The Drug Trial: Emergency at the Hospital


The Drug Trial: Emergency at the Hospital

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Transcript


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This programme contains some scenes which some viewers may find upsetting.

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I thought I was doing something good for science,

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but in the end it was the worst thing I could ever have done.

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They thought they were coming here to take part in medical testing of a new drug.

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Something went wrong.

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When you take a new drug into humans for the first time,

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it's never without risk.

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My whole body just went freezing cold.

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I started shaking.

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This wasn't something you could stop.

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Everything was happening all at once.

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Vomiting, screaming in pain.

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It was extremely scary.

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Ryan, are you still with me?

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We had no way of predicting how severe it was going to get.

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There's no rule book for how to deal with this.

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This was a mystery.

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They thought we looked like the elephant man.

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Everybody wanted to get a glimpse of these atrocious monsters.

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It's a never event.

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It should never happen. It was profound.

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I mean, this is unprecedented.

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It was like a horror movie with the way it was set up.

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Something could have been tampered with, sabotage.

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Poisoned. I've never seen anything like this before.

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I was in intensive care...

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..fighting for my life...

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..and someone was responsible for that.

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Parexel is a large multinational contract research organisation.

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They had a site

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which they leased from Northwick Park Hospital

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and we were doing clinical trials independently from the hospital

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on early-phase development of new drugs.

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I was about 31.

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I'd just come back from LA.

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I'd been there for two months doing an acting course for Screen.

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It was a really good time but I'd managed to get a little bit of debt behind me.

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A friend of mine had done trials and he said I should sign up.

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They were offering £2,000 and I thought that was OK.

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I was interested in the kind of historical...

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Just the scientific contribution I could be making.

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When I saw the ad I was like,

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£2,000 for three days' work seemed like a good deal to me

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considering I'd done two previous trials and it wasn't hard work.

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When I first arrived at the Parexel unit, I was running late.

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I was only 23, so I was a baby.

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I'd just finished university.

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I was in between a couple of jobs.

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Medical trials were kind of like a get-rich-quick scheme.

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A no-brainer, really.

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Just some information for you to look through

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while we're dealing with the preliminaries.

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After we'd had some tests done, we received our pile of paperwork.

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There was a doctor there.

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And he quickly went through what the drug was going to be about.

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The drug itself was supposed to be able to treat leukaemia.

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TGN1412 is a type of drug called a monoclonal antibody.

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It's important to realise, I think, that we stand on the threshold

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of a revolution in the way certain types of illnesses,

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particularly cancers, are treated.

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The traditional approach to treating cancers has been options

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such as surgery, chemotherapy or radiotherapy.

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Chemotherapy agents, as you probably know, are essentially poisons.

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So TGN1412 was intended to treat cancers by educating

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our own immune system into dealing with them.

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Now that's clearly a preferable option.

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I thought, it's a nice thing to do these trials because not only am

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I getting some cash for participating but it's helping science and

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it's going to help cure people further on down the track, hopefully.

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And you get paid as well, so bonus.

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Every one of the drugs that we all commonly use were once first used in humans.

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They have to go through that stage before they go into bigger

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trials and then into widespread use.

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This was a drug that had shown great promise in animal studies.

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And the TGN1412 trial

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was a first-in-man study, and the first study in humans

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is about getting to understand how the body deals with the medicine,

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how it handles it.

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It was the first-in-man study at the time.

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It didn't really, kind of, sink in

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actually, how important the first-in-man study is.

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It was never really discussed in great detail,

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it was just one point in 10, 15 points that were set out.

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The thing I need to get you to do now is to sign a consent form.

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It's important to know that when

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one participates in a first-in-man study,

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all that is possible should have been done

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in the pre-clinical studies to limit any anticipated risk.

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But when you take a new drug into humans for the first time,

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it's never without some risk.

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We all knew there was a tiny element of risk,

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but the side effects were things like, you could end up with hives,

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you could get anaphylactic shock... You can get that from a bee sting.

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And you can even do a cosmetics trial and have the same reaction,

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so, hey, there's no concern here.

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I don't ever remember having any second thoughts.

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I kind of breezed through and signed off quite quickly.

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It was a medicine being tested in a laboratory situation,

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approved by the government.

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What could go wrong?

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The trial was a double-blind

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randomised control trial.

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And that means that some of the men will have had the active treatment

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and two of them will have had a placebo or dummy treatment

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that has no effect.

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Neither the clinicians nor the men themselves would know who has the

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active or inactive treatment.

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There were eight of us, a bit of a mix of nationalities.

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Quite a good mix,

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I think it definitely covered the bases for men of our age.

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Just to get a good idea of how the body handles the drug,

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then it's better to have healthy people,

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usually men because there's always the risk to

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reproductive system studying women.

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From looking around,

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I think I worked out that I was probably the oldest.

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I was 34 years old and I had lots to look forward to in my life.

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I'd just recently got engaged.

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We were planning a nice wedding for family,

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honeymoon and hopefully children.

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The drug company looked at the highest dose without any adverse

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effects in monkeys and then they scaled that back 500-fold

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to give the first dose in humans,

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giving what they felt was substantial leeway

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in terms of safety.

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Let's get started.

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Number one, you're first.

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With hindsight, being the first person to receive a drug

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which is the first time in humans,

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yeah, probably not the smartest thing.

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We're going to get ready and administer the compound.

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We'll start the machine. OK.

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There we go.

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MACHINE BEEPS

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'As a medical student,

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'I volunteered for lots of drug trials to make extra money.

