It's unclear what Prasad's FDA exit means, but some drug makers are happy to see him go.
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Trump’s divisive FDA vaccine regulator self-destructs, will exit agency (again)
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He won't be missed. Sadly, given this Administration's track record, whoever replaces him will probably, somehow, be worse.
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Can the company sue him for defamation if he claimed without evidence that the therapy data were distorted and manipulated?
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So you're saying we need him to be in this position as much as we need another hole in our head?
That is just WILD. Who would agree to that under any circumstances? That makes no sense ethically OR financially. One of those two is the language that these people speak so you'd think the right decision would be made if even for the wrong reasons.
That is just WILD. Who would agree to that under any circumstances? That makes no sense ethically OR financially. One of those two is the language that these people speak so you'd think the right decision would be made if even for the wrong reasons.
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The stream (if not a geyser) of MAGA orcs forced out of the government testifies to the resilience of the Federal government and the (mostly, cf. MAGA) democratic society that produced it for a quarter millennium. The republic part of that government now faces a long term project to excrete the rest of the MAGA injected into it. Since Trump has spent a year or so already (after his first 4 years) replacing the government workers he fired and agencies he dissolved with his own Deep State, that project is very challenging. But existential.
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The cruelty and destruction is the point of these corporate anarchists and their enemies of democracy sponsors. Finance is just a means to power.
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Having watched my grandfather and his father go through the degeneration of Parkinsons I have some idea of the level of desperation that accompanies a slowly progressing disease like this.
Using that desperation to get people to sign up for a trial in which they undergo major surgery with the knowledge they have a high probability of getting a placebo? That's movie villain levels of evil.
Using that desperation to get people to sign up for a trial in which they undergo major surgery with the knowledge they have a high probability of getting a placebo? That's movie villain levels of evil.
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ReadandShare
Wise, Aged Ars Veteran
ATTENTION: November 3, 2026 - Trash Pick Up Day!
[Edit - Date correction - thank you for the heads up - lurknomore!]
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Thanks for the follow-up, and an extra special thanks for not using a photograph of the brain surgery (sham or otherwise) that Prasad was demanding happen in a placebo arm.
It's really hilarious to watch various journalists walk around the obvious ethical conflicts that this sort of "press briefing" must have caused:
The obvious conclusion from these sentences, and those of others' articles, is that Prasad held a press briefing, and then "on background" or whatever just issued a bunch of highly defamatory claims about a treatment that he was personally reviewing.
Is there anybody appointed by Trump that isn't completely compromised and lacking in any moral character? This is just all so astounding. Even on the way out the door, Prasad couldn't keep it together enough to avoid some completely self-owning defamation. What a way to destroy your own reputation and future career. I hope he's about 10000x better a heme-onc than a regulator, but I doubt it.
It's really hilarious to watch various journalists walk around the obvious ethical conflicts that this sort of "press briefing" must have caused:
The obvious conclusion from these sentences, and those of others' articles, is that Prasad held a press briefing, and then "on background" or whatever just issued a bunch of highly defamatory claims about a treatment that he was personally reviewing.
Is there anybody appointed by Trump that isn't completely compromised and lacking in any moral character? This is just all so astounding. Even on the way out the door, Prasad couldn't keep it together enough to avoid some completely self-owning defamation. What a way to destroy your own reputation and future career. I hope he's about 10000x better a heme-onc than a regulator, but I doubt it.
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"I miss my podcast." Same nonsense we heard when the deputy FBI director left. Unserious people in roles of serious consequence making life worse for everyone. Trump's voters are the biggest idiots on the fucking planet.
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Placebo controlled requirements for a therapy that requires dangerous and invasive surgery to even do that treats an incurable degenerative neuronal disease is a level of disgusting evil that is just sickening, quite frankly.
I would argue that opinion alone should be justification to be hauled in front of his state's medical board for censure or other penalties.
I would argue that opinion alone should be justification to be hauled in front of his state's medical board for censure or other penalties.
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So much easier to sit around a bitch about things on their podcasts than actually having to do real work.
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No. Or at least it wouldn't work. The government would claim he's protected by the federal employee indemnification against personal lawsuits and intervene. The courts would have little choice but to accept that. All the government would have to do is claim a legitimate exercise of the political/regulatory process, "just asking questions", and it would be tossed out.
Distasteful? Yes, but the same legal arguments would protect any employee just doing their job in any hostile political environment, not just the most odious ones under Trump.
Even if they could get around the public employee indemnification, not only does the plaintiff have to prove the statements were deliberately inaccurate, they have to prove, because the companies are public entities*, that reputational harm was done by sheer malice not mere incompetence.
That's a lot harder to prove than it might appear. There's a great deal of sheer incompetence being promoted in the anti-vax/MAGA party line beyond the malicious trolling of the left by the general fan base. Incompetence is being actively rewarded, not because it's malicious per se, but because it meets up with the preconceived notions of the far right which can be equally attributed to incompetence, ignorance, and/or yes, maliciousness.
