Guinea pigs or heroes?
This week, came the news that a person who was involved in a phase 1 trial of a drug (BIA 10-2474) in France, has died. Five other participants are in critical condition. These six men had been given higher doses of a drug that was hopefully going to help with treating pain and anxiety as a result of Parkinson’s disease.
You can read the details of the study here.
Neither the manufacturers or researchers knew what would happen with higher doses of the drug – but they needed to know before they could risk recommending higher doses into the market. Because of the suffering of these six men, the drug will never be used in high doses and as a result – the world will have less suffering.
But one man died and 5 are critically ill as a result. What do you think of these men? Were they stupid to be used as ‘guinea pigs’ for research or are they heroes?
Have a look at any of the drugs you use – paracetamol, antimalarials, ARV’s – have you ever thought what goes into determining the number of pills you should swallow and how often?
The truth is hundreds of laboratory animals and thousands of human beings were used to determine that. Once a drug has been shown in the laboratory conditions to have an effect – perhaps it can kill malaria parasites in a testtube, it can slow the development of a cancer cells on a petri-dish– the drug does not straight away get on the shelves to be used by humans. The drug or vaccine is first tested on animals and then when it is proved to still have an effect, studies start in humans. All this testing before the drug/vaccine is ever used in humans is called pre-clinical trials.
Clinical trials start when the drug is first introduced into humans. Neither the researchers nor the manufacturers of the product know what it can do in a human being at this point. Just because a drug is safe in monkeys and mice does not mean it will be safe in humans and so when the drug is first tested, the monitoring is very strict.
The very first clinical trials are called phase 1 studies – these studies main aim is to determine whether the drug is safe in humans and so phase 1 studies are also called safety trials. In almost all drug/vaccine trial, the product is first tested in healthy male adults. Females have been avoided due to fear of what would happen to an unborn child should she accidentally get pregnant during the trial. There are many arguments made against this – many feeling that women are being treated as the ‘other’ but I do believe that since no contraceptive is 100% effective, the protection of the potential unborn is paramount. However, that is another debate….
So, the product is first tested in healthy adults – usually in a very controlled setting depending on the drug being tested. These phase 1 trials are crucial – researchers determine the dose of drug to be used and look very carefully for side effects. Safety trials are often conducted in less than 10 people and several sets of studies are conducted with different doses of the drug. Sometimes small studies like these are conducted in different countries.
In the French study with a fatality, the drug had already been tested in several people from various countries before. The six men badly affected were given much higher doses of the drug. These men had been admitted into the facility during the trial and had rigorous tests conducted from the moment the drugs were given to them. Many blood samples were taken and everything was done by the book. Unfortunately for them, despite the close monitoring, the way in which this drug works is still not very clear and the researchers were not able to pick up trouble until it had set in.
I consider these men, heroes of science and it’s a pity that people who participate in safety trials are not recognised for the heroes they are. Men die at war killing other people (who often have done them no wrong) – and they are counted as heroes who are remembered for generations. I do not know the reasons the man participated in this trial – one thing for sure is that he must have felt very strongly about the need to end the pain caused by Parkinson’s disease. He tried to make the world a better place – doing no one any harm. He should be saluted as the hero he is.