Date: Mon, 4 Sep 95 00:41:33 -0400 From: Bob Broedel To: als@huey.met.fsu.edu Subject: ALSD214 ALS-ON-LINE =============================================================== == == == ----------- ALS Interest Group ----------- == == ALS Digest (#214, 04 September 1995) == == == == ------ Amyotrophic Lateral Sclerosis (ALS) == == ------ Motor Neurone Disease (MND) == == ------ Lou Gehrig's disease == == ------ maladie de Charcot == == == == 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 == == 960+ 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 == =============================================================== == Back issues of the ALS Digest are available on-line at: == == http://http1.brunel.ac.uk:8080/~hssrsdn/alsig/alsig.htm == =============================================================== CONTENTS OF THIS ISSUE: 1 .. Our International ALS E-mail Network. 2 .. Documentaries on ALS 3 .. Letter to House and Senate 4 .. Letter to FDA advisory panel 5 .. Where to buy Neurotrophins? 6 .. ALS and dental materials 7 .. Rilutek Early Access Program (1) ===== Our International ALS E-mail Network. ========== The following countries are represented here on-line with us: Argentina, Armenia, Australia, Belgium, Bermuda, Brazil, Canada, Finland, France, Germany, Greece, Hungary, Iceland, Iran, Israel, Italy, Japan, Korea (South), Luxembourg, Monaco, Netherlands, New Zealand, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States of America. Please let me know if I left anyone out. bro (2) ===== Documentaries on ALS ========== Date : Sun, 3 Sep 1995 18:58:03 +0000 >From : jongus@rhi.hi.is (Jon E Gustafsson) Subject: Documentaries on ALS I am a film and television director in Iceland and I am preparing a documentary about ALS for the Icelandic MND Society. Does anyone know about available documentaries on ALS? I would be greatful for any information about material that might be useful. Jon. Jon Einarsson Gustafsson P.O.Box 30 172 Seltjarnarnes Iceland Phone: (354) 561 1880 Fax: (354) 561 2435 e-Mail: jongus@rhi.hi.is (3) ===== Letter to House and Senate ========== Date : Thu, 31 Aug 1995 16:41:59 -0400 >From : JACKN74940@aol.com (Jack Norton) Subject: Re: ALSD211 ALS-ON-LINE Bob, Many of us on Prodigy are attempting to get FDA reform in front of Congress. We have developed a letter to send to Senators and can be modified for representatives. Ted Hein, Larry Sing and others contributed to this set of amendments to a circulating senate bill with similar bills in the house. Hope others will send letters to their senators and reps. Jack Norton Paul Wellstone 717 Hart Senate Office Building Washington D.C. 20510 2303 Dear Senator Wellstone I am a victim of amyotrophic lateral sclerosis (Lou Gehrig's disease), and am eager to obtain access to new drugs that have demonstrated efficacy in clinical trials but are not yet available commercially, specifically Cephalon's Myotrophin and Amgen's BDNF. The Senate will soon consider legislation to reform the Food and Drug Administration. Please support S.1035, the "Access to Medical Treatment Act." I believe that this bill, although a major improvement over the present, can be strengthened in the area of access to new and promising drugs for patients with terminal and untreatable diseases, such as ALS. Addition of a new section to the bill, along the following lines, is desirable: Compassionate Access or Expedited access to products (drugs or therapy) for individuals diagnosed with a terminal illness. for which no clinical treatment exists for the remission or cure of the terminal illness, during human drug trials, Phases 1-3. 1. Drugs that have successfully completed Phase 1 safety trials, or any level past Phase 1, can be made available to patients provided the Drug Sponsor has sufficient supply; that the patient, attending physician, and Drug Sponsor reach a financial agreement for payment and treatment protocol in accordance with Drug Sponsor Charges (Point 6, below). 2. During Phase 2 trials, experimental drugs may be made available by the Drug Sponsor to those patients not able to qualify for the trials after the trials are full; the drug will be offered only for its intended use and intended population and the Drug Sponsor may charge for the drug in accordance with Drug Sponsor Charges (Point 6, below). 