the diagnosis will be missed if only the PCR test is relied upon.

Soon after this article was published the public press reported that the test used in this study was the new test we have been looking for to diagnose Lyme disease. In order for this test to become important in the widespread commercial diagnosis of Lyme disease it would appear that multiple primer-probe sets will need to be used in laboratories using meticulous laboratory technique. In the research laboratory this would seem to be possible but is it in the busy commercial laboratory setting?

The authors offer several possible reasons for the presence of Bb OspA DNA in synovial fluid and then make the following statement: "Thus, it seems likely that the detection of OspA DNA in joint fluid indicates the presence of viable spirochetes."

If the above statement proves to be correct then the information presented demonstrates persistence of Bb in both untreated and treated patients. Serial samples from 12 untreated patients taken from months to years following initial diagnosis during episodes of arthritis were positive for Bb DNA. It would be interesting to know if during the quiescent periods Bb DNA could have been detected. Twelve patients sampled 2 to 4 months after short course antibiotic treatment were all (100%) positive. Of 19 patients tested following longer courses of antibiotic treatment 7 (37%) were still positive 1 day to 17 months following treatment. Of twelve patients treated even longer all were negative (100%) 1 day to 4 years following treatment. Of 10 patients with chronic arthritis despite multiple courses of antibiotic 7 had consistently negative tests but 3 (30%) were positive. It is unclear if any of the patients in this group are included in the 12 patients of the longer treatment group that were negative following treatment.

The group of 19 were treated for median course lengths of 37 (20-56) days orally or 14 (14-21) days IV. The group of 12 treated even longer were treated for median lengths of 48 (21-120) days orally or 30 (7-44) days IV. The authors state that statistically there is no difference between the two groups based on the length of treatment; however there certainly seems to be a clinical difference. Based on these numbers it would appear that initial treatment with longer uninterrupted courses of antibiotic would be preferred. The authors state that PCR was usually negative after antibiotic treatment but their data do not show this. Of 43 patients tested following treatment 19 (44%) tested positive following treatment. This seems like an unacceptably high percent to me.

Negative tests, especially in symptomatic patients, could mean that there was not enough DNA to detect or that Bb are in the synovial tissue and not the fluid or that they are true negative results and the symptoms are due, as the authors state, to another mechanism. We must be cautious about drawing conclusions about Lyme disease based on the data presented. The authors were working with a very small population of patients. They are using retrospective data and information developed over 17 years. They are investigating only one aspect of Lyme -- arthritis.

This study makes some important contributions to the knowledge base of Lyme disease. There is a need for prospective studies of this nature to be done for patients exhibiting all the diverse manifestations of Lyme disease in which various body fluids and tissues are sampled. And yet, without a "gold standard test" interpretation of the study results remain somewhat uncertain.

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II. ANNOUNCEMENT: LDF Medical Advisor Seeks Patient Input ----------------------------------------------------------- Sender: Craig Cleveland, M.D. <[email protected]>

I am working with a group of physicians to gather information about the experiences of Lyme disease patients.

First, we are looking for information regarding insurance companies and their treatment of the patients with Lyme Disease. We are looking for patients who had been diagnosed with Lyme, and had their therapy paid for by the insurance companies, and for those who had their therapy cut off by the insurance companies. We need specific names of the patients, their addresses (mail or e-mail), the insurance company, the doctor's name, and any brief note concerning their treatment.

Second, we are looking specifically for patients thought to have Lyme, but whose diagnosis was denied by a university or medical center, or who were declared "cured" due to their 3-4 week course of meds. Any patients treated by short term treating physicians (i.e. Dr. Allen Steere and his colleagues) would be great to contact.

I would like to mention one thing of great importance concerning the request about the insurance companies. There is a great deal of pressure coming down on the doctors treating Lyme for more than 4 weeks. There are threats to their licenses and one doctor has had his license to practice pulled for treating Lyme. Unless there is a monumental effort by the Lyme community (i.e. patients and families), doctors will possibly be pulling out of the treatment arena. As practicing physicians, we cannot risk our licenses over a small group of patients, no matter how great their need is. If the ability to practice medicine is taken away, we have all lost. The patients and their families must come forward and help to protect the right of doctors to treat this disease.

