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, Volume 4U.S. Government Printing Office, 1989 - 219 pages |
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activities addition aerosolized pentamidine agency AIDS drugs AIDS epidemic AIDS patients AIDS-related Allergy American appropriate approval areas Association Astra behavior Bethesda blood budget CDC's centers CHAIRMAN clinical trials CMV retinitis committee community-based compassionate Congress coordinated costs currently DHPG Director drug abuse Drug Administration drug application education programs effective evaluation Fauci FDA's Federal fiscal Food and Drug foscarnet funds ganciclovir GAO/HRD-89-21 AIDS Education grants HIV infection home health hospital hotline HRSA Human Infectious Diseases issue Kaposi's Sarcoma MATHENY million national AIDS National Institute NIAID NOBLE opportunistic infections organizations pediatric pentamidine percent pharmaceutical Pneumocystis carinii pneumonia populations prevention problem protocol public service announcements request response retinitis risk San Francisco Senator HATCH Senator MIKULSKI sponsors studies Syntex testing tion treat treatment IND trimetrexate vaccine virus YOUNG zidovudine
Popular passages
Page 118 - Recognize Our Special Responsibility in International Health Efforts to Control AIDS The rationale for US involvement in international AIDS activities is more broadly based than the protection of American troops and tourists. AIDS can destabilize the work forces and the economies of developing countries whose advancement has been aided by US dollars. AIDS can also reverse the child survival figures in countries where our help only recently has improved infant and child survival. Finally, some countries...
Page 113 - HTV infection to overt illness. Another frequently cited purpose of testing, that knowledge of one's antibody status may encourage behavior change, is a hoped for but still unproven relation. In addition, it has been argued that uninfected persons can use the knowledge of others' test results to protect themselves from infection; or, in some situations (eg, the military, jails, and other closed populations), authorities can intervene to protect uninfected persons by testing and then segregating infected...
Page 112 - The ability to detect antibody to HIV has prompted various proposals for testing individuals and screening populations for evidence of HIV infection. However, these proposals must be assessed carefully to evaluate what they might add to interventions that are possible in the absence of testing. The President can encourage a level-headed approach to testing strategies by conveying the belief that HIV testing alone is not a panacea.
Page 111 - Administration's treatment investigational new drug mechanism. • Piecemeal solutions to the problems of health care financing must not sidetrack the need for a more comprehensive scheme. Your Secretary of HHS should take the lead in developing a comprehensive national plan for delivering and financing care for needy HIV-infected and AIDS patients. The following principles should guide the development of such a financing strategy: (1) coverage from the time HIV infection is discovered, (2) consideration...
Page 29 - ... for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely-debilitating illnesses, than they would accept from products that treat less serious illnesses.
Page 113 - 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 116 - 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....
Page 117 - Although the best designed clinical trial would enroll the fewest people needed to demonstrate drug effectiveness, many persons with HIV infection want to participate in clinical trials. • The National Institutes of Health (NIH) should provide wider access to clinical trials by broadening their geographic base; by extending trials to previously untapped populations including women, IV drug abusers, and pediatric patients; and by testing all compounds that appear to have a possibility of effectiveness....
Page 146 - HRSA is to improve the education of heal-th 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 107 - HIV-infected persons from discrimination; (3) develop a comprehensive plan for financing the care of those with HTV infection and AIDS; (4) initiate a forceful program for the treatment of substance abuse and the prevention of the associated spread of HIV; (5) institute aggressive and unambiguous educational programs and evaluate their effects; (6) ensure that HTV testing and other public health measures are employed only when their purposes are clear and their results productive; (7) bolster efforts...