0:00:02 > 0:00:07This programme contains some scenes which some viewers may find upsetting.
0:00:07 > 0:00:09I thought I was doing something good for science,
0:00:09 > 0:00:13but in the end it was the worst thing I could ever have done.
0:00:14 > 0:00:18They thought they were coming here to take part in medical testing of a new drug.
0:00:18 > 0:00:20Something went wrong.
0:00:27 > 0:00:30When you take a new drug into humans for the first time,
0:00:30 > 0:00:32it's never without risk.
0:00:39 > 0:00:41My whole body just went freezing cold.
0:00:41 > 0:00:42I started shaking.
0:00:42 > 0:00:44This wasn't something you could stop.
0:00:44 > 0:00:46Everything was happening all at once.
0:00:46 > 0:00:48Vomiting, screaming in pain.
0:00:48 > 0:00:50It was extremely scary.
0:00:50 > 0:00:52Ryan, are you still with me?
0:00:55 > 0:00:59We had no way of predicting how severe it was going to get.
0:00:59 > 0:01:02There's no rule book for how to deal with this.
0:01:02 > 0:01:04This was a mystery.
0:01:04 > 0:01:07They thought we looked like the elephant man.
0:01:07 > 0:01:12Everybody wanted to get a glimpse of these atrocious monsters.
0:01:18 > 0:01:20It's a never event.
0:01:20 > 0:01:24It should never happen. It was profound.
0:01:24 > 0:01:25I mean, this is unprecedented.
0:01:26 > 0:01:29It was like a horror movie with the way it was set up.
0:01:36 > 0:01:39Something could have been tampered with, sabotage.
0:01:40 > 0:01:43Poisoned. I've never seen anything like this before.
0:01:46 > 0:01:47I was in intensive care...
0:01:48 > 0:01:49..fighting for my life...
0:01:51 > 0:01:54..and someone was responsible for that.
0:02:27 > 0:02:33Parexel is a large multinational contract research organisation.
0:02:33 > 0:02:35They had a site
0:02:35 > 0:02:37which they leased from Northwick Park Hospital
0:02:37 > 0:02:41and we were doing clinical trials independently from the hospital
0:02:41 > 0:02:44on early-phase development of new drugs.
0:02:59 > 0:03:01I was about 31.
0:03:01 > 0:03:02I'd just come back from LA.
0:03:02 > 0:03:06I'd been there for two months doing an acting course for Screen.
0:03:06 > 0:03:10It was a really good time but I'd managed to get a little bit of debt behind me.
0:03:14 > 0:03:18A friend of mine had done trials and he said I should sign up.
0:03:18 > 0:03:21They were offering £2,000 and I thought that was OK.
0:03:23 > 0:03:26I was interested in the kind of historical...
0:03:29 > 0:03:32Just the scientific contribution I could be making.
0:03:36 > 0:03:40When I saw the ad I was like,
0:03:40 > 0:03:43£2,000 for three days' work seemed like a good deal to me
0:03:43 > 0:03:49considering I'd done two previous trials and it wasn't hard work.
0:03:58 > 0:04:01When I first arrived at the Parexel unit, I was running late.
0:04:01 > 0:04:04I was only 23, so I was a baby.
0:04:04 > 0:04:07I'd just finished university.
0:04:07 > 0:04:09I was in between a couple of jobs.
0:04:11 > 0:04:14Medical trials were kind of like a get-rich-quick scheme.
0:04:16 > 0:04:18A no-brainer, really.
0:04:19 > 0:04:22Just some information for you to look through
0:04:22 > 0:04:24while we're dealing with the preliminaries.
0:04:24 > 0:04:30After we'd had some tests done, we received our pile of paperwork.
0:04:30 > 0:04:31There was a doctor there.
0:04:35 > 0:04:39And he quickly went through what the drug was going to be about.
0:04:39 > 0:04:44The drug itself was supposed to be able to treat leukaemia.
0:04:45 > 0:04:50TGN1412 is a type of drug called a monoclonal antibody.
0:04:52 > 0:04:55It's important to realise, I think, that we stand on the threshold
0:04:55 > 0:04:58of a revolution in the way certain types of illnesses,
0:04:58 > 0:05:01particularly cancers, are treated.
0:05:01 > 0:05:04The traditional approach to treating cancers has been options
0:05:04 > 0:05:07such as surgery, chemotherapy or radiotherapy.
0:05:08 > 0:05:12Chemotherapy agents, as you probably know, are essentially poisons.
0:05:12 > 0:05:17So TGN1412 was intended to treat cancers by educating
0:05:17 > 0:05:20our own immune system into dealing with them.
0:05:20 > 0:05:22Now that's clearly a preferable option.
0:05:24 > 0:05:28I thought, it's a nice thing to do these trials because not only am
0:05:28 > 0:05:33I getting some cash for participating but it's helping science and
0:05:33 > 0:05:37it's going to help cure people further on down the track, hopefully.
0:05:37 > 0:05:40And you get paid as well, so bonus.
0:05:40 > 0:05:45Every one of the drugs that we all commonly use were once first used in humans.
0:05:45 > 0:05:48They have to go through that stage before they go into bigger
0:05:48 > 0:05:51trials and then into widespread use.
0:05:52 > 0:05:56This was a drug that had shown great promise in animal studies.
0:05:56 > 0:05:58And the TGN1412 trial
0:05:58 > 0:06:04was a first-in-man study, and the first study in humans
0:06:04 > 0:06:08is about getting to understand how the body deals with the medicine,
0:06:08 > 0:06:10how it handles it.
0:06:12 > 0:06:15It was the first-in-man study at the time.
0:06:15 > 0:06:18It didn't really, kind of, sink in
0:06:18 > 0:06:23actually, how important the first-in-man study is.
0:06:23 > 0:06:26It was never really discussed in great detail,
0:06:26 > 0:06:29it was just one point in 10, 15 points that were set out.
0:06:32 > 0:06:37The thing I need to get you to do now is to sign a consent form.
0:06:37 > 0:06:39It's important to know that when
0:06:39 > 0:06:41one participates in a first-in-man study,
0:06:41 > 0:06:44all that is possible should have been done
0:06:44 > 0:06:48in the pre-clinical studies to limit any anticipated risk.
0:06:49 > 0:06:53But when you take a new drug into humans for the first time,
0:06:53 > 0:06:55it's never without some risk.
0:06:56 > 0:06:59We all knew there was a tiny element of risk,
0:06:59 > 0:07:03but the side effects were things like, you could end up with hives,
0:07:03 > 0:07:07you could get anaphylactic shock... You can get that from a bee sting.
0:07:07 > 0:07:11And you can even do a cosmetics trial and have the same reaction,
0:07:11 > 0:07:13so, hey, there's no concern here.
0:07:16 > 0:07:19I don't ever remember having any second thoughts.
0:07:19 > 0:07:22I kind of breezed through and signed off quite quickly.
0:07:25 > 0:07:29It was a medicine being tested in a laboratory situation,
0:07:29 > 0:07:31approved by the government.
0:07:34 > 0:07:35What could go wrong?
