10 ms·
Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot
by EternalFury 2y ago
Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure.
This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.
- cchi_co 2y ago[dead]
- vasco 2y agoSince these are cancer trials I'm assuming no test subjects get paid, and university PhDs research for free, like in every other field, so what necessarily has to be expensive about it? If you have to pay 200 homeless to take your 0.0001% better than placebo antidepressants in the context of a huge corporation, and maybe redo the trial a few times, I can see how that gets expensive, but I don't see why it's a de facto rule. But even the big trials it's weird how expensive people say they are. Most other products require a lot of high paid labor to produce, think of a video game studio for example, also without any guarantee it won't flop, and it certainly takes longer to develop than to do a clinical trial.
- rahkiin 2y agoPhD candidates are paid salary in the Netherlands. Less of course than the senior trial researchers at pharma. I also would not assume there is no compensation for subjects as thats part of the medical-ethical process and not just ‘it helps the subject so no money’.
- vasco 2y agoThe €30k to €35k per year they make in this context approximates to free. Any normal company has to pay much more than that for less. A non-phd software engineer will get paid much more to change button colors for example. So that can't be the reason they are expensive and a PhD candidate is doing many other things than just helping to run trials.
- JPLeRouzic 2y ago> Any normal company has to pay much more than that for less In most EU countries, the employee receives much less than what they cost the employer. In France, if an employee gets 30K euros, the employer has to provision ~45K Euros.
- vasco 2y agoWhat's your point? I've lived in 3 different european countries, I'm familiar with fully loaded costs, I don't see how social security changes anything. By paying more for less I mean PhDs candidates are very cheap labor for what they bring to the table.
- StefanBatory 2y agoAlso as much as it pains to say, 30-35k Euro is high salary there. :(
- monero-xmr 2y agoThis is the most misinformed unknowing take in all of the comments. You can’t just recruit “200 homeless” and have it pass research standards. The homeless population is the most difficult of all to track, maintain accurate records, and even recruit for that matter. You think the homeless just line up for novel drug trials and report back for updates on a strict schedule? You need good candidates for the trial. You need them to follow up. You need admins to properly track them and ensure it’s at least mostly accurate. Even the best trial candidates won’t follow the protocol correctly.
- deleted 2y ago[deleted]
- vasco 2y agoI invite you to read https://www.researchgate.net/profile/Carl-Elliott/publication/5587588_Guinea-pigging_healthy_human_subjects_for_drug_safety_trials_are_in_demand_But_is_it_a_living/links/61eec7749a753545e2f3b51b/Guinea-pigging-healthy-human-subjects-for-drug-safety-trials-are-in-demand-But-is-it-a-living.pdf https://www.researchgate.net/profile/Carl-Elliott/publicatio... If you genuinely think the medical and pharma industry don't exploit homeless and other marginalized populations out the wazoo as lab rats. They also only stopped doing it to prisioners when it was made illegal, because that's what they did before. Of course using them has a lot of practical problems, as you outline, other than the much bigger ethical issue. You managed to miss the whole point of the comment though. Which is, how is it possible that a multibillion dollar industry, exploiting both the test subjects AS WELL as the researchers in the form of practically free PhD candidates can still claim it's one of the most dificult / expensive endeavours? Where does the money go? When you look, it goes to the bureocrats and to the "bio-investors".
- pfdietz 2y agoI (not homeless!) was recently in a vaccine trial (Moderna's mRNA vaccine for RSV). The trial paid me $100 per office visit, just to show up. There were periodic phone checkups ($50) and a weekly status check through an app ($10). I did follow the protocol pretty damn well. There was an incentive to come in and get checked when symptoms occurred, including when I came down with COVID at one point after a trip to Europe.
- robertlagrant 2y ago> Most other products require a lot of high paid labor to produce, think of a video game studio for example, also without any guarantee it won't flop, and it certainly takes longer to develop than to do a clinical trial. You have to try really hard to make a video game no-one wants[0]. You might not recoup all your investment, but you won't sell zero copies. A drug can have all that money poured in, and nothing come of it. [0] https://arstechnica.com/gaming/2024/09/two-weeks-after-launch-sony-shooter-concord-goes-offline-and-offers-refunds https://arstechnica.com/gaming/2024/09/two-weeks-after-launc...
