When A Drug Trial Goes Wrong: Emergency At The Hospital (Medical Documentary) | Real Stories
I thought I was doing something good for science but in the end it was the worst thing I could ever have done they thought they were coming here to take part in
medicaltesting of a new
whenyou take a new
druginto humans for the first time it's never without risk my whole body just went freezing cold I started shaking this wasn't something you could stop everything was happening all at once vomiting screaming in pain it was extremely scary to do with me we are no way of predicting how severe is gonna guess there's no rulebook for how to deal with this there's just a mystery they thought we look like the Elephant Man six men remains everybody wanted to get glimpse of these atrocious monsters as an ever event it should never happen it was profound this is unprecedented it was like a horror movie with with the way it was set up something could have been tampered with sabotage poison I have never seen anything like this before there is an intensive-care fighting for my life and someone was responsible for that Perik Selma is a large multinational contract research organization they had a site which they leased from Northrop Park
Hospitaland they were doing clinical
trials independently from the
hospitalon early phase development of new
drugs I was about 31 I just come back from LA I've been there for two months - in an acting course for screen I was a
really good time but I'd managed to get a little bit of debt behind me a...
friend of might have done
trials and he said I should sign up they were offering two thousand pounds and I thought that was okay I was interested in the kind of historical just a scientific contribution I could be making
whenI saw the ad I was like 2,000 pounds for three days work seemed like a a good deal to me considering I'd done two previous
trials and and it wasn't it wasn't hard work
whenI first arrived at the parasail unit I was running late I was only 23 so was a baby and I just finished University I was in between a couple of jobs
trials were kind of like a get-rich-quick scheme I know brain that
really after we had had some tests done we received that pile of paperwork there was a doctor there and he quickly went through what the
drugwas going to be about the
drugitself was supposed to and be able to treat leukemia cgn one four one two is a type of
drugcalled a monoclonal antibody it's important to
realize I think that we stand on the threshold of a revolution in the way certain types of illnesses particularly cancers are treated the traditional approach to treating cancers has been options such as surgery chemotherapy or radiotherapy chemotherapy agents as you probably know are essentially poisons so TGN 1412 was intended to treat cancers by educating our own immune system into dealing with them now that's clearly a preferable option I thought it's a nice thing to do these
trials because not only am I getting some cash for...
participating but it's helping science and and it's going to help cure people further and down the track hopefully every one of the
drugs that we all commonly use were once first used in humans they have to go through that stage before they go into bigger
trials and then into widespread use this was a
drugthat had shown great promise in animal studies and the TGN 1412
trialwas a first in man study and the first study in humans is about getting to understand how the body deals with the medicine how it handles it it was a first in man study at the time you didn't
really kind of sitting thinking about how actually how important the first man's that he is it was never
really discussed in great detail it was just one point in 10 15 points that was set out it's important to know that
whenone participates in a first in man's study all that's possible should have been done in the preclinical studies to limit any anticipated risk but
whenyou take a a new
druginto humans for the first time it's never without some risk we all knew there's a tiny element of risk but the side-effects work things like you could end up with hives you could get anaphylactic shock which is we can get that from a bee sting and you can even do a cosmetics
trialand have the same reaction so hey you know this there's no concern here I don't ever remember having any second thought I kind of breeze through and signed off and quite quickly it was a medicine being...
tested in a laboratory situation approved by the government the
trialwas a double-blind randomized controlled
trialand that means that some of the men would have had the active treatment and two of them will have had a placebo or dummy treatment that has no effect neither the clinicians nor the men themselves would know who has the active or inactive treatment there was eight of us a bit of a mix of nationalities quite a good mix I think it definitely covered the bases for men of our age just to get a good idea of how the body handles the
drugthen it's better to have healthy people usually men because there's always the risk to reproductive system of studying women from looking around I think I worked out that I was probably the oldest I was 34 years old and I had lots to look forward to in my life I just recently gotten engaged we were planning a nice wedding for family honeymoon and hopefully children the
drugcompany looked at the highest dose without any adverse effects in monkeys and then they scaled that back 500 fold to give the first dose in humans giving what they felt was substantial leeway in terms of safety let's get started number one your first wit hindsight being the first person to receive a
drugwhich is the first time the Newman's yeah probably not the smartest thing we're gonna get rid of and administer the copper stop them she's okay as a
medicalstudent I volunteered for lots of
trials to make extra money after I...
