06 March 2026
Thought For The Day - 6 March 2026
Now that BLS has told the truth: Ayatollah 49% Don©'s self-aggrandizing bullshit has put the employment situation in the toilet, 92,000 job loss. He He He. Will the current (interim) director, William J. Wiatrowski get fired, too?
Reefer Madness
It was back in 1936 when "Reefer Madness" was produced. Now we have the modern version: "FDA Madness". Under the misdirection of Prince Bobby, it's a gang that can't shoot straight.
One of the latest fiascos is about Huntington's Disease. If you're an Olde Folkie, you surely know of Arlo Guthrie and "Alice's Restaurant" who was exempted from Vietnam because of the littering offense told in the song. Bet he didn't know that would happen. His father Woody, had (what was then called) Huntington's Chorea. Woody died in 1967. It is progressive and fatal and is yet without therapy for the disease directly (some symptom therapies exist). Two of Woody's daughters died of it. His mother died of it, from whom he inherited the disease.
It is classified as a Rare Disease, and FDA, at least titularly, has recently loosened the requirements on therapies for Rare Disease. uniQure is a drug company in the Netherlands and previously in Lexington, MA which has been developing a gene therapy. They recently published the results of a trial of the therapy, and claimed that the therapy reduced disease progression by 75% after 3 years.
Enthusiasm reigned and the stock price soared. Then FDA went on the warpath against both the therapy and the company. Now, the WSJ has a report, anonymously sourced, that FDA calls uniQure liars and the therapy worthless. Being the WSJ, one must be subscribed to read it up.
The sticking point is simple: uniQure claims it has, in writing, approval for the trial while this FDA source claims that it never gave its approval and requires a (double?) blind, placebo controlled study for approval. Even before the recent 'loosening' of Rare Disease study requirements, given the small patient population typical of Rare Disease, running such trials is difficult; small patient pool and reluctance to take the chance of NOT getting the therapy. Moreover, in fatal diseases with no other therapy, is it ethical to demand standard structure trials? Mayhaps not.
The Fierce Biotech report mentions other Rare Disease
As I was typing this out, the wonderful Adam Feuerstein made (a free!!) account of the fiasco available at STAT. Enjoy.
One of the latest fiascos is about Huntington's Disease. If you're an Olde Folkie, you surely know of Arlo Guthrie and "Alice's Restaurant" who was exempted from Vietnam because of the littering offense told in the song. Bet he didn't know that would happen. His father Woody, had (what was then called) Huntington's Chorea. Woody died in 1967. It is progressive and fatal and is yet without therapy for the disease directly (some symptom therapies exist). Two of Woody's daughters died of it. His mother died of it, from whom he inherited the disease.
It is classified as a Rare Disease, and FDA, at least titularly, has recently loosened the requirements on therapies for Rare Disease. uniQure is a drug company in the Netherlands and previously in Lexington, MA which has been developing a gene therapy. They recently published the results of a trial of the therapy, and claimed that the therapy reduced disease progression by 75% after 3 years.
Enthusiasm reigned and the stock price soared. Then FDA went on the warpath against both the therapy and the company. Now, the WSJ has a report, anonymously sourced, that FDA calls uniQure liars and the therapy worthless. Being the WSJ, one must be subscribed to read it up.
Federal Health Officials Attack Rare-Disease Drug, Say Company LiedFortunately, Fierce Biotech has a report which covers the main points of the battle betwixt uniQure and FDA.
The sticking point is simple: uniQure claims it has, in writing, approval for the trial while this FDA source claims that it never gave its approval and requires a (double?) blind, placebo controlled study for approval. Even before the recent 'loosening' of Rare Disease study requirements, given the small patient population typical of Rare Disease, running such trials is difficult; small patient pool and reluctance to take the chance of NOT getting the therapy. Moreover, in fatal diseases with no other therapy, is it ethical to demand standard structure trials? Mayhaps not.
The Fierce Biotech report mentions other Rare Disease
"Moreover, FDA, as a general rule, never makes such assurances. FDA will always say, 'Well, we have to see the data when we get it.'"And that's, at best, a half truth. There are discussions with FDA about trial design as a matter of course. FDA has a separate, formal approach, called a Special Protocol Assessment. It's a semi-fixed agreement on the conduct of a trial, however FDA has been known to toss out an SPA if they change their mind.
