duxup a day ago

>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.

  • Kapura a day ago

    it's crazy how much of the current regime's position is "crime is legal if it's my guys doing it."

    • watwut a day ago

      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.

      • smithoc 11 hours ago

        It's not, and the current administration isn't conservative.

        The MAGA movement has completely purged all the conservatives from the Republican party.

        They've increased the deficit by a trillion dollars, built an army of ICE agents and deployed them to terrorize people in cities around the country, added billions of dollars in import taxes, taken state ownership stakes in multiple companies.

        They're closer to Stalin or Mao than to any conservative ideology of a small government that stays out of people's business.

        • tastyface 8 hours ago

          And yet the non-MAGA Republicans in Congress are (almost) fully complicit. After all, just a handful of their votes would be sufficient to shutter the whole operation.

  • teddy-smith 17 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.

    • yongjik 9 hours ago

      Trump tariffs are extortion. It's orthogonal to whether it's a good policy for the US, but nobody outside the US has any doubt about it being extortion. It's not even a back room deal kind of stuff; "Give America your money or I'll raise tariffs" is how Trump is openly talking to every country.

    • tastyface 8 hours ago

      Backroom? The Korean government publicly gifted Trump a golden crown just last week!

      • yongjik 6 hours ago

        Well as a Korean I can't say I'm proud of what happened, but if the choice is between "get robbed by someone who fancies himself a king" and "get robbed by someone who fancies himself a king, but also get a nuclear submarine deal" ...

vibrio a day ago

“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)

  • terminalshort a day ago

    [flagged]

    • ropable a day ago

      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.

      • terminalshort a day ago

        It's a risk / reward tradeoff. There is no objectively correct decision or subject matter expert in that.

    • bdangubic a day ago

      this would lead to a whole lot of bleach drinking…

      • hansvm a day ago

        I hear bleach kills cancer in a petri dish.

      • terminalshort a day ago

        It's a free country

        • bdangubic a day ago

          USA is everything but a “free country” is absolutely not - you are too funny!

    • eulgro a day ago

      Most people aren't equipped to be making such a decision.

      • terminalshort a day ago

        It's a risk reward tradeoff which is fundamentally not an objective decision. Nobody is equipped to make it.

        • Retric 16 hours ago

          You assume there is a benefit to be had. Most drugs fail because they don’t do the thing people want them to do.

          In general prescription drugs have massive downsides and they still got approved.

      • RobotToaster a day ago

        Doctors are supposed to be.

        • Retric a day ago

          They really aren’t, it’s the work of more than one human to keep up with this stuff.

          So you need a government agency or a private group doing the same functions while facing huge lawsuits and thus requiring the same or more data. Granted US doctors could use European etc guidelines, but that’s a different discussion.

        • tartuffe78 a day ago

          Yeah they loved giving people oxy

    • jiggawatts a day ago

      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.

      • vibrio 19 hours ago

        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)

      • terminalshort a day ago

        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.

        • tliltocatl 21 hours ago

          Clinical trials are so expensive it only makes sense to run them if regulation mandates so. So without regulation you would never be able to tell snake oil from something that works. And then because making working drugs is more expensive than sticking a label on sugar balls they would get out-competed completely. Sadly, free market doesn't really work when the customer has no way to tell if a good is any good until it's too late.

          • terminalshort 18 hours ago

            So what you are saying is the majority of the public wants a faster and higher risk option for new drugs, but they should be forced to have a slower and lower risk system because that's what you want? Nobody is talking about selling sugar pills here. That's just simple fraud which always has and always will be illegal.

            • whatisthiseven 18 hours ago

              So, yes, you agree the "faster" market will produce a larger quantity of sugar pill fraud because you are so willing to dismiss it as "obvious", yet you won't acknowledge the other kinds of near equivalent fraud such as silver pills, horse dewormers, and more.

              Sure, sometimes the FDA is slow to approve drugs that have science behind them. Or from other countries that proved efficacy and safety. But frankly people can already do whatever they want with regards to health. The wellness and alternative medicine industry is larger than the actual pharmaceutical industry. Your fears are unfounded.

