[Script Info] Title: [Events] Format: Layer, Start, End, Style, Name, MarginL, MarginR, MarginV, Effect, Text Dialogue: 0,0:00:00.67,0:00:03.46,Default,,0000,0000,0000,,Hi. So, this chap here, Dialogue: 0,0:00:03.46,0:00:05.72,Default,,0000,0000,0000,,he thinks he can tell you the future. Dialogue: 0,0:00:05.72,0:00:07.70,Default,,0000,0000,0000,,His name is Nostradamus, although here the Sun have Dialogue: 0,0:00:07.70,0:00:11.37,Default,,0000,0000,0000,,made him look a little bit like Sean Connery. (Laughter) Dialogue: 0,0:00:11.37,0:00:14.27,Default,,0000,0000,0000,,And like most of you, I suspect, I don't really believe Dialogue: 0,0:00:14.27,0:00:15.38,Default,,0000,0000,0000,,that people can see into the future. Dialogue: 0,0:00:15.38,0:00:18.08,Default,,0000,0000,0000,,I don't believe in precognition, and every now and then, Dialogue: 0,0:00:18.08,0:00:21.26,Default,,0000,0000,0000,,you hear that somebody has been able to predict something that happened in the future, Dialogue: 0,0:00:21.26,0:00:24.32,Default,,0000,0000,0000,,and that's probably because it was a fluke, and we only Dialogue: 0,0:00:24.32,0:00:26.94,Default,,0000,0000,0000,,hear about the flukes and about the freaks. Dialogue: 0,0:00:26.94,0:00:31.02,Default,,0000,0000,0000,,We don't hear about all the times that people got stuff wrong. Dialogue: 0,0:00:31.02,0:00:33.18,Default,,0000,0000,0000,,Now we expect that to happen with silly stories Dialogue: 0,0:00:33.18,0:00:36.32,Default,,0000,0000,0000,,about precognition, but the problem is, Dialogue: 0,0:00:36.32,0:00:39.66,Default,,0000,0000,0000,,we have exactly the same problem in academia Dialogue: 0,0:00:39.66,0:00:44.16,Default,,0000,0000,0000,,and in medicine, and in this environment, it costs lives. Dialogue: 0,0:00:44.16,0:00:47.53,Default,,0000,0000,0000,,So firstly, thinking just about precognition, as it turns out, Dialogue: 0,0:00:47.53,0:00:50.06,Default,,0000,0000,0000,,just last year a researcher called Daryl Bem conducted Dialogue: 0,0:00:50.06,0:00:51.89,Default,,0000,0000,0000,,a piece of research where he found evidence Dialogue: 0,0:00:51.89,0:00:55.55,Default,,0000,0000,0000,,of precognitive powers in undergraduate students, Dialogue: 0,0:00:55.55,0:00:58.12,Default,,0000,0000,0000,,and this was published in a peer-reviewed academic journal Dialogue: 0,0:00:58.12,0:01:00.40,Default,,0000,0000,0000,,and most of the people who read this just said, "Okay, well, Dialogue: 0,0:01:00.40,0:01:02.58,Default,,0000,0000,0000,,fair enough, but I think that's a fluke, that's a freak, because I know Dialogue: 0,0:01:02.58,0:01:05.42,Default,,0000,0000,0000,,that if I did a study where I found no evidence Dialogue: 0,0:01:05.42,0:01:07.93,Default,,0000,0000,0000,,that undergraduate students had precognitive powers, Dialogue: 0,0:01:07.93,0:01:11.48,Default,,0000,0000,0000,,it probably wouldn't get published in a journal. Dialogue: 0,0:01:11.48,0:01:14.34,Default,,0000,0000,0000,,And in fact, we know that that's true, because Dialogue: 0,0:01:14.34,0:01:16.87,Default,,0000,0000,0000,,several different groups of research scientists tried Dialogue: 0,0:01:16.87,0:01:20.39,Default,,0000,0000,0000,,to replicate the findings of this precognition study, Dialogue: 0,0:01:20.39,0:01:23.02,Default,,0000,0000,0000,,and when they submitted it to the exact same journal, Dialogue: 0,0:01:23.02,0:01:26.17,Default,,0000,0000,0000,,the journal said, "No, we're not interested in publishing Dialogue: 0,0:01:26.17,0:01:30.70,Default,,0000,0000,0000,,replication. We're not