What is a phase 3 trial?
A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, phase III clinical trials may compare which group of patients has better survival rates or fewer side effects.
What did Pfizer do in Africa?
An investigation by a panel of experts hired by the Nigerian government found Pfizer at fault in the children’s deaths and guilty of conducting human trials without informed consent. In subsequent years, several lawsuits were filed against Pfizer by parents and the Kano state government.
Who paid the largest criminal crime in history?
Who paid the largest criminal fine in history?
- TEPCO – $450bn (£330bn)
- BP – $64bn (£47bn)
- Bank of America – $16.65bn (£11bn)
- Volkswagen – $14.7bn (£10bn)
- Google – $9.5bn (£7bn)
- Pharmaceuticals – up to $1bn (£720m)
What is Trovan used for?
The TROVAN/ZITHROMAX Compliance Pak refers to a specific dual treatment for uncomplicated urethral gonorrhea in males and endocervical and rectal gonorrhea in females caused by Neisseria gonorrhoeae and non-gonoccocal urethritis/cervicitis caused by Chlamydia trachomatis.
Did Pfizer get fined?
Glaxo’s $3 billion settlement included the largest civil False Claims Act settlement on record, and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine.
Did Pfizer make polio vaccine?
And their widespread use has resulted in the control, elimination, or near-elimination of many infectious diseases that were once pervasive and often fatal. At Pfizer, we have a long history in vaccine research and development, including a pivotal role in the eradication of polio and smallpox.
What is the largest criminal fine in history and why?
Under an out-of-court deal with the US department of justice, a Pfizer subsidiary, Pharmacia & Upjohn, is paying a criminal fine of $1.3bn (nearly £800m), a record in American judicial history.
What class of drug is trovafloxacin?
Trovafloxacin is an antibiotic in the class of drugs called fluoroquinolones. It fights bacteria in the body. Trovafloxacin is used to treat serious infections including pneumonia, complicated abdominal infections, gynecologic and pelvic infections, and skin infections.
How many people are selected for phase trials?
During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1.
How many patients are in a phase 2 trial?
Key points of phase II clinical trials A group of 25 to 100 patients with the same type of cancer get the new treatment in a phase II study. They’re treated using the dose and method found to be the safest and most effective in phase I studies. Usually in a phase II clinical trials, everyone gets the same dose.
Did the Trovan study pass ethical review process in Nigeria?
In the Trovan study, it was established that the clinical trial protocol did not pass through ethical review process in Nigeria. Infact, there was no HREC in the health facility where the children were treated and the Kano State ministry of health had no HREC.
Did Pfizer conduct unethical drug testing in Nigeria in 1996?
HISTORY: The Failed Trovan Drug Trial by Pfizer in Kano that killed and maimed Nigerians/Pfizer unethical drug testing in Nigeria in 1996/unethical clinical trials in Africa. The article was prompted by the highly controversial plan by some French scientists/doctors to start the unethical clinical trial of the COVID-19 vaccine in Africa.
What is the Pfizer Trovan study in Nigeria?
The Pfizer Trovan study in Nigeria. Pfizer brought in a team to conduct a research on its test drug TROVAFLOXACIN (TROVAN) – a quinolone antibiotic. Pfizer recruited a total of 200 children into the study in two arms- one arm had the test drug Trovan orally and the control arm was given Ceftriaxone or Chloramphenicol.
What happened to the Ethical Letter of approval from Nigeria government?
A year later it was found out that the ethical letter of approval from Nigerian government was forged/falsified. The Nigerian government described the clinical trial as “an illegal trial of an unregistered drug.”