0:07:56 > 0:07:59The trial was a double-blind
0:07:59 > 0:08:01randomised control trial.
0:08:01 > 0:08:05And that means that some of the men will have had the active treatment
0:08:05 > 0:08:09and two of them will have had a placebo or dummy treatment
0:08:09 > 0:08:10that has no effect.
0:08:10 > 0:08:14Neither the clinicians nor the men themselves would know who has the
0:08:14 > 0:08:16active or inactive treatment.
0:08:20 > 0:08:24There were eight of us, a bit of a mix of nationalities.
0:08:24 > 0:08:25Quite a good mix,
0:08:25 > 0:08:30I think it definitely covered the bases for men of our age.
0:08:32 > 0:08:35Just to get a good idea of how the body handles the drug,
0:08:35 > 0:08:38then it's better to have healthy people,
0:08:38 > 0:08:41usually men because there's always the risk to
0:08:41 > 0:08:44reproductive system studying women.
0:08:44 > 0:08:46From looking around,
0:08:46 > 0:08:49I think I worked out that I was probably the oldest.
0:08:49 > 0:08:54I was 34 years old and I had lots to look forward to in my life.
0:08:54 > 0:08:56I'd just recently got engaged.
0:08:56 > 0:09:00We were planning a nice wedding for family,
0:09:00 > 0:09:03honeymoon and hopefully children.
0:09:06 > 0:09:10The drug company looked at the highest dose without any adverse
0:09:10 > 0:09:15effects in monkeys and then they scaled that back 500-fold
0:09:15 > 0:09:17to give the first dose in humans,
0:09:17 > 0:09:20giving what they felt was substantial leeway
0:09:20 > 0:09:21in terms of safety.
0:09:27 > 0:09:28Let's get started.
0:09:28 > 0:09:30Number one, you're first.
0:09:31 > 0:09:35With hindsight, being the first person to receive a drug
0:09:35 > 0:09:37which is the first time in humans,
0:09:37 > 0:09:40yeah, probably not the smartest thing.
0:09:45 > 0:09:48We're going to get ready and administer the compound.
0:10:03 > 0:10:05We'll start the machine. OK.
0:10:07 > 0:10:08There we go.
0:10:08 > 0:10:10MACHINE BEEPS
0:10:13 > 0:10:14'As a medical student,
0:10:14 > 0:10:17'I volunteered for lots of drug trials to make extra money.
0:10:19 > 0:10:20'After I graduated,
0:10:20 > 0:10:23'I worked as a junior doctor in hospitals before joining
0:10:23 > 0:10:26'a private drugs company that ran trials.
0:10:26 > 0:10:31'I had been involved in more than 300 trials when I was put in charge
0:10:31 > 0:10:33'of testing a new drug.'
0:10:33 > 0:10:34Right, comfortable?
0:10:34 > 0:10:36- Yeah.- Great. All right,
0:10:36 > 0:10:38we'll come and check on you again in a few minutes.
0:10:38 > 0:10:40- Cool.- Great.- Thank you.
0:10:45 > 0:10:47Get everyone else going.
0:10:55 > 0:10:58When you're in the ward, when you have everything connected to you,
0:10:58 > 0:10:59it gets a bit more real.
0:10:59 > 0:11:00Your feelings are a bit more...
0:11:02 > 0:11:03..maybe nervous.
0:11:06 > 0:11:08You're kind of just locked in,
0:11:08 > 0:11:10in the sense that you're going to be here now.
0:11:10 > 0:11:13This is where you are, you're not going to move.
0:11:13 > 0:11:18You know, like a long journey that you're trying to prepare for
0:11:18 > 0:11:20and that was the set-up then.
0:11:20 > 0:11:21OK. Going to start the machine.
0:11:26 > 0:11:28The whole process was quite quick.
0:11:28 > 0:11:31Once they'd finished with myself, they moved over there.
0:11:31 > 0:11:34Obviously the drug was still going in at the time.
0:11:39 > 0:11:41I had a couple of books with me that I was really looking
0:11:41 > 0:11:43forward to getting stuck into.
0:11:46 > 0:11:52And the first side effect I noticed would have been a headache.
0:11:52 > 0:11:55Just a slight headache to start with.
0:11:55 > 0:11:59Round about 20 or so minutes after receiving the drug.
0:11:59 > 0:12:02But then that got worse and worse and worse.
0:12:02 > 0:12:06And it was not until the point where it was on the verge
0:12:06 > 0:12:10of a full-blown migraine that I put two and two together and thought,
0:12:10 > 0:12:12hey, hang on a second,
0:12:12 > 0:12:15I've just had this drug pumped into me and now I'm getting a migraine
0:12:15 > 0:12:16which I never get.
0:12:16 > 0:12:19I need to be telling somebody about this.
0:12:19 > 0:12:20Nurse.
0:12:20 > 0:12:24I told the nurse that I'm having a major headache.
0:12:24 > 0:12:25This might help.
0:12:25 > 0:12:30She arranged a cold compress on my forehead but she didn't give me
0:12:30 > 0:12:34anything for it because they don't want anything
0:12:34 > 0:12:37to taint the effects of the drug that they're testing.
0:12:42 > 0:12:44I know they'd been in the previous ward
0:12:44 > 0:12:49and activated the syringe and then they came into ours.
0:12:49 > 0:12:52You're first on my list. How are you feeling?
0:13:00 > 0:13:03Machine is going to administer the drug.
0:13:03 > 0:13:05Ryan was quite a bit younger than me,
0:13:05 > 0:13:08I think he must have been about 19 or 20.
0:13:08 > 0:13:12I think he was saving up for driving lessons or something.
0:13:12 > 0:13:15He's a nice guy, I enjoyed talking to him.
0:13:18 > 0:13:20I didn't think it would have been done
0:13:20 > 0:13:22like such a production line.
0:13:22 > 0:13:26I think they would have given it and watched and then the next person
0:13:26 > 0:13:31and watched but it seemed like they just gave everybody the injection with ten minutes space.
0:13:41 > 0:13:45The headache got progressively worse,
0:13:45 > 0:13:50to a migraine, but it was slightly different to a regular migraine,
0:13:50 > 0:13:52whereas it was coming in waves.
0:13:54 > 0:13:56It would get really bad and then it would sort of ease off a bit,
0:13:56 > 0:13:58then it got really bad, then it would ease off
0:13:58 > 0:14:00but over a period of, like, minutes.
0:14:02 > 0:14:07It was only a short period of time before the incidents were starting to occur.
0:14:07 > 0:14:11I remember still reading my book and I hadn't got too far into it.
0:14:11 > 0:14:14David was complaining that he was burning up and his body was getting
0:14:14 > 0:14:16really hot and his head was hurting.
0:14:16 > 0:14:20He had to take his top off because he just couldn't handle
0:14:20 > 0:14:21how hot he was getting.
0:14:24 > 0:14:26I started thinking, this is going to happen to me.
0:14:26 > 0:14:28- Still the headache?- Yeah.
0:14:28 > 0:14:30I'm assuming that maybe I'm a bit slower,
0:14:30 > 0:14:31maybe it's going to kick in shortly.