The main concern at this time is to see why there is a group of individuals who are going after the doctors who aggressively treat Lyme disease. Why is there a strong influence to investigate the doctors and suspend their licenses? Finally, why has there been an effort to publish incomplete or misleading patient data to illustrate that Lyme has been over-diagnosed and over-treated?

I will be the only one to have access to all the information. I will compile the information without using the patient's names, but if necessary, the patients will be contacted prior to any use of the information they have submitted. We are very sensitive to the need to isolate the patients and to protect the good physicians and the good insurance companies.

I am hoping to have this information well before the 1994 Lyme Disease Conference on April 22-23. The Lyme Disease Foundation and the supporting/advising doctors will be getting together during that time to determine the approaches we need to make. I can assure you that the doctors involved are the ones who have been helping the patients the most.

The responses can be sent to me via Compuserve 72602,777 or via the Internet [email protected] or to the office address. Dr. Craig Cleveland 3330 Erie Ave. Cincinnati, OH 45208

Craig Cleveland, M.D., is one of the medical advisors to the Lyme Disease Foundation.

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III. NIH RFA: Intravenous Antibiotics for Rheumatoid Arthritis --------------------------------------------------------------- Source: NIH gopher server <helix.nih.gov>

94.02.25 RFP-RFA PILOT STUDY: INTRAVENOUS ANTIBIOTICS FOR RHEUMATOID ARTHRITIS NIH GUIDE, Volume 23, Number 8, February 25, 1994 RFA AVAILABLE: AR-94-006 P.T. 34

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: July 13, 1994

THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW.

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) requests applications to initiate a pilot clinical study designed to test the hypothesis that intravenous antibiotic therapy is an effective and safe treatment for rheumatoid arthritis. The budget appropriation report language for the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) indicated that funds were provided to "...initiate a pilot clinical trial to study the efficacy of intravenous antibiotic therapy in treating rheumatoid arthritis. This study should include measures of disease activity and, pending the outcome, be considered the initial step in developing a multicenter clinical trial."

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged.

FUNDS AVAILABLE

A sum of $500,000 (total cost) is available for this RFA. One award is anticipated. Of this amount, $50,000 is reserved for the operation of a Data and Safety Monitoring Committee.

RESEARCH OBJECTIVES

Background

The role of infectious agents in the pathogenesis of rheumatoid arthritis is uncertain. In 1971 a small clinical trial of low dose tetracycline treatment for rheumatoid arthritis demonstrated no beneficial effect (Skinner et al., Arthritis Rheum 1971;14:727-35). In two small open trials oral minocycline appeared to improve outcome in rheumatoid patients (Breedveld et al., J Rheumatol 1990;17:43-6; Langevitz et al., J Rheumatol 1992;19:1502-4). In April 1991, the NIAMS initiated a double-blind, placebo-controlled clinical trial of oral minocycline. The results of this trial, as well as the results of a similar trial in the Netherlands, were presented at the 57th Annual Meeting of the American College of Rheumatology in San Antonio, Texas, on November 8, 1993 (Tilley et al., Arthritis Rheum 1993;36:s46 and Kloppenburg et al., Arthritis Rheum 1993;36:s47). The American study showed modest benefit and low toxicity, while the European study showed little benefit and moderate toxicity.

For many years the Senate Appropriations Committee has expressed an interest in the infectious theory of rheumatoid arthritis, especially the possibility that mycoplasma organisms cause rheumatoid arthritis. In its 1994 Appropriations Report, the Committee directed "that NIAMS, within the funds provided, initiate a pilot clinical trial to study the efficacy of intravenous antibiotic therapy in treating rheumatoid arthritis. The study should include measures of disease activity... " The NIAMS now solicits applications to fulfill this directive.

Goals and Scope

The goal of this RFA, accordingly, is to encourage development of a pilot clinical research project designed to test the hypothesis that intravenous antibiotic therapy is a potentially effective and safe therapy for RA.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Susana A.S. Sztein at the address listed under INQUIRIES.

INQUIRIES

Written and telephone requests for the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome.