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'After I graduated,

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'I worked as a junior doctor in hospitals before joining

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'a private drugs company that ran trials.

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'I had been involved in more than 300 trials when I was put in charge

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'of testing a new drug.'

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Right, comfortable?

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-Yeah.

-Great. All right,

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we'll come and check on you again in a few minutes.

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-Cool.

-Great.

-Thank you.

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Get everyone else going.

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When you're in the ward, when you have everything connected to you,

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it gets a bit more real.

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Your feelings are a bit more...

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..maybe nervous.

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You're kind of just locked in,

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in the sense that you're going to be here now.

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This is where you are, you're not going to move.

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You know, like a long journey that you're trying to prepare for

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and that was the set-up then.

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OK. Going to start the machine.

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The whole process was quite quick.

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Once they'd finished with myself, they moved over there.

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Obviously the drug was still going in at the time.

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I had a couple of books with me that I was really looking

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forward to getting stuck into.

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And the first side effect I noticed would have been a headache.

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Just a slight headache to start with.

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Round about 20 or so minutes after receiving the drug.

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But then that got worse and worse and worse.

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And it was not until the point where it was on the verge

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of a full-blown migraine that I put two and two together and thought,

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hey, hang on a second,

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I've just had this drug pumped into me and now I'm getting a migraine

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which I never get.

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I need to be telling somebody about this.

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Nurse.

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I told the nurse that I'm having a major headache.

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This might help.

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She arranged a cold compress on my forehead but she didn't give me

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anything for it because they don't want anything

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to taint the effects of the drug that they're testing.

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I know they'd been in the previous ward

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and activated the syringe and then they came into ours.

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You're first on my list. How are you feeling?

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Machine is going to administer the drug.

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Ryan was quite a bit younger than me,

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I think he must have been about 19 or 20.

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I think he was saving up for driving lessons or something.

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He's a nice guy, I enjoyed talking to him.

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I didn't think it would have been done

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like such a production line.

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I think they would have given it and watched and then the next person

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and watched but it seemed like they just gave everybody the injection with ten minutes space.

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The headache got progressively worse,

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to a migraine, but it was slightly different to a regular migraine,

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whereas it was coming in waves.

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It would get really bad and then it would sort of ease off a bit,

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then it got really bad, then it would ease off

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but over a period of, like, minutes.

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It was only a short period of time before the incidents were starting to occur.

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I remember still reading my book and I hadn't got too far into it.

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David was complaining that he was burning up and his body was getting

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really hot and his head was hurting.

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He had to take his top off because he just couldn't handle

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how hot he was getting.

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I started thinking, this is going to happen to me.

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-Still the headache?

-Yeah.

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I'm assuming that maybe I'm a bit slower,

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maybe it's going to kick in shortly.

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It was daunting, it was extremely scary.

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I'm really surprised that they didn't stop the trial next door.

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From what was happening to us,

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they had a chance to save one or two guys.

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-Good evening, 007.

-Hello.

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When they put the syringe onto that mechanical device,

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pressed go on the machine,

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you could hear the noise of the syringe pump as it was infusing us.

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You can just see this liquid creeping down the clear pipe

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and going into your body

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and it's an unusual situation knowing that there's, to you,

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an unknown fluid going into your veins.

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It's a weird experience.

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After I'd given the dose to the seventh man,

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a nurse told me one of the men had a headache.

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While dosing the eighth, the nurse returned

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and told me that the first man was feeling worse.

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Doctor, can I have word?

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It was an instant point, I was like, bang.

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Severe back pain in my lower back.

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It was way worse than the migraine.

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How are we doing, David?

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I was trying my hardest to twist and turn to find a position

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that I could feel less pain. I couldn't understand it.

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It was so debilitating, it was horrible.

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HE GROANS

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How are we doing?

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And then the guy to my left started saying that he had a headache

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and his head was sore and his back was hurting.

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As bad as it sounds,

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it made me feel slightly better

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that I wasn't going through this on my own.

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Once we'd been injected,

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within a minute or two I was feeling like I had hypothermia.

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It was a bit like if you could imagine

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being dipped into ice quite rapidly,

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my whole body just went freezing cold and I started shaking.

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This was like this.

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Shivering with cold but I wasn't cold.

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This wasn't something you could stop.

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It was just so extreme that it was just horrendous.

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Everybody was failing.

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HE GROANS

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'Then they tumbled like dominoes.'

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I remember being sick into one of those big, yellow biohazard bags.

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It was terrible. I must have brought up a good litre of bile,

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just solid bile.

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It was all manic.

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Everything was happening all at once.

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They were vomiting, they were screaming in pain.

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People fainting.

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They couldn't control their bowels.

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For some reason patient three

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started to think he would do better if he got out of this place.

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He was saying things like, "I don't want the money any more, I just want to get out."

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He just started panicking, started freaking out.

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It's really important that you stay in the bed.

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He was begging when he was saying he wanted to go home.

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He was screaming in pain, which was the most kind of,

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harrowing kind of moment.

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Because he was in complete agony.

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Let's bring you back.

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He just freaked, he just thought they were out to get him.

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And that he would do better if he actually got out of the hospital,

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as if getting out of the hospital, the pain would go away.

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Calm down and relax, OK?

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MAN GROANS

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'The wards became chaotic.

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'The men were getting worse.

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'Their bodies were in shock.'

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MAN SCREAMS

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There was chaos.

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The nurses were taken off guard.

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I remember the doctors not knowing what to do.

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They were probably afraid.

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They probably hoped it would only last a short time.

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They weren't expecting it to carry on and get worse and everything else that happened.

