Path: utzoo!utgpu!jarvis.csri.toronto.edu!mailrus!uunet!wuarchive!psuvax1!psuvm!auvm!ASUACAD!ATW1H From: ATW1H@ASUACAD.BITNET (Dr David Dodell) Newsgroups: bit.listserv.mednews Subject: HICN305 News Part 3/3 Message-ID: Date: 10 Feb 90 22:51:10 GMT Sender: MEDNEWS - Health Info-Com Network Newsletter Lines: 495 Approved: NETNEWS@AUVM Gateway --- begin part 3 of 3 cut here --- in the detection of low levels of carcinogenic substances. The Administration is concerned about the rigidity of the Delaney Clause and has proposed a change on a similar risk assessment issue involving pesticides in foods as part of its food safety initiative announced last fall. "Today's action is yet another reminder of the need for Congress to consider updating the law to reflect advances in the methods of scientific assessment that were not available when the law was originally passed in 1960," Sullivan said. The action on Red No. 3 removes the last color additive from a "provisional list" established by Congress under the Color Additive Amendments of 1960, which set up a premarket approval system for all new color additives. About 200 color additives which were already in use in 1960 were placed on the provisional list, permitting continued use while safety studies were conducted. Initially, the provisional list was to be in effect for 30 months. But when necessary research studies could not be done so quickly, Congress authorized postponing the closing dates when warranted. Of the original 200 Health InfoCom Network News Page 20 Volume 3, Number 5 February 10, 1990 provisionally listed color additives, 90 have been listed as safe and the rest have either been withdrawn by industry or delisted by FDA. While Red No. 3 was, as noted above, the last color additive on the provisional list, most lakes, or tints, of certain permanently listed colors remain provisionally listed. Opposing the delisting of Red No. 3, the Cosmetic, Toiletry and Fragrance Association and the Certified Color Manufacturer's Association had originally argued that there was no direct carcinogenic effect shown at the low levels in use. But FDA decided that the evidence of thyroid tumors in rats was clear, and that the additional research cited had not proved the additive to be safe. The FDA therefore rejected the manufacturers' petition for permanent listing of the color. As a result of the decision, to be published this week in the Federal Register, FD&C Red No. 3 may not be added to cosmetics and externally applied drugs, and its lakes may not be added to foods, drugs, or cosmetics. The requirement is effective today. Today's action applies to new manufacturing and production of affected products. Because any health risks posed by FD&C Red No. 3 are extremely small, FDA concluded consumers may continue to use existing supplies of products that already contain the color. After delisting the provisional uses, FDA will follow the mandate of the Delaney Clause and will take steps to eliminate the rest of the color's uses. These "permanently" listed uses of Red No. 3 for ingested drugs and foods may be legally continued until the process of de-listing them is completed. Again, this continued use is consistent with the very low public health risk involved. Any person who will be adversely affected by the decision may submit written objections within 30 days to the FDA Dockets Management Branch (HFA- 305), 5600 Fishers lane, Rockville, Md. 20857. #### Thursday January 25, 1990 Warning Against NutriCology, Inc.'s L-tryptophan P90-7 Food and Drug Administration FOR IMMEDIATE RELEASE Chris Lecos - (202) 245-1144 Jan. 25, 1990 (Home) -- (703) 354-4418 The Food and Drug Administration today warned consumers against buying or using potentially dangerous L-tryptophan dietary supplements distributed nationally by NutriCology Inc. of San Leandro, Calif., which also markets under the name Allergy Research Group. The products are: -- L-tryptophan capsules (500 milligrams), 100 capsules to a bottle, under the Allergy Research Group label. -- Tryptophan P.R.N., (350 mg) 30 capsules to a bottle under the NutriCology and Allergy Research labels. -- Free Aminos (750 mg) capsules and Free Aminos without Cystine and Cysteine, both in 100-capsule bottles, and Free Aminos powder in 50 and 100 gram bottles, all under both labels. L-tryptophan, an amino acid, has been linked to serious illnesses. As a result, FDA on Nov. 17 requested an urgent recall of L-tryptophan products, and 334 manufacturers, repackers and distributors have complied. However, while saying they "may recall" their products, NutriCology and Allergy Health InfoCom Network News Page 21 Volume 3, Number 