graduated I worked as a junior doctor in
hospitals before joining the private
drugs company that ran
trials I had been involved in more than 300
whenI was put in charge of testing a new
drugright yeah great all right come to check on you again in a few minutes
whenyou're in the wars or
whenyou have everything connected to you it gets a bit more
realyou know your feelings are a bit more maybe nervous you kind of just locked in in the sense that you're gonna be here now this is where you are you're not gonna move you know like a long journey that you're trying to prepare for and that was the setup then okay I'm gonna start machine the whole process is quite quick once they finished finished with myself they moved over there and obviously the
drugwas still going in at the time I had a couple of books with me that I was
really looking forward to getting stuck into and the first side-effect I noticed would have been a headache and it was just a slight headache to start with around about 20 or so minutes after receiving the
drugbut then that got worse and worse and worse and it was not until the point where it was on the verge of a full-blown migraine that I put two and two together and say hey hang on a second I just had this
drugpumped into me and now I'm cutting at getting a migraine which I never get I need to be telling somebody about this I told the nurse that I'm having a major headache she arranged a cold compress my forehead but...
she didn't give me anything for it because they don't want anything to taint the effects of the
drugthat they're testing I know they'd been in the previous ward and activated their syringe and then they came into ours machine is going to administer the
drugbrian was quite a bit younger than me I think he must been about 19 or 20 I think he was saving up for driving lessons or something but no he's a nice guy I enjoyed talking to him I didn't think it would have been done like such a production line I think they would have given it and watched and then the next person and watched but it seemed like they just gave everybody the injection with ten minutes pace the headache got progressively worse - a migraine but it was slightly different to a regular migraine whereas it was coming in waves it would get
really bad didn't it was sort of eased off a little bit then it got
really bad then it leagues off but over a period of like minutes it was only a short period of time before the incident started to occur I remember still reading my book and I hadn't got too far into it David it was complaining that he was burning up and his body was getting
really hot and his head was hurting he had to take his top off because he he just couldn't handle how hot he was getting I started thinking is this gonna happen to me yeah yeah I'm assuming that maybe I'm a bit slower maybe it's gonna kick in shortly it was daunting it was it was extremely...
really surprised that they didn't stop the
trialnext door from what was happening to us they had a chance to save one or two guys
whenthey put the syringe onto that mechanical device okay press go on the machine you could hear the noise of the syringe pump as it was infusing us we can just see this liquid creeping down the clear pipe and going into your body and it's an unusual situation knowing those to you an unknown fluid going into your veins it's a weird experience after had given the dose to the seventh mode a nurse told me one of the men had headache while dosing the eighth the nurse returned and told me that the first man was feeling worse it was an instant point of like bang severe back pain in my lower back it was way worse than the migraine oh how we doing David oh I was trying my hardest to twist and turn to find a position that I could feel less pain I couldn't understand it it was so debilitating it was it was horrible and then the guy who was my left started saying that he had a headache and his head was sore and his back was hurting it's bad as it sounds it made me feel slightly bitter that I wasn't going through this on my own once we've been injected within a minute or two I was feeling like I had hypothermia it was a bit like if you could imagine me and dipped into ice quite rapidly my whole body just went freezing cold and I started shaking this was like this shivering with cold but I wasn't cold this...
wasn't something you could stop it was just so extreme that it was just horrendous everybody was failing then they tumbled like dominoes I would remember being sick into a most big yellow biohazard bags it was terrible I must have brought up a good leader of bile just solid well it was all manic everything was happening all at once they were vomiting they were screaming in pain people fainting they can control their bowels for some reason patient three started to think he would do better if he got out of this place he was saying things like I don't want the money anymore I just want to get out he's just started panicking started freaking out he was begging he just
whenhe was saying he wanted to go home he screaming in pain which was the most kind of heroin kind of moments because he was in complete agony yeah he just freaked he just thought that they were out together and that he would do better if he actually got out of the
hospitalas if getting out of the
hospitalthe pain will go away the wards became chaotic the men were getting worse their bodies were in shock there was chaos the nurses would take him off guard I remember the doctors not knowing what to do they were probably afraid they probably hoped it would only last a short time they weren't expecting it to carry on and get worse and everything else that happened it was like a horror movie with the way it was set up as time was progressing you're just kind of thinking is this gonna happen to...
