Conference call helps answer Axonex questions.News about Avonex -- the second approved medication capable of altering the course of MS -- spread rapidly last May. Biogen, the manufacturer of Avonex, reported receiving almost 1200 telephone calls in the first business day following the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. announcement. To help disseminate information, Biogen hosted a teleconference to provide quick access to its medical experts for Society chapters, clinic administrators, and other members of the MS community nationwide. Biogen's panel of experts included Dr. Lawrence D. Jacobs, head of Neurology neurology (n rŏl`əjē, ny –), study of the morphology, physiology, and pathology of the human nervous system. at Buffalo General Hospital and principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research projectPI scientist - a person with advanced knowledge of one or more sciences of the Avonex clinical trial; Dr. Nancy Simonian, associate director of Medical Research at Biogen; and James L. Vincent James L. Vincent is the manager and CEO of Biogen Idec. He graduate from Duke University's Pratt School of Engineering in 1961 with a Bachelor of Science degree. He received an MBA from the Wharton School of Business at the University of Pennsylvania in 1963. , Biogen's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . Before taking calls, the experts clarified some points: Whether or not a person should take this new medication is a decision to be made by the individual and his or her physician. In general, they agreed, Avonex should not be taken by women who are pregnant or trying to become pregnant. People who have heart disease, depression, or seizure disorders Seizure Disorder Definition A seizure is a sudden disruption of the brain's normal electrical activity accompanied by altered consciousness and/or other neurological and behavioral manifestations. should be carefully monitored, but not necessarily excluded. Four people taking Avonex in the trial experienced seizures, but it isn't clear what role the drug played. There were no seizures in the placebo group. Questions came from National MS Society chapters all over the country: San Diego San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. Area: Will Avonex be tested in progressive MS? Biogen: A small pilot study in primary progressive MS will start later this year. We have also promised the FDA that we will follow up on our intention to study Avonex in secondary progressive disease, but the details of a trial are not yet set. Rio Grande Rio Grande, city, Brazil Rio Grande (rē` grän`dĭ), city (1991 pop. : What about use in people who don't have a definite diagnosis? Biogen: We are conducting a large, multicenter study of Avonex in "suspected",or monosymptomatic MS which will begin soon. It will examine whether Avonex can prevent progression to definite MS in people who have had only one symptom and so can't be diagnosed for certain. Mountain Valley California: Are you researching effects of Avonex on cognitive problems? Biogen: We collected some data on cognitive problems and on fatigue as well in the clinical trial, but they are still being analyzed. We have no results to report. National Office, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of : The study did not find depression as a side effect, but the package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific warns, "Use with caution in people with depression." Why? Biogen: While our study showed equal levels of depression in treated and untreated groups, caution is indicated because depression has been reported in people taking other interferon interferon (ĭn'tərfēr`ŏn), any of a group of proteins produced by cells in the body in response to an attack by a virus. A cell infected by a virus releases minute amounts of interferons, which attach themselves to neighboring cells, compounds. In general, people with MS experience depression at higher than normal rates. Wisconsin: Is it safe to take Avonex with birth control pills birth control pill n. See oral contraceptive. birth control pill Oral contraceptive, see there ? Biogen: This decision must be made by the woman's physician. No formal drug interaction study was conducted but there were many women taking oral birth control medication in the clinical trial. No adverse effects due to drug interactions were noted. Some other people in the trial were also taking anti-depressants, and no drug-interaction problems were reported with these either. Greater Carolinas: Did anyone in the trial develop necrosis necrosis /ne·cro·sis/ (ne-kro´sis) pl. necro´ses [Gr.] the morphological changes indicative of cell death caused by progressive enzymatic degradation; it may affect groups of cells or part of a structure or an organ. (skin breakdown) at the injection site? Biogen: No, no one. North Texas: Does Avonex need refrigeration refrigeration, process for drawing heat from substances to lower their temperature, often for purposes of preservation. Refrigeration in its modern, portable form also depends on insulating materials that are thin yet effective. ? Biogen: Yes, but if refrigeration is unavailable -- when you're traveling for example -- it can be stored at room temperature up to 30 days, provided it isn't stored in a hot place. Southwestern Ohio/Northern Kentucky: Should people who are interested contact the Avonex Support Line or their own physician first? Biogen: The decision to take any drug involves three parties, a patient, a physician, and a payer. Call the Avonex Support Line for insurance counseling and information on our patient service programs; call your physician for an appointment to review your personal medical issues. Only your physician can provide a prescription. However, there is no reason to wait until after you have been seen by your physician to gather the other information you need for a final decision. A Call for Art "The Creative Will," the Society's juried, biennial exhibition program for professional artists with MS, is now accepting entries for 1997-1998. The program was founded in 1983 to educate the public about the ability of those with the disease to adapt and succeed. The deadline is November 15, 1996. General rules for entries: 1. All artists with MS are eligible and must enter on behalf of themselves. Artists who have entered before may enter again. 2. All original visual fine art created since the onset of the artist's MS is eligible. 3. Candidates may submit 5-10 works. Video and film may be submitted on video. All other work must be submitted via slides. 4. An entry form and brief autobiography are part of the entry requirements. The selections will be based on the merit of the art by a panel of three museum curators. The exhibit will open in a prestigious New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. gallery and travel to additional venues across the country. Finalists' art will also be considered for the Society's holiday cards and annual calendar. For the entry form or further information, write or call Andrea Furey, "The Creative Will," NMSS NMSS National Multiple Sclerosis Society NMSS Nuclear Material Safety and Safeguards NMSS New Model Special Schools NMSS Network Management Support Services , 733 Third Avenue, New York, NY 10017-3288, Tel: 212-476-0442 or e-mail: furey@nmss.org Training in self-injection is essential If your physician has prescribed Avonex and considers you or your carepartners to be candidates for self-administration, you must receive proper training -- even if you have had experience injecting Betaseron. Both preparation and injection processes for these two drugs are different. Training will start by reviewing a video and handbook prepared by Biogen for Avonex patients, available through your physician or the Avonex Support Line. Next, you should attend a hands-on training session. If your physician opts to use the free Avonex Administration Training Program, the physician's office must call the Avonex Support Line for referral. Then, a representative of Interim HealthCare, which is operating this program for Biogen, will call you to schedule your appointment. Most training sessions are done in small groups. You will bring your first dose pack to the session and give yourself your first self-injection there, under the supervision of an Interim HealthCare nurse. Interim is also providing some training to staff members of MS clinics. Please call the Avonex Support Line, not Interim HealthCare. |
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