A storm over steroid therapy

Article Abstract:

An article in the New York Times on Wednesday November 14, 1990 stated that the notification of doctors of the successful use of corticosteroids for treatment of pneumonia caused by the microorganism Pneumocystis carinii (PCP) in patients with AIDS was delayed for five months by the National Institute of Allergy and Infectious Diseases (NIAID). This article stirred up a great deal of controversy. On May 15, 1990, the results of clinical trials of the use of corticosteroids in conjunction with other antipneumonia drugs in patients with PCP were discussed by 17 clinical researchers. It was not until October 10, 1990 that officials from NIAID started to notify doctors of the results. The reasons why the NIAID did not notify doctors and the public immediately on the findings was that there was no agreement on which patients with PCP should be given the treatment, what the appropriate dose should be, or when treatment should begin. In the past, corticosteroids have appeared to be effective treatments for various diseases, but after long, carefully controlled clinical trials have been shown to be of no benefit or actually caused harmful side effects. One of the known side effects of treatment with corticosteroids is the suppression of the immune system. Since AIDS is an immunodeficiency disease, where the immune system no longer functions properly, no drugs should be given that would enhance suppression of the immune system. Also, it has been shown that the addition of corticosteroids to cells infected with HIV, the virus that causes AIDS, increases production of the virus. Corticosteroid treatment of patients with Kaposi's sarcoma, which is associated with AIDS, has caused the sarcoma to advance more aggressively. Thus, treating AIDS patients with corticosteroids is risky. This issue is an example of the ongoing controversy about when results of scientific research should be made known to the public and after what degree of scientific scrutiny. (Consumer Summary produced by Reliance Medical Information, Inc.)

Social policy, Corticosteroids, Adrenocortical hormones, Pneumocystis carinii pneumonia, Pneumocystis carinii, United States. National Institute of Allergy and Infectious Diseases

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International doubts about a Kenyan cure

Article Abstract:

Dramatic claims of cures for AIDS are received skeptically by Western researchers and this has been true of recent reports of a miraculous AIDS cure from Kenya. Small doses of alpha interferon, one of a group of proteins important in immune function, reportedly depressed symptoms in every AIDS patient given the drug, with elimination of signs of infection in 10 percent of the patients. Many AIDS patients subsequently went to Kenya for the treatment, and the World Health Organization sponsored quick tests of alpha interferon in four African countries. However, both original and follow-up studies were conducted without controls, and effects could have been due to patients' own raised expectations, the placebo effect, or to an actual drug effect. Properly controlled studies of low-dose interferon are needed, and two such studies are underway in the US. Preliminary reports show no striking effects of alpha interferon, although other studies have shown improvement with much larger doses of the protein. The low dosage used was partially responsible for the initial skepticism. Nevertheless, Kenyan president Arap Moi has hailed the success and announced plans for Kenyan mass production of alpha interferon. However, several patents for production of the drug are held by a Texas company. The president of that company has been trying to interest researchers in the possible effectiveness of alpha interferon in treating AIDS and other viral infections, but is himself cautious about the ability to draw any conclusions from the Kenyan AIDS-interferon study. (Consumer Summary produced by Reliance Medical Information, Inc.)

Medical research, Kenya, Interferon alpha

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A new antiviral drug: promising or problematic?

Article Abstract:

In a revolutionary move, the US Food and Drug Administration recently approved widespread distribution of the experimental AIDS drug dideoxyinosine (ddI) after only minimal testing. AIDS activists had fought for the early distribution of the new treatment, but concern is now growing about its toxic side-effects. Dideoxyinosine (ddI) has caused pancreatitis (inflammation of the pancreas) and severe pain in the extremities. Researchers are worried that these toxic reactions may not be recognized promptly and that other adverse effects are likely to show up as more people take the drug. In the first phase of testing, only eight or 10 AIDS patients took the dose that will now be tested further. This tiny number of subjects cannot be expected to give a representative picture of the safety and efficacy of ddI. A major disadvantage for scientists studying ddI is that even the limited data that have been collected on toxicity are not readily available. The investigators who have the toxicity results feel bound to keep the information confidential because certain medical journals generally will not publish results that have been released previously. Fortunately the journal editors recognize the urgency of publicizing research on AIDS and are allowing prior distribution of data to physicians. Also because of journal publication requirements, communication between American and European AIDS researchers has faltered. The two groups were conducting parallel studies of another AIDS drug, AZT, and when the US investigators cancelled their project the European group was unsure of how to proceed with testing.

Complications and side effects, Didanosine

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