Date: Sat, 18 Feb 95 03:29:58 -0500 From: Bob Broedel To: als@huey.met.fsu.edu Subject: ALSD#175 ALS-ON-LINE =============================================================== == == == ----------- ALS Interest Group ----------- == == ALS Digest (#175, 17 February 1995) == == == == ------ Amyotrophic Lateral Sclerosis (ALS) == == ------ Motor Neurone Disease (MND) == == ------ Lou Gehrig's disease == == ------ Charcot's Disease == == == == This e-mail list has been set up to serve the world-wide == == ALS community. That is, ALS patients, ALS researchers, == == ALS support/discussion groups, ALS clinics, etc. Others == == are welcome (and invited) to join. The ALS Digest is == == published (approximately) weekly. Currently there are == == 490+ subscribers. == == == == To subscribe, to unsubscribe, to contribute notes, == == etc. to ALS Digest, please send e-mail to: == == bro@huey.met.fsu.edu (Bob Broedel) == == Sorry, but this is *not* a LISTSERV setup. == == == == Bob Broedel; P.O. Box 20049; Tallahassee, FL 32316 USA == =============================================================== CONTENTS OF THIS ISSUE: 1 .. Some Thoughts on CNTF Trials 2 .. ALS and Spiritual Healing 3 .. Interesting Video and a Question 4 .. Disability Solutions by Apple 5 .. Update on Riluzole 6 .. New Internet Neuroscience Resource (1) ===== Some Thoughts on CNTF Trials ========== Date : Thu, 16 Feb 1995 22:23:55 EST >From : TASM76A@prodigy.com (MR TED HEINE) Subject: Some Thoughts on CNTF Trials The Regeneron trial used two dose levels: 15 and 30 ug/kg three times a week. The Synergen trial used three dose levels: 0.5, 2, and 5 ug/kg seven times a week. Translating this to weekly rates we have 45 and 90 for Regeneron; 3.5, 14 and 35 for Synergen. Therefore the Regeneron low dose was greater than the Synergen high dose. The Regeneron trial collapsed because initial serious side effects, primarily affecting the high dose patients, obscured later beneficial results so much that the trial could not be recovered statistically to the satisfaction of the FDA, which insisted that the trial be considered as a whole and the protocol not be revised in the middle of a trial. Apparently Regeneron had the option of starting over but did not have the economic resources to do that. Feedback from Synergen patients did not disclose nearly the side effects that Regeneron patients suffered. We can therefore conclude that one should not start giving CNTF to any patients in large doses, but should start at a low level and build up tolerance in the body. That is what Amgen is doing in the BDNF trials. Essentially, Synergen patients did not get enough drug for it to be effective; Regeneron patients got too much drug to start with. I am really concerned about measures of "effectiveness." The standard scientific measure is a probability of .05 or less (five chances out of 100) that results are not due to random factors. In other words, there is a 95% chance that any effectiveness observed is due to the drug and not something else. My personal belief is that this scientific standard is much too stiff when dealing with terminal illnesses where a marginal difference may be important to extending the lives of patients. I would be happy to take a drug if the chance were only 50/50 that it might do me some good, or even a 20% chance. A recent conversation with a biostatistician resulted in a statement that the FDA is not wed to a .05 probability, but is not likely to accept results departing much from that number. It sounds to me that we are being protected to death, and not being given choices that we could make rationally and individually, based on our own acceptance of odds. Given the fact that clinicians believed that Synergen's CNTF is effective (perhaps wishful thinking) it is still very disappointing that a drug which may well be effective for some patients will probably never reach the market, except maybe when combined with other neurotrophic factors. It is still important to expedite safety trials of the BDNF-CNTF combination so that human trials may follow. Ted Heine in Waverly, Iowa (2) ===== ALS and Spiritual Healing ========== Date : Thu, 16 Feb 1995 22:43:29 -0500 >From : rbm@hookup.net (Robert Macdonald) Subject: ALS and Spiritual Healing ALS and Spiritual Healing I now realize that my experience with ALS has been somewhat different from what other people have, and are experiencing. Maybe I have been very lucky, and I hope that by writing this article, I can pass some of my good luck on to you. First, I should tell you that my grandmother and her son, my father, died of ALS, so for me the disease was not an unknown mystery. Yet, I still have lots of regrets about having a terminal illness. I have gone through normal feelings of denial, and dealing with the dilemma that having a positive attitude can seem the opposite to accepting that you really have a terminal disease. However, through it all I've been in pretty good humour, and I've had a determination to learn a lot more about ALS and potential cures. As I said, I am lucky, I had a head start, emotionally. ALS is not new to my family. Also I'm very lucky to have the continuous helpful support of my wife and family. That too makes a big difference. Another source of my inspiration has come from my awareness of the determination of other ALSers, such as Denis Kay, Sue Rodriquez, and the many new ALS friends I have been in contact with over the last year. Soon after my diagnosis, I started reading as many research papers and articles about ALS as I could find. It just takes a few research papers to learn that medical research is an awesome and infinitely complex subject. Incredible progress is being