ALBERT

Keywords: *Budgets ; *Financial Management ; Government Agencies ; Politics ; *Research Support as Topic ; United States

Keywords: *Drug Industry ; Evaluation Studies as Topic ; Patents as Topic ; Research ; United States

Keywords: *Biological Warfare ; Biomedical Research ; Federal Government ; Genetic Engineering ; Humans ; Internationality ; Ussr ; United States ; Advancement of Science addressed concerns that recent developments in molecular ; biology have undermined the 1972 Biological and Toxin Weapons Convention, ; necessitating compliance verification changes in this international treaty ; banning the development and use of biological weapons. A group of scientists, ; military analysts, and arms control experts discussed types of biological ; research projects funded by the Department of Defense which could be diverted to ; the production of relatively efficient, inexpensive new weapons. Most of the ; panelists challenged the Pentagon's claim that biological weapons are currently ; being developed by the Soviet Union.

Keywords: Humans ; *Jurisprudence ; Neoplasms, Radiation-Induced/*etiology ; *Radioactive Fallout ; United States

Keywords: *Biomedical Research ; *Crime ; Federal Government ; *Fraud ; *National Institutes of Health (U.S.) ; Research ; Schools, Medical ; United States ; Medical School, from the first known act of fraud to recent evidence that ; implicates Darsee's earlier work at Emory University and Notre Dame. Darsee's ; Harvard data were eventually re-examined both by Harvard and by a panel appointed ; by the National Heart, Lung, and Blood Institute (NHLBI), which had funded much ; of his research. The NHLBI findings, which were reviewed by senior staff at the ; National Institutes of Health, faulted the supervisory practices of Darsee's ; mentor, Dr. Eugene Braunwald. Braunwald acknowledges the need for change but ; believes that his pattern of supervision is common to many laboratories.

Keywords: National Institutes of Health (U.S.)/*organization & administration ; Research Support as Topic ; Training Support ; United States

Keywords: *Advisory Committees ; Behavior Control ; *Ethics, Medical ; *Genetic Engineering ; Humans ; Religion ; United States

Keywords: *Carcinogens ; Dioxins/adverse effects ; *Government Agencies ; Humans ; Policy Making ; Trichloroethylene/adverse effects ; United States ; *United States Environmental Protection Agency

Keywords: Adolescent ; Adult ; Antineoplastic Agents/*therapeutic use ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Leukemia/drug therapy/mortality ; Male ; Neoplasms/*drug therapy/mortality ; United States

Keywords: *Dust ; Environmental Exposure ; Gossypium ; United States ; United States Occupational Safety and Health Administration

Keywords: Child ; Humans ; *Intelligence ; Lead/analysis ; Lead Poisoning/*complications ; Tooth/analysis ; United States ; United States Environmental Protection Agency

Keywords: *Acquired Immunodeficiency Syndrome ; Female ; Humans ; Male ; National Institutes of Health (U.S.) ; Research Support as Topic ; United States

Keywords: Costs and Cost Analysis ; Humans ; *Liver Transplantation ; National Institutes of Health (U.S.) ; Patient Selection ; Tissue and Organ Procurement ; United States ; Liver Transplantation has concluded that, with some exceptions, transplantation ; could be considered for most patients who are near death with liver disease. This ; recommendation comes despite problems in interpreting existing data on survival ; rates. The panel did not address the issues of who should pay for liver ; transplants, or of how many donor livers would be needed if more transplantation ; centers were established.

Keywords: Adult ; Brain Death ; Female ; Humans ; Male ; Mandatory Programs ; Middle Aged ; Tissue Donors ; *Tissue and Organ Procurement ; *Transplantation ; United States ; tissue are revolutionizing organ transplantation, but the current shortage of ; donated organs is expected to worsen. The reasons for this shortage and possible ; solutions to the problem are discussed briefly, and the ethical and legal ; implications of salvaging organs from brain-dead patients are mentioned. Presumed ; consent laws, already in force in several European countries, would drastically ; increase the number of available organs, but American ethicists are divided over ; a policy permitting automatic use of organs unless a person has left explicit ; instructions to the contrary.

