The news about the J&J vaccine causing blood clots in something like six women between 18 and 48 out of close to seven million people vaccinated naturally caught my ear and prompted my inner systems engineer to say something like, "WTF does that mean?" Naturally everywhere you go, you come across people essentially saying, "well, if they're telling you it's six you'd be an idiot to think the real number isn't much more." That's the kind of thinking that there's just no way to deal with if you want to deal with numbers and risk assessment quantitatively.
I'm big on evidence; actual data. I live by the axiom that half a measurement is better than none, and it has been in most of my home radio projects over the years. I've improved the test equipment to make the measurements better, but I'm resigned that I won't have the measurement quality I had when I was working with test equipment sent for calibration every six months and that cost well into 5 or 6 figures!
It just leads to some thoughts; thinking about the limits of the situation, better known as "bounding the problem." Of course, six out of nearly seven million is less than a 1.0 part per million (ppm) risk. One of those patients died or 0.15ppm. My first thought is that I wonder how many other drugs out there have a risk of serious side effects that's greater than one part per million? Second thought, on any given summer day in Florida, your chance of dying by lightning strike is probably greater than 1 ppm. Maybe that's too me-centered, but I live in Florida. Third thought: the demographic is odd. All six were women under 50? Is that due to something else they had in common or that women are more likely to get clots or just what? I've known one 21 year old woman who had a nearly fatal blood clot from birth control pills (I was 18 at the time), and I understand it's not an uncommon side effect. In other words, is this observation even relevant to a post-menopausal woman or any age man?
Back at the end of December, and then again in mid-January, I posted stories that centered on the fact that the FDA has a predictable bias in their decision making. The stories were both that vaccines were being delayed by the FDA's decision making processes which have a bias toward avoiding what are called Type 1 errors, to approve a bad drug, at likely cost of increasing the number of Type 2 errors, which is failing to approve a good drug. In the type 1 error, they approve a bad drug and a large number of people are harmed. Even worse, from the FDA bureaucrat's perspective, is they're more likely to be called in front of an investigation board. In the type 2 error, they block a good drug and there are people that are harmed as well, but those people are invisible. "Too bad your relative died because there was no drug for their condition!"
The question to ask is which decision is best for the largest number of people. The FDA has shown over and over, for years, their default is to block the probably good drug in an effort to not allow a bad drug on the market.
My attitude toward the vaccines remains that if you're not in a particular risk group, the risk of the vaccines appears to be the same order of magnitude as the virus itself. That means your best chance at long lasting immunity to it is by getting infected and surviving. As always, I'm just some dood on the intertubes and if you're dumb enough to take my advice, there's just no telling what will happen to you!
I have two little pieces of space news to pass on, First Elon Musk has said their goal is to launch SN15 next week. That's being taken to mean static firing on Monday, for what it's worth.
The next manned mission to the ISS leaving from American soil will be the Crew-2 mission, currently planned no earlier than 6:11 am EDT (10:11 UTC) on Thursday, April 22nd. This mission will be the first time that NASA astronauts have flown on a reused booster. The Crew Dragon spacecraft itself is the one flown in May of '20 by Bob Behnken and Doug Hurley, so it's reused as well.
I'm big on evidence; actual data. I live by the axiom that half a measurement is better than none, and it has been in most of my home radio projects over the years. I've improved the test equipment to make the measurements better, but I'm resigned that I won't have the measurement quality I had when I was working with test equipment sent for calibration every six months and that cost well into 5 or 6 figures!
It just leads to some thoughts; thinking about the limits of the situation, better known as "bounding the problem." Of course, six out of nearly seven million is less than a 1.0 part per million (ppm) risk. One of those patients died or 0.15ppm. My first thought is that I wonder how many other drugs out there have a risk of serious side effects that's greater than one part per million? Second thought, on any given summer day in Florida, your chance of dying by lightning strike is probably greater than 1 ppm. Maybe that's too me-centered, but I live in Florida. Third thought: the demographic is odd. All six were women under 50? Is that due to something else they had in common or that women are more likely to get clots or just what? I've known one 21 year old woman who had a nearly fatal blood clot from birth control pills (I was 18 at the time), and I understand it's not an uncommon side effect. In other words, is this observation even relevant to a post-menopausal woman or any age man?
