DGREEN@IBM.COM (Dan R. Greening) (02/21/91)
[From Dan: I have been away on business, and this was buried in my mail. Its comments are still valid, and useful.] >From anonymous: ------------------ The.Bird@f38.n135.z1.fidonet.org (The "Bird") wrote recently: > For those of you who believe we are now in "superhuman research and >testing modes", I have learned that that is pure horseshit. There are a total >of 5 AIDS patients at the NIH being tested for various items. My friend is >the only patient currently undergoing this particular phase I trial. It is hard to know what "The Bird" was seeing when he wrote that, so I thought I would share some of my observations on the subject of AIDS research at the National Institutes of Health (NIH). Note, I am not employed by the NIH. The NIH is a big complex of Institutes. I cannot speak for the entire NIH, but I'm aware that AIDS work is being done by at least: National Eye Institute, National Institute of Dental Research, National Cancer Institute (NCI), National Institute of Mental Health (NIMH), National Institute of Alcohol and Drug Abuse and primarily by the National Institute of Allergy and Infectious Diseases (NIAID). I suspect The Bird was referring to a study by the NCI which is only enrolling 5 patients. The NIMH recently awarded two multi-year studies (totaling about $9 million) to clinics in San Diego to study different aspects of the neuropsychology of AIDS. That's a lot of study! Currently at the Bethesda campus, NIAID is seeing some 300 patients on several protocols including 2 vaccine trials (one of which is the first human trial of an AIDS vaccine), trials on anti-virals to HIV, some alone, some with combinations of drugs to enhance their effect. There are also several trials for several Opportunistic Infections, such as PCP, CMV retinitis and toxoplasmosis. All of the NIAID trials are out-patient. Volunteers are sometimes hospitalized due to the complications of the study; sometimes the protocol requires brief in-patient status. One protocol specifies 21 days of in-patient stay to administer the drug, another needs stays of 2-3 days to measure the pharma- cokinetics of the drug. The NIAID protocols range in duration from 6-8 weeks to several years. During this time the volunteers will visit the Clinic as often as once or twice weekly for a year, or monthly or once every 2-3 months. That's a lot of clinic work! I am impressed with the dedication of these volunteers; many need to self-inject themselves twice daily with drugs; sometimes their blood counts drop so low they need blood transfusions. Often times the drugs cause headaches or flu like symptoms. Many travel great distances from cities across the nation. (That's a lot of time off work). Most continue with their protocol to the conclusion, or until they can no longer tolerate the drugs under study. As well, the NIAID sponsors an AIDS Clinical Trials Group (ACTG) at many centers around the county. They, too, are testing a similar set of drugs and are currently tracking 7-10,000 patients. Seems to me that the NIH is in fact doing a lot of AIDS work.