3. The FDA shall require that Drug Sponsors submitting protocols for Phase 3 clinical trials, must make the drug trial protocol available to all patients to whom the Drug Sponsor intends to market the approved drug. After the trial is full, the Drug Sponsor may charge for the drug in accordance with Drug Sponsor Charges (Point 6, below). 4. The FDA shall identify Investigational New Drugs as "Non-FDA" approved when the Drug Sponsor initiates Phase 3 clinical trials, to allow physicians to prescribe and to require insurance carriers to pay for experimental life saving drugs. 5.The FDA will encourage alternative drug trial designs that incorporate history controls, dose variances, and other humane methodologies. It will discourage the use of placebos on terminally ill patients and encourage innovative surrogate endpoints. 6. Drug Sponsor Charges defined: Until the FDA has approved a New Drug Application, the Drug Sponsor can only recover the cost of manufacture (including allocation of overhead), research, development, distribution and handling costs, plus an escrow account amount. The purpose of the escrow account is to allow distribution to patients who are unable to pay the established price. Escrow accounts are recommended to be administered, for Orphan Diseases, jointly by the National Organization for Rare Disorders (NORD) and the Drug Sponsor. Drug costs for each category will be disclosed only to the FDA to ensure proprietary trade confidentiality and are exempt from the Freedom of Information Act. 7. The attending physician is prohibited from accepting any additional compensation from the Drug Sponsor. 8. Drug Sponsor defined: Any company, corporation, educational institution, research laboratory or foundation, charitable organization defined under Section 401 of the Internal Revenue Code, foreign or domestic, that submits drug trial or therapy protocols to the FDA for approval. I am sure that the substance of this letter is clear: make experimental drugs available to patients suffering from terminal illnesses and allow drug companies to recover direct costs. I hope that you will consider adding this amendment to S.1035. Don't "Protect Us to Death!" Offer the Choice. The Quest Continues!... (4) ===== Letter to FDA advisory panel ========== Date : Fri, 1 Sep 1995 17:03:42 -0400 >From : JACKN74940@aol.com (Jack Norton) Subject: Re: ALSD211 ALS-ON-LINE Bob, Please help us keep the ALS community aware of FDA Advisory panel meeting Sept. 18. Here is my letter to the panel. Perhaps others will write also. Jack 1 September, 1995 Executive Secretary Michael Bernstein MPH Center for Drug Evaluation and Research FDA 56001 Fishers Lane Rockville, MD 20857 Dear Mr. Bernstein, On August 2nd, I sent you a letter urging the FDA Advisory Panel to accelerate the review and approval process from 19 months to six months, for drugs that impact life threatening diseases. such as ALS. RPR has presented the FDA with documentation supporting their ALS drug Rilutek, the last week of June. We urge you to concentrate your time on this review in order to award approval, if there is even the slightest potential in helping the terminally ill. Do this within six months of drug sponsor submission, or no later than December 1st! The approval of Rilutek will mean the end of inhumane use of placebos on the terminally ill ALS victims. Future trials will now have to allow for Rilutek to be the baseline or alternative treatment. It also means that the FDA can begin approval of combination drug trials where Rilutek and other biologic drugs can be tested on humans. There is no " Magic Bullet", but the prevailing sentiment is that a combination treatment is the only way to slow or stop this horrific disease. Thousands of ALS victims will be monitoring your proceedings. Be diligent in your task. Demonstrate compassion and a sense of urgency. Again I remind you of your Commissioner's quote to the New York Newsday "When people are suffering and dying from a devastating disease, we cannot wait for all the evidence to come in - for all the i's to be dotted and all the t's crossed. We must be prepared to accept greater risks when greater benefits are possible." Dr. David Kessler! The Quest Continues! Jack and Cindy Norton (5) ===== Where to buy Neurotrophins? ========== >From : mulderry@castle.ed.ac.uk (P Mulderry) Newsgroups: bionet.neuroscience, bionet.cellbiol Subject : Where to buy Neurotrophins? Date : 29 Aug 1995 16:44:07 GMT I am looking for commercial sources of Neurotrophins (NGF, BDNF, NT-3, etc.) for research use. I'd be grateful to hear comments from anyone on quality of supplied material or