0:14:34 > 0:14:36It was daunting, it was extremely scary.
0:14:40 > 0:14:44I'm really surprised that they didn't stop the trial next door.
0:14:44 > 0:14:46From what was happening to us,
0:14:46 > 0:14:48they had a chance to save one or two guys.
0:14:51 > 0:14:54- Good evening, 007.- Hello.
0:14:54 > 0:14:57When they put the syringe onto that mechanical device,
0:14:57 > 0:15:01pressed go on the machine,
0:15:01 > 0:15:06you could hear the noise of the syringe pump as it was infusing us.
0:15:09 > 0:15:14You can just see this liquid creeping down the clear pipe
0:15:14 > 0:15:16and going into your body
0:15:16 > 0:15:20and it's an unusual situation knowing that there's, to you,
0:15:20 > 0:15:24an unknown fluid going into your veins.
0:15:24 > 0:15:25It's a weird experience.
0:15:27 > 0:15:30After I'd given the dose to the seventh man,
0:15:30 > 0:15:33a nurse told me one of the men had a headache.
0:15:34 > 0:15:39While dosing the eighth, the nurse returned
0:15:39 > 0:15:43and told me that the first man was feeling worse.
0:15:43 > 0:15:45Doctor, can I have word?
0:15:51 > 0:15:55It was an instant point, I was like, bang.
0:15:55 > 0:15:58Severe back pain in my lower back.
0:15:58 > 0:16:01It was way worse than the migraine.
0:16:02 > 0:16:04How are we doing, David?
0:16:05 > 0:16:10I was trying my hardest to twist and turn to find a position
0:16:10 > 0:16:14that I could feel less pain. I couldn't understand it.
0:16:14 > 0:16:19It was so debilitating, it was horrible.
0:16:19 > 0:16:22HE GROANS
0:16:22 > 0:16:24How are we doing?
0:16:24 > 0:16:27And then the guy to my left started saying that he had a headache
0:16:27 > 0:16:30and his head was sore and his back was hurting.
0:16:31 > 0:16:34As bad as it sounds,
0:16:34 > 0:16:36it made me feel slightly better
0:16:36 > 0:16:40that I wasn't going through this on my own.
0:16:51 > 0:16:53Once we'd been injected,
0:16:53 > 0:16:59within a minute or two I was feeling like I had hypothermia.
0:16:59 > 0:17:01It was a bit like if you could imagine
0:17:01 > 0:17:04being dipped into ice quite rapidly,
0:17:04 > 0:17:07my whole body just went freezing cold and I started shaking.
0:17:11 > 0:17:13This was like this.
0:17:13 > 0:17:15Shivering with cold but I wasn't cold.
0:17:17 > 0:17:20This wasn't something you could stop.
0:17:20 > 0:17:24It was just so extreme that it was just horrendous.
0:17:24 > 0:17:26Everybody was failing.
0:17:26 > 0:17:28HE GROANS
0:17:36 > 0:17:38'Then they tumbled like dominoes.'
0:17:45 > 0:17:49I remember being sick into one of those big, yellow biohazard bags.
0:17:52 > 0:17:56It was terrible. I must have brought up a good litre of bile,
0:17:56 > 0:17:57just solid bile.
0:18:01 > 0:18:02It was all manic.
0:18:04 > 0:18:07Everything was happening all at once.
0:18:07 > 0:18:12They were vomiting, they were screaming in pain.
0:18:12 > 0:18:13People fainting.
0:18:13 > 0:18:15They couldn't control their bowels.
0:18:18 > 0:18:20For some reason patient three
0:18:20 > 0:18:24started to think he would do better if he got out of this place.
0:18:26 > 0:18:29He was saying things like, "I don't want the money any more, I just want to get out."
0:18:29 > 0:18:32He just started panicking, started freaking out.
0:18:32 > 0:18:34It's really important that you stay in the bed.
0:18:34 > 0:18:37He was begging when he was saying he wanted to go home.
0:18:37 > 0:18:40He was screaming in pain, which was the most kind of,
0:18:40 > 0:18:43harrowing kind of moment.
0:18:43 > 0:18:45Because he was in complete agony.
0:18:45 > 0:18:47Let's bring you back.
0:18:49 > 0:18:51He just freaked, he just thought they were out to get him.
0:18:51 > 0:18:54And that he would do better if he actually got out of the hospital,
0:18:54 > 0:18:57as if getting out of the hospital, the pain would go away.
0:18:57 > 0:18:59Calm down and relax, OK?
0:18:59 > 0:19:01MAN GROANS
0:19:01 > 0:19:03'The wards became chaotic.
0:19:03 > 0:19:06'The men were getting worse.
0:19:06 > 0:19:07'Their bodies were in shock.'
0:19:10 > 0:19:12MAN SCREAMS
0:19:12 > 0:19:13There was chaos.
0:19:13 > 0:19:16The nurses were taken off guard.
0:19:16 > 0:19:19I remember the doctors not knowing what to do.
0:19:19 > 0:19:21They were probably afraid.
0:19:21 > 0:19:25They probably hoped it would only last a short time.
0:19:27 > 0:19:32They weren't expecting it to carry on and get worse and everything else that happened.
0:19:43 > 0:19:46It was like a horror movie with the way it was set up.
0:19:46 > 0:19:48As time was progressing, you're just kind of thinking,
0:19:48 > 0:19:50this is going to happen to me.
0:19:50 > 0:19:52It's like going on a rollercoaster.
0:19:52 > 0:19:55You know it's going to be scary.
0:19:55 > 0:19:58You're thinking, "Oh, no, why am I doing this, why am I doing this?"
0:20:00 > 0:20:02They closed the curtains.
0:20:03 > 0:20:07You're just there left with nothing, just noises.
0:20:07 > 0:20:10MEN SCREAM AND GROAN
0:20:13 > 0:20:15I was just like a ghost in a room.
0:20:18 > 0:20:23This must have just been terrible for everyone involved.
0:20:23 > 0:20:26Clearly, it was catastrophic for the volunteers,
0:20:26 > 0:20:30but I think it would've been really scary for the medical staff as well.
0:20:30 > 0:20:31It's not something you expect to see
0:20:31 > 0:20:34in your lifetime doing clinical trials
0:20:34 > 0:20:37and suddenly there are people getting extremely ill
0:20:37 > 0:20:38all around you.
0:20:38 > 0:20:42It was obvious that there was something really serious going on.
0:20:54 > 0:20:57'I couldn't reach the medical registrar.
0:20:58 > 0:21:02'I ended up running down two flights of stairs to the intensive care unit
0:21:02 > 0:21:05'and grabbing the first two doctors I saw.'
0:21:29 > 0:21:31I was still unsure what was happening.
0:21:31 > 0:21:34Then one of the nurses came to unplug everything.
0:21:35 > 0:21:37I was told then to go and get some food
0:21:37 > 0:21:39and someone would be with me shortly.
0:21:41 > 0:21:44I remember just kind of thinking, what have I just sat through?
0:21:44 > 0:21:46Just unsure of everything.
