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Former U.S. Surgeon General Endorses Little Known Treatment For Chronic Pain Called Prolotherapy, Says Dr. Ross A. Hauser

CLEARWATER, Fla., Nov. 25 /PRNewswire/ -- While the medical industry searches for drugs and surgical procedures to eliminate chronic pain, a therapy introduced over half a decade ago is becoming popular among medical practitioners in the United States. It's called "Prolotherapy" and a strong proponent is former U.S. Surgeon General C. Everett Koop, M.D.

American Medical Women's Association (AMWA) Launches Major Initiative to Improve Diagnosis and Treatment of Arthritis Physicians Trained in Comprehensive Curriculum in Response to Recent Survey Results
NEW ORLEANS, Nov. 23 /PRNewswire/ -- A major educational initiative to educate physicians and inform consumers concerning recent advances in the diagnosis and treatment of arthritis, especially as it relates to women, was launched at the 83rd Annual Meeting of the American Medical Women's Association. The two-hour educational activity for health care providers is AMWA's first presentation of a two-fold approach to arthritis education. In partnership with Searle and Pfizer, through a generous educational grant, AMWA has developed a comprehensive physician education curriculum on arthritis targeting primary care providers.

 

At least 40 million Americans have some form of arthritis or other rheumatic condition. By 2020, that number is expected to climb to 59.4 million, or 18.2 percent of the population(1). Arthritis is a leading cause of disability and is difficult to diagnose. The Office of Women's Health of the National Institutes of Health has identified arthritis as a leading women's health challenge. Arthritis is the most prevalent condition among women; in addition, the prevalence of arthritis is approximately 60 percent greater among women than men(2). With the aging of the population, arthritis will increasingly impact the lives of individuals as well as the economy.

 AMWA recognizes arthritis as a major women's health issue which demands consumer education and physician training and intends to lead the way in focusing attention on the magnitude of this disease. A carefully crafted curriculum was developed and designed by a multi-disciplinary team of AMWA specialists. A select Master Faculty has been trained in this curriculum which provides a practical, every day approach for primary care providers to utilize in managing their patients affected by arthritis. This initiative included an assessment of the educational needs of both practitioners and their patients, along with programs to fill those needs.

 According to a recent national survey of 8,000 physicians representing the entire range of physician specialties, three major factors of arthritis have been identified as topics of greatest interest: diagnosis, risk factors and prevention strategies, and understanding treatment options. Survey results were analyzed and grouped according to sub-specialties.

 "Survey results give us an insight into the arthritis educational needs of health care providers," said Sharyn Lenhart, MD, AMWA President. "The Arthritis Education Initiative is an ideal vehicle for AMWA to respond to these needs and to continue our longstanding commitment to improve women's health. Our partnership with Searle and Pfizer will enable us to provide advanced education to health care professionals who diagnose and treat

 1 Callaghan LF, Rao J, Boutagh M. Arthritis and Women's Health: Prevalence, Impact and Prevention.. Am J Prev Med 1996;12:401-9 2 Centers for Disease Control and Prevention. Arthritis prevalence and activity limitations _ United States, 1990 MMWR 1994;43:433-8 arthritis on a daily basis, ultimately helping to improve medical care for the millions of women who suffer from this condition." Joseph Papa, President, Searle U.S. Operations states, "We are very excited about working with AMWA to better inform medical professionals and heighten public awareness about arthritis."

 

AMWA's curriculum, Arthritis Education for Primary Care Providers, offers a complete syllabus of arthritis topics which include musculoskeletal examination techniques, osteoarthritis, utilization and complications of drug therapy, rheumatoid arthritis, fibromyalgia, interpretations of laboratory tests and serologies, nonarticular rheumatic conditions such as bursitis/tendinitis, as well as therapeutic injection of joints and soft tissues. In addition, clinical case presentations integrate conditions of arthritis with recent advances in pharmacologic and nonpharmacologic treatments, utilizing patient scenarios.

 In addition to educating health care professionals, AMWA will begin consumer awareness and education efforts aimed at alerting the public to treatment options and disease modifying behaviors in 1999. This multi-faceted, comprehensive approach to arthritis encourages physicians and consumers to take a "new look at an old problem" in an effort to provide better health care and make informed choices. AMWA plans to conduct at least 20 presentations in 1999. Plans for an extension are underway.

 

Founded in 1915, AMWA, a national medical association representing 10,000 women physicians, has long taken an active role in promoting women's health through physician education activities. Recent activities include educational curricula and campaigns developed by AMWA physician specialists on breast cancer, reproductive health, cardiovascular disease in women, tobacco control and prevention, and osteoporosis. For years AMWA has led the way in developing Master Faculty teams who present superior education instruction to health care professionals in the U.S. Public Health Service, Department of Defense, managed care arenas, as well as hospital settings, and national and regional medical conferences.