special price deals. Also, are there any good commercial sources of GDNF? Thanks. -- Peter Mulderry, e-mail: mulderry@castle.ed.ac.uk MRC Brain Metabolism Unit phone: (+44) 131 537 6527 Royal Edinburgh Hospital FAX: (+44) 131 537 6110 Edinburgh, Scotland EH10 5HF (6) ===== ALS and dental materials ========== >From : sallitt@netcom.com (Dan Sallitt) Subject: ALS and dental materials Date : Wed, 30 Aug 1995 11:15:41 -0400 I saw the posting in #211 about someone who developed ALS after major dental work, among other things. There is a book by Dr. Hal A. Huggins called IT'S ALL IN YOUR HEAD: THE LINK BETWEEN MERCURY AMALGAMS AND ILLNESS (Avery Publishing Group, 1993) that puts forth the idea that dental materials like mercury can cause immune reactions in many people and trigger illnesses to which they are susceptible. I can't vouch for the value of the research in the book, but I thought it might be worth quoting a few passages. The controversy about mercury in dental fillings goes back many years. Huggins came at the subject through the study of blood chemistry, and he noted large changes in various blood counts after placement or removal of fillings, even though the ADA claimed that no such systemic reactions should occur. Over the years, Huggins claims to have been able to affect the course of many illnesses by removing fillings; he claims that his success rate increased over the years as he learned about various techniques like removing fillings in order of electrical charge. According to his claims, the onset of disease will often correlate with the placement of fillings, root canals, or other dental operations, though he says that the first exposure to toxic materials is not always the exposure that causes the illness. Here is a passage on ALS from Huggins' book. "From 1973 until 1990, my treatment achieved no response in ALS patients, yet I could see all the chemical earmarks that suggested it was an auto- immune disease of dental origin. Finally, in early 1991, I hit upon a new button that could give a wake-up call for nerves and muscles in the ALS patient - cavitations. This is my term for a literal 'hole in your head.' "When teeth are removed, the periodontal ligament (a membrane that attaches the tooth to the bone) is usually left in the socket. I now compare this membrane to the afterbirth that is delivered after a baby is born. If the afterbirth is left in, the mother will probably die. When the periodontal ligament is left in, the patient does not die, but neither does the socket area completely heal. Bone cells will naturally grow to connect with other bone cells after tooth removal - providing that they can communicate with each other. If the periodontal ligament is left in the socket, however, bone cells look out and see the ligament, so they do not attempt to 'heal' by growing to find other bone cells. "In these cases, I have found that the top of the socket seals over with two or three millimeters (mm) of bone; under that, a hole remains. This bony hole is usually lined with chronic inflammatory lymphocytes, which are the cells of autoimmune disease, and some strange cells that took a while to identify. They turned out to be monocytes (large white blood cells with a single nucleus) that had somehow evolved three more nuclei. This type of cellular change can occur in an extremely toxic environment. "The significant discovery I made is that if these cavitations are opened and the periodontal ligament is removed (a five-minute procedure), ALS patients respond. Now, these people did not hop out of their wheelchairs and run the 100-yard dash, but their mobility improved, their voices improved, and their attitudes improved. These changes indicated that healing could take place, and that ALS is not an entirely nonresponsive disease. Some patients who received very early treatment have returned to near normal - I say near because these people will never be able to play three sets of tennis a day or overtax their damaged immune systems. But their life expectancy is increased by eighteen months to three years." Huggins then quotes an article by Douglas Swartzendruber, Ph.D., an experimental pathologist at the University of Colorado, as follows: "The accumulation of mercury from amalgam in the [central nervous system] is an important connection to the etiology of neurologic disorders such as multiple sclerosis and amyotrophic lateral sclerosis. The neurotoxicity of mercury has been long known, mercury-induced