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It was like a horror movie with the way it was set up.

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As time was progressing, you're just kind of thinking,

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this is going to happen to me.

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It's like going on a rollercoaster.

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You know it's going to be scary.

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You're thinking, "Oh, no, why am I doing this, why am I doing this?"

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They closed the curtains.

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You're just there left with nothing, just noises.

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MEN SCREAM AND GROAN

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I was just like a ghost in a room.

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This must have just been terrible for everyone involved.

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Clearly, it was catastrophic for the volunteers,

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but I think it would've been really scary for the medical staff as well.

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It's not something you expect to see

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in your lifetime doing clinical trials

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and suddenly there are people getting extremely ill

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all around you.

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It was obvious that there was something really serious going on.

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'I couldn't reach the medical registrar.

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'I ended up running down two flights of stairs to the intensive care unit

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'and grabbing the first two doctors I saw.'

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I was still unsure what was happening.

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Then one of the nurses came to unplug everything.

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I was told then to go and get some food

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and someone would be with me shortly.

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I remember just kind of thinking, what have I just sat through?

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Just unsure of everything.

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Then I was told to collect my things.

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I came back and the ward was empty.

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One minute you're in a ward with patients who sounded like they're

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fighting for their lives and then you come back and they're gone.

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It was so surreal.

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What's going on? What's happening?

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MACHINES BEEP

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The lights were kept dimmer in there and I'm pretty sure I was

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falling asleep and waking up, falling asleep, waking up.

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That whole day, where did it go?

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I felt concerned, but I still had a lot of trust in the company that were doing this trial.

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I believed that we were safe and even though it wasn't feeling good,

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I would never have thought that we were at death's door.

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It had become quite dark outside,

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hours had passed and then there seemed to be a problem with Ryan.

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MACHINE BEEPS RAPIDLY

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HE PANTS

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Ryan, you're still with me.

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Talk to me, tell me how you're feeling.

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All of a sudden, some surgeon guys came up.

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OK, what's been going on here, Doctor?

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And they drew the curtain around him.

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I remember then, a few of us were looking at each other, like,

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what's going on here because it's quite worrying.

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That was when I thought, OK, we could be in serious trouble.

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Is that what we've all got to look forward to?

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They then wheeled him away... connected to these machines.

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That was probably the moment that I remember thinking, this is scary.

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PHONE RINGS

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I wasn't scheduled to be on duty that night.

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I was having supper with my wife when the phone call came in.

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My colleague explained the situation.

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A drug no human had had before, an unknown illness,

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there were six of them,

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one of them in intensive care.

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Things were changing very quickly.

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They were deteriorating in front of us.

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I said, "Look, this is clearly unprecedented, I'll come in."

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He said words to the effect of, yes, that would be a good idea,

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although shorter and more expletive.

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So I walked through to the intensive care unit,

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where the first of the patients had been brought down.

0:24:590:25:02

Looking at him as an intensivist,

0:25:020:25:04

he was really as unwell as anyone I've seen.

0:25:040:25:07

His blood pressure was very low

0:25:070:25:09

and the settings on the ventilator showed me that,

0:25:090:25:11

again, his lungs had been quite badly affected.

0:25:110:25:13

We were having to set things to a fairly high level to keep him safe and stable.

0:25:130:25:17

So it was clear that this was a very serious situation.

0:25:170:25:21

We also knew there were five more people up there who'd received the same drug.

0:25:210:25:24

The clock was ticking.

0:25:250:25:27

The rate at which they were deteriorating was very rapid.

0:25:280:25:32

The doctors from the hospital, they were seriously concerned.

0:25:320:25:35

This was in the hands of the NHS now and they obviously have to...

0:25:350:25:41

Well, they've got a different criteria.

0:25:410:25:43

They're in it for saving lives, not for making money as well.

0:25:430:25:47

We knew that this was serious.

0:25:540:25:56

There was a feeling of, who's next?

0:25:570:25:59

Then, not long after, the two guys came to collect me.

0:26:010:26:05

I remember saying, but why am I being taken there?

0:26:060:26:09

And he said, you're all very ill.

0:26:090:26:11

And I remember saying, well no-one's going to die, are they?

0:26:130:26:16

He was reluctant to answer.

0:26:170:26:18

And he was like, "Well...we'll see."

0:26:200:26:23

'The men all had multiple organ failure.

0:26:270:26:30

'Someone said it looks as though one man might die

0:26:320:26:35

'and that I might be charged with manslaughter.

0:26:350:26:39

'I felt completely out of control.'

0:26:390:26:40

I don't remember being moved.

0:26:450:26:47

I just woke up in a hallway outside of ICU.

0:26:470:26:50

My temperature was really high.

0:26:520:26:54

Apparently, by that stage, our organs had started failing.

0:26:540:26:58

They wanted us to all have this mask on our face.

0:27:000:27:03

Solid on the face.

0:27:030:27:05

It was because the blood and fluids were leaking into our lungs.

0:27:050:27:09

How close I was to dying...

0:27:130:27:15

..it's hard to say.

0:27:160:27:18

It's not something I went out of my way to find out.

0:27:190:27:23

It's not something I wanted to know.

0:27:230:27:25

They were going into kidney failure.

0:27:310:27:34

We had a full intensive care unit at that stage,

0:27:340:27:36

we'd generated five extra beds in the recovery area.

0:27:360:27:40

What we didn't have was enough kidney machines to suddenly provide extra support.

0:27:400:27:44

So by this stage of the night, there were police vans crisscrossing,

0:27:440:27:47

carrying equipment from many hospitals,

0:27:470:27:49

all converging on Northwick Park.

