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The role of epidemiology in the regulation of oral contraceptives.
  • Published Date:
    1984 Jul-Aug
  • Source:
    Public Health Rep. 99(4):350-354
  • Language:
    English
Filetype[PDF-1.09 MB]


Details:
  • Alternative Title:
    Public Health Rep
  • Personal Author:
    Sobel, S
  • Description:
    The U.S. Food and Drug Administration (FDA) has relied to a great degree on epidemiologic studies in the regulation of oral contraceptives (OC). These epidemiologic studies range from individual case reports of adverse reactions to case-control studies and cohort studies. Important findings about adverse reactions to OCs have been communicated through "labeling," which includes information leaflets provided as package inserts for physicians and patients. Also, the FDA communicates its position through publications in medical journals, the FDA Drug Bulletin, public advisory committee meetings, workshops, and symposia. The agency responds to new epidemiologic information; labeling guidelines are under continuing review and revision. Patterns of oral contraceptive use have been affected by the dissemination of this information. There has been a decline in the use of OCs, a shift to formulations with lesser steroidal content, and a greater emphasis on OC use in optimal groups, such as young, nonsmoking women. Considered for future epidemiologic studies that may have an impact on regulatory action are a clarification of the role of various progestins in regard to blood lipid alteration and atherogenesis, a delineation of the possible persistence of cardiovascular risk after termination of OC use, and further clarification in regard to neoplasia, particularly breast and cervical carcinoma.
  • Subject:
  • Pubmed ID:
    6431481
  • Pubmed Central ID:
    PMCnull
  • Document Type:
    Journal Article
  • Collection(s):
    Public Health Reports
  • Main Document Checksum:
  • Supporting Files:
    No Additional Files
    1. Nitrosamines in bacon: a case study of balancing risks.
      Personal Author:
      McCutcheon, J W
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):360-364
      Description:
      Nitrite has been used for centuries to preserve, color, and flavor meat. Today, about 10 billion pounds of cured meat products are produced annually, accounting for some one-tenth of the American food supply. Regulators became concerned about the saf...
      File Type:
      Filetype[PDF - 926.17 KB]
    2. Analysis of the reversal in breast feeding trends in the early 1970s.
      Personal Author:
      Eckhardt, K W; Hendershot, Gerry E.;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):410-415
      Description:
      The long downward trend in the practice of breast feeding was reversed during the 1972-73 period. Data from the National Survey of Family Growth conducted by the National Center for Health Statistics were used to investigate the social correlates of ...
      File Type:
      Filetype[PDF - 1.17 MB]
    3. The story of "Joseph M."--mass media against "medical bureaucracy".
      Personal Author:
      Fuks, Z; Modan, B;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):338-342
      File Type:
      Filetype[PDF - 1.26 MB]
    4. Public Health Rep ; v. 99, no. 4 : table of contents
      Published Date:
      Jul-Aug 1984
      Source:
      Public Health Rep. 99(4)
      File Type:
      Filetype[PDF - 414.54 KB]
    5. Public Health Rep ; v. 99, no. 4 : Masthead
      Published Date:
      Jul-Aug 1984
      Source:
      Public Health Rep. 99(4)
      File Type:
      Filetype[PDF - 727.50 KB]
    6. Thyroid tumors associated with radiation exposure.
      Personal Author:
      Silverman, C
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):369-373
      Description:
      Epidemiologic studies of medically and environmentally exposed populations have been central to establishing ionizing radiation as a cause of malignant and benign thyroid tumors. Issues currently under investigation concern low dose effects, age sens...
      File Type:
      Filetype[PDF - 1.17 MB]
    7. Technology assessment, a private-public partnership.
      Personal Author:
      Brandt, E N
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):329-330
      File Type:
      Filetype[PDF - 359.99 KB]
    8. The projected supply of registered nurses, 1990.
      Personal Author:
      West, M D
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):391-400
      Description:
      The number of employed registered nurses (RNs) in the United States stood at an all-time high of 1.3 million in 1980. This paper, using life table techniques, develops a population base of all living graduates from data on graduations from basic nurs...
