'Parallel trick' for ddI
Article Abstract:
AIDS activists have been seeking early access to experimental drugs for AIDS treatment. The Food and Drug Administration's (FDA) usual process for testing and approving a new drug can take a long time. However, the FDA has made an exception for the experimental AIDS medicine dideoxyinosin (ddI), allowing its manufacturer, Bristol-Myers, to release it very early in the testing process. While research continues, ddI will be available to AIDS patients who have not been helped by AZT (the only medication approved for widespread use in treating AIDS). The program will be managed and funded by Bristol-Myers. This new approach is known as 'parallel track' because the drug is simultaneously being tested by and distributed to patients who need it most. While AIDS activists have achieved a breakthrough in improving access to new drugs, this victory may be clouded by reports that ddI has more serious toxic side-effects than expected. The drug has only been tested on fewer than 30 patients so far. This Phase 1 trial revealed that when used in higher doses, ddI may cause nerve damage in the feet and damage to the pancreas. Phase 2 of the testing process is about to begin at the National Institute of Allergy and Infectious Diseases; over 2,500 AIDS patients will take part in comparing the effectiveness of ddI and AZT. The way in which ddI works is it blocks the reproduction of the human immunodeficiency virus in the body. Two concerns have been raised about the new parallel track approach. The drug's safety is still not understood, and making the drug available outside of the research environment may lower participation in research studies.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1989
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New York State leads on genetic fingerprinting
Article Abstract:
Genetic fingerprinting examines the DNA (deoxyribonucleic acid, which codes for the molecules involved in the processes of life) of an individual, which like a fingerprint is totally unique to the individual. Genetic fingerprinting is being used in forensic medicine, to determine if a particular individual committed a crime. The Department of Justice of New York State will establish a committee to decide on regulations and standards of the DNA tests before they can be used in the courts. New York State has plans for three state-run laboratories. There have been criticisms of private laboratories concerning the secrecy of the methods used in DNA testing and standards of quality. Only one of the 300 forensic laboratories in the United States is currently using DNA fingerprinting, but most laboratories will be using the testing within the next few years. National standards for testing procedures, analysis, interpretation and coding of the data are needed. The Federal Bureau of Investigation has been deciding on the technical standards. The National Academy of Sciences will begin a study on the technical, legal and ethical issues of the use of DNA fingerprinting in forensic medicine. The implementation of a national DNA database is recommended, but access to the database must be restricted and used only for the identification of suspected criminals.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1989
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Abortion issue destroys board
Article Abstract:
The United States Congressional Bioethics Board will be dissolved in October 1989. The board was created to make decisions on controversial ethical issues in biomedical research and health care, such as genetic engineering, fetal research, in-vitro fertilization and the rights of terminally ill patients. In the four years that the board has existed, the advisory committee has spent much of its time selecting the members of the board, based on their views on abortion. It has been claimed that the committee was designed such that there would be a stalemate on virtually every issue. Progress in many areas of research, including infertility, prenatal transmission of AIDS, the use of fetal tissue in disease treatment and the development of new diagnostic techniques, is inhibited without legislature from the board. The Association of American Medical Colleges is urging the government to reconstitute the Ethics Advisory Board of the Department of Health and Human Services, which was dissolved in 1980, to make decisions on these issues.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1989
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