So I'm a doctor, but I kind of slipped sideways into research, and now I'm an epidemiologist. And nobody really knows what epidemiology is. Epidemiology is the science of how we know in the real world if something is good for you or bad for you. And it's best understood through example as the science of those crazy, wacky newspaper headlines. And these are just some of the examples.
Ja sam doktor, ali sam nekako zalutao u istraživačku oblast i sada sam epidemiolog. I niko u principu ne zna šta je epidemiologija. To je nauka koja nas uči šta je u stvarnom svetu zaista dobro ili loše za vas. I najbolje se razume kroz primer kao nauka o ovim ludim, zabavnim naslovima u novinama. A ovo su samo neki od primera.
These are from the Daily Mail. Every country in the world has a newspaper like this. It has this bizarre, ongoing philosophical project of dividing all the inanimate objects in the world into the ones that either cause or prevent cancer. Here are some of the things they said cause cancer: divorce, Wi-Fi, toiletries and coffee. Some things they say prevent cancer: crusts, red pepper, licorice and coffee. So you can see there are contradictions. Coffee both causes and prevents cancer. As you start to read on, you can see that maybe there's some political valence behind some of this. For women, housework prevents breast cancer, but for men, shopping could make you impotent.
Ovo je uzeto iz "Daily Mail"-a. Svaka zamlja na svetu ima novine kao što su ove. Poseduje ovaj čudan, filozofski projekat koji se bavi podelom svih neživih stvari u svetu na one koji ili uzrokuju ili štite od raka. Ovo su neke za koje je rečeno da uzrokuju rak: razvod, "Wi-Fi", sredstva za higijenu i kafa. A ovo su neke od stvari koje deluju preventivno: kore, crvena paprika, sladić i kafa. Već i sami možete uočiti kontradiktornosti. Kafa i uzrokuje i sprečava rak. Kada nastavite da čitate, uočićete da tu možda postoji neka vrsta političke pozadine. Rad u kući štiti žene od raka dojke, a kupovina može muškarce učiniti impotentnim.
(Laughter)
Tako da znamo da moramo da počnemo
So we know that we need to start unpicking the science behind this. And what I hope to show is that unpicking the evidence behind dodgy claims isn't a kind of nasty, carping activity; it's socially useful. But it's also an extremely valuable explanatory tool, because real science is about critically appraising the evidence for somebody else's position. That's what happens in academic journals, it's what happens at academic conferences -- the Q&A session after a postdoc presents data is often a bloodbath. And nobody minds that; we actively welcome it. It's like a consenting intellectual S&M activity.
da analiziramo nauku koja stoji iza toga. Ono što se ja nadam da ću vam pokazati je da analiziranje sumnjivih tvrdnji, analiziranje dokaza koji podržavaju sumnjive tvrdnje, nije neka vrsta zanovetajuće aktivnosti; već je socijalno korisno, i veoma značajno pomagalo za objašnjavanje. Jer prava nauka se bavi kritičnom procenom dokaza iza tvrdnji drugih ljudi. To je ono što se dešava u akademskim časopisima. I na akademskim konferencijama. Sesije pitanja i odgovora nakon prezentacija rezultata su često vrlo oštre. To nikome ne smeta. Svi se raduju tome. To je kao intelektualna sado-mazo aktivnost.
(Laughter)
Tako da ću vam ja objasniti glavne stvari,
So what I'm going to show you is all of the main things, all of the main features of my discipline, evidence-based medicine. And I will talk you through all of these and demonstrate how they work, exclusively using examples of people getting stuff wrong.
glavne karakteristike discipline kojom se bavim - a to je medicina zasnovana na dokazima. Pokazaću vam sve to i demonstrirati kako to funkcioniše, isključivo koristeći primere ljudi koji stvari shvataju pogrešno.
We'll start with the absolute weakest form of evidence known to man, and that is authority. In science, we don't care how many letters you have after your name -- we want to know what your reasons are for believing something. How do you know that something is good for us or bad for us? But we're also unimpressed by authority because it's so easy to contrive. This is somebody called Dr. Gillian McKeith, PhD, or, to give her full medical title, Gillian McKeith.
