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..... | News & Views Newletter edited by Jack Nicholas, cornishpro@aol.com
PSORIATIC ARTHRITIS NEWS AND VIEWS FDA CLEARS LEFLUNOMIDE FOR EXPANDED RHEUMATOID ARTHRITIS INDICATION NEW YORK (Reuters Health) Jun 17, 2003 Franco-German drugmaker Aventis SA reported on Tuesday that it received a supplementary approval from the U.S. Food and Drug Administration (FDA) to market its rheumatoid arthritis drug leflunomide (Arava) to improve patients' physical function. Arava is an oral disease-modifying antirheumatic drug (DMARD) that the FDA first approved in 1998 as a first-line therapy for the rheumatoid arthritis. The drug has since also been approved for slowing the structural damage often associated with the chronic condition. Aventis had applied for the additional supplementary approval in December 2002. The FDA also approved revisions and additions to the safety information, including revised recommendations for monitoring patients' liver function and hematology, the company said. A FDA advisory panel had recommended the changes in March to emphasize the potential risk. The panel members, who were convened in part to review a petition calling for the drug to be pulled from the U.S. market, expressed strong support for the drug and voted unanimously to tell the FDA that they believed the benefits outweighed the risks. "We believe the new physical function indication will reinforce for physicians the clinically meaningful benefits of Arava treatment," Aventis North American vice president Dr. Franois Nader commented in a statement. Aventis said the supplementary indication was based on data from three long-term, phase III trials that showed the drug's ability to improve the ability of patients to conduct daily activities such as walking, eating and dressing. The data further showed that the effect was sustained for 2 years in patients continuing treatment, the firm said. **************************************************
LEFLUNOMIDE COMPARABLE TO SULFASALAZINE AND METHOTREXATE IN RHEUMATOID
ARTHRITIS NEW YORK Leflunomide demonstrates efficacy and adverse effect profiles similar to those of sulfasalazine and methotrexate in the treatment of rheumatoid arthritis (RA), the results of a meta-analysis suggest. Leflunomide is a novel disease modifying antirheumatic drug (DMARD) that inhibits pyrimidine synthesis. "Since pyrimidine nucleotides are required for the proliferation of activated autoimmune T lymphocytes, reduction of pyrimidine synthesis will reduce the number of these T cells, downregulating the related autoimmune responses," the investigators explain in the June issue of the Journal of Rheumatology. Dr. Peter Tugwell, of the University of Ottawa in Ontario, and associates, reviewed literature to find randomized controlled trials that compared leflunomide with placebo, methotrexate or sulfasalazine in patients with rheumatoid arthritis. Of the six trials they selected, three included methotrexate as the comparator, two included sulfasalazine, and one included placebo alone. Data were pooled for the 948 patients randomly assigned to an effective dosage of leflunomide, 680 patients assigned to methotrexate, 132 to sulfasalazine and 312 to placebo. Those taking leflunomide were twice as likely as those receiving placebo to respond to treatment according to American College of Rheumatology 20 (ACR20) criteria at 6 months and at 12 months. "No statistically significant differences were observed between leflunomide and methotrexate or sulfasalazine in most of the clinical outcomes, except that leflunomide did better than sulfasalazine in improving the ACR20 response rate at 24 months," the authors write. Withdrawals due to adverse events from leflunomide were significantly higher than for placebo. Leflunomide was associated significantly more often with GI symptoms, alopecia and hypertension compared with treatment with methotrexate. However, adverse effects in the leflunomide group were not significantly different from those seen in the other treatment groups. Dr. Tugwell and his colleagues recommend that economic evaluations be performed to compare the cost-effectiveness leflunomide with that of other currently used DMARDs. J Rheumatol 2003;30:1182-1190. *****************************************************
