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Fda approves betaseron® for use after the first event suggestive of multiple sclerosis early treatment with betaseron significantly delayed the time to a second clinical event wayne, nj, october 23, 2006 prnewswire - berlex, inc, a affiliate of schering ag, germany fse: sch; nyse: shr ; , announced today that the food and drug administration fda ; has expanded the indication of betaseron® interferon beta-1b ; to include patients with multiple sclerosis ms ; who have experienced a first clinical episode and have mri features consistent with ms
Wished to take a specific therapy with side effects that have been most acceptable to them rather than risk being randomized to one of two or three therapies with less appealing side effects. The number of untreated patients referred to MS Centers has diminished as community physicians have increased their skill and experience in applying therapies which have now been available the last two to 10 years. Because current treatments do not completely control disease in all patients, the need to improve therapies continues. Although some people would still like to participate in a research trial, they are increasingly harder to identify. By developing a partnership between the MS Center and academically-minded private neurologists, we can expand the reach of research to many patients and conduct more and more successful research studies. While we hope that basic research will lead to cure of MS, it is likely that well-designed clinical trials will gradually lead to improved control of early disease. Some forms of cancer have been controlled and cured through the types of studies we propose that combine available agents. On May 1, 2003, we announced our plans to form a research consortium of local private practices. I happy to report the investigators for our first co-operative study convened March 8, 2004. Investigators from three area practices and the MS Center, discussed the purpose and conduct of the BEYOND trial and a number of topics crucial to the performance of clinical research. The trial, sponsored by Berlex Inc., will compare regular dose Betaseron to double-dose Betaseron to Copaxone in patients who have not been previously treated. Two other studies are currently being considered for the consortium. The major hurtle for each site to participate in this study was to furnish four neurologists to serve as evaluating and treating physicians and their backups. Due to the necessity of having four neurologists and because the consortium is in its infancy only a few practices were able to join this study. We hope to extend projects to other practices as the consortium matures. The consortium research effort will depend upon physicians at Carolinas Neurological Clinic in Charlotte, Metrolina Neurological Associates in Rock Hill, and Northeast Neurology in Concord. The head research nurse at the MS Center, Priscilla Russo, will serve as the research coordinator at all of sites as well as assume the regulatory duties required by multicenter trials. Monies available through the MS Fund will help to supplement this effort. 2.
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Avonex, Betaseron and Copaxone can also cause long-lasting sadness, nervousness, grouchiness, guilt, trouble concentrating, confusion and trouble sleeping or eating. If you have these symptoms, you should tell your doctor as soon as possible. Avonex, Betaseron, Copaxone and Rebif Reactions at the place where the medicine is injected swelling, redness, color change and pain ; . Some things you can do to help reduce these reactions are.
Dr. Lori Howarth: The Berlex product, Betaseron, is one of the foremost commonly used agents to treat multiple sclerosis. Betaseron was approved by the FDA in 1993 and has 16 years of clinic data. Betaseron is a high dose, frequently administered interferon. In 2002, the American Academy of Neurology published its consensus report on disease modifying therapies in the treatment of multiple sclerosis. Reviewing the pivotal trials and using an evidence-based medicine approach, the AAN offered a set of guidelines based on their evidence-based analysis that higher and or more frequent dosing results in more successful outcomes. Since Betaseron was the first interferon to be approved, we have the longest amount of data. We just performed a 16-year long-term follow-up study that showed Betaseron was well tolerated over the long-term with high adherence rates and mean treatment duration of over 10 years. After 16 years, it was possible to identify close to 90% of the patients from the original pivotal trial. Treatment with Betaseron was associated with a slower Expanded Disability Status Scale EDSS ; progression. The EDSS was delayed by six years in those treated with Betaseron for greater than 80% of the time as compared to those treated for less than 10% of the time. Betaseron has the longest evaluation of clinical efficacy of any interferon in multiple sclerosis. Several studies were reviewed. Betaseron is a high-dose, frequently administered interferon, which according to the AAN guidelines, leads to more successful outcomes. It has 16 years of clinical data that shows a delay in EDSS progression. Betaseron should be included on the PDL. Dr. Sater gave the First Health review of Multiple Sclerosis Agents. There are four available products, all of which are FDA approved for the treatment of relapsing forms of MS. They have similar clinical efficacy. Avonex and Rebif may have less formation of neuralizing antibodies. Copaxone is not an interferion. It modulates the immune response through a different, and not fully understood, process. In October there were 22 claims: Rebif, 32%; Avonex, 27%; Copaxone, 27%; and Betaseron, 14%. All the drugs are currently preferred. Previous discussion mostly centered