25 January 2016
Drug Trial Death Shows Clinical Trials Can Never be Risk-Free
The recent death of a man who was left brain-dead after a disastrous experimental drug trial in France has illustrated how such tests can never be risk-free.
The man was one of 90 people who volunteered to take an orally-administered drug manufactured by Portuguese company Bial.
The trial, which also left four others hospitalised with “neurological problems,” was conducted by Biotrial at a private hospital in Rennes, France. It has now been suspended and the Paris prosecutor has opened an investigation.
Ten of the remaining 84 volunteers have been tested but none have exhibited any of the “anomalies” of those in hospital. The French Health Ministry has denied reports that the drug was a cannabis-based painkiller. There was apparently no known antidote to the drug.
How Do Clinical Trials Work?
Clinical trials are a type of clinical research used to ascertain whether:
- treatments are safe
- treatments have any side effects
- new treatments perform better than existing available treatments.
Before new medicines and treatments can be given to patients, substantial data must be collected detailing how the medicine works and how safe it is for use in humans.
Clinical trials can last 12 months or more and involve several thousand patients. They typically have three phases to assess how safe and effective a new medicine is.
- Phase I trials aim to test new treatments for safety. A small number of healthy people are given a tiny dose of the drug under careful supervision. Researchers will test for side effects and calculate what the correct dose might be for use in future treatments. Phase I trials are potentially the most dangerous as they will usually be the first time the medicine has been tested on humans;
- Phase II trials are normally carried out on larger groups of people who have the medical condition the medicine is designed to treat to see if it helps them;
- Phase III trials will see the new treatment compared with existing therapies or a placebo. Phase III trials are only carried out for medicines that have already passed the first two phases.
The tragic death of the volunteer in Rennes revives memories of the Northwick Park drug trial disaster in 2006 in which six volunteers ended up in intensive care at the north London hospital after being given a new immunosuppressant designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.
After the drug unexpectedly induced widespread organ failure within hours of the volunteers taking the drug, two of the six became critically ill, with the worst affected losing his fingers and toes. All were subsequently told they would likely develop cancers or auto-immune diseases in the future as a result of their exposure to the drug. As with the French trial, the Northwick Park Hospital trial was the first time the drug had been given to humans.
The safety and effectiveness of these drugs are rigorously tested on tissue samples and animals before human trials are allowed to take place. Although thousands of people take part in such trials every year and serious complications are extremely rare, there is always an element of risk when new medicines are tested on people for the first time.
But without volunteers to take part in clinical trials there would be no new treatments for diseases such as cancer or multiple sclerosis. Indeed, clinical trials are often the only way some cancer patients ever gain access to the latest experimental therapies.
The trial that induced the French volunteer’s brain injury and subsequent death had reportedly been taking place since July last year without mishap. In such Phase I trials, the drug dosage is typically increased slowly over time. This may be a reason why side effects only recently became apparent.
Following the Northwick Park debacle, an inquiry by Professor Gordon Duff made 22 recommendations on how to prevent such mistakes from happening again. The so-called Duff Report led to guidelines on the conduct of clinical trials in human volunteers being revised.
The Medicines and Health Products Regulatory Agency (MHRA), which regulates clinical trials and medicines in the UK, says the conduct on Phase I trials “has moved on significantly” since the report and there are now various provisions and guidance in place to ensure there is as much information and assurance on risk factors and safety as possible before trials are authorised.
Unfortunately however, although you can mitigate against the risks of clinical trials you can never eliminate the possibility that things may not always go entirely to plan.
Paul Sankey is a senior clinical negligence solicitor at Slater and Gordon in London.
Our clinical negligence solicitors offer a free consultation about securing compensation and rehabilitation for victims of brain injuries caused by medical mistakes. Home and/or hospital visits are available for people who cannot visit our offices.
Call Slater and Gordon 24/7 on freephone 0800 916 9049 or contact us online and we will call you.