INFLIXIMAB PLUS METHOTREXATE EFFECTIVE IN EARLY RHEUMATOID ARTHRITIS The combination of infliximab (Remicade; Centocor) and methotrexate is the first regimen to show superiority to methotrexate alone in early rheumatoid arthritis, investigators reported here on Thursday. Almost half of the patients given methotrexate plus infliximab 3 mg or 6 mg per kilogram achieved ACR 50 or better in a year-long study, compared with 32% given only methotrexate, Professor Josef Smolen told a crowded auditorium at the Annual European Congress of Rheumatology. The multicentre study included 1049 patients with active early disease, the University of Vienna researcher said. They were randomized to either 3 mg or 6 mg infliximab plus methotrexate, or to methotrexate plus placebo at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. Methotrexate was used in an accelerated fashion, increasing by 2.5 mg every 1 or 2 weeks, to a maximum of 20 mg/wk at week 8. The ASPIRE trial's primary endpoints were percent improvement in ACR-N scores at week 54, structural damage assessed by change in van der Heijde modified Sharp score and physical disability measured by the health assessment questionnaire averaged between weeks 30 and 54. "The trial showed a significant difference in all primary and secondary endpoints compared to methotrexate head-to-head," Professor Smolen told Reuters Health. "Early treatment with disease-modifying agents in rheumatoid arthritis--as early as possible--is mandatory today. And this study shows that the early treatment with the combination of infliximab plus methotrexate is superior to the early treatment with methotrexate alone." At week 54, ACR 50 was achieved by 32% of those given methotrexate, 46% of those on the combination with the lower dose of infliximab and 50% of those receiving the TNF-blocker at the higher dose. Twice as many patients receiving the higher-dose infliximab combination achieved remission as defined by a disease activity score of less than 2.6, compared with those given methotrexate alone (31% versus 15%). Overall, the results were impressive, Professor Smolen said. "After all, methotrexate is currently regarded as our gold standard therapy, and [until now] there have not been trials that have conclusively shown that any regimen is better than methotrexate." ************************************************** NEW IL-6 RECEPTOR BLOCKER PROMISING FOT RHEUMATOID ARTHRITIS By Stephen Pincock LISBON (Reuters Health) Jun 19, 2003 A new rheumatoid arthritis drug that inhibits the cytokine IL-6 has shown positive results in a phase II study, researchers said on Thursday. Called MRA, the drug is a recombinant humanised monoclonal antibody that blocks the IL-6 receptor, is being developed by Japanese firm Chugai Pharmaceuticals. At the Annual European Congress of Rheumatology, Professor Ravinda Maini from Imperial College London reported the outcome of a large study of MRA monotherapy and in combination with methotrexate. "A clear dose response was observed for both MRA monotherapy and for MRA in combination with methotrexate," Professor Maini said. "The targeted blockade of IL-6 is a potential further therapeutic target in rheumatoid arthritis," he told conference participants during his presentation. v The researchers randomly assigned 359 patients to seven different treatment groups: MRA monotherapy at 2, 4, and 8 mg/kg doses, the same three doses plus methotrexate and methotrexate alone. The primary measure of efficacy used in the study was the ACR 20 score after 16 weeks of treatment. Professor Maini reported that 48% of patients given methotrexate alone achieved ACR20, a high figure "suggesting patients hadn't responded fully to methotrexate before starting the study." Of those treated with MRA monotherapy, ACR 20 was reached by 31% of the 2 mg/kg group, 61% in the 4 mg group (p = 0.04 compared to methotrexate) and 63% in the highest dose group (p = 0.029). In the combination arms, ACR 20 response was seen in 64% of patients on the lowest MRA dose (p = 0.021), 63% in the middle dose and 74% at 8 mg/kg. "At 8 mg/kg alone and with methotrexate there was a marked difference in joint count," Professor Maini added. There were 15 treatment-related adverse events in the study, including three infections in patients given combination treatments, and 2 in those receiving MRA monotherapy. There were also increases in total cholesterol and LDL cholesterol in treated patients. "The full significance of these findings are not known, but clearly of some importance," the researcher said. Phase III trials of the drug are planned, he said. ****************************************** Editors note: The following article is continuing confirmation that good things are beginning to happen for some of us. NEW PSORIASIS TREATMENT OFFERS HOPE By Jennifer Warner WebMD Medical News Reviewed By Michael Smith, MD June 16, 2003 -- A new psoriasis treatment that gets right to the core of psoriasis provides lasting relief for people who have run out of options. A new study shows weekly injections of the drug Amevive can significantly reduce the pain, itching, inflammation, and other symptoms of psoriasis without serious side effects. Earlier this year, Amevive became the first biologic drug approved by the FDA to treat moderate to severe psoriasis. This new psoriasis treatment works