Počećemo od najslabijeg tipa dokaza poznatog čovečanstvu, a to je autoritet. U nauci, nas ne interesuje koliko titula imate iza svog imena. U nauci, želimo da znamo iz kojih razloga vi verujete u nešto. Kako vi znate da li je nešto dobro ili loše za nas? Ali nismo impresionirani autoritetom, zato što ga je lako izmisliti. Ovo osoba se zove Dr. Džilijan MekKit, ili, po punoj medicinkoj tituli, Džilijan MekKit.
(Laughter)
(Smeh)
Again, every country has somebody like this. She is our TV diet guru. She has five series of prime-time television, giving out very lavish and exotic health advice. She, it turns out, has a non-accredited correspondence course PhD from somewhere in America. She also boasts that she's a certified professional member of the American Association of Nutritional Consultants, which sounds very glamorous; you get a certificate. This one belongs to my dead cat, Hettie. She was a horrible cat. You go to the website, fill out the form, give them $60, it arrives in the post. That's not the only reason we think this person is an idiot. She also says things like eat lots of dark green leaves, they contain chlorophyll and really oxygenate your blood. And anybody who's done school biology remembers that chlorophyll and chloroplasts only make oxygen in sunlight, and it's quite dark in your bowels after you've eaten spinach.
Naravno, u svakoj zemlji postoji takva osoba. Ona je naš TV-guru za ishranu. Ona ima ogromne serijale na najboljim kanalima, i daje veoma temeljne i egzotične savete o zdravlju. Završila je neakreditovan doktorski kurs zasnovan na preprisci negde u Americi. A takođe se hvali da je sertifikovani profesionalni član Američke asocijacije konsultanata za ishranu, što zvuči veoma glamurozno i uzbudljivo. Dobijete sertifikat i sve što ide uz to. Ovaj priprada mojoj preminuloj mački Heti. Bila je očajna mačka. Odete na sajt, ispunite formular, platite 60$ i stiže vam poštom. Ali to nije jedini razlog zašto mislimo da je ova osoba idiot. Ona zastupa i mišljenja tipa: treba da jedete puno tamno-zelenog lišća jer sadrži puno hlorofila, i on će oksidisati vašu krv. Svako ko je imao časove biologije u školi se seća da hlorofil i hloroplasti proizvode kiseonik samo na svetlosti,
Next, we need proper science, proper evidence.
a kada već pojedete spanać, u vašim crevima je mrak.
So: "Red wine can help prevent breast cancer." This is a headline from The Daily Telegraph in the UK. "A glass of red wine a day could help prevent breast cancer." So you find this paper, and find that it is a real piece of science. It's a description of the changes in the behavior of one enzyme when you drip a chemical extracted from some red grape skin onto some cancer cells in a dish on a bench in a laboratory somewhere. And that's a really useful thing to describe in a scientific paper. But on the question of your own personal risk of getting breast cancer if you drink red wine, it tells you absolutely bugger all. Actually, it turns out that your risk of breast cancer increases slightly with every amount of alcohol you drink. So what we want are studies in real human people.
Dalje, neophodna je prava nauka, pravi dokazi. "Crno vino sprečava nastanak raka dojke." To je naslov u "Daily Telegraph"-u u Velikoj Britaniji. "Čaša crnog vina dnevno može vas zaštiti od raka dojke." A onda nađete naučni rad, i shvatite da je to zaista prava nauka. Opisuje promene u jednom enzimu koje se dešavaju kada ubacite supstancu izolovanu iz kožice neke sorte grožđa na neke ćelije raka negde u laboratoriji, u plastičnoj posudi. To je dobar fenomen za opisivanje u naučnom radu, ali o pitanju o povezanosti vašeg ličnog rizika za oboljenje od raka dojke i korišćenja crnog vina vam ne govori apsolutno ništa. U stvari, ispostavilo se da se rizik razvijanja raka dojki pomalo povećava sa svakom čašom alkohola koju popijete. Tako da ono što mi želimo su studije na ljudima.
And here's another example. This is from Britain's "leading" diet nutritionist in the Daily Mirror, our second-biggest selling newspaper. "An Australian study in 2001 found that olive oil, in combination with fruits, vegetables and pulses, offers measurable protection against skin wrinklings," and give the advice: "If you eat olive oil and vegetables, you'll have fewer wrinkles." They helpfully tell you how to find the paper, and what you find is an observational study. Obviously, nobody has been able to go back to 1930, get all the people born in one maternity unit, and half of them eat lots of fruit and veg and olive oil, half of them eat McDonald's, and then we see how many wrinkles you've got later.