0:21:59 > 0:22:01Then I was told to collect my things.
0:22:04 > 0:22:07I came back and the ward was empty.
0:22:07 > 0:22:10One minute you're in a ward with patients who sounded like they're
0:22:10 > 0:22:14fighting for their lives and then you come back and they're gone.
0:22:14 > 0:22:15It was so surreal.
0:22:16 > 0:22:18What's going on? What's happening?
0:22:22 > 0:22:25MACHINES BEEP
0:22:37 > 0:22:41The lights were kept dimmer in there and I'm pretty sure I was
0:22:41 > 0:22:45falling asleep and waking up, falling asleep, waking up.
0:22:46 > 0:22:50That whole day, where did it go?
0:22:52 > 0:22:57I felt concerned, but I still had a lot of trust in the company that were doing this trial.
0:22:58 > 0:23:03I believed that we were safe and even though it wasn't feeling good,
0:23:03 > 0:23:06I would never have thought that we were at death's door.
0:23:12 > 0:23:14It had become quite dark outside,
0:23:14 > 0:23:20hours had passed and then there seemed to be a problem with Ryan.
0:23:20 > 0:23:22MACHINE BEEPS RAPIDLY
0:23:22 > 0:23:25HE PANTS
0:23:25 > 0:23:26Ryan, you're still with me.
0:23:26 > 0:23:29Talk to me, tell me how you're feeling.
0:23:30 > 0:23:33All of a sudden, some surgeon guys came up.
0:23:33 > 0:23:37OK, what's been going on here, Doctor?
0:23:37 > 0:23:40And they drew the curtain around him.
0:23:40 > 0:23:43I remember then, a few of us were looking at each other, like,
0:23:43 > 0:23:46what's going on here because it's quite worrying.
0:23:51 > 0:23:55That was when I thought, OK, we could be in serious trouble.
0:23:56 > 0:23:58Is that what we've all got to look forward to?
0:24:01 > 0:24:06They then wheeled him away... connected to these machines.
0:24:07 > 0:24:11That was probably the moment that I remember thinking, this is scary.
0:24:18 > 0:24:19PHONE RINGS
0:24:19 > 0:24:22I wasn't scheduled to be on duty that night.
0:24:22 > 0:24:25I was having supper with my wife when the phone call came in.
0:24:28 > 0:24:31My colleague explained the situation.
0:24:31 > 0:24:35A drug no human had had before, an unknown illness,
0:24:35 > 0:24:37there were six of them,
0:24:37 > 0:24:39one of them in intensive care.
0:24:39 > 0:24:41Things were changing very quickly.
0:24:41 > 0:24:43They were deteriorating in front of us.
0:24:43 > 0:24:47I said, "Look, this is clearly unprecedented, I'll come in."
0:24:47 > 0:24:50He said words to the effect of, yes, that would be a good idea,
0:24:50 > 0:24:52although shorter and more expletive.
0:24:56 > 0:24:59So I walked through to the intensive care unit,
0:24:59 > 0:25:02where the first of the patients had been brought down.
0:25:02 > 0:25:04Looking at him as an intensivist,
0:25:04 > 0:25:07he was really as unwell as anyone I've seen.
0:25:07 > 0:25:09His blood pressure was very low
0:25:09 > 0:25:11and the settings on the ventilator showed me that,
0:25:11 > 0:25:13again, his lungs had been quite badly affected.
0:25:13 > 0:25:17We were having to set things to a fairly high level to keep him safe and stable.
0:25:17 > 0:25:21So it was clear that this was a very serious situation.
0:25:21 > 0:25:24We also knew there were five more people up there who'd received the same drug.
0:25:25 > 0:25:27The clock was ticking.
0:25:28 > 0:25:32The rate at which they were deteriorating was very rapid.
0:25:32 > 0:25:35The doctors from the hospital, they were seriously concerned.
0:25:35 > 0:25:41This was in the hands of the NHS now and they obviously have to...
0:25:41 > 0:25:43Well, they've got a different criteria.
0:25:43 > 0:25:47They're in it for saving lives, not for making money as well.
0:25:54 > 0:25:56We knew that this was serious.
0:25:57 > 0:25:59There was a feeling of, who's next?
0:26:01 > 0:26:05Then, not long after, the two guys came to collect me.
0:26:06 > 0:26:09I remember saying, but why am I being taken there?
0:26:09 > 0:26:11And he said, you're all very ill.
0:26:13 > 0:26:16And I remember saying, well no-one's going to die, are they?
0:26:17 > 0:26:18He was reluctant to answer.
0:26:20 > 0:26:23And he was like, "Well...we'll see."
0:26:27 > 0:26:30'The men all had multiple organ failure.
0:26:32 > 0:26:35'Someone said it looks as though one man might die
0:26:35 > 0:26:39'and that I might be charged with manslaughter.
0:26:39 > 0:26:40'I felt completely out of control.'
0:26:45 > 0:26:47I don't remember being moved.
0:26:47 > 0:26:50I just woke up in a hallway outside of ICU.
0:26:52 > 0:26:54My temperature was really high.
0:26:54 > 0:26:58Apparently, by that stage, our organs had started failing.
0:27:00 > 0:27:03They wanted us to all have this mask on our face.
0:27:03 > 0:27:05Solid on the face.
0:27:05 > 0:27:09It was because the blood and fluids were leaking into our lungs.
0:27:13 > 0:27:15How close I was to dying...
0:27:16 > 0:27:18..it's hard to say.
0:27:19 > 0:27:23It's not something I went out of my way to find out.
0:27:23 > 0:27:25It's not something I wanted to know.
0:27:31 > 0:27:34They were going into kidney failure.
0:27:34 > 0:27:36We had a full intensive care unit at that stage,
0:27:36 > 0:27:40we'd generated five extra beds in the recovery area.
0:27:40 > 0:27:44What we didn't have was enough kidney machines to suddenly provide extra support.
0:27:44 > 0:27:47So by this stage of the night, there were police vans crisscrossing,
0:27:47 > 0:27:49carrying equipment from many hospitals,
0:27:49 > 0:27:51all converging on Northwick Park.
0:27:57 > 0:27:59This was a major incident.
0:28:01 > 0:28:02By now...
0:28:03 > 0:28:06..things were pretty complex. There were a lot of unknowns.
0:28:06 > 0:28:08There was no rule book for how to deal with this.
0:28:08 > 0:28:12Looking at them from the outside, they had unstable blood pressures,
0:28:12 > 0:28:14their breathing was affected,
0:28:14 > 0:28:17they were developing organ failures.
0:28:17 > 0:28:20They looked like people who had become septic.
0:28:20 > 0:28:23This happens when you have blood poisoning from infection.
0:28:25 > 0:28:28They looked as though they might have an infection,
0:28:28 > 0:28:30so one of the possibilities
0:28:30 > 0:28:33was that the infusions were contaminated in some way.
0:28:33 > 0:28:38They'd all received injections from a batch of vials,
0:28:38 > 0:28:43so although it would have been made under sterile conditions,
0:28:43 > 0:28:46there is always a risk that something could have happened.
