No. 208 May, 2000
MEDICAL ORPHANS FAMILY There are many diseases and medical conditions which affect fewer than 4,000 individuals in the United States. These individuals have (the orphan) diseases which were not being researched. They need drugs and medical devices which are not being developed. Orphan drugs and diseases have no parent organization, researcher, or developer, because costs are high and marketability is small (4000 or fewer patients). The Office of Orphan Products Development 's List of Orphan Product Designations and Approvals at http://www.fda.gov/orphan/designat/index.htm and the Orphan Drug Act of 1983 gave birth to Orphan Drugs by providing incentives for the pharmaceutical industry to develop and market orphan drugs to the "10 million to 20 million Americans who suffer from one of the approximately 5,000 rare and (many of which are also) orphan diseases. (Report of the The National Commission on Orphan Diseases, February 1989, HE 20.2:Or 7). The Safe Medical Devices Act of 1990 paved the way for Humanitarian Use Devices (HUD). The HUD is a device intended to benefit the patient by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. ("Medical Devices; Humanitarian Use Devices, Final Rule" Federal Register, v. 61, No. 124, June 26, 1996 pages 33232-33248.) The next and most cost-effective step is preventive immunization. Disease control and the prevention of the spread of these contagious diseases is the purpose of vaccines. Basically, vaccines are an area of drugs and drug products that will be expensive to develop for a small number of rare infectious diseases and for those important but geographically limited (such as arboviral or diarrheal) diseases involving a small number people. High development costs offsetting little or no profits results in orphan vaccines. Jean Lang and Susan C. Wood "Development of Orphan Vaccines: An Industry Perspective" in Emerging Infectious Diseases, V. 5, No. 6, November-December 1999, pages 749-756 http://www.cdc.gov/ncidod/EID/vol5no6/lang.htm has a very good description and discussion on orphan vaccines, the third member of the medical orphan family, in both the United States and Europe.
CONCRETE BARRIERS Initially designed and intended for the protection of highway construction workers, concrete barriers are now used as a safety protection device and divider for multilane highways that lack a physical divider between the two sides of the highway. These barriers are usually found in areas where there is a lack of a safety space between the driving lanes. This concrete barrier is the only safety device preventing vehicles from going across the center of the highway and crashing into the oncoming traffic. "The basics of concrete barriers are not generally known or understood. Concrete barriers appear to be simple and uncomplicated, but in reality, they are sophisticated safety devices." So says Charles F. McDevitt in "Basics of Concrete Barriers" Public Roads, v. 63, no. 5 March/April 2000 pages 10-14 (TD 2.19:63/5). There are four different kinds of barriers that range from 2 feet to 3 ½ feet high and have four basic designs. Most are about one foot wide at the top and (about) two or three feet wide at the bottom. The temporary moveable barriers can be about 30 (or more) feet long. The concrete divider in a multilane highway is one continuous barrier constructed to be immovable. Each barrier, with it's specific design, reflects it's unique purpose in how it "handles and guides" the moving truck or cars which hit these barriers in a vehicular crash. The barrier is designed to control and slow the crashing vehicle with the minimum damage to the vehicle and to the surrounding vehicles. The ultimate goal is to keep all the vehicles from crossing over into the oncoming traffic.
CRITTER CROSSINGS When people leave home and go to the store or to visit a friend they carefully cross the street(s),avoiding cars, and get back home safely. Before the existence of cars and highways, animals could easily go visiting or hunting for food and return home safely. Now, with about 4 million miles of public roads crisscrossing the United States, automobiles and roads have had a very adverse impact on America’s animal population. Roads result in habitat loss and habitat fragmentation. These animals also run the risk of being killed on or along the roads and highways. Hitting a deer will kill the deer but will also result in major car damage. Each year, more than 200 motorists are killed and thousands more are injured in animal/vehicle collisions. "Critter Crossings" by Ginny Finch in Public Roads, v. 63, no. 5 March/April 2000, pages 35-39 (TD 2.19:63/5) which show some of the examples of critter crossings, i.e. under-the-road(s) tunnels which are enabling the wildlife in Massachusetts, Florida, and Washington State to safely cross under the roads. In Washington State, there are also special fish ladders to help specific endangered fish populations to migrate safely. The complete version of Ginny Finch’s critter article "Critter Crossings: Linking Habitats and Reducing Roadkill" is on the FHA Web site at http://www.fhwa.dot.gov/environment/wildlifecrossings/ .
DIETARY SUPPLEMENTS: ALL LEGAL, BUT (ALL) NOT LETHAL? Are all dietary supplements safe? How safe? Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417, U.S. Statutes at Large, v.108 pages 4325-4335) on October 25, 1994 and in Section 2, FINDINGS, there are about 15 reasons why this law was passed. About 50% of the (260 million) American people use dietary supplements. The dietary supplement industry is part of the American economy, and annual sales are about 4 billion dollars. There was a need to setup a Federal legal framework for dietary supplements and supersede the outdated (existing) regulations. This law does not require the herbal industry to study these herbal products unless the product is to be marketed as a drug. Since dietary supplements are not drugs and not under the drug laws, the manufactures don’t have to test them as drugs. Once marketed, the burden of proof is on the FDA to prove a dietary supplement is unsafe before it can be removed from the shelves. Thus these dietary supplements fall into the jurisdiction and congressional mandate of the U. S. National Toxicology Program (NTP) to study biological or physical agents that might not be tested without federal involvement. Substances approved for NTP study undergo a series of assays to determine acute, subchronic, and chronic effects. The NTP has begun to test and evaluate some of the most popular medicinal herbs and has written up their results in "Medicinal Herbs: NTP Extracts the Facts" in Environmental Health Perspectives v. 107, no. 12 December 1999 pages A604-A605 http://ehpnet1.niehs.nih.gov/docs/publications.html . I thought: All drugs are LEGAL and useable only after (FDA) testing and being proven they are NOT LETHAL. Yet, all dietary supplements become LEGAL, before testing, and with the possibility of being LETHAL, or HARMFUL…. Right???