 

Through the Arthritis Education Initiative, AMWA intends to uphold its reputation as a leader in promoting women's health issues by reaching as many health care providers as possible. For more information on AMWA, access www.amwa-doc.org.

 Searle, the pharmaceutical section of Monsanto (NYSE: MTC) Company is a research-based company that develops, manufacturers and markets prescription pharmaceuticals worldwide. Based in Skokie, Illinois, it is the world's third-largest marketer of arthritis treatments. Visit the company's website at www.searlehealthnet.com.

 

11/23/98 18:55 EST http://www.prnewswire.com

Amarillo Biosciences Begins Phase II Clinical Trial in Treatment of Fibromyalgia

 AMARILLO, Texas, July 9 /PRNewswire/ -- Amarillo Biosciences Inc. (Nasdaq: AMAR) today announced the commencement of a Phase II clinical trial to test low dose oral interferon alpha (IFNa) in the treatment of fibromyalgia syndrome (FMS).

"The objective of this study is to evaluate the relative clinical value of administering low-dose oral IFNa treatment to subjects with FMS," said Dr. Joseph M. Cummins, president and CEO of Amarillo Biosciences. "Previous studies have indicated that IFNa reduces pain and stiffness in some FMS patients. We expect this confirmatory study to further define the role of IFNa in the treatment of this painful condition."

Subjects will take low-dosage (10 mg) amitriptyline at bedtime for a four- month period. Amitriptyline will be administered to each patient based on its pain-relieving properties and to ensure that the study has a uniform test population. After the first month of treatment with amitriptyline, subjects will be randomly assigned to one of three treatment groups where they will take either placebo lozenges three times a day, one 50 IU low dose interferon lozenge three times a day, or one 50 IU low dose interferon lozenge each morning followed by two placebo lozenges later in the day.

Subjects will be evaluated monthly during the study using a visual analogue scale questionnaire to measure factors such as morning stiffness severity, physical function ability and quality of sleep. Additional questionnaires such as the Stanford Health Assessment Questionnaire will be administered at each visit. Comprehensive information regarding morning stiffness will be gathered at the beginning and end of the study using various techniques including specialized questionnaires, diagrams and electromyography to measure passive leg movement.

Researchers are seeking 120 patients for the study, which will take place at the University of Texas Health Science Center in San Antonio. The clinical trial will be conducted by Dr. I. Jon Russell of the University of Texas. Patient enrollment will be open until July 1999 with the trial closing by the end of 1999. Final results could be available in the first quarter of 2000.

Fibromyalgia is a syndrome characterized by achy pain and stiffness in the soft tissues, including the muscles, tendons and ligaments. The syndrome is estimated to affect approximately 7.5 million Americans according to Defined Health Care Research.

Amarillo Biosciences, founded in 1984, is a world leader in the development of oral interferon alpha as a treatment for a variety of conditions including Sjogren's syndrome, fibromyalgia, opportunistic infections in patients who are HIV positive, hepatitis B and hepatitis C.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon alpha or the company's other product candidates and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. In particular, see "Item 1. The Description of Business" of the company's Form 10-KSB for the year ended Dec. 31, 1997.

 SOURCE Amarillo Biosciences Inc.

 

 07/09/98 13:24 EDT http://www.prnewswire.com

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Age and Social Factors Are Critical in `Quality Of Life'For Arthritis Sufferers, New Studies Show Duration of Illness is Not a Factor in Patients' Sense of Well-Being

ADVANCE/ MONTREAL, June 23 /PRNewswire/ -- Marital status, age, education, income and smoking are emerging as critical factors affecting the quality of life of arthritis patients, according to new studies presented today at the PanAmerican Congress of Rheumatology. Surprisingly, the studies also showed that the length of time an individual had suffered from arthritis did not have a very significant impact on quality of life.

 "How long a person has suffered with arthritis is not the most important factor in a person's sense of well-being and happiness," explained study director Frederick Wolfe, M.D., clinical professor of Internal Medicine and Community and Family Medicine at the University of Kansas School of Medicine, and director of the Arthritis Research Center, Wichita, Kansas, USA.

 "In addition to disease-related factors, a patient's sense of well-being appears to be influenced by certain social and psychosocial factors, such as marital status, smoking, education and income levels," he said.