0:28:52 > 0:28:54'I kept going back to read the document
0:28:54 > 0:28:56'that detailed everything known about the drug.
0:28:57 > 0:29:01It mentioned the unlikely possibility of cytokine storm,
0:29:01 > 0:29:04an extreme immune reaction.
0:29:04 > 0:29:06Cytokines are small proteins
0:29:06 > 0:29:10involved in the inflammatory response,
0:29:10 > 0:29:14either to an injury or to an external infection.
0:29:16 > 0:29:20Cytokine storm is when these become super active throughout the body.
0:29:20 > 0:29:25It leads to a cascade of activity, cells attacking other cells,
0:29:25 > 0:29:28immune cells attacking tissue,
0:29:28 > 0:29:32and that can lead to organ failure,
0:29:32 > 0:29:34inflammation, high temperatures.
0:29:34 > 0:29:36A very nasty outcome.
0:29:40 > 0:29:41The clinical trials team told us
0:29:41 > 0:29:43cytokine release syndrome
0:29:43 > 0:29:46is a possible side-effect profile for this drug.
0:29:46 > 0:29:48The treatment for that would be to give really powerful
0:29:48 > 0:29:51immune suppressant drugs, high doses of steroids.
0:29:51 > 0:29:54The trouble was, if we did that and actually this was infection,
0:29:54 > 0:29:57if for some reason they were all reacting to a severe infection,
0:29:57 > 0:30:00then we could have made them worse rather than better.
0:30:01 > 0:30:04So, I spoke to people for a reality check.
0:30:06 > 0:30:07We involved a lot of people.
0:30:09 > 0:30:12I got a call at 12.04 in the morning.
0:30:12 > 0:30:13At first, I didn't believe him
0:30:13 > 0:30:16because I just thought this was so incredulous.
0:30:16 > 0:30:20To have six healthy volunteers in a first-in-man trial with
0:30:20 > 0:30:23such a drug, all at once being very unwell,
0:30:23 > 0:30:26I mean, this is unprecedented.
0:30:27 > 0:30:31From the signs and symptoms that my colleague was describing to me over
0:30:31 > 0:30:35the phone, it was more consistent with a cytokine release syndrome by
0:30:35 > 0:30:39that point in time. And it should be treated as so and aggressively so.
0:30:39 > 0:30:43But if this was infection, then it would have the opposite effect.
0:30:43 > 0:30:45It would dampen down the immune system of six people
0:30:45 > 0:30:49who were fighting with an overwhelming infection.
0:30:49 > 0:30:52The patients could deteriorate to the point of death.
0:30:52 > 0:30:54These patients may die.
0:30:56 > 0:30:58So there's really no margin for error.
0:31:00 > 0:31:03It was a big decision to take but it's one that we had to get on with
0:31:03 > 0:31:05because even the drugs that we were giving for this
0:31:05 > 0:31:07would take time to work.
0:31:07 > 0:31:09So we made the decision.
0:31:09 > 0:31:11We would treat them as cytokine release syndrome.
0:31:20 > 0:31:24So 1000mg of steroids is a significant dose.
0:31:29 > 0:31:31Really all we could do is wait and see.
0:31:31 > 0:31:33MACHINES BEEP
0:31:39 > 0:31:42PHONE RINGS
0:31:45 > 0:31:49It was about 3:30am and my phone rang.
0:31:52 > 0:31:55It was one of the nurses and she said that there had been an issue
0:31:55 > 0:31:57with the drug trial
0:31:57 > 0:32:00and I needed to get down to the hospital as soon as I could.
0:32:02 > 0:32:05It was really shocking news.
0:32:05 > 0:32:08My heart kind of raced and I had no idea what was really happening.
0:32:10 > 0:32:12What you're seeing is response to that kind of pain
0:32:12 > 0:32:14that they're trying to deal with...
0:32:14 > 0:32:16One of the doctors came out and explained
0:32:16 > 0:32:20that David was in very serious condition.
0:32:20 > 0:32:23He said he may look different,
0:32:23 > 0:32:28that what they'd been given was starting to swell their bodies.
0:32:31 > 0:32:33He just wouldn't look quite the same.
0:32:34 > 0:32:38Hold his hand, let him know you're here.
0:32:38 > 0:32:41I don't think anything could prepare you
0:32:41 > 0:32:44for what you see when you first go in.
0:32:44 > 0:32:45OK.
0:32:49 > 0:32:54Right, come a bit further close to him.
0:32:54 > 0:32:56His cheeks were very swollen.
0:32:56 > 0:33:01So much so that his eyes, they looked more like slits.
0:33:01 > 0:33:04His face was just round like a ball.
0:33:06 > 0:33:08And his stomach was huge.
0:33:08 > 0:33:11I thought he had had his hands on his stomach
0:33:11 > 0:33:13because it was that large
0:33:13 > 0:33:17until I realised that his hands were actually beside him on the bed.
0:33:18 > 0:33:23It was pretty scary to see somebody you love
0:33:23 > 0:33:26suddenly be so disfigured
0:33:26 > 0:33:30from what you remember them just the day before.
0:33:38 > 0:33:40A horrific feeling.
0:33:42 > 0:33:44SHE SOBS
0:33:48 > 0:33:51- NEWS REPORT:- The drugs test that went badly wrong...
0:33:51 > 0:33:55They thought they were coming here to take part in relatively routine
0:33:55 > 0:33:57medical testing of a new drug.
0:33:57 > 0:34:00Doctors here have been dealing with an extremely complicated set of
0:34:00 > 0:34:04circumstances, ones they simply haven't come across before.
0:34:04 > 0:34:07They are suffering from major organ failure.
0:34:07 > 0:34:11Six men remain seriously ill in hospital after taking part in
0:34:11 > 0:34:13trials for a new medicine.
0:34:13 > 0:34:16The next day, I'm just glued to the news.
0:34:16 > 0:34:19They had multiple organ failure, they were in intensive care units.
0:34:19 > 0:34:20All these emotions,
0:34:20 > 0:34:24you didn't want to think of the worst that could happen.
0:34:24 > 0:34:26Just watching what's unfolding.
0:34:26 > 0:34:29'The girlfriend of one of the victims says her partner is fighting for his life.
0:34:29 > 0:34:32'Experts say the adverse reaction...'
0:34:32 > 0:34:37The news caught wind of this story partly because that woman said we
0:34:37 > 0:34:39looked like the elephant man.
0:34:39 > 0:34:43So everybody wanted to get a glimpse of these atrocious monsters.
0:34:43 > 0:34:47'In the morning, the story was all over the front pages.
0:34:47 > 0:34:49'Somebody had used the words elephant man
0:34:49 > 0:34:53'after seeing the swollen face and body of one of the patients.
0:34:53 > 0:34:56'It became a headline that stuck.'
0:34:58 > 0:35:00I was quite lucky that,
0:35:00 > 0:35:05physically, I escaped because I had the placebo.
0:35:05 > 0:35:08You know, we're all there at the same time in the same place.
0:35:08 > 0:35:10Why am I the lucky one?
0:35:10 > 0:35:12It was like Russian roulette.
