| ▲ | prox 7 months ago |
| Is 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. |
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| ▲ | DrScientist 7 months ago | parent | next [-] |
| In 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. |
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| ▲ | llamaimperative 7 months ago | parent | next [-] | | Pointing 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. | | |
| ▲ | DrScientist 7 months ago | parent [-] | | > prove that it’s better than what currently exists. So how do you do that ethically? How do you justify taking off something that you know works to some extent and try something completely new or worse placebo? ie don't you have to construct the trial in the context of existing treatments etc? These are the kind of challenges that makes drug development slow - in the end you don't do one trial, but a series of trials, slowly building confidence and making the case. Often that's what takes the time during the clinical phase. Of course it would be much faster to go straight to a big trial that would show how well your treatment works in conditions optimal to it - however that kind of 'move-fast break-things' approach involves potentially breaking things which happen to be people. Regulation just reflects the cautious 'first do no harm' philosophy. Now let's be honest - big pharma will simultaneous complain about regulation and the cost of development, and at the same time know it creates barriers to entry - there is always some frustration about the slowest of regulatory authorities to adopt new methods - however you wouldn't want your regulatory to be gungho. | | |
| ▲ | rflrob 7 months ago | parent | next [-] | | > or worse placebo Just to be clear, most drug trials for anything where we have an effective treatment are not “new drug vs placebo”, but instead “new drug vs standard of care”. Thus the goal being to prove it’s better than what already exists. | | |
| ▲ | DrScientist 7 months ago | parent [-] | | Sure - it rather depends on how good the 'standard of care' is or how much consensus there is on what that should actually be. If the standard of care is already good and you don't need a placebo - then you have another problem - you probably are going to have to do quite a big trial to get the stats to show a significant difference, and you are going to find it harder to persuade people to participate with an experimental treatment if there already is a fairly good treatment. The whole point about the challenges with clinical trials is that it's not an intellectual exercise in designing the perfect experiment and 'just doing it'. It's about persuading yourself, the regulators, the doctors and ultimately the patients that it's something you should try - and before you've done your first trial you don't have any human data to show it's safe and effective - all a bit chicken and egg - the solution is often to move slowly in stages. |
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| ▲ | fragmede 7 months ago | parent | prev | next [-] | | This is particularly difficult for drugs that affect the brain, like MDMA for PTSD in veterans. What do you use as the control group for that, when patients and clinicians can tell that who got the real thing and who did not. I call this the bridge problem. In order to do science, you have to have a control group, but if I built a bridge across a ravine, we don't have to have cars drive off a cliff and fall into the ravine in order to scientifically prove that the bridge works and exists. We engineered a bridge and put it there and obviously if there was no bridge cars would just fall into the ravine so we don't need to test that the bridge exists. We design the bridge, we rate it up to a certain capacity, we don't test it until it fails, we simply prohibit really heavy trucks from driving on smaller bridges that can't take their weight. We can't do any of that for drugs that affect emotions and consciousness because we're barely in the stone age of our understanding of the brain and the technology we have to affect it. | | | |
| ▲ | datavirtue 7 months ago | parent | prev [-] | | [flagged] | | |
| ▲ | wat10000 7 months ago | parent | next [-] | | Sorry, are you having difficulty with the concept that human prisoners should have more rights than mice? | | | |
| ▲ | DrScientist 7 months ago | parent | prev | next [-] | | Purdue Pharma, fentanyl and doctors abrogating responsibility for patient safety is an example of 'go wild'. On your second point - I'd agree that a lot of animal experiments are not that informative - but lets be clear 'clinical trials' are simply experiments on people. I'm not sure I'd want to give Musk, Zuckerberg or Bezos free reign to experiment on desperate people in the medical space. Depends on whether you treat people as just grist to your money making mill - or perhaps you think the ends justify the means? | |
| ▲ | binary132 7 months ago | parent | prev [-] | | the minds and qualia of incarcerated human beings and of rodents are very unequal in import and value. what’s more, establishing legal precedent that incarcerated human beings may be freely experimented on is a recipe for ethical catastrophe. |
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| ▲ | jorvi 7 months ago | parent | prev | next [-] | | Uber disrupted taxis because taxis were a sleazy experience, with dirty old cars, “broken” meters and rude drivers that tried to get you to pay extortionate prices if they knew you were in a pinch. Stop trying to venerate the taxi industry, they’re horrible. | | |
