FDA described as a "clown show" amid latest scandal; top drug regulator is out
(arstechnica.com)139 points by duxup 14 hours ago
139 points by duxup 14 hours ago
This makes me wonder how much of the Tariffs are extortion of other countries.
How randomly they seem to be applied to makes me wonder if theres back room deals going on.
To be fair, that was always conservative position.
Edit: I do not mean it cynically or as a joke. I think that is exactly what conservative position was for years. The only difference now is that it is not possible to euphemism away or plausible deniality away out of it.
“He had the temerity to reject a drug that had lousy data…”
Was that data really “lousy”? (Referencing the REPL data?) Was it a trial design issue? (which he has very strong and unconventional opinions on) Is it the role of his position to overrule his specialist review teams ? (in the absence of any clear safety risks or malfeasance)
Profoundly misguided take. "These bureaucrats" are subject matter experts regarding the topics about which they have input. It's fine for people to do their own research about what car to drive. Which compounds they might consume to affect health issues? Not so much.
It's a risk / reward tradeoff. There is no objectively correct decision or subject matter expert in that.
It's a risk reward tradeoff which is fundamentally not an objective decision. Nobody is equipped to make it.
That’s how you end up with snake oil, traditional medicine, herbal medicine, and people trying to cure their cancer with supplements instead of surgery and chemo.
Such lax rules are invariably exploited to death (literally!) by unscrupulous profit-seekers.
Even if you’re smarter than the average bear and “do your own research”, your relatives won’t all be of the same intellectual calibre and you’ll occasionally lose a loved one to a huckster selling mercury compounds as a cure all.
You’ll get mad and “demand something be done.”
That something looks like the FDA.
This is a summary of my view. The danger is an overly opinionated “leader” with strong opinions has veto power over expert fda review teams, the system fails and decisions are not made on data and consensus but rather ideology and self importance. Patients and even practicing Physicians cannot be expected to review the nuances of every aspect of clinical studies for therapies in their area. The FDA and expert advisory committees (do these still exist?) are crucial in providing a data-driven analysis. This should not be done by an outspoken “leader” that is confident that he is smarter than the rest of the field. (This isn’t limited to medicine,but that is a can of worms)
No I won't. I know that trying to keep idiots from screwing themselves over is an impossible task and would never demand that. I'm not willing to be treated like a child just because some idiot might benefit from the same.
Those are all of the things exempt from their scope, hence the relentless useless and downright dangerous products in those categories.
This is a terrible idea. A lot of people would certainly die if we got rid of drug certifications
They are adults, and adults should have the right to make dumb choices.
Absolutely nothing suggests op talks about adults only.
Also, there is difference between individual dumb choice and market where bad actors are enabled and normal person have zero chance to distinguish them.
It would not be just dubm choices. It would be people in set up to fail situation.
I work in biotech and the FDA is openly reviewing our submissions with LLMs now. The shark has been jumped.
https://www.fda.gov/news-events/press-announcements/fda-anno...
I don't know. If this speeds up their work and helps them do more with the same staff I can see this as being a good thing. a.i. is really good at combing through data to answer questions.
Singular scandal? It is about the top dog using his position to settle a personal vendetta for financial gain.
How is it political hackery? There is a clear pattern of this administration appointing inept leadership to public health positions. The article is not C-SPAN dry, but it's not New York Post hackery either.
Laura Loomer affecting staffing decisions because one of their stooges isn't the right flavor of corrupt and incompetent for her is what a clown show is. Pretending this deserves the same dignity as a competent and good faith administration would be the ultimate participation trophy.
Having a stance is not the same thing as bias and it's not the same thing as partisanship.
Two wrongs don't make a right. Sure, the US decision was certainly ideologically motivated (which isn't to say right or wrong) and one could notice that, but that rabid reaction to an absolute nothing is ridiculous and the arguments presented are questionable in tone and intellectual integrity (e.g. calling your side "the world" to put weight behind your opinion).
Let's be honest, since Ars has been bought by Condé Nast, it has progressively become something between Reddit and Gawkers.
Several times people here on HN dismissed factually accurate articles I posted, that cited all their claims to trusted, non-controversial sources [1], because they thought the article publisher was too right-wing. The only way such dismissals stop, is if they are applied evenly.
[1] E.g. government statistics, or public announcements by a university regarding their programs, in an article about what kind of programs that university offers. I.e. sources nobody disputed for those claims.
>proudly display her Bluesky account
You have to be kidding me. A division director of FDA was extorting people mafia style, with links to a lawsuit with evidence and your first thoughts were: "she hurt me feefees with a article about inane culture war bullshit" and "how dare she display her twiter-clone account".
As always, https://www.jwz.org/ is right.
Yep, this is not the first time I have read the first few paragraphs of an article by her and told myself: why should I care about this partisan political bullshit.
People like like to pretend their favorite side doesn't do as much bullshit, yet they do, even if it's more subtle or hidden.
What a waste of time. Complaining about the drama while creating it...
>In early August, soon after joining the FDA, Tidmarsh announced actions that would effectively remove from the market a drug ingredient made by a company associated with Tang. Tidmarsh’s lawyer then sent a letter to Tang proposing that he extend a “service agreement” for “another 10 years,” which would see Tang making payments to a Tidmarsh-associated entity until 2044. The email was seen as attempted extortion, with such payments being in exchange for Tidmarsh rolling back the FDA’s regulatory change.
Straight up extortion.