              • terminalshort 14 hours ago

                No you can't do whatever you want. I have narcolepsy. There is currently a drug in development that is known to work (TAK-861). My doctor is involved in the research. It works so well that in phase 2 trials they couldn't keep them blind because the research subjects know instantly that they got the real medicine. My doctor would have prescribed it to me a year ago if he could. But he couldn't because the worthless bureaucrats at the FDA won't allow him to. I will have to suffer for another year before I can get it because of this bureaucracy. There is ample data published so far to show safety and effectiveness on top of the advice of my doctor. But I can't get it because of these worthless safetyist bureaucrats and their endless process and procedure. I demand to be treated like an adult and be allowed to judge the data for myself and take the risk rather than have the decision made for me by a bunch of government stooges. And on top of that, the drug will be much more expensive than it has to be because Takeda has to spend so much more money developing it. So I lose two ways.

                https://www.takeda.com/newsroom/newsreleases/2025/takeda-ore...

            • tliltocatl 16 hours ago

              > simple fraud which always has and always will be illegal

              Wikipedia says homeopathy market was 2.7B in 2007 and I'm too lazy to find new data. AFAIK there has not been issued a single fraud sentence against the manufacturers. That's with a half-functioning FDA that actually made some moves to stop this. Now how bad would it be with no regulation at all? Because, again, there is no doubt that homeopathy has overwhelmingly higher profit margin compared to actual drugs.

              • terminalshort 14 hours ago

                I don't want no regulation at all. I want the regulation to stop at ensuring labeling and dosage is correct. Punishment for mislabeling medication should be medieval. If you want to buy snake oil, that's not my problem. What I care about is that the bottle that says snake oil on it actually contains snake oil.

      • eviks a day ago

        > 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.

        So no different than with the current FDA approvals?

        • jiggawatts a day ago

          Those are all of the things exempt from their scope, hence the relentless useless and downright dangerous products in those categories.

    • danny_codes a day ago

      This is a terrible idea. A lot of people would certainly die if we got rid of drug certifications

      • terminalshort a day ago

        They are adults, and adults should have the right to make dumb choices.

        • watwut a day ago

          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.

          • BizarroLand 9 hours ago

            Terminal seems to think that there are no people who would intentionally lie about the effects or possible side effects of a drug in order to make millions or billions of dollars.

ubiquitysc a day ago

At least clowns can be fun to watch

  • _carbyau_ a day ago

    From another country, it is mildly amusing in one sense of schadenfreude.

    It is also incredibly saddening to see great institutions of expertise be treated as playthings by the ignorant.

  • vibrio 19 hours ago

    It’s much less fun if you have a loved one, say an aggressive autoimmune disease. Do not recommend.

pstuart a day ago

My ex works in QA for a biotech company and FDA audits are a regular thing and are taken very seriously.

There's plenty to criticize of the org (as with almost all others) but the rank and file are doing good work to help try to keep us safe.

  • wswope a day ago

    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...

    • teddy-smith 16 hours ago

      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.

      • Balgair 16 hours ago

        It will not.

        One (of many) issue is that this has no bearing on other regulatory regimes. So, sure, the FDA approves of the drug/device/thingy because the AI got lost and no one is checking what it's saying. But Canada's CFIA doesn't because they are still using real people or centaurs ( people + AI, but I'm not 100% sure so don't quote me on that ).

        That makes it so that you can only sell the drug/device/thingy in the US and some other countries that blindly follow US FDA (mostly poorer nations with very small markets and a lack of legal recourse, they'll just turn to the EFSA/EMA).

        Which fine, but that is not the bet that these large companies made about a decade ago when it came to whether or not this drug/device/thingy would be worth it to pursue. These big drugs need to pay off all the failed research with international sales. Same is somewhat true with devices (mostly internal these days). These big drug makers want stability. Profits are fine, but revenue is just as important as these pipelines are sooooo long and soooo fraught. The human body is just too variable.

        The tariffs and all the monkey business with this admin is very much not good for the US when it comes to these large drug/device/thingy makers. Chaos is not good for business. They have all learned that Donny and his ilk (per the article here) do not keep their words when it comes to corruption. They do not stay bought, they are not stable.

        We're already shedding jobs here in favor of moving to the EU. Yes, not India or China, but the Baltics mostly (inside Schengen zone). We lost 10 people with jobs opening up there (same day) just this last week. The EU is stable in the eyes of my very own bosses.

      • cameldrv 13 hours ago

        Waiting to see the job posts popping up for a prompt engineer for FDA submissions.

  • cosmicgadget 15 hours ago

    And they are slowly being attrited by layoffs, being led by corrupt shitbirds, and the Russell Vought ethos of making career public servants miserable.