Ovo je još jedan primer. Ovo je iz članka glavnog britanskog dijetetičara i nutricioniste u "Daily Mirror"-u, a to su druge najprodavanije novine u našoj zemlji. "Australijska studija iz 2001. je pronašla da maslinovo ulje u kombinaciji sa voćem, povrćem i vežbanjem dovodi do značajne zaštite od pojave bora na koži." A onda vam daju savet: "Ukoliko jedete maslinovo ulje i povrće, imaćete manje bora." Kažu vam kako da pronađete originalan rad. Vi ga pronađete, i tu se radi o opisnoj studiji. Očigledno niko nije u stanju da se vrati u 1930, okupi sve ljude koji su rođeni u istoj bolnici, i podeli ih u jednu grupu koja jede puno voća, povrća i maslinovog ulja, i drugu, koja se hrani u MekDonaldsu,
You have to take a snapshot of how people are now. And what you find is, of course: people who eat veg and olive oil have fewer wrinkles. But that's because people who eat fruit and veg and olive oil are freaks -- they're not normal, they're like you; they come to events like this.
a mi potom pratimo koliko bora imaju kasnije. Morate da fotkate kako ljudi izgledaju danas. Potom, naravno, zaključite da ljudi koji jedu sve to imaju manje bora. Ali to je zbog toga što su oni čudaci, oni nisu normalni, oni su kao vi, oni dolaze na događaje kao što je ovaj.
(Laughter)
Oni su elegantni, bogati i manje je verovatno
They're posh, they're wealthy, less likely to have outdoor jobs, less likely to do manual labor, they have better social support, are less likely to smoke; for a host of fascinating, interlocking social, political and cultural reasons, they're less likely to have wrinkles. That doesn't mean it's the vegetables or olive oil.
da se bave poslovima na otvorenom prostoru, manja je verovatnoća da se bave fizičkim radom, imaju bolju socijalnu podršku, manje je verovatno da puše - tako da iz mnogo fascinirajućih, povezanih socijalnih, političkih i kulturoloških razloga, je manja verovatnoća da će imati bore.
(Laughter)
To ne znači da su razlog tome povrće ili maslinovo ulje.
So ideally, what you want to do is a trial. People think they're familiar with the idea of a trial. Trials are old; the first one was in the Bible, Daniel 1:12. It's straightforward: take a bunch of people, split them in half, treat one group one way, the other group, the other way. A while later, you see what happened to each of them. I'm going to tell you about one trial, which is probably the most well-reported trial in the UK news media over the past decade. This is the trial of fish oil pills. The claim: fish oil pills improve school performance and behavior in mainstream children. They said, "We did a trial. All the previous ones were positive, this one will be too." That should ring alarm bells: if you know the answer to your trial, you shouldn't be doing one. Either you've rigged it by design, or you've got enough data so there's no need to randomize people anymore.
Idealno, želite da obavite studiju. Svi misle da su dobro upoznati sa konceptom studija. Studije su veoma stare. Prvo istraživanje datira iz perioda Biblije - Danijel 1:12. Veoma je jasno - analizirate grupu ljudi, podeljenu u dve pod-grupe, jedna dobije jedan tretman, a druga drugi tretman, i nakon nekog vremena analizirate ih i vidite šta im se desilo. Objasniću vam sada jednu studju, koja je verovatno medijski najpropraćenija u Britaniji tokom protekle decenije. Radi se o izučavanju efekata pilula ribljeg ulja. Tvrdnja: riblje ulje poboljšava uspeh u školi i ponašanje kod prosečne dece. Rekoše: "Uradili smo studiju. Sve prethodne studije su dale pozitivne rezultate i znamo da će i ova biti pozitivna." To je izjava koja zove na opreznost. Jer ukoliko već znate odgovor, ne bi trebalo ni da radite studiju.
So this is what they were going to do in their trial: They were taking 3,000 children, they were going to give them these huge fish oil pills, six of them a day, and then, a year later, measure their school exam performance and compare their performance against what they predicted their exam performance would have been if they hadn't had the pills. Now, can anybody spot a flaw in this design?