*Public entity in the legal defamation term - well known by the public, not being listed on a publicly traded exchange
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Probably goes without saying but to answer your question, no, there aren't.
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I’d generally consider that a major plus. To lose Loomer and still be a horror takes a special effort.
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That is for the main dumpster/bio hazard cleanup. But lots of places are having regular trash pickups well before then, some in the next few weeks.
https://ballotpedia.org/Elections_calendar
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Why does the article not mention that he was on a 1-year sabbatical as the original tweet said? This seems relevant to his decision to leave the FDA as planned by his sabbatical.
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Trump was told by his Russian masters acting on behalf of their Chinese owners* to destroy the United States from within, and he's doing a bang-up job of it.
* To explain that, Trump laundered Russian mob money through his businesses in the 1980s, selling his soul to them in the process. You don't bankrupt a company four times for legitimate reasons, after all. The Russian mob took over when the USSR fell and are in charge of Russia today, and they still own Trump's soul. They had to turn to the Chinese to help in their war in Ukraine (started because they wanted warm water ports for their exports and Ukrainian oligarch and mobsters didn't want Russian oligarch and mobsters horning in on their territories), and so with financial and/or material help from China, Russia stays in that battle by doing China's bidding against the US - a kind of proxy war between them and the US, but with aid from a treasonous administration instead of just one owned by the military-industrial complex.
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Please tell me the unnamed senior FDA official was wearing Groucho glasses for this briefing.
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So, up to now how many cures or slowed disease progressions have their been in Huntington's Disease? Is there any doubt as to the diagnosis? Is there a known disease progression? The answer to those three questions are as any modestly educated pharma researcher knows are 1. None. 2. A quick look at the HTT gene will provide an unequivocal diagnosis by measuring the size of the CAG repeats on both alleles. 3. The disease is remorseless and can be pretty accurately timed based on the size of the polyQ repeats. Anyone who does not get the sheer immorality of telling people who are going to die horribly (100% guaranteed) that you may be helping them, by adding the complications of drilling holes in their skull, and then doing fuck all, should never be allowed into the public sphere.
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Honestly it probably just takes being an immigrant (or child of immigrants), being non-christian or just non-evangelical, or being non-white. Vinay fits at least two of those categories, and a lack of performative public expressions of faith give a reasonable indicator where he falls in the third. He never stood a chance with her no matter how odious his beliefs.
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I’ve spent the last few hours thinking about who would be a good replacement. Multitasking I also ate some fried chicken.
The best person that could step right in and continue the history of excellence is…Dr. Phil.
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This really warps my head. I get that someone can give information on background, but I didn't think you could do a press conference on background. It's open to the press, so by it's nature not confidential. I don't get why the journalists there felt the need to kowtow to Prasad's demand that they don't name the senior agency official holding a press conference. Or give him background status so he can slander someone!
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I have not read about UnieQure’s product specifically, but I think people need to keep in mind that while sham surgery is invasive (but does not have to be nearly as invasive as some comments on here imply), there’s a massive need for better clinical trials when it comes to surgery (in general, not just for this treatment in particular) - yes, some may miss out on an effective treatment (and the added harm of sham surgery makes it that much more ethically challenging), but this presumes that the treatment is effective in the first place. Without conclusive studies, many, many, many more people might end up getting surgery and treatment that is completely or mostly ineffective with all the risk and costs that entails.
Lots of surgeries have over time been proven to be no better than placebo only when eventually comparisons with sham surgery was done. It’s ethically very uncomfortable, but the alternative (potentially treating many more patients with possibly entirely ineffectual treatments) is worse in my book.
In the case that UniQure is so effective that there can be no argument (like, say, penicillin in meningitis), I’ll be content to forego RCTs, though at least a non-blinded, not placebo controlled study would be prudent and pose no extra risk to patients.
I’m kinda adding to this as I read more, and UniQure already enrolled a cohort of sham surgery controls, and apparently they did not do statistically significantly different than the treatment groups. Meanwhile at 1 year they also received treatment and have since then only been compared to historical controls. I think that is a weak study design, and while there is definitely a humanitarian element to enrolling those patients into the treatment group, there can be no doubt that UniQure has a financial interest as well. Why include a 1-year long sham surgery cohort if elsewhere you’re gonna argue that this timeline is too short to provide a meaningful difference (https://www.fiercebiotech.com/biote...arly-approval-path-huntingtons-gene-therapy)?
I think this blog post gives a probably more coherent commentary on this than me: https://www.science.org/content/blog-post/unique-situation-uniqure
Either way, I don’t want to (and have no partially reason to) rail against UniQure (and there’s no love lost between Prasad and myself, I’ll add), but sham surgery should not be unfairly maligned, and I think it’s ethically necessary to strive for concrete evidence when introducing new products or procedures. Sometimes it’s a necessary evil.
There are massive financial interests at stake, and the moment something is on the market, it becomes standard of care and almost unassailable.
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