Debatt

Unpublished trials are a cancer at the core of evidence based medicine | Ben Goldacre

  • Ben Goldacre

Foto: badscience.net/Ben Goldacre

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Debatt
Dette er et debattinnlegg. Meninger i teksten står for skribentens regning.

NORWEGIAN VERSION HERE

Foto: Ingar Storfjell

Medicine has a dirty secret, and we need your help.

Like most doctors, I always assumed that textbooks and academic journals were full of simple facts. But as I became an academic researcher, I found a vast problem looming in the background.

We do clinical trials to find out whether a treatment is effective. But the evidence shows that around half of those trials go unpublished:

Results are routinely withheld from doctors, and researchers, and patients, at the whim of the commercial sponsor, or the individual researcher.

This is a cancer at the core of evidence based medicine.

Regulations provide false reassurance

Are there no laws? Well, there are occasional regulations around the world; but these are so poorly enforced that they have arguably made things worse, by providing false reassurance.

The FDA Amendment Act 2007, for example, in the US, requires all trials to post results within 12 months of completion.

Everyone celebrated when this law was passed, believing that the problem had been fixed. But nobody bothered to check if the law was working:

And when independent audits were finally published, in 2012 and 2015, we found that only one trial in five complies with this law. And yet nobody has ever once been prosecuted for withholding results. This is “transparency theatre”: nothing more than a fake fix.

We need all trials

Meanwhile, doctors have to get on with being doctors: but we cannot make truly informed decisions with our patients, about which treatments work best, if we can’t see all the evidence. And we cannot fix this problem by only getting access to new trial results:

We need the trials done over the past two decades, because these are the trials done on the treatments we use today.

This week twenty Norwegian healthcare organisations signed up to a campaign I co-founded, to try and fix this problem. We are called AllTrials.net, and we campaign for all trials to be registered, with their full methods and results reported.

There are people who think “campaigning” is not a scientific or seemly thing for an academic doctor to do. Those people are wrong.

When academics see a problem, they shouldn’t just write an academic paper describing it: they should act. That’s the responsibility of a doctor, and it’s your responsibility to.

Foto: Ingar Storfjell

So here is my pitch. Norway is a small, independent, strong, and wealthy country. You have the power to change the world, by asking your government to do two achievable things.

Firstly, anyone receiving government funds to do a trial should be compelled to share the results, before they receive the last slice of funding;

And anyone applying for such funds should be required to sign a formal declaration stating that they’ve shared all their previous trials’ results.

Secondly, anyone receiving ethics committee approval to conduct a trial in patients should be compelled to share results;

Ethics committes should check compliance; and they should blacklist those who breach. You can do this. The sky will not cave in, and you will show the whole world what is possible.

It would be a very, very great gift to us all.

Foto: Ingar Storfjell

About the writer:

Twitter: @bengoldacre

First book: Bad Science

Second book: Bad Pharma

Third book: Bad Writing

Blog here.

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