me it's like going on a roller coaster you know it's gonna be scary you're thinking I'll know what am i doing this why am i doing this they close the curtains you're just there left with nothing just noises I was just like a ghost in the room this must have just been terrible for everyone involved clearly it was catastrophic for the volunteers but I think it would have been
really scary for the
medicalstaff as well it's not something you expect to see in your lifetime doing clinical
trials and suddenly there are people who are getting extremely ill all around you it was obvious that there was something
really serious going on I couldn't reach the
medicalregistrar I ended up running down two flights of stairs to the intensive care unit and grabbing the first two dots as I saw I was still unsure what was happening then one of the nurses came to unplug everything I was told then to go get some food and someone would be with me shortly I remember just kind of thinking what if I just sat through just unsure of everything and I was told to collect my things I came back and the ward was empty one minute you're in a wars with patients who sounded like they fighting for their lives and then you come back and they're gone it was so sur
realwhat's going on what's happening the lights were kept dimmer in there and I'm pretty sure I was falling asleep and waking up falling asleep waking up the whole day where did it go I felt concerned...
but I still had a lot of trust in the company that were doing this
trialI believed that we were safe and even though it wasn't feeling good I would never have thought that we were at death's door it become quite dark outside hours have passed and then there seem to be a problem with Ryan all of a sudden some surgeon guys came up and they threw the curtain around him I remember them a few of us were looking at each other like what's going on here because it's quite worrying that was
whenI thought okay we could be in serious trouble is that what we've all got to look forward to they been wheeled him away connected to these machines that was probably the moment but I remember thinking this is scary I wasn't riddled to be on duty that night I was having supper with my wife
whenthe phone call came in my colleague explained the situation a
drugno human and had before an unknown illness there was six of them one of them intensive care things were changing very quickly they were deteriorating in front of us I said look this is clearly unprecedented I'll come in and he said was the effect of yes that would be that idea although shorter and more exploited so I walked through to the intensive care unit where the first patients had been brought down looking at him as an intensivist he was
really as unwell as anyone I've seen his blood pressure was very low and the settings on the ventilator showed me that again his lungs have been quite badly...
affected we were having to set things to a fairly high level to keep him safe and stable so it was clear that this was a very serious situation but we also knew there were five more people up there had received the same
drugthe clock was ticking the rate at which they were deteriorating was very rapid the doctors from the
hospitalit was seriously concerned this was in the hands of the NHS now and they obviously have to have got different criteria they're in it for saving lives not for making money as well we knew that this was serious there was a feeling of who's next then not long after the two guys came to collect me I remember saying but why am I being taken there and he said well you're all very ill and I remember saying well no one's gonna die are they he was reluctant to answer and he was like well you will see the men all had multiple organ failure someone said it looked as though one man might die and that I might be charged with manslaughter I felt completely out of control I don't remember being moved I just woke up in a hallway outside of ITU my temperature was
really high apparently by that stage our organs had started failing it wanted us to all have this mask on our face solid on the face it's because the blood and fluids were leaking into our lungs how close I was to dying it's hard to say it's not something I went out of my way to to find how it's not something I wanted to know they were giving in to kidney failure we...
had a full intensive care unit that stage we generated five extra beds in the recovery area what we didn't have was enough kidney machines to suddenly provide extra support so by this stage of the night there were police vans criss-crossing carrying put in from many
hospitals all converging and all hit hard this was a major incident by now and things were pretty complex there were a lot of unknowns there's no rulebook for how to deal with this looking at them from the outside they had unstable blood pressures their breathing was affected they were developing organ failures they looked like people who had become septic this happens I only have blood poisoning from infection they looked as though they might have an infection so one of the possibilities was that the infusions were contaminated in some way that all received injections from a batch of vials so although it would have been made under sterile conditions there is always a risk that something could have happened I kept going back to read the document that detailed everything known about the
drugit mentioned the unlikely possibility of a cytokine storm an extreme immune reaction cytokines are small proteins involved in the inflammatory response either to an injury or to an external infection cytokine storm is
whenthese become super active throughout the body leads to a cascade of activity cells attacking other cells immune cells attacking a tissue and that can lead to organ failure inflammation high...
