” In January the phase I study of the drug BIA-10-2474 conducted in Rennes, France, left one initially healthy volunteer dead and three with serious neurological damage, some of which may be permanent.
This was a not unusual phase 1 study of a new wannabe drug and included four substudies:
- single ascending doses,
- multiple ascending doses,
- a food interaction study,
- and some pharmacodynamic testing looking for potential indications.
Dose escalation was based on pharmacokinetic data from animal studies and from the previous series in this phase I study.
The study of single ascending doses took place uneventfully up to the maximum dose of 100 mg. The first four series of multiple ascending doses had no problem up to 20 mg for 10 days. Suddenly, on the fifth day of the fifth series (50 mg daily) one participant developed neurological problems and was admitted to hospital. The next day the other participants received their treatment. Three of the four remaining participants had neurological symptoms and were admitted to hospital. They recovered, some with severe sequelae, but the first participant died. ” …
This recent story reminded me the 1950 tragedy study at the University of Chicago, where every pregnant woman at the University’s Lying-In Hospital (1,646) was a test subject for a DES experiment without their knowledge or consent, and became part of a clinical trial: one-half were randomized to receive DES and the other half received placebos. None of the women were told they were part of a study, nor were they told what drug they were taking. The study found that twice as many of the DES-treated mothers had miscarriages, premature births, small babies, …
Chemicals in broken test tube, Iwan Gabovitch.
… Continue reading Lessons from the fatal French study BIA-10-2474, BMJ 2016;353:i2727, 18 May 2016.
Related Press Releases
- The fatal BIA 10-2474 trial and lessons learned, martinalutter, 20 April 2016.
- BIA 10-2474 saga continues – who knew what and when – and nobody comes out a winner, collabchem, 13 April 2016.
- BIA 10-2474: Expert calls for better pharmacology before protocols are approved, in-pharmatechnologist, 16-Mar-2016.
- A double-blind, randomised, placebo-controlled, combined single and multiple ascending dose study including food interaction, to investigate the safety, tolerability, pharmacokinetic and pharmacodynamie profile of BIA 10-2474, in healthy volunteers, Clinical Study Protocol N° BIA-102474-101.
- Report by the Temporary Specialist Scientific Committee (TSSC), “FAAH (Fatty Acid Amide Hydrolase)”, on the causes of the accident during a Phase 1 clinical trial in Rennes in January 2016 (25/04/2016), ansm.