differently from topical creams or light therapy, which are designed to treat the symptoms. Amevive uses advances in biotechnology to target specific elements of the immune system that cause the plaque buildup and inflammation typically found in psoriasis. Previous clinical trials of Amevive were based on delivering the drug intravenously, but this study looked at its effectiveness when given by weekly injections into the thigh muscle. In this study, 507 adults with chronic psoriasis were randomly assigned to receive either 10 mg or 15 mg of Amevive per week by injection or a placebo. The results appear in the June issue of The Archives of Dermatology. Long-Lasting Results- The higher dose of Amevive offered the best results. Overall, more than half of the patients who received the higher dose of Amevive had at least a 50% reduction in symptoms compared with only 35% of those getting the placebo. Researcher Mark Lebwohl, MD, of Mount Sinai School of Medicine in New York, and colleagues say the benefits of the new psoriasis treatment tend to be long lasting. Twelve weeks after the psoriasis treatment had been stopped, psoriasis symptoms were still better than before the study. Although Amevive works by weakening the immune response, which could increase the risk of infection, researchers say the psoriasis treatment was generally well tolerated and did not cause major problems. The most commonly reported side effects from Amevive included headache, itching, and infection, such as the common cold. In an editorial that accompanies the study, Alice Gottlieb, MD, PHD, of the University of Medicine and Dentistry at the Robert Wood Johnson Medical School in New Brunswick, N.J., says that finding new, more effective psoriasis treatments is a critically important issue because the disease has serious psychological as well as physical effects. "Psoriasis is a life-disabling disorder in which 8% to 10% of patients aged 18 to 54 years actively contemplate suicide because of their disease," writes Gottlieb. Recent research has demonstrated that psoriasis is an immune disorder. And Gottlieb says new psoriasis treatments targeting the immune system, such as Amevive, have the potential for changing the practice of dermatology and "give the hope of long-term safe and effective control of psoriasis and psoriatic arthritis." SOURCES: The Archives of Dermatology, June 2003. WebMD Medical News: "New Psoriasis Drug Available." WebMD Medical News: "Psoriasis Treatments Entering New Era." © 2003 WebMD Inc. All rights reserved. ************************************************ BOGUS CHOLESTEROL DRUG - (AGAIN) The FDA first warned consumers and healthcare professionals about counterfeit Lipitor last month. Now additional counterfeit lots of Lipitor, the cholesterol-lowering drug made by Pfizer, have been uncovered by the FDA. As a result, Pfizer is suing Med-Pro Inc., a pharmaceutical repackaging company in Nebraska, and Albers Medical Distributors in Kansas City for shipping the counterfeit Lipitor. Pfizer first became aware of the counterfeit Lipitor because patients and pharmacists complained about an unusually bitter taste. Pfizer is lucky it has some alert consumers. WASHINGTON (Reuters Health) - The U.S. Food and Drug Administration (FDA) reported that it has discovered additional counterfeit lots of Pfizer Inc.'s cholesterol-lowering drug Lipitor. The agency said it has uncovered two additional counterfeit lots of 10-mg tablets in 90-tablet bottles (coded 20842V and 16092V) and one counterfeit lot of 20-mg tablets in 90-tablet bottles (coded D270481). As with previously discovered counterfeit lots of the drug, the bottles' labeling states that the product was repackaged by Med-Pro Inc. of Lexington, Nebraska, the FDA said. The FDA first warned consumers and health care professionals to look out for counterfeit Lipitor last month. That alert involved lots of 90-tablet bottles coded 20722V, 04132V and 16942V. The FDA said it has since pursued a variety of leads along the supply and distribution chain, and the investigation is still ongoing. Separately, Pfizer said on Tuesday it is suing Med-Pro and Albers Medical Distributors Inc., the Kansas City distributor that shipped the counterfeit lots. Pfizer spokeswoman Vanessa McGowan told Reuters Health the lawsuit was filed in part to stop the distribution of the counterfeit products and in part to identify the source. Copyright © 2003 Reuters Limited. **************************************************