0:27:490:27:51

This was a major incident.

0:27:570:27:59

By now...

0:28:010:28:02

..things were pretty complex. There were a lot of unknowns.

0:28:030:28:06

There was no rule book for how to deal with this.

0:28:060:28:08

Looking at them from the outside, they had unstable blood pressures,

0:28:080:28:12

their breathing was affected,

0:28:120:28:14

they were developing organ failures.

0:28:140:28:17

They looked like people who had become septic.

0:28:170:28:20

This happens when you have blood poisoning from infection.

0:28:200:28:23

They looked as though they might have an infection,

0:28:250:28:28

so one of the possibilities

0:28:280:28:30

was that the infusions were contaminated in some way.

0:28:300:28:33

They'd all received injections from a batch of vials,

0:28:330:28:38

so although it would have been made under sterile conditions,

0:28:380:28:43

there is always a risk that something could have happened.

0:28:430:28:46

'I kept going back to read the document

0:28:520:28:54

'that detailed everything known about the drug.

0:28:540:28:56

It mentioned the unlikely possibility of cytokine storm,

0:28:570:29:01

an extreme immune reaction.

0:29:010:29:04

Cytokines are small proteins

0:29:040:29:06

involved in the inflammatory response,

0:29:060:29:10

either to an injury or to an external infection.

0:29:100:29:14

Cytokine storm is when these become super active throughout the body.

0:29:160:29:20

It leads to a cascade of activity, cells attacking other cells,

0:29:200:29:25

immune cells attacking tissue,

0:29:250:29:28

and that can lead to organ failure,

0:29:280:29:32

inflammation, high temperatures.

0:29:320:29:34

A very nasty outcome.

0:29:340:29:36

The clinical trials team told us

0:29:400:29:41

cytokine release syndrome

0:29:410:29:43

is a possible side-effect profile for this drug.

0:29:430:29:46

The treatment for that would be to give really powerful

0:29:460:29:48

immune suppressant drugs, high doses of steroids.

0:29:480:29:51

The trouble was, if we did that and actually this was infection,

0:29:510:29:54

if for some reason they were all reacting to a severe infection,

0:29:540:29:57

then we could have made them worse rather than better.

0:29:570:30:00

So, I spoke to people for a reality check.

0:30:010:30:04

We involved a lot of people.

0:30:060:30:07

I got a call at 12.04 in the morning.

0:30:090:30:12

At first, I didn't believe him

0:30:120:30:13

because I just thought this was so incredulous.

0:30:130:30:16

To have six healthy volunteers in a first-in-man trial with

0:30:160:30:20

such a drug, all at once being very unwell,

0:30:200:30:23

I mean, this is unprecedented.

0:30:230:30:26

From the signs and symptoms that my colleague was describing to me over

0:30:270:30:31

the phone, it was more consistent with a cytokine release syndrome by

0:30:310:30:35

that point in time. And it should be treated as so and aggressively so.

0:30:350:30:39

But if this was infection, then it would have the opposite effect.

0:30:390:30:43

It would dampen down the immune system of six people

0:30:430:30:45

who were fighting with an overwhelming infection.

0:30:450:30:49

The patients could deteriorate to the point of death.

0:30:490:30:52

These patients may die.

0:30:520:30:54

So there's really no margin for error.

0:30:560:30:58

It was a big decision to take but it's one that we had to get on with

0:31:000:31:03

because even the drugs that we were giving for this

0:31:030:31:05

would take time to work.

0:31:050:31:07

So we made the decision.

0:31:070:31:09

We would treat them as cytokine release syndrome.

0:31:090:31:11

So 1000mg of steroids is a significant dose.

0:31:200:31:24

Really all we could do is wait and see.

0:31:290:31:31

MACHINES BEEP

0:31:310:31:33

PHONE RINGS

0:31:390:31:42

It was about 3:30am and my phone rang.

0:31:450:31:49

It was one of the nurses and she said that there had been an issue

0:31:520:31:55

with the drug trial

0:31:550:31:57

and I needed to get down to the hospital as soon as I could.

0:31:570:32:00

It was really shocking news.

0:32:020:32:05

My heart kind of raced and I had no idea what was really happening.

0:32:050:32:08

What you're seeing is response to that kind of pain

0:32:100:32:12

that they're trying to deal with...

0:32:120:32:14

One of the doctors came out and explained

0:32:140:32:16

that David was in very serious condition.

0:32:160:32:20

He said he may look different,

0:32:200:32:23

that what they'd been given was starting to swell their bodies.

0:32:230:32:28

He just wouldn't look quite the same.

0:32:310:32:33

Hold his hand, let him know you're here.

0:32:340:32:38

I don't think anything could prepare you

0:32:380:32:41

for what you see when you first go in.

0:32:410:32:44

OK.

0:32:440:32:45

Right, come a bit further close to him.

0:32:490:32:54

His cheeks were very swollen.

0:32:540:32:56

So much so that his eyes, they looked more like slits.

0:32:560:33:01

His face was just round like a ball.

0:33:010:33:04

And his stomach was huge.

0:33:060:33:08

I thought he had had his hands on his stomach

0:33:080:33:11

because it was that large

0:33:110:33:13

until I realised that his hands were actually beside him on the bed.

0:33:130:33:17

It was pretty scary to see somebody you love

0:33:180:33:23

suddenly be so disfigured

0:33:230:33:26

from what you remember them just the day before.

0:33:260:33:30

A horrific feeling.