- vasco 2y agohttps://247wallst.com/media/2024/08/04/9-biggest-video-game-flops-of-all-time/ https://247wallst.com/media/2024/08/04/9-biggest-video-game-...
- robertlagrant 2y agoThere is certainly a difference between profit and revenue, yes.
- vasco 2y agoI guess it's easier to casually mention you might not recoup your investment when it's not your $200mil but my point it's just that there's a lot of speculative technical research or cultural output that is very hard to predict outcome, some of these things also requiring high paid labor, and we don't have a huge thing around "omg if they don't all become billionnaires selling drugs nobody will make drugs because it's so hard and expensive", meanwhile people are going to space and so on.
- robertlagrant 2y agoMore people are developing drugs than going to space. And going to space is valuable and makes billionaires, because it's a super high risk, high reward industry. If you want to make it into only a high risk industry, no one is going to space.
- InDubioProRubio 2y agoDoes it? There is a billion people on this planet without adequate medical system - whose health is not considered worth investing into. If they get auto-diagnosed by app (zero-cost), they could volunteer for a free chemical trial (delivery of package), a application of said package (local nurse - not free) and a series of follow up scans + analysis. The office behemoths involved are optional. Whats missing is tools to scan the body locally for cheap. The rest can be automated or distributed to people with an interest in success (high-level-analysis by the cure developers). Here are the volunteers: https://www.sciencedirect.com/science/article/pii/S2667005424000061 https://www.sciencedirect.com/science/article/pii/S266700542...
- llamaimperative 2y agoLovely: so just give tons of people an experimental drug and collect garbage data by doing so!
- bilbo0s 2y agoI'm not sure people fully understand the scientific method. All data is not reliable data.
- wesselbindt 2y ago> whose health is not considered worth investing into. If they get auto-diagnosed by app (zero-cost), they could volunteer for a free chemical trial What a profoundly ineffective and broken system we have that this could be uttered as anything other than satire.
- InDubioProRubio 2y agoSo the perfect nothing is allowed to block the imperfect something, because we wait for humans to transcend to angelic beeings?
- wesselbindt 2y agoYeah, not doing human testing on poor folks without a choice is really "angelic" and "perfect". Very high bar to set, how could we possibly achieve such high standards of morality?
- ano-ther 2y agoFrom the article translation it sounds like they have phase 3 data and submitted or are about to submit an application to the European Medicines Agency. That means they have gone all the way to prove it’s safe and effective, and now have to convince the regulators. Can anyone find the studies?
- null08 2y agohttps://www.nejm.org/doi/full/10.1056/NEJMoa2402604 https://www.nejm.org/doi/full/10.1056/NEJMoa2402604
- null08 2y agoThis article is about a phase III RCT that the hospital managed to do without major industry capital injection. This truly was a major achievement (I have been involved in a phase III RCT myself). It was published in the New England recently: https://www.nejm.org/doi/full/10.1056/NEJMoa2402604 https://www.nejm.org/doi/full/10.1056/NEJMoa2402604
- kijalo 2y agoThis trial is using an existing drug in a potentially novel way (before surgery as opposed to after surgery). I dont think it really lives up the original article title.
- Gokevin 2y agoSupported by Bristol Myers Squibb;
- refurb 2y agoThe article literally says "Funded by Bristol Myers Squibb and others".
- null08 2y agoArgh, I'm so sorry, I linked to the wrong New England paper in my post above. (That is a different major achievement from the same institution, but the above was industry funded as others correctly pointed out). The correct New England paper about this treatment is here: https://www.nejm.org/doi/10.1056/NEJMoa2210233 https://www.nejm.org/doi/10.1056/NEJMoa2210233 This one is TIL therapy, where you basically take tumor-infiltrating lymphocyte from the patient, stimulate them ex vivo, and put them back. The reason this is so impressive -- and highlighted by this article -- is that large phase III trials like this have now become so complicated due to various technical, financial, logistic, ethical, and above all regulatory challenges, that they are now mostly done by companies, or at least as joint ventures with companies (and often in jurisdictions with less of these issues, certainly not in the EU like this one). It is very, very impressive to pull off something like this as an academic institution (at least in Europe). What's more, the funding came from KWF (the Dutch cancer foundation), which is actually a public charity that mainly relies on donations.