interested in your negative data." Dialogue: 0,0:01:30.70,0:01:33.45,Default,,0000,0000,0000,,So this is already evidence of how, in the academic Dialogue: 0,0:01:33.45,0:01:38.32,Default,,0000,0000,0000,,literature, we will see a biased sample of the true picture Dialogue: 0,0:01:38.32,0:01:41.79,Default,,0000,0000,0000,,of all of the scientific studies that have been conducted. Dialogue: 0,0:01:41.79,0:01:46.22,Default,,0000,0000,0000,,But it doesn't just happen in the dry academic field of psychology. Dialogue: 0,0:01:46.22,0:01:50.59,Default,,0000,0000,0000,,It also happens in, for example, cancer research. Dialogue: 0,0:01:50.59,0:01:54.66,Default,,0000,0000,0000,,So in March, 2012, just one month ago, some researchers Dialogue: 0,0:01:54.66,0:01:57.56,Default,,0000,0000,0000,,reported in the journal Nature how they had tried Dialogue: 0,0:01:57.56,0:02:01.40,Default,,0000,0000,0000,,to replicate 53 different basic science studies looking at Dialogue: 0,0:02:01.40,0:02:04.96,Default,,0000,0000,0000,,potential treatment targets in cancer, Dialogue: 0,0:02:04.96,0:02:07.60,Default,,0000,0000,0000,,and out of those 53 studies, they were only able Dialogue: 0,0:02:07.60,0:02:10.67,Default,,0000,0000,0000,,to successfully replicate six. Dialogue: 0,0:02:10.67,0:02:15.01,Default,,0000,0000,0000,,Forty-seven out of those 53 were unreplicable. Dialogue: 0,0:02:15.01,0:02:18.92,Default,,0000,0000,0000,,And they say in their discussion that this is very likely Dialogue: 0,0:02:18.92,0:02:21.56,Default,,0000,0000,0000,,because freaks get published. Dialogue: 0,0:02:21.56,0:02:23.66,Default,,0000,0000,0000,,People will do lots and lots and lots of different studies, Dialogue: 0,0:02:23.66,0:02:25.78,Default,,0000,0000,0000,,and the occasions when it works they will publish, Dialogue: 0,0:02:25.78,0:02:27.45,Default,,0000,0000,0000,,and the ones where it doesn't work they won't. Dialogue: 0,0:02:27.45,0:02:31.40,Default,,0000,0000,0000,,And their first recommendation of how to fix this problem, Dialogue: 0,0:02:31.40,0:02:34.68,Default,,0000,0000,0000,,because it is a problem, because it sends us all down blind alleys, Dialogue: 0,0:02:34.68,0:02:36.39,Default,,0000,0000,0000,,their first recommendation of how to fix this problem Dialogue: 0,0:02:36.39,0:02:39.78,Default,,0000,0000,0000,,is to make it easier to publish negative results in science, Dialogue: 0,0:02:39.78,0:02:42.69,Default,,0000,0000,0000,,and to change the incentives so that scientists are Dialogue: 0,0:02:42.69,0:02:47.04,Default,,0000,0000,0000,,encouraged to post more of their negative results in public. Dialogue: 0,0:02:47.04,0:02:50.89,Default,,0000,0000,0000,,But it doesn't just happen in the very dry world Dialogue: 0,0:02:50.89,0:02:54.74,Default,,0000,0000,0000,,of preclinical basic science cancer research. Dialogue: 0,0:02:54.74,0:02:58.40,Default,,0000,0000,0000,,It also happens in the very real, flesh and blood Dialogue: 0,0:02:58.40,0:03:01.99,Default,,0000,0000,0000,,of academic medicine. So in 1980, Dialogue: 0,0:03:01.99,0:03:05.00,Default,,0000,0000,0000,,some researchers did a study on a drug called lorcainide, Dialogue: 0,0:03:05.00,0:03:07.33,Default,,0000,0000,0000,,and this was an anti-arrhythmic drug, Dialogue: 0,0:03:07.33,0:03:09.58,Default,,0000,0000,0000,,a drug that suppresses abnormal heart rhythms, Dialogue: 0,0:03:09.60,0:03:11.83,Default,,0000,0000,0000,,and the idea was, after people have had a heart attack, Dialogue: 0,0:03:11.83,0:03:13.36,Default,,0000,0000,0000,,they're quite likely to have