Read the following scenario carefully. Then complete the work below.

You have recently completed years of medical trainingundergraduate work, medical school, internships, and residencyand are excited to have gotten a job with Rezip, one of the largest pharmaceutical companies in the world. Based in the United States but operating in 150 countries, Rezip discovers, develops, manufactures, and delivers prescription medicines to patients. Many Rezip drugs make life easier and healthier for millions on a daily basis.

You have been interested in global health since middle school, and chose to focus on infectious diseases during your medical training. It seems unbelievable to you that each year hundreds of thousands of people die from bacterial diseases like meningitis, cholera, and pneumonia, especially in developing countries. Your passion for global health and your new job at Rezip seem like the perfect match. Rezip has developed what it hopes will be a "blockbuster antibiotic" - an antibiotic that would fight a wide range of bacteria and could be taken in tablet form. The drug, called Trovan, is in the late stage of development and so far has been successfully tested on over 5,000 adult patients in the United States, Europe, and elsewhere. The results are very promising, and Rezip anticipates that the drug will receive approval for adult use. However, additional clinical trials with younger patients are needed to prove its effectiveness and safety for children; otherwise the drug will not receive approval for pediatric use. Rezip is sending you to Africa for two weeks to dispense Trovan to children as part of this needed clinical trial. If Trovan proves successful overall, millions of adults and children suffering from a variety of deadly bacterial diseases could be cured easily by taking a few pills. Rezip also projects its total sales could reach over a billion dollars a year as a result.

Drug clinical trials are heavily regulated by the FDA (Food and Drug Administration). In Phase I trials, the drug dosage must be proven to be safe in 20-80 healthy volunteers. Phase II trials then prove effectiveness of the drug in 100-300 patient volunteers sick with the disease the drug will treat. Finally, Phase III trials prove widespread safety and effectiveness of the drug in 1,000-3,000 patient volunteers. Clinical trials must be conducted in target populations - in other words, if the drug will be used on women, it must be tested on women; if the drug will be used on children, it must be tested on children. Certain drugs have been known to affect different populations differently, and therefore the FDA demands rigorous clinical trials on all target populations. In the United States, the full clinical trials cycle can take two to ten years depending on how many people sign up to be in the trial, the way the trials are conducted, and whether the results are decisive.

Your boss tells you that you are going to Nigeria, which is experiencing the most serious meningitis outbreak ever recordedhundreds are dying each month. In the first weeks of the epidemic, only about 80% of those with the disease have survived. Understandably, this presents a severe public health crisis for the government of Nigeria. When you arrive at the Nigerian slum city of Kano, you are overwhelmed by the needs of the peoplemany of whom are childrenand the huge crowds gathered at the Kano Infectious Diseases Hospital.

Nearby, an aid group called Doctors Without Borders has set up a medical station and is dispensing treatments to ease the epidemic. Despite their efforts, the lines at the medical station are overwhelmed with people needing treatment. You and your team have been instructed to set up camp close to the Doctors Without Borders station to aid in the relief efforts and collect data for the clinical research study. As a Rezip doctor, you will choose 200 children with serious symptoms. Half will be given doses of the experimental drug Trovan, while others will be treated with an antibiotic from a rival company for comparison (this rival drug has already gone through standard clinical trials and has been shown to be effective and safe). The children and their families will not know which of the two drugs they are receiving. If Trovan has a very negative effect on the children, the other drug can be administered. Given the chaos of the crowds gathered, it is decided that getting consent from individual families will be impractical, so it is agreed that permission from a Kano ethics committee will serve as consent for everyone. Rezip sought and received permission and consent for the study from a Kano ethics committee made up of local doctors, health officials, and tribal elders. Culturally, tribal elders often represent their communities.

You look around at the malnourished and severely ill children from the slum city raging with meningitis, cholera and measles. These are the children you will dispense medicine to and gather data from for the clinical trial. You have some concerns about how the trial will be conducted.

Questions

1.Write down 7 relevant facts from the story above

2.Write 4 specific questions that you would like to know more about

3.Identify 4 different stakeholders (people/entities affected by the decision). For each stakeholder, identify their concerns as well as the specific bioethical principle/s that would relate to them.

4.Listed here are possible solutions to the identified ethical question. Choose ONE that you will justify.*

a.The trial should not proceed at this time of intense need and the doctors should return to the U.S.

b.The trial should proceed as planned.

c.The trial should proceed only if the families of the children give their fully informed consented to participate in the clinical trial.

d.The trial should proceed under the oversight of the Nigerian government.

e.The trial should proceed but only if Rezip stays in Nigeria for longer than two weeks to offer ongoing medical care for the study participants and their families

5.Using the solution you highlighted above, write a well reasoned justification to support the solution you chose. Be sure to make it a strong justification by making sure you include the following: Your position on this issue The factual content to support your position Ethical principles used to support the position The views and interests of the individuals or groups affected by the decision that you think are most relevant to your position

6.Would you feel differently if you knew the following facts: A) The outcome of the trial: Eleven children died during the drug trialfive of whom had been given Trovan, six of whom had been given the other approved antibiotic. B) Some doubts existed as to the legitimacy of the ethics committee: Some documents suggest that the ethics committee referenced by Rezip was actually set up a year after the doctors conducted the trial. C) Trovan is now banned: The "blockbuster antibiotic" Rezip was testing did not live up to expectations. The European Union later banned the drug and it is no longer in production or for sale. In 4-5 sentences explain how your response would have potentially changed based on the true facts listed above:

Please someone answer this