0:33:380:33:40

SHE SOBS

0:33:420:33:44

-NEWS REPORT:

-The drugs test that went badly wrong...

0:33:480:33:51

They thought they were coming here to take part in relatively routine

0:33:510:33:55

medical testing of a new drug.

0:33:550:33:57

Doctors here have been dealing with an extremely complicated set of

0:33:570:34:00

circumstances, ones they simply haven't come across before.

0:34:000:34:04

They are suffering from major organ failure.

0:34:040:34:07

Six men remain seriously ill in hospital after taking part in

0:34:070:34:11

trials for a new medicine.

0:34:110:34:13

The next day, I'm just glued to the news.

0:34:130:34:16

They had multiple organ failure, they were in intensive care units.

0:34:160:34:19

All these emotions,

0:34:190:34:20

you didn't want to think of the worst that could happen.

0:34:200:34:24

Just watching what's unfolding.

0:34:240:34:26

'The girlfriend of one of the victims says her partner is fighting for his life.

0:34:260:34:29

'Experts say the adverse reaction...'

0:34:290:34:32

The news caught wind of this story partly because that woman said we

0:34:320:34:37

looked like the elephant man.

0:34:370:34:39

So everybody wanted to get a glimpse of these atrocious monsters.

0:34:390:34:43

'In the morning, the story was all over the front pages.

0:34:430:34:47

'Somebody had used the words elephant man

0:34:470:34:49

'after seeing the swollen face and body of one of the patients.

0:34:490:34:53

'It became a headline that stuck.'

0:34:530:34:56

I was quite lucky that,

0:34:580:35:00

physically, I escaped because I had the placebo.

0:35:000:35:05

You know, we're all there at the same time in the same place.

0:35:050:35:08

Why am I the lucky one?

0:35:080:35:10

It was like Russian roulette.

0:35:100:35:12

You know, I was just very fortunate that the blanks fell on me.

0:35:120:35:16

There were people appearing on camera,

0:35:200:35:22

speculating what this might be, what might be going on.

0:35:220:35:26

When anyone's admitted to intensive care and as they start to receive

0:35:260:35:29

organ support, the treatment that we give them can make them look even more distressing.

0:35:290:35:33

It can be a shock. The fluid that we give them can make them swollen

0:35:330:35:36

because you're giving fluid in and it's leaking out.

0:35:360:35:39

The cause of it, well, it's really not the clinical trial.

0:35:390:35:42

Apparently they did pump in a lot of fluid and it wasn't really until

0:35:450:35:49

afterwards, you know, talking about it with people,

0:35:490:35:52

that I realised how swollen we got and where we received the tag,

0:35:520:35:57

the elephant men.

0:35:570:35:59

NEWS REPORT: 'They're treating the inflammation

0:35:590:36:02

'with every drug they can find

0:36:020:36:04

'and a lot of questions to be answered.'

0:36:040:36:06

In something that the authorities say is virtually unprecedented in

0:36:060:36:09

British medical history.

0:36:090:36:11

The media interest, although very understandable,

0:36:120:36:15

did add pressure to us.

0:36:150:36:17

There were comments that this is very serious, they could all die.

0:36:170:36:20

'It's left doctors at the hospital in a very difficult situation.

0:36:200:36:24

'It's unknown territory, treating a reaction to an untested drug.'

0:36:240:36:28

The patients had, by now, two doses of steroids

0:36:280:36:31

but we couldn't tell if the things we were doing

0:36:310:36:33

were going to help in the long run.

0:36:330:36:36

You give the treatment that you think is best.

0:36:360:36:39

In this case everything was deteriorating further.

0:36:390:36:42

'Scotland Yard has also become involved.

0:36:430:36:45

'It's trying to establish if there was any foul play at all.

0:36:450:36:49

'If any of the drugs had been tampered with in any way.'

0:36:490:36:51

On the Tuesday morning,

0:37:040:37:06

there was a phone call from the special crime unit in the police.

0:37:060:37:09

Something had gone very much wrong with a clinical trial.

0:37:110:37:14

A tragedy, a crisis that affected the lives of at least six young men

0:37:150:37:21

and I've never seen anything like this before.

0:37:210:37:24

This was treated as a crime scene.

0:37:250:37:28

The police seized not only the drug that has been administered but also

0:37:280:37:33

the placebo, they seized clinical samples, blood samples.

0:37:330:37:37

Something could have been tampered with, sabotaged,

0:37:410:37:43

poisoned and that these folk

0:37:430:37:46

might have been the victims of such foul play.

0:37:460:37:50

These drugs were seized and held

0:37:560:37:58

under the rules of criminal evidence,

0:37:580:38:00

so they came to us in sealed evidence bags.

0:38:000:38:02

The first and basic level is that somebody made a mistake.

0:38:040:38:08

It was the wrong drug, it had been mislabelled,

0:38:080:38:11

it had been contaminated, it was the wrong strength.

0:38:110:38:14

The basic pharmaceutical science

0:38:140:38:16

of this drug had not been carried out properly. And, of course,

0:38:160:38:19

included in that list of possibilities

0:38:190:38:21

is a possibility that someone had deliberately adulterated this drug.

0:38:210:38:24

These are real people and we owe it to them and their families

0:38:260:38:29

to find out what had gone wrong.

0:38:290:38:31

This needed to be investigated.

0:38:310:38:33

'While doctors at the Northwick Park Hospital

0:38:350:38:38

'are trying to save the lives of the six volunteers,

0:38:380:38:41

'other experts are already trying to find out why they all suffered

0:38:410:38:44

'such extreme reactions to what should have been a routine test.'

