Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine trials have given the placebo group the real drug once safety and efficacy is clear - before the end of the trial.
This is not new, and frankly I’m a little surprised to see such conspiracy theories on HN.
Remdesivir [0], for one, which received Fast Track and Priority Review designation from the FDA. It was also noted in a 2019 Wall Street Journal article [1] that the majority of new drug approvals are now done through a Fast Track process.
Garasdil was approved by the FDA in 2006 and, as this press release shows [0], continued running studies into it as a condition of the approval. They conceded that full results could not be available before approval; “While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.”
From what I can gather, the Phase III study participants continued to receive follow-up checks for at least a decade.
The completion date was changed multiple times since April 2020 and they clearly appended booster trials to the existing trials and pushed back the dates.
I would like to see an example of previous trials where the placebo group was invalidated prematurely by informing them and giving them the actual drug. If this is common practice I'm not aware of it.
The use of placebos in controlled clinical trials must be justified by a positive risk-benefit analysis, and the subjects must be fully informed of the risks involved in the assignment to the placebo group.
Continued assignment of subjects to placebo is unethical, once there is good evidence to support the efficacy of the trial therapy.
Unfortunately (or fortunately) since there was such strong evidence to prove the efficacy, it became unethical for the continued assignment of placebo.
The good old "is unethical to do a double blind study". This one is by far the best invention of the Big Pharma PR departments, you basically cannot make the study that will prove for sure that their product is safe (and stick it to all those anti vaxxers once and for all) Talk about having your cake and eating it too...
This happened with low-dose Aspirin for prevention of heart-attacks and strokes. The protective effect was so profound that they considered it unethical to let the control group proceed without it.
Here's one. I'm sure you can find others ("terminated for benefit"). For statistical reasons, terminating a trial for benefit is relatively uncommon (most terminations occur for other reasons):
Surely the point of a placebo in this case was to measure effectiveness rather than detect long term side effects. There are other methods of establishing a control such as comparing to the general population.
The quality of discourse here is so so low, disguising antivax stands as concerns for the speed of the vaccine approval while disregarding simple verifiable facts such that 98%[0] of the people on ICU are unvaccinated
Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine trials have given the placebo group the real drug once safety and efficacy is clear - before the end of the trial.
This is not new, and frankly I’m a little surprised to see such conspiracy theories on HN.
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