No. 199 August 1999

Y2K & MEDICAL DEVICES In the Food and Drug Administration's Notice: "Computer-Controlled Potentially High Risk Medical Devices--List of Device Types, Notice" Federal Register v. 64, no 146, July 30, 1999 pages 41440-41441 you will find a list of the types of computer-controlled potentially high-risk medical devices that have the potential for the most serious consequences for the patients should they fail because of date-related problems. This list will be useful to the FDA, manufacturers, and health care professionals that are concerned with the Y2K problems and medical devices. There are medical devices used in direct treatment (such as lasers) and the monitoring of vital patient parameters (such as cardiac monitors). There are also medical devices that support or sustain life during treatment or patient care (such as heart-lung machines used during surgery). Easy access to the latest version of this list is at the FDA's "Federal Y2K Biomedical Equipment Clearinghouse" web site: http://www.fda.gov/cdrh/yr2000/cdrh/phrds/phrds.html . This "Y2K & MEDICAL DEVICES" site provides "Current news", information for industry, health care facilities, and the consumer are four information options. Other choices include an "equipment search" or click on "links" to the 18 other governmental and international agencies Y2K related sites. The documents found in this FDA website are available in one or more of the following file formats: Adobe Acrobat (PDF), Microsoft Word 97 (DOC), and/or HTML-text.

JAZZ (PARK) LOVERS TAKE NOTE(S) This jazz park opus started in 1987 with a congressional overture designating jazz as "a rare and valuable national American treasure". On October 31, 1995, the New Orleans Jazz National Historical Park Act of 1994 (law) was signed and the first major movement was complete. Planning for the Park began late in 1995 for the premiere which would not be until 1999. The members New Orleans Jazz Commission consists of jazz musicians, jazz music educators, and other music industry individuals. The Park's purpose, as outlined in its general plan, is to manage and protect America's jazz resources, to improve the interpretation of jazz, and provide the necessary and appropriate jazz lover-visitor use facilities. The plan written by the National Park Service and titled Final General Management Plan/Environmental Impact Statement_(FEIS) for New Orleans Jazz National Historical Park, New Orleans, Louisiana is a major opus for the jazz lover. The Park's general plan, in a brief form, appears in "Record of Decision [ROD] Final Environmental Impact Statement; General Management Plan; New Orleans Jazz National Historical Park, LA" Federal Register v. 64, no. 141, July 23, 1999 pages 40034-40037 presenting the goals, functions, and basic organizational structure of the Park. The ROD is a summary version of two documents. The Final Environmental Impact Statement which is composed of The Draft New Orleans Jazz National Historical Park, General Management Plan, Environmental Impact Statement released on November 21, 1998 and the Final General Management Plan cited above. The full text of these documents and other information is available from the New Orleans Jazz National Historical Park Headquarters, 365 Canal Street, Suite 2400, New Orleans, LA 70130-1136.

ORGAN TRANSPLANTS FIRSTS AND CURRENT(S) In 1906, Alexis Carrel, a French physician in Chicago transplanted a heart into a dog, and a kidney into a cat. In that same year, Mathieu Jaboulay implanted a pig's kidney into one woman and a goat's liver into another woman. Neither woman survived. ("Organ Transplants from Animals: Examining the Possibilities" by Rebecca D. Williams, FDA Consumer, v. 30, no. 5, June 1996, pages 12-16 [HE 20.4010:30/5] ) Currently, the United Network handles organ transplants for Organ Sharing (UNOS), an organization and network of hospitals, laboratories, and health professionals who administer the organ transplant programs. Under contract to the Department of Health and Human Services, UNOS set and administer organ transplants and transplant policies. The UNOS homepage http://www.unos.org/frame_Default.asp states that: "Through the UNOS Organ Center, organ donors are matched to waiting recipients 24 hours a day, 365 days a year. Through its policies, UNOS ensures that all patients have a fair chance at receiving the organ they need - regardless of age, sex, race, lifestyle, religion, financial or social status," ( http://www.unos.org/frame_Default.asp?Category=About ). UNOS also maintains a waiting list of those waiting for organ donations. The latest organ transplant statistics http://www.unos.org/patients/data.htm are available on the UNOS website. The 1998 UNOS annual report (web page) http://www.unos.org/frame_Default.asp?Category=anrpt reviews a full year and provides links to statistical data by donor categories, type of organ transplant, recipient survival rates, patient waiting list characteristics and waiting list times, etc. Organ transplants are now an essential part of America's medical life.

