By: Nawa Arsala
A volunteer participating in a clinical trial in France died last week, while five more remain hospitalized in critical condition. On January 17th, the Portuguese company Bial conducting the trial issued a press release confirming the death of the volunteer at the University Hospital of Rennes, while the remaining five could be permanently disabled due to neurological damage.
The drug being tested, which has been referred to as BIA 10-2474, is a painkiller meant to treat anxiety and motor disorders. A major public health issuing plaguing the United States today is addiction to pain relief drugs, therefore, there is a great need for non-addictive drugs in this therapeutic area. Study-provided documents explained that the drug in development was for “the treatment of different medical conditions from anxiety to Parkinson’s disease, but also for the treatment of chronic pain of sclerosis, cancer, hypertension or the treatment of obesity.”
The drug was intended to work on the body’s endogenous cannabinoid system, which deals with pain. Simply put, the drug should have stimulated the same receptors as the active components of marijuana. Bial believes that the drug has the potential to reduce pain and anxiety, among other neurological conditions. Earlier reports said the drug was related to cannabis, but Bial maintains that it does not contain cannabis or cannabis extracts.
The trial was run by the clinical research organization, Biotrial. Clinical research or contract research organizations, provide support and various services for pharmaceutical companies through various stages of drug development. In this case, the French company Biotrial ran the Phase I trial. In the European Union, this stage is the first time the drug is tested in humans. Generally during this stage, trials are conducted on healthy volunteers and are intended to see how the body responds to various dosages of the drug. As this trial began in July, it is likely this accident could have been a result of an increased dosage. This phase is not intended to test the effectiveness of the drug, but rather to see if there are any side effects. Phase II is intended to test for effectiveness, and Phase III increases the volunteer pool and compares the effectiveness to a placebo. In this case, 90 volunteers were given the drug. All of the volunteers were men, ranging from 28 to 49 years old. Further, there were an additional 38 volunteers who received placebo, which is considered highly unusual in a Phase 1 trial, since the purpose is to test safety, not effectiveness.
The trial has been suspended and the Paris prosecutor’s office has opened an investigation. The health minister of France Marisol Touraine said she has “no knowledge of a comparable event.” Bioethicists around the world have called into questions the consent of the volunteers. The most vital aspect of human research is the ability for the volunteer to give informed consent. As many volunteers in clinical trials are compensated, many Phase I volunteers could be poor and easily exploited, as ascertained by bioethicist Carl Elliott.
The tragedy in Paris was truly unprecedented. With countless diseases vying for medications, the clinical trial process is vital for innovation. Although lives were lost in this instance, volunteers in clinical trials have saved innumerable of lives throughout history.