0:35:12 > 0:35:16You know, I was just very fortunate that the blanks fell on me.
0:35:20 > 0:35:22There were people appearing on camera,
0:35:22 > 0:35:26speculating what this might be, what might be going on.
0:35:26 > 0:35:29When anyone's admitted to intensive care and as they start to receive
0:35:29 > 0:35:33organ support, the treatment that we give them can make them look even more distressing.
0:35:33 > 0:35:36It can be a shock. The fluid that we give them can make them swollen
0:35:36 > 0:35:39because you're giving fluid in and it's leaking out.
0:35:39 > 0:35:42The cause of it, well, it's really not the clinical trial.
0:35:45 > 0:35:49Apparently they did pump in a lot of fluid and it wasn't really until
0:35:49 > 0:35:52afterwards, you know, talking about it with people,
0:35:52 > 0:35:57that I realised how swollen we got and where we received the tag,
0:35:57 > 0:35:59the elephant men.
0:35:59 > 0:36:02NEWS REPORT: 'They're treating the inflammation
0:36:02 > 0:36:04'with every drug they can find
0:36:04 > 0:36:06'and a lot of questions to be answered.'
0:36:06 > 0:36:09In something that the authorities say is virtually unprecedented in
0:36:09 > 0:36:11British medical history.
0:36:12 > 0:36:15The media interest, although very understandable,
0:36:15 > 0:36:17did add pressure to us.
0:36:17 > 0:36:20There were comments that this is very serious, they could all die.
0:36:20 > 0:36:24'It's left doctors at the hospital in a very difficult situation.
0:36:24 > 0:36:28'It's unknown territory, treating a reaction to an untested drug.'
0:36:28 > 0:36:31The patients had, by now, two doses of steroids
0:36:31 > 0:36:33but we couldn't tell if the things we were doing
0:36:33 > 0:36:36were going to help in the long run.
0:36:36 > 0:36:39You give the treatment that you think is best.
0:36:39 > 0:36:42In this case everything was deteriorating further.
0:36:43 > 0:36:45'Scotland Yard has also become involved.
0:36:45 > 0:36:49'It's trying to establish if there was any foul play at all.
0:36:49 > 0:36:51'If any of the drugs had been tampered with in any way.'
0:37:04 > 0:37:06On the Tuesday morning,
0:37:06 > 0:37:09there was a phone call from the special crime unit in the police.
0:37:11 > 0:37:14Something had gone very much wrong with a clinical trial.
0:37:15 > 0:37:21A tragedy, a crisis that affected the lives of at least six young men
0:37:21 > 0:37:24and I've never seen anything like this before.
0:37:25 > 0:37:28This was treated as a crime scene.
0:37:28 > 0:37:33The police seized not only the drug that has been administered but also
0:37:33 > 0:37:37the placebo, they seized clinical samples, blood samples.
0:37:41 > 0:37:43Something could have been tampered with, sabotaged,
0:37:43 > 0:37:46poisoned and that these folk
0:37:46 > 0:37:50might have been the victims of such foul play.
0:37:56 > 0:37:58These drugs were seized and held
0:37:58 > 0:38:00under the rules of criminal evidence,
0:38:00 > 0:38:02so they came to us in sealed evidence bags.
0:38:04 > 0:38:08The first and basic level is that somebody made a mistake.
0:38:08 > 0:38:11It was the wrong drug, it had been mislabelled,
0:38:11 > 0:38:14it had been contaminated, it was the wrong strength.
0:38:14 > 0:38:16The basic pharmaceutical science
0:38:16 > 0:38:19of this drug had not been carried out properly. And, of course,
0:38:19 > 0:38:21included in that list of possibilities
0:38:21 > 0:38:24is a possibility that someone had deliberately adulterated this drug.
0:38:26 > 0:38:29These are real people and we owe it to them and their families
0:38:29 > 0:38:31to find out what had gone wrong.
0:38:31 > 0:38:33This needed to be investigated.
0:38:35 > 0:38:38'While doctors at the Northwick Park Hospital
0:38:38 > 0:38:41'are trying to save the lives of the six volunteers,
0:38:41 > 0:38:44'other experts are already trying to find out why they all suffered
0:38:44 > 0:38:49'such extreme reactions to what should have been a routine test.'
0:38:53 > 0:38:56Underlying it all, this was still a mystery.
0:38:58 > 0:39:04We didn't know if this was going to get more severe
0:39:04 > 0:39:05or if this was the extent of it.
0:39:08 > 0:39:12David was in and out of consciousness all the time.
0:39:12 > 0:39:15He had enough strength to sort of squeeze my hand
0:39:15 > 0:39:18but that was about it and then he kind of dropped off again.
0:39:20 > 0:39:25All the doctors could tell her was that they were doing as much for us
0:39:25 > 0:39:28as they could but they had no certainty
0:39:28 > 0:39:30on what was going to happen next.
0:39:32 > 0:39:35I could only,
0:39:35 > 0:39:38you know, feel for them because it must have been a horrible time,
0:39:38 > 0:39:41especially not knowing if they were going to pull through or not.
0:39:58 > 0:40:01The first round of tests that were carried out
0:40:01 > 0:40:03were identity and purity tests.
0:40:04 > 0:40:06We were able to show very quickly
0:40:06 > 0:40:08using a simple chemical test that this was the right drug
0:40:08 > 0:40:11and it was the right strength and it wasn't contaminated
0:40:11 > 0:40:14with anything else that would have caused this reaction.
0:40:14 > 0:40:16The next step was to understand
0:40:16 > 0:40:19why those pre-clinical safety tests hadn't worked.
0:40:33 > 0:40:35- NEW REPORT:- 'Six men remain in intensive care this morning
0:40:35 > 0:40:37after falling dangerously ill
0:40:37 > 0:40:40while taking part in clinical trials...
0:40:40 > 0:40:42Suddenly on Wednesday morning,
0:40:42 > 0:40:45we were doing a ward round and we said, "Something's happened."
0:40:45 > 0:40:48The four patients who were awake suddenly told us,
0:40:48 > 0:40:52almost within an hour of each other, I feel much better, suddenly.
0:40:52 > 0:40:58After two days or so, that's when I could feel things were improving.
0:41:00 > 0:41:02His life wasn't on the line any more.
0:41:04 > 0:41:05We all seemed to perk up.
0:41:05 > 0:41:12I remember feeling really hungry and feeling that I was going to be safe.
0:41:13 > 0:41:16The fevers all went down at about the same time
0:41:16 > 0:41:19and even the two patients who were already on ventilators or in multi-organ failure,
0:41:19 > 0:41:22needing a lot of support, their fevers went down,
0:41:22 > 0:41:24some of their numbers started getting better.
0:41:24 > 0:41:28The signs of the underlying inflammation seemed to be burning out.
0:41:29 > 0:41:32I suppose everyone felt relief.
0:41:32 > 0:41:36But also we had to ensure that we weren't going to miss something
0:41:36 > 0:41:39- in feeling that relief.- It was a long way from knowing that they were
0:41:39 > 0:41:42completely out of the woods, but it was the first sign that
0:41:42 > 0:41:44we'd had that things might be turning a corner.