 "The presence of these factors plays such an important role not only in the severity of the illness," according to Dr. Wolfe, "but also in how patients and their families cope with the illness. Social disadvantage makes it much harder for the patient and the physician."

 At the scientific meeting, Dr. Wolfe presented results from two quality of life studies in 2,463 patients with arthritic conditions -- 1,145 patients with rheumatoid arthritis, 675 with osteoarthritis of the hip and knee and 713 with fibromyalgia (a rheumatic condition characterized by achy pain, tenderness and stiffness of muscles and adjacent areas, but not involving the joints).

 "Quality of life reflects a patient's global sense of well-being, which can be measured by disease-specific questionnaires," Dr. Wolfe said. In the first study, he explained, researchers asked patients to complete surveys that measured functional disability, pain and psychological distress.

 The researchers found that, as expected, functional disability scores were higher in patients with rheumatoid arthritis than in patients with osteoarthritis. However, scores having to do with pain were higher with osteoarthritis than with rheumatoid arthritis. Fibromyalgia patients rated themselves worse than osteoarthritis or rheumatoid arthritis patients in each quality of life dimension studied, with the exception of disability.

 In a second study of the same group of patients, researchers found that the duration of time during which patients had the disease did not play a very important role in how patients assessed their quality of life.

 "This finding is surprising," Dr. Wolfe said. "Since rheumatic disorders progress slowly, it would seem intuitive that patients' quality of life would decrease slowly over time as the illness progresses. However, our studies showed that this is not the case."

 Quality of life measures help physicians understand better what is happening in the lives of patients and allows them to intervene in ways that help patients manage the disease in the context of their lives. "We need to try to understand what happens to people with arthritis so that appropriate interventions can be instituted which one might hope would be effective in reducing the burden of these painful diseases," Dr. Wolfe said.

 The studies were conducted at the Arthritis Research Center and funded by a research grant from Merck & Co., Inc. (NYSE: MRK) (which operates in many countries as MSD). The Arthritis Research Center houses the largest active database of patients with arthritic conditions in the United States. The 25- year-old databank contains information on nearly 15,000 patients and 91,000 patient visits, and is used in a variety of quality of life studies.

 Merck is currently involved in arthritis research. Merck scientists have made important scientific advances in the treatment of pain and inflammation, beginning with the discovery of Myochrysine(R) (gold sodium thiomalate) in 1936, followed by the synthesis of cortisone in 1941 and the development of the first corticosteroid medication, Cortone(R) (cortisone) in 1949. In 1964, Merck scientists synthesized indomethacin, a nonsteroidal anti-inflammatory drug (NSAID) against which other NSAIDs are measured to this day.

 SOURCE Arthritis Research Center

 06/23/98 08:05 EDT http://www.prnewswire.com

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Amarillo Biosciences Reports New Patent Issues in USA and Japan  

AMARILLO, Texas, July 13 /PRNewswire/ -- Amarillo Biosciences Inc. (Nasdaq: AMAR) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for its patent entitled "Treatment of Autoimmune Diseases." Amarillo also received a notice of allowance from the Japanese Patent Office for a patent entitled "Reduction of Side Effects of Cancer Therapy."

 The U.S. patent will grant Amarillo Biosciences' claims to the use of low dose oral interferon in the treatment of multiple sclerosis (MS). Initial preclinical data indicate that oral interferon is beneficial in the treatment of experimental allergic encephalomyelitis, a model for MS.

 The patent in Japan will grant claims to the use of oral interferon to relieve the toxicity associated with radiation or chemotherapy in cancer patients.

 "The strategy of broadening our intellectual patent portfolio will benefit the company and its shareholders as we negotiate research, development and distribution agreements worldwide," said Dr. Joseph M. Cummins, president and CEO of Amarillo Biosciences.

 Amarillo Biosciences maintains a dominant global patent position in oral interferon for use as a human therapeutic.

 Amarillo Biosciences, founded in 1984, is a world leader in the development of oral interferon alpha as a treatment for a variety of conditions including Sjogren's syndrome, fibromyalgia, opportunistic infections in patients who are HIV positive, hepatitis B and hepatitis C.

 Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon alpha or the company's other product candidates and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. In particular, see "Item 1. The Description of Business" of the company's Form 10-KSB for the year ended Dec. 31, 1997.

 SOURCE Amarillo Biosciences Inc.

