About Careers Internship MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

Pharma Company’s Experimental Drug Trial Turns Fatal in France

by Reshma Anand on January 18, 2016 at 6:25 PM
Font : A-A+

Pharma Company’s Experimental Drug Trial Turns Fatal in France

During a drug trial in France, a man who was left brain-dead after suffering serious side-effects has died, according to the hospital which had been treating him.

Five other volunteers hospitalized a week ago when the drugs trial went wrong were "in a stable condition", the hospital in the western city of Rennes said in a statement.

Advertisement


The private laboratory Biotrial was testing a new pain and mood disorder medication for Portuguese pharmaceutical company Bial on humans for the first time, in what is known as a Phase I trial, to test the drug's safety.

A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses while the rest were given placebos. The six men who were hospitalized, aged 28 to 49, were the group which received the highest dose.
Advertisement

Pierre-Gilles Edan, head of the neurology department at the Rennes hospital said that three of the men were suffering a "handicap that could be irreversible" and another also had neurological problems. The sixth volunteer had no symptoms but was being monitored.

"The 84 other volunteers exposed to the drug" have been contacted, said the hospital. Ten of them came in to be examined and did not have the "anomalies" seen in the hospitalized patients.

The incident is the worst of its kind ever to have taken place in France, which has launched three separate probes to determine whether the tragedy was caused by an error in the trial's procedures or in the substance tested.

Bial is cooperating with the investigation and vows it followed "international best practice" in developing the drug.

"Our principal concern, at the moment, is taking care of participants in the trial," Bial said in a statement.

Biotral said in a statement that it is planning to work with the international scientific community to develop "changes to the standards governing such trials", without giving further details.

The company, which has been carrying out drug trials on behalf of pharmaceutical companies since 1989, said the situation is "even more upsetting given that there is as yet no explanation".

Previous testing, notably on animals, had not thrown up any unusual results.

Damaged for life

Such serious mishaps are rare during the development of a drug, which begins in the laboratory before being animal tested and then three phases of human trials before it can be brought to market.

France's public body ONIAM, which is responsible for compensating the victims of medical accidents, said it had in its files only around 10 cases of accidents during drugs trials over the past 15 years, and "with consequences infinitely less serious" than the case in Rennes. Although a rarity, there have been precedents in other countries.

A comparable accident took place in 2006 in London when six people taking German drug manufacturer TeGenero's TGN1412, which it was developing to treat certain types of cancer and other immunological diseases, fell seriously ill, with one suffering from multiple organ failure.

Two of the volunteers were in a critical condition and one lost all his fingers and toes. The victims said they had the impression that their brains were on fire and that their eyes were coming out of their sockets. Although they all survived, experts said at the time that their immune systems would be damaged for life.

Source: AFP
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
What's New on Medindia
H1N1 Influenza Prevention in Children: What Parents Need to Know
Dietary Factors Responsible for Dihydrotestosterone (DHT) Production and Hair Loss
Test Your Knowledge About Chromosomes?
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Clinical Trials Clinical Trials - The Past and The Future Clinical Trials - Different Phases of the trial Signature Drug Toxicity 

Most Popular on Medindia

Iron Intake Calculator Diaphragmatic Hernia Turmeric Powder - Health Benefits, Uses & Side Effects Indian Medical Journals Sinopril (2mg) (Lacidipine) Selfie Addiction Calculator How to Reduce School Bag Weight - Simple Tips Color Blindness Calculator Pregnancy Confirmation Calculator Accident and Trauma Care
This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use
×

Pharma Company’s Experimental Drug Trial Turns Fatal in France Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests