Business 616 Week 1
What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U - Business 616 Week 1 introduction. S. and Europe? “New medicines are developed through a series of controlled trials which assess the safety and efficacy of each new medicine by applying high scientific standards” (Pfizer. com). According to the information provided in Pfizer’s website the first step towards getting approval for the sale of an experimental drug is to the test the drug in laboratories that include animal testing.
This stage is referred to “preclinical” testing after which clinical testing begins. These are the mentioned phases of development: Phase 1; This phase does not consider the efficacy of the experimental durg. Human subjects are administered low doses under the supervision of an investigator to determine the “safety and tolerability” of the experimental drug. Normally, healthy individuals take the drug in incremental amounts and researchers measure the participants physical response to the drug. Phase 2: This phase focuses on the effectiveness of the drug on a specific disease or condition.
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Side effects and potential resks are documented as well as adequate doses and the best method of delivery. Thousands of participants are selected from clinics and hospitals worldwide. Phase 3: Larger populations which could number in the thousands are tested once previous tests have proven successful. Participants nor physician-researchers know who has been administered the experimental drug, placebo or other medication. This is the “benefit-risk assessment” phase of the experimental drug. Registration: Once the drug and the experiments have been deemed successful, Pfizer must request permission for distribution.
In the U. S. a New Drug Application (NDA) is filed with the Food and Drug Administration (FDA). In Europe a Market Authorization Application (MAA) is filed with the European Agency for the Evaluation of Medicinal Products (EMEA). Pfizer must disclose the manufacturing process along with trial results and drug safety. Once it has been approved the drug can finally be sold to the public. Phase 4: This final phase is labeled as “post marketing studies,” in which drugs on the market are evaluated for long-term risks and benefits.
This phase could include thousands of users and continue for several years. Did Pfizer behave unethically by rushing to take advantage of an epidemic in Nigeria to test experimental drugs on children? Yes, on the surface it appears that Pfizer made a decision to research this experimental drug in a country that has is known for violating human rights. “Widespread violations of children’s rights take place throughout Nigeria. The combination of high poverty levels, environmental degradation and corruption mean that many children do not enjoy their basic rights” (steppingstonesnigeria. org).
It appears that Pfizer acted unethically by taking advantage of children in a country that is known for violating human rights. “Basic human rights still are not respected in many nations. Rights that we take for granted in developed nations…” (Hill). According to the article the FDA requires parental consent regardless of where in the world the experimental research takes place and this fundamental ethical practice was violated. Pfizer’s methods have come into question because children suffered ill effects and others died as a result of the drug effects. Should it have been less opportunistic and proceeded more carefully?
Yes, it appears that Pfizer’s only objective was to get favorable results in order to get approval for sale of the drug which was estimated to have sales of one-billion dollars per year. Pfizer overlooked its moral obligations and social responsibility in order to meet its financial objectives. “The concept of social responsibility refers to the idea that business people should consider the social consequences of economic actions when making business decisions, and that there should be a presumption in favor of decisions that have both good economic and social consequences” (p. 131).
The fact that children died under dubious circumstances should make Pfizer reconsider the methods of their experimental research. Were corners cut with regard to patient consent in the rush to establish a trial? Did doctors keep patients on Trovan too long when they should have switched them to another medication? Yes, it appears that Pfizer took advantage of desperate Nigerian parents and authorities who gave the go-ahead for the trial experiment. Pfizer researchers insisted in administering Trovan to children even after the drug was not having healing effect on their meningitis.
Pfizer researchers did not take into account side effects such as the onset of arthritis. Their insistence and denial to switching to a proven antibiotic cost some children their lives. One of the causes of unethical behavior is a result of the parent company demanding unrealistic performance goals that can be attained only by cutting corners. (p. 134). 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?
According to Pfizer they apply “high scientific standards” in their drug experiment procedures. It appears that they did the opposite when experimenting on Nigerian children. Their approach was very opportunistic and did not show to be based on any ethical principles. Morals and ethics should be something that applies to all and not just people from someone’s own race or country. According to Hill, businesspeople make the mistake of “applying a straightforward business calculus to what they perceive to be a business decision, forgetting that the decision may also have an important ethical dimension” (p.
133). Pfizer took advantage of the place and situation and they behaved in a manner that they could not have in places such as Europe or the United States. References Hill, C. international business. competing in the global marketplace. (8th edition). McGraw-Hill Irwin. New York, NY No author. (2013). http://www. pfizer. com/research/rd_works/phases_development. jsp. Retrieved March 25, 2013 No author. (2013). http://www. steppingstonesnigeria. org/child-rights. html. Retrieved March 25, 2013