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  • FINALLY, A BLOOD TEST FOR FIBROMYALGIA!!!

    Medical validation of fibromyalgia discovered through a study done by local rheumatolgists and a researchers sponsored partially by the National Institute of Health.

          NEWS RELEASE

       From:   Contact:
    Autoimmune Technologies LLC   Russell B. Wilson, Ph.D., President or
    144 Elks Place Suite 1402   Michael D. Charbonnet, Manager
    New Orleans LA 70112 USA   (504) 529-9944
       www.autoimmune.com   mailbox@autoimmune.com

       FOR IMMEDIATE RELEASE

    NEW ANTIBODIES DISCOVERED IN MANY FIBROMYALGIA PATIENTS

    (NEW ORLEANS, February 10,1999) Autoimmune Technologies, LLC, a New Orleans biotechnology company, today announced that scientists have discovered a new antibody in the blood of many fibromyalgia patients.  This research is described in an article entitled "Anti-Polymer Antibody Reactivity in a Subset of Patients with Fibromyalgia Correlates with Severity," which appears in the February 1999 issue of The Joumal of Rheumatology, a prominent scientific journal.

    Using a patented test-called-the Anti-Polymer Antibody Assay, or APA Assay, researchers found anti-polymer antibodies in approximately one-half of all patients who were diagnosed with fibromyalgia and in more than 60%',,of the fibromyalgia patients with severe fibromyalgia symptoms.  Patients with diseases frequently confused with fibromyalgia, including rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis/scleroderma, had a much lower incidence of these antibodies than did the fibromyalgia patients.

    Fibromyalgia syndrome is a chronic pain disorder that affects millions of individuals, primarily women, in many countries throughout the world.  The cause or causes of fibromyalgia are currently unknown, but researchers have suggested that trauma, infection, and exposure to environmental factors may all participate in the development of this debilitating illness.  Together with widespread pain and tender points in various areas of the body, signs and symptoms include fatigue, sleep disorder, morning stiffness, headache, cognitive problems, and other symptoms.  In the United States, some 3% to 5% of adult women meet the strict diagnostic criteria of the American College of Rheumatology for fibromyalgia, but as many as 15% to 20 % of adult women may have fibromyalgia-like symptoms.

    Fibromyalgia syndrome is often difficult to diagnose, and typically a diagnosis is reached through the time-consuming and expensive process of ruling out other illnesses that have similar symptoms.  In addition, many physicians consider fibromyalgia to be the result of aging and other normal body processes and do not regard it as a distinct clinical disorder.  The resulting reluctance on the part of some physicians to attribute their patients' symptoms to a specific illness has added considerably to the distress of many fibromyalgia patients.  Until now, there has been no laboratory test to help identify fibromyalgia.

    "Our results show that there is a unique immunological response in many fibromyalgia patients, " said Russell B. Wilson, Ph.D., president of Autoimmune Technologies and lead investigator of the published study.  "We hope that these findings will lead to a better understanding of the illness and to the development of treatments for these patients."

    It is possible, Dr. Wilson pointed out, that anti-polymer antibodies are associated with one of the several different causes of fibromyalgia, perhaps the cause that tends to produce the most severe symptoms.  The published data indicate that this may be the case, although more research will be needed.  In addition to serving as a marker for fibromyalgia, he noted, it is also possible that these antibodies are directly involved in initiating or promoting fibromyalgia.

    The development of a laboratory test for fibromyalgia was welcomed by experts in the field.

    "The fibromyalgia syndrome is common in clinical medicine and in the general community.  We also have data on its cost," said 1. Jon Russell, M.D., Ph.D., an internationally recognized fibromyalgia investigator and clinician form the University of Texas Health Center at San Antonio.  "The direct medical costs of this disorder to the U.S. economy are over $16 billion annually.  The findings of this study raise the hopeful prospect that a new test will help us better understand fibromyalgia.  Further research is needed to confirm the clinical specificity of the test relative to other painful conditions.  In addition, it will be important to determine whether the antibody identified by this test in the blood of people with fibromyalgia is related to the cause of the disorder or simply represents an interesting epiphenomenon," Dr. Russell said.

