The AllTrials Campaign Re-printed with the kind permission of the Auckland Womens Health Group
An international campaign has been mounted for the publication of the results from all clinical trials – past, present and future – on all treatments currently being used.( 1)
Currently companies and researchers can withhold the results of clinical trials even when they are asked for them. It has been like this for a very long time, and it has resulted in poor treatment decisions, patients being harmed or dying, law suits, drug company scandals, and a waste of health dollars.
The problem is well documented. The current best estimate is that half of all the clinical trials that have been completed have never been published in academic journals. Trials with positive results are twice as likely to be published as others while many trials with negative results are simply swept under the carpet.
It goes without saying that doctors and regulators need the results of all clinical trials to make informed decisions about which treatment is best. Without all the evidence it is impossible to know what the real risks and benefits of a particular drug or medical device are. It results in ridiculously absurd situations whereby patients are at risk of being exposed to unnecessary harm through being prescribed the wrong treatment or their doctor prescribes an expensive new drug when an older cheaper one is actually more effective.
Ben Goldacre gives a personal example of why missing data matters so much
20 in his latest book“ Bad Pharma.”( 2) He describes how several antidepressants had done nothing for one of his patients, so he and his patient decided to try something new. Ben Goldacre writes:“ I’ d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelm-ingly positive results. Reboxetine [ the anti-depressant ] was better than a placebo, and as good as any other antidepressant in head-to-head comparisons... Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next.”
Subsequent investigation by a group of researchers, a long process that involved searching in academic journals, arduous requesting of data from the manufacturers and gathering documents from regulators, revealed a very different picture. Out of seven trials comparing reboxetine against a placebo only one, conducted in 254 patients, had a positive result. It was the only study that was published in an academic journal. The other six trials involving almost ten times as many patients were never published as they showed that reboxetine was no better than a dummy sugar pill.
The trials comparing reboxetine against other drugs produced the same result. The three small studies involving 507 patients that showed that reboxetine was just as good as any other drugs were published, but the other studies which involved 1657 patients were not published as they showed that patients on reboxetine did