Decorum

Very long time readers may recall references to Bermuda in these musings. That trip, by boat I may add, was before these missives began. But I've been on the email listserve of "The Royal Gazette" since then. Today is one of the few times I've felt the compulsion to share. It seems that the Attorney General of that Overseas Territory went ballistic in court. How very UnBritish.

"The Royal Gazette" asked the Bermuda Police Service if police were called to the court and a spokesman said: "On Tuesday, October 15, 2024, an officer assisted with a minor incident at the courts that was quickly resolved and did not require any further police action. There will be no further comment made."

Imagine if Bill Barr had blown his top? Well... crickets from the back benchers. Merrick Garland? The world is coming to an end.

By The Numbers - part the seventy fourth

For some years, all of them while I've been keeping track, the pharma bulls have bitched and moaned about the onerous steeplechase that has to be navigated to get these wonderful (new, occasionally) drugs approved. About 3 decades ago, FDA more or less caved to this bitching, and created a less onerous track called, as one might expect, accelerated approval. The gig was that if a drug had stat sig (mostly), clinically meaningful (mostly) benefit before doing a PIII trial(s), and (mostly) targeted an unmet need in the population, then the drug could be sold. The gotcha was that this was a conditional approval, requiring a full-blooded PIII trial post-approval.

The cynical among us (raises hand, very high) found this regime ripe for gaming. And so it has been. Today's Derek Lowe post reviews a rigorous study of these accelerated approvals in oncology. It ain't a pretty sight. In fact, recently FDA now requires that the all-important full-blooded PIII be underway before the accelerated approval can be granted; fobbing off the PIII has not been as rare as hen's teeth.

But the trends in these oncology trials are worth noting: the failure rates of the traditional Phase III oncology trials have been gradually falling over this period (with an overall Phase III failure rate of about 41%, but currently at 34%), whereas the confirmatory post-marketing Phase III oncology trial failure rates have been increasing in recent years, from around 14% during the 1992-2015 period to 33% in 2016-2023.

Conmen will con.

And, it's worth knowing that truly good new drugs don't have to complete a PIII. If the sponsor really, really believes that New Drug X is better than high button shoes, then the sponsor has the option to schedule (not make up as the trial goes along; mostly) interim analysis. It's a bit more convoluted than simply doing the same arithmetic that gets done with the full data set after all patients have been run through the trial; the stat requirements are a tad more stringent. If New Drug X meets the stat requirements, and FDA agrees with the trial data, then New Drug X will get standard approval before trialing all patients. But, as I say, if the sponsor really, really believes in New Drug X, then such is the more ethical avenue.

One might wonder how much worse the situation is in the CNS world. Alzheimer's strikes a familiar note. If you watch carefully on the teeVee, the mood altering compounds display some less than stellar efficacy in the fleeting, tiny print at the end of the advert.

Here's another report in that same space.

End of the Hype?

Well... it did have to happen, and may be it has. ASML has tanked bigly, stock market wise. As I type, it's down $180 from Monday's close and bouncing up a little and down a bit more. Seems that demand for their bottleneck machines is predicted, by them, to wane going forward. The AI chipmakers are collateral damage. May be the AI fever has broken? One hopes so.

Captain Obvious

Well, today's gobsmacking revelation just popped up on CNN

"The biggest single, best predictor of how someone's going to vote in American politics now is education level. That is now the new fault line in American politics," Sosnik told David Chalian on the "CNN Political Briefing" podcast.

I've never heard of Sosnik, but if he really, really believes this is "now", he's an idiot. Smart people, at least 99.44% of them, vote liberal/progressive/pussy today and since the beginning of the Republic. In order to keep control in the hands of the dirty boot idiots, we get the Electoral College and 3/5 and so on. FDR gave so much to pull the dirty boot idiots out of the muck that they think they pulled themselves up by their bootstraps, and immigrants and Jews and Negroes and HighSpanics are taking it all away.

As the topic has arisen in these essays over time, the cause has been since the beginning of the Republic: the dirty boot folk have always elected politicians who do all they can to keep them in dirty boots; sick, poor, and uneducated.

