Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
A tragic outcome from a clinical trial
In France, a new drug code-named BIA 10-2474, manufactured by the long-standing (Est. 1924) Portuguese company Bial, was given to 90 people. There is a large need for non-opioid painkillers and BIA 10-2474 was supposed to be the solution.
As an inhibitor of an enzyme called fatty acid amide hydrolase, it was not supposed to be very harmful, since the human body produces several fatty acid amides, or FAAH. It was supposed to target pain and cause relief by acting on cannabinoid receptors.
But the result is that one man has died and three men have possibly permanent brain damage. A fifth person is dealing with neurological problems and a sixth is being monitored. The hospitalised men started taking the drug regularly on 7th January 2016 and began showing severe side effects three days later.
These events occurred in Rennes, France, where the Phase 1 trial was conducted by the clinical research organisation Biotrial at a private research centre. A Phase 1 drug trial is the first time an experimental drug is given to volunteers after a series of laboratory and animal studies.
Without volunteers, there would be no new drugs or treatments. Some say there is a price to pay for a cure. But the scientists and the public are asking: What went wrong in this tragic incident?
1) The study was ongoing from July 2015, with no previous major events reported. But, as doses increase, side effects can too. This is one of the reasons why companies conduct these trials.
2) The study was a Phase 1 clinical trial, in which healthy volunteers take the medication to evaluate the safety of its use. Bial confirmed that all volunteers had been thoroughly checked and were healthy. It is followed by Phase 2, in which the drug is given to the people with the relevant medical condition and if both stages are a success, Phase 3 follows, where the new drug is compared to existing ones or to placebo.
3) Testing on animals often fails to predict outcomes on humans, plus it is viewed as controversial and cruel. We need to think about new solutions and methodologies for pre-clinical studies. Using life-like human simulators; building artificial organs or “organs-on-chips”; in vitro, using human cells and tissue; in silico, using computer simulation; or computer modelling could be the answer.
4) According to The European Medicines Agency, since 2007, approximately 12,500 Phase 1 clinical trials have been conducted in the European Union without any major incidents being reported except one, known as the Elephant Man trial, which happened in 2006 in London. Years later, Professor David Webb of the University of Edinburgh and vice president of the British Pharmacological Society said it is "much less likely to happen again". This story proves otherwise. We still have a lot to learn.
On April 14, 2014, a new regulation on the authorisation of clinical trials was adopted at the European Union level by the Council of the EU. A new set of EU regulations on clinical trials and testing are due to take effect in 2018. Companies are taking measures and research facilities are following procedures. In a case from France, authorities are even looking into the possibility of manufacturing or transportation error. But is it possible to eliminate the risks entirely?
"You can mitigate against the risks, but nothing is 100% certain. We can never be sure," Professor Webb says.
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.