Ili nameštate rezultate studije dizajnom, ili već imate dovoljno podataka, tako da nema potrebe da istražujete. Evo šta su oni uradili. Okupili su 3.000 dece, i planirali su da im daju pilule ribljeg ulja, šest dnevno, i godinu dana kasnije, bi analizirali njihove rezultate na školskim ispitima i potom bi uporedili te rezultate sa onima koje su očekivali da će dobiti ukoliko nisu uzimali pilule. Da li iko uočava grešku u ovom dizajnu?
(Laughter)
Ni jednom profesoru metodologije kliničkih studija
And no professors of clinical trial methodology are allowed to answer this question. So there's no control group. But that sounds really techie, right? That's a technical term. The kids got the pills, and their performance improved.
nije dozvoljeno da odgovori na ovo pitanje. Tu nema kontrole, ne postoji kontrolna grupa. Zvuči poprilično tehnički. To je tehnički izraz. Klinci su uzimali pilule i njihovi rezultati u školi su se poboljšali.
What else could it possibly be if it wasn't the pills? They got older; we all develop over time. And of course, there's the placebo effect, one of the most fascinating things in the whole of medicine. It's not just taking a pill and performance or pain improving; it's about our beliefs and expectations, the cultural meaning of a treatment. And this has been demonstrated in a whole raft of fascinating studies comparing one kind of placebo against another. So we know, for example, that two sugar pills a day are a more effective treatment for gastric ulcers than one sugar pill. Two sugar pills a day beats one a day. That's an outrageous and ridiculous finding, but it's true. We know from three different studies on three different types of pain that a saltwater injection is a more effective treatment than a sugar pill, a dummy pill with no medicine in it, not because the injection or pills do anything physically to the body, but because an injection feels like a much more dramatic intervention. So we know that our beliefs and expectations can be manipulated, which is why we do trials where we control against a placebo, where one half of the people get the real treatment, and the other half get placebo.
Šta bi drugo mogao da bude uzrok tome osim pilula? Oni su stariji. Mi se svi razvijamo tokom vremena. Takođe, postoji tu i placebo efekat. To je jedan od najfascinantnijih fenomena u celokupnoj medicini. Ne radi se samo o pozitivnom uticaju pilula na vaše rezultate i bol koji osećate. Tiče se i naših verovanja i očekivanja, kulturološkog smisla tretmana. A to je pokazano u čitavoji seriji fascinantnih studija u kojima je jedan placebo upoređivan sa drugim. Tako da znamo, na primer, da dve pilule šećera dnevno imaju veći efekat na uklanjanje čireva na želucu od jedne pilule dnevno. Dve pilule sećera dnevno su efektnije od jedne dnevno. To je nečuveno i smešno otkriće, ali je tačno. Znamo na osnovu tri različite studije urađene na tri različite vrste bola da je injektiranje slane vode efektivniji tretman za tretiranje bola u odnosu na pilulu šećera, na lažnu pilulu bez ikakvih medicinskih svojstava - ne zato što injekcija ili pilule dovode do nekih fizičkih promena u telu, već zato što injekciju doživljavamo kao mnogo drastičniju intervenciju. Dakle, znamo da naša verovanja i iščekivanja mogu biti manipulisana i zbog toga radimo studije gde kontrolišemo efekat placeba - u kojima jedna polovina ljudi dobija pravi tretman,
But that's not enough.
a druga placebo.
What I've just shown you are examples of the very simple and straightforward ways that journalists and food supplement pill peddlers and naturopaths can distort evidence for their own purposes. What I find really fascinating is that the pharmaceutical industry uses exactly the same kinds of tricks and devices, but slightly more sophisticated versions of them, in order to distort the evidence they give to doctors and patients, and which we use to make vitally important decisions.
Ali to nije dovoljno. Ono što sam vam upravo pokazao su primeri veoma jednostavnih načina pomoću kojih novinari i prodavci suplemenata hrani i naturopate mogu da izmene dokaze u svoje svrhe. Ono što mene zaista fascinira jeste da farmaceutska industrija koristi upravo iste vrste trikova i izuma, ali malo sofisticiranije verzije, ne bi li izobličila dokaze koje daju doktorima i pacijentima, i koje mi koristimo kako bismo doneli važne odluke.
So firstly, trials against placebo: everybody thinks a trial should be a comparison of your new drug against placebo. But in a lot of situations that's wrong; often, we already have a good treatment currently available. So we don't want to know that your alternative new treatment is better than nothing, but that it's better than the best available treatment we have. And yet, repeatedly, you consistently see people doing trials still against placebo. And you can get licensed to bring your drug to market with only data showing that it's better than nothing, which is useless for a doctor like me trying to make a decision.