Direct requests for the RFA, inquiries regarding programmatic issues and requests for guidelines for the DSMC to:

Dr. Susana A.S. Sztein Rheumatic Diseases Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 594-9953 FAX: (301) 594-9673

Direct inquiries regarding fiscal matters to:

Mrs. Diane M. Watson Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 594-9965 FAX: (301) 594-9950

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis and Musculoskeletal and Skin Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

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IV. Q&A: Roxithromycin and Lyme (A) ------------------------------------- Sender: Jerry Grandoni <[email protected]>

I would like to comment on Dr. Miller's question concerning selection of antibiotic resistant variants of Borrelia by antibiotic treatment. Many antibiotic resistance genes are carried on plasmids that are not required for survival of the cell unless there is selection for them. The selection comes from the antibiotic treatment. When the treatment is halted the plasmid becomes an energetic load on the bacterial cell and is often discarded. That is why it is important to rotate the use of various antibiotics. Treatment with roxithromycin may select for spirochetes that contain a plasmid carrying a gene that confers resistance to the drug. Furthermore, if the plasmid is a conjugative type it can be transferred directly from cell to cell so resistance can spread quickly. One of the major problems that clinics are facing now is the emergence of strains containing multi-resistant plasmids. This is important because the genes for resistance to several antibiotics can be carried on one plasmid. Selection for one of these genes
causes the retention of all the resistance genes. Formation of such multi-resistant plasmids may take years of selective pressure and B. burgdorferi may not have developed them yet.

Jerry Grandoni Univ. of Med. and Dent. of NJ School of Osteopathic Med. Stratford, NJ 08084

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V. Q&A: Neuroreport article on Alzheimer's and LD (Q) ------------------------------------------------------- Sender: Jerry Grandoni <[email protected]>

In one of the back issues of the lymenet newsletter there was an article about a paper that reported a possible connection between Alzheimer's disease and the presence of spirochetes in the blood. The paper is from the journal Neuroreport, July, 1993. Has there been any confirmation of these findings or even further studies done to test them?

Jerry Grandoni Univ. of Med. and Dent. of NJ School of Osteopathic Med. Stratford, NJ 08084

-Ed. No follow-up reports, confirmations or analyses have come to the attention of the editors. Various computer searches have also failed to yield any results. If anyone is aware of any such publications, please let us know. We will report any new information as soon it becomes available.

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VI. Q&A: Roxithromycin and Lyme (A) -------------------------------------- Sender: SUZANNE COLTER <[email protected]>

I began doing some reading and researching into the use of Roxithromycin in the treatment of Lyme Disease a few years ago when I had been diagnosed and was to begin treatment for late-stage Lyme.

According to the book, "LYME DISEASE: Patient/Physician Perspectives", Roxithromycin has shown promise in treating later stage Lyme, especially after "traditional" antibiotic regimens have failed. It has also been investigated for treating Toxoplasmosis (a protozoan infection of the brain often associated with AIDS). This looks promising for Lyme patients experiencing chronic infection of brain tissues.

However, Roxithromycin has proven ineffective "after" cerebral abscesses or lesions have formed. Consequently, Lyme patients who have white matter lesions revealed on an MRI may not benefit from its use. Possibly, its failure is because this drug is unable to adequately penetrate the lesions where the Lyme "spirochetes" can hide out. There are newer generation antibiotics available that better penetrate the blood brain barrier. One or a combination of these may be a better choice, in this case.

Roxithromycin has been used in combinations as well for treating Lyme Disease. One of such combinations include the use with Bactrim, showing good results. However, Bactrim is not tolerated by some. In this case, other drugs such as Dapsone (also a sulfur drug) have been used.

In my personal search for Roxithromycin, I found it was not available in the USA but that it was being used in other countries including England, Germany, France, and Spain. I contacted a good friend that resides in Mannheim, Germany and she discussed this with her physician there. Her physician was willing to work with mine in making it available for my use.

At that time, a 3 month supply of Roxithromycin, or "Rulid", could be ordered and made available to physicians in the USA. Persons visiting in Europe could also bring back a 3 month supply if they had a valid prescription from a doctor that would be monitoring its use. During its use, Liver enzyme levels should be checked on a regular basis, especially upon commencing treatment. The FDA has approved this type of importation under the category of "compassionate uses" for people with serious or life-threatening illnesses.

