Expanding Access to Investigational Therapies for HIV Infection and AIDS (1991) / Chapter Skim
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2 RIGHTS AND RESPONSIBILITIES
2 RIGHTS AND RESPONSIBILITIES
Pages 19-26
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From page 19... ...
The "beneficence versus autonomy" approach suggests that providing protection to people with HIV infection must conflict with respect for their individual rights. In fact, most efforts to simplify the debate over expanded access do a disservice by diverting attention from a host of complex issues that must be considered in any discussion of increased access to AIDS drugs.
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From page 20... ...
Two of the most troublesome factors are the lack of adequate information about drug products and the shortage of health care options-for some people with HIV disease, clinical trials may represent the only opportunity for access to a knowledgeable medical team. Information Resources For most persons with HIV infection and their physicians, the first encounter with a new drug or treatment alternative occurs through
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From page 21... ...
The treatment IND was issued in February 1989, simultaneously with a press release announcing the effectiveness of the therapy as prophylaxis for Pneumocystis car~nii pneumonia. San Francisco investigators presented a formal abstract describing community trials of the treatment at the international AIDS meeting in Montreal several months later, and by late June the FDA had approved the drug for marketing.
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From page 22... ...
journal publication Other options include a mechanism similar to the "Clinical Alert System" adopted by the National Cancer Institute, or a federally sponsored on-line data base that would provide relevant data from clinical trials to HIVinfected patients and their physicians. The proposed policy statement for parallel track protocols emphasizes the development of appropriate mechanisms to educate potential drug recipients and their physicians.
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From page 23... ...
Similarly, the patient's right to withdraw from a trial at any point is jeopardized if dropping out means losing touch with essential health care providers. Parallel track protocols are unlikely to ease this situation because the primary care provider is the fundamental link between the patient and the drug sponsor.
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From page 24... ...
Organized expanded access may help resolve this conflict, but only if parallel track protocols do not interfere with enrollment in conventional clinical trials. Patient advocates suggest that one way to increase patient accrual in conventional trials and to decrease the risk of misrepresentation is to include patients, their advocates, and their primary care physicians in the planning of each protocol.
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From page 25... ...
NI:VV ATTITUDES The effect of the AIDS epidemic on drug regulators has not received a great deal of attention, but some observers suggest that calls for expedited development and early expanded access could have a major impact on the way regulators view their own responsibilities. For decades, regulators and drug sponsors have had an almost adversarial relationship.
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From page 26... ...
Identifying promising drugs and getting them to the marketplace as quickly as possible are extremely worthwhile goals, but everyone should be aware of the potential costs as well as the potential benefits. For example, the new emphasis on expedited development greatly increases the demands on postmarketing testing and surveillance systems.
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