5 February 10, 1990 Research representatives have refused to furnish FDA with any proof that any such recall has been initiated. In addition, FDA visits to several stores have shown no evidence of a recall. Reports of 1,143 cases of eosinophilia-myalgia syndrome possibly associated to L-tryptophan supplements have been made to the federal Centers for Disease Control in Atlanta. These include nine deaths, one of which has been confirmed as being clearly associated with the taking of L-tryptophan. FDA has asked for the recall of products that would result in a total dietary intake of 100 milligrams or more a day. The investigations by FDA, CDC and other public health agencies have not been able to link the outbreak of illnesses and deaths to any specific lot, brand, manufacturer or supplier of L-tryptophan, nor have extensive laboratory analyses of products been able to identify a specific chemical or microbial contaminant responsible for the outbreak. Cases have been reported in all 50 states, plus the District of Columbia and Puerto Rico. Health InfoCom Network News Page 22 Volume 3, Number 5 February 10, 1990 ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Columns ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: DIABETES HIGHLIGHTS #1 J. Martin Wehlou MD Bitnet: WEHLOU@BGERUG51 CIS: 72047,2444 CIS: 72047,2666 CIS: >INTERNET:WEHLOU@BGERUG51.BITNET BBS: 32-91-30.46.25, 1200/2400 8N1 Fax: 32-91-31.33.12 Voice: 32-91-31.67.40 GSA BETTER THAN HBA1 GSA (Glycosylated Serum Albumin) is a better indicator of short-term improvement in glycemic control in IDDM than fructosamine or HbA1. Diabetes Care 12:665-72, 1989. PRE-PUBERTAL DURATION NOT THAT IMPORTANT The contribution of the prepubertal years of diabetes to the long-term prognosis may be minimal. The postpubertal duration of IDDM may be a more accurate determinant of microvascular complications and mortality. Diabetes Care 12:686-93, 1989. VANADATE MIMICS INSULIN ACTIONS Vanadate ions, low-weight phosphate analogues: mimics insulin in action and improves on insulin sensitivity. It may work by another pathway than insulin itself, but the exact action is unknown. Diabetes 39:1-5, 1990. CLOSING IN ON THE TYPE-I GENE HLA-DQbeta chain residue at position 57 correlates much better with the inherited risk of type I diabetes than the DR3/DR4 haplotypes. The real inheritance factor may be a specific combination of DQbeta and DRbeta sequences. Diabetes 39:96- 103, 1990. A practical and comparatively simple method for determining the DQB1 gene is to be found in Diabetes 38:1617- 22, 1989. PANCREAS PULSES INSULIN The pancreas releases insulin in pulses, with the interval and amplitude increasing as glycemia goes up. Diabetes 39:112-17, 1990. BETA CELL BOOT CAMP Earlier maturation of beta cells during pregnancy may protect against diabetes in later life. So, if the mother has a high glycemia, the child has better beta cells. Is this the reason why children of diabetic mothers have less Health InfoCom Network News Page 23 Volume 3, Number 5 February 10, 1990 diabetes than children of diabetic fathers? Lancet 1990; 335: 134-35. ORAL INSULIN (!) Take some porcine insulin, cholesterol, aprotinin, lecithin and esterified fatty acids, spray onto carboxymethylcellulose calcium and if you're lucky, and very careful, you've got a working insulin tablet. Not only won't you need those syringes again, but the insulin gets into the portal circulation, i.e. the place it should've been in, in the first place. Lancet 1989; #8679: 1518-9. LESS PROTEIN, MORE KIDNEY Restricting dietary protein retards progression of diabetic nephropathy, independently of blood pressure changes and glycemic control. Lancet 1989; #8677: 1411-4. AMYLINAMIDE FROM BETA CELL Amylinamide is an osteoclastinhibiting peptide secreted from the beta cell. It can form an insoluble deposit that may precipitate diabetes type II. Lancet 1989; #8670: 1026-7. HUMAN INSULIN: LESS NORADRENALIN Comparing the response to hypoglycemia caused by human and porcine insulin in healthy volunteers, it was shown that the noradrenalin response was significantly less pronounced in the human insulin group. Can this be the basis for the possible "hypoglycemic un-awareness" in some users of human insulin? Lancet 1989; #8669: 946-8. FISH FOR THE ARTERIES NIDDM fish eaters preserve their arterial wall characteristics better than non-fish eaters. This goes for healthy people, too. Lancet 1989; #8669: 944- 6. CYCLOSPORIN AND FLUCONAZOLE Fluconazole can interact with cyclosporin A and cause renal damage. This was already known for ketaconazole. Lancet 1989; #8667: 867-8. KEEP IT BELOW 10% Mean HbA1 levels show a strong