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The Replication Crisis | Understanding Medical Research

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The replication crisis refers to the significant problem in scientific research where initial positive study results cannot be reproduced when the same experiments are repeated. To illustrate this concept, the video uses a demonstration where the speaker claims psychic powers to predict numbers between one and twenty; while some viewers correctly guess the number three, the majority do not. This scenario mirrors real-world medical studies where researchers might obtain a "positive" result simply due to luck rather than because their hypothesis is actually true. Consequently, a positive study does not guarantee that a treatment works in reality, just as guessing the correct number once does not prove one has psychic abilities. Similarly, a negative study does not definitively prove a drug is ineffective; it could merely be the result of bad luck or poor experimental conditions that masked a real effect. The core issue with the replication crisis lies in the severe consequences of false positives and false negatives. False positive studies are particularly dangerous because they lead researchers to pursue treatments that do not work, potentially harming patients through unnecessary side effects and wasting resources on unproductive directions. Conversely, false negative studies cause scientists to abandon effective therapies prematurely, missing opportunities to save lives. The video highlights that while positive studies often receive extensive media attention and social praise, negative studies are frequently ignored, leading to a skewed perception of scientific progress. This imbalance is exacerbated by the fact that many highly cited studies have been found to be incorrect upon replication; for instance, research from 2005 showed that out of forty-nine widely cited studies, seven were completely reversed, and only eleven had no follow-up attempts at all, despite the immense time and money required to conduct such replications. Several systemic factors contribute to the lack of replication in science, primarily revolving around time, funding, and academic incentives. Conducting a replication study is expensive and time-consuming, often taking years from design to publication, which discourages researchers who are under pressure to produce new findings. Furthermore, major funding agencies like the National Institutes of Health prioritize innovation over replication because their grant criteria favor novel approaches rather than repeating existing work. While regulatory bodies like the FDA require two independent trials to confirm a drug's efficacy before approval, the broader scientific community lacks similar mandates. This environment encourages scientists to chase novelty and notoriety rather than verifying established knowledge, leading to a situation where many widely accepted medical practices are later proven wrong through better-designed studies, a phenomenon known as medical reversal. Ultimately, the video concludes that relying on a single study is never sufficient to establish medical truth, as luck and design flaws can easily skew results. The history of medicine is filled with examples where standard practices were overturned by new evidence, such as the discovery that aggressively lowering blood sugar in diabetics could cause heart attacks or the finding that allergen-proof bed covers offer no benefit for asthma patients. These cases underscore the critical importance of skepticism and the iterative process of replication to refine scientific knowledge. The best defense against erroneous medical breakthroughs is a healthy dose of skepticism, recognizing that one study can get lucky while another can go wrong, and that true understanding only emerges when results are consistently verified across multiple independent investigations.
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[Music] we're now going to discuss the replication crisis we're now going to discuss the replication crisis sorry that's a little replication crisis humor for you so our goals today are to define the replication crisis like what does this actually mean why is there crisis about it and to discuss the difference between a positive study and a true study we'll introduce the concept of medical reversal and remind you that a single medical study is almost never the final answer to illustrate all of this though i am going to do a demonstration for you so i'm not sure if you knew this but i am psychic and uh i'm going to project into your mind a number between uh 1 and 20. okay so i'm i'm sending it to you now and everyone have their number between 1 and 20. okay well the answer is three now most of you are very unimpressed right now but but some of you guessed three and think that i really do have some kind of powers or you you probably don't but maybe you were mildly impressed for a moment those of you who got three just experienced getting kind of a a positive result when the hypothesis was not true i don't actually have psychic powers i just got lucky nevertheless you got a positive result and you might be excited to to trumpet that and to to post on your facebook feed that the professor for this course you're watching has real psychic powers i do not the vast majority of people did not guess three i'm afraid so this brings us to the four types of studies there is positive study of a true hypothesis a negative study of a true hypothesis a positive study of a false hypothesis and a negative study of a false hypothesis so so what the heck does this actually mean so let's talk about a positive study a positive study is a study in which the data supports the hypothesis you hypothesized that your new drug would cure this disease and the data in the study supports that that is a positive study we can measure how strongly the data supports the hypothesis using statistical tests and we'll get to those in subsequent lectures but this doesn't mean my hypothesis is true just like guessing the number i might show that the data is consistent with my drug actually working but in this sort of platonic ideal world like does the drug actually work if we were to give it to the entire world would it actually work that may be false maybe we just got lucky like i did guessing the number three for some of you so we can have a positive study of a true hypothesis the drug really does work and we showed that it worked or a positive study of a false hypothesis the drug doesn't work we just got lucky what's a negative study just the opposite the data in the study doesn't support the hypothesis the data shows the drug doesn't work and that can be because in fact the drug doesn't work but you can also have a drug that works but you just had really bad luck when you ran your study and because of the way the chips fell you don't show the effect that it works and when we get to the statistical analysis part of this course we'll sort of show how that can happen but you do have to realize that just because a study says that it is positive does not necessarily mean that the drug they're talking about actually works now what happens when there's a positive study this is what happens there are headlines across multiple places in on your social network feed that says there's a medical breakthrough and and there were seven apparently in 2017 that are going to wow the world and and this these scientists produced artificial blood i guess and here are the five most wondrous medical breakthroughs this year so you know there are seven here so you might want to start there my point is positive studies get a lot of press and a lot of attention you rarely see people arguing back and forth on facebook about a negative study this is what happens when a negative study is published right just kind of nothing crickets not much going on what does this have to do with replication well replication is really important because false negative studies are bad but false positive studies are really bad all right so if we have a false negative study what does that mean it means that we had