  • vibrio 18 hours ago

    This. They don’t get paid much, or much glory if any, but overall they are smart and hard working and are eager to have rational and data driven discussions about the programs they oversee. Current status is heartbreaking.

timr a day ago

[flagged]

  • 0cf8612b2e1e a day ago

    Singular scandal? It is about the top dog using his position to settle a personal vendetta for financial gain.

    • timr a day ago

      Yes, that's one scandal, from one person. It has nothing to do with Vinay Prasad, certainly nothing to do with the CDC, and whatever you think of the administration, connecting this event to "everything else" is political hackery.

      • Hnrobert42 a day ago

        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.

        • timr a day ago

          It's an article about a single corrupt individual. Instead of just reporting the facts of the case (as was done by the Stat piece, which they're ripping off) they spend multiple paragraphs making ad hominem attacks about the CDC, Prasad, etc. Almost unbelievably, they put those things first.

          I don't care what your opinions are of the administration. This is crappy journalism. I'm even willing to entertain the notion that this is representative of a systematic staffing problem -- but not when the reporting is so obviously, viciously partisan.

          • smithoc 11 hours ago

            > I'm even willing to entertain the notion that this is representative of a systematic staffing problem -- but not when the reporting is so obviously, viciously partisan.

            I'm even willing to admit that water might be wet, but not when someone is standing in a swimming pool splashing it around.

          • abduhl a day ago

            I don’t think these are ad hominem attacks. The article seems to just state the (perhaps biased) facts: people are calling it a clown show, Prasad was ousted, Prasad did gain popularity on social media as a COVID-skeptic. It doesn’t become an ad hominem just because you don’t like the way the facts are stated or the inferences your own brain makes.

            • timr a day ago

              > people are calling it a clown show

              Not "people" -- a single, unnamed, VC. It's right there in the article. Read it.

              > Prasad was ousted

              No, he wasn't. He voluntarily resigned pre-emptively after the WSJ editorials, then he was re-hired almost immediately. You are just misinformed. You'd know this if you read a better source.

              • abduhl 16 hours ago

                So, again, you’re not showing how it’s an ad hominem, you’re just disagreeing with the biased reporting.

                • timr 16 hours ago

                  Where did I say it was an ad hominem?

                  • abduhl 15 hours ago

                    >> Instead of just reporting the facts of the case (as was done by the Stat piece, which they're ripping off) they spend multiple paragraphs making ad hominem attacks about the CDC, Prasad, etc. Almost unbelievably, they put those things first.

                    • timr 15 hours ago

                      Touché. I shouldn't have said "ad hominem attacks", because, while these arguments are certainly specious, and completely unrelated to the subject of the article, they're not strictly ad hominem.

                      I agree with your comment that my criticism is (and was) biased reporting.

      • bdangubic a day ago

        put the one person for that one scandal into a federal prison - problem solved

        • UniverseHacker a day ago

          What about the nearly everyone else in the administration that is also a blatantly corrupt, unqualified, and incompetent bootlicker, many of which are even self described Nazis?

          • bdangubic a day ago

            not much different from any other asministration in the last 20-ish years. some are criming privately and some publicly but they are all criminals

            • UniverseHacker 14 hours ago

              I'm a scientist that works closely with the federal government granting agencies that fund my research. People I had interacted with were extremely competent and professional for decades under both Republicans and Democrats, and most of them have been purged and replaced with completely unqualified loyalists. This is unprecedented and a marked departure from the past.

              • bdangubic 8 hours ago

                I am at NIH so same… and while everything seems unprecendented these days it is really not. elections have consequences and there isn’t more proof than 2024. but sun will rise in the morning, we’ll vote in 2026 and 2028 and those elections will also have (hopefully different) consequences…

  • eviks a day ago

    > If you're going to fling that kind of petty invective, cite your sources

    Why? The cost of citation is very high, so you'd simply not report on valuable sentiment

  • add-sub-mul-div a day ago

    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.

a-french-anon a day ago

[flagged]

  • nougati 21 hours ago

    Can you clarify your meaning? Genuinely trying to understand. Is it that Beth criticises partisan actions (if you consider FDA's actions partisan, or the CDC's renaming of the mpox), while being partisan herself, which is hypocritical?

    • a-french-anon 21 hours ago

      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.

    • watwut 21 hours ago

      She has bluesky account. Checkmate.

      And also, if you are democrat or democratic leaning, you are not allowed to criticize republican administration. Criticism, insults and such can flow only one way - from conservatives to democrats. Checkmate.

    • like_any_other 20 hours ago

      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.

  • lisdexan 18 hours ago

    >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.

  • seec 19 hours ago

    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...