Gadchiroli trial was a randomized control trial which was conducted in 1993 in Gadchiroli district of Maharashtra, the research group introduced Home Based Neonatal Care to reduce the IMR in that rural area, but the study later on criticized on the ethical issues of procedure of that study.
In this study various ethical issues, international guide lines will be discussed and to understand the topic widely TROVAN trial in Nigeria will also be discussed.
Definition of some words related to this study
Ethics is the activity of man directed to secure the inner perfection of his own personality. By,Albert Schweitzer.
Helsinki declaration: This declaration is a set of ethical principals regarding human experimentation developed for the …show more content…
Over populated, filthy and hot climate was ideal for spread the meningitis.
There was about 15000people died and 1000 of children were permanently disabled due to the disease.
Treatment of Patient and Testing of Trovan at Kano Government Hospital
A NGO named Medicines Fans Frontiers (MFS) provided free treatment for the disease in Kano government hospital.
PFIZER had joined in that hospital to provide the treatment in association with the existing health care providers. The PFIZER team tested a drug called Trovan or Trovafloxesin on about 200 children who were selected for that trial.
But the government hospital and the MSF were using Chloranphenicol for treatment of meningitis on children.
The Post trial Scenario:
Eleven children died due to this trial and others suffered brain damage, some were partly paralyzed or became deaf.
Ethical Issues:
PFIZER conducted that trial without approval from relevant administration.
They did not get any ethical approval from any appropriate authority.
To defend themselves PFIZER dismissed the acquisition and to support the trial they claimed that Trovan decreased the mortality rate to 6%. But in other hand Chloranphenicol lowered the rate to …show more content…
The Placebos can be used in those studies where no proven diagnostic or therapeutic method exists. The most favorable arguments for using of placebos is they are very much economically found, but there is always a controversy about the beneficiary aspect. Some scientist argues for a more controlled and balanced design for the alternative model of scientific research, which is more ethically granted. But these are more time consuming and more