As I was typing this out, the wonderful Adam Feuerstein made (a free!!) account of the fiasco available at STAT. Enjoy.
05 March 2026
The Totally Unhinged - part the third
It's considered bad form to begin an essay with "I...", so let's just say that I'm not surprised by the latest episode of the Totally Unhinged. Absolutely fucking predictable. When you're dealing with a degenerate psychopath, expect the most Unhinged.
And, by the bye, the two previous Supreme Leaders were chosen by a rotating council of 88. Kind of like our Electoral College. Ooops.
One might expect that Ayatollah 49% Don© will, eventually, come around to demanding that Shah, Jr. be the New Dictator. After all, Shah Sr. was such a good fit with the oil and gas oligarchy.
And, of course, if the mullahs demur, Ayatollah 49% Don© can just blow them up, too.
I don't know... what's the Islam for chutzpah?
President Trump said on Thursday that he should have a say in choosing Iran's new leader, in the most explicit statement he has made yet about his vision of the U.S. role in creating a new government in Tehran.The NYT report references an Axios report which states
President Trump told Axios in an interview Thursday that he needs to be personally involved in selecting Iran's next leader — just as he was in Venezuela.It would be one thing to assert that the USofA, working/negotiating with Iran's appointing mullahs should have some input, given that we blew up Dear Leader, and apparently, the second and third tier Ayatollah 49% Don© choices. It's takes a boatload of chutzpah to demand his own self be the Decider.
And, by the bye, the two previous Supreme Leaders were chosen by a rotating council of 88. Kind of like our Electoral College. Ooops.
One might expect that Ayatollah 49% Don© will, eventually, come around to demanding that Shah, Jr. be the New Dictator. After all, Shah Sr. was such a good fit with the oil and gas oligarchy.
And, of course, if the mullahs demur, Ayatollah 49% Don© can just blow them up, too.
I don't know... what's the Islam for chutzpah?
02 March 2026
The Totally Unhinged - part the second
Anyone with a functioning brain knew that The United States of Alabama had entered a New Dark Ages with Ayatollah 49% Don©'s ascension to the Throne of Washington. The crowning of Prince Bobby at FDA was among the Unhinged appointments which led the way.
Now, the wonderful Adam Feuerstein posts a perfect example of Acts of The Totally Unhinged
What Feuerstein is referring to is FDA's two-faced behavior: really stupid DMD drugs get approved on lousy data, but Huntington's developers get cut no slack even with actionable data. For myself, I smell the rancid odor of Baksheesh.
Thank you Ayatollah 49% Don© for your attention to this matter.
Now, the wonderful Adam Feuerstein posts a perfect example of Acts of The Totally Unhinged
The Duchenne muscular dystrophy [DMD] patient & advocacy community keeps a gene therapy and multiple drugs on the US market, stopping the FDA from taking action, despite failed confirmatory clinical trials showing no efficacy and questionable safety.A bit of background. Under pressure from many patient/advocate communities to loosen up the approval process for rare and/or unmet needs, FDA did adopt some 'looser' regulations. DMD was among the recent cases where highly questionable drugs gained approval.
The Huntington's disease patient and advocacy community can't even persuade the FDA to allow a filing of a gene therapy, despite a positive clinical trial.
What Feuerstein is referring to is FDA's two-faced behavior: really stupid DMD drugs get approved on lousy data, but Huntington's developers get cut no slack even with actionable data. For myself, I smell the rancid odor of Baksheesh.
Thank you Ayatollah 49% Don© for your attention to this matter.
28 February 2026
Goldfinger
The Lamestream Media is all agog: what is Ayatollah 49% Don©'s point in starting a war with Iran? He of "Peace President" propaganda?
"Wag the Dog" is all you need to know. That was specifically about a sex scandal, and so today. But the reason specific to today is the Rich Guys' need to extract value from The Rest of Us. And, in this case, fossil fuels, Ayatollah 49% Don©'s major fixation. If the Strait of Hormuz gets really clogged, or essentially shut down... well Goldfinger didn't go to Fort Knox to steal the gold, but to leave it a radioactive dump for all time. In Ayatollah 49% Don©'s mind (such as a lower brain stem might be), the future is burning stuff. American based stuff becomes, thus, more valuable if other supplies are sequestered. Bank shot.
