There is no denying in the fact that literature and journal publications have always been and continue to be the primary source of scientific experise and knowledge. Unfortunately, buried underneath there is an aspect of the so called “publication bias” expecially in the field of evidence based medicine. Well as the name says, its just how the unflattering data get’s lost and get’s unpublished.
Dr. Ben Goldacre (I neither endorse nor criticise his views, this is a mere topic of discussion for all of us) has been a long time critic in medical journalism and his views on this area are very radical. The following examples were taken from one of his talks where I happened to be in the audience:
In 1980, a small trial of anti-arrhythmic drug ‘Locrainide’ was conducted in 100 patients in the development stage. 50 patients were given Lorcainide, and 10 people died and the other 50 were dosed with a placebo, of which 1 died. So they regarded this drug as a failure and it’s commercial development was stopped. And because this drug was never released, the trail results were never published. Unfortunately 5-10 years later other companies had the same idea about anti-arrhythmic drugs and these drugs were commercialised and highly prescribed. By the time they knew, 100000 people already died in America. So now in 1993 the researchers who carried Lorcainide trial published a ‘mea culpa’ regarding this incident stating it would have helped as an early warning if the results had been published back in 1980. This is a good example of Publication Bias.
Another example is “Reboxetine”, an antidepressant. Seven studies were conducted where Reboxetine was compared to a placebo. One of these was positive and got published, and 6 were negative and were left unpublished.Three trials were published comparing reboxetine against other antidepressants in which reboxetine was just as good, and they were published, but three times as many patients’ worth of data was collected which showed that reboxetine was worse than those other treatments, and those trials were not published. Majority of doctors out there will be misled by these published data.
Ben quotes: “This is a cancer at the core of evidence-based medicine. If I flipped a coin 100 times but then withheld the results from you from half of those tosses, I could make it look as if I had a coin that always came up heads. But that wouldn’t mean that I had a two-headed coin. That would mean that I was a chancer and you were an idiot for letting me get away with it. But this is exactly what we blindly tolerate in the whole of evidence-based medicine. And to me, this is research misconduct. If I conducted one study and I withheld half of the data points from that one study, you would rightly accuse me, essentially, of research fraud. And yet, for some reason, if somebody conducts 10 studies but only publishes the five that give the result that they want, we don’t consider that to be research misconduct. And when that responsibility is diffused between a whole network of researchers, academics, industry sponsors, journal editors, for some reason we find it more acceptable, but the effect on patients is damning.”
This is not an impossible problem to fix. We need to force people to publish all trials conducted in humans, including the older trials, because the FDA Amendment Act only asks that you publish the trials conducted after 2008, which is just a “fake-fix”. We need to publish all trials in humans, including the older trials, for all drugs in current use, and you need to tell everyone you know that this is a problem and that it has not been fixed.