What I still can't wrap my head around is that they vaccinated the control group after less than a year <i>and got away with it</i>. Here we are, with a novel coronavirus, a novel vaccine technology and a novel vaccine, and we can't even do a 2 year longterm study.<p>> "During that visit we discussed the options, which included staying in the study without the vaccine," he says, "and amazingly there were people — a couple of people — who chose that." He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.<p><a href="https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni" rel="nofollow">https://www.npr.org/sections/health-shots/2021/02/19/9691430...</a>
Why are we suddenly pretending that the same industry that gave us the opioid crisis (in addition to dozens of other serious unethical practices for which they've been sued) is suddenly above shady research and massaging of results? Particularly when they have been legally absolved of liability and stand to gain tens-hundreds of billions of dollars?<p>It doesn't take a conspiracy. Just a little pressure from upper management. People don't want to lose their jobs and usually the way these things go only a handful of employees are actually involved in fraud while the rest are unaware or look the other way when confronted with suspicious circumstances.<p>This pandemic is not an excuse to give pharmaceutical companies the free reign to rake in cash with no accountability. And that accountability comes not just from government, but from laypeople too. It took five years to discover that thalidomide was causing severe birth defects in children, and the covid vaccines are based on an untested technology. I'm not being "anti-vaxx" here, just trying to offer up some common sense: when money is involved, there is no limit to what executives and unscrupulous employees are willing to do if they think they can get away with it. And in a complex system with so many moving parts, a handful of seemingly innocuous violations of good practices can combine to produce a serious outcome.<p>We should all be far more critical of this entire rushed process, especially in light of not just financial but political pressure to produce evidence of a working vaccine.<p>Edit: I didn't even bring up regulatory capture that we've also suddenly forgotten all about. The former FDA commissioner is on Pfizer's board of directors. As is the CEO of Reuters. Our economic system is ethically sick, the pandemic did not suddenly fix it.
The alleged issues apply to only a small subset of the clinical sites/volunteers in the trial:<p><i>> In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres.</i><p>Ventavia looks sketchy, but this affects 1/44th of the patients and 3/153 of the sites. There's nothing to suggest they fudged the numbers in Pfizer's favor either, only that they were sloppy.
> <i>Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial</i>
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