abnormal heart rhythms, Dialogue: 0,0:03:13.36,0:03:15.74,Default,,0000,0000,0000,,so if we give them a drug that suppresses abnormal heart Dialogue: 0,0:03:15.74,0:03:19.45,Default,,0000,0000,0000,,rhythms, this will increase the chances of them surviving. Dialogue: 0,0:03:19.45,0:03:22.46,Default,,0000,0000,0000,,Early on its development, they did a very small trial, Dialogue: 0,0:03:22.46,0:03:24.10,Default,,0000,0000,0000,,just under a hundred patients. Dialogue: 0,0:03:24.10,0:03:27.76,Default,,0000,0000,0000,,Fifty patients got lorcainide, and of those patients, 10 died. Dialogue: 0,0:03:27.76,0:03:30.80,Default,,0000,0000,0000,,Another 50 patients got a dummy placebo sugar pill Dialogue: 0,0:03:30.80,0:03:33.76,Default,,0000,0000,0000,,with no active ingredient, and only one of them died. Dialogue: 0,0:03:33.76,0:03:36.41,Default,,0000,0000,0000,,So they rightly regarded this drug as a failure, Dialogue: 0,0:03:36.41,0:03:39.28,Default,,0000,0000,0000,,and its commercial development was stopped, and because Dialogue: 0,0:03:39.28,0:03:43.62,Default,,0000,0000,0000,,its commercial development was stopped, this trial was never published. Dialogue: 0,0:03:43.62,0:03:49.02,Default,,0000,0000,0000,,Unfortunately, over the course of the next five, 10 years, Dialogue: 0,0:03:49.02,0:03:52.85,Default,,0000,0000,0000,,other companies had the same idea about drugs that would Dialogue: 0,0:03:52.85,0:03:55.44,Default,,0000,0000,0000,,prevent arrhythmias in people who have had heart attacks. Dialogue: 0,0:03:55.44,0:03:57.16,Default,,0000,0000,0000,,These drugs were brought to market. They were prescribed Dialogue: 0,0:03:57.16,0:04:00.57,Default,,0000,0000,0000,,very widely because heart attacks are a very common thing, Dialogue: 0,0:04:00.57,0:04:04.41,Default,,0000,0000,0000,,and it took so long for us to find out that these drugs Dialogue: 0,0:04:04.41,0:04:07.32,Default,,0000,0000,0000,,also caused an increased rate of death Dialogue: 0,0:04:07.32,0:04:10.07,Default,,0000,0000,0000,,that before we detected that safety signal, Dialogue: 0,0:04:10.07,0:04:16.12,Default,,0000,0000,0000,,over 100,000 people died unnecessarily in America Dialogue: 0,0:04:16.12,0:04:19.57,Default,,0000,0000,0000,,from the prescription of anti-arrhythmic drugs. Dialogue: 0,0:04:19.57,0:04:23.17,Default,,0000,0000,0000,,Now actually, in 1993, Dialogue: 0,0:04:23.17,0:04:26.73,Default,,0000,0000,0000,,the researchers who did that 1980 study, that early study, Dialogue: 0,0:04:26.73,0:04:30.57,Default,,0000,0000,0000,,published a mea culpa, an apology to the scientific community, Dialogue: 0,0:04:30.57,0:04:33.70,Default,,0000,0000,0000,,in which they said, "When we carried out our study in 1980, Dialogue: 0,0:04:33.70,0:04:35.63,Default,,0000,0000,0000,,we thought that the increased death rate that occurred Dialogue: 0,0:04:35.63,0:04:38.99,Default,,0000,0000,0000,,in the lorcainide group was an effect of chance." Dialogue: 0,0:04:38.99,0:04:41.02,Default,,0000,0000,0000,,The development of lorcainide was abandoned for commercial reasons, Dialogue: 0,0:04:41.02,0:04:42.66,Default,,0000,0000,0000,,and this study was never published; Dialogue: 0,0:04:42.66,0:04:45.05,Default,,0000,0000,0000,,it's now a good example of publication bias. Dialogue: 0,0:04:45.05,0:04:46.94,Default,,0000,0000,0000,,That's the technical term for the phenomenon where Dialogue: 0,0:04:46.94,0:04:51.18,Default,,0000,0000,0000,,unflattering data gets lost, gets unpublished, is left Dialogue: 0,0:04:51.18,0:04:54.55,Default,,0000,0000,0000,,missing