9 ms·

This really, really is not true. Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine tri

This really, really is not true. 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.

notheretoo 5y ago
Can you prove your statement by providing an example please?
- frockington1 5y ago
  Tuskegee Syphilis Trials
- zuminator 5y ago
  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. [0] https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 https://www.fda.gov/news-events/press-announcements/fda-appr... [1] https://www.wsj.com/articles/fast-track-drug-approval-designed-for-emergencies-is-now-routine-11562337924 https://www.wsj.com/articles/fast-track-drug-approval-design...
- pgalvin 5y ago
  Sure. 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. [0]https://web.archive.org/web/20091019080918/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm https://web.archive.org/web/20091019080918/https://www.fda.g...
- StephenAmar 5y ago
  Please actually look at the change history in https://clinicaltrials.gov/ct2/history/NCT04368728 https://clinicaltrials.gov/ct2/history/NCT04368728 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. It truly is that simple.
jboggan 5y ago
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. Note the date on this article - this was back in February of this year: https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430... Don't denigrate a perfectly valid criticism of deviations from historical norms of drug validation and approval by calling it a "conspiracy theory".
- 7952 5y ago
  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.
  - yonaguska 5y ago
    Not if the general population is mandated to be vaccinated.
    - 7952 5y ago
      But that is not what happened. Not everyone has had the jab. And those that were vaccinated did not all receive the same vaccine. Anyway none of your comments actually address the science involved. A few factoids without any context is not useful.
- gzer0 5y ago
  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.
mattigames 5y ago
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 [0] https://apnews.com/article/coronavirus-pandemic-health-941fcf43d9731c76c16e7354f5d5e187 https://apnews.com/article/coronavirus-pandemic-health-941fc...

notheretoo 5y ago

Can you prove your statement by providing an example please?

frockington1 5y ago
Tuskegee Syphilis Trials
zuminator 5y ago
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. [0] https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 https://www.fda.gov/news-events/press-announcements/fda-appr... [1] https://www.wsj.com/articles/fast-track-drug-approval-designed-for-emergencies-is-now-routine-11562337924 https://www.wsj.com/articles/fast-track-drug-approval-design...
pgalvin 5y ago
Sure. 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. [0]https://web.archive.org/web/20091019080918/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm https://web.archive.org/web/20091019080918/https://www.fda.g...
StephenAmar 5y ago
Please actually look at the change history in https://clinicaltrials.gov/ct2/history/NCT04368728 https://clinicaltrials.gov/ct2/history/NCT04368728 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. It truly is that simple.

jboggan 5y ago

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. Note the date on this article - this was back in February of this year: https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430... Don't denigrate a perfectly valid criticism of deviations from historical norms of drug validation and approval by calling it a "conspiracy theory".

7952 5y ago
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.
- yonaguska 5y ago
  Not if the general population is mandated to be vaccinated.
  - 7952 5y ago
    But that is not what happened. Not everyone has had the jab. And those that were vaccinated did not all receive the same vaccine. Anyway none of your comments actually address the science involved. A few factoids without any context is not useful.
gzer0 5y ago
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.

mattigames 5y ago

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 [0] https://apnews.com/article/coronavirus-pandemic-health-941fcf43d9731c76c16e7354f5d5e187 https://apnews.com/article/coronavirus-pandemic-health-941fc...