Keywords: *Advertising as Topic/legislation & jurisprudence ; Drug Prescriptions ; Federal Government ; *Government Regulation ; Humans ; Information Dissemination ; *Pharmaceutical Preparations ; Risk Assessment ; United States ; *United States Food and Drug Administration ; companies would like to be allowed to advertise their prescription drugs to the ; general public as well as to health professionals. The Food and Drug ; Administration, concerned about the legal and ethical implications of ; direct-to-consumer advertising, has asked for time to study the proposal.

Keywords: Cerebrovascular Disorders/*epidemiology/prevention & control ; Humans ; Hypertension/prevention & control ; United States

Keywords: *Research Support as Topic ; United States

Keywords: Ecology ; United States ; United States Environmental Protection Agency ; Water Pollution/*analysis

Keywords: DNA/biosynthesis ; Environmental Exposure ; Humans ; Leukocytes/*radiation effects ; Maximum Allowable Concentration ; Protein Biosynthesis ; RNA/biosynthesis ; Radio Waves/*adverse effects ; United States

Keywords: *Carcinogens ; United States ; United States Environmental Protection Agency

Keywords: Alcoholism/*therapy ; *Behavioral Research ; Canada ; *Editorial Policies ; *Ethics, Medical ; Humans ; United States

Keywords: Child ; *Cognition ; Female ; Humans ; Male ; *Mathematics ; Sex Factors ; United States

Keywords: Congenital Abnormalities/therapy ; *Euthanasia ; Federal Government ; *Government Regulation ; Humans ; Infant, Newborn ; Judicial Role ; Parental Consent ; United States ; *United States Dept. of Health and Human Services ; *Withholding Treatment ; as "arbitrary and capricious," a Department of Health and Human Services ; regulation that required hospitals to post notices concerning the illegality of ; denying life-saving care to handicapped infants and encouraged anyone with ; knowledge of such a case to report it to HHS via a telephone hotline. This ; article reviews the evolution and implementation of the HHS regulation, the legal ; challenge to it, and the judge's ruling.

Keywords: *National Institutes of Health (U.S.) ; *Research Support as Topic ; United States ; Universities/economics

Keywords: *Legislation, Nursing ; *National Institutes of Health (U.S.) ; *Nursing ; Research ; United States

Keywords: Budgets ; *National Institutes of Health (U.S.)/organization & administration ; Research Support as Topic ; United States

Keywords: *Biomedical Research ; *Crime ; *Fraud ; Georgia ; Humans ; National Institutes of Health (U.S.) ; Research ; United States ; he was appointed a fellow at the Harvard Medical School, has revealed fabrication ; of data, unauthorized use of co-authors' names, and fictitious collaborators. The ; Emory investigation was undertaken after Harvard notified Emory of its suspicion ; of Darsee's Harvard research. Emory's investigative report focused only on the ; extent of Darsee's data fabrication. A copy of the report was sent immediately to ; the National Institutes of Health, but the university was reluctant to send it to ; medical licensing boards or to the hospital where Darsee is currently employed.

Keywords: Animals ; *Crime ; *Fraud ; Illinois ; Mice ; Pesticides/toxicity ; Rats ; *Toxicology ; United States ; United States Environmental Protection Agency

Keywords: Bioethical Issues ; Ethics ; *Federal Government ; *Infant Food ; *National Institutes of Health (U.S.) ; United States ; discussion of a dispute on the marketing of infant formula from a symposium on ; bioethics because of protests by the Nestle Company. NIH administrators deny that ; censorship was the reason for the cancellation.

Keywords: Advisory Committees ; Cell Line ; *Ethics, Medical ; Federal Government ; Genetic Diseases, Inborn/therapy ; *Genetic Engineering ; *Germ Cells ; *Government Regulation ; Human Characteristics ; Humans ; Risk Assessment ; United States ; cells has been signed by leaders of almost every major church group in the United ; States. Some of the religious leaders, while not certain that a total moratorium ; should be placed on altering germline cells, signed the statement in order to ; stimulate public debate on the issue. Legislation has recently been introduced in ; Congress to set up a committee to monitor genetic engineering and its human ; applications, but author Jeremy Rifkin, the impetus behind the church leaders' ; resolution, argues that such tampering threatens the gene pool and should be ; banned altogether.