DANISH STUDY DOUBTS INJURY RISKS FROM COMPUTERS Using a computer does not appear to pose a severe occupational hazard for developing the wrist and hand ailment known as carpal tunnel syndrome, according to a Danish study published on Tuesday. The finding is based on a survey of nearly 7,000 workers at 3,500 locations who were questioned initially on symptoms, and 5,568 of the group who were assessed a year later. "This study found a prevalence of possible carpal tunnel syndrome between 1.4 percent and 4.8 percent based on a screening questionnaire and a clinical interview, and an incidence of new or aggravated symptoms of possible carpal tunnel syndrome of 5.5 percent," the authors report in this week's Journal of the American Medical Association. Carpal tunnel syndrome, marked by tingling and numbness in the hand and fingers, occurs when one of the nerves that pass through the wrist becomes compressed. Work and hobbies that involve repetitive motions of the upper limbs have been implicated in the risk of the condition. But the authors of the new study conclude that computer use "does not pose a severe occupational hazard for developing (the) symptoms" of carpal tunnel syndrome. Dr. Johan Hviid Andersen of the department of occupational medicine at Herning Hospital in Denmark led the study, with financing from the Danish Medical Research Council and the Danish Ministry of Employment, National Work Environment Authority. The authors said that while there was evidence that forceful industrial work contributes to carpal tunnel syndrome, previous research has left the role of less forceful work with a computer keyboard and mouse less clear. "Can keyboard use then be considered an occupational risk for developing carpal tunnel syndrome? From our data it seems unlikely," the researchers said in the report. "But based on other studies," they add, "we cannot exclude the possibility that very intensive and repetitive keyboard use could be a risk factor ... however our opinion is that it is not an important one." The researchers said they did find an association between use of a mouse for more than 20 hours a week and a slightly elevated risk of possible carpal tunnel syndrome, but no statistically significant association with keyboard use. According to the U.S. National Institute of Neurological Disorders and Stroke, a 2001 study conducted by the Mayo Clinic also found that heavy computer use -- up to seven hours a day -- did not increase the user's risk of developing the injury. ********************************** FDA APPROVES OVER-THE-COUNTER HEARTBURN DRUG The U.S. Food and Drug Administration approved Friday the sale of Prilosec OTC, the first over-the-counter treatment for frequent heartburn. "As has been the case for many other over-the-counter switches, the availability of Prilosec OTC will help reduce costs and expand the availability of treatment options for millions of Americans," said FDA Commissioner Dr. Mark B. McClellan. Prilosec OTC is expected to cost about $1 a day, about one-third less than the prescription rate. Unlike the two classes of currently available over-the-counter heartburn treatments -- antacids and acid reducers -- Prilosec OTC is designed to treat heartburn that occurs two or more days a week. It stops acid production at its source -- in the stomach, the FDA says. The American College of Gastroenterology says more than 60 million Americans experience heartburn at least once a month. Some studies have indicated 15 million Americans experience heartburn daily. Heartburn occurs when stomach contents containing acid back up and out of the stomach into the esophagus, causing a burning sensation in the chest or throat. Copyright © 2003 ScoutNews, LLC. All rights reserved. Last updated 6/22/2003. ************************************************ Editors note: For our members living in California who are willing to look at alternative approaches, the following is great news. NATUROPATHS LIKELY TO GAIN CALIFORNIA LICENSING Legislation to expand statewide access to naturopathic medicine was passed for the first time by the California Senate. The bill, SB 907, has now advanced to the State Assembly. If the bill is passed it will extend state licensure to clinically trained naturopathic doctors in California. Californians would then have the have access to qualified providers of natural health care. Advocates of the bill state that naturopathic medicine may offer valuable health care options that emphasize health promotion. This emphasis could reduce the need for expensive medical treatments by optimizing the body's intrinsic capacity for self-healing and repair. v The naturopathic approach to medicine involves health promotion and disease prevention using elements of both conventional and alternative medicine. Naturopathic medical education is a four year program that includes basic medical sciences, such as anatomy, biochemistry, and pathophysiology, as well as the study and application of natural therapies, such as clinical nutrition, botanical medicine, homeopathy, physical medicine, and health counseling. NaturalMedicineNow.org The following comments are taken from Dr. Mercola's website.
