They call it ‘volunteering’ for a clinical trial but after the shocking drugs trial horror earlier this year why would anyone make themselves a human guinea pig? One answer-Cash.
“When I woke up that morning our room was unusually quiet, I remember looking up at the white ceiling wondering if I was dreaming. Then I saw nurses running down the corridor and a sense of panic everywhere, it was then I realised something dreadful was happening.”
That is what Damian Brown remembers from that dreadful morning in Northwick Park Hospital in August this year when the morning dosage ended up with two men instantly fighting for their lives. Damian, aged 26 from Bournemouth was in the next room on a trial for a completely different drug.
The six healthy men on the trial for an anti-inflammatory drug called TGN1412 were put into intensive care after it went drastically wrong. One patient-David Oakley better known as ‘The Elephant man’ reacted so badly that he had multi organ failure and his head ballooned to elephant sized proportions. To add insult to injury he has now been diagnosed with aggressive cancer in the lymphoid glands. Still he has not received one penny from the drugs manufacturer Paraxel in compensation or medical fees. The good old NHS was left to treat all six previously healthy men for conditions induced by the human drugs testing.
Despite this catastrophic testing that you would imagine would scare anyone off participating in these trials, business for human trials is never better. When I rang up a medical Centre in Cardiff to enquire about the trials, a nurse told me applicants have nearly doubled since the Paraxel trials in August, explaining, “It’s weird but when people saw how much money was to be made doing these trials our phone did not stop ringing.”
The Engineer Graduate Damian said: “Although seeing those guys so ill, it would not put me off doing another test, Last time I got £4000 for testing stomach antacids.”
He has only ever tested drugs that have previously had other tests on humans. When asked if he thought the six men on the TGN1412 knew it was the first test on humans he said. “Yeah they knew- they just didn’t care very much, they would have thought it was like any other trial we’ve all done. They just wanted the money.”
Damian explains that most people he has met are doing the trials for the financial benefits. “ Most people do them for a good reason. It can change your life a little, you know by going travelling or starting up your own business or paying off debt. No-one enters into these trials thinking it is a sensible way to earn your living.”
The most severely effected from the Northwick Park trials, David Oakley or ‘Patient A’ as he was known initially went on the trial to get money for his wedding later on that summer. He now has multiple sclerosis, lupus, ME (chronic fatigue), rheumatoid arthritis and an aggressive form of cancer.
Phase one drug trials are potentially the most dangerous, as it can be the first time the drug has ever been tested on a human being. After this the drug has to go through two more trials before it is deemed safe for licensing. Around 2500 people take part in these every year in the UK. You are paid compensation for your time in there, not how dangerous the drug is. That means that you are paid the same for testing the lethal TGN1412 as you are for testing a fungus cream on your foot.
It is true that many people keen to do these highly lucrative trials are students, but many participants are simply your average Joe fancying a working holiday.
24 year old Ross White from Cornwall started doing drugs trials whilst he was living in Swansea. He was drawn in by a pleasing ad in a newspaper offering £2000 for two weeks work. He is now a secondary school teacher and is still participating in trials during his long holidays from work. What is really surprising about Ross is that he is dead against doing recreational drugs and in his life has never once tried any drug or even smoked a cigarette. He reason for this is that you never know what is going into your body.
When asked whether the possibility of life threatening side effects might deter him from doing any trials, he said: “It makes no odds to me what happened to them, I’ve done them before I’ve been fine, its just that they were really unlucky.”
Ross has completed three different drugs trials in Cardiff for drugs used for blood thinning, pain relieving tablets and stomach acids. “In a group of 10 of us there are always at least three on a placebo tablet or so mild you won’t even notice that, I think that’s been me twice.”
The trials start by the drugs company selecting a group of healthy young people with good blood pressure and medical history. The human guinea pigs are then chosen and warned about the drug to be tested and their possible side effects. Ross says this is the only daunting bit: “You read this list of side effects which I can admit be daunting but I have only had side effects once and it was just weepy eyes and a headache.” He said. Although this does not seem much to him but to many this conjures up images of rabbits in cages.
In July Ross undertook a trial for a blood thinning drug, but it was unexpectedly cancelled after only three days. Out of 10 participants, four people had started fainting and had really high temperatures. As part of the terms when you sign up for trials you are allowed to leave at any point. The drugs company took the decision to cancel the trials but still gave every patient their £2000 as they walked out of the door. Ross was one of the lucky ones and this suggests he again was on either a placebo or a very low dosage of the drug.