My physician was reluctant to pursue this endeavor due to unknown obstacles that might occur, such as delays in receiving the drug on a timely basis, its continued availability, etc. He would rather wait until the FDA approves its use in the USA (who knows how long that might take?!!).

Note: (Some food for thought) This physician from Germany questioned as to why I specifically wanted Roxithromycin (Rulid) for the treatment of Lyme Disease. He stated that there were other, better drugs being used for the treatment of this tick related spirochetal infection (they do not refer to it as "Lyme Disease" in Germany - that is just the given name for it here in the US) that offered much better cure success rates. Unfortunately, despite several attempts to learn what these better drugs he referred to are, I have had no luck in getting a reply! But I later received a 1-month supply of "Rulid" that this physician prescribed and had my friend send to me, just in case I wanted to try it. I never began taking it due to the fact my physician was hesitant to get me started on it for the reasons stated above.

In the meantime, I received IV Rocephin, sometimes accompanied with IV Doxycycline, for several months throughout 1992. Since then, we have found I do well on the combination oral antibiotic regimen of Biaxin, Vantin and Rimactane. That is - as long as I stay on it. Attempts to decrease, or "wean me down", causes my Lyme symptoms to flare up.

My physician, having both a degree in Pharmacology and Internal Medicine, is very knowledgeable in the use of combination antibiotic treatments for his Lyme patients here in northern Missouri. His reasoning for the use of the drug, Rimactane, (which is usually restricted to the treatment of TB) is that in using it allows better penetration, especially with the blood brain barrier, of the other two antibiotics.

He has helped many of us to improve and relentlessly works in keeping our conditions "stable". We are VERY lucky to have him.

I want to wish you the best in your endeavors with the National LymeNet. I commend you on all your efforts in getting it started. It was a wonderful idea and will benefit many. I am looking forward to being a part of it.

Many thanks, Suzanne Colter, President GREEN HILLS LYME DISEASE SUPPORT GROUP

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VII. Q&A: Pulse Therapy (Q) ---------------------------- Sender: Rolf K. Taylor <[email protected]>

Keep up the good work on the LymeNet Newsletter.

I am doing some research on "Pulse Therapy" and would like to enlist the help of fellow readers.

1) Do any readers know of physicians who are actively using "Pulse Therapy" for Lyme Disease (See Definition below). If so please send the name, address and phone number of this physician so I can contact her/him.

2) Have any readers under gone "Pulse Therapy" under the advice of a physician? If so please send me your name and address and phone number so I can contact you.

3) Do any readers know of published research on "Pulse Therapy"? My only references so far are a letter in The Lancet (By D. Hassler) 07-20-91, An article in Lyme Disease Update Nov 1991 and one other reference from the LymeNet Newsletter about 4 issue back.

"Pulse Therapy is the deliberate interruption of antibiotic treatment for a few days to week and then resuming treatment on a regular schedule. The theory is that the bacteria may not try to divide while treatment is in progress, but that it may due so when the treatment has stopped, and thus be more vulnerable when the therapy re-starts.

This information is needed for an article I am writing and will appear in one of the Lyme Publications. People who have assisted me in collecting this information will receive a copy of the article by e-mail along with an complete bibliography on Pulse Therapy.

Please respond by 1) E-mail, 2) Fax 216-397-0321, or 3) By US Mail; R. K. Taylor; 14128 Superior Rd; East Cleveland, OH 44118-1103

Thank You for your assistance.

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VIII. Q&A: Alternative Treatments? (Q) -------------------------------------- Sender: Carol Gardner <[email protected]>

I have been taking antibiotics for Lyme Disease on and off for almost a year. The last round of IV eliminated the symptoms of Lyme, but I started having painful digestive problems that seem to be a result of an overgrowth of yeast. I am now being treated for that problem, but the Lyme symptoms are beginning to return. My question concerns nutrition. Are there any particular vitamins, minerals, herbs, etc. that help? I'd like to get the yeast problem under control before taking more antibiotics, but I don't want the Lyme symptoms to become debilitating. (My main problems are cognitive--confusion, memory loss, trouble reading, disorientation, blurred vision, dangerous driving, etc.) Does anyone know of alternative treatments? What are my options?

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