Website Explaining the Tysabri TOUCH Program (Elan/BiogenIdec therapy for MS)
Tysabri is now available in Canada. Below is from Lauren whose blog is at http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/ ————————————————————————– Website Explaining the Tysabri TOUCH Program | ||
For true and accurate information about Tysabri, please see: www.mspatientsforchoice.org/. I also wish to post add’l information here, as I find I’m having to re-type over and over again some of the information below in separate threads here, and hopefully this should alleviate the problem somewhat for my numb hands, so here goes: www.mspatientsforchoice.org/ is an all volunteer nonprofit group. Our group was formed by MS patients following the February 2005 temporary withdrawal of Tysabri to evaluate the issues raised by the three cases of PML in Tysabri clinical trial patients (two in "MS"[1] patients with the combination of Avonex and Tysabri, and one in a Crohn’s patient with a history of using strong immuno-suppressant drugs — such as Azathioprine/Imuran for 6 years), for the purpose of providing accurate Tysabri information, and to push FDA to re-approve Tysabri for relapsing forms of multiple sclerosis as soon as possible to meet the substantial unmet medical need among MS patients. In case any of you are wondering, our group is not affiliated with, and has no support from, any drug company. Since the re-approval of Tysabri, our role has evolved to include assisting MS patients with obtaining insurance reimbursement for Tysabri equivalent to that available for the "less effective older generation MS drugs [2]", and fostering the development of even more effective MS drugs. Much incorrect information has been circulated and passed on to MS patients by various means (Tysabri’s competitors, the media, neurologists, other patients, etc.), and our website seeks to clear up most of this misinformation, including helping MS patients make a fully informed choice regarding their MS therapy in consultation with their neurologist. See Tysabri’s proven superior efficacy in preventing new and further relapses & cumulative disability, reducing existing lesion load, improving disabilities and improving the MS patient’s Quality of Life [3]. Specifically, regarding the risk of Progressive Multifocal Leukoencephalopathy (PML) — a rare brain disease, a patient cannot "catch" PML. From studies done, it is caused by the JC Virus, which normally lies dormant in the kidneys in 70% to 80% of the general population — MS patients included. When the JC Virus is released into the bloodstream — thought to be caused by a dimished (severely compromised) immune system [4], it is then when PML can develop. Note: out of the 3,000 Tysabri trial patients plus the 5,000 general population patients between 11/04-2/05 , with a confirmed diagnosis of MS and without a compromised immune system who received Tysabri as a monotherapy, not one single case of PML was reported, i.e., a risk factor of 0:8000 patients. No drug is without risk, including aspirin. The FDA approved the T.O.U.C.H. Program (Tysabri Outreach Unified Commitment to Health) to minimize the risk of PML (which has actually been shown to be associated with other drugs as well). Our website also has information to help assist other MS patients (if needed) with TOUCH-related questions or problems that might be encountered. Relapsing forms of MS may include those with relapsing-remitting MS, progressive-relapsing MS, and those with secondary-progressive MS who experience relapses. Per Dr. Richard Katz of the FDA, following the March 7 and 8, 2006 FDA Tysabri Advisory Committee hearings in a conference call, clarified that Tysabri has been approved as a first line and/or second line MS therapy. Tysabri is indicated for use as a monotherapy, meaning it should not be used in combination with other immune system modifying drugs, and is for patients who have not responded adequately to, or cannot tolerate [e.g., needle phobic patients or those with injection site reactions or flu-like symptoms from the older generation MS drugs], other treatments for MS[5]. This is further evidenced by the Tysabri label which states: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations." Please visit our website www.mspatientsforchoice.org/ for further Tysabri information, including a short video explaining how Tysabri works, as well as providing an explanation of the TOUCH Program protocol, with responses to frequent questions raised, as many of our members (myself included) were among the first MS patients to actually experience going through the TOUCH Program/RiskMap, and provide solutions to many of the initial frustrations encountered. Please also feel free to contact us at admin@mspatientsforchoice.org "Contact Us" link at the top of our Home Page should you have further questions, comments, or need assistance with regard to Tysabri. For a very thorough discussion of MS and the various treatments available, see: http://doodah95.blogspot.com/2006/08/so-you-want-to-know-bit-about-tysabri.htm No matter which MS therapy you choose, it is your choice. All my very best wishes to each of you..take care, Lauren  Footnotes [1] Woman misdiagnosed with MS and enrolled in Tysabin clinical trial dies [2] NEJM Volume 354:965-967 March 2, 2006 Number 9 [3] NEJM 2006 Mar 2;354(9):899-910 and information at MS Patients For Choice [4] Medline Abstract-Neurol Res, Apr 1, 2006; 28(3): 291-8. [5] http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html | ||