a drug or an intervention that works it would work if we gave it to everyone it would work it would save lives but when we tested it the study came out negative we didn't show a difference between the group we gave the drug in the group we gave the placebo just because of bad luck when that happens we miss out on an important therapy potentially and we might take the field in kind of a non-productive direction we should have stuck with that class of drugs and maybe we move on to something else so that's bad we don't want that to happen but false positive is is really really bad because there we've got a drug that doesn't work doesn't do anything if we give it to everyone it doesn't save any lives but just we got lucky we guessed three and we got lucky in our clinical trial and so now we're going to treat a bunch of people unnecessarily right we're going to potentially harm them because most drugs have side effects and we're going to take the field in a really unproductive direction because everyone's going to chase after this drug now and drugs that are similar to this drug to see if it works for the disease when we were wrong in the first place so the answer to why replicate replicate is to check your results for those of you who guessed three back at the beginning of this lecture if i did it again and was right again you would be even more impressed right but chances are that wouldn't be the case chances are i wouldn't do quite as well guessing two in a row and of course three in a row four in a row five in a row there'd be very few people watching this that i would have hit all the numbers although granted that one guy who had exactly the same numbers as me would really you know would really think i'm cool um we measure how often replication happens so this was an article that appeared in the journal of the american medical association in 2005 and what they did is they found 49 research studies that had been cited a thousand times or more so like getting your study cited a thousand times that is a very important study okay so a thousand times these studies have been cited of the 49 seven were subsequently contraindicated the results were completely reversed seven were replicated but the effects weren't as strong so the initial study showed that the drug worked really well and then the second study showed it works but maybe not as well 20 replicated successfully so that's good drug still works yep everything's on the up and up here and 11 had no follow-up at all so a study that was cited a thousand times and just no one has tried to do it again kind of crazy now why aren't people replicating these studies it seems like a no-brainer well number one is time because studies take a lot of time it can take years from the point where you start starting to design a study to where you can publish replication and many people don't have that kind of time in their hands especially when they're working on their own studies number two money studies cost a ton of money and very few people are willing to pay for replication studies which i think is a travesty but i don't have billions of dollars to give out to anyone number three is money studies are very expensive i'm deliberately putting this in twice because that is the major driver frankly of what gets researched it's someone has to pay for it and number four impact scientists are obsessed with how much notoriety or impact their studies make and if you just reproduce someone else's results you'll get your paper published but no one's writing a new york times article about it right no and no no reporters are calling you you've done the world in a tremendous public service and it's completely unrecognized and so many scientists just choose to do their own thing the nih isn't helping much to be honest and and full disclosure i have funding from the nih but um the grant review criteria from the national institutes of health have three major components the significance of what you're researching okay so is this important for public health fine the innovation and the approach now the approach is how you're doing the study that's that's just technical stuff but innovation is one of the three major criterias innovation means how new is this has anyone done this before are you on the cutting edge of technology well replication is not innovative by definition someone has already done it before so even our biggest funding agency does not put a priority on replication studies now the fda on the other hand knows that replication is important but remember the fda doesn't fund studies the fda tells pharmaceutical companies largely what studies they need to run out of their own pockets so it's a bit of a different when it's not different when it's not your money on the line the fda says before uh before filing a marketing application a developer must have adequate data from two large controlled clinical trials two there are rare circumstances where they will allow just one trial but it is for this reason that the fda makes sure that you have two independent studies confirming that your drug works because anyone can get lucky once getting lucky twice is pretty unlikely now this brings us to the issue of medical reversal medical reversal is a term coined by vinay prasad and adam chifu these two guys here defined as when a new trial superior to predecessors because of better design contradicts current medical practice and so these guys have made a study of these medical reversals and they looked at studies appearing in the venerable new england journal of medicine over 10 years there were 363 articles that they looked at that assessed the standard of care the things that like all doctors know you should do right and what they found is that forty percent of them of those studies reversed the standard of care practice so forty percent of the time the thing that we all know that you should do we were entirely wrong about um 38 of the time affirmed it and the rest kind of neither affirmed nor reversed it so one of the major points is that some of the things that we we believe to be true without strong evidence once we start replicating or even improving upon the evidence we do better um i'll give you an example of a couple of of sort of big reversals that happened intensive glucose lowering type 2 diabetes diabetes is a disease where the blood sugar the blood glucose is too high we all knew prior to the study that if we got the sugar lower people would do better right that just kind of makes sense no one really tested it or they tested in limited ways when it was formally tested we found that if you drive the sugar too low actually those patients do quite badly and had more heart attacks and things like that so we still control the sugar but we don't push it down as hard as we used to here's a fun one control of exposure to mite allergen and allergen impermeable bed covers for adults with asthma so at one point in time we thought that if you're allergic to dust mites you can put these like might covers on your on your uh on your mattresses you know and they zip up and they like prevent the mites from being there and that would improve asthma outcomes well when they actually tested this they found no it doesn't make a difference whether you put a cover on your mattress or not your asthma is just as bad so the importance of verifying results that we believe to be true is really critical to advance science forward so the take-home points here number one and this is a huge take-home point for the entire course one study is almost never enough one study can get lucky one study can just go wrong one study can be badly designed a positive study doesn't mean the hypothesis is true it means the study is positive but replication is necessary a negative study doesn't mean the drug doesn't work it doesn't mean the hypothesis is false it might mean that it often might mean that but it's not the final say one study is never enough replication fixes science it allows us to iteratively improve our knowledge but we are not incentivized to replicate we are incentivized to innovate finally the best defense against medical breakthroughs is a healthy dose of skepticism thanks a lot