Biden Day 1, Extraordinary Evidence

Random bits

Michigan beat Maryland handily yesterday (19 January 2021) in basketball.  The Michigan Women's basketball team is also a top 10 team and currently undefeated.  Go Blue.

I worked less than 10 hours today, but it was still a long day.  

Biden Inauguration

This evening I watched the presidential election and it was struck by what a different vision of the United States it was.  The only positive about the 'rona is that the evening broadcast was it allowed for a highly polished virtual celebration in the evening.  My son probably could see the fireworks in DC, so I am a bit jealous about that.  The production was very much in line with the Democratic convention but smoother and more studded with A list stars.   I would not be surprised to see this repeated in the future.

This Digby's Hullabaloo post a nice piecing together of key snippets of the actual inauguration.  The Amanda Gorman poem was my favorite part.

The evening "concert" is such a different vision of America than the January 6th siege crowd that it is hard to think they co-exist ... if we did not all know a Qanon fan boy or girl and realize that Fox probably didn't cover it at all.

Extraordinary Evidence

In the run up to 2016 my brother-in-law's wife's father, an evangelical, trying to get into a discussion about the secret cabal controlling everything.  It was straight up Protocol of the Elder's of Zion stuff (racist hate-justifying bunk).  Given his age I tried to basically say I did not really for that kind of conspiracy theory stuff and we have not spoken too much since then.  Suffice to day he believed that "Trump was going to be a game changer."   Admittedly, he was right about that. 

To the old man's point, I did posit that there was also the impact of money and control of the media that did give people a lot of control of the narrative which allowed them to control people's beliefs.  I had in mind Fox and the highly funded bubble it had created; and how that provided enormous control of people's beliefs.  The January 6th coup attempt was the ultimate metastasis of the the right wing bubble.  The US may yet fall to a right wing fascist regime, but it was averted for now.

The Qanon stuff is one I've never quite understood. In the beginning Fox very craftily shaped the narrative about what was going on and intermixed it with factual reporting.  That selective reporting and messaging about intent is very potent. On the surface, the Qanon conspiracy requires accepting very extreme beliefs that are pretty out of the range of common sense explanations of events.  When I hear those kind of things, my first reaction the easiest explanation is usually the correct one.  Common sense frequently rules - even in complex modeling situations.  It always brings back Carl Sagan's position on aliens:  extraordinary claims require extraordinary evidence.   Show me a captured Bigfoot, show me live alien, otherwise kindly don't try to kill me or people like me.  Find a better hobby.

After Trump won, I was asked what I thought about Trump.  It was January 2016 and I said, Trump is a destroyer.  HIs gig is contradicting everyone else, lying, and seizing on the fact that most people are not used to dealing with that all of the time.   Of course, I also had a boss that did the same stuff and I was forced to quit my job to get away from it.  I was proven profoundly correct.  

I did get a "smart" response that "sometimes you have to destroy stuff to make it better."

I guess that could be true if the problem is a group of people trying to overthrow the government in a coup who also believe in racial purity and killing everyone else.  

Our government is more like a bridge across a river that allows people to get together and supports all sorts of positive benefits.  If you destroy the bridge, all you are left with is nothing.  Terrorists blow up bridges.  Trump was really nothing more than a terrorist who spent 4 years trying to tear about our nation.   But, you watch enough Fox and Newsmax, and there you go.

Today was so much about the believing in a common good and the value a functional government.  Of course, I'd like to be hopeful, but much of the mechanics of the the last 30 years of the right have not changed just because Trump inspired extremists attempted a coup.  (Of course, there was no real Qanon seizure of power and Trump isn't some kind of secret genius spy.  You'd have to provide some pretty extraordinary evidence for that when a lying sociopathic grifter is the common sense explanation.  I'm pretty thankful for that since I'm a Democrat and I'd hate to be killed in part of some societal purge).  