0:38:440:38:49

Underlying it all, this was still a mystery.

0:38:530:38:56

We didn't know if this was going to get more severe

0:38:580:39:04

or if this was the extent of it.

0:39:040:39:05

David was in and out of consciousness all the time.

0:39:080:39:12

He had enough strength to sort of squeeze my hand

0:39:120:39:15

but that was about it and then he kind of dropped off again.

0:39:150:39:18

All the doctors could tell her was that they were doing as much for us

0:39:200:39:25

as they could but they had no certainty

0:39:250:39:28

on what was going to happen next.

0:39:280:39:30

I could only,

0:39:320:39:35

you know, feel for them because it must have been a horrible time,

0:39:350:39:38

especially not knowing if they were going to pull through or not.

0:39:380:39:41

The first round of tests that were carried out

0:39:580:40:01

were identity and purity tests.

0:40:010:40:03

We were able to show very quickly

0:40:040:40:06

using a simple chemical test that this was the right drug

0:40:060:40:08

and it was the right strength and it wasn't contaminated

0:40:080:40:11

with anything else that would have caused this reaction.

0:40:110:40:14

The next step was to understand

0:40:140:40:16

why those pre-clinical safety tests hadn't worked.

0:40:160:40:19

-NEW REPORT:

-'Six men remain in intensive care this morning

0:40:330:40:35

after falling dangerously ill

0:40:350:40:37

while taking part in clinical trials...

0:40:370:40:40

Suddenly on Wednesday morning,

0:40:400:40:42

we were doing a ward round and we said, "Something's happened."

0:40:420:40:45

The four patients who were awake suddenly told us,

0:40:450:40:48

almost within an hour of each other, I feel much better, suddenly.

0:40:480:40:52

After two days or so, that's when I could feel things were improving.

0:40:520:40:58

His life wasn't on the line any more.

0:41:000:41:02

We all seemed to perk up.

0:41:040:41:05

I remember feeling really hungry and feeling that I was going to be safe.

0:41:050:41:12

The fevers all went down at about the same time

0:41:130:41:16

and even the two patients who were already on ventilators or in multi-organ failure,

0:41:160:41:19

needing a lot of support, their fevers went down,

0:41:190:41:22

some of their numbers started getting better.

0:41:220:41:24

The signs of the underlying inflammation seemed to be burning out.

0:41:240:41:28

I suppose everyone felt relief.

0:41:290:41:32

But also we had to ensure that we weren't going to miss something

0:41:320:41:36

-in feeling that relief.

-It was a long way from knowing that they were

0:41:360:41:39

completely out of the woods, but it was the first sign that

0:41:390:41:42

we'd had that things might be turning a corner.

0:41:420:41:44

And it was striking how

0:41:440:41:45

it all happened in all of them simultaneously.

0:41:450:41:48

It was almost like a switch going off.

0:41:480:41:51

We were taken off the machines.

0:42:140:42:16

The doctors felt that our organs

0:42:160:42:18

were back to a state which they could start doing their job again.

0:42:180:42:22

The intensive care unit was wonderful.

0:42:220:42:25

I know there's a few other drug trial companies out there

0:42:250:42:29

that are not located in a major hospital

0:42:290:42:32

and if I'd been there when this had happened, well,

0:42:320:42:35

I guess I might not have been so lucky.

0:42:350:42:40

I'm really proud of the teamwork people showed. Everybody.

0:42:420:42:47

And the way the hospital as a whole responded to the challenge.

0:42:470:42:50

Just a fantastic example of how people come together

0:42:500:42:54

when things get really tough in a very unprecedented event.

0:42:540:42:58

I knew that I'd been very ill and I was still recovering

0:43:010:43:04

but if it wasn't for Dr Ganesh and his team,

0:43:040:43:07

which I'm sure we're all very grateful for,

0:43:070:43:09

making those decisions, it would be a very different story.

0:43:090:43:13

We're really lucky to have had the NHS.

0:43:130:43:18

-NEWS REPORT:

-'The company running the trials, Parexel,

0:43:220:43:24

'has apologised to the families concerned.

0:43:240:43:27

'Well, they do, though, warn that at this early stage

0:43:270:43:30

'it is still difficult to make a comment

0:43:300:43:33

'about a longer term prognosis for all of these patients.'

0:43:330:43:37

You know, there are different types of recovery phases.

0:43:390:43:42

The blood counts will start

0:43:420:43:44

to recover in a different way over days,

0:43:440:43:46

the liver enzymes will start

0:43:460:43:48

to respond in a different way over a month.

0:43:480:43:52

Even anaemia, which comes as a consequence of cytokine storm,

0:43:520:43:57

takes up to six months to recover,

0:43:570:43:59

so there are different phases of recovery from cytokine storm,

0:43:590:44:01

especially one as severe as this.

0:44:010:44:03

I was watching some TV show which talked about us.

0:44:050:44:09

Why we did it. Should we have done it?

0:44:090:44:11

What we should deserve compensation-wise.

0:44:110:44:14

And I thought, I wanted to get solicitors involved.

0:44:140:44:18

After the trial took place, some of the trial participants

0:44:200:44:24

wanted some legal advice as to what they should do next.

0:44:240:44:28

They were feeling incredibly shocked and frightened,

0:44:280:44:32

had no idea what the future held for them at that point.

0:44:320:44:36

There was the huge concern about cancer

0:44:360:44:39

and any autoimmune diseases.

0:44:390:44:42

There was a concern also that it may impact

0:44:420:44:45

on their ability to have children.