Damian also believes he has always had the placebo: “ I have never had any side effects, a few other guys have got head aches and stuff. I think it’s the mindset you go in with, too many people just get overly paranoid about an itchy throat or pins and needles.”
A typical day would involve waking up at 6am and blood taken after breakfast, followed by the elusive pill and then 25ml of blood taken. This is then repeated at 1pm and again at 5pm. In between this time you are allowed to sleep or watch tv, occasionally you are then let out to walk around, but of course unauthorised running is forbidden. You really are a walking talking experiment. That was a good day. There are days called the ‘Kinetic’ day that most participants I have spoken to come to dread. Its where you have blood taken in intervals of 1minutes, 2 minutes, 3 minutes to see how fast the drug is consumed into your blood. This is repeated throughout the day with pill after pill being swallowed, at all times closely watched by a Doctor who requires the patients to stick out their tongue to prove they have actually swallowed the mysterious substance.
The smooth talking drugs companies who test in the UK must have one incredible legal team, or just someone who can hold persuasive talks to potential participants of the trials. Even three months after the disastrous drugs trial in Northwick Park Hospital the six men still have not got any compensation or been helped by the drug company responsible. The six volunteers are now seeking massive damages for £5 million each. What is noticeable is the firm belief that both Ross and Damian have that these men will get compensation and that really these drugs companies aren’t as bad as everyone makes out. Ross said: “I am surprised the men weren’t helped by the German company, they have so much money so you would just expect them to pay for those guys treatment after.”
Ross said that before he took part in the trials, the drug companies explain that, ‘the trials are regulated by the General Medical Council so they are always covered for compensation.’ Damian was told firmly that the ‘Any participant in the trial would be the same legal protection as if he/she was in an NHS hospital.’
There seems to be a lack of guidelines and confusion over liability throughout this drug testing world.
The lack of official safety guidelines provoked the expert watchdog Ceres to announce it would close down this December, stating it was used as a fig leaf for the Government’s failure to provide volunteers with independent advice or support. The failures of the Government were brought out to the public domain such as no monitoring for post trial problems or even knowing how many people take part in drugs trials each year and what incentives they are paid.
Ceres (consumers for ethics in research) launched itself in 1989 and was known as “The Voice of the Guinea pigs,” after a student died a long and painful death in a respiratory drug trial. The EU Clinical Trials Directorate requires volunteers to be given an “independent point of advice.” In a damning report by Ceres they accuse the Government’s Clinical Ethics committee of advising drug companies that they can just show volunteers a Ceres leaflet to satisfy the EU requirement. Ceres say this is done without their permission and that the government is bowing to the pressure of these big drug companies.
There is an overlap in governing bodies between the NPSA and MHRA which means essential monitoring of these trials is not being carried out.
Another serious area where rules seem to have been ignored is who exactly can be accepted onto these trials. Both volunteers Damian and Ross said that there are frequently people on Government benefits such as the job seekers allowance participating in the trials, without declaring it. The money is seen as ‘tax free’ because the volunteers are loosely advised to declare it, and surprise surprise, this does not happen. It was only recently that the trials started taking the National Health Number so that they could see how many trials the volunteer had done. There is a legal requirement of three months gap between each trial, but this is easy to get around. Damian laughs when he tells me about a man that has notoriously done over 90 tests in a few years by moving around the UK dodging the system.
The laid back attitude that these two men have towards the testing and its effects is very surprising. When asking if there was anything they wouldn’t do they both did have guide lines. The school Teacher, Ross said: “ I would not do anything to do with my groin or reproductive organs or anything that could cause cancer.”
Damian said: “ I would not touch any drugs that has not been tested on humans or maybe reproductive ones.” So they do have some limits.
I can’t help feeling when speaking to Damian that he is a really clever guy but doesn’t seem to have really thought about what all this testing could do to his long term health. When I ask what does he feel when he is pushing pill after pill down his throat he said. “Its quite exciting, everything is busy, it’s a little adventure. There are people constantly checking on you and that makes you feel really special.”
No one can argue that drug testing is a necessity and many people do test drugs for moral reasons or to save a loved one. A shocking statistic is that more people die from the side effects of drugs than are killed on the road every year.
There is much speculation about how many people die in clinical trials. A German Doctor talking on a Radio 4 debate suggests only six, but for the more cynical of you, the secrecy and cover ups that these top Drug Companies are accused of could mean many more.
At the end of the day it’s a personal choice, what is £2000 worth to you? If you know the risks and trust the drugs companies then it might be less dangerous than a weekend out for thousands of people all over the UK. If like those six men everything goes wrong, then it could be a life in pain. After all that’s the risk you take when you decide to become a human guinea pig.