AIDS policies change rules

Article Abstract:

Two drugs for treating AIDS, dideoxyinosine (ddI) and dideoxycytidine (ddC), are scheduled to begin trials by the Food and Drug Administration (FDA) in the first months of 1991, using new procedures for evaluating such drugs. Pressure on the FDA to approve drugs more quickly has changed the politics of health care; AIDS sufferers who cannot take AZT, the only drug currently approved, have no other treatment alternatives at present. Results of clinical trials of ddI and ddC were promising, but the side-effects were serious. The FDA must now establish criteria to determine whether these drugs are safe and effective. How they will do this has not been revealed, a situation that could lead to additional delays. A formal petition protesting the slow response of the FDA was filed by the Community Consortium in San Francisco, a group of 180 health care providers who treat many patients who have human immunodeficiency virus (HIV) infection, the agent associated with AIDS. The manufacturers of the new drugs, Bristol Myers Squibb (ddI) and Hoffmann-La Roche (ddC), want to perform lengthy additional tests. The matter should be somewhat resolved after the February 13 meeting of the FDA Antiviral Drugs Advisory Committee, when drug efficacy standards are to be set. The Consortium has stated that the drugs could be acted on by March 1; the FDA has not commented upon this. Ellen Cooper, the director of the Division of Antiviral Drug Products and a perceived advocate of the activists, resigned recently, raising additional alarm about the drug review process. The thousands of AIDS patients who take ddI or ddC under expanded access programs are not enough, according to activists, since only certain patients qualify for these trials (for instance, only those with private physicians). Control data are also lacking, since the current research approach considers the use of placebo groups unethical. Another problem that needs to be resolved is determining acceptable surrogate markers, such as blood levels of CD4 cells, to compare the efficacy of various drug treatments. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, United States. Food and Drug Administration, Drug testing, Didanosine, Zalcitabine

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Row over controversial new AIDS drug

Article Abstract:

Compound Q is a new drug used for the treatment of AIDS, acquired immunodeficiency syndrome. In a laboratory tissue culture test system, the drug selectively kills cells infected with HIV, human immunodeficiency virus, which causes AIDS. With these promising results, the San Francisco advocacy group Project Inform set up a trial study for the use of Compound Q in patients with AIDS in May 1989 because the group felt the Food and Drug Administration (FDA) was too slow in evaluating the efficiency and safety of the drug. There is controversy over this trial, with critics questioning the protocol used and the fact that there was no review of the drug trial before it began. Consequently the FDA has launched an investigation of the clinical trial of Compound Q. Concern is also focused on the extremely toxic reactions that some patients experienced. A spectrum of side effects, ranging from fever and rash to violent dreams and coma, have been seen with this drug. However, Compound Q is beneficial in the treatment of AIDS. CD4 cells, a subset of T lymphocytes which are necessary to mount an immune response against the virus, are usually destroyed by HIV. However, after the drug was given to the 34 AIDS patients in the trial, the number of CD4 cells increased. The patients also experienced other positive effects such as increased energy, weight gain, and mental acuteness. Compound Q is not a cure for AIDS, but it may be an important drug for treatment, especially if it is used in combination with other drugs such as AZT, 3'-azido-3' deoxythimidine, which is currently used for the treatment of AIDS.

Testing, editorial, Project Inform

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AIDS myths that need eradicating

Article Abstract:

Certain incorrect perceptions about the spread and treatment of AIDS need to be refuted in the aftermath of the international conference on AIDS at Vancouver, Canada. Despite successful trials of combination therapies, such treatments preclude a permanent cure. Competitive drug companies have spawned promising variants of protease inhibitors despite the controversy over the mechanism. By limiting mutations, new therapies reduce the risk of producing new drug-resistant HIV virus. While fractionalism still haunts the AIDS research community, myths of a western remedy precluding prospects of an effective vaccine for the third world are unwarranted.

Canada, Conferences, meetings and seminars, Pharmaceutical industry, Reports, Ethical aspects, International Conference on AIDS

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