Pro and con. Gallo argued in defense of the study. But the central question was whether HIV is the cause of AIDS not debates over protocols. After all even aspirin was used for many years without anyone understanding how it worked let alone run protocols.
I haven’t the background to know whether proper protocols were followed and accusations that they weren’t is hardly proof of anything. Got any evidence?
...
Preliminary results from a Veterans Administration (VA) study of AZT therapy were presented on 14 February 1991 in Washington, DC, at a special meeting of the Antiviral Drugs Advisory Committee of the Food and Drug Administration (FDA)...
<snip>
The Veterans Administration Study
The main focus of the meeting on Thursday 14 February was Veterans Administration Cooperative Study 298, whose preliminary findings were presented by John Hamilton, MD. This study involved 338 HIV-positive individuals whose T4 cells were in the range between 200 and 500 and who showed some "symptoms or signs of HIV infection", including thrush, oral hairy leukoplakia, zoster, unintentional weight loss of 10% or more, unexplained persistent diarrhea, fever (100.5 degrees Fahrenheit), night sweats, fatigue, dermatitis, or lymphadenopathy. According to "risk group" category, 65% were gay men, 15% were intravenous drug users, and 8% were both gay men and intravenous drug users. Ethnically, 65% were white and 35% were black or hispanic. Patients were enrolled into the study as early as January 1987 or as late as January 1990.
The patients were randomized into two treatment arms: the first (early treatment) received 1500 mg. of AZT per day; the second (later treatment) received placebo followed by AZT at the point where their CD4 count fell below 200 on two successive occasions.
Hamilton stated his overall conclusions twice-at the beginning of his talk, and then again at the very end. His first statement of conclusions is as follows (verbatim):
Early zidovudine delayed progression to AIDS, as compared to later treatment. But no benefit for either treatment arm was detected for survival or the combined clinical endpoints of AIDS and death. Early zidovudine resulted in transitory benefits in whites and neutral or harmful effects in black and hispanic patients.
At the end of his talk, Hamilton expanded his conclusions somewhat, as follows (verbatim): We found that early zidovudine therapy delayed the progression of AIDS. We also found that survival was comparable in the two treatment groups. That is, no benefit-no detectable benefit. We found that early zidovudine resulted in transitory benefits in whites and neutral or harmful effects in black and hispanic patients. And we conclude that further studies are mandatory in minority populations.
I made the two brief transcripts above from listening dozens of times to the tape I made of Hamilton's talk. They are, word for word, what he said. I emphasize this because reports on Hamilton's talk have strangely distorted, or neglected to mention, the conclusions that he himself presented. For the record, there they are.
Hamilton described the toxicities of AZT treatment, all of which were found more often in the early treatment group.Comparing early vs. later, more patients on early zidovudine: were anemic, were neutropenic, had nausea and vomiting, had diarrhea, had central nervous system abnormalities, and had headaches. In response to questioning, Hamilton said that transfusions were given when necessary. (See Table 1 below)
Not only did AZT not confer any benefit in terms of survival, a slightly higher proportion of patients died in the early treatment group (14%) than in the later treatment group (11%). One astounding finding was that in the early AZT group, 10 patients (6%) died without ever progressing to CDC-defined "AIDS", whereas none of the patients in the later AZT group did so. One must ask, then, what these patients died from, if not from "AIDS"; and the answer is that they probably died, at least in part, from AZT poisoning. It would seem a dubious benefit to take a drug that will prevent you from progressing to "AIDS" by killing you first. (See Table 2 below)
By far the most controversial finding was the possibility that AZT treatment might be more harmful to black and hispanic patients than to whites. Among the minority patients, the death rate was significantly much higher in the early treatment group (14%) than in the later treatment group (2%). One can only speculate as to why there should be ethnic differences in the response to AZT treatment. But, at least for the patients in this study, the differences appear to be real.
http://www.duesberg.com/articles/jlsecond.html