around access to drugs, including a grandfather clause and the importance of having one interferion product and Copaxone on the PDL. The original motion was that one interferion and Copaxone be added to the PDL, with the interferion considered therapeutically equivalent, was amended to include a grandfather clause, and then passed unanimously. There have not been any significant changes to this class since the last review. Dr. Sponslor uses all drugs in this class, but said the choice of the initial agent is very individualized and all drugs should be available. Dr. Brodsky said Dr. Gordon agreed that one interferion, as well as Copaxone, should be on the PDL and the initial prescribed agent was very individualized. Dr. Hunt said if the drugs appear to be clinically equivalent, one should not be preferred over the other. The grandfather clause was discussed. Dr. Briggs felt writing medically necessary was sufficient due to the limited number of claims in this class. Dr. Sherrie pointed out that although people have testified that these drugs should be available on the PDL, the committee has decided not to make a motion that it is a class effect, which is inconsistent with what was done earlier today. Dr. Hunt pointed out that these drugs were the same, just different delivery systems.
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Especially tell your healthcare professional if you take: corticosteroid medicines any other medicines to treat multiple sclerosis , such as interferon beta-1a avonex , rebif interferon beta-1b betaseron ; , or glatiramer acetate copaxone.
P .02 ; . At higher stimulation frequencies, the deficit in twitch tension increased. It was 74% P .003 ; at a contraction frequency of 168 min` Table ; . In addition to this severe blunting of the frequency treppe "Bowditch treppe" ; , the position of the peak of the tensionfrequency curve optimum frequency ; was shifted from 173 to 134 min` P .02 ; . The myosin heavy chain content of the failing myocardial strips did not differ significantly from the nonfailing strips either on a blotted-weight basis Table ; or on a dry weight basis 21929 nmol g dry wt versus 22015 nmol g dry wt and betaxolol.
Lated mortality among patients who receive vitamin D 50 ; . The biology of vitamin D is tightly interwoven with the biology of serum calcium, phosphorus, and PTH, which themselves have an independent yet complex relationship with survival 51 ; . Nevertheless, previous observational studies implicating alterations of serum calcium, phosphorus, or PTH as independent factors associated with mortality among chronic hemodialysis patients did not often account for whether patients were receiving injectable vitamin D, and whether vitamin D administration itself altered these associations 52, 53 ; . In contrast, the potential adverse consequences of vitamin D administration have been highlighted 54 57 ; and include alterations in serum minerals and the potential for arterial calcification. A survival advantage associated with the group that received injectable vitamin D was present in 48 of strata examined, even after adjusting for other potential confounders within each stratum. Thus, although we did adjust for potential confounders in our primary analyses Table 2 ; , multivariable stratified analysis further mitigated the effect of residual confounding. For example, the results favored vitamin D therapy within patient groups with comparable levels of serum albumin, and even among patients with the lowest levels of PTH or the highest levels of serum calcium or phosphorus at the time of starting injectable vitamin D. The finding that vitamin D injections appeared to benefit these latter subgroups should be viewed in light of recent recommendations to withhold previously initiated vitamin D injections if serum levels of PTH are low or if serum calcium or phosphorus levels are elevated 5 ; . In our previous study, we observed a benefit of paricalcitol.
FORMER STUDENTS SETTLE FRAUD CASE IN WASHINGTON Students in Washington State, who alleged they were defrauded by the now defunct Business Computer Training Institute, have reached a million settlement. An insurance company for BCTI, once based in Gig Harbor, Washington, agreed to pay million to settle claims that the school preyed on lowincome students, charging them almost , 000 for 30 weeks of basic computer training that wasn't worth it. If approved by the trial court, the settlement would close one phase of a class action lawsuit filed two years ago, just before BCTI closed its seven campuses in Washington and Oregon. The lawsuit claims BCTI targeted lowincome students with promises of hightech training and good-paying jobs. Instead, students got substandard training and low-paying jobs at fast-food restaurants, retailers, convenience stores and telemarketing firms. An investigation conducted last year revealed that BCTI recruited students outside welfare and unemployment offices, sometimes in violation of state law. BCTI allegedly pressured recruiters to meet enrollment quotas and fired them when they fell short. Instructors said they were pressured to keep unqualified students enrolled so the school could collect their financial aid from federal and state governments. All of the details of the initial settlement have yet to be worked out, including how the money will be divided among the former students. Some 28, 000 students who attended BCTI from 1985 to 2005 could potentially benefit.The parties have an "agreement in principle" on another feature of the case.A stipulated judgment for an additional million will be entered.That figure represents one-tenth of the estimated economic damages for the 28, 000 students who attended BCTI. However, that money would have to come from a second insurance company. But that company says that its policy would not cover such damages and bevacizumab.
