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Comment by jboggan | Hacker News Reader

"It has been clear for a while now that the Pfizer vaccine works and is safe."

Yes, except there is an established process for quantifying "clear for a while now" and it involves sufficient time and control groups. That process isn't being followed and it is concerning for a number of reasons, including the effect of political pressure on expedited drug approvals in the future now that this precedent is being set. The elected leaders capable of bringing such political pressure to bear are invested in the very companies which stand so much to gain by relaxing the time-tested regulatory approval process. This is bad science and bad governance.

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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.

Can you prove your statement by providing an example please?

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-appr...

[1] https://www.wsj.com/articles/fast-track-drug-approval-design...

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.g...

Please actually look at the change history in 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.

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/2021/02/19/9691430...

Don't denigrate a perfectly valid criticism of deviations from historical norms of drug validation and approval by calling it a "conspiracy theory".

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):

https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.111...

Here's an article on the ethics of a placebo-controlled trial in the first place. It's complicated.

https://acrpnet.org/2018/12/06/ethical-deliberations-on-usin...

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.

Not if the general population is mandated to be vaccinated.

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.

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-941fc...

One aspect of the time element is not "this much time has past" but rather "the subjects have had enough exposures to the virus". For some viruses, like HIV, this may take a long time to accomplish. But for COVID, in the middle of a pandemic, it doesn't take that long to accomplish.

> political pressure on expedited drug approvals

I feel like people keep forgetting the definition of "public health crisis."

Time is lives. And economic dollars.

The standard process is designed around limiting harm. Not rapid delivery. Not maximizing good.

In times of business as usual, that's fine. In times of public health crises, it's not.

If we'd rapid approved HIV / AIDS treatments in the 1980s, the world as a whole would have been better.

This is wrong in two big ways:

1. The FDA requires six months of clinical data to establish safety before FDA approval. The normal requirements for FDA approval absolutely were followed

2. With longer-term studied it's not like we don't know anything about them until it's complete. Data is released on a rolling basis so we know how the results of the studies so far, and (surprise!) data so far say it's safe.

And in the cases where there have been question marks that have come up about safety (AZ, JJ), even with miniscule likelihood, those have quickly been withdrawn.

>That process isn't being followed

Evidence?

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