But may be, just may be, we will see some discussions of policy and compromise in the coming year.  You know, the kind of thing you'd expect in a democracy.

Everyone stay safe.

PS - There was some talk about CA pulling a hold on a lot of Moderna COVID vaccines.  That seemed to disappear, but it was simultaneously good see epidemiologic principles of tracking in use and bad to hear about a potential issue with one of the vaccines.   I'll have to research it a bit more I guess. 

Howdy World

I hope everyone is doing well.  With some luck I managed to get the email back for this blogger account.  That makes 8 years.  A lot happens in 8 years... my last post was about Mitt Romney's 2012 campaign against Barack. 

It is a little bit like getting back in touch with a High School friend.   So much time has past that you can't help but be curious to see how they have fared.  

I analyze data for drug companies, devices, diagnostics, and similar such stuff.  I've been meaning to do this on Facebook, but I kind of  boycott Facebook because it is used to spread lies and hate messages for the profit of Mark Z.   So, ah, no.

So my public service work is to point out that when the FDA approves something it publishes a summary basis of approval or a summary of safety and effectiveness.  They have varying levels of details and often results will be included in the labeling materials for a product.  The FDA is kind of picky about what makes it into a label, so typically you can look for publications with the main study results for clinical trials.

The work done on clinical trials is regulated.  The study sites that participate in studies can be audited and sanctioned if they are not following rules well enough.  If you work on trials in the US, the government can show up and audit you.  If you happen to be involved in the analysis of data for a pivotal clinical trial for publicly traded company and it looks like there is suspicious trading, the government can ask you to share the names of everyone who knew the results before they become publicly shared.  I'll skip the other rules that are in place to make sure what the FDA is getting honest data and honestly reporting the results, but the point is ... the information the FDA is providing goes through a lot more vetting and rigorous protection than most of the stuff that shows up on the web.  Especially the dark web and internet chat boards.

In my work, I have worked on many approved products and in all of them the FDA's summary documents replicated the analyses tables that were provided to them.  There was never anything going on.  The same goes for publications in medical journals of the study results.

The Moderna Vaccine Emergency Use Authorization (EUA) is here.

Skip right to Page 20 - it covers the study disposition.  This covers the number of subjects who entered the study, were randomized, and if they completed the study.  This includes more than 30,000 subjects.  A per-protocol population was defined and included 27,000 subjects.  A per-protocol population typically excludes subjects who deviate from the planned study assessments in some significant way.

If you look at Page 29, the results of an interim analysis of the per-protocol population was completed.  This is interesting because the confirmed cases was quite low when in both arms (5 cases in 13,934 person years in the vaccine arm and 90 in 13,883 person years).  This surprised me as I expected the rates would be higher.  When Moderna reports a 94.5% vaccine efficacy they are talking about the reduction in this rate of cases).  The rate in person years is dependent upon exposure in the populations and the comparison assumes that people getting randomly exposed is similar in the groups.  Note this is a blinded trial, so participants will not know what they received.  

The final analysis was 11/13,914 and 185/13,883.   If you ever had a statistics class you will know a p-value is hovering around.  A p-value says how likely the relative difference is to occur by chance.  The p-value for this comparison was <0.0001.  That means the 11 vs 185 events would happen by chance is less than that 1 in 10,000.  Here is a link to a John Hopkins site that at mortality in COVID infected individuals.  Much of this appears higher than 1 in 100 in many countries.  Given that many people who are not symptomatic likely do not get tested, the actual mortality must be lower.  

Is it safe?  There are clearly more events and higher grade events when subjects were solicited for them and more injection site reactions.  Serious related events and deaths were similar in both arms, so from 30,000' it looks safe in terms of the most serious results by not without some additional risk of an event. Assessing risk benefit is something you should do with your doctor if you are concerned.

If you ever really want to find out for yourself what a drug, biologic or device looks like, start with fda. gov and work out from there.

Stay safe.