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Placebo Trials End, Controversy Continues.
When the
findings of the CDC study in Thailand were released in February 1998 and
the PETRA
trials in Africa one year later, both sides in the debate saw vindication.
While researchers exulted over the definitive results of the four-week AZT regimen,
Sidney Wolfe attacked the study for simply confirming what researchers should
have known all along. "This is inexcusable, sloppy research," he asserted. "They
have wasted a large number of lives and a huge amount of money."
When, the following year, the PETRA
results indicated the effectiveness of an even shorter regimen, Joseph Saba
of UNAIDS told reporters that the findings of the study justified the use of
placebos. "Without a placebo group," he maintained, "we would have been totally
misled. Now we can say with a peaceful mind that we made the right choice."
But in a February 10, 1999 letter
to the Wall Street Journal, Lurie and Wolfe contended that "this study
would have reached the same conclusion even if no placebo group had been used.
The HIV transmission rates in the more effective treatment arms in the present
study (8.6% to 10.8%) are so much lower than the transmission rates in the untreated
groups in previous studies in developing countries (generally 18% to 40%), that
it would have been easy to correctly conclude that these regimens are effective,
even without a placebo."
In any event, the Thai results of
February 1998 effectively marked the end, at least for the time being, of placebo-controlled
trials to reduce perinatal HIV transmission in developing countries. The CDC
suspended the placebo arm of the Thai study, and other trials also halted
further recruitment to placebo control groups. Some viewed this as a long overdue
step, taken only after unnecessary risk to hundreds of young lives, while others
saw it as a possibly premature action, based on too little evidence and too
much pressure from critics. Both sides agreed that, although the placebo-controlled
trials had ended, the controversy--and its effects--lingered on.
Helsinki revised?
One likely arena in which the debate
would continue to be played out was a proposed
revision of the Declaration of Helsinki, which began circulating in early
1999.Among the changes being considered in the draft document was one passage
which, depending on the viewspoint, represented either an effort to clarify
previously vague and unworkable language, or a retreat from universal principles
of care.
In place of the requirement to assure
every patient, including those in the control group, of receiving "the
best proven diagnostic and therapeutic method," the proposed revision would
assure patients that they would "not be denied access to the best proven,
diagnostic, prophylactic or therapeutic method that would otherwise be available
to him or her."
The draft revisions also included,
unlike previous versions, guidelines on the "ethical and scientific justification"
for conducting placebo-controlled clinical trials.
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