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.
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.
Usually there’s hundreds of people in a trial. Big trials can include thousands of people. These people are patients, mostly, who volunteer for the trials knowing that it might, or might not, help them personally to be part of it but knowing that it will help other people in society in the future.
The people who volunteer for clinical trials and I think they’re amazing, these people willingly and for the good of all of us put themselves at risk because there’s always some risk when you’re testing something new. And they take a gamble, because it might be the medicine they get in the trial is not as good as the medicine they would otherwise take.
And they give up time, so much time, going to endless hospital and doctors’ appointments as part of the trial. Time they would probably prefer to be spending with their friends and families.
So they put themselves at risk, they take a gamble and they give up their time and they do all this trusting that if something is uncovered about their condition or the medicine in the trial, that that will be shared with doctors and researchers who can take it and use it to make life better for people like them in the future.
So when the results of half of all trials are kept hidden and the results are never used, what an enormous betrayal of these people’s trust. If thousands of clinical trials have never published results, that’s hundreds of thousands, probably millions of people whose trust has been betrayed.
Now you might be wondering, how do we know that clinical trials haven’t published results? What do we know about this missing information?
And the truth is we’ll never have an exact number of the clinical trials that never published results because there’s no list of all the trials that have happened that we can check against.
But researchers have started to get a feel for the amount of missing information. A researcher looking into this, the first thing they would do is try and identify what trials have happened.
To do that they would go to a clinical trial register. These registers are online databases set up by governments, by the WHO, by universities, where clinical trial sponsors are encouraged to go and log details of trials they’re running so that doctors and patients can see the trials that are happening and maybe join them.
So, once researchers have identified trials on a register, then they can follow those up, they search around, they look in medical journals, or in reports from conferences or in other registers to try and see if they can find any results from that trial.
Now that’s not easy to do. It’s not easy to find clinical trial results; they could be in one of hundreds of different places and it’s not always easy when you do find some results to be sure they do actually match the trial you identified.
It would take an eternity for a researcher to do that with the millions of clinical trials that are now on registers.
So what researchers have started to do is to focus in on some subsets of trials. Like, a researcher might look at all the trials done just on one certain drug or all the trials done looking at a particular condition or maybe all the trials that happened in one year in a particular country.
Hundreds of pieces of research like those have happened now each looking at a small piece of the puzzle and they, quite consistently, are showing that half of the body of clinical trials have never published results.
And researchers have begun to look too at the kind of results that do and don’t get published. And it looks like there are a lot more results from trials which show that a medicine works, published, than trials which show that a medicine doesn’t work.
And now we know that trials which give a so-called positive result are twice as likely to have published results than trials which give a negative result.
So not only is a huge amount of the information about our medicines missing the information that is there doesn’t necessarily give a true picture. It’s biased.
When I tell people this, that it’s more than likely the trials which show that medicine is dangerous and doesn’t work are kept hidden, they ask me, well, does it matter if a medicine doesn’t work? It doesn’t matter if the trial isn’t published.
But that’s what happened in the cases of Lorcainide and Tamiflu earlier. When those trials aren’t published, we’re at risk of wasting money and hurting people. We need the results from all of those trials to be made available.
How did we get into this situation, where information is being withheld, that means we are wasting money and we are hurting people. When I tell people that this is what’s happening, they almost always ask me back: isn’t there a law against this? And the answer to that is: sort of yes.
But in reality, no. There isn’t. There is a piece of law in the United States which says that for some particular trials that happen in America should be put on a register and report results within a year of the end of the trial. That law has existed since 2008.
Yet, in 2015, when researchers looked at those particular trials in the States they found that only about 20% had actually reported results within a year. That’s only one out of five trials following the law. Four out of five trials were breaking the law. Yet no one has ever been fined.
There’s going to be a law like this in Europe soon when the new clinical trials regulation comes into force in 2018 but where the laws exist now no one’s following them so, will anybody follow that?
Clinical trials are carried out by companies, by universities, by charities, by governments for all sorts of different reasons and they happen all around the world. There will never be a law or a set of guidelines that is enforceable across all of those.
Different countries and different sectors have different practices. However, something that does seem to unite many sectors running clinical trials is the culture of secrecy that has grown up around clinical trial results. It’s become the norm.
In fact, it’s become OK that if you get a result in a trial that you don’t like, that you can put that trial in your bottom drawer forget about it and move on to the next thing. It’s what’s been done the world over. And it’s not OK. And it’s got to stop. It has got to stop.
So how do we fix this? Imagine there was a law. Imagine a brand new, strong, global law comes into force tomorrow which says that from now on every clinical trial will be registered and results from them will be reported. Good, yeah?
But that wouldn’t be enough. Because the medicines we and our families use today and will continue to use for years into the future were tested in trials that happened in the past. Trials that happened years ago or decades ago. And not until all the information from those old trials is made available to regulators and researchers will we be able to trust that we know everything we should about those medicines.
So what to do about those old trials? Academics have known about the problem of clinical trial information missing for decades, for more than 30 years now. And not much has happened to fix that.
But, and here’s the good news, things are starting to change now that a lot more people are getting involved in this. Thousands of people persuaded the European Parliament to vote in the new clinical trials law. Hundreds of organizations backed the World Health Organization when they said that clinical trial results should be published.
There’s now a movement led by patients and by patient groups all around the world, including here in Spain, which is calling on policymakers and clinical trial sponsors to do everything they can to get that old information out there and used before it’s lost from us forever. We’re called All Trials. And we’re called All Trials Español.
We’re telling everybody we can about this problem and we’re asking you all to pass it on because not until a lot more of us know about this and are talking about this, will we be able to overturn that culture of secrecy and make it so that keeping clinical trial information hidden is no longer OK.
People don’t quite believe me when I tell them that we’re not sure that we know everything we should know about our medicines, but it is true.
Now, we’ve got to do everything we can to get hidden information out and into the light before it’s too late.
NOTE: Find out more about the AllTrials campaign ad references for claims made in the talk at www.AllTrials.net.
Download This Transcript as PDF here: The Hidden Side of Clinical Trials_ Sile Lane (Full Transcript)
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