0:41:44 > 0:41:45And it was striking how
0:41:45 > 0:41:48it all happened in all of them simultaneously.
0:41:48 > 0:41:51It was almost like a switch going off.
0:42:14 > 0:42:16We were taken off the machines.
0:42:16 > 0:42:18The doctors felt that our organs
0:42:18 > 0:42:22were back to a state which they could start doing their job again.
0:42:22 > 0:42:25The intensive care unit was wonderful.
0:42:25 > 0:42:29I know there's a few other drug trial companies out there
0:42:29 > 0:42:32that are not located in a major hospital
0:42:32 > 0:42:35and if I'd been there when this had happened, well,
0:42:35 > 0:42:40I guess I might not have been so lucky.
0:42:42 > 0:42:47I'm really proud of the teamwork people showed. Everybody.
0:42:47 > 0:42:50And the way the hospital as a whole responded to the challenge.
0:42:50 > 0:42:54Just a fantastic example of how people come together
0:42:54 > 0:42:58when things get really tough in a very unprecedented event.
0:43:01 > 0:43:04I knew that I'd been very ill and I was still recovering
0:43:04 > 0:43:07but if it wasn't for Dr Ganesh and his team,
0:43:07 > 0:43:09which I'm sure we're all very grateful for,
0:43:09 > 0:43:13making those decisions, it would be a very different story.
0:43:13 > 0:43:18We're really lucky to have had the NHS.
0:43:22 > 0:43:24- NEWS REPORT:- 'The company running the trials, Parexel,
0:43:24 > 0:43:27'has apologised to the families concerned.
0:43:27 > 0:43:30'Well, they do, though, warn that at this early stage
0:43:30 > 0:43:33'it is still difficult to make a comment
0:43:33 > 0:43:37'about a longer term prognosis for all of these patients.'
0:43:39 > 0:43:42You know, there are different types of recovery phases.
0:43:42 > 0:43:44The blood counts will start
0:43:44 > 0:43:46to recover in a different way over days,
0:43:46 > 0:43:48the liver enzymes will start
0:43:48 > 0:43:52to respond in a different way over a month.
0:43:52 > 0:43:57Even anaemia, which comes as a consequence of cytokine storm,
0:43:57 > 0:43:59takes up to six months to recover,
0:43:59 > 0:44:01so there are different phases of recovery from cytokine storm,
0:44:01 > 0:44:03especially one as severe as this.
0:44:05 > 0:44:09I was watching some TV show which talked about us.
0:44:09 > 0:44:11Why we did it. Should we have done it?
0:44:11 > 0:44:14What we should deserve compensation-wise.
0:44:14 > 0:44:18And I thought, I wanted to get solicitors involved.
0:44:20 > 0:44:24After the trial took place, some of the trial participants
0:44:24 > 0:44:28wanted some legal advice as to what they should do next.
0:44:28 > 0:44:32They were feeling incredibly shocked and frightened,
0:44:32 > 0:44:36had no idea what the future held for them at that point.
0:44:36 > 0:44:39There was the huge concern about cancer
0:44:39 > 0:44:42and any autoimmune diseases.
0:44:42 > 0:44:45There was a concern also that it may impact
0:44:45 > 0:44:49on their ability to have children.
0:44:49 > 0:44:51It's quite a stressful situation, really.
0:44:54 > 0:44:58My organs were back working, but I was like an 80-year-old.
0:44:58 > 0:45:01My muscles were just wasted away.
0:45:01 > 0:45:05What was in the drug, or the storm created, it's supposed to, like,
0:45:05 > 0:45:09attack your cells, such as bad cells like cancer and things like that.
0:45:09 > 0:45:11But because we didn't have anything like that,
0:45:11 > 0:45:13it started attacking our own tissue,
0:45:13 > 0:45:16our own muscle and it just wasted away our muscles.
0:45:23 > 0:45:27I definitely remember thinking that although they say we could be OK
0:45:27 > 0:45:29within three years,
0:45:29 > 0:45:31there was the concern that we wouldn't because who knows
0:45:31 > 0:45:33what's going to happen?
0:45:34 > 0:45:38There's the chance that all of us end up with the same illnesses...
0:45:40 > 0:45:41..and then what happens?
0:45:43 > 0:45:46We had no immune system at all,
0:45:46 > 0:45:50so we were given instructions on not to go on the tube, or trains,
0:45:50 > 0:45:54or buses just in case if someone was to cough near us with some sort of
0:45:54 > 0:45:56germs, we'd have no way to fight it off.
0:46:04 > 0:46:06I knew he was still in intensive care
0:46:06 > 0:46:09and I wanted to give him a bit of support.
0:46:12 > 0:46:17So I went down to say goodbye to him and he wasn't able to speak,
0:46:17 > 0:46:18so he was just like,
0:46:18 > 0:46:22I remember him showing his hands and a bit like,
0:46:22 > 0:46:24"Hey, what about my hands?"
0:46:27 > 0:46:29I saw that his fingers had blackened...
0:46:31 > 0:46:37..and there was no hope for saving the fingers.
0:46:40 > 0:46:43I realised that he was certainly in a worse condition
0:46:43 > 0:46:47and he'd come off of this in a very bad way
0:46:47 > 0:46:51and someone was responsible for that.
0:47:07 > 0:47:13For me, one of the most shocking features of the drug trial was
0:47:13 > 0:47:16the spacing between the doses.
0:47:17 > 0:47:22Our clients were being injected with this new monoclonal antibody
0:47:22 > 0:47:25in quite quick succession.
0:47:25 > 0:47:26Some of our clients were left,
0:47:26 > 0:47:29actually starting to experience problems,
0:47:29 > 0:47:32while others were actually just being injected for the first time.
0:47:32 > 0:47:38That, even from a layman's point of view, seems ridiculous, frankly.
0:47:39 > 0:47:42Another significant concern,
0:47:42 > 0:47:46they seemed to receive the whole drug in 3-6 minutes.
0:47:48 > 0:47:52I'm not sure that the preclinical testing on animals
0:47:52 > 0:47:53was done at that pace.
0:48:10 > 0:48:12Once the lawyers were involved,
0:48:12 > 0:48:15we ended up doing a lot more blood tests and so on
0:48:15 > 0:48:19to try and figure out how is our body recovering, how fast,
0:48:19 > 0:48:23how much damage has been done and they managed...
0:48:23 > 0:48:27They found an anomaly in my blood which is like,
0:48:27 > 0:48:31something that quite often appears
0:48:31 > 0:48:36prior to cancerous lymphoma cells appearing.
0:48:38 > 0:48:40It was a big shock because by that point
0:48:40 > 0:48:43I thought we were starting to move on.
0:48:45 > 0:48:46We got married
0:48:46 > 0:48:51roughly three months after the drug trial and, of course,
0:48:51 > 0:48:54normally with wedding, marriage,
0:48:54 > 0:48:57you think about children afterwards
0:48:57 > 0:49:00and that was something that I was very worried about.
