Module 5 Presentations

19/07/2024

Case Study 2 (2)

• Davis v Jacobs

– Claimed over £9M compensation – Investigation of claim revealed evidence of dishonesty and bizarre behaviour after dopamine agonist therapy discontinued – Led to claim treatment / trial had produced permanent brain injury

The Organisation for Professionals in Regulatory Affairs

39

Case Study 3 (1)

• Abdullahi v. Pfizer Inc • Trial of new antibiotic treatment, trovafloxacin, for meningitis conducted in children in Nigeria • Comparator, cephtriazone, administered at dose lower than that approved by FDA (reasons given) • 5 children given trovafloxacin died and 6 given cephtriazone • Letter of approval authorising lead investigator to conduct research later found to be false

The Organisation for Professionals in Regulatory Affairs

40

20