Keywords: Budgets ; *National Institutes of Health (U.S.) ; Research Support as Topic/*legislation & jurisprudence ; United States

Keywords: Animals ; Ethylene Dibromide/*toxicity ; *Government Agencies ; Humans ; Hydrocarbons, Brominated/*toxicity ; United States ; *United States Environmental Protection Agency

Keywords: United States ; United States Food and Drug Administration/*organization & administration

Keywords: Animals ; Female ; Humans ; *Jurisprudence ; *Shock, Septic ; Staphylococcus aureus/metabolism ; Swine ; Tampons, Surgical/adverse effects ; United States

Keywords: United States ; *United States Dept. of Health and Human Services/organization & administration ; *United States Food and Drug Administration/organization & administration

Keywords: Adult ; Child ; *Edible Grain ; *Ethylene Dibromide ; *Food Contamination ; Humans ; *Hydrocarbons, Brominated ; Massachusetts ; Maximum Allowable Concentration ; New York ; United States ; United States Environmental Protection Agency

Keywords: *Aborted Fetus ; *Federal Government ; *Fetal Research ; *Fetus ; *Government Regulation ; *Human Experimentation ; Humans ; *Infant, Newborn ; *Legislation, Medical ; United States

Keywords: Animals ; *Carcinogens ; Environmental Exposure ; Ethylene Dibromide/*toxicity ; Florida ; *Food Contamination ; *Government Agencies ; Humans ; Hydrocarbons, Brominated/*toxicity ; Pesticide Residues/toxicity ; United States ; *United States Environmental Protection Agency ; *Water Pollution, Chemical

Keywords: DNA, Recombinant ; *Genetic Engineering ; National Institutes of Health (U.S.) ; United States

Keywords: Budgets ; Education, Medical, Continuing/economics ; *National Institutes of Health (U.S.)/organization & administration ; Research Support as Topic/*economics/trends ; Training Support/*economics/trends ; United States

Keywords: Federal Government ; *Genetic Engineering ; *Government Regulation ; Judicial Role ; *Jurisprudence ; *National Institutes of Health (U.S.) ; United States ; of genetically engineered bacteria, the National Institutes of Health will ; conduct the simpler of two ecological analyses required by the National ; Environmental Policy Act on three proposed experiments. In May 1984 a federal ; district court ruling halted a University of California field test pending a ; decision on Rifkin's 1983 suit, which alleged that NIH had violated the Act by ; approving experiments without studying the ecological consequences. Still to be ; decided by the U.S. Court of Appeals is whether NIH must also issue full-scale ; environmental impact statements.

Keywords: Environmental Exposure ; *Government Agencies ; Humans ; Legislation, Medical ; Neoplasms, Radiation-Induced/prevention & control ; Radioisotopes/*adverse effects ; United States ; *United States Environmental Protection Agency

Keywords: Humans ; Parasitic Diseases ; Parasitology/*economics ; Research Support as Topic ; United States

Keywords: Drug Hypersensitivity/*etiology ; Food Hypersensitivity/etiology ; Food Preservatives/*adverse effects ; Humans ; Sulfites/*adverse effects ; United States ; United States Food and Drug Administration

Keywords: Containment of Biohazards ; Federal Government ; *Genetic Engineering ; *Government Regulation ; Legislation as Topic ; *Technology ; United States ; two federal acts to regulate the products of genetic engineering, and has worked ; closely with members of the biotechnology industry to develop draft regulations. ; The Office of Management and Budget now contends that the Federal Insecticide, ; Fungicide, and Rodenticide Act and the Toxic Substances Control Act do not cover ; living organisms, suggests that it chair a working group to review the issues, ; and recommends four other regulatory options. Some industry officials have ; reservations about OMB's involvement in regulating biotechnology, and there could ; also be opposition from Democratic members of Congress.