DR. MERCOLA'S COMMENT: N.D.s are at the forefront of the revolution of our health care system as a health conscious public is wisely turning to these experts in natural health and turning away from drug-based, symptom-suppression medicine. If you or someone you know lives in California and would like to help naturopathic doctors become licensed in California, please visit the www.NaturalMedicineNow.org Web site to help this worthy cause. I would like to see naturopathic medicine licensed in all 50 states and licensing in California would make a tremendous impact toward that goal. If you would like more information about finding a qualified naturopathic doctor near you, visit www.naturopathic.org for that information. For those who are interested, here is additional information on naturopathic medicine: Naturopathic doctors are primary care physicians clinically trained in natural therapeutics and whose philosophy is derived in part from a Hippocratic teaching more than 2,000 years old: Vis mediatrix naturae---nature is the healer of all diseases. Their practice is based on the same basic bio-medical science foundation that allopathic practice is; however, their philosophies and approaches differ considerably from their conventional counterparts. Naturopathic physicians diagnose disease and treat patients by using natural modalities such as physical manipulation, clinical nutrition, herbal medicine, homeopathy, counseling, acupuncture and hydrotherapy, among others. They choose treatment based on the individual patient, not based on the generality of symptoms. This approach has proven successful in treating both chronic and acute conditions. The six principles that guide the therapeutic methods and modalities of naturopathic medicine include: First Do No Harm--primum non nocere: Naturopathic medicine uses therapies that are safe and effective. The Healing Power of Nature--vis medicatrix naturae: The human body possesses the inherent ability to restore health. The physician's role is to facilitate this process with the aid of natural, non-toxic therapies. Discover and Treat the Cause, Not Just the Effect--tolle causam: Physicians seek and treat the underlying cause of a disease. Symptoms are viewed as expressions of the body's natural attempt to heal. The origin of disease is removed or treated so the patient can recover. Treat the Whole Person--tolle totum: The multiple factors in health and disease are considered while treating the whole person. Physicians provide flexible treatment programs to meet individual health care needs. The Physician is a Teacher-docere: The physician's major role is to educate, empower, and motivate patients to take responsibility for their own health. Creating a healthy cooperative relationship with the patient has a strong therapeutic value. Prevention is the best "cure:" Naturopathic physicians are preventive medicine specialists. Physicians assess patient risk factors and heredity susceptibility and intervene appropriately to reduce risk and prevent illness. Prevention of disease is best accomplished through education and a lifestyle that supports health. Editors note again: I am also proud of the fact that our oldest daughter is a licensed Naturopathic Physician in the state of Oregon, and is one of very few who practices in the Public Health sector. ****************************************************
HERBALS TRIGGER MIGRAINE AND MAY ALSO INTERFERE WITH MIGRAINE DRUGS Some herbal supplements may make migraine drugs ineffective or even toxic. Ginkgo biloba, ginseng, echinacea, St. John's wort and valerian root may trigger or worsen migraines. Commonly prescribed migraine medications can potentially be rendered ineffective or even toxic when taken along with certain popular herbal supplements, according to researchers. In addition, their study found that some supplements -- including ginkgo biloba, ginseng, St. John's wort and valerian root -- might actually trigger or worsen migraines in some people prone to them. The findings are being presented at the American Headache Society's annual meeting in Chicago. According to the researchers, migraine medications in the triptan class of drugs and tricyclic antidepressants -- which are used to prevent migraines in some people -- can interact with supplements such as gingko biloba, ginseng, echinacea and St. John's wort. The herbs can interfere with the liver enzymes that metabolize these drugs and potentially make them toxic, they say. "In the U.S. herbal products are not standardized or regulated by the FDA (Food and Drug Administration)," said study author Dr. Carla Rubingh of the University of Utah in Salt Lake City. "People see them as all-natural ... and are not informing their physicians that they are taking them." "But just because (manufacturers) say the herbs are all-natural or from plants doesn't mean that they are without side effects or drug interactions," Rubingh told Reuters Health. "These supplements need to be recognized as medications," she said. "Patients need to tell their physicians they are taking them, and physicians need to ask if they are taking them and know how they might interact with medications." Rubingh and her colleagues also caution that some herbal supplements -- often taken in the hopes of boosting memory and energy or to alleviate colds and depression -- could help trigger or worsen both migraines and so-called cluster headaches among people predisposed to them. Migraines typically involve severe pain on one or both sides of the head, sometimes accompanied by nausea, loss of appetite and blurred vision. Cluster headaches are marked by sudden, severe pain, often centered in one eye; these headaches come in waves, typically with several pain-free