    Associated factors appear in parallel in epiphenomena.  If further research shows the production of anti-polymer antibodies to be an epiphenomenon, the antibodies would serve as a laboratory marker for fibromyalgia without playing a direct role in the disease process.

    Kristin Thorson is president of The Fibromyalgia Network, a patient self-help organization headquartered in Tucson, Arizona, and president of The American Fibromyalgia Syndrome Association, a charitable organization dedicated to funding research on fibromyalgia and chronic fatigue syndrome.  "In the past," Ms. Thorson said, "many health insurance companies and some members of the medical community have argued that fibromyalgia is not real-all because no one had developed a lab marker to indicate otherwise.  Now that there is a blood marker that can be shown to correlate with the disease severity, there should be no more debate over the existence of fibromyalgia and scientists should be encouraged to research effective therapies for this potentially disabling illness."

    Robert M. Bennett, M.D., a physician and scientist who is chairman of the Division of Arthritis and Rheumatic Disease of Oregon Health Sciences University in Portland and a widely published and internationally known expert on fibromyalgia syndrome, said, "There are two major problems for most physicians in accepting fibromyalgia.  The first is the lack of an easily performed laboratory test.  The second is its recalcitrance to therapy.  The promise of a potentially useful diagnostic marker is an exciting development in this field.  If the sensitivity and specificity of this test can be confirmed by independent laboratories, it could open up an important new research avenue for a condition that compromises the quality of life of five to ter, i-rdffior, '%IS.

    Autoimmune Technologies expects during 1999 to apply to the U.S. Food and Drug Administration for approval of a kit form of the Assay as a diagnostic test.  "The reproducibility of the APA Assay has already been independently demonstrated by the National Institute of Public Health and the Environment, or RIVM, in The Netherlands," said Dr. Wilson.  "The RIVM has found the APA Assay to give reproducible results and to be useful for the evaluation of the presence of anti-polymer antibodies in human serum.  The other confirmatory studies discussed by Drs.  Russell and Bennett are already under way.  These studies, together with our research published in The Joumal of Rheumatology, will be included in our application to the FDA for approval of the Assay as an in vitro diagnostic test to aid in the diagnosis of fibromyalgia."

    Other authors of the article in this month's issue of The Joumal of Rheumatology include Dr. Oscar S. Gluck and Dr. John R.P. Tesser of the Arizona Rheumatology Center in Phoenix, Dr. Janet C. Rice of Tulane University School of Public Health and Tropical Medicine, and Dr. Alan J. Bridges of the University of Wisconsin School of Medicine in Madison.

    Anti-polymer antibodies were discovered by researchers at Tulane University Medical Center, where the APA Assay was developed.  Autoimmune Technologies has licensed the APA Assay from Tulane.  An APA Assay kit is not currently in commercial distribution in the U.S., although the Assay is being performed by Autoimmune Technologies as a service to physicians and researchers for investigational use only.  A kit form of the APA Assay will be available in the near future in other countries.

    The APA Assay is covered by U.S. and European patents, and patents in other countries are pending.
    For further information, visit the Autoimmune Technologies Web site at www.autoimmune.com.


    This news release is for educational and information purposes only.  Provided by Autoimmune Technologies, Inc. and reprinted by Fibromyalgia Network, PO Box 31750, Tucson, AZ, 85751-1750 800-853-2929.  Additional details onn the APA Assay will appear in the April 1999 issue of Fibromyalgia Network newsletter.

    Please feel free to copy and distribute this press release at your support group meetings.