made, and future generations will certainly benefit from the research that is now happening. But, I can't do much about that, and I've learnt enough to feel that research is not going to do much for me! Current drug research was another area I investigated. What an expensive and time consuming process drug research is. Only large pharmaceutical companies with deep pockets can afford that sort of thing, and the size of the ALS patient market is pretty small when it comes to spending a lot of money on drug research. None-the-less, with all the work that is being done to get a better understanding of neurological diseases, there are bound to be discoveries that will help future generations. As I began to understand the limitations of so called "traditional medicine", I concurrently I began to read about the other and vast world of "alternative healing". I started with a book my daughter gave me, by the well known author Dr. Chopra, and as a result I went off, at considerable cost, to an Ayur Veda Health Clinic in Quebec for their special treatment and to learn to meditate. Whether or not the treatment helped my body is hard to tell for sure, but it was an enriching experience and the meditation lessons have been invaluable. I continue to meditate first thing every morning, and it is now an important part of my life. I have always been an agnostic, or at least ever since I realized there was no Santa Claus! Religion was fine for people who needed it, but I always thought that I didn't need it. However as I continued to read about alternative healing techniques, I discovered that research has demonstrated the reality of what many think of as supernatural activities. It has been scientifically proven that therapeutic touch and praying can really work! I had to find out for myself, so I went to a number of so called spiritual and semi spiritual events, such as a "laying on of hands" service at a very traditional church, therapeutic touch and energy transfer by specialists, a vibrant service at the Vineyard Church (near the Airport), a service by a "Shaman", etc. What you get out of these sorts of events is a very personal matter. I have approached them all with a very open, innocent and delighted frame of mind, and I have came away with some wonderful experiences, and a very heightened spiritual awareness. I have not spent a lot of money on these explorations, and on two occasions when the "giver" learnt I couldn't speak, they didn't charge me for their service! After several months of reading about and experiencing various spiritual activities, I have discovered a common theme. We as humans have a spiritual being and energy fields that are linked to God/nature and our past and future being. Maybe you discovered that a long time ago. For me it's new, and has opened my awareness so that I can draw energy and wisdom from nature, such as the plants on my shelf, and the trees outside my window. And I can have conversations with the cells in my body. This has all happened in less than a year. A year ago I would have been very skeptical about spiritual communication. But over the past year I have been able to find out what I can believe because of my own experiences, and it's given me a vast new world to explore. Obviously my new found spiritualism hasn't meant that I can get up and walk away from ALS, but I think it must have a lot to do with why I usually feeling pretty good, and I am really looking forward to the future. I have so many things I want to do and write. When most of us are ill, we look to our doctors and the medical system to find out what's wrong, and expect them to make it right. Perhaps we should also spend some time helping ourselves, by looking into our own spiritualism. Maybe the ultimate cure for ALS will be when we have the ability to discover, and fill ourselves with an awareness of the spirit of beauty and love in our own beings, and in the spirit of nature around us. Robert Macdonald, 1/18/95 rbm@hookup.net (3) ===== Interesting Video and a Question ========== Date : Fri, 17 Feb 1995 03:07:18 -0500 >From : DanB5974@aol.com Subject: Interesting Video and a Question In exploring what my friend Robert would accept in the way of a device with which to communicate as his voice goes (and control of his limbs are long gone), I reviewed with him the fantastic TextReader that was discussed in here (developed by DEC? ,anyway) packaged with SoundBlaster. And the ASYST and other devices about which he received material 1 1/2 year ago. Robert insisted I watch the Steven Hawking video, A Point In Time, and find out about the "more sophisticated" system identified there. Got the video through a library system. It was very interesting, and I recommend all associated with ALS to watch it just for interest and entertainment. In that movie there was shown a system called "Equalizer" that looks much like ASYST. It had come from "World Plus Inc., Lancaster California. Can anyone point to "Equalizer" or "World Plus Inc."