      File Type:
      Filetype[PDF - 3.38 MB]
    9. Toxic shock syndrome: chronology of state and federal epidemiologic studies and regulatory decision-making.
      Personal Author:
      Donawa, M E; Schmid, G R; Osterholm, M T;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):342-350
      File Type:
      Filetype[PDF - 2.14 MB]
    10. Meeting the health care needs of children with disabilities: a progress report.
      Personal Author:
      Koop, C E
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):330-332
      File Type:
      Filetype[PDF - 653.35 KB]
    11. The social desirability of preventive health behavior.
      Personal Author:
      Kristiansen, C M; Harding, C M;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):384-388
      Description:
      The relationship between measures of social desirability and various preventive health behaviors was examined directly for 235 females and 171 males from the British public and 182 females and 49 males from the University of Toronto, Canada. Both sim...
      File Type:
      Filetype[PDF - 1.04 MB]
    12. High utilizers of ambulatory care services: 6-year followup at Alaska Native Medical Center.
      Personal Author:
      Nighswander, T S
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):400-404
      Description:
      In a retrospective study, 100 randomly selected, high utilizers of ambulatory care services in 1972 were followed for a 6-year period, 1973-78. The 22 men and 78 women had visited the Alaska Native Medical Center in Anchorage 15 or more time in 1972....
      File Type:
      Filetype[PDF - 1.23 MB]
    13. Laetrile: the regulatory challenge of an unproven remedy.
      Personal Author:
      Nightingale, S L
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):333-338
      Description:
      The controversy over Laetrile is nearly at an end, the worthlessness of the drug having been demonstrated beyond reasonable doubt. But the Laetrile experience raised important questions of public policy, some of which remain unresolved and all of whi...
      File Type:
      Filetype[PDF - 1.44 MB]
    14. Marital status and its relation to the use of short-stay hospitals and nursing homes.
      Personal Author:
      Lewis, W F
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):415-424
      Description:
      Marital status has been associated with a wide variety of health indices and health practices. To better understand the relation of marital status to use of health facilities, discharge data from two surveys conducted by the National Center for Healt...
      File Type:
      Filetype[PDF - 3.16 MB]
    15. The 1990 objectives for the nation for control of stress and violent behavior: progress report.
      Personal Author:
      Silver, B J; Goldston, S E; Silver, L B;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):374-384
      Description:
      The control of stress and violent behavior is 1 of the 15 priority areas addressed in the Public Health Service's Objectives for the Nation. The National Institute of Mental Health, which provides a national focus for the Federal effort to increase k...
      File Type:
      Filetype[PDF - 4.00 MB]
    16. Using epidemiology to regulate food additives: saccharin case-control studies.
      Personal Author:
      Cordle, F; Miller, S A;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):365-369
      Description:
      The increasing use of nonnutritive sweeteners and the widely publicized 1969 ban on cyclamate led to additional investigations in rodents of the carcinogenic potential of saccharin. Preliminary results of a long-term feeding study indicated formation...
      File Type:
      Filetype[PDF - 1.20 MB]
    17. Investigational trials of anticancer drugs: establishing safeguards for experimentation.
      Personal Author:
      Chabner, B A; Wittes, R; Hoth, D; Hubbard, S;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):355-360
      Description:
      The National Cancer Institute since 1955 has been charged with responsibility for discovering new anti-cancer agents and bringing them to clinical trial. These activities are carried out by NCI's Developmental Therapeutics Program, which has establis...
      File Type:
      Filetype[PDF - 1.14 MB]
    18. Prescribing estrogen during menopause: physician survey of practices in 1974 and 1981.
      Personal Author:
      Pasley, B H; Standfast, S J; Katz, S H;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):424-429
      Description:
      A physician survey was conducted in 13 counties surrounding Albany and Syracuse, N.Y., to determine estrogen prescribing patterns for treatment of problems associated with menopause. A case history of a 51-year-old woman was included in questionnaire...
      File Type:
      Filetype[PDF - 1.41 MB]
    19. Public Health Reports ; v. 99 , no. 4 : cover
      Published Date:
      Jul-Aug 1984
      Source:
      Public Health Rep 99 (4)
      File Type:
      Filetype[PDF - 549.58 KB]
    20. Epidemiology of Haemophilus influenzae type B disease among Navajo Indians.
      Personal Author:
      Coulehan, J L; Michaels, R H; Hallowell, C; Schults, R; Welty, T K; Kuo, J S;
      Published Date:
      1984 Jul-Aug
      Source:
      Public Health Rep. 99(4):404-409
      Description:
      During a 7-year period ending June 30, 1980, the annual incidence of all Haemophilus influenzae type b disease among Navajo children less than 5 years old was 214 per 100,000, and that of H. influenzae meningitis was 152 per 100,000. Eighty-one perce...
      File Type:
      Filetype[PDF - 1.34 MB]
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