"Wag the Dog" is all you need to know. That was specifically about a sex scandal, and so today. But the reason specific to today is the Rich Guys' need to extract value from The Rest of Us. And, in this case, fossil fuels, Ayatollah 49% Don©'s major fixation. If the Strait of Hormuz gets really clogged, or essentially shut down... well Goldfinger didn't go to Fort Knox to steal the gold, but to leave it a radioactive dump for all time. In Ayatollah 49% Don©'s mind (such as a lower brain stem might be), the future is burning stuff. American based stuff becomes, thus, more valuable if other supplies are sequestered. Bank shot.
Thought For The Day - 28 February 2026
The MAGA crowd, at least some, are having their ultimate wet dream, Middle East episode: Iran run by Shah Jr. For those not up on the history, Shah Sr. was installed by a CIA led coup which threw out a democratically elected leader, Mosaddegh. As always, the Big Guys That Matter just want the natural resources.
The cradle of democracy. My flat ass.
The cradle of democracy. My flat ass.
27 February 2026
Kill All The Workers - part the second [update, yeah didn't take long]
In episode 1 was discussed the Wet Dream Supreme of the capitalist class wrt AI: send labour productivity through the roof, and keep all the attendant growth to themselves. None for the working classes.
Now comes new reporting on the declining birthrate. Ya know, The Musk Ox's present diatribe. Turns out, according to the report, that it's the dirty Redneck women who are opting out. All those college educated wimins keep popping them out. Who wooda thunk it? Anyone with a brain. Across the board, the main reason to have fewer (or no) little brats is the cost (short and long term). Ya cain't afford a Benz? May be ya cain't afford a drooler.
Such an economy, and its adherents, ought to thank all those young lower class wimins for doing the hard part: reducing the number of future idlers and welfare queens. I mean, if the under class DID keep breeding like rabbits, and still got Uncle Sugar's support and Medicaid and the like, the Right Wingnut Stasi would have much larger kill quotas each year. I mean, does the United States of Alabama really need more banjo picking albinos?
[update]
That didn't take long. Block (nee, Square) just axed 40% of its workers. White collar folk. Educated folk. We're all disposable now. Stop making more of us!!!!!
Now comes new reporting on the declining birthrate. Ya know, The Musk Ox's present diatribe. Turns out, according to the report, that it's the dirty Redneck women who are opting out. All those college educated wimins keep popping them out. Who wooda thunk it? Anyone with a brain. Across the board, the main reason to have fewer (or no) little brats is the cost (short and long term). Ya cain't afford a Benz? May be ya cain't afford a drooler.
[R]esearchers found that teenagers and white women ages 20 to 24 without a bachelor's degree accounted for over half of the drop. College-educated women accounted for another 18 percent.BTW, the same aspect is true of abortion: it's mostly married wimins with more than enough brats to suit them, thank you very much.
"One of the main reasons people report wanting to have an abortion is so they can be a better parent to the kids they already have," Professor Upadhyay says.What's especially stupid about The Musk Ox and his ilk: they are all foaming at the mouth to get the bestest worker killing AI that there is. Of course, that only works for one, or may be two, such. At scale, The Musk Ox and his ilk will kill the economy. Eccles was right. What Eccles didn't forsee is a top heavy service economy which caters to the 1%. Much less an economy that does nothing else. Who needs a proletariat?
Such an economy, and its adherents, ought to thank all those young lower class wimins for doing the hard part: reducing the number of future idlers and welfare queens. I mean, if the under class DID keep breeding like rabbits, and still got Uncle Sugar's support and Medicaid and the like, the Right Wingnut Stasi would have much larger kill quotas each year. I mean, does the United States of Alabama really need more banjo picking albinos?
[update]
That didn't take long. Block (nee, Square) just axed 40% of its workers. White collar folk. Educated folk. We're all disposable now. Stop making more of us!!!!!
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