Biotrial, a French laboratory has been testing a drug created by a Portuguese pharmaceutical, and the drug’s side effects left a patient brain dead. The brain dead patient died on Sunday. The drug being tested was designed to help control pain and mood disorders. Five other people in the drug trial had to be hospitalized last week. Those five drug trial participants are said to be in stable condition.
The drug trial had a total of 108 participants. Out of the 108, 90 participants received the same drug that led to the condition suffered by the brain dead patient. The ages of the five participants who were hospitalized last week and the deceased patient ranged from 28-years-old to 49-years-old. The CEO of the drug company that created this new pain pill, Antonio Portela, commented on the tragic results of the Phase I drug trial.
“On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule.”
The head neurologist of the hospital that treated the patients who had major side effects said that three of the drug trial participants had a “handicap that could be irreversible.”
The other drug trial participants that received the drug were all told of the other participants that experienced the major side effects. Only ten of them went to the hospital to be examined. None of the ten showed any problems related to the drug.
This French drug trial is considered to be the biggest disaster of its kind. Investigations have now been opened in order to determine what exactly caused the major side effects. The investigation is trying to determine if the problems came from the ingredients in the drug or if the procedure used by Biotrial caused the problems.
Medical problems from drug trials are rare. The French National Office for Compensation for Medical Accidents, Iatrogenic Disorders, and Nosocomial Infections (ONIAM) is responsible for compensating patients that acquire bad side effects from drug trials. The ONIAM states that, over the course of 15 years, only 10 people needed to be compensated. Those 10 patients did not have side effects as serious as the five that were hospitalized and the brain dead one who died.
In 2006, a German drug was being tested in London for treatment of different forms of cancer. Some of the participants in that drug trial became dangerously sick from effects of the drug. Doctors who treated these participants have stated that they will have permanent problems with their immune systems.
Drug trials are done in four phases. During the Phase I trial, human patients are selected to receive the drug in order to determine proper dosage and side effects of the drug. Participants are given varying doses of the drug being tested, and they are monitored to see what effects the dose has on the participants. Phase I drug trials normally do not have more than 100 people in their study.
Side effects that lead to permanent injury or death are extremely rare during drug trials. Before the drug gets to the point of human trials, multiple studies and animal testing are done in order to see what happens. The problem lies in the fact that, no matter what results are received after animal trials, humans may have a different reaction.
The deadly effects of this particular drug will be identified after the investigations are completed. It is not yet known if the creators of the drug will modify the ingredients in it and continue the drug trials on it.
Do you think the drug created the problem or the way it was administered in the drug trial?
[Image Via AP Photo/David Vincent]