- ramraj07 2y agoGot my PhD from a lab that works on antibody drugs, they eventually even released one to the market. I’d argue that our current system is broken. There’s no reliable metric of drug effectiveness in any of our pre-clinical models, and thus we end up going into clinical trials quite blind indeed. And more often than not, what drug gets into trials has more to do with ego and politics than actual scientific merit. And the folks involved in these types of activities are (IMO) the most unoriginal types I’ve ever seen. There’s a lot we can do to improve our drug development process. It really doesn’t need to cost billions to bring a drug to the market. But the odds are stacked against anyone with a contrarian hypothesis and I just figured I’d save my sweat and leave this field instead.
- prox 2y agoIs this a market that can be disrupted? It sounds if you know how to save a few billion and introduce more science based drugs, it’s ripe for an overtake.
- DrScientist 2y agoIn the same way Uber disrupted licensed taxis - or the big internet firms disrupted ad supported media. ie totally ignoring existing regulations, pretending they don't apply to you and just hoping you can push through. In a lot of the 'problems' are the regulations ( which are double edged and tricky to get right ) - and pharma companies are just following the rules. I think governments might be less lax in letting there be a new wildwest in drug development.
- llamaimperative 2y agoPointing the finger at regulation is misleading IMO. The regulations for bringing a drug to market are essentially quite simple: prove that it’s better than what currently exists. What makes it difficult is the word “prove” It turns out it’s obscenely hard to make a drug that’s good, and even harder to prove that it’s good.
- 2y ago
- refurb 2y agoExactly. I work in this field. Doing phase 3 clinical trials costs between $5,000 to $20,000 per patient per year. This particular drug did a phase 3 with 423 patients for 2 years, so you're looking at a cost of $4M to $16M just for this one trial alone. Then add on top all the CMC (manufacturing) research that needs to happen, the regulatory filing work, etc, etc. Unless someone has a few hundreds of millions sitting around, you aren't bringing a novel drug to market without external funding.
- yread 2y agoWhen hospitals are contracted to do work in a clinical trial setting they take their costs and multiply it by 10 (at least). This was done in house with in house resources. This hospital has its own pharmacy that can synthesize drugs and give it to the patients. The pharmacy probably charged just the material costs internally and not for the time.
- refurb 2y agoI don't know of any hospital pharmacy that has a full fledge biochemistry lab and production facility. Drug production is very different from the typical work done in a hospital pharmacy.
- yread 2y agoOf course they don't have capacity to make millions of pills. But they are GLP and GMP certified and make all kinds of custom stuff https://www.avl.nl/en/preparing-for-your-appointment/departments-and-centers/pharmacy/ https://www.avl.nl/en/preparing-for-your-appointment/departm... https://www.avl.nl/en/preparing-for-your-appointment/departments-and-centers/pharmacys-laboratory/ https://www.avl.nl/en/preparing-for-your-appointment/departm... https://www.nki.nl/research/facilities-platforms/bioanalytical-laboratory-of-the-pharmacy/ https://www.nki.nl/research/facilities-platforms/bioanalytic...
- refurb 2y agoAll of those examples are at best pharmacies with compounding capabilities and/or sterile fill capability. They aren't manufacturing any medicines in those pharmacies. They are buying final product and then preparing it for administration. GLP and GMP certified don't mean they are manufacturing. GLP are lab best practices and GMP is manufacturing, but it covers a lot of ground, so a basic pharmacy can be GMP and all they do is prepare sterile product.
- TheToadKnows 2y agoDrug development faces a forecasting problem, not a measurement problem. In the same way that temperature, pressure, and humidity readings have been collected for centuries, it wasn’t until we developed models and computational power that accurate weather forecasting became possible. Similarly, in drug development, we’ve long had access to extensive pre-clinical data and measurement tools. However, without predictive models to interpret this data, we will continue to struggle to forecast a drug’s safety and effectiveness in humans. Interesting coincidence that for the last several decades, the rate of success of a drug advancing from a phase 1 clinical trial to approval is about 10%, which was just about how good we were at forecasting tomorrow’s weather between 1900-1950.
- mistercheph 2y ago* proving it's safe and effective, *and* getting the go-ahead from the drug cartels
- rdruxn 2y agoTo quote xkcd, "So does a handgun" https://xkcd.com/1217/ https://xkcd.com/1217/
- wordpad25 2y agoThere is an xkcd comics that says anytime somebody says they found a thing that kills cancer cells in a lab, remember that so does a handgun.