FOOD COMMERCIALISM: HOT WHEELS, BARBIE DOLLS, GLASSWARE, OR MUGS? In 1997, fast foods account for the largest share of the foodservice industry with $97 billion McDonald’s, Subway Sandwiches, Pizza Hut, KFC, and Burger King leading the way, as presented by Charlene C. Price, "Sales of Meals and Snacks Away From Home Continue to Increase," Food Review, v. 21 no. 3, September-December 1998, pages 28-30 (A 93.16/3:21/3). The lure of seasonal or sports mugs, cups, and glassware for adults combined with tired parents and kids who like the toys go to McDonalds (etc.) to eat lunch and/or dinner. Back in 1990, $22.75 billion was spent on fast foods aimed at children, with 34% of the total food dollar spent on fast foods. The fast food industry is very cooperative since marketers have identified how to attract children to restaurants in terms of food, toys, prizes, meal packs, most fun, playgrounds, etc. Vivica Kraak and David L. Pelletier's "The Influence of Commercialism on the Food Purchasing Behavior of Children and Teenage Youth" in Family Economics and Nutrition Review, v.11, no. 3 1998 pages 15-24 (A 98.20:11/3). There are many adults who got "hooked" on fast foods long before their children. The 31-item bibliography at the end of the article provides further information such as "The Littlest Shoppers" which tells more about commercialism's influence on the "child consumer". Well, did you get a hot wheels or Barbie doll in your McDonald's happy meal?

ADVERSE DRUG REACTIONS DATABASE Every FDA approved drug undergoes premarket testing to learn what adverse reactions the person or animal will experience when using each drug. It seems reasonable to assume these test results are what are found in the PDR (Physicians Desk Reference) when researching a drug in that sourcebook. As perfect as it may be, there are still adverse drug experiences that do not show up in premarket testing but do showup on the health professional's patient, the "drug consumer". These postmarket adverse drug experiences are reported with FDA's MedWatch Forms to the MedWatch Program. The Annual Adverse Drug Experience Report: 1996 (dated October 1997) is the latest annual issuance presenting a descriptive overview of the 159,504 evaluable cases reported to the FDA in 1996. These 1996 cases goes into a FDA database which has now accumulated 1.4 million adverse drugs experience cases (ADEs). Health professionals and consumers send reports and contribute to the database and can also search the database for ADEs not detected during premarket tests. The 1996 Report's http://www.fda.gov/cder/dpe/annrep96/index.htm Table of Contents has 20 topics, 15 of which relate to the cases reported in 1996. The case consists of the original report of an ADE on a patient plus any follow-up information. The remaining 5 topics relate to introductory information, and discussion of the MedWatch Reports, and the Reporting by Health Professionals and Consumers. This 1996 Report ( http://www.fda.gov/medwatch/articles.htm ), the MedWatch Reports forms ( http://www.fda.gov/medwatch/how.htm ), online MedWatch reporting ( https://www.accessdata.fda.gov/medwatch/medwatch-online.htm ), and the Database "Adverse (Drug) Reactions" online searching through the FDA Web Site Index at http://www.fda.gov/opacom/hpchoice.html (for case reports of adverse reactions to human drugs, animal drugs, blood products, medical devices, and vaccines) are part of the MedWatch: The FDA Medical Products Reporting Program http://www.fda.gov/medwatch/index.html .

