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Assignment Read The Time and the Place Case Study below. These are the Stakeholders: You (the doctor) Rezip The children The families of the children Other sick people in Kano The U.S. government The Nigerian government Doctors without Borders Rezip shareholders Other pharmaceutical companies Other doctors employed by Rezip Kano ethics committee Consider if you would feel different if you knew: The outcome of the trial? Eleven children died during the drug trial – five of whom had been given Trovan, six of whom had been given the other approved antibiotic. Families of the children who received Trovan claim that many of them suffered serious side effects from the drug, such as brain damage and organ failure. Rezip claimed that these effects were from the meningitis itself. Rezip claimed that Trovan clearly saved lives since the survival rate from the epidemic went from 80% at the beginning to 94% after the trial. Answer the following questions below: Ethical Decision-Making Framework Ethical Question Facts and Questions Relevant facts (known) Questions that remain (unknown, need to know) Stakeholder Values Stakeholders (people/entities affected by the decision) Values/concerns of each stakeholder Bioethical Principle(s) given priority Generating Options What are some possible options to resolve the ethical question? Make a strong justification paragraph for your decision on the topic. Make sure to answer the following questions while using the evidence (such as the facts and ethical considerations) to support your claim in a way that shows your reasoning. What is your position on this issue? What is the factual content to support your position that can be confirmed or refuted regardless of cultural or personal views? What ethical considerations can be included to support the position? (Respect for Others, Maximize Benefits/Minimize Harms) What are the views and interests of the individuals or groups affected by the decision that you think are most relevant to your position? What are the alternative options and why are they not as strong as your position? The Time and the Place – Case Study You have recently completed years of medical training – undergraduate work, medical school, internships, and residency – and 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 recorded – hundreds 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 people – many of whom are children – and 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, but you also recognize the potential health benefits of the drug. Should Rezip conduct this clinical trial research? This is a fictionalized account of a true story. Contributed by Rosetta Eun Ryong Lee, Seattle Girls’ School.

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