in action, and they say the results described here Dialogue: 0,0:04:54.55,0:04:59.36,Default,,0000,0000,0000,,"might have provided an early warning of trouble ahead." Dialogue: 0,0:04:59.36,0:05:02.57,Default,,0000,0000,0000,,Now these are stories from basic science. Dialogue: 0,0:05:02.57,0:05:07.36,Default,,0000,0000,0000,,These are stories from 20, 30 years ago. Dialogue: 0,0:05:07.36,0:05:10.50,Default,,0000,0000,0000,,The academic publishing environment is very different now. Dialogue: 0,0:05:10.50,0:05:14.50,Default,,0000,0000,0000,,There are academic journals like "Trials," the open access journal, Dialogue: 0,0:05:14.50,0:05:17.15,Default,,0000,0000,0000,,which will publish any trial conducted in humans Dialogue: 0,0:05:17.15,0:05:20.46,Default,,0000,0000,0000,,regardless of whether it has a positive or a negative result. Dialogue: 0,0:05:20.46,0:05:24.42,Default,,0000,0000,0000,,But this problem of negative results that go missing in action Dialogue: 0,0:05:24.42,0:05:27.98,Default,,0000,0000,0000,,is still very prevalent. In fact it's so prevalent Dialogue: 0,0:05:27.98,0:05:33.83,Default,,0000,0000,0000,,that it cuts to the core of evidence-based medicine. Dialogue: 0,0:05:33.83,0:05:36.85,Default,,0000,0000,0000,,So this is a drug called reboxetine, and this is a drug Dialogue: 0,0:05:36.85,0:05:39.38,Default,,0000,0000,0000,,that I myself have prescribed. It's an antidepressant. Dialogue: 0,0:05:39.38,0:05:41.92,Default,,0000,0000,0000,,And I'm a very nerdy doctor, so I read all of the studies Dialogue: 0,0:05:41.92,0:05:44.97,Default,,0000,0000,0000,,that I could on this drug. I read the one study that was published Dialogue: 0,0:05:44.97,0:05:47.92,Default,,0000,0000,0000,,that showed that reboxetine was better than placebo, Dialogue: 0,0:05:47.92,0:05:49.78,Default,,0000,0000,0000,,and I read the other three studies that were published Dialogue: 0,0:05:49.78,0:05:53.35,Default,,0000,0000,0000,,that showed that reboxetine was just as good as any other antidepressant, Dialogue: 0,0:05:53.35,0:05:55.54,Default,,0000,0000,0000,,and because this patient hadn't done well on those other antidepressants, Dialogue: 0,0:05:55.54,0:05:58.01,Default,,0000,0000,0000,,I thought, well, reboxetine is just as good. It's one to try. Dialogue: 0,0:05:58.01,0:06:01.40,Default,,0000,0000,0000,,But it turned out that I was misled. In fact, Dialogue: 0,0:06:01.40,0:06:03.85,Default,,0000,0000,0000,,seven trials were conducted comparing reboxetine Dialogue: 0,0:06:03.85,0:06:06.56,Default,,0000,0000,0000,,against a dummy placebo sugar pill. One of them Dialogue: 0,0:06:06.56,0:06:08.87,Default,,0000,0000,0000,,was positive and that was published, but six of them Dialogue: 0,0:06:08.87,0:06:12.92,Default,,0000,0000,0000,,were negative and they were left unpublished. Dialogue: 0,0:06:12.92,0:06:14.66,Default,,0000,0000,0000,,Three trials were published comparing reboxetine Dialogue: 0,0:06:14.66,0:06:16.88,Default,,0000,0000,0000,,against other antidepressants in which reboxetine Dialogue: 0,0:06:16.88,0:06:18.68,Default,,0000,0000,0000,,was just as good, and they were published, Dialogue: 0,0:06:18.68,0:06:23.07,Default,,0000,0000,0000,,but three times as many patients' worth of data was collected Dialogue: 0,0:06:23.07,0:06:24.94,Default,,0000,0000,0000,,which showed that reboxetine was worse than Dialogue: 0,0:06:24.94,0:06:29.64,Default,,0000,0000,0000,,those other treatments, and those trials were not published. Dialogue: 0,0:06:29.64,0:06:33.40,Default,,0000,0000,0000,,I