The hidden side of clinical trials | Sile Lane | TEDxMadrid

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 Lorcinide was tested
in clinical trials in the 1980's.

The results of those trials showed
that the patients given Lorcinide

were far more likely to die
during the trial

than the patients not given Lorcinide.

Those results weren't published.

Not until ten years later.

And in those ten years, doctors
continued to prescribe medicines

like Lorcinide 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 Lorcinide 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.

(Spanish) Thank you.

(Applause)