MUTCD: MILLENIIUM EDITION The MUTCD was first written in 1924 but MUTCD's history and the ideas of highway signage and safety on the roads and highways has been around since 1899 http://mutcd.fhwa.dot.gov/kno-history.htm . The (letters) CD have nothing to do with music and compact disks, although the new 2000 edition will be in a CD-ROM format. The MUTCD is the Manual on Uniform Traffic Control Devices (TD 2.8:T 67/988). This volume was, is, and will be THE ONLY LEGAL GUIDE, AUTHORITY, and BIBLE for every transportation and highway designer and worker in the United States. It is the standard for every aspect of highway design and traffic control. MUTCD covers traffic control in school areas, highway crossings, bicycles facilities, signs, lights, traffic signals, road specifications, lines, etc. from Palm Springs, California north to Seattle, Washington, east to Bangor, Maine, south to Miami, Florida, and west (back) to Palm Springs. It covers all the streets and highways in the coterminous United States (but don’t forget Hawaii, Alaska, Guam, and Puerto Rico). This uniformity allows safe and easy travel anywhere within America's highway system because of the MUTCD. The 2000 Edition of MUTCD will include traffic control for light-rail transit systems. Linda Brown’s "MUTCD: The Millenium Edition" Public Roads, v. 63, no. 4, January/February 2000, page 43 presents the new MUTCD, and states that MUTCD will be out in paper, CD-ROM, and on the Internet. Some questions can be answered at the "frequently asked questions" page http://mutcd.fhwa.dot.gov/kno-faq.htm , but most of the text of MUTCD 2000 can be found through the home page http://mutcd.fhwa.dot.gov . These web pages are the electronic format of what should appear as the paper version of the 2000 MUTCD. The 1988 edition has the SUDOC No. TD 2.8:T67/988. Watch for the 2000 edition in paper and its updates which will appear as "Notices" in the Federal Register.
COAL TREES BARE FRUITS – TREE-MENDOUS RESOURCES There are two main species of coal trees. There is the Coalus Productus Directus species that produces fruit directly from the branches. Fuel, synthetic rubber, medicines, phonograph records, paint pigments, electric plugs, sulfuric acid, and laughing gas are some of the products which come from coal, coal tar, coal gas, and coal -based chemicals. A second species, the Coalus Productus Indirectus, sometimes known as the Coalus By-Productus bares the fruits whhich exist because of the use of coal in their manufacture. It was because of the use of coal that Andrew Carnegie melted iron ore to produce iron and steel. These are best known of the Coalus By-Productus species of coal fruit trees. Any questions about these fruits warrant a visit to the Kentucky KERA based coal-education lesson plans for elementary schools. The Coalus By-Productus Indirectus Coal Tree can be found at http://www.coaleducation.org/lessons/twe/bytree.htm and the Coalus Productus Directus, a Tree-mendous primary resource can be found at http://www.coaleducation.org/lessons/primary/uses/atree.htm. Actually these two species are the results of a grafting of the original species Coalus-Productus which was first identified by the Kentucky Department of Mines in 1983. It was a pre-Internet species but is featured on the cover of the Kentucky Department of Mines and Minerals Bulletin, March 1983 (STATE DOC 18 MM 1, 3:983/3)
YOUR HOUSE COMES FROM A MINE This is another Kentucky KERA educational concept that is found in the Coal Education website: http://www.coaleducation.org/lessons/MII/doc5.htm . There is picture of a miner holding a house. The accompanying text tells us that: the house’s concrete foundation (and driveway) is made from limestone, clay, shale, and gypsum and aggregate. An asphalt driveway comes from petroleum and aggregate. The lumber in the floor, roof, and walls are held together by nails and screws made of iron ore and zinc. The interior walls are usually wallboard made of gypsum. Doorknobs, locks, and hinges are made of copper, zinc, iron ore, and alloys. Exterior walls may be brick (clay), concrete, stone, or aluminum (bauxite) siding, all provided by mining. Gutters may be galvanized steel (zinc and iron), aluminum (bauxite), or plastic (petroleum). Windows are made of glass (trona, silica, sand, and feldspar). Toilets, tubs, and sinks are made of porcelain (clay) over iron, or plastic (petroleum). The roof is covered with asphalt shingles (petroleum and a variety of colored silicates), fiber glass (silica sand), clay, or corrugated iron. Insulation in the walls may be glass wool (silica, feldspar, trona) or expanded vermiculite (available from mining). Plumbing fixtures may be made of brass (copper and zinc) or stainless steel (iron, nickel, and chrome). The sewer system is made of clay or iron pipe (plastic pipes are made from petroleum). Septic tanks are made from concrete and there is a leach field filled with sand and gravel. The carpeting is made from synthetic fibers (petroleum) and the backing is filled with limestone (even if you carpet is made of wool). Any fireplace are made of rock, brick, stone, but, if you have a wood/coal burning stove, it is made of steel, iron, alloys, etc. House paint is made with mineral fibers and pigments. The electrical wiring should be made of copper since aluminum is no longer within the building codes. Finally, your mortgage or rental contract is written on paper made from wood or cloth fibers. The fibers are filled with clay and other minerals to determine its texture and color. The conclusion is that "Your house came out of the ground". How far man has progressed from his cave man ancestors to whom it would have been said: "Your house is in the ground".
May 26, 2000
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