temperatures a very nasty outcome the clinical
trials team told us cytokine release syndrome is a possible side effect profile for this
drugthe treatment for that would be to give
really powerful immune suppressant
drugs high doses of steroids the trouble was if we did that and actually this was infection if for some reason they were all reacting to a severe infection then we could have made them worse rather than better so respected people a
reality check we involved a lot of people I got a call at 12:04 in the morning at first I didn't believe him because I just thought this was so incredulous to have six healthy volunteers in a first-in man all at once being very unwell I mean this is unprecedented from the signs and symptoms that my colleague was describing to me over the phone it was more consistent with a cytokine release syndrome by that point in time and it should be treated as so and aggressively so but if this was infection then it would have the opposite effect it would dampen down the immune system six people who were fighting with an overwhelming infection patients could deteriorate to the point of death these patients may die so there's
really no margin for error it was a big decision to take but it's one that we had to get on with because even the
drugs that we were giving for this would take time to work so we made the decision we would treat them as cytokine release syndrome so a thousand milligram of steroids is a significant dose
really all we...
could do is wait and see it was about 3:30 a.m. and my phone rang it was one of the nurses and she said that there being an issue with the
trialand I needed to get down to the
hospitalas soon as I could it was
really shocking news my heart kind of raced and I had no idea what was
really happening what you're seeing his response to that kind of pain that they tried to deal with because you know one of the doctors came out and explained that David was in very serious condition he said he may look different that what they had been given was starting to swell their bodies he just wouldn't look quite the same I don't think anything could prepare you for what you see
whenyou first go in his cheeks were very swollen so much so that his eyes were they look more like slits his face was just round like a ball and his stomach was huge I thought he had had his hands on a stomach because there was that large until I
realized that his hands were actually beside him on the bed it was pretty scary to see somebody you love suddenly be so disfigured from what you remember them just a day before that horrific feeling the
drugs tests that went badly
wrongthey thought they were coming here to take part in relatively routine
medicaltesting of a new fear have been dealing with an extremely complicated set of circumstances once they simply haven't come across before they are suffering from a major organ failure the next day I've just glued to the news and multiple...
organ failure their intensive care units all these emotions you just you didn't want to think of the worst that could happen just watching what's unfolding the girlfriend of one of the victims says her partner is fighting for his life experts the news caught wind of this story partly because that woman said we looked like the Elephant Man so everybody wanted to get a glimpse of these atrocious monsters in the morning the story was all over the front pages somebody had used the words Elephant Man after seeing the swollen face and body of one of the patients it became a headline that stuck that was quite lucky that I know physically III escaped because I had to perceive her you know we're all there at the same time in the same place why am I the lucky one it was it was like Russian roulette I was oh you know I was just very fortunate that what the blanks fell on me there were people appearing on camera speculating what this might be what might be going on
whenanyone's admitted to intensive care and as they start to receive all them support the treatment that we give them can make them look even more distressing they can be a shock the fluid that we give them can make them swollen because you're giving fluid in and it's leaking out the cause of it there's
really not the clinical
trialapparently they did pump in a lot of fluid and it wasn't
realuntil afterwards um you know talking about it with people that I
realized how swollen we got and where...
