Was that a half-truth or a lie by omission? Trick question…
Malcolm Kendrick reports on a new study that he says should “shake the foundations of medical research” but laments that it almost certainly won’t.
In the year 2000, the US National Heart Lung, and Blood Institute (NHLBI) insisted that all researchers register their “primary aim” and then later their “primary outcome” with clinicaltrials.gov. This one small change in the way medical studies were reported transformed the “success” rates in peer reviewed papers. Before 2000, fully 57% of studies found the success they said they were testing for, but after that, their success rate fell to to a dismal 8%. When people didn’t have to declare what their aim was, they could fish through their results to find some positive, perhaps tangential association, and report that as if they had been investigating that effect all along. The negative results became invisible. If a diet, drug or treatment showed no benefit at all, or turned up bad results, nobody had to know.
The world of peer reviewed climate research: like a universe of dark matter
It’s not like climate science suffers from unpublished “negative results” — no, it’s more like it’s built on them: like all the model runs that ran off the ranch and disappeared, and the hot spot that never went missing, but keeps being “found”. The infamous Pause in the Climate barely existed until a forest of explanations for it appeared. Then there are the strange missing proxies — like the tree rings from the last 30 years. Did no one look, have all the trees gone, or were those awkward results dropped down the memory hole? Or is it because when someone did, the proxy turns out to be useless like the Sheep Mountain hockey-stick tree rings did?
Without a hypothesis, research isn’t science, just a glorified PR machine.
A group of researchers recently looked at 55 large clinical studies funded by the NHLBI between 1970 and 2012 to see if the transparency rules had made any difference. What they found should shake the foundations of medical research…but it almost certainly won’t:
- 57% of studies (17/30) published before 2000 showed a significant benefit in the primary outcome
- 8% (2/25 trials published after 2000 showed a significant benefit in the primary outcome
As the researchers said ‘The requirement of prospective registration in ClinicalTrials.gov is most strongly associated with the trend towards null clinical trials. The prospective declaration of the primary outcome variable required when registering trials may eliminate the possibility of researchers choosing to report on other measures included in a study. Almost half of the trials [published after 2000] might have been able to report a positive result if they had not declared a primary outcome in advance.1’
Pharmaceutical companies have been asked to register trials since 2005.
At this point I am going to try and join two thoughts together. Almost every study done on blood pressure lowering, blood sugar lowering and cholesterol lowering was done before the year 2005. I only choose these three areas as they are the three area of maximum drug prescribing in the world. Billions upon billions are spent in these areas, hundreds of millions are ‘treated’.
The evidence used for this mass medication of the Western World is demonstrably, horribly, biased. Had companies been forced to register their trials prior to publication, positive results would have been reduced by at least 49%. Almost certainly far more. You could put this another way around and say that it very likely that only 8% of studies would have been positive.
We do not know which trials would have been positive, or which negative. Yet we have based the entire edifice of drug treatment, of hundreds of millions of people, on unreliable nonsense. The study in PLOS is only the latest demonstration of this fact. The database of medical research – everything until at least 2005 is a gigantic festering mess. It needs to be stripped out and cleansed.
Read it all: The Augean stables – he has quotes from the editors of major medical journals to back up his dire warnings.
Hidden, unpublished results in peer reviewed medicine are not just wasted tax dollars, they’re dangerous. How many people died because of drug test results that were never published?
Kaplan RM, Irvin VL (2015) Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time. PLoS ONE 10(8): e0132382. doi:10.1371/journal.pone.0132382