weeks in between. For their study, Rubingh and her colleagues used data from the FDA and other sources to rank the top-selling herbal products in the U.S. They then reviewed past research on the herbs, looking particularly at the products' mechanisms of action and possible side effects to see how they might interact with migraine drugs or contribute to headaches. For example, they explain, one mechanism of ginkgo is to boost blood flow to the brain, which might worsen migraine or cluster headaches in some people. Speaking during a telephone press conference this week, Rubingh focused on the potentially large number of patients who should be concerned about such potential drug-supplement interactions. She noted that an estimated 30 million American men and women suffer from migraine headaches, while about 2.5 million experience cluster headaches. And although the exact percentage of migraine and cluster-headache patients who take herbal supplements is not clear, Rubingh said the overlap is probably substantial since an estimated 40 percent of Americans have taken herbal supplements at some point. "So if I could tell people one thing," she said, "it would be that these patients do need to let their physician and their pharmacists know that they are taking these supplements." Copyright © 2003 Reuters Limited. ***********************************************
WHAT HAPPENS WHEN THE CARETAKER IN THE FAMILY BECOMES INCAPACITATED? What happens when the caretaker in the family becomes incapacitated? This type of situation is loaded with stress for everyone. It was quite apparent that I was in big trouble when I was booted out of the hospital in 48 hours with 4 chest drains and both arms affected from a double mastectomy. I couldn't even dress myself. All I can say is thank heaven for a daughter. The tables turn very quickly when the daughter is helping the mother with the most basic tasks in life like getting dressed and going to the bathroom. My daughter was only 19 years old at a time, just finishing her first year of college. She was never interested in medical things, and certainly didn't know how to irrigate a chest drain. My husband taught her though, and then he had to go to work. I have to give my daughter a lot of credit. She jumped right in and agreed that her summer job was rehabilitating mom. And her job wasn't easy. Besides the medical part of irrigating and changing dressings, she needed to take me to the doctor for the followups. Then she had to take me to physical therapy three times a week. She had to do all the shopping for the organic food and help my friend with the juicing. She had to feed her dad dinner, and take care of the pets, and then after her long day, she would tuck mom in bed with a movie, and get out of the house for a few hours. The hardest part of all for her was listening to me with my constant verbalization of fear. People cope in different ways, and I am a talker. So I talked non-stop about what I was feeling emotionally. It was very draining on her to constantly listen, but listen she did from morning until night. My husband took over with the listening when he came home from work having listened to his women patients all day long. I constantly had questions he couldn't answer and it was very frustrating for everyone. My college-aged son also did his share of listening. Just this week as I cleaned my son's old room, I came upon a college paper he wrote around the time that I was recovering from surgery. It brought tears to my eyes. My son, Will Lloyd, wrote this: I was my mother's shoulder. My long nights at work brought me home after midnight everyday, and mom was the only person up. I was there for reassurance and for the sensitivity that came from my long arms that were always outstretched, hugging her sobbing soul. I think just hearing my comforting words and support made her feel better. Sometimes there just isn't enough you can tell a person, but like the situation with my mother, just being there helps more than you know. Most every night we went over and over what was happening to her, listening and responding and trying to help her through it all. And all the while, I was thinking: What would I do without her? This is my mother, my shield, my mother. I have often wondered how people make it through situations like this without the support of a loving family. Besides my family, friends also listened, brought over food, took me to lunch, visited, and a lot of people sent cards. When you are cooped up in the house, it is amazing how one waits for the mail. Those cards from acquaintances made a big difference. And then there were the prayers. I wrote what was happening to me right after my diagnosis, and the local paper The Free Lance Star printed my story and my decision about surgery. At the end of the article, I asked for prayers, and apparently many churches and individuals took up the plea, and I'm sure it helped. I learned something really important that summer: that givers can learn to accept the gift of help, time, and love from others. Although I am still much happier in life in the giving mode, I learned to take and to simply say, thank you. When the first year of my survival came up and I went to the Relay for Life, they had a lap for the survivors and a lap for the caregivers. I had my family walk with me. My husband, Stacy, daughter Holly and son, Will, walked around that track realizing that they learned a lot that summer too. That they came through when I needed them. Everyone should be so lucky. *************************************************** The race is not always to the swift, but to those who keep on running. Good Health to All,
Jack Nicholas |
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