we received the tag the elephant in something that the authorities say is virtually unprecedented in British
medicalhistory the media interest although very understandable did add pressure to us there were comments that this is very serious they can all die in a very difficult situation it's unknown territory treating a reaction to an untested
drugthe patient had by now two doses of steroids but we can tell if the things we were doing we're going to help in the long run you give the treatment that you think is best in this case everything was deteriorating further Scotland Yard has also become involved it's trying to establish if there was any foul play at all if any of the
drugs had been tampered with in any way on the Tuesday morning there was a phone call from the special crime unit in the police something had gone very much
wrongwas a clinical
triala tragedy a crisis affected the lives of at least six young men and and and I have never seen anything like this before this was treated as a crime scene the police seized not only the
drugthat had been administer but also the placebo they seized clinical samples blood samples something could have been tampered with sabotage poisoned and that these folk might have been the the victims of such foul play these
drugs were seized and held under the rules of criminal evidence so they came to us in sealed evidence bags the first invasive level is that somebody made a mistake it was the
Etling contaminated with something it was the
wrongstrength that the basic pharmaceutical science of this
drughad not been carried out properly and of course included in that list of possibilities is a possibility that someone had deliberately adulterated this
realpeople and we owe it to them and their families to find out what had gone
wrongthis needed to be investigated to save the lives of six volunteers other experts already trying to find out why they want something such extreme reactions what should have underlying it all this was still a mystery we didn't know if this was going to get more severe or if this was the extent of it David was in and out of consciousness all the time he had enough strength to sort of squeeze my hand but that was about it and then he kind of dropped off again all the doctors could tell her was that they were doing as much for us as they could but they had no certainty on what was going to happen next I can only you know feel for them because it must have been a horrible time especially you know not knowing if they were going to pull through or not the first round of tests that were carried out of identity and purity tests we were able to show very quickly using the simple chemical test that this was the right
drugit was the right strength and it wasn't contaminated with anything else that would have caused this reaction the next step was to understand why those preclinical safety tests hadn't worked six men...
remain in intensive care this morning after falling a dangerously ill while taking part in clinical
trials suddenly on Wednesday morning we were doing a ward round and we said something's happened the four patients who were awake suddenly told us almost within an hour of each other and I feel much better suddenly after two days or so that's
whenI was I could feel things were improving his life wasn't on the line anymore we all seemed to perk up I remember feeling
really hungry and feeling that I was gonna be safe the fevers all went down at about the same time and even the two patients who are already on ventilators were in multi-organ failure needing a lot of support their fevers went down some of their numbers started getting better the signs of the underlying information seemed to be burning out I suppose everyone felt relief but also we had to ensure that we weren't going to miss something in feeling that relief it was a long way from knowing that they were completely out of the woods but it was the first sign we'd had that things might be turning a corner and it was striking how it all happened in autumn simultaneously it was almost like a switch going off we were taken off the machines the doctors felt that our organs were back to her to a state which they could start doing their job again the intensive care unit was wonderful I know there's a few other
trialcompanies out there that are not located in a major
hospitaland if I'd been...
whenthat this had happened wow I I guess I might not have been so lucky I'm very proud of the teamwork people showed everybody and the way the
hospitalis a whole responded to the challenge just a fantastic example of how people come together
really tough in a very unprecedented event I knew that I'd been very ill and I was still recovering but if it wasn't for dr. Ganesh and his team which I'm sure we're all very grateful for making those decisions it'd be a very different story we were
really lucky to have had the NHS accompany running a
trialour Excel has apologized to the families concerned at this early stage it is still difficult to make a comment about a longer-term prognosis for all of these patients you know there are different types of recovery phases the the blood counts will start to recover in a different way over days the liver enzymes will start to respond in a different way over a month and even anemia which comes as a consequence of cytokine storm takes up to six months to recover so there are different phases of recovery from cytokine storm especially one as severe as this I was watching some TV show which talked about us why we did it should we have done it what we should deserve compensation wise and I thought I wanted to get solicitors involved after the
trialtook place some of the
trialparticipants wanted some legal advice as to what they should do next they were feeling incredibly shocked and frightened...
had no idea what the future held for them at that point there was the huge concern about cancer and any autoimmune diseases there was a concern also that it may impact on their ability to have children it's quite a stressful situation
really my organs were back working but I was like an 80 year old my muscles were just wasted away what was in the
drugor the storm that created it's supposed to like attack yo cells such as bad cells like cancer and things like that but because we didn't have anything like that it started attacking our own tissue Eero muscle and it just wasted wasted away our muscles I definitely remember thinking that although they say where we could be okay within three years there was the concern that we wouldn't because who knows what's going to happen there's a chance that all of us end up with the same illnesses and then what happens and we had no immune system at all so we're given instructions all not to go on the tube or trains or buses just in case yeah if someone was to cough near us with some sort of germs we'd have no way to fight it off I knew he was still in intensive care and I wanted to give him a bit of support so I went down to say goodbye to him and he wasn't able to speak so he was just like you know I remember him showing his hands and a bit like hey what about my hands I saw that his fingers have blackened and there was no hope for saving their fingers I
realized that he was certainly in a worse...