0:44:450:44:49

It's quite a stressful situation, really.

0:44:490:44:51

My organs were back working, but I was like an 80-year-old.

0:44:540:44:58

My muscles were just wasted away.

0:44:580:45:01

What was in the drug, or the storm created, it's supposed to, like,

0:45:010:45:05

attack your cells, such as bad cells like cancer and things like that.

0:45:050:45:09

But because we didn't have anything like that,

0:45:090:45:11

it started attacking our own tissue,

0:45:110:45:13

our own muscle and it just wasted away our muscles.

0:45:130:45:16

I definitely remember thinking that although they say we could be OK

0:45:230:45:27

within three years,

0:45:270:45:29

there was the concern that we wouldn't because who knows

0:45:290:45:31

what's going to happen?

0:45:310:45:33

There's the chance that all of us end up with the same illnesses...

0:45:340:45:38

..and then what happens?

0:45:400:45:41

We had no immune system at all,

0:45:430:45:46

so we were given instructions on not to go on the tube, or trains,

0:45:460:45:50

or buses just in case if someone was to cough near us with some sort of

0:45:500:45:54

germs, we'd have no way to fight it off.

0:45:540:45:56

I knew he was still in intensive care

0:46:040:46:06

and I wanted to give him a bit of support.

0:46:060:46:09

So I went down to say goodbye to him and he wasn't able to speak,

0:46:120:46:17

so he was just like,

0:46:170:46:18

I remember him showing his hands and a bit like,

0:46:180:46:22

"Hey, what about my hands?"

0:46:220:46:24

I saw that his fingers had blackened...

0:46:270:46:29

..and there was no hope for saving the fingers.

0:46:310:46:37

I realised that he was certainly in a worse condition

0:46:400:46:43

and he'd come off of this in a very bad way

0:46:430:46:47

and someone was responsible for that.

0:46:470:46:51

For me, one of the most shocking features of the drug trial was

0:47:070:47:13

the spacing between the doses.

0:47:130:47:16

Our clients were being injected with this new monoclonal antibody

0:47:170:47:22

in quite quick succession.

0:47:220:47:25

Some of our clients were left,

0:47:250:47:26

actually starting to experience problems,

0:47:260:47:29

while others were actually just being injected for the first time.

0:47:290:47:32

That, even from a layman's point of view, seems ridiculous, frankly.

0:47:320:47:38

Another significant concern,

0:47:390:47:42

they seemed to receive the whole drug in 3-6 minutes.

0:47:420:47:46

I'm not sure that the preclinical testing on animals

0:47:480:47:52

was done at that pace.

0:47:520:47:53

Once the lawyers were involved,

0:48:100:48:12

we ended up doing a lot more blood tests and so on

0:48:120:48:15

to try and figure out how is our body recovering, how fast,

0:48:150:48:19

how much damage has been done and they managed...

0:48:190:48:23

They found an anomaly in my blood which is like,

0:48:230:48:27

something that quite often appears

0:48:270:48:31

prior to cancerous lymphoma cells appearing.

0:48:310:48:36

It was a big shock because by that point

0:48:380:48:40

I thought we were starting to move on.

0:48:400:48:43

We got married

0:48:450:48:46

roughly three months after the drug trial and, of course,

0:48:460:48:51

normally with wedding, marriage,

0:48:510:48:54

you think about children afterwards

0:48:540:48:57

and that was something that I was very worried about.

0:48:570:49:00

The fact that having this cancer scare, even the effect,

0:49:000:49:07

with the drug having been in my system,

0:49:070:49:10

is there any chance it could flow onto the children.

0:49:100:49:12

Do you want a child born and then have the possibility

0:49:120:49:15

of their father having cancer or dying soon after?

0:49:150:49:20

I was very down.

0:49:210:49:23

The worst down.

0:49:240:49:25

Those findings were that

0:49:410:49:44

the trial had been conducted as intended and we had not discovered

0:49:440:49:49

anything that was deliberately or intentionally wrong with the way in

0:49:490:49:54

which the trial had been managed.

0:49:540:49:56

I'm very sorry to hear about what's happened.

0:50:000:50:03

'Our clients felt that the MHRA report was a report'

0:50:030:50:08

that was rushed out

0:50:080:50:10

and unfortunately was a bit of a whitewash.

0:50:100:50:14

The MHRA saying that it was unpredictable

0:50:290:50:33

is just their way of passing blame

0:50:330:50:35

because they are the ones who said it was an OK trial to do.

0:50:350:50:39

I believe that the decisions that were taken were entirely appropriate

0:50:390:50:44

and consistent with the current state of scientific knowledge,

0:50:440:50:47

and I don't think anybody can be held responsible

0:50:470:50:50

for knowing something

0:50:500:50:52

that they don't know and they couldn't know at the time.

0:50:520:50:55

Parexel embarked upon a medical trial and they were ill-prepared.

0:50:550:51:00

They didn't have any backup.

0:51:000:51:02

'Everything we did had followed protocol.

0:51:040:51:08

'If you knew what was going to happen, you wouldn't need to do it.

0:51:080:51:12

'That's why you do trials.'

0:51:120:51:14

They should have had an idea of what to do.

0:51:180:51:21

Positive things didn't really start happening to treat us until they

0:51:210:51:26

involved the outside community and they had the answers.

0:51:260:51:30

There were people saying that it was rushed and they didn't feel that

0:51:300:51:34

it was happening in a, I don't know, a considerate way.

0:51:340:51:38

It was all about it being churned over, on with the next one,

0:51:380:51:42

on with the next one, so we probably felt disgruntled,

0:51:420:51:46

like we were just cogs in the machine.

