COVID-19 has provided a great example of how well this process works: even the emergency use authorizations required multiple levels of clinical trials and the anti-vax propagandists mining the VAERS database for talking points can do so because there's a requirement to make a public report of anything which happens after someone is vaccinated even if there's no real suspicion that it was related to the vaccine.
Further, there were big political and financial reasons to push the vaccines through. Those are all conflicts of interest. Pfizer had millions of doses manufactured before approval. If trial results didn't look good, they certainly had the incentive to "massage" the results to get it approved and get those millions of doses sold rather than a huge loss.
As the original poster shared, it should be a considered a reasonable position to be skeptical of small scale results. Pfizer's position appears to have scaled well (Moderna as well). 100s of millions of doses across diverse populations show its relative safety and efficacy.
We actually have an interesting example which I think validates that process even though it comes in the unlikely form of the FDA's recent mistake approving Aducanumab. There is a lot of criticism, including IG investigations, over the approval because it was approved despite having failed to go through the process successfully. The Phase III trials were cancelled after they concluded that the drug was not successful, the FDA's internal scientific review found it did not meet the mark, and the outside scientific advisory panel rejected it so strongly that multiple panel members resigned after it was approved anyway. That to me seems like a pretty good argument that the process was doing what we expect and the way to avoid expensive mistakes is to follow it.
If this wondrously robust multi-layered process buckles in the face of a few hysterical anti-vax groups, you should ask yourself how robust it remains in the face of a billion-dollar pharmaceutical conglomerate with politicians in their pockets.
Similarly, it's no secret that companies have a vested interest in promoting their products but it's not like Pfizer says “Trust us, we employ doctors!” and the FDA says “Sounds great, no need to check!”. Each step of that process involves peer-reviewed publications, public data releases, and reviews by panels of scientific experts. It is quite valid to say that companies need to be strictly regulated to keep everyone honest but we don't have any indication that this has been happening and anyone who thinks the process is just a large pharma company waving money at doctors to buy silence really needs to learn how cut-throat academic competition is — the career benefits to being the first to report that plot would be huge! Remember also that this happens in many different countries around the world so that hypothetical conspiracy needs to be kept secrete by a multinational group of hundreds or even thousands of people.
Due to public pressure, the FDA reconvened to take another look.
While the FDA did not change its opinion (except for requesting some additional labeling and studies) the effect was disastrous for marketing. Sales plummeted. And, it was no longer worthwhile to pursue. The ‘official act’ of the FDA reconvening arose solely due to pressure.
That’s my point.
If anti-vax groups can cause the FDA to “take another look” at a drug that has already passed muster, it is obvious and not fairly deniable that the agency is not immune to political pressure.
Yet some HN posters seem to think the organization exists to protect us from skeptics.
What a twisted view.
All these "steps in the process" are completely meaningless when there is a revolving door with big pharma and FDA. This is nothing more than safety/peer-review theater.
Example: Scott Gottlieb FDA commissioner 2017-2019, currently sits on the board of directors at Pfizer.
Are you really going to put up a stink and fight on an approval if the end goal is cushy job at one of these companies? You can bet if you just "push it through" you will be looked on favorably for one of these jobs, but if you put up resistance and actually want to do due diligence, well then you will never be considered.
"It is difficult to get a man to understand something when his salary depends upon his not understanding it." - Upton Sinclair
https://www.sciencedirect.com/science/article/pii/S0264410X0...
> An adjuvanted recombinant vaccine (LYMErix™) has been approved in the United States for the prevention of Lyme disease in adults, and has demonstrated both safety and efficacy. A clinical trial of over 10 000 adults showed 76% efficacy following the third dose of a 0, 1, 12 schedule. Accelerated schedules demonstrate equivalent levels of protective antibody. Up to 100% of children 2–14 years of age achieve seroprotective levels of antibody. Booster doses induced protective levels of antibody in more than 96% of recipients when administered at months 12 and 24. Only mild or moderate, transient vaccine-associated adverse events have been reported after immunization. The vaccine is a safe and effective method of preventing Lyme disease.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/
> The OspA vaccines proved effective in animal models and safe in human volunteers [18]. Both manufacturers conducted clinical trials in a race to gain the first license for their vaccine [19, 20]. In the LYMErix™ phase III safety and efficacy trial, researchers enrolled 10 906 subjects between 15 and 70 years old who lived in endemic areas and randomized them to receive either the three-dose Lyme vaccine regimen or placebo injections. Vaccinated individuals showed a 76% reduction in Lyme disease in the year following vaccination [20], with no significant side-effects noted. Based on these promising findings, the U.S. Food and Drug Administration (FDA) approved LYMErix™ on 21 December 1998.
Do you not understand the FDA approval process? Or do you not understand how to Google that question yourself? Or is it something else?
Seriously. What possessed you to create an account to challenge this comment without doing any research at all, yourself?
There are industrial-grade chemicals fully FDA approved for ingestion by the US populace which are outright banned by various European countries.
That's a real high quality contribution there.
It's the kind of thing that's made HN so... different... over the last year (or four)
You think so? I thought it was the youthful boot-lickers and random "software developers" constantly marketing their "web apps". Also, feel free to express your emotions, I feel that you may be hiding your true feelings with that word - "different". It seems you don't feel the same, but I'm not concerned about quality of "contributions" on a random message board on the internet...I'm just having a random conversation with random strange strangers. It seems you've held the HN board at as high of a pedestal as the FDA approval process (but perhaps I'm projecting).
Not sure what your argument is though? You don't like the term fuck-all (sorry, English is not my native tongue), or you don't understand that the FDA process is ementhal-cheese-like by comparison to European standards?
Go easy on the arrogance over substance.
What's the under-reporting multiplier? Why would anyone except for those affected, or god forbid, their families pursue and report bad events?
Just extra paperwork for no or little money.
But in this case, the facts are on the table. There is no scientific basis in pulling the vaccine from the market. But there was enough propaganda to stoke so much fear that everybody got scared and that was that.
Yeah, me too. I got Lyme's (in my backyard) and just finished up my treatment a few days ago (only 10 days of doxycycline). I had the rash, but now I'm concerned that some infections don't show one. I'd jump at a vaccine in a heartbeat.