Prvo o studijama koje kontrolišu efekat placeba: svi misle da znaju kako one treba da izgledaju - upoređivanje vašeg novog leka i efekta placeba. Ali u stvari je to u mnogim situacijama pogrešno. Jer već imamo veoma dobre dostupne lekove, ne želimo da znamo da li je taj alternativni tretman bolji ni od čega. Želimo da znamo da li je bolji od najboljeg tretmana koji trenutno postoji. A opet, iznova i iznova, vi stalno slušate o studijama koje koriste placebo kao komparator. Možete dobiti i licencu da vaš lek pustite na tržište samo sa podacima koji pokazuju da je tretman bolji ni od čega,
But that's not the only way you can rig your data. You can also rig your data by making the thing you compare your new drug against really rubbish. You can give the competing drug in too low a dose, so people aren't properly treated. You can give the competing drug in too high a dose, so people get side effects. And this is exactly what happened with antipsychotic medication for schizophrenia. Twenty years ago, a new generation of antipsychotic drugs were brought in; the promise was they would have fewer side effects. So people set about doing trials of the new drugs against the old drugs. But they gave the old drugs in ridiculously high doses: 20 milligrams a day of haloperidol. And it's a foregone conclusion if you give a drug at that high a dose, it will have more side effects, and your new drug will look better.
a to je beskorisno za doktora poput mene koji pokušava da donese odluku. Ali to nije jedini način da namestite svoje rezultate. Možete ih promeniti tako što komparator sa kojim upoređujete vaš novi lek potpuno obezvredite. Možete dati niže doze konkurentnog leka, tako da ne lečite ljude na pravi način. A možete dati i preveliku dozu, tako da ljudi pokažu mnogo kontraindikacija. To se upravo desilo u slučaju anti-psihotičkih lekova za šizofreniju. Pre 20 godina, nova generacija anti-psihotičkih lekova se pojavila i obećavala je manje kontra-efekata. Tako da su ljudi počeli sa izučavanjem tih novih lekova i upoređivanjem istih sa starim, ali su stare lekove primenjivali u smešno velikim dozama - 20mg haloperidola dnevno. A odavno je poznato da ukoliko primenite lek u visokim dozama, doći će do više kontraindikacija i vaš novi lek će imati bolji efekat.
Ten years ago, history repeated itself, when risperidone, the first of the new-generation antipsychotic drugs, came off copyright, so anybody could make copies. Everybody wanted to show their drug was better than risperidone, so you see trials comparing new antipsychotic drugs against risperidone at eight milligrams a day. Again, not an insane dose, not an illegal dose, but very much at the high end of normal. So you're bound to make your new drug look better. And so it's no surprise that overall, industry-funded trials are four times more likely to give a positive result than independently sponsored trials.
Interesantno je da se pre 10 godina istorija ponovila, kada je risperidonu, a to je jedan od prvih lekova nove generacije anti-psihotika, istekla licenca, tako da je svako mogao da ga sintetiše. Svi su želeli da dokažu da je njihov novi lek bolji od risperidona, tako da je došlo do gomile studija o novim anti-psihoticima koji su upoređivani sa risperidonom u dozi od 8mg dnevno. To nije luda doza leka, nije nezakonita, ali jeste na gornjoj granici normale. Tako da će sigurno vaš novi lek izgledati bolje. Tako da uopšteno gledajući nije iznenađujuće što studije koje finansira industrija imaju 4 puta više izgleda da dođu do pozitivnih rezultata
But -- and it's a big but --
u odnosu na nezavisno sponzorisane studije.
(Laughter)
Ali - i to je jedno veliko ali -
it turns out, when you look at the methods used by industry-funded trials, that they're actually better than independently sponsored trials. And yet, they always manage to get the result that they want. So how does this work?
(Smeh) ispostavlja se, da kada pogledate metode koje se koriste u studijama koje finansira industrija, one su u stvari bolje u odnosu na nezavisno finansirane studije. A opet, oni uvek uspeju da dođu do rezultata koji žele. Pa kako to funkcioniše?
(Laughter)
Kako bismo mogli da objasnimo ovaj čudan fenomen?