felt misled. Dialogue: 0,0:06:33.40,0:06:35.53,Default,,0000,0000,0000,,Now you might say, well, that's an extremely unusual example, Dialogue: 0,0:06:35.53,0:06:37.54,Default,,0000,0000,0000,,and I wouldn't want to be guilty of the same kind of Dialogue: 0,0:06:37.54,0:06:40.52,Default,,0000,0000,0000,,cherry-picking and selective referencing Dialogue: 0,0:06:40.52,0:06:42.31,Default,,0000,0000,0000,,that I'm accusing other people of. Dialogue: 0,0:06:42.31,0:06:44.19,Default,,0000,0000,0000,,But it turns out that this phenomenon of publication bias Dialogue: 0,0:06:44.19,0:06:46.32,Default,,0000,0000,0000,,has actually been very, very well studied. Dialogue: 0,0:06:46.32,0:06:48.54,Default,,0000,0000,0000,,So here is one example of how you approach it. Dialogue: 0,0:06:48.54,0:06:50.98,Default,,0000,0000,0000,,The classic model is, you get a bunch of studies where Dialogue: 0,0:06:50.98,0:06:53.16,Default,,0000,0000,0000,,you know that they've been conducted and completed, Dialogue: 0,0:06:53.16,0:06:55.48,Default,,0000,0000,0000,,and then you go and see if they've been published anywhere Dialogue: 0,0:06:55.48,0:06:58.35,Default,,0000,0000,0000,,in the academic literature. So this took all of the trials Dialogue: 0,0:06:58.35,0:07:00.50,Default,,0000,0000,0000,,that had ever been conducted on antidepressants Dialogue: 0,0:07:00.50,0:07:04.14,Default,,0000,0000,0000,,that were approved over a 15-year period by the FDA. Dialogue: 0,0:07:04.14,0:07:07.90,Default,,0000,0000,0000,,They took all of the trials which were submitted to the FDA as part of the approval package. Dialogue: 0,0:07:07.90,0:07:11.10,Default,,0000,0000,0000,,So that's not all of the trials that were ever conducted on these drugs, Dialogue: 0,0:07:11.10,0:07:13.20,Default,,0000,0000,0000,,because we can never know if we have those, Dialogue: 0,0:07:13.20,0:07:16.69,Default,,0000,0000,0000,,but it is the ones that were conducted in order to get the marketing authorization. Dialogue: 0,0:07:16.69,0:07:19.04,Default,,0000,0000,0000,,And then they went to see if these trials had been published Dialogue: 0,0:07:19.04,0:07:21.61,Default,,0000,0000,0000,,in the peer-reviewed academic literature. And this is what they found. Dialogue: 0,0:07:21.61,0:07:24.78,Default,,0000,0000,0000,,It was pretty much a 50-50 split. Half of these trials Dialogue: 0,0:07:24.78,0:07:28.38,Default,,0000,0000,0000,,were positive, half of them were negative, in reality. Dialogue: 0,0:07:28.38,0:07:33.12,Default,,0000,0000,0000,,But when they went to look for these trials in the peer-reviewed academic literature, Dialogue: 0,0:07:33.12,0:07:35.35,Default,,0000,0000,0000,,what they found was a very different picture. Dialogue: 0,0:07:35.35,0:07:39.72,Default,,0000,0000,0000,,Only three of the negative trials were published, Dialogue: 0,0:07:39.72,0:07:44.37,Default,,0000,0000,0000,,but all but one of the positive trials were published. Dialogue: 0,0:07:44.37,0:07:48.13,Default,,0000,0000,0000,,Now if we just flick back and forth between those two, Dialogue: 0,0:07:48.13,0:07:50.72,Default,,0000,0000,0000,,you can see what a staggering difference there was Dialogue: 0,0:07:50.72,0:07:54.17,Default,,0000,0000,0000,,between reality and what doctors, patients, Dialogue: 0,0:07:54.17,0:07:56.79,Default,,0000,0000,0000,,commissioners of health services, and academics Dialogue: 0,0:07:56.79,0:08:00.07,Default,,0000,0000,0000,,were able to see in the peer-reviewed academic literature. Dialogue: 0,0:08:00.07,0:08:04.53,Default,,0000,0000,0000,,We were