| ▲ | DrScientist 7 months ago | parent [-] | | I think that depends on what part of the world you live in. My experience of taxi companies in the UK is that they are generally safe, reliable and operate based on reputation. My experience of taxi's in the US is that they appear to be often operated by desperate people living on the edge of existence. | | |
| ▲ | immibis 7 months ago | parent [-] | | Isn't that every service in the US? It takes pride on pushing the under people to the brink of death. |
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| ▲ | adventured 7 months ago | parent | prev [-] | | There's no hoping you can push through. The US Government has complete top-down control over the sale of prescription drugs in the US, from clinicals to approval to distribution & sale. The sole reason Uber pulled off what they did, is there's no national authority governing taxi style services for all states and cities, it's a state and local effort. So Uber counted on navigating around zillions of slow local governments long enough to get big, and it worked very well. You can't do that in prescription drugs, the feds have a big hammer and can (and will) use it anytime they like. |
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| ▲ | ramraj07 7 months ago | parent | prev [-] |
| Absolutely, and if you recall, even YC tried to get in on this idea. Except they did the same mistake anyone who comes up with this disruption plan commits (including Google with Calico, or Zuck with CZI) - they recruit existing academics to do the disruption. Unfortunately this just fails miserably because they’re culturally corrupted to think of standard dogmas (like there can never be a single cure for cancer). I remember a time when other such dogmas existed (remember how it was considered impossible to de-differentiate somatic cells?). The other mistake tech bros make in biology is they think they can make any cool idea work if they are smart enough. Because this is actually true in tech. But biology is restricted by laws of nature. If a drug doesn’t work, it can’t be made to work. There’s no room for wishful thinking. Third mistake I see often is individual bias towards fields that they come from. Someone who has an RNA background will only try to use RNA to solve everything, likewise with antibodies, or imaging, etc. The current research funding system incentivizes such thinking and it becomes entrenched in anyone already in this field. There’s never a thought of “which is the exact technology and approach I should use to solve this problem independent of what I’m an expert at?” So a lot of projects are doomed from the start. As long as you’re cognizant of these three facts, I think it’s very possible to disrupt this field. |
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| ▲ | nradov 7 months ago | parent [-] | | Is there any plausible biological reason to think that there could ever be a single cure for cancer? | | |
| ▲ | ckemere 7 months ago | parent | next [-] | | Perhaps immune-based therapies like CAR-T are based on the premise that there are many cancerous cells in your body all the time, but your immune system deals with them, and it’s only when it fails to do so that you end up in the pathological state. So the “single cure” is the normally-functioning immune system? | | |
| ▲ | nradov 7 months ago | parent [-] | | That might be part of it. And yet sometimes people with normally-functioning immune systems also get cancer. So while that might be an effective treatment for some patients it's not going to be a universal cure. | | |
| ▲ | inglor_cz 7 months ago | parent [-] | | Human "normal" may not be enough. Bat "normal" might be. Of course, now we are crossing the threshold from medicine to bio-augmentation. | | |
| ▲ | nradov 7 months ago | parent [-] | | There is no free lunch in biology. Augmenting the immune system to better attack cancer is going to cause other problems. It's so naive to think there is some simple solution that will improve on a billion years of evolution. I mean it's not impossible but realistically what are the odds? There won't be any magic for cancer. It's just going to be slow grind to solve one hard problem after another. | | |
| ▲ | inglor_cz 7 months ago | parent [-] | | There is no free lunch outside biology either. The problems that come with stronger immune systems may be more tractable or at least less unpleasant than cancer. Also, you seem to be very pessimistic. Many interventions in the history of medicine, like washing hands or the first vaccine against smallpox, were almost "magical" in their efficiency: they addressed a lot of problems through a relatively trivial intervention. It is likely that a lot of this low-hanging fruit has been picked up, but you insinuate that there isn't any low-hanging fruit to begin with, only an endless slog of attacking hard problems. That is way too negative. |
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| ▲ | inglor_cz 7 months ago | parent | prev [-] | | Some mammal species like bats, whales and naked mole rats seem to be extremely unlikely to get cancer. Which may be an indication that a very efficient immune system can keep cancer in check indefinitely. |
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