AIDS Education, Care, and Drug Development: Hearing Before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, First Session, on Examining the Adequacy of the Federal Government Efforts to Combat AIDS, with Regard to Education, Care, and Drug Development, February 7, 1989

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U.S. Government Printing Office, 1989 - 219 pages

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Page 144 - The purpose of the service demonstration projects is to support and facilitate the organization of HIV-related patient care systems which will: Identify service needs and develop strategies to meet them; Integrate available community resources into a system of care; Provide effective case management to ensure continuity of services; and Reduce the costs of providing medical services by providing alternatives to hospitalization.
Page 117 - For example, serologic testing and counseling should be extended immediately to all settings in which IV drug abusers are seen or treated. The technical aspects of HIV testing must also be considered. Although the current tests for HIV antibody are highly accurate, there will inevitably be false-positive and false-negative results (and the proportion of positive test results that are false is largest when the test is applied to populations with a low prevalence of infection). • The federal government...
Page 197 - ... 1987, and subsequent discussions with your staff, we have reviewed selected aspects of the administration's Acquired Immunodeficiency Syndrome (AIDS) education programs. Overall, you were concerned with what you considered to be inexcusable delays in implementing a thorough, effective national AIDS education program. You asked us to look at six aspects of the Centers for Disease Control's (CDC'S) AIDS education program for the general public, including its budgetary resources, and specific educational...
Page 40 - ... aspects of the preclinical, chemical manufacturing, and clinical phases of drug development; and, investigations of drug products marketed under fraudulent claims related to AIDS and AIDS-related diseases.
Page 150 - HRSA is to improve the education of health professionals in providing health care and support services to AIDS patients and to provide continuing education, information and referral resources to support practicing health professionals working with HIV infected people.
Page 117 - ... false-negative results (and the proportion of positive test results that are false is largest when the test is applied to populations with a low prevalence of infection). • The federal government should give more attention to establishing standards for laboratory proficiency in HIV antibody testing, setting criteria for interpreting assays, and instituting quality assurance procedures. Other public health measures should also be carefully considered for their potential effectiveness in controlling...
Page 118 - HTV antibodies, on the other hand, should not be required at this time. In fact, the effect of mandatory reporting may be to discourage individuals from seeking voluntary testing, a cost that does not justify its potential benefit. For determining how many people in a population are infected, well-designed studies are more useful than random reporting of cases. 7. Bolster Efforts at Surveillance, Case Reporting, and the Gathering of Information About Risk Behavior By November 1988, over 76,000 AIDS...
Page 130 - Force on AIDS American Association for Counseling and Development American Association for Marriage and Family Therapy American Association of...
Page 28 - FDA's application of the statutory standards for marketing approval shall recognize the need for a medical risk-benefit judgment in making the final decision on approvability. As part of this evaluation, consistent with the statement of purpose in §312.80, FDA will consider whether the benefits of the drug outweigh the known and potential risks of the drug and the need to answer remaining questions about risks and benefits of the drug, taking into consideration the severity of the disease and the...
Page 120 - However, the diversion of FDA personnel necessary to approve zidovudine resulted in a backlog of applications in the FDA's Division of AntiInfective Drug Products. As the number of applications for treatment IND status grows, these personnel problems may become more severe. At present, FDA is not a bottleneck in the availability of new drugs to treat HIV infection and AIDS. The paucity of new drugs is related more to shortcomings in the science of antiviral agents than to the drug approval process....

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