0:51:460:51:48

And we were human guinea pigs and nobody wants to feel that way.

0:51:480:51:54

We had no scientific or rational explanation.

0:52:240:52:28

It was dangerous in humans

0:52:290:52:31

and completely ineffective in the monkeys.

0:52:310:52:33

I think the biggest problem with that study was that three of

0:52:330:52:37

the preclinical tests gave an answer

0:52:370:52:39

which suggested there wasn't a risk where there actually was.

0:52:390:52:44

Over the next three to four years, we came to understand why.

0:52:450:52:48

We know, of course, that macaques and humans are very similar species.

0:52:500:52:53

The T cells, which is the particular cell of the immune system that this

0:52:530:52:56

drug is supposed to target,

0:52:560:52:58

have on their surface a molecular structure called a receptor,

0:52:580:53:01

which binds to the drug and when the drug binds to the receptor,

0:53:010:53:06

the cell is stimulated to respond.

0:53:060:53:08

We also know that the monkey T-cell receptor

0:53:080:53:11

and the human receptor are virtually identical.

0:53:110:53:15

But despite the fact that the monkey T-cell binds TGN1412,

0:53:160:53:20

it has a very similar receptor to the human's,

0:53:200:53:23

it does not respond to the TGN1412 stimulus in the way that

0:53:230:53:28

the human T-cell does

0:53:280:53:30

and does not stimulate this kind of T-cell proliferation

0:53:300:53:33

and cytokine response in monkeys without an additional stimulus.

0:53:330:53:36

It's what one might call in clinical trials community as a never event.

0:53:380:53:43

It should never happen.

0:53:430:53:45

And that's why this has changed

0:53:450:53:48

how first-in-human studies are done internationally.

0:53:480:53:51

The independent review was commissioned

0:54:040:54:07

by the Secretary of State for Health.

0:54:070:54:10

The findings of the review are really very interesting

0:54:100:54:13

in that they recognised and developed areas

0:54:130:54:17

where we could improve our practices.

0:54:170:54:21

One of the critical recommendations was that where individuals

0:54:210:54:25

are receiving a drug for the first time,

0:54:250:54:28

that drug shouldn't be given

0:54:280:54:30

to a number of volunteers all in the same day.

0:54:300:54:32

There were other recommendations in relation to the size of the dose

0:54:320:54:36

that the individual should receive.

0:54:360:54:39

Clinical trials are certainly safer than they've ever been because

0:54:390:54:43

there is now more attention to the potential risks.

0:54:430:54:47

The report has been adopted by the European Medical Agency

0:54:550:55:01

and therefore applied to the whole of Europe.

0:55:010:55:04

So those recommendations that have had a long

0:55:040:55:07

and hopefully long-lasting effect.

0:55:070:55:09

'That was the last first-in-man trial I did.

0:55:130:55:16

'As doctors, we swear to do no harm.

0:55:180:55:20

'I felt guilty every day for years.'

0:55:220:55:25

'I'd like to look them in the eye and say sorry.'

0:55:280:55:31

Summing up the whole period, the whole miserable, sad time,

0:55:480:55:54

I would just simply say I was unlucky.

0:55:540:55:56

But it didn't kill me and that's pretty good.

0:55:590:56:05

We have three kids now.

0:56:070:56:08

Having my first child with the fact

0:56:120:56:15

that we might not have been able to have kids,

0:56:150:56:19

made it even more special.

0:56:190:56:21

I think one of the things, for me, is that I'm glad to have been part

0:56:330:56:36

of something that has reformed the whole industry,

0:56:360:56:39

and the trial has made me realise that life is quite precious

0:56:390:56:44

and that we need to make the most of it, really,

0:56:440:56:46

and have a sort of healthy mindset about being alive.

0:56:460:56:50

I think medical trials are very important and it is to advance our

0:56:510:56:56

knowledge of medicine.

0:56:560:56:58

And it's not really until you have a loved one

0:56:580:57:02

that is really sick and could be dying

0:57:020:57:07

and they're saved by a drug which has

0:57:070:57:11

obviously went through this sort of drug trial initially,

0:57:110:57:15

do you fully appreciate how important those things are.

0:57:150:57:18

On Monday 13 March 2006, eight healthy young men took part in a clinical trial of an experimental drug known as TGN1412. The drug was intended to treat leukaemia and had already been successfully tested on monkeys but never on humans.

It should have been a routine clinical trial but it soon spiralled into one of the most infamous medical emergencies in recent British history. Within an hour of receiving the drug, six of the volunteers were fighting for their lives - 'It was all manic, everything was happening all at once, they were vomiting, they were screaming in pain, people fainting'. The men's temperatures soared, their organs failed and some of their bodies swelled so severely that they became known in newspapers around the world as the elephant men.

A decade on, this drama documentary tells the story of what really happened during the trial, during the critical hours as medical staff fought to save the patients' lives, and through the aftermath as the authorities sought to understand what had happened. Featuring candid personal testimony from doctors who struggled to bring the clinical catastrophe under control - 'This was a mystery, we had no way of predicting how severe it was going to get. There was no rule book for how to deal with this'. The investigators tasked with discovering what went wrong - 'This was treated as a crime scene. Something could have been tampered with, sabotaged, poisoned and that these folk might have been the victims of such foul play'. And the patients themselves: 'I thought I was doing something good for science, but in the end it was the worst thing I could ever have done'.

This dramatic, thought-provoking science documentary tells the story in gripping detail.


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