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Each year, fraud costs the health care industry over billion, largely contributing to the rising cost of health care for all Americans. In response to this problem, Blue Cross and Blue Shield of Oklahoma created the Special Investigations Department SID ; . The SID is committed to fighting fraud, reducing health care costs, and protecting the integrity of the Blue Cross and Blue Shield of Oklahoma health care provider networks. To be successful, the SID needs your help. Providers should report any suspicions of fraud committed by others in the medical profession or by patients. Examples of common fraud schemes include: Identity Swapping A member works for a company that does not provide health insurance benefits to its employees, but has health insurance through his spouce's employer. The member's co-worker injures his hand on the job and is rushed to the emergency room. Knowing that his co-worker did not have health insurance, the member presents his insurance card at the emergency room. When the member's spouse receives an Explanation of Benefits form indicating the member had surgery to repair an injury to his hand, the spouse contacts Blue Cross and Blue Shield of Oklahoma to report a billing error, since the spouse did not injure his hand or require emergency room care on the specified date. Black Market Drug Sales A pharmacy informs a doctor that two of his patients have been presenting multiple prescriptions for expensive drugs that were allegedly prescribed by the doctor. The pharmacy also informs the doctor that the quantity and nature of the drugs were unusual and potentially dangerous to the patients' health. As a result, the doctor suspects that a prescription pad was stolen from his office and used to obtain drugs that he did not authorize or prescribe. The doctor reports his suspicions to the SID. Provider Checklist Some simple steps can help prevent situations like these and ensure that you do not encounter other problems within your own practice. Verify patient ID: Ask for a picture ID to ensure that the person presenting the Blue Cross.
Drug discussions drug list betaseron pages : 1 2 list of topic discussions that mention the drug betaseron and bioflavonoids.
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B A B J., action of butter cultures in butter, 79; action of lipase on fat of C A O., heat treatments of milk for cheddar cheese, 679 cheddar cheese, 681 BAKER, 'T. A., a new feeding standard, 630 CAMPBELL, . J. J. R., bacteriology of bull BARNES, B. W., oxidation of vitamin A and semen, 357; storage temperature and carotene, 249 keeping quality of butter, 678 BARTLETT, J. W., incidence of udder inCANNON, C. Y., intramammary temperafection, 656 tures, 181; factors affecting the chyloBEAM, A. L., pre-partum milking, 638 micron count, 645 BECHDEL, S. I., pre-partum milking, 638 CAVE, H. W., peanut hay as a roughage, 646 BECK, G. H.~ bacterlolog.y of bull semen, CAVE, R. A., testing in areas of smalI herds, 357 621 BECKER, R. S., citrus molasses, 269; urea CHAPMAN, A. B., estimating 305-day lactain sorghum silag% 649 tion production, 463 BELL, R. W., prevention of milkstone forCLARK, JAMES D 'A., army packaging and mation, 499; sterilization of evaporated packing of dried milk, 608 milk, 909; effects of sterilization upon CLAYDON, T. J., medicinal flavor encounproperties of evaporated milk, 913 tered in butter, 668 BENNETT~ EMMETT, sulfur compounds as disinfectants, 1007 COLE, H. H., studies on bloat, 779 COLE, W. C., iron content of evaporated BERRY, IV~.H., feeding value of cheat, 627 ; milk, 689 effect of feeding cod-liver oil, 640 ; kelp COMAE, C. L., urea in sorghum silage, 649 meal for dairy cattle, 861; effect of COMBS, W. B., use of buttermilk powder in colostrum, 867 ice cream, 419 BOLIN, D. W., shark ]iver oil in the ration, 155 CONE, J. FRANK, effect of machine milking, 215; quality of Swiss cheese, 483 BORLAND, A. A., pre-partum milking, 638 1057 and bexarotene.