Keywords: History, 20th Century ; United States ; United States Food and Drug Administration/*history

Keywords: *Drug Industry ; *Legislation, Drug ; Patents as Topic ; Therapeutic Equivalency ; United States

Keywords: *Containment of Biohazards ; *DNA, Recombinant ; *Federal Government ; Government ; *Government Regulation ; United States ; and the Office of Management and Budget, has convened a working group ; representing 15 federal agencies to discuss the regulation of biotechnology. ; George A. Keyworth, presidential science adviser, asked the agencies to report ; back at the next meeting what jurisdiction they claim in biotechnology ; regulation. The Environmental Protection Agency (EPA) is currently developing a ; proposal on its role. Various other agencies have been discussing federal ; involvement with industry representatives.

Keywords: Animals ; *Genetic Engineering ; Humans ; *National Institutes of Health (U.S.) ; Sheep ; Swine ; United States

Keywords: *Equipment and Supplies ; United States ; *United States Food and Drug Administration

Keywords: *Legislation, Medical ; *National Institutes of Health (U.S.)/organization & administration ; United States

Keywords: Female ; Humans ; Jurisprudence ; *Shock, Septic/etiology ; Tampons, Surgical/adverse effects ; United States

Keywords: Advisory Committees ; Federal Government ; *Genetic Engineering ; *Government Regulation ; Jurisprudence ; National Institutes of Health (U.S.) ; United States ; of Health, and the Environmental Protection Agency in a campaign to prevent ; private companies, as well as universities, from releasing genetically modified ; organisms into the environment until the possible environmental impact of these ; experiments has been analyzed. Rifkin is seeking to stop Advanced Genetic ; Sciences and Cetus Corporation from conducting field tests respectively of ; modified frost-resistant bacteria and disease-resistant plants. His efforts have ; already led scientists at Stanford University to postpone voluntarily the ; planting of corn seed containing recombinant DNA.

Keywords: Formaldehyde/*adverse effects ; Humans ; United States ; United States Environmental Protection Agency

Keywords: Animals ; *Government Agencies ; Humans ; Radio Waves/*adverse effects ; United States ; *United States Environmental Protection Agency

Keywords: *Dioxins ; *Environmental Pollutants ; *Government Agencies ; United States ; *United States Environmental Protection Agency

Keywords: Female ; Humans ; Medroxyprogesterone/*analogs & derivatives/toxicity ; Medroxyprogesterone Acetate ; Risk ; United States ; United States Food and Drug Administration

Keywords: Advisory Committees ; Containment of Biohazards ; Ethics Committees, Research ; Federal Government ; Genetic Diseases, Inborn ; *Genetic Engineering ; Government Regulation ; Judicial Role ; Jurisprudence ; *National Institutes of Health (U.S.) ; United States ; Administration, the first authorized experiments in human gene therapy are ; expected to begin sometime in 1985. Anticipating approval, the congressional ; Office of Technology Assessment (OTA), at the request of then Representative ; Albert Gore, Jr. (D-Tenn), compiled a report on the scientific and ethical issues ; involved. OTA found no unique ethical obstacles to somatic cell therapy if ; conducted safely and with a reasonable expectation of efficacy. It reached no ; agreement concerning the necessity, feasibility, or ethical acceptability of ; germline therapy, and recommended further evaluation and public discussion.

Keywords: Advisory Committees ; DNA, Recombinant ; *Federal Government ; *Genetic Engineering ; *Government Regulation ; Industry ; Legislation as Topic ; National Institutes of Health (U.S.) ; United States ; United States Environmental Protection Agency ; engineering industry. Federal officials are aware of the pressing need for a ; comprehensive, coordinated policy that will regulate biotechnology without ; hampering its growth or driving companies abroad. A Cabinet-level working group ; involving 15 agencies and the Environmental Protection Agency plans to issue ; reports in Fall 1984 on the direction federal involvement should take. ; Consideration is being given to expanding the regulatory role of the National ; Institutes of Healths' Recombinant DNA Advisory Committee, even while the ; committee awaits judicial review of its past decisions.