misled, and this is a systematic flaw Dialogue: 0,0:08:04.53,0:08:07.86,Default,,0000,0000,0000,,in the core of medicine. Dialogue: 0,0:08:07.86,0:08:10.52,Default,,0000,0000,0000,,In fact, there have been so many studies conducted on Dialogue: 0,0:08:10.52,0:08:13.90,Default,,0000,0000,0000,,publication bias now, over a hundred, that they've been Dialogue: 0,0:08:13.90,0:08:17.10,Default,,0000,0000,0000,,collected in a systematic review, published in 2010, Dialogue: 0,0:08:17.10,0:08:19.86,Default,,0000,0000,0000,,that took every single study on publication bias Dialogue: 0,0:08:19.86,0:08:21.16,Default,,0000,0000,0000,,that they could find. Dialogue: 0,0:08:21.16,0:08:24.02,Default,,0000,0000,0000,,Publication bias affects every field of medicine. Dialogue: 0,0:08:24.02,0:08:28.33,Default,,0000,0000,0000,,About half of all trials, on average, go missing in action, Dialogue: 0,0:08:28.33,0:08:31.39,Default,,0000,0000,0000,,and we know that positive findings are around twice as likely Dialogue: 0,0:08:31.39,0:08:34.44,Default,,0000,0000,0000,,to be published as negative findings. Dialogue: 0,0:08:34.44,0:08:38.50,Default,,0000,0000,0000,,This is a cancer at the core of evidence-based medicine. Dialogue: 0,0:08:38.50,0:08:42.37,Default,,0000,0000,0000,,If I flipped a coin 100 times but then Dialogue: 0,0:08:42.37,0:08:45.63,Default,,0000,0000,0000,,withheld the results from you from half of those tosses, Dialogue: 0,0:08:45.63,0:08:49.03,Default,,0000,0000,0000,,I could make it look as if I had a coin that always came up heads. Dialogue: 0,0:08:49.03,0:08:50.84,Default,,0000,0000,0000,,But that wouldn't mean that I had a two-headed coin. Dialogue: 0,0:08:50.85,0:08:52.56,Default,,0000,0000,0000,,That would mean that I was a chancer Dialogue: 0,0:08:52.56,0:08:55.68,Default,,0000,0000,0000,,and you were an idiot for letting me get away with it. (Laughter) Dialogue: 0,0:08:55.68,0:08:59.32,Default,,0000,0000,0000,,But this is exactly what we blindly tolerate Dialogue: 0,0:08:59.32,0:09:03.10,Default,,0000,0000,0000,,in the whole of evidence-based medicine. Dialogue: 0,0:09:03.10,0:09:07.54,Default,,0000,0000,0000,,And to me, this is research misconduct. Dialogue: 0,0:09:07.54,0:09:10.28,Default,,0000,0000,0000,,If I conducted one study and I withheld Dialogue: 0,0:09:10.28,0:09:13.28,Default,,0000,0000,0000,,half of the data points from that one study, Dialogue: 0,0:09:13.28,0:09:17.99,Default,,0000,0000,0000,,you would rightly accuse me, essentially, of research fraud. Dialogue: 0,0:09:17.99,0:09:20.77,Default,,0000,0000,0000,,And yet, for some reason, if somebody conducts Dialogue: 0,0:09:20.77,0:09:25.33,Default,,0000,0000,0000,,10 studies but only publishes the five that give the result that they want, Dialogue: 0,0:09:25.33,0:09:28.12,Default,,0000,0000,0000,,we don't consider that to be research misconduct. Dialogue: 0,0:09:28.12,0:09:30.68,Default,,0000,0000,0000,,And when that responsibility is diffused between Dialogue: 0,0:09:30.68,0:09:33.84,Default,,0000,0000,0000,,a whole network of researchers, academics, Dialogue: 0,0:09:33.84,0:09:37.37,Default,,0000,0000,0000,,industry sponsors, journal editors, for some reason Dialogue: 0,0:09:37.37,0:09:38.82,Default,,0000,0000,0000,,we find it more acceptable, Dialogue: 0,0:09:38.82,0:09:42.50,Default,,0000,0000,0000,,but the effect on patients is damning. Dialogue: 0,0:09:42.50,0:09:47.52,Default,,0000,0000,0000,,And this is happening right now, today. Dialogue: 0,0:09:47.52,0:09:50.23,Default,,0000,0000,0000,,This is a drug called