Which brings us to the only reason to question immigration from the shithole countries: such countries are (nearly?) all dictatorships, and have been for generations and even the escapees are enured to such treatment. The MAGAnauts ought to be welcoming them with open arms. Why do you think that the Central and South American immigrants tilt toward The Orange Shitgibbon^©anon.? He's what they know.

By The Numbers - part the seventy third

Well, I suppose it had to happen. The anti-vaxx crowd has organized and exploded. This report in the NYT (there are myriad others) makes the lunatics obvious. And gives them publicity they probably shouldn't get. Be that as it may.

It's the No Nothing Party gone beserk. They really do want to party like it's 1829. If the mRNA vaccines, not to mention the decades old childhood vaccines (not mRNA), were turning people into vegetables and the like, you'd think there'd be widespread reporting on such. Fox and Newsmax and such. Crickets.

Number of jabs of Covid mRNA in the USofA: 677 million. Of that total, aprox. 83,000 are Novavax, a 'traditional' type.

So, with all that mRNA circulating in the blood of witless Americans, you'd expect to see some instances of mRNA's perniciousness. Crickets. Yes, there are some rare cases. Here's the real skinny (if you believe in science): non-trivial side effects are about a handful per million doses, and occur in otherwise healthy young-uns.

Here's the CDC report on incidence of myocarditis deaths. Of course, the MAHA cabal will insist in roaring voice, that CDC/FDA/space lasers from Mars are conspiring to keep the gullible on the verge of death. No one was found to have been killed by mRNA caused myocarditis. Zero.

But, that's not the Big Kahuna of the MAHA crowd. The Big Kahuna is that mRNA, however administered or why, alters DNA of the patient. Um, nope. And, btw, Nebraska isn't a hotbed of Leftist elite.

The lunatic fringe, on a revenge ride like the surviving Earps, will wreak havoc and death to the USofA. Be careful who you vote for.

Junk Yard

Commie Law and the Junk Yard Dog^© is a recent title. The latter is Walz, of course. His latest contretemps is the call to get rid of the Electoral College. The sort of bomb throwing one expects from the Junk Yard Dog. Not quite on the level of MTG's assertion that Sleepy Joe and Commie Law have been engineering hurricanes to devastate Red Counties just before the election. Get the hell out of Hurricane Alley. Blowback has ensued.

Today brings new reporting of backpedaling. Ah well.

But the notion boils down to the simple choice: do you want a Damn Gummint run by chucklehead hillbillies? They'll steal all the moolah from the Rest of Us to pay for living in Tornado Alley, Hurricane Alley, filthy Hollers, and any Desert they can find (with myriad water guzzling golf courses, of course; water supplied by the Great Lakes). And insisting that Earth is 6,000 years old and must be taught to first graders. Who don't get lethal vaccinations, of course.

Sleepy Joe squeaked out an EC win, but with 7,059,526 more total votes than Alzheimer's Ronnie, II. Covfefe!

The EC was created for the same reason as the 3/5 thing: to bring along the slave states, and guarantee them more than one-man-one-vote. It's right up their with the rule for deciding a tied EC: the House votes the President, but not on the House seat count, but by states, which just happen to be more MAGA. That's quite a catch, that Catch 22.

By The Numbers - part the seventy second [update]

Well... it's been clear for some decades that Big Time college sport, first football then basketball, were merely instructional leagues for the pros. Now the bandaid of "amateurism" has been ripped off. What's the over/under on years until Big Time college sports no longer require any classes for Big Time college athletes?

[A] group led by former Disney executives-turned-investment professionals has proposed a 70-team super league featuring schools from the four power conferences that would infuse up to $9 billion in private capital cash into the sport.

What's that olde saw? "I went to a fight and a hockey game broke out". I went to a football game, and no one went to class.

I wouldn't find it quite so repulsive if at least some, preferably mostly, of those billions went into the academic functions of the schools. And, if memory serves, a lot of Big Time college sports (in the Red states, most) are state schools. Reminds me of those speed traps in the small town Red South. [update... didn't take long, did it?] Well, the bet is off, mostly. It's already here. Color me Shocked!! Shocked I say!!!

Last April, near the end of his third semester on campus, Sanders attended an in-person class for the first time. It was filmed for his social media accounts.