Where are the naysayers who are always trumpeting about "risky" unproven treatments with doctors at stem cell clinics who urge us instead to get into clinical trials?
Drugmaker Unnamed as Botched Trial in France Leaves One Patient Brain Dead and Five Hospitalized
January 15, 2016
By Alex Keown, BioSpace.com
PARIS – A clinical trial in France testing a cannabis-based medication for an undisclosed use has been halted after the experimental drug was linked to serious medical issues with six patients, including one being left brain dead, Reuters reported this morning.
It is not known which company was holding the trial or what use the drug had, although Reuters cited an unnamed source who said the drug was to be used in the treatment of pain, however a report by the BBC refutes this. England’s Independent reported the trial aimed to evaluate the cannabis-based drug for “safety, tolerance and pharmaceutical properties of the molecule” in healthy volunteers. It is unclear how many volunteers were participating in the trial.
England’s GW Pharma (GWPH), which develops a cannabis-based drug to treat spasticity caused by multiple sclerosis told Reuters it was not involved in the trial. The French health ministry said the trial was conducted in a private lab. Agency representatives told Bloomberg they will be conducting an inspection of the trial facility and plan to hold a press briefing later today.
The French health ministry told Reuters the six patients were healthy entering the trial, but fell ill after taking the oral medication. The patients who took the medication have been hospitalized in France. A spokeswoman for the European Medicines Agency in London told Reuters it did not have “full details of the case but that it was monitoring the situation.”
This is not the first time a Phase I trial testing safety of a drug has gone wrong. In an England-based trial, German drugmaker TeGenero AG was testing a drug for the treatment of rheumatoid arthritis and leukemia when six healthy patients suffered organ failure.
TrialScope, a company focused on clinical transparency management, has called for greater transparency in Phase I trials, citing the TeGenero incident as a reason. Thomas Wicks, TrialScope’s chief strategy officer, told BioSpace that a company had conducted a similar trial about 10 years before the TeGenero incident and abandoned it. Wicks said if that information was public, TeGenero may not have attempted to replicate the trial.
There are two medications that contain cannabinoid chemicals in pill form that have been approved by the U.S. Food and Drug Administration. Researchers are investigating the use of cannabinoids for the treatment of several diseases and conditions including HIV/AIDS, multiple sclerosis, Alzhiemer’s disease and pain. California-based Kalytera Therapeutics is developing cannabinoid-based drugs for the treatment of obesity and osteoporosis.
Drugmaker Unnamed as Botched Trial in France Leaves One Patient Brain Dead and Five Hospitalized
January 15, 2016
By Alex Keown, BioSpace.com
PARIS – A clinical trial in France testing a cannabis-based medication for an undisclosed use has been halted after the experimental drug was linked to serious medical issues with six patients, including one being left brain dead, Reuters reported this morning.
It is not known which company was holding the trial or what use the drug had, although Reuters cited an unnamed source who said the drug was to be used in the treatment of pain, however a report by the BBC refutes this. England’s Independent reported the trial aimed to evaluate the cannabis-based drug for “safety, tolerance and pharmaceutical properties of the molecule” in healthy volunteers. It is unclear how many volunteers were participating in the trial.
England’s GW Pharma (GWPH), which develops a cannabis-based drug to treat spasticity caused by multiple sclerosis told Reuters it was not involved in the trial. The French health ministry said the trial was conducted in a private lab. Agency representatives told Bloomberg they will be conducting an inspection of the trial facility and plan to hold a press briefing later today.
The French health ministry told Reuters the six patients were healthy entering the trial, but fell ill after taking the oral medication. The patients who took the medication have been hospitalized in France. A spokeswoman for the European Medicines Agency in London told Reuters it did not have “full details of the case but that it was monitoring the situation.”
This is not the first time a Phase I trial testing safety of a drug has gone wrong. In an England-based trial, German drugmaker TeGenero AG was testing a drug for the treatment of rheumatoid arthritis and leukemia when six healthy patients suffered organ failure.
TrialScope, a company focused on clinical transparency management, has called for greater transparency in Phase I trials, citing the TeGenero incident as a reason. Thomas Wicks, TrialScope’s chief strategy officer, told BioSpace that a company had conducted a similar trial about 10 years before the TeGenero incident and abandoned it. Wicks said if that information was public, TeGenero may not have attempted to replicate the trial.
There are two medications that contain cannabinoid chemicals in pill form that have been approved by the U.S. Food and Drug Administration. Researchers are investigating the use of cannabinoids for the treatment of several diseases and conditions including HIV/AIDS, multiple sclerosis, Alzhiemer’s disease and pain. California-based Kalytera Therapeutics is developing cannabinoid-based drugs for the treatment of obesity and osteoporosis.