How can we explain this strange phenomenon? Well, it turns out that what happens is the negative data goes missing in action; it's withheld from doctors and patients. And this is the most important aspect of the whole story. It's at the top of the pyramid of evidence. We need to have all of the data on a particular treatment to know whether or not it really is effective. There are two different ways you can spot whether some data has gone missing. You can use statistics or you can use stories. I prefer statistics, so that's what I'll do first.
Ispostavlja se da nekako negativni rezultati nestanu u akciji, ne pokazuju se doktorima i pacijentima. A to je najznačajniji momenat cele priče. To je na vrhu piramide dokaza. Neophodno je da imamo sve podatke o određenom tretmanu kako bismo znali da li je zaista efektan. Postoje dva načina pomoću kojih možete uočiti da li su neki podaci nestali u akciji. Možete koristiti statistiku ili se oslanjati na priče.
This is a funnel plot. A funnel plot is a very clever way of spotting if small negative trials have disappeared, have gone missing in action. This is a graph of all of the trials done on a particular treatment. As you go up towards the top of the graph, what you see is each dot is a trial. As you go up, those are bigger trials, so they've got less error; they're less likely to be randomly false positives or negatives. So they all cluster together. The big trials are closer to the true answer. Then as you go further down at the bottom, what you can see is, on this side, spurious false negatives, and over on this side, spurious false positives. If there is publication bias, if small negative trials have gone missing in action, you can see it on one of these graphs. So you see here that the small negative trials that should be on the bottom left have disappeared. This is a graph demonstrating the presence of publication bias in studies of publication bias. And I think that's the funniest epidemiology joke you will ever hear.
Ja lično više volim statistiku, tako da ću to obrazložiti prvo. Ovo je tzv grafik-levak. To je veoma pametan način da uočimo da li su male studije sa negativnim rezultatima nestale tokom procesa. Ovo je grafik svih studija koje su sprovedene za određeni tretman. Kako se penjete ka vrhu grafika, ono što vidite je da svaka tačka predstavlja jednu studiju. Kako se krećete ka vrhu, ovo su velike studije, sa manje grešaka. Manja je verovatnoća da su one slučajno lažno pozitivne ili negativne. Grupisane su zajedno. Velike studije su bliže pravom odgovoru. A onda kako se spuštate ka dnu grafika, vidite, na ovoj strani grafika su lažno negativni, a na ovoj strani su lažno pozitivni rezultati. Ukoliko postoje određene sklonosti u objavljivanju studija, ukoliko su male studije sa negativnim rezultatima nestale, možete to uočiti u jednom od ovih grafika. Ovde možete videti da su male studije sa negativnim rezultatima koje bi trebalo da su u donjem levom uglu, nestale. Ovaj grafikon pokazuje pristrasnost u publikacijama u studijama o pristrasnosti u objavljivanju. Ja mislim da je to najsmešnija šala u epidemiologiji koju ćete čuti.
(Laughter)
That's how you can prove it statistically. But what about stories? Well, they're heinous, they really are. This is a drug called reboxetine. This is a drug which I, myself, have prescribed to patients. And I'm a very nerdy doctor. I hope I go out of my way to try and read and understand all the literature. I read the trials on this. They were all positive, all well-conducted. I found no flaw. Unfortunately, it turned out, that many of these trials were withheld. In fact, 76 percent of all of the trials that were done on this drug were withheld from doctors and patients. Now if you think about it, if I tossed a coin a hundred times, and I'm allowed to withhold from you the answers half the times, then I can convince you that I have a coin with two heads. If we remove half of the data, we can never know what the true effect size of these medicines is.
Ovako to možete statistički pokazati, ali šta se dešava sa pričama? E pa one su gnusne, zaista jesu. Ovo je lek reboksetin. Ovaj lek sam ja prepisivao pacijentima. A ja sam pravi doktor-štreber. Mislim da dajem sve od sebe da pročitam i razumem literaturu. Pročitao sam studije o tom leku. Sve su bile pozitivne. Bile su veoma dobro izvedene. Nisam pronašao nijednu manu. Na nesreću, ispostavilo se da su mnoge studije bile povučene. U stvari, 76% studija koje su ispitivale ovaj lek nisu pokazane doktorima i pacijentima. Sada ako porazmislite o tome, ukoliko bih ja bacio novčić 100 puta, i ukoliko mi je dozvoljeno da sakrijem od vas rezultate 50% bacanja, onda mogu i da vas ubedim da imam novčić sa dve glave. Ukoliko sakrijemo polovinu podataka, nikada nećemo znati koji je pravi efekat nekog leka.
