moleculo
Footballguy
moleculo said:I'm going to assume that this isn't what the twitterer thinks it is.Insein said:Data starting to trickle out now.
9 pages of known side effects.
https://twitter.com/TheMFingCOO/status/1498714453214474246?t=-Rg-XETPgJHy6O6BYOCCUQ&s=19
Insein said:I assume he thinks it's "List of Adverse Events of Special Interest." Since that's the title of the appendix. Is there a code to decipher here we're missing?
from the twitter stream, linked above:
https://twitter.com/ENirenberg/status/1498852915758485509?s=20&t=Mco2vEpfXMVRtQFAvs2pdQ
We need to get some definitions out of the way or we won't get anywhere (this is dry- sorry). I'll limit this to important ones from the abbreviations.
Adverse events (AEs) do not mean what you (probably) think they do. AEs ≠ side effects.
https://fda.gov/media/93884/download
AEs are monitored regardless of whether you get the active agent or the placebo in a trial, and that information may be reported in e.g. package inserts. E.g. Gardasil has a report on its package insert of gunshot wounds as an AE. Need I explain that it doesn't cause them?
In many clinical trial designs, there is blinding, so you don't know in advance whether or not you get placebo or active agent so you monitor everyone. Additionally, the placebo group helps you to see what is normal for similar people at similar times in similar places.
Formally, what most people think of as a side effect is more properly described as an adverse drug reaction (ADR), and for formal purposes the term "side effect" is best avoided altogether: https://ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-15.pdf… However, it can be very hard to tease apart what is AE vs. ADR.
AEs can be classified as serious or non-serious. These also have very specific definitions. There is also the term "life-threatening adverse event" which has a very specific meaning.
"AE of special interest" is a term that appears here (commonly abbreviated AESI). These are literally just adverse events that it's just especially important to track or monitor. That could be because they're serious, because of something about how the drug works...
or how related drugs work, or because of how significant it is as a problem. If an AESI occurs, the sponsor (the pharmaceutical company paying for the trial) generally needs to be alerted of it rapidly. https://cioms.ch/wp-content/uploads/2017/01/Mgment_Safety_Info.pdf
AESIs get specified in protocols, generally before the trial has even begun, although protocols can be amended to include new AESIs as data emerges. In other words, that big scary list in Appendix 1 that people are claiming are side effects of the Pfizer vaccine? Blatant lie.
That list alone tells us nothing about whether or not any of those things happened to anyone in the dataset. They are just things Pfizer wrote in the protocol to be watched for as AESIs. Now, onto the data: