Pfizer Trials in Nigeria

There are four different phases that a drug company goes through for it to bring a new drug product in the European and American market. The first phase is the phase 0 where drugs are ranked in order to decide which drug has the greatest pharmacokinetic parameters in human beings so that it can be taken forward for further development. The second phase is Phase I where the drug is tested in humans to assess factors such as safety, pharmacokinetics and tolerability of the drugs. Phase II is the third phase where tests are performed on larger groups to asses safety in a bigger group of volunteers and patients, in Phase III there are randomised studies on a larger group aimed at making a definitive assessment of the effectiveness of the drug in comparison with the existing standards (Hill, 2011). The last phase is the post marketing surveillance trial where a drug receives the licence to enter the market especially in Europe and US.

Pfizer behaved unethically by taking advantage of an epidemic in the African Nation of Nigeria and testing an experimental drug on children. The company was very opportunistic and therefore violated the required health and ethical standards by rushing to administer the drugs. The company should have treaded more carefully especially because an epidemic is a very sensitive health issue and had the company progressed more carefully, it would not have violated the ethical standards and the deaths that were caused by the test would have been avoided. The main problem is that Pfizer team kept the children on the drug it was testing (Trovan) even after those children failed to respond to the drug. They should have switched those students to other drugs. Failure to switch them to another drug led to the death of the children. The safety of the oral formulation of Trovan was another ethical issue that arose because health experts feared that there was a high probability of it causing arthritis in the children.

I believe that corners were cut with regard to the consent of patients as Pfizer rushed to conduct these trials. FDA requirements states that a patient or a parent of the patient should give consent before the patients take part in any drug trial in any part of the world. However, in its rush, Pfizer did not follow these FDA requirements because most parents of the children that were affected by the drug did not know that their children were taking part in a trial for an experimental drug (Boseley, 2010). It is unethical for a company to test experimental drugs on children who are undergoing a crisis especially in the developing world where the general standard of health care is lower as compared to the developed world. This is because the company will be forced to take advantage of the vulnerability and the unfortunate situation of this people to appear as if it is helping yet it is pursuing its own selfish agenda. In such a situation, a company may not follow the required protocols and it can end up endangering the lives of the patients just like Pfizer did in Nigeria.

Therefore, Pfizer's experiment was an unethical and illegal trial on a drug that had not been registered and this trial violated the laws of Nigeria, the United Nations Convention on the Rights of the Child and the International declaration that was signed in Helsinki to govern medical research (Stephens, 2006)