Back at the end of December, and then again in mid-January, I posted stories that centered on the fact that the FDA has a predictable bias in their decision making. The stories were both that vaccines were being delayed by the FDA's decision making processes which have a bias toward avoiding what are called Type 1 errors, to approve a bad drug, at likely cost of increasing the number of Type 2 errors, which is failing to approve a good drug. In the type 1 error, they approve a bad drug and a large number of people are harmed. Even worse, from the FDA bureaucrat's perspective, is they're more likely to be called in front of an investigation board. In the type 2 error, they block a good drug and there are people that are harmed as well, but those people are invisible. "Too bad your relative died because there was no drug for their condition!"
The question to ask is which decision is best for the largest number of people. The FDA has shown over and over, for years, their default is to block the probably good drug in an effort to not allow a bad drug on the market.
My attitude toward the vaccines remains that if you're not in a particular risk group, the risk of the vaccines appears to be the same order of magnitude as the virus itself. That means your best chance at long lasting immunity to it is by getting infected and surviving. As always, I'm just some dood on the intertubes and if you're dumb enough to take my advice, there's just no telling what will happen to you!
I have two little pieces of space news to pass on, First Elon Musk has said their goal is to launch SN15 next week. That's being taken to mean static firing on Monday, for what it's worth.
The next manned mission to the ISS leaving from American soil will be the Crew-2 mission, currently planned no earlier than 6:11 am EDT (10:11 UTC) on Thursday, April 22nd. This mission will be the first time that NASA astronauts have flown on a reused booster. The Crew Dragon spacecraft itself is the one flown in May of '20 by Bob Behnken and Doug Hurley, so it's reused as well.
Had a friend who was a bank regulator for the Feds. The only way he could get in real trouble?
ReplyDeleteActually try to make big banks follow the rules.
Now he's a banker.
That revolving door between regulatory agency and the things they regulate is another thing that needs to be shut down.
DeleteA simple law like a mandatory number of years between going to/from the regulatory agency and the regulated places. Maybe 40?
Good idea. Maybe even 60. And horsewhip you if you are a consultant.
DeleteHow many people have bad reactions to flu shots every year? Nobody is asking that question because there is a reluctance to conflate the plague with the flu. I'm not pro-vax. I'm up to letting people make decisions for themselves. I think that's hate speech these days.
ReplyDeleteI’m kind of wondering about the six women’s deaths and I point out that the ages are generally the childbearing age span. So it just pure conjecture on my part but there might be a common reactive agent if all six women were taking birth control at the time of vaccination.
ReplyDeleteEVERYTHING about COVID-19 is about keeping people in fear and controlling them. I worked numbers when I was in industry. Chances of something bad happening being 1 in 1,000,000 are a good thing. Not good to that one though that it happens to but we can't shut down the World based on those numbers.
ReplyDeleteSG As pertaining to RF,I thought of you when I read this. https://spectrum.ieee.org/tech-talk/aerospace/military/fcc-shoot-down-drones.
ReplyDeleteTeX
That's pretty freaking amazing.
DeleteThe opening story with a "high power microwave device" at 270 MILLION watts is mind blowing. It must be very narrow pulses because they quote someone saying it's harmless to humans because the heating is so low. I'd need to look at real specs for that.
Interesting the FCC's answer to all them is pretty much "you applied to the wrong agency; we're not allowed to authorize systems like this."
Heres another off subject tidbit from IEEE Spectrum readers might find interesting.
ReplyDelete“The great light bulb conspiracy”
https://spectrum.ieee.org/tech-history/dawn-of-electronics/the-great-lightbulb-conspiracy