Keywords: *Animal Feed ; Animals ; *Anti-Bacterial Agents ; *Food Additives ; Humans ; Legislation as Topic ; R Factors ; Salmonella Food Poisoning/microbiology ; United States ; United States Food and Drug Administration

Keywords: Ethylene Oxide/*adverse effects ; Humans ; United States ; *United States Occupational Safety and Health Administration

Keywords: *Cyclosporins ; *Federal Government ; Humans ; *Legislation, Drug ; Medicare/*legislation & jurisprudence ; *Resource Allocation ; Transplantation/economics ; United States ; and Means health subcommittee minus the so-called "cyclosporine amendment," a ; provision which would have extended Medicare coverage to the long-term use of ; immunosuppressive drugs for organ transplant recipients. Cyclosporine became a ; focus of dispute because of its high cost. Opponents of the deleted provision ; argued that it would break the precedent under which Medicare pays for drugs only ; while a patient is in the hospital. Committee members report that pressure from ; physicians and patients is building to revive the deleted proposal.

Keywords: Animals ; *Carcinogens ; Formaldehyde/*adverse effects ; Humans ; Mice ; Public Policy ; United States ; United States Environmental Protection Agency ; United States Occupational Safety and Health Administration

Keywords: *Legislation, Medical ; *National Institutes of Health (U.S.)/organization & administration ; Research ; United States

Keywords: Animals ; *Animals, Laboratory ; Dogs ; Goats ; Haplorhini ; *Legislation as Topic ; National Institutes of Health (U.S.) ; Swine ; United States

Keywords: Federal Government ; Female ; *Government Regulation ; Humans ; Neural Tube Defects/*diagnosis ; Pregnancy ; Pregnant Women ; *Prenatal Diagnosis/instrumentation ; Risk Assessment ; United States ; United States Food and Drug Administration ; Administration on 17 June to approve the wider use of diagnostic kits for the ; detection of fetal neural tube defects. The American College of Obstetricians and ; Gynecologists and the American Academy of Pediatrics are among the critics who ; favor tighter restrictions on use of the kits, which measure levels of ; alpha-fetoprotein in serum samples taken from expectant mothers, on the grounds ; that false positive results are common, necessitating careful quality control ; monitoring of physicians, manufacturers, and laboratories performing the test.

Keywords: Government Agencies ; *Politics ; Research Support as Topic ; *Science ; United States

Keywords: *Federal Government ; *Health Policy ; United States ; country without any comprehensive, nonpartisan forum for assessing the safety and ; cost effectiveness of biomedical technologies. While many private and public ; groups found the Center's evaluations useful, the American Medical Association ; and the Health Industry Manufacturers Association viewed it as a regulatory ; agency and lobbied for its closure. Despite the efforts of various medical ; societies, insurers, and the medical device industry to establish their own ; review programs, many policy analysts would like to see a federal panel revived.

Keywords: *National Institutes of Health (U.S.) ; *Neoplasms ; *Professional Staff Committees ; United States

Keywords: Aggression/*psychology ; Child ; Humans ; National Institute of Mental Health (U.S.) ; *Television ; United States ; *Violence

Keywords: *Biological Warfare ; Federal Government ; Government Regulation ; *Laboratories ; Research ; United States ; devoted to testing highly infectious, lethal biological agents in aerosol sprays. ; The proposed $1.4 million laboratory is a small part of an ongoing effort to ; modernize and expand chemical and biological facilities at Dugway Proving Ground. ; Several eminent biologists who reviewed the Pentagon's proposal at the request of ; Science are concerned that the facility will eventually be used to develop ; prohibited offensive weapons, particularly genetically modified pathogens of ; enhanced virulence and antibiotic resistance, though some scientists think the ; danger can be averted through surveillance by an independant panel. The Pentagon ; denies that such development is planned and claims that the facility is urgently ; needed to test defensive military equipment.

Keywords: *DNA, Recombinant ; Genetic Engineering/*methods ; *Patents as Topic ; United States ; powerful gene-splicing technique to Biogen, whose chairman, Walter Gilbert, ; developed the process while at the university. Although Biogen has invested ; heavily in the gene-splicing technique and is confident it will replace or ; successfully compete with methods currently used to manufacture human insulin and ; other proteins, some experts question whether Gilbert's process is commercially ; feasible.

Keywords: *Drug Industry ; Legislation as Topic ; *Patents as Topic ; United States

Keywords: *Foundations ; History, 20th Century ; Research Support as Topic ; *Science ; United States

Keywords: Humans ; National Institutes of Health (U.S.) ; *Physicians ; *Research ; Research Support as Topic ; United States