? There's no phone listing for that company in that city. Maybe they moved, changed name, don't have a business phone, out of business, or in Lancaster of another state. The list of download files associated with this subject look interesting. Would take a lot of research to see what would fit in the specific situation. ===== = I saw a movie about Stephen Hawking. It was A BRIEF HISTORY OF TIME. = It mentioned the Equalizer. I think the vendor you are looking for = is Words+ Inc. According to the TRACE RESOURCEBOOK: ASSISTIVE TECH- = NOLOGIES FOR COMMUNICATION, CONTROL AND COMPUTER ACCESS, the company = can be reached at: Words+, Inc.;P.O. Box 1229; Lancaster, CA 93584. = TEL 805-949-8331/800-869-8521. = = The TRACE RESOURCEBOOK is available from the Trace Resource Center; = S-151 Waisman Center; University of Wisconsin-Madison; 1500 Highland = Avenue; Madison WI 53705. TEL 608-262-6966. = rgds,bro ===== (4) ===== Disability Solutions by Apple ========== Date : Fri, 17 Feb 1995 17:01:22 EST Sender : L-HCAP List >From : Bill McGarry Subject: Handicap Digest # 3746 ===================================================================== To subscribe to the Handicap Digest mailing list or have your thoughts in the next issue, please send electronic mail to Bill McGarry at the following addresses: INTERNET: wtm@bunker.shel.isc-br.com Bill McGarry (Moderator) (203) 926-6187 < many parts deleted > Subject: Disability Solutions by Apple >From : nrcgsh@ultb.isc.rit.edu (N.R. Coombs) The following announcement came to me via e-mail, and I believe it is worth passing along. Norman Coombs nrcgsh@rit.edu Macintosh Disability Resources (v4.0) Released The latest version of Apple's comprehensive database of Macintosh assistive technology products is now available. Version 4.0 of the Macintosh Disability Resources (MDR) database includes descriptive information of over 100 Macintosh solutions for individuals with disabilities. Each record in the MDR database contains a product description and developer contact information. MDR includes information on tools for individuals with physical motor impairments, blindness, hearing and speech difficulties, and learning disabilities. The database can be searched by keywords, product name, developer name, disability type, and description text. Macintosh Disability Resources is available free-of-charge to anyone who requests a copy. To receive MDR, call (800) 776-2333-voice or (800) 833-6223-TTY. Write to: Apple Computer, Inc.; One Infinite Loop, MS-38DS; Cupertino, CA 95014. Or, e-mail your request, along with your full mailing address, to applewdsg@eworld.com. Macintosh Disability Resources is available for downloading on many of the major online services including eWorld (The Disability Connection; shortcut: disability), America Online (The Assistive Technology Forum; keyword: disability), and AppleLink (The Empower Bulletin Board; path: Community Center -> Disability Solutions -> Empower BB). Macintosh Disability Resources is maintained by Apple Computer's Worldwide Disability Solutions Group which is celebrating its 10 year anniversary in 1995. (5) ===== Update on Riluzole ========== --- - The following update was posted by ALSA National Office on the ALS - Bulletin Board on the Prodigy Computer Network on February 6, 1994. --- Recently there have been several notes, comments and questions on the Prodigy Bulletin Board regarding the clinical trial of riluzole, its projected outcome and potential expanded access to the drug. Some of this information is inaccurate. While we are all anxiously (and hopefully) awaiting the results of the global study involving 900 patients, it is important to keep the ALS information highway accurate and realistic in trial outcome expectations. ALSA maintains ongoing communication with Rhone-Poulenc Rorer (RPR) regarding the status of their trial with riluzole. The note that appeared on the BB stating "the drug doubled the survival time in bulbar onset ALS" was reported in the first study, published in the New England Journal of Medicine. This information is NOT available from the second study yet. Through discussions with people working in and around the riluzole trial, the data collection cut-off did occur on 12/31/94. This data is being collected and analyzed as rapidly as possible. While speed is truly a main concern, it is important to remember there were 31 centers partici- pating from around the world that must complete and submit their data; it must be done precisely and that does take time. Until the data is available, RPR is not in a position to propose a compassionate use or expanded access program to the FDA. ALSA is aware of and has participated, in part, with the internal effort by RPR to put such a program in place so that it's ready to go if the results prove positive. In the interim, RPR has informed ALSA that it has set up a toll-free hotline to access information on the status of the riluzole project. Getting your name on that database mailing list is the best way to insure that the day RPR announces anything, you will receive the latest, most accurate information as rapidly as possible! The toll-free number is 1-800-RX-TRIAL (1-800-798-7425). In addition, riluzole is not available for compassionate use or expanded access in any other country. As all of the clinical trials come closer to reporting the results of their final analysis, there will be many rumors circulating about the projected outcomes. ALSA is maintaining ongoing contact with all the drug companies and will keep you informed as we receive the accurate, up- to-date information. Lynn Klein (6) ===== New Internet Neuroscience Resource ========== Date : Thu, 16 Feb 1995 19:02:35 -0500 Sender : Methods in Modern Neuroscience >From : Cara Kaufman Subject: New Internet Neuroscience Resource I am writing to let you know that a new neuroscience resource can now be accessed via the internet. THE NEUROSCIENTIST, a new bimonthly review journal edited by Stephen G. Waxman, M.D, Ph.D., of the Yale University School of Medicine, has begun posting selected articles in gopherspace and will soon have a World Wide Web homepage available for access. To find out more about THE NEUROSCIENTIST and how you can access these articles, simply send an e-mail message to me at the address ckaufman@access.digex.net and put the words "MORE INFORMATION" in the subject heading. === end of als 175 ===