Tamiflu. Tamiflu is a drug Dialogue: 0,0:09:50.23,0:09:52.82,Default,,0000,0000,0000,,which governments around the world have spent billions Dialogue: 0,0:09:52.82,0:09:55.40,Default,,0000,0000,0000,,and billions of dollars on stockpiling, Dialogue: 0,0:09:55.40,0:09:58.54,Default,,0000,0000,0000,,and we've stockpiled Tamiflu in panic, Dialogue: 0,0:09:58.54,0:10:02.49,Default,,0000,0000,0000,,in the belief that it will reduce the rate of complications of influenza. Dialogue: 0,0:10:02.49,0:10:05.18,Default,,0000,0000,0000,,Complications is a medical euphemism for pneumonia Dialogue: 0,0:10:05.18,0:10:09.99,Default,,0000,0000,0000,,and death. (Laughter) Dialogue: 0,0:10:09.99,0:10:13.20,Default,,0000,0000,0000,,Now when the Cochrane systematic reviewers Dialogue: 0,0:10:13.20,0:10:15.72,Default,,0000,0000,0000,,were trying to collect together all of the data from all Dialogue: 0,0:10:15.72,0:10:19.37,Default,,0000,0000,0000,,of the trials that had ever been conducted on whether Tamiflu actually did this or not, Dialogue: 0,0:10:19.37,0:10:22.32,Default,,0000,0000,0000,,they found that several of those trials were unpublished. Dialogue: 0,0:10:22.32,0:10:24.17,Default,,0000,0000,0000,,The results were unavailable to them. Dialogue: 0,0:10:24.17,0:10:28.13,Default,,0000,0000,0000,,And when they started obtaining the writeups of those trials through various different means, Dialogue: 0,0:10:28.13,0:10:29.81,Default,,0000,0000,0000,,through Freedom of Information Act requests, through Dialogue: 0,0:10:29.81,0:10:34.62,Default,,0000,0000,0000,,harassing various different organizations, what they found was inconsistent. Dialogue: 0,0:10:34.62,0:10:37.09,Default,,0000,0000,0000,,And when they tried to get a hold of the clinical study reports, Dialogue: 0,0:10:37.09,0:10:40.13,Default,,0000,0000,0000,,the 10,000-page long documents that have Dialogue: 0,0:10:40.13,0:10:43.73,Default,,0000,0000,0000,,the best possible rendition of the information, Dialogue: 0,0:10:43.73,0:10:46.62,Default,,0000,0000,0000,,they were told they weren't allowed to have them. Dialogue: 0,0:10:46.62,0:10:49.30,Default,,0000,0000,0000,,And if you want to read the full correspondence Dialogue: 0,0:10:49.30,0:10:52.59,Default,,0000,0000,0000,,and the excuses and the explanations given by the drug company, Dialogue: 0,0:10:52.59,0:10:55.31,Default,,0000,0000,0000,,you can see that written up in this week's edition Dialogue: 0,0:10:55.31,0:10:59.68,Default,,0000,0000,0000,,of PLOS Medicine. Dialogue: 0,0:10:59.68,0:11:03.54,Default,,0000,0000,0000,,And the most staggering thing of all of this, to me, Dialogue: 0,0:11:03.54,0:11:06.84,Default,,0000,0000,0000,,is that not only is this a problem, not only do we recognize Dialogue: 0,0:11:06.84,0:11:11.03,Default,,0000,0000,0000,,that this is a problem, but we've had to suffer fake fixes. Dialogue: 0,0:11:11.03,0:11:14.09,Default,,0000,0000,0000,,We've had people pretend that this is a problem that's been fixed. Dialogue: 0,0:11:14.09,0:11:16.28,Default,,0000,0000,0000,,First of all, we had trials registers, and everybody said, Dialogue: 0,0:11:16.28,0:11:19.88,Default,,0000,0000,0000,,oh, it's okay. We'll get everyone to register their trials, they'll post the protocol, Dialogue: 0,0:11:19.88,0:11:21.90,Default,,0000,0000,0000,,they'll say what they're going to do before they do it, Dialogue: 0,0:11:21.90,0:11:24.02,Default,,0000,0000,0000,,and then afterwards we'll be able to check and see if all the trials which Dialogue: 0,0:11:24.02,0:11:26.49,Default,,0000,0000,0000,,have