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4.4.3 The Committee considered that the assumptions linking influenza to morbidity and mortality were more realistic for at-risk groups, making prophylaxis more likely to be cost effective in these groups. All people aged 65 years or older were defined as `at-risk' irrespective of whether they had other risk factors. This is because, even without other risk factors, people aged 65 or older have hospital admission rates for influenza similar to those for people aged 18 64 years in the other at-risk categories. 4.4.4 The Committee was aware that vaccination is the most cost-effective defence against influenza and that prophylaxis with an antiviral drug should not replace or discourage the uptake of vaccination. The possibility that recommending routine prophylactic use of an antiviral drug for at-risk groups might lead to a longer-term reduction in the uptake of vaccination within this population was a concern for the Committee, because this might more than negate the benefits of prophylaxis using antiviral drugs. 4.4.5 No RCT evidence was available on the clinical effectiveness of amantadine at a dose of 100 mg for at-risk groups for either seasonal or post-exposure prophylaxis. Although in healthy adults the frequency of adverse events at the dosage of 100 mg day is lower than at the 200 mg dose, similar evidence is not available for at-risk groups. The Committee was therefore unable to accept that the clinical effectiveness of amantadine at a daily dose of 100 mg for the prophylaxis of influenza A among at-risk people was sufficiently proven to allow its cost effectiveness to be considered. 4.4.6 The Committee considered that post-exposure prophylaxis is cost-effective to at-risk people in a residential care establishment, firstly because the risk of contracting influenza is greatly increased among those living in close proximity to an infected person, and the risk increases as the number of these contacts increases. Secondly, in the main, people in residential care establishments are among the most frail and, whether they have been vaccinated or not, the probability of their being hospitalised as a result of contracting influenza is much higher than for any of the other groups.
Must follow specified step order. 1. Neurologists do not need a PA for Avonex Betaseron and Rebif. Use PA Form # 20420 and bidil.
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Patients with coronary artery disease and ventricular arrhythmia may have different degrees of variability than those with mitral valve prolapse or cardiomyopathy. We evaluated a relatively homogeneous group of patients with coronary artery disease, most of whom had a history of myocardial infarction. Our standards for antiarrhythmic drug efficacy are therefore most directly applicable to clinically similar patients and bilberry.
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Agent: Avonex interferon beta-1a, Biogen Idec ; vs. TERMINATED Rebif interferon beta-1a, EMD Serono, Inc. and Pfizer Inc. ; Purpose of study: To determine impact of NAbs on clinical MRI outcomes, also known as PROOF Study Possible mechanism: Slows down immune response, possibly by interfering with T cell activation movement across blood-brain barrier, inducing suppressive T cells Avonex, Rebif ; Study description: Prospective, retrospective, observational Dose route: Avonex 30 mcg wk im vs. Rebif 44 mcg tiw sc for 12-24 mos Outcome parameters: Brain parenchymal fraction, EDSS, relapse rates, EDSS, MRI Type of MS: RR Number of Subjects: 374 Start date: August 2002 Observation period: 3 years Investigators: T. J. Murray and others Sites: Multicenter, United States and Canada Results Publications: Discontinued due to insufficient recruitment; data analysis showed that EDSS to month 6 increased significantly more in NAb + compared with NAb- patients communication with principal investigator; Abstract #P705, ECTRIMS 2006 ; Funding: Biogen Idec, Inc. ClinicalTrials.gov Identifier: Not available Last update: 2007 * Agent: Betaseron interferon beta-1b, Bayer HealthCare Pharmaceuticals, Inc. ; Purpose of study: To delay time to definite MS in patients with clinically isolated syndrome, also known as BENEFIT study Possible mechanism: Slows down immune response, possibly by interfering with T cell activation and movement across blood-brain barrier, and inducing suppressive T cells Study description: Double blinded, placebo controlled Dose route: 250 mcg qod sc vs. PBO sc Outcome parameters: Time to definite MS, frequency of relapse, EDSS, MSFC, MRI Type of MS: First clinical demyelinating event suggestive of MS Number of Subjects: 487 Start date: January 2002 Observation period: 24 months Investigators: Multiple Sites: Multicenter, Europe, Canada, Israel Results Publications: 28% of Betaseron group developed definite MS compared with 45% of PBO group; development of MS delayed by 363 days in Betaseron group compared to PBO group; in 1st year of 5-yr follow-up study, group that had early treatment with Betaseron had reduced risk of EDSS progression by 40% over delayed treatment group Abstracts #P50, #P583, ECTRIMS 2005; Abstracts #P01.073, #S02.001, #S02.002, AAN 2006; Abstract #S02.004, AAN 2007 ; Funding: Schering AG ClinicalTrials.gov Identifier: Not available Last update: 2007.