0:49:00 > 0:49:07The fact that having this cancer scare, even the effect,
0:49:07 > 0:49:10with the drug having been in my system,
0:49:10 > 0:49:12is there any chance it could flow onto the children.
0:49:12 > 0:49:15Do you want a child born and then have the possibility
0:49:15 > 0:49:20of their father having cancer or dying soon after?
0:49:21 > 0:49:23I was very down.
0:49:24 > 0:49:25The worst down.
0:49:41 > 0:49:44Those findings were that
0:49:44 > 0:49:49the trial had been conducted as intended and we had not discovered
0:49:49 > 0:49:54anything that was deliberately or intentionally wrong with the way in
0:49:54 > 0:49:56which the trial had been managed.
0:50:00 > 0:50:03I'm very sorry to hear about what's happened.
0:50:03 > 0:50:08'Our clients felt that the MHRA report was a report'
0:50:08 > 0:50:10that was rushed out
0:50:10 > 0:50:14and unfortunately was a bit of a whitewash.
0:50:29 > 0:50:33The MHRA saying that it was unpredictable
0:50:33 > 0:50:35is just their way of passing blame
0:50:35 > 0:50:39because they are the ones who said it was an OK trial to do.
0:50:39 > 0:50:44I believe that the decisions that were taken were entirely appropriate
0:50:44 > 0:50:47and consistent with the current state of scientific knowledge,
0:50:47 > 0:50:50and I don't think anybody can be held responsible
0:50:50 > 0:50:52for knowing something
0:50:52 > 0:50:55that they don't know and they couldn't know at the time.
0:50:55 > 0:51:00Parexel embarked upon a medical trial and they were ill-prepared.
0:51:00 > 0:51:02They didn't have any backup.
0:51:04 > 0:51:08'Everything we did had followed protocol.
0:51:08 > 0:51:12'If you knew what was going to happen, you wouldn't need to do it.
0:51:12 > 0:51:14'That's why you do trials.'
0:51:18 > 0:51:21They should have had an idea of what to do.
0:51:21 > 0:51:26Positive things didn't really start happening to treat us until they
0:51:26 > 0:51:30involved the outside community and they had the answers.
0:51:30 > 0:51:34There were people saying that it was rushed and they didn't feel that
0:51:34 > 0:51:38it was happening in a, I don't know, a considerate way.
0:51:38 > 0:51:42It was all about it being churned over, on with the next one,
0:51:42 > 0:51:46on with the next one, so we probably felt disgruntled,
0:51:46 > 0:51:48like we were just cogs in the machine.
0:51:48 > 0:51:54And we were human guinea pigs and nobody wants to feel that way.
0:52:24 > 0:52:28We had no scientific or rational explanation.
0:52:29 > 0:52:31It was dangerous in humans
0:52:31 > 0:52:33and completely ineffective in the monkeys.
0:52:33 > 0:52:37I think the biggest problem with that study was that three of
0:52:37 > 0:52:39the preclinical tests gave an answer
0:52:39 > 0:52:44which suggested there wasn't a risk where there actually was.
0:52:45 > 0:52:48Over the next three to four years, we came to understand why.
0:52:50 > 0:52:53We know, of course, that macaques and humans are very similar species.
0:52:53 > 0:52:56The T cells, which is the particular cell of the immune system that this
0:52:56 > 0:52:58drug is supposed to target,
0:52:58 > 0:53:01have on their surface a molecular structure called a receptor,
0:53:01 > 0:53:06which binds to the drug and when the drug binds to the receptor,
0:53:06 > 0:53:08the cell is stimulated to respond.
0:53:08 > 0:53:11We also know that the monkey T-cell receptor
0:53:11 > 0:53:15and the human receptor are virtually identical.
0:53:16 > 0:53:20But despite the fact that the monkey T-cell binds TGN1412,
0:53:20 > 0:53:23it has a very similar receptor to the human's,
0:53:23 > 0:53:28it does not respond to the TGN1412 stimulus in the way that
0:53:28 > 0:53:30the human T-cell does
0:53:30 > 0:53:33and does not stimulate this kind of T-cell proliferation
0:53:33 > 0:53:36and cytokine response in monkeys without an additional stimulus.
0:53:38 > 0:53:43It's what one might call in clinical trials community as a never event.
0:53:43 > 0:53:45It should never happen.
0:53:45 > 0:53:48And that's why this has changed
0:53:48 > 0:53:51how first-in-human studies are done internationally.
0:54:04 > 0:54:07The independent review was commissioned
0:54:07 > 0:54:10by the Secretary of State for Health.
0:54:10 > 0:54:13The findings of the review are really very interesting
0:54:13 > 0:54:17in that they recognised and developed areas
0:54:17 > 0:54:21where we could improve our practices.
0:54:21 > 0:54:25One of the critical recommendations was that where individuals
0:54:25 > 0:54:28are receiving a drug for the first time,
0:54:28 > 0:54:30that drug shouldn't be given
0:54:30 > 0:54:32to a number of volunteers all in the same day.
0:54:32 > 0:54:36There were other recommendations in relation to the size of the dose
0:54:36 > 0:54:39that the individual should receive.
0:54:39 > 0:54:43Clinical trials are certainly safer than they've ever been because
0:54:43 > 0:54:47there is now more attention to the potential risks.
0:54:55 > 0:55:01The report has been adopted by the European Medical Agency
0:55:01 > 0:55:04and therefore applied to the whole of Europe.
0:55:04 > 0:55:07So those recommendations that have had a long
0:55:07 > 0:55:09and hopefully long-lasting effect.
0:55:13 > 0:55:16'That was the last first-in-man trial I did.
0:55:18 > 0:55:20'As doctors, we swear to do no harm.
0:55:22 > 0:55:25'I felt guilty every day for years.'
0:55:28 > 0:55:31'I'd like to look them in the eye and say sorry.'
0:55:48 > 0:55:54Summing up the whole period, the whole miserable, sad time,
0:55:54 > 0:55:56I would just simply say I was unlucky.
0:55:59 > 0:56:05But it didn't kill me and that's pretty good.
0:56:07 > 0:56:08We have three kids now.
0:56:12 > 0:56:15Having my first child with the fact
0:56:15 > 0:56:19that we might not have been able to have kids,
0:56:19 > 0:56:21made it even more special.
0:56:33 > 0:56:36I think one of the things, for me, is that I'm glad to have been part
0:56:36 > 0:56:39of something that has reformed the whole industry,
0:56:39 > 0:56:44and the trial has made me realise that life is quite precious
0:56:44 > 0:56:46and that we need to make the most of it, really,
0:56:46 > 0:56:50and have a sort of healthy mindset about being alive.
0:56:51 > 0:56:56I think medical trials are very important and it is to advance our
0:56:56 > 0:56:58knowledge of medicine.
0:56:58 > 0:57:02And it's not really until you have a loved one
0:57:02 > 0:57:07that is really sick and could be dying
0:57:07 > 0:57:11and they're saved by a drug which has
0:57:11 > 0:57:15obviously went through this sort of drug trial initially,
0:57:15 > 0:57:18do you fully appreciate how important those things are.