neuropathology well described, and the mechanisms of toxicity have been studied in great detail. It has also been documented by at least five independent studies that chronic exposure to mercury is an etiologic agent in the ALS syndrome. It has been clearly demonstrated that mercury from amalgam accumulates in the brain and [central nervous system] and autopsy studies show that the level of mercury in the brain linearly correlated with the number of amalgam surfaces on fillings. Concentrations in the tissues reached as high as 120 nanograms per gram of tissue." Later in the book, Huggins is speaking about removing fillings in order of electrical charge. "Once the process of amalgam removal is begun, removing a few fillings will alter the components of the [electrical system of the mouth], resulting in changing current. For most people, these...fluctuations are not great enough to be significant until after a week or so, but this is not true for people with leukemia or ALS. These folks respond when the fillings are removed in absolute sequence - that is in descending order, from high negatives to low positives, such as in -12, -9, -2, +20, +10, +3. This means that the dentist may be jumping from an upper tooth to a lower tooth, from right to left, in a time-comsuming pattern, but the results have been decisive. Neither of these diseases falls into the totally reversible category, but when the absolute sequence is used, I frequently see improvements. When fillings are not removed in this way - even though all other procedures are followed - there is no interruption in the downward progression of the disease." In a section on Alzheimer's disease, Huggins writes: "Strangely, it was Alzheimer's that taught me about coloring agents in dentures. Several patients in a row had had dentures, and I decided to investigate the coloring agents in denture acrylic. It turns out that the pink coloring agents are cadmium sulfate and mercury sulfate. Today I make all plastic appliances, including dentures, out of clear acrylic. Sometimes I tint the first three millimeters of gum tissue over the upper front teeth with pink, because they certainly do look better. I figure that is one one-thousandth of the acrylic in a denture, and I have been getting away with it." Again, I can't vouch for any of this information, which is much disputed in the dental and medical community. Huggins runs a dental center in Colorado and has a phone number for information calls: (800) 331-2303. - Dan Sallitt (sallitt@netcom.com) (7) ===== Rilutek Early Access Program ========== Date : Thu, 31 Aug 1995 21:37:30 -0600 (MDT) >From : DRIEVER_JIM Subject: Rilutek Early Access Program I have a problem before me that many of you probably wish you had. Let me first explain my situation: I'm a 40 year old man that has had ALS for over 11 years. After reading about the drug "Riluzole" in an MDA newsletter, I decided that it didn't sound very promising for me. The information stated that the drug mildly helped a few ALS patients that had their symptoms begin with their speech. It also said that most ALS patients typically live 3 to 5 years after the onset of this disease but "Riluzole" was adding another 6 months to the lives of most on the medication. My symptoms began in my hands and arms and then to my speech. I haven't seen a doctor for ALS for 4 years but keep updated on recent developements from MDA literature. When the "Rilutek (Riluzole) Early Access Program" lottery became available I didn't bother applying. A good friend submitted my name so I filled out the application to appease those around me. I figured I wouldn't have to worry because I probably wouldn't be selected. Well, today I received a letter advising me that I was selected and of the next steps I need to take before possible acceptance into a "double-blind study." I promised myself I wouldn't participate in a "double-blind study" but when you're drowning you can't be too picky about clinging to a life raft no matter how many holes it has in it. I'd like some input from a doctor concerning the slim advantages for me that this drug "might" offer in light of my longevity and the onset of my symptoms. With the continuing tensions between those that take care of me, I just don't know it's worth the hassel of traveling 175 miles to an MDA Center only to take a placebo. Thanks for your time, Jim Driever 790 Natalie Pocatello, Id 83202 208-237-9731 driejim@ucs.isu.edu === end of als 214 ===