PULMONARY NEUTROPHIL ACCUMULATION AFTER BURN INJURY IS EXACERBATED WITH AGE V. Nomellini, C.R. Gomez, E.J. Kovacs Loyola University Medical Center, Maywood, IL 60153. Burn injury can result in leukocyte accumulation in distal organs, such as the lungs, potentially causing tissue damage and organ failure. In addition, it is widely recognized that advanced age is a significant risk factor for increased pulmonary complications after burn injury. To determine whether age is associated with increased pulmonary inflammation from burn injury, we first examined lungs of young and aged mice after burn and observed a 10-fold increase in neutrophils within lungs of young mice at 6 hours after injury when compared to those of sham animals p 0.05 by 24 hours, they had diminished to levels indistinguishable from shams. In aged animals, the pulmonary neutrophil levels were increased to the same degree as those of young mice at 6 hours after burn injury. At 24 hours, in contrast, they were still 4 times higher in the lungs of aged, burn-injured animals compared to sham controls p 0.05 ; . This was confirmed by immunostaining lung sections with anti-Gr-1, a marker for neutrophils. Since chemoattraction is a major player in leukocyte migration, levels of KC and macrophage inflammatory protein-2 MIP-2 ; in lung homogenates were measured by ELISA. Levels of KC were 6-fold higher in lungs of young mice at 6 hours after burn, compared to sham animals, then returned to sham levels by 24 hours p 0.05 ; . In aged mice, however, KC levels were 11-fold higher at 6 hours after burn and they remained 4 times higher by 24 hours p 0.05 ; . MIP-2 levels were elevated in the lungs at both time points after burn, but there were no detectable age differences. Future studies are necessary to clarify the source of these chemokines in this model and to determine whether blocking their actions will help alleviate the severity of pulmonary complications after burn injury, especially for the elderly. Supported by NIH AG18859 and Ralph and Marian C. Falk Medical Research Trust and betaseron.
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31 Meininger G, Routh L, Granger H: Autoregulation and vasoconstnction m the intestine during acute renal hypertension. Hypertension 1985; 7 354-373 Roman R: Abnormal renal hemodynamics and pressure natriuresis relationship in Dahl salt-sensitive rats. J Physiol 1986; 251: F57-F65 33. Arendshorst WJ: Autoregulation of renal blood flow in spontaneously hypertensive rats Cure Res 1979; 44: 344-349 KEYWORDS cardiac output autoregulation blood volume vascular resistance blood pressure renal circulation mesenteric arteries and biperiden.
ACTIVE DISEASE MANAGEMENT IN MULTIPLE SCLEROSIS May 26, 2005 Teleconference Kenneth Johnson, MD 1. The CMSC has developed a series of teleconferences which from time to time analyze important changes or information which occur in the area of MS treatment: an example is Bob Herndon's discussion of Tysabri and PML in March. 2. Treatment options and public information continues to change so tonight is an opportunity to reassess the field of MS treatment. 3. First a little history: Glatiramer acetate or Copaxone has been in human trials since the mid 1970's while my colleague Hill Panitch and I began the first studies of Type 1 interferons given systemically in 1979. Yet it took 14 years and multiple trials of both drugs before Betaseron was approved by the FDA in 1993. Soon after that the National MS Society put out a Disease Management Consensus Statement which recommended use of a Disease Modifying Therapy soon after establishing a diagnosis of clinically definite MS. This statement has recently been updated and is available on the NMSS website. Now 13 additional years have flown by and Copaxone and two additional interferon products. Avonex and Rebif have passed FDA muster and are available. Additional trials for instance the Betaseron SPMS trials in Europe and North America, the Avonex CIS trial Champs ; and the Copaxone MRI trial all showed significant treatment effects over placebo and helped establish confidence in these agents.
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