And this is not an isolated story. Around half of all of the trial data on antidepressants has been withheld, but it goes way beyond that. The Nordic Cochrane Group were trying to get ahold of the data on that to bring it all together. The Cochrane Groups are an international nonprofit collaboration that produce systematic reviews of all of the data that has ever been shown. And they need to have access to all of the trial data. But the companies withheld that data from them. So did the European Medicines Agency -- for three years.
A ova priča nije izuzetak. Otprilike polovina studija o anti-depresivima je nedostupna, ali problem je mnogo veći od toga. "Nordic Cochrane Group" je pokušavala da dođe do podataka kako bi sagledali celu sliku. "Cochrane Groups" je neprofitna internacionalna kolaboracija koja se bavi sistematskim pregledom svih podataka koji su ikada pokazani. Neophodno je da oni imaju pristup svim podacima iz studija. Ali kompanije čine te rezultate nedostupnim, kao i Evropska medicinska agencija (EMA) u periodu od tri godine.
This is a problem that is currently lacking a solution. And to show how big it goes, this is a drug called Tamiflu, which governments around the world have spent billions and billions of dollars on. And they spend that money on the promise that this is a drug which will reduce the rate of complications with flu. We already have the data showing it reduces the duration of your flu by a few hours. But I don't care about that, governments don't care. I'm sorry if you have the flu, I know it's horrible, but we're not going to spend billions of dollars trying to reduce the duration of your flu symptoms by half a day. We prescribe these drugs. We stockpile them for emergencies on the understanding they'll reduce the number of complications, which means pneumonia and death. The infectious diseases Cochrane Group, which are based in Italy, has been trying to get the full data in a usable form out of the drug companies, so they can make a full decision about whether this drug is effective or not, and they've not been able to get that information. This is undoubtedly the single biggest ethical problem facing medicine today. We cannot make decisions in the absence of all of the information.
Ovo je problem za koji trenutno ne postoji rešenje. Kako bih vam dočarao njegove razmere, obajsniću vam priču o leku "Tamiflu", za koji su vlade širom sveta potrošile milijarde i milijarde dolara. A potrošili su pare na osnovu obećanja da ovaj lek smanjuje stopu komplikacija povezanih sa gripom. Već imamo podatke koji pokazuju da smanjuje trajanje simptoma gripa za nekoliko sati. Ali meni, ni vladama uopšte nije stalo do toga. Žao mi je ako imate grip, znam da je to odvratno, ali mi nećemo potrošiti milijarde dolara kako bismo smanjili trajanje simptoma vašeg gripa za pola dana. Mi prepisujemo te lekove, čuvamo ih za hitne slučajeve na osnovu saznanja da će umanjiti brojne komplikacije, a to su upala pluća i smrt. Ogranak "Cochraine Group"-e za infektivne bolesti, sa sedištem u Italiji, pokušavao je da dođe do svih podataka u formatu dostupnom za analizu od kompanija kako bi mogla da donesu odluku o tome da li je ovaj lek efektivan ili ne i nije uspela da dođe do tih informacija. Ovo je bez ikakve sumnje najveći etički problem sa kojim se medicina danas suočava. Mi ne možemo da donosimo odluke ukoliko neke informacije nisu dostupne.
So it's a little bit difficult from there to spin in some kind of positive conclusion. But I would say this: I think that sunlight is the best disinfectant. All of these things are happening in plain sight, and they're all protected by a force field of tediousness. And I think, with all of the problems in science, one of the best things that we can do is to lift up the lid, finger around at the mechanics and peer in.
Tako da je malo teško doći do pozitivnog zaključka. Ali ja bih rekao sledeće: mislim da je transparentnost najbolje dezinfekciono sredstvo. Sve ove stvari se dešavaju na očigled svih nas i zaštićene su silom monotonije. Mislim da pored svih problema koji postoje u nauci, jedna od najboljih stvari koje možemo da uradimo je da podignemo poklopac, sagledamo i razmotrimo problematiku koju smo tu uočili.
Thank you very much.
Hvala vam mnogo.
(Applause)
(Aplauz)