Drug Trials - What Happens Now?
Following the complications that resulted from the trial of the anti-inflammatory drug - TGN1412, to treat conditions such as Rheumatoid Arthritis and Leukemia at PAREXEL, the independent drug-research firm based at
Northwick Park Hospital, I ask what happens to the future of Drug Trials?
Drug Trials are a necessary part of development of medicines. Before a drug is tested in humans, it would have been through various laboratory and animal testing. There are then three stages of drug testing in humans - and any such trials have to be approved by ethics committee.
- Phase one - this stage tests for safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects
- Phase two - the drug is given to people who have the condition to see if it does indeed help them
- Phase three - large scale studies usually involving tens or thousands of people
Participants are often randomly allocated to either get the drug or a dummy version. In most cases neither the scientists nor the patients know who has got the real drug so that the results cannot be skewed by expectations. Once a drug has been through all these stages of testing - which can take up to 10 years - it will be considered for licensing. But even then, pharmaceutical companies must keep carrying out research to ensure a drug is still safe and effective.
PAREXEL were going through Phase 1 when this happened and that worries me. They had done the necessary animal and laboratory testing and were just testing for side-effects! What a result they ended up with.In fact of the eight men that took part in the trials, two are not ill because they were given dummy pills while the remaining six suffered multiple organ failure as a result of the drugs – 2 of them in a critical condition. All these complications happened within hours of taking the drugs. I know that I will never volunteer for any drug trials in future but I am searching for alternatives. I was going to use this as a foundation for my Pro Animal-Testing stance but that is not necessary as the drug had already been tested on animals with no side-effects! This incident leaves me with no answers and many questions!!