VIRTUAL CELLS INTERNET DEBUT The Virtual Cell is now on the internet courtesy of the National Resource for Cell Analysis and Modeling within the Center for Biological Imaging Technology at the University of Connecticut Health Center in Farmington http://www.nrcam.uchc.edu . The new Virtual Cell will allow investigators to do virtual experiments. "The Virtual Cell will be a valuable tool for drug designers because it can help identify the parts of a complex pathway that are critical targets for intervention." I assume this means that the drug manufacturers can easily identify and "test" their drugs on the specific part(s) of the cell, which is in need of the drug(s) they are designing. "The Center's computer center runs the Virtual Cell software http://www.nrcam.uchc.edu/vcell_dev.html , and the drug designers and other scientists can build their models over the Web using Java or an Internet browser. There will also be the design and development of a database of virtual cell models. …The development of the Virtual Cell will extend well into the new millenium" so says William Oldendorf in "Virtual Cell Debuts on the Web" NCRR Reporter, v. 23, no3, Summer 1999 pages 12-13 (HE 20.3013/6:23/3) and at http://www.ncrr.nih.gov/newspub/jul99rpt/Virtual.htm

VIRTUAL MICROSCOPE(Y) Did you know there is a virtual microscope? Microscopy? And Microanalysis? You might answer "yes", if you had already visited the "Microscopy & Microanalysis WWW Site" at http://www.amc.anl.gov/ . The Argonne National Laboratory and the Microscopic Society of America host this virtual microscope web site. Two of the major links found at this website will lead to (first) the "MicroScape, From Ants to Atoms, A Virtual Laboratory" http://www.microscopy.com/MicroScape/MicroScape.html . This introductory page links to more information about how one can have "Microscopic Views of the World using a Virtual Microscope". There is a link to the "MicroScape Virtual Laboratory" http://www.msa.microscopy.com/MicroScape/MicroScapeVL.html where you will find digital images, which begin at High Magnification and progress down in Magnification simulating an on-line "Virtual Microscope". An equally important page is the "NJZ, M & M Tools, On-Line Software (JAVA) http://tpm.amc.anl.gov/NJZTools/NJZTools.html . Using this interactive website requires Netscape 4.0, JAVA capabilities, and other software requirements. Did you ever see the image of the tip of a sewing needle magnified so that the tip was wider than your index finger? Intended for middle and high school science classes http://tpm.amc.anl.gov/Docs/TPMMSHSProposal.html , this website would be a most interesting learning experience without having to return to high school.

PEDIATRIC/GERIATRIC DRUG(S) USE On December 2, 1998, the FDA issued a proposed rule calling for a pediatric drug-testing plan. ("FDA, 21 CFR Parts 201,312,314, and 601, Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biologic Products in Pediatric Patients, Final Rule" Federal Register v. 63, no. 231, December 2, 1998 pages 6632-66672; AE 2.106:63/231). Drug manufacturers would be required to test and include pediatric use information on the labels of drugs commonly used in the medical treatment of children. "Safety and effectiveness information is especially sparse for over 7 million children under age 2" who are taking drugs which lack pediatric labeling information states "Top 10 Drugs Prescribed to Kids Without Pediatric Labeling". This is found in Tamara Nordenberg’s "Pediatric Drug Studies: Protecting the Pint-sized patients" FDA Consumer, v. 33, no. 3, May-June, 1999, pages 23-28 (HE 20.4010:33/3). Within this article, on page 25 "Protecting Older Patients" tells us that as people age, their organs change and their drug reactions can change. The elderly also have a higher risk of drug(s) interactions. For safe use, the geriatric drug patient also requires special user information on drug labels. For geriatric drug dosage information, the FDA issued "FDA, 21 CFR Part 201, Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of 'Geriatric Use' Subsection in the Labeling, Final Rule," Federal Register v. 62, no. 166, August 27, 1997 pages 45313-45326 which does not require further drug testing for geriatric drug use, but does require a separate "Geriatric Use" information section on drug labels. Some drug labels may have already had geriatric use information dispersed throughout the label, but the new "Geriatric Use" section is more user friendly.

September 20, 1999

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