condition and he'd come off of this in very bad way and someone was responsible for that for me one of the most shocking features off the
trialwas the spacing between the doses our clients were being injected with this new monoclonal antibody in quite quick succession some of our clients were left actually starting to experience problems whilst others were actually just been injected for the first time that even from a layman's point of view seems ridiculous frankly it's another significant concern they seem to receive the whole
drugin three to six minutes I'm not sure that the preclinical testing on animals was done at that pace once the lawyers were involved we ended up doing a lot more blood tests and so on to try and figure out you know how is our body recovering how fast how how much damage has been done and they managed they they found a normally in my blood which as they come which is something that is quite often appears prior to a camp cancerous lymphoma cells appearing it was a big shock because by that point I thought we were starting to move on we got married roughly three months after the
trialand of course normally wasn't winning marriage and you think about children afterwards and that was something that I was very worried about with the fact that having having this cancer scare and even the effect you know would the
drughadn't been in my system is there any chance I could flow on to the children do you want a child...
born and then have the possibility of their father having cancer or dying soon after I was very down the worst down those findings were that the
trialhad been conducted as intended and we had not discovered anything that was deliberately or unintentionally
wrongwith the way in which that
trialhad been been managed our clients felt that the MHRA report was a report that was rushed out and unfortunately was a bit of a whitewash the MHRA saying that it was unpredictable is just their way of passing blame because they're the ones who said it was an okay
trialto do I believe that the decisions that were taken were entirely appropriate and consistent with the current state of scientific knowledge and I don't think anybody can be held responsible for knowing something that they don't know and they couldn't know at the time per exhale embarked upon a
trialand they were ill-prepared they didn't have any backup everything we did had followed protocol if you knew what was going to happen you wouldn't need to do it that's why you do
trials they should have had an idea of what to do think positive things didn't
really start happening to treat us until they involve the outside community and they had the answers there were people saying that was rushed and they didn't feel that it was happening in a I don't know a considerate way it was all a barrier being turned over on with the next one on with the next one and so we felt probably felt...
disgruntled like we were just cogs in the machine and we were human guinea pigs and nobody wants to feel that way we had no scientific or rational explanation it was dangerous in humans and completely ineffective in the monkeys I think the biggest problem with that study was that three of the preclinical tests gave an answer which suggested there wasn't a risk whether actually was over the next three to four years we came to understand why we now of course the macaques and humans are very similar species the t-cells which is the particular cell of the immune system that this
drugis supposed to target have on their surface a molecular structure called a receptor which binds to the
drugbinds to the receptor the cell is stimulated to respond we also know that the monkey t-cell receptor and the human reset are virtually identical but despite the fact that the monkey t cell binds TGN 1412 it has a very similar receptor to the humans it does not respond to the TG n 14 stimulus in the way that the human t-cell does and it does not stimulate this kind of t-cell proliferation and cytokine response in monkeys without an additional stimulus this one one might call in a clinical
trials community as an ever event it should never happen and that's why this has changed how first in human studies are done internationally the independent review was commissioned by the Secretary of State for health the findings of the review are
really very interesting in that...
they recognized and developed areas where we could improve our practices one of the critical recommendations was that where individuals are receiving a
drugfor the first time that
drugshouldn't be given to a number of volunteers all in the same day there were other recommendations in relation to the size of the dose that individuals should receive clinical
trials are certainly safer than they have ever been because there is now more attention to the potential risks the report has been adopted by the European
medicalagency and therefore applied to the whole of Europe so those are recommendations that have had a long and hopefully long-lasting effect that was the last first in man
trialI did as doctors we swear to do no harm I felt guilty every day for years I'd like to look them in the eye and say sorry summing up the whole period that whole vegetables had time I would just simply say I was unlucky I but but it didn't kill me and that's pretty good we have three kids now having my first child with the fact that there's a chance we might not have been able to have kids made it even more special I think one of the things for me is that I'm glad to have been part of something that has reformed the whole industry and the child has made me
realize that life is quite precious and that we need to make the most of it
really and have a sort of healthy mindset about being alive I think
trials are very important and it's to advance our...
knowledge of Medicine and it's it's not