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What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U.S. and Europe?
In the US and Europe markets, new drugs are released in the market after a number of trials have been done. This is necessary to asses their efficacy and safety. Phase one revolves around experimental medicine where trials are done to asses the drugs tolerability and safety. As much as the drug might be administered, this is usually done under a lot of supervision.
Phase two revolves around the effectiveness of the drug in relation to the illness (Pfizer, 2011, p. 8). In this case, the effectiveness of the drug in treating the illness is evaluated. This phase is characterized by collecting a lot of information on the drug to see its safety, risks and side effects. As a matter of fact, the best way by which the drug can be administered and the right dosage are evaluated.
Phase three is done on large populations to gauge the effectiveness of the drug. In this case, a large number of participants are chosen to provide a primary basis for the experimental drug. The next step after phase three is registration with the regulatory authority (Pfizer, 2011, p. 5). For instance, the FDA in US and the EMEA in Europe are responsible for registration.
After this has been granted, new medicines can then be sold to patients. A new approval refers to drugs that have been given the green light to be marketed. Phase four revolves around post marketing studies that are occasionally done on a drug after it has been registered.
Did Pfizer behave unethically by rushing to take advantage of an epidemic in Nigeria to test experimental drugs on children?
Pfizer behaved unethically because the drug had not been approved to be administered on 100 children (BBC, 2001, p. 23). The company violated three laws thereby leading to the death of five children. As a matter of fact, children and their parents did not know that they were using an experimental drug.
Should it have been less opportunistic and proceeded more carefully?
There are all indications to show that the company was somehow opportunistic in its moves. It seems that Pfizer did not follow the right step because all the phases were not undertaken (BBC, 2001, p.14). The company took advantage of this epidemic to test its experimental drug and this should have been done more carefully.
Were corners cut with regard to patient consent in the rush to establish a trial?
Corners were cut with regard to patient consent because children and their parents did not know that they were using an experimental drug. It can be well proven that patients did not know that they were using an experimental drug because the company could not prove it.
Did doctors keep patients on Trovan too long when they should have switched them to another medication?
It is quite obvious that patients were kept too long on Trovan. This is because five deaths were reported yet this could have been avoided (BBC, 2001, p. 9). As a matter of fact, some children developed arthritis yet there were other approved drugs at the field hospital that could have been used. This is well elaborated by the fact that Doctors Without Borders were using an approved drug at that place.
Is it ethical to test experimental drugs on children in a crisis setting in the developing world where the overall standard of health care is so much lower than in the developed world and proper protocols might not be followed?
It is not ethical at all to test experimental drugs in a crisis setting because better drugs can be used to avert a crisis. The company could have used the right steps in introducing a new drug unlike what they did (BBC, 2001, p.17). Later on, the drug was approved to be used by adults in USA yet the company was testing the drug with children. This is very unethical of a large multinational that is supposed to uphold ethical standards in its practices.
Reference List
BBC. (2001). Nigerians sue Pfizer over test deaths. Web.
Pfizer. (2011). Phases of Development. Web.
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