 07/13/98 14:07 EDT http://www.prnewswire.com

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Ampligen to be Distributed to U.S. Patients With Chronic Fatigue Syndrome

 

                      Olsten Health Services and Hemispherx Biopharma, Inc. announced
                   today that they have signed a treatment protocol specialty distribution
                   agreement to treat U.S. patients suffering from Chronic Fatigue
                   Syndrome (CFS) with the emerging drug therapy Ampligen(R). CFS,
                   also known as Chronic Fatigue Immune Dysfunction Syndrome
                   (CFIDS), is a severely debilitating disease which afflicts a minimum of
                   400,000 Americans. Ampligen, a nucleic acid developed by Hemispherx,
                   is the only drug being investigated at the Phase III level for the treatment
                   of CFS. 
         
                   "This agreement is part of Olsten's strategic focus on providing essential
                   marketing, distribution and staffing services to the pharmaceutical and
                   biotechnology industries," said Michael Ellis, Olsten Health Services'
                   Senior Executive, Corporate Development. "As North America's largest
                   home health care company and the second-largest provider of home
                   infusion services, we offer pharmaceutical companies access to
                   approximately 500 offices staffed with the skilled personnel needed for
                   distribution of new drug therapies. We look forward to working with
                   Hemispherx."
         
                   "We welcome this opportunity to work with a leader such as Olsten,"
                   said William A. Carter, M.D., F.A.C.P., Chairman and CEO of
                   Hemispherx. "Olsten's expertise in chronic disorders, staffing and their
                   nationwide pharmacy network allow us to distribute Ampligen in a
                   cost-effective and timely manner."
         
                   The distribution agreement will initially cover six clinical sites nationwide
                   that treat patients under a protocol approved by the Food and Drug
                   Administration (FDA). Olsten will also provide various patient education
                   and support services to assist CFS sufferers to deal more effectively with
                   this severely debilitating disease. The FDA-approved protocol allows for
                   the administration of Ampligen to the most severely debilitated CFS
                   patients, with cost recovery. The price of Ampligen is approximately
                   $7,200 for a six-month treatment cycle, and allows Hemispherx to
                   recover certain costs of manufacture, research and development.
                   Additionally, the cost of infusion and related medical services is between
                   $8,000 and $9,000. Under this new distribution agreement, both
                   companies agree to provide the drug and infusion at no cost to 5 percent
                   of patients who cannot afford the treatment and who are severely
                   debilitated with CFS.
         
                   From Sapient Health Network 


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Neck
         Injuries May Lead to Fibromyalgia
People who sustain a neck injury may be at an increased risk of developing fibromyalgia, a chronic and painful muscle disorder, a team of Israeli and U.S. researchers report.

 Fibromyalgia occurs in about 2 percent of the general population and is marked by stiffness and pain throughout the body. While doctors are not sure what causes the disorder, the new findings suggest that neck trauma may be one possible cause.

 The researchers, led by Dr. Dan Buskila of the Soroka Medical Center in Israel, found that fibromyalgia was 13 times more common among patients with neck injury compared to those with a leg fracture.

 Neck injury patients with fibromyalgia had more muscle tenderness, and were more likely to have symptoms such as dizziness, fatigue, headaches and sleep disturbance, Buskila reported in the March issue of the journal Arthritis and Rheumatism.

 ``This is a very intriguing and important article,'' said Dr. Robert Bennett, head of the division of arthritis and rheumatic diseases at the Oregon Health Sciences University in Portland.

 Researchers have debated whether fibromyalgia actually exists. But the new study lends ``more scientific certainty that [fibromyalgia] does happen. This study is very welcome verification to what we have known,'' he said.

 Dr. Paul Davidson, medical director of the fibromyalgia clinic at the Kentfield Rehabilitation Hospital in Kentfield, Calif., said that stress plays a major role in the development of fibromyalgia. ``Most people carry their stress in the neck and shoulder girdle area, so it's not surprising that if anything is jarred in this area, it could set off fibromyalgia,'' he said.

 In the study, nearly 22 percent of the 102 people with a neck injury developed fibromyalgia about three months after an accident. By contrast, only about 2 percent of the 59 people with leg fractures developed fibromyalgia.

 The American College of Rheumatology defines fibromyalgia as chronic, widespread body pain and tenderness in 11 or more of 18 ``tender points.''

 During an exam, a doctor presses on 18 tender-point sites, such as the elbow and neck, where muscles join tendons. The site is considered tender if the patient makes an involuntary verbal or facial expression of pain, or winces or tries to pull away.

 Women are also six times more likely to suffer fibromyalgia than men, Bennett said.

 ``The pain can go on 10, 15 or more years and can cause mental distress,'' he said. Currently, there is no cure for the disorder, he added.

 People with fibromyalgia should continue to be active so that the body does not tense up, Davidson said.

 Bennett recommends a gentle stretching and exercise program to help ease the pain.

  © Medical Tribune News Service

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