    THE ANTI-POLYMER ANTIBODY ASSAY                                                                       Autoimmune Technologies LLC, New Orleans

    APA ASSAY REQUISITION FORM FOR PHYSICIANS AND RESEARCHERS

    COMPLETED FORM MUST ACCOMPANY SAMPLE

    LABORATORY INSTRUCTIONS:
    Collect a 7 ml blood specimen in a standard UNCOATED RED-TOP tube and allow the sample to clot.  Separate the serum aseptically and refrigerate the serum until it is shipped.  Ship in a standard blood sample mailer.

    WITHIN THE U.S.:
    (1)   The APA Assay is available as a service for investigational use only and is not in commercial distribution in the United States.  Autoimmune Technologies expects during 1999 to apply to the U.S. Food and Drug Administration for approval of the APA Assay ELISA Kit as a diagnostic test.
    (2)   Ship the sample at room temperature Monday through Thursday via overnight courier to ALJTOIMMUNE TECHNOLOGIES in New Orleans.
    (3)   Include a check for the test fee of $145 with the sample unless prior arrangements have been made.  Visa and MasterCard are also acceptable.

    OUTS]IDE THE U.S.:
    (1)   The APA Assay is available as a service while an APA Assay kit is being finalized and kit distribution arrangements are being completed.
    (2)   Ship the sample IN DRY ICE for two-day to four-day delivery via DHL Worldwide Express or other courier to AUTOIMMUNE TECHNOLOGIES in
    New Orleans.  To expedite the shipment at U.S. customs, mark your invoice (on your stationery) or the courier's waybill with the following:
    0 HUMAN BLOOD, NOT CONTAINED IN ANY MEDIUM
       NOT INFECTIOUS AND NOT CONTAGIOUS
       CONTAINS NO ANIMAL PRODUCTS
       REASON FOR IMPORT: TO CONDUCT PATENTED LABORATORY TEST
    (3)   Include either Visa or MasterCard authorization for the test fee of $145 US with the sample unless prior arrangements have been made.

    Physician or Other investigator Information
    Name      Address
    City/State/Zip/Country      Telephone Number   Fax Number
    Patient Information
    Name      Address
    City/State/Zip/Country      Telephone Number   Fax Number
    Date of Birth   Gender   Medical Record Number   Social Security (or Other) Number

    Has patient used immunosuppressive agents or corticosteroids in the last six months?  Yes             No        SUCH USE MAY AFFECT THE TEST RESULTS
    Current medications: '
    Fatigue ( ) Morning stiffness             Sleep disturbance           Anxiety

    (   )-Paresthesias ( ) Headache ( ) Dysmenoffhea history            Sicca symptoms           Depression          Irritable bowel syndrome

    (   ) Urinary urgency ( ) Raynaud's phenomenon ( ) Other

       Presence of implant of any type? Yes   No   Type of implant

       Date specimen collected:   Date shipped:      Lab contact namelphone:

       Reporting            Billing
    Send Report to:         Check enclosed   VISA card ( ) MasterCard   Other

    Name on card (or Billing Name, if Other)


    Card Number (or Billing Address, if Other)
    By mail
    By fax, at
    Expiration Date (or City, State, Zip, Country if Other) Telephone

    Address and Contacts: Russell B. Wilson, Ph.D., President, or Michael D. Charbonnet, Manager, Auto@une Technologies LLC, 144 Elks Place, Suite 1402, New Orleans, Louisiana 70112, USA, telephone (504) 529-9944, e-mail maflbox@autoimmune.com, fax (504) 568-0634, Web www.autoinunune.com.

    The APA Assay is covered by U.S. patent No. 5,620,859 dated April 15, 1997, U.S. patent No. 5,834,215 dated November 10, 1998, and European patent application No. 96934107.2 published October 28, 1998.  Other patents are pending.

    Autoimmune Technologies Use Only: Date Received Accession Number Results (Rev.: 2/99)

    Differential diagnosis:
    Signs and symptoms: Tender Point count                          Widespread pain

    For copies of this article and the blood form please email me at vkf222@aol.com  please put fms/cfs in the subject line

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