been conducted and completed have been published. Dialogue: 0,0:11:26.49,0:11:28.69,Default,,0000,0000,0000,,But people didn't bother to use those registers. Dialogue: 0,0:11:28.69,0:11:31.31,Default,,0000,0000,0000,,And so then the International Committee of Medical Journal Editors came along, Dialogue: 0,0:11:31.31,0:11:32.85,Default,,0000,0000,0000,,and they said, oh, well, we will hold the line. Dialogue: 0,0:11:32.85,0:11:35.48,Default,,0000,0000,0000,,We won't publish any journals, we won't publish any trials, Dialogue: 0,0:11:35.48,0:11:38.17,Default,,0000,0000,0000,,unless they've been registered before they began. Dialogue: 0,0:11:38.17,0:11:41.70,Default,,0000,0000,0000,,But they didn't hold the line. In 2008, a study was conducted Dialogue: 0,0:11:41.70,0:11:44.71,Default,,0000,0000,0000,,which showed that half of all of trials published by journals Dialogue: 0,0:11:44.71,0:11:47.38,Default,,0000,0000,0000,,edited by members of the ICMJE Dialogue: 0,0:11:47.38,0:11:52.19,Default,,0000,0000,0000,,weren't properly registered, and a quarter of them weren't registered at all. Dialogue: 0,0:11:52.19,0:11:54.99,Default,,0000,0000,0000,,And then finally, the FDA Amendment Act was passed Dialogue: 0,0:11:54.99,0:11:57.34,Default,,0000,0000,0000,,a couple of years ago saying that everybody who conducts Dialogue: 0,0:11:57.34,0:12:00.78,Default,,0000,0000,0000,,a trial must post the results of that trial within one year. Dialogue: 0,0:12:00.78,0:12:04.88,Default,,0000,0000,0000,,And in the BMJ, in the first edition of January, 2012, Dialogue: 0,0:12:04.88,0:12:07.58,Default,,0000,0000,0000,,you can see a study which looks to see if people kept Dialogue: 0,0:12:07.58,0:12:11.30,Default,,0000,0000,0000,,to that ruling, and it turns out that only one in five Dialogue: 0,0:12:11.30,0:12:14.17,Default,,0000,0000,0000,,have done so. Dialogue: 0,0:12:14.17,0:12:17.45,Default,,0000,0000,0000,,This is a disaster. Dialogue: 0,0:12:17.45,0:12:21.02,Default,,0000,0000,0000,,We cannot know the true effects of the medicines Dialogue: 0,0:12:21.02,0:12:24.23,Default,,0000,0000,0000,,that we prescribe if we do not have access Dialogue: 0,0:12:24.23,0:12:27.41,Default,,0000,0000,0000,,to all of the information. Dialogue: 0,0:12:27.41,0:12:31.37,Default,,0000,0000,0000,,And this is not a difficult problem to fix. Dialogue: 0,0:12:31.37,0:12:36.50,Default,,0000,0000,0000,,We need to force people to publish all trials Dialogue: 0,0:12:36.50,0:12:39.47,Default,,0000,0000,0000,,conducted in humans, including the older trials, Dialogue: 0,0:12:39.47,0:12:43.41,Default,,0000,0000,0000,,because the FDA Amendment Act only asks that you publish the trials conducted after 2008, Dialogue: 0,0:12:43.41,0:12:46.03,Default,,0000,0000,0000,,and I don't know what world it is in which we're only Dialogue: 0,0:12:46.03,0:12:50.48,Default,,0000,0000,0000,,practicing medicine on the basis of trials that completed in the past two years. Dialogue: 0,0:12:50.48,0:12:52.59,Default,,0000,0000,0000,,We need to publish all trials in humans, Dialogue: 0,0:12:52.59,0:12:55.66,Default,,0000,0000,0000,,including the older trials, for all drugs in current use, Dialogue: 0,0:12:55.66,0:12:58.58,Default,,0000,0000,0000,,and you need to tell everyone you know Dialogue: 0,0:12:58.58,0:13:02.02,Default,,0000,0000,0000,,that this is a problem and that it has not been fixed. Dialogue: 0,0:13:02.02,0:13:04.97,Default,,0000,0000,0000,,Thank you very much. (Applause) Dialogue: 0,0:13:04.97,0:13:08.24,Default,,0000,0000,0000,,(Applause)