Drug trials
As I’m sure you’re aware, there are 6 men terribly ill in hospital in London at the moment. These 6, and two very fortunate people, were participating in the first human phase trial of a new drug. However, apart from the two who were given a placebo, all the participants became critically ill within about an hour and a half of being injected with this new drug, TGN1412. What exactly happened will no doubt come out in the next few months.
The first phase human trial typically occurs about 6 years into the 10 year drug development cycle. It uses healthy people to determine if there are any adverse reactions. Before this, it’s likely that the pharma company will have spent $200million in developing the drug, testing it in the lab, and on animals. The company developing the drug will have had to provide evidence to numerous approvals committees before the trial could begin on humans.
Quite simply, this is a disaster, and we should all be praying for these poor men to recover speedily, and to suffer no long-term harm. The fiasco will cause huge problems for future drugs trials, unless the cause of this can be readily determined and isolated. It’s likely that the root problem falls into one of the following:
- Wrong dosage
- Contaminated drug
- Unanticipated effect of the drug in humans
However, it’s hard to know which of these will cause the minimal long term damage to pharma-reputation in the UK. Wrong dosages occur, tragically, quite frequently, and I suspect this will be the ‘best’ outcome.
But, it should be remembered that this is a novel drug, one of a new class of drugs that’s based on proteins. With the exception of insulin, there are few protein based drugs approved for clinical use. It may be that the manufacturers still need to learn more about mass protein synthesis.
The worst outcome is that the procedures followed by the drugs company, the clinical trial providers, the ethics committees, the approvals committees, and everyone involved were correct - that no mistake was made - and that there were side effects that were not predicted. This will cause mayhem for drug development. However, it may well be the case. One of my flatmates told me that penicilin kills guinea pigs, and so if it were developed today it would never be allowed to a clinical trial. Yet over the past 70 years, it’s saved countless millions of people. Indeed, the same could be said about potatoes - they’d not be approved for human consumption if they were invented today.
It’s a mess. Let’s all stop and pause for a minute, to wish these critically ill men our full support. Then we have the reconciliation. What went wrong, and how can we fix it? But we mustn’t let this hinder future drug development.
March 21st, 2006 at 8:53 am
On the radio the other day they were suggesting that a similar drug had been trialed recently in the US and was deemed unsafe for human use. I haven’t checked these reports or looked into any details, but it could be worth looking into.
There is always the chance that the procedures in place for checks are not adequate. No matter how well you try and anticipate all circumstances, there is always the unexpected. Over time the procedures and checks that run up to a human trial will need to be reviewed and modified. I don’t know if this is the worst case outcome or just an early warning that as a society we place too much trust in “procedure”.
Given that the reaction was almost instant you might have thought they would stagger the drug administration so that there were several hours between each person being given the drug.
I think the biggest questions surrounds the practice of paying people to take part in trials. New drugs need to be tested, there is no doubt about this. But offering financial incentives to take part in trials may not be the right thing to do. I think it is still possible to take part in multiple trials. Maybe GPs should be involved in the whole trials process to act as an independent moderator to ensure the patients are represented medically.