Expanding AIDS drug availability
Article Abstract:
The Food and Drug Administration (FDA) is expanding the availability of experimental drugs for use by AIDS patients. Experimental drugs, according to FDA guidelines, are those that are at an early stage of testing. AIDS activists, as well as the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, have prompted the FDA to change a long-standing policy that prevents experimental drugs from being used by patients. The expanded policy will permit some experimental drugs in the Phase I stage of testing to be used by AIDS patients. Certain guidelines, however, must be observed. The drug must show some evidence that it is effective and safe; use of the drug must be accompanied by data accumulation; and patient safety must never be compromised. This policy has yet to be implemented, and before it is in place, other questions, related to cost, reimbursement, informed consent, and supply of testable drugs, must be addressed by an FDA committee. Once the system is established, experts believe that experimental drugs will be evaluated on a case-by-case basis before patients are treated with them.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1989
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HIV/AIDS care calls for reallocation of resources
Article Abstract:
Physicians discussed ways to allocate resources to fight AIDS effectively at a 1997 conference. New drug combinations that include protease inhibitors have turned HIV infection from a fatal disease into a chronic disease. More than 30 million people are now infected worldwide, and 95% cannot afford expensive AIDS drugs. In the US, about 750,000 people have HIV infection and about two-thirds have no private insurance. Many cannot qualify for Medicaid unless they are ill. An AIDS vaccine is ready for testing but behavioral counseling can also prevent HIV infection.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1998
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Coma-inducing drug GHB may be reclassified
Article Abstract:
The US Drug Enforcement Agency is considering classifying gamma-hydroxybutyrate (GHB) as a schedule I controlled substance. This classification would make possession of GHB a criminal offense. The chemical occurs naturally in the brain and was synthesized in 1960. It was used by many body builders after a report indicated it might stimulate growth hormone. Its euphoric effect has led to its abuse and this has resulted in many serious illnesses such as seizures and coma.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1997
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