The Hidden Side of Clinical Trials: Sile Lane (Full Transcript)

Sile Lane on Clinical Trials at TEDxMadrid

Following is the full text of Sile Lane’s talk titled “The Hidden Side of Clinical Trials” at TEDxMadrid conference.

Sile Lane – TEDx Talk TRANSCRIPT

What I’m about to tell you will shock you. It shocked me the first time I heard about it and frankly it still shocks me.

When you go to a doctor and they prescribe you a medicine you presume it’s been tested and we know everything there is to know about whether it works, right?

Well guess what. A lot of the time that’s just not the case. And this is because around half of the clinical trials that have been carried out on medicines that we use today have never published results.

So we don’t know what was found out about our medicines in around half of the biggest trials that have happened on them.

Clinical trials are those big tests where some people are given a new medicine and some other people are given a different medicine or no medicine at all to test whether the new medicine works and to see if it’s safe.

The results from those trials are then used by governments who have to decide whether to pay for the medicine. By regulators, who decide whether to allow the medicine to be sold. By doctors, deciding which medicine to give to their patients. By researchers, deciding whether to do more research on that medicine.

So if the results from half of these tests are missing, it means that these decision makers lack a huge amount of the information they need to make good decisions.

It means that doctors have no way of knowing for sure that the medicines they’re giving their patients are the best medicines and that they’re not in fact doing harm.

Here’s an example: a heart drug called Lorcainide was tested in clinical trials in the 1980’s. The results of those trials showed that the patients given Lorcainide were far more likely to die during the trial than the patients not given Lorcainide.

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Those results weren’t published. Not until 10 years later.

And in those 10 years, doctors continued to prescribe medicines like Lorcainide to their patients. And it’s been estimated that more than 100,000 people died as a result.

When clinical trial information is kept hidden, it means governments and regulators are at risk of making the wrong decisions. One regulator, for example, in the UK recommended that the UK government buys a stock of a drug called Tamiflu on the basis of the results of clinical trials that it had seen.

So the UK government went ahead and spent 480 million pounds. That’s nearly half a billion pounds on this medicine.

But then, some researchers saw that the government had only seen the results from a small number of all the clinical trials that had happened on Tamiflu. They battled for years to get the results of all of those trials released.

And when all the results were put together, it turned out that Tamiflu just wasn’t that effective. That was half a billion pounds of government money wasted.

And here’s another problem: when the results of trials aren’t published, it means that researchers and doctors can’t build on research that’s already been done.

So much knowledge about medicines and about diseases is generated in clinical trials but if the results aren’t shared, all of that knowledge is lost.

And it means that clinical trials get repeated unnecessarily wasting loads of money — they’re very expensive to run — and putting the people who volunteer for the trials needlessly at risk.

Now we’re getting to the heart of why I really care about this. It’s because of people who volunteer for clinical trials. You know, clinical trials can’t just happen. People have to volunteer to be part of them.

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