correlation with the development of proliferative retinopathy. None was seen in patients with an HbA1 below 10%. Lancet 1989; #8667: 824-7. RISK OF NIDDM GOES UP WITH PARITY There's a slight increase in the risk of NIDDM with increasing parity many years after childbearing, unassociated with obesity. N Engl J Med 1989; 321: 1214-9. MORE RENAL RISK IN BLACKS Health InfoCom Network News Page 24 Volume 3, Number 5 February 10, 1990 There's a higher risk of end-stage renal disease in black diabetics compared to whites, particularly with NIDDM. N Engl J Med 1989; 321: 1074-9. Health InfoCom Network News Page 25 Volume 3, Number 5 February 10, 1990 ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Articles ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: AIDS AND PERSONNEL MANAGEMENT A sampling of books on AIDS AND PERSONNEL MANAGEMENT AIDS IN THE WORKPLACE: RESOURCE MATERIAL, 2nd Ed. Washington, D.C.: Bureau of National Affairs; 1987. AIDS IN THE WORKPLACE: A POLICY DEVELOPMENT AND RESOURCE GUIDE FOR HUMAN SERVICE ORGANIZATIONS. Memphis, Tenn.: Shelby House; 1989. AIDS IN THE WORKPLACE: LEGAL QUESTIONS AND PRACTICAL ANSWERS. Banta, W.F. Lexington, Mass.: Lexington Books; 1987. AIDS, THE NEW WORKPLACE ISSUES. New York: AMA Membership Publications Division, American Management Association; 1988. AIDS: A MANAGER'S GUIDE. Schachter, V.; Von Seeburg, S. New York: Executive Enterprises Publications; 1986. MANAGING AIDS IN THE WORKPLACE. Puckett, S.B.; Emery, A.R. Reading, Mass.: Addison-Wesley; 1988. UNDERSTANDING AIDS: A PERSONAL HANDBOOK FOR EMPLOYEES AND MANAGERS. Katz, M.A. Washington, D.C.: Employee Benefits Review; 1988. Other books on AIDS AND PERSONNEL MANAGEMENT may be found by searching MESH subject headings: Searching by subject: ACQUIRED IMMUNODEFICIENCY SYNDROME ACQUIRED IMMUNODEFICIENCY SYNDROME--legislation ACQUIRED IMMUNE DEFICIENCY SYNDROME AIDS (DISEASE) AIDS (DISEASE)--Social aspects AIDS (DISEASE)--Law and legislation A sampling of journal articles on AIDS AND PERSONNEL MANAGEMENT AIDS and the law. Franklin, G.M.; Robinson, R.K. PERSONNEL ADMINISTRATOR. April 1988; 33(4): 118-121. AIDS raises policy issues for many hospital departments. James, A.N. HEALTHCARE FINANCIAL MANAGEMENT. Nov. 1988; 42(11): 60-64. The employment policy implications of AIDS. Nowlin, W.A. INDUSTRIAL MANAGEMENT. May/June 1988; 30(3): 24-28. Health InfoCom Network News Page 26 Volume 3, Number 5 February 10, 1990 Interpreting AIDS discrimination. Obdyke, L.K. PERSONNEL ADMINISTRATOR. June 1989; 34(6): 83-89. Relieving the fear of contagion. Dilauro, T.J. PERSONNEL ADMINISTRATOR. Feb. 1989; 34(2): 52-58. Uncommon decency: Pacific Bell responds to AIDS. Kirp, D.L. HARVARD BUSINESS REVIEW. May/June 1989; 67(3): 140-151. Universal precautions: employee resistance and strategies for planned organizational change. Kearns, K.P.; Hogg, M. HOSPITAL AND HEALTH SERVICES ADMINISTRATION. 1988; 33(4): 521-530. The workplace & AIDS: a guide to services and information. PERSONNEL JOURNAL. Oct. 1987; 66(10): 65-80. The workplace & AIDS: a guide to services and information, part II. PERSONNEL JOURNAL. Feb. 1988; 67(2): 101-111. Workplace testing: who's testing whom? Greenberg, E.R. PERSONNEL. May 1989; 66(5): 39-45. Other articles on AIDS AND PERSONNEL MANAGEMENT may be found by searching various indexing and abstracting tools in the areas of business administration, social sciences, and medicine. HOSPITAL LITERATURE INDEX Acquired Immunodeficiency Syndrome Acquired Immunodeficiency Syndrome/Occurrence BUSINESS INDEX Acquired Immune Deficiency Syndrome AIDS (Disease) (1986+) BUSINESS PERIODICALS INDEX AIDS (Disease) and employment A sampling of OTHER INFORMATION on AIDS AND PERSONNEL MANAGEMENT Online databases ABI/INFORM and Management Contents can be searched as computer databases where available. Audiovisuals ONE OF OUR OWN: a story about AIDS in the workplace [videorecording]. Vesely, J.; Trimble, M. Chicago, Ill.: Dartnel Films; Buffalo, N.Y.: Kinetic Film Enterprises [distributor]; 1987. 1 tape cassette; VHS; 30 min.; sd; col; 1/2". Health InfoCom Network News Page 27 Volume 3, Number 5 February 10, 1990 Additional information on this topic may be found in other issues or updates of the Health Sciences Library Information Series on AIDS. WE WELCOME YOUR SUGGESTIONS AND COMMENTS If you have comments on this bibliography or wish to suggest resources or future topics please contact: Health Sciences Library CB# 7585 University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7585 (919) 962-0700 (